Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd
[2020] FCAFC 116
•3 July 2020
FEDERAL COURT OF AUSTRALIA
Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116
Appeal from: Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28 File number: NSD 182 of 2019 Judges: MIDDLETON, JAGOT, YATES, BEACH AND MOSHINSKY JJ Date of judgment: 3 July 2020 Catchwords: PATENTS – infringement – Swiss type claims – whether mental element imported into claims – whether it is necessary to establish manufacturer’s intention to prove infringement – discussion of correct approach to determining infringement
PATENTS – validity – lack of novelty – prior publication of documents – correct test for determining lack of novelty – whether there can be anticipatory disclosure by prior publication of the invention based on a reasoned hypothesis
PATENTS – validity – lack of inventive step – where case presented on basis of common general knowledge and documentary disclosure – whether primary judge erred in finding lack of inventive step on basis of common general knowledge alone
PATENTS – validity – whether claims fairly based on the matter described in the specification – proper construction of the specification
Legislation: Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)
Patents Act 1990 (Cth) ss 7(1)(a), 7(1)(b), 7(2), 7(3), 13(1), 40(3), 117(1), 117(2)(b)
Therapeutic Goods Act 1989 (Cth) s 9D(2)
Patents Act 1977 (UK) ss 125(1), 125(3)
European Patent Convention 2000
Cases cited: Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411
Aldi Foods Pty Ltd v Moroccanoil Israel Ltd [2018] FCAFC 93; 133 IPR 375
Apotex Pty Ltd v Sanofi-Aventis [2008] FCA 1194; 78 IPR 485
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50; 253 CLR 284
Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) [2016] FCA 1238; 122 IPR 17
AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; 226 FCR 324
Branir Pty Ltd v Owston Nominees (No 2) Pty Ltd [2001] FCA 1833; 117 FCR 424
Bristol-Myers Squibb Company v FH Faulding & Company Limited [2000]FCA 316; 97 FCR 524
Bristol-Myers Squibb Co v FH Faulding & Co Ltd (1998) 41 IPR 467
Flour Oxidizing Company Ltd v Carr & Company Ltd (1908) 25 RPC 428
General Tire & Rubber Co Ltd v Firestone Tyre & Rubber Co Ltd [1972] RPC 457
Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73; 222 FCR 336
Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2018] FCAFC 183; 267 FCR 428
Generics (UK) v Warner-Lambert Company LLC [2018] UKSC 56; [2018] RPC 21
Hill v Evans (1862) 31 LJ Ch 456; 4 De GF & J 288; 45 ER 1195
Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat)
Hospira UK Limited v Genentech Inc [2015] EWHC 1796 (Pat); [2016] RPC 1
ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc [2000] FCA 1349; 106 FCR 214
InterPharma Pty Ltd v Hospira, Inc (No 5) [2019] FCA 960; 149 IPR 182
Lockwood Security Products Pty Limited v Doric Products Pty Ltd (No 1) [2004] HCA 58; 217 CLR 274
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; 235 CLR 173
Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91; 154 FCR 31
Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228
Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253
Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia PtyLtd) [2019] FCA 28; 138 IPR 402
Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd (No 2) [2019] FCA 505; 141 IPR 26
Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513
Optical 88 Ltd v Optical 88 Pty Ltd [2011] FCAFC 130; 197 FCR 67
Otsuka Pharmaceutical Co. Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634; 113 IPR 191
Raleigh Cycle Co Ltd v H Miller & Co Ltd [No 1] (1946) 63 RPC 113
Regeneron Pharmaceuticals Inc v Genentech Inc [2012] EWHC 657 (Pat)
Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132; (2011) 119 IPR 194
Warner-Lambert Company LLC v Apotex Pty Ltd (No 2) [2018] FCAFC 26; 129 IPR 205
Date of hearing: 5-7 February 2020 Date of last submissions: 3 March 2020 Registry: New South Wales Division: General Division National Practice Area: Intellectual Property Sub-area: Patents and associated Statutes Category: Catchwords Number of paragraphs: 588 Counsel for the Appellants: Mr B Caine QC with Mr T Cordiner QC and Mr J Cooke Solicitor for the Appellants: Minter Ellison Counsel for the First Respondent: Mr N Murray SC with Ms C Cunliffe Solicitor for the First Respondent: Ashurst Australia Counsel for the Second Respondent: The second respondent filed a submitting notice ORDERS
NSD 182 of 2019 BETWEEN: MYLAN HEALTH PTY LTD
First Appellant
BGP PRODUCTS OPERATIONS GMBH
Second Appellant
AND: SUN PHARMA ANZ PTY LTD
First Respondent
ALKERMES PHARMA IRELAND LIMITED
Second Respondent
JUDGES:
MIDDLETON, JAGOT, YATES, BEACH AND MOSHINSKY JJ
DATE OF ORDER:
3 JULY 2020
THE COURT ORDERS THAT:
1.The appeal be dismissed.
2.The first respondent’s notice of contention be dismissed.
3.The appellants pay the first respondent’s costs.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
REASONS FOR JUDGMENT
INTRODUCTION
[1]
Some Medical Conditions
[16]
The 711 patent: Background
[32]
The complete specification
[32]
Relevant claims
[37]
The 711 Patent: Prior art
[44]
The ACCORD Eye Study Protocol
[44]
ETDRS 22
[51]
The 711 patent: Grounds 5 – 7
[59]
The primary judge’s reasons
[59]
The appeal
[66]
Discussion
[73]
The 711 patent: Grounds 10 – 15
[112]
The primary judge’s reasons
[112]
The appeal
[123]
Discussion
[143]
The 711 Patent: Grounds 1 – 4
[175]
The primary judge’s reasons
[175]
The appeal
[185]
Discussion
[193]
The 711 patent: notice of contention
[232]
The 807 patent: background
[237]
Introduction
[237]
The complete specification
[249]
Relevant claims
[302]
The 807 Patent: Section 7(3) Information
[312]
The 807 patent: Grounds 33 – 35; 38
[337]
Introduction
[337]
The primary judge’s findings – common general knowledge
[346]
The appeal
[360]
Discussion
[373]
The 807 patent: Ground 36
[404]
The primary judge’s reasons
[405]
The appeal
[410]
Discussion
[419]
The 807 patent: Ground 37
[434]
The primary judge’s reasons
[435]
The appeal
[454]
Discussion
[461]
The 807 patent: Grounds 39 – 42
[492]
The appeal
[492]
Discussion
[502]
The 807 Patent: notice of contention
[515]
The primary judge’s reasons
[518]
Discussion
[529]
The 964 patent: background
[551]
The issue
[551]
Claims 12 and 13
[552]
The specification
[554]
The 964 patent: Grounds 22 - 25
[563]
The primary judge’s reasons
[563]
The appeal
[571]
Discussion
[582]
Conclusion and disposition
[588]
THE COURT:
INTRODUCTION
The appellants, Mylan Health Pty Ltd (Mylan Health) and BGP Products Operations GmbH (BGP), unsuccessfully sued the first respondent, Sun Pharma ANZ Pty Ltd (Sun Pharma), for threatened patent infringement: Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28; 138 IPR 402. Mylan Health and BGP are related entities. We will refer to them as a single entity (Mylan), unless it is necessary to distinguish between them.
Three patents were in suit. The first was Patent No. 2006313711 (the 711 patent), the complete specification of which is entitled “Use of fenofibrate or a derivative thereof for preventing diabetic retinopathy”. The second was Patent No. 2003301807 (the 807 patent), the complete specification of which is entitled “Nanoparticulate fibrate formulations”. The third was Patent No. 731964 (the 964 patent), the complete specification of which is entitled “Pharmaceutical composition of fenofibrate with high biological availability and method for preparing same”.
BGP is the patentee, and Mylan Health is the exclusive licensee, of the 711 patent and the 964 patent. BGP is also the co-patentee of the 807 patent. The other co-patentee is the second respondent in this appeal, Alkermes Pharma Ireland Ltd. Mylan Health is a licensee of the 807 patent.
Fenofibrate is a fibric acid derivative (or fibrate) that is used to regulate lipoproteins and triglycerides in the blood. It is also used to treat diabetic retinopathy. The knowledge that fenofibrate is useful to treat diabetic retinopathy is more recent than the knowledge that fenofibrate is useful to regulate lipoproteins and triglycerides in the blood. The 711 patent is concerned with the second, and later-discovered, medical use of fenofibrate as a known active pharmaceutical ingredient.
At the time of the primary proceeding, Lipidil was the only fenofibrate product on the Australian market. It had been on the market since August 2006. Since February 2015, Mylan Health has marketed and sold Lipidil into that market.
Mylan sued Sun Pharma because, on 29 February 2016, Sun Pharma obtained entry on the Australian Register of Therapeutic Goods (ARTG) of certain fenofibrate film-coated tablets, which it proposed to market and supply in Australia. The primary judge described these products as the Ranbaxy Products. We will do likewise.
The primary judge dismissed Mylan’s case on threatened infringement. With regard to the 711 patent, his Honour found that the claims in suit (some of which are Swiss type claims and some of which are method of treatment claims) were invalid on the ground that the invention, as claimed, was not novel in light of the publication of The ACCORD Eye Study Protocol: Version January 2004 (the ACCORD Protocol). His Honour also found that the invention, as claimed in the relevant claims, lacked an inventive step.
For completeness, we note that the primary judge found that some of the claims in suit were not novel in light of the publication of European Patent Application EP D 482 498A, when read with the Physicians’ Desk Reference, 59th Edition 2005 at pages 523 – 525 and 1325 – 1328. No appeal is pursued in respect of that finding.
We also note that the primary judge rejected Sun Pharma’s case that the claims in suit were not novel having regard to the conduct of the study to which the ACCORD Protocol was directed (the ACCORD Study) and another study called the FIELD Study.
Aside from his findings on validity, the primary judge found that Mylan had not established that there was a threatened infringement of the Swiss type claims in any event. In essence, his Honour found that claims in this form imported a purposive element which, in order to establish infringement or threatened infringement, require proof of the manufacturer’s intention when making the medicament. In this case, the intention to be proved was use of the Ranbaxy Products for the prevention or treatment of diabetic retinopathy. The primary judge was not satisfied that Mylan had proved that intention.
Finally, with respect to the method of treatment claims in respect of which threatened infringement would have been established had the claims been valid, the primary judge said that he would not have granted quia timet injunctive relief, as sought.
With regard to the 807 patent, his Honour found that the claims in suit were invalid on the ground that the invention, as claimed, lacked an inventive step. The primary judge was not in a position to make any finding as to whether these claims would have been infringed had they been valid. This was because it had been recognised prior to the hearing that extensive experimental evidence would need to be adduced on that question. Therefore, as a matter of case management, the question of infringement was deferred until after the determination of other issues in the proceeding, including the validity of those claims.
With regard to the 964 patent, his Honour found that some of the claims in suit were invalid. As to the other claims in suit, he was not satisfied that Mylan had established its case on threatened infringement.
After judgment had been given dismissing Mylan’s case on threatened infringement, Mylan moved the Court for interim injunctive relief to restrain Sun Pharma from marketing and supplying the Ranbaxy Products in Australia pending the determination of this appeal. A hearing was conducted on 4 April 2019. The application for interim relief was dismissed on 11 April 2019: Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd (No 2) [2019] FCA 505; 141 IPR 26.
For the reasons which follow, the appeal should be dismissed, with costs.
Some Medical Conditions
The 711 patent is concerned with the second medical use of fenofibrate as an active pharmaceutical ingredient. In his reasons for judgment, the primary judge discussed various medical conditions and their treatment. Knowledge of these matters was necessary to understand the 711 patent and the evidence given in respect of it. For the purposes of this appeal, it is not necessary for us to summarise all his Honour’s findings in this regard. It will suffice for us to note some of the key findings, none of which are controversial.
Dyslipidaemia is a condition in which a patient presents with abnormal levels of lipids (fats) in the body, specifically cholesterol and triglycerides.
Cholesterol is insoluble in blood and exists as one of the following complexes: (a) very low density lipoprotein cholesterol (VLDL-C); (b) low-density lipoprotein cholesterol (LDL-C); and (c) high density lipoprotein cholesterol (HDL-C).
VLDL-C is the form in which cholesterol is secreted from the liver, where most cholesterol is made. As it enters the bloodstream, it is converted into LDL-C, which transports the cholesterol around the body. HDL-C (so-called “good cholesterol”) transports cholesterol present in the body back to the liver, to remove it from circulation. A patient’s total cholesterol is the sum of these complexes.
Triglycerides are principally used for energy. A large proportion of dietary fat is transported around the body in the form of triglycerides.
A patient will have dyslipidaemia (abnormal lipid levels) or hyperlipidaemia (elevated lipid levels) if he or she has: (a) elevated LDL-C levels; (b) elevated triglyceride levels; and/or (c) low HDL-C levels. Elevated triglycerides coupled with reduced levels of HDL-C are a hallmark of a condition sometimes called diabetic dyslipidaemia.
Statins have been the primary drug treatment for patients with elevated total cholesterol and LDL-C levels. For patients with elevated triglyceride levels and/or low HDL-C levels, fibrates are a primary drug treatment.
Fenofibrate is a fibrate which became available in Australia in late 2004. As we have noted, at the time of the primary proceeding, Lipidil was the only fenofibrate product on the Australian market.
As at 10 November 2005, fenofibrate was also an effective cholesterol-lowering agent that was approved for use in Australia for the treatment of hypercholesterolaemia. It was believed to be more effective at lowering cholesterol than other fibrates available at the time. However, fibrates, including fenofibrate, were not prescribed for the treatment of hypercholesterolaemia if target lipid levels could be achieved by the use of a statin, unless there was some other reason (such as side-effects) why a patient’s elevated lipid levels could not be treated by statins.
Diabetes mellitus (diabetes) is an endocrine (or hormonal) disorder characterised by an absolute or relative deficiency of insulin. Insulin is a hormone produced in the pancreas. It is responsible for regulating glucose metabolism in the body. Patients with diabetes are at risk of developing a wide variety of acute and long-term complications including macrovascular complications, such as coronary artery disease (leading to heart attack), cerebrovascular disease (leading to strokes), peripheral vascular disease (leading to infection or gangrene), microvascular complications (including diabetic retinopathy), diabetic nephropathy (kidney disease) and diabetic neuropathy (nerve damage).
There are two forms of diabetes. Type 1 diabetes is most often diagnosed in children and young adults, although it can present at any stage of life. It is an autoimmune condition. In affected patients, there is a progressive destruction of the cells in the pancreas that are responsible for insulin synthesis and release. Patients affected by type 1 diabetes may present with a range of symptoms and signs, including fatigue, increased thirst, increased urine production, weight loss, increased appetite and dehydration. In some cases, patients affected by type 1 diabetes may develop life-threatening acute complications, such as the metabolic disturbance known as diabetic ketoacidosis.
Type 2 diabetes is the more common form of diabetes in Western countries. Affected patients suffer from insulin resistance, whereby insulin is less efficient in transporting glucose from the blood stream into cells. To exert its normal biological action, insulin must attach to specific receptors on the surface membranes of cells. With insulin resistance, there is typically a reduction in the number of these receptors, as well as a reduction in the affinity (or attraction) between insulin and the receptors. In the initial stages of type 2 diabetes, the body responds to insulin resistance by increasing the production of insulin in the pancreas, leading to an increase in the levels of insulin circulating in the blood (hyperinsulinaemia). Blood glucose levels typically remain within the normal range, but as the disease progresses, blood glucose levels rise. Over the longer term, insulin production typically declines to such an extent that insulin deficiency develops and insulin therapy is required to normalise blood glucose levels.
Diabetic retinopathy is a disease of the retina related to increasing changes to the blood vessels in the retina. It is a long-term complication associated with diabetes. The first stage of the development of retinopathy is non-proliferative retinopathy, which is characterised by lesions in the form of microaneurysms (macular swelling across the course of a retinal capillary), and then haemorrhages (which may indicate blood vessel leakage), in the retina. Both of these lesions occur in the capillary bed of the retina. The early signs of retinopathy generally do not affect vision, unless the macula is affected.
Macular oedema is the most frequent cause of vision loss in people with diabetic retinopathy. It is caused when capillaries (small blood vessels) in the retina close to the macula become occluded (closed or non-perfused), resulting in reduced flow through them. In response, adjacent capillaries start to leak fluid (oedema) into the retina. The macula is structured so that all of the supporting cells are aligned to give a maximum light signal to the cones at the base of the macula, which means that it can accumulate fluid easily, leading to swelling and damage to the macula. Because of its importance in providing sharp vision, the macula is critical to vision function. It should be noted that oedema can also occur at other parts of the retina, away from the macula. This generally does not need to be treated unless it threatens the macula.
In addition to the damage caused by swelling as a result of oedema, the leakage of fluid from the bloodstream into the retina can result in the formation of small deposits of lipid and other materials in the retina. These small deposits are called hard exudates. Hard exudates can form at any stage of diabetic retinopathy, as a result of fluid leakage from the retinal capillary bed. Hard exudates tend to occur in the outer part of the retina and, in most patients, close to, or involving, the macula. Hard exudate deposition is damaging when it occurs at the macula because it can cause irreversible structural changes to the macula within a period of months and, if present for a long time, will result in permanent vision loss.
Persistently elevated (poorly controlled) blood glucose levels (hyperglycaemia) is the primary risk factor for diabetic retinopathy. The longer a patient has had diabetes, the more likely it is that diabetic retinopathy will develop.
The 711 patent: Background
The complete specification
The complete specification of the 711 patent describes the invention as relating to “the use of fenofibrate or a derivative thereof for the manufacture of the medicament for the prevention and/or treatment of retinopathy”. At p 1 lines 29 to 36 and p 2 lines 1 to 5 of the specification, it describes diabetic retinopathy as a specific microvascular complication of both type 1 and type 2 diabetes, and one of its most debilitating complications:
Diabetic retinopathy is a progressive diabetic complication. It advances from a stage referred to as “simple” or initial (background retinopathy) to a final stage referred to as “proliferative retinopathy” in which there is formation of fragile retinal neovessels, leading to severe haemorrhages, sometimes with detachment of the retina, and to loss of vision. The microvascular lesions in simple retinopathy are characterised by microaneurysms, small petechial haemorrhages, exudates and venous dilations. This simple retinopathy form can remain clinically silent for a long period of time. At this simple retinopathy stage cellular and structural deterioration of the retinal capillary can be observed in the post-mortem examinations of retinas from diabetic patients, compared to the retinas from normal subjects of comparable age. If proliferative retinopathy is left untreated, about half of those who have it will become blind within five years, compared to just 5% of those who receive treatment.
After briefly referring to the treatment of diabetic retinopathy with laser photocoagulation, the complete specification continues at p 2 lines 25 to 36:
Preventing the development or progression of diabetic retinopathy has the potential to save vision at a relatively low cost compared to the costs associated with a loss of vision. Thus, it is an object of the present invention to provide further means which contribute to the prevention of the development or progression of diabetic retinopathy.
The present invention is based on the discovery that patients taking fenofibrate or a derivative thereof need fewer treatment[s] by retinal laser therapy than placebo-allocated patients. The results obtained from a large clinical trial demonstrate the favourable effect of fenofibrate in the prevention of retinopathy.
According to a first aspect, the present invention is directed to the use of fenofibrate or a derivative thereof for the manufacture of a medicament for the prevention and/or treatment of retinopathy, in particular diabetic retinopathy.
The complete specification uses “prevention” to mean preventing the development or progression of diabetic retinopathy: p 3 lines 1 to 2. It refers to “diabetic retinopathy” as severe non-proliferative grades of diabetic retinopathy, proliferative grades of diabetic retinopathy, macular oedema, and hard exudates: p 3 lines 3 to 5.
The complete specification provides certain pharmacological data, including from the FIELD Study at p 8 lines 21 to 35 and p 9 lines 1 to 2:
As fibrates are known to correct the typical dyslipidaemia of diabetes, their role in cardiovascular risk reduction in diabetes may be especially important. A study called Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) has been carried out which study is a multicentre, double-blind, placebo-controlled [trial] evaluating the effects on coronary morbidity and mortality of long-term treatment with fenofibrate to elevate high-density lipoprotein (HDL) cholesterol levels and lower triglyceride (TG) levels in patients with type 2 diabetes and total blood cholesterol between 3 and 6.5 mmol/L (115 and 250 mg/dL) at study entry. In type 2 diabetes, rates of coronary heart disease (CDH) are 3 to 4 times higher than those of persons without diabetes at any given level of blood cholesterol, and at any given age. Evidence also suggests that in women with diabetes, the natural protection against CDH afforded by sex may be lost. Further, people with type 2 diabetes have both higher in-hospital mortality after myocardial infarction (MI) and a poorer outcome in the subsequent years, losing on average between 5 and 10 years of life expectancy. It follows the type 2 diabetes contributes significantly to the overall burden of premature CHD morbidity and mortality, far in excess of its prevalence in the community.
The complete specification describes the FIELD Study as having principal, secondary and tertiary outcomes. The principal study outcome was the combined incidence of first non-fatal myocardial infarction or coronary heart disease death among all randomised patients during the schedule treatment period. Secondary outcomes included the effects of fenofibrate on major cardiovascular events. Tertiary outcomes included the effects of treatment by fenofibrate on the development of vascular and neuropathic amputations, non-fatal cancers, the progression of renal disease, hospitalisation for angina pectoris and, importantly to the present case, laser treatment for diabetic retinopathy. In relation to the results concerning the effects of fenofibrate on laser treatment for diabetic retinopathy, the complete specification discloses at p 14 lines 23 to 27:
These results provide the first evidence of the favourable effect of fenofibrate on the need for retinal laser therapy. As the patients taking fenofibrate had fewer treatment for retinal laser therapy than the placebo-allocated patients, the prevention and treatment of retinopathy by fenofibrate has been clearly demonstrated.
Relevant claims
Claim 1 of the 711 patent is:
1.Use of fenofibrate or a derivative thereof for the manufacture of a medicament for the prevention and/or treatment of retinopathy, in particular diabetic retinopathy.
Claim 5 is:
5.Use according to any of claims 1 to 4, wherein said medicament contains 200 mg, 160 mg, 145 mg or 130 mg of fenofibrate or a derivative thereof.
Claim 7 is:
7.A method for the prevention and/or treatment of retinopathy, the method comprising administration of fenofibrate or a derivative thereof to a patient in need thereof.
Claims 10 and 11 are:
10.The method according to any one of claims 7 to 9 wherein said method further comprises administration of a statin.
11.The method according to any one of claims 7 to 10 wherein 200 mg, 160 mg, 145 mg or 130 mg of fenofibrate or a derivative thereof is administered.
The priority date of the claims is 10 November 2005.
Claims 1 and 5 are Swiss type claims. At trial, Mylan also sued on these claims and another Swiss type claim—claim 6. Only claim 5 is relevant to this appeal.
Claims 7 and 10 - 11 are method of treatment claims. At trial, Mylan sued on these claims and another method of treatment claim—claim 12. Mylan’s case on the threatened infringement of these claims relied on the application of s 117(1) read with s 117(2)(b) of the Patents Act 1990 (Cth) (the Act). Only claims 10 and 11 are relevant to this appeal.
The 711 Patent: Prior art
The ACCORD Eye Study Protocol
ACCORD is the acronym for The Action to Control Cardiovascular Risk in Diabetes. The ACCORD Trial was a randomised clinical trial on cardiovascular disease in patients with type 2 diabetes. It had three components—namely, determining the effects of (1) lowering blood glucose; (2) lowering blood pressure; and (3) lowering serum triglycerides plus raising serum HDL-C levels, in those patients. The ACCORD Study was conducted within the ACCORD Trial. It was designed to evaluate the effects of treatment on diabetic retinopathy.
In a section dealing with diabetic retinopathy, the ACCORD Protocol referred to various data, including data obtained from a study which the Protocol called “ETDRS” (Early Treatment Diabetic Retinopathy Study Report No 18) (ETDRS 18). In that regard, the ACCORD Protocol stated:
The ETDRS study has shown a relationship between progression to high risk proliferative DR over 5 years and baseline serum triglycerides in the age group 50 – 69. Progression was 23% higher in those with serum triglycerides > 190mg/dl versus those whose serum triglycerides were normal, after adjustment for 11 significant covariates.
The ACCORD Protocol then stated:
It is therefore reasonable to hypothesize that fibrate therapy which decreases serum triglycerides will reduce the risk of DR.
The ACCORD Protocol identified four aims for the ACCORD Study, the second of which was:
2.In type 2 diabetic patients whose low density lipoprotein cholesterol levels have been reduced appropriately by statin therapy, will the additional fibrate therapy, to reduce triglyceride levels and raise high density lipoprotein cholesterol levels, decrease the risk of DR?
The ACCORD Protocol referred to three primary hypotheses for the ACCORD Study in relation to middle-aged or older people with type 2 diabetes at high risk for having a cardiovascular event. One of those hypotheses was:
2.In the context of good glycaemic control, a therapeutic strategy that uses a fibrate to lower triglyceride levels and raise HDL cholesterol levels in patients already receiving a statin drug for treatment of LDL cholesterol levels, will reduce the rate of development or progression of DR compared to a strategy that only uses a statin drug for treatment of LDL cholesterol levels.
Thus, the ACCORD Protocol envisaged that, for patients having good glycaemic control, and having already received a statin to reduce LDL-C, a fibrate would be administered to lower triglyceride levels and raise HDL-C levels. The hypothesis was that the administration of the fibrate will reduce the rate of development or progression of diabetic retinopathy compared to a strategy that only used a statin for the treatment of LDL-C levels.
The ACCORD Protocol is relevant to Grounds 5 – 7 of the appeal concerning the primary judge’s finding that the claims in suit of the 711 patent were invalid on the ground that the invention, as claimed, was not novel.
ETDRS 22
The Early Treatment Diabetic Retinopathy Study Report 22 (ETDRS 22) was an observational study undertaken as part of a larger clinical trial. The larger clinical trial was designed to evaluate the effect of photocoagulation and aspirin therapy in patients with mild to severe non-proliferative or early proliferative diabetic retinopathy. The data provided in the larger clinical trial provided an opportunity to assess the relationship between baseline serum lipid levels and the presence of retinal hard exudates at baseline, as well as the development of retinal hard exudates during follow-up in patients who had no evidence of hard exudates at baseline. This was the subject of ETDRS 22, the stated objective of which was:
To evaluate the relationship between serum lipid levels, retinal hard exudate, and visual acuity in patients with diabetic retinopathy.
In an introductory paragraph, the authors of ETDRS 22 stated:
Retinal hard exudate is thought to be the result of lipoproteins “leaking” from retinal capillaries into the extracellular space of the retina. The relationship of serum cholesterol level to the severity of retinal hard exudate has previously been assessed in the Wisconsin Epidemiologic Study of Diabetic Retinopathy, a population-based study. These investigators found that elevated levels of serum cholesterol were associated with increased severity of retinal hard exudate in this cross-sectional evaluation of persons with diabetes mellitus.
The authors went on to describe the Early Treatment Diabetic Retinopathy Study. They recorded the fact that fasting serum lipid levels were measured at baseline (at the commencement of the study) with total serum cholesterol, LDL-C, HDL-C, and triglycerides separately evaluated for association with the presence of hard exudates. The authors found that only total cholesterol and LDL-C levels were statistically significantly associated with the presence of hard exudates at baseline. Based on stereoscopic photographs of the fundus taken at baseline, four months, and then annually for a seven-year follow-up period, the authors found that increased total cholesterol and triglyceride levels were associated with a more rapid onset of obvious retinal hard exudate:
Patients with total serum cholesterol levels of 6.21 mmol/L (240 mg/dL) or more, or triglyceride levels greater than 4.50 mmol/L (399 mg/dL), developed hard exudate approximately 50% faster than patients in the ETDRS with serum cholesterol levels less than 5.17 mmol/L (200 mg/dL) or triglyceride levels less than 2.30mmol/L (204 mg/dL) … Increased levels of LDLC also resulted in a similarly shortened time to the development of retinal hard exudate …
The authors of ETDRS 22 concluded that the data demonstrated that elevated serum lipid levels were associated with an increased risk of retinal hard exudates in persons with diabetic retinopathy and that lipid lowering may decrease the risk of hard exudate formation and associated vision loss in patients with diabetic retinopathy. Specifically, the authors stated:
… Because lipid lowering is currently the standard of care for persons with elevated serum lipid levels, either with or without diabetes mellitus, a clinical trial designed to evaluate the effects of lipid lowering on retinal hard exudates or visual acuity is unlikely. However, long-term observational data from the ETDRS can provide important information on the association of lipids with both retinal hard exudate and change in visual acuity.
In the ETDRS, the patients who had elevated serum total cholesterol or LDLC levels were more likely to have retinal hard exudate at baseline. In addition, patients with elevated serum total cholesterol, LDLC, or triglyceride levels, who did not have obvious retinal hard exudate at baseline, were at increased risk of developing retinal hard exudate during follow-up. These associations, along with the finding that the severity of hard exudate is associated with the risk of visual loss even after adjusting for the extent of macular oedema, may have important clinical implications.
Lipid-lowering treatment is currently recommended by the National Heart, Lung, and Blood Institute, National Institutes of Health, for patients who are at high risk of cardiovascular disease. Although our data are observational, they suggest that a reduction of elevated serum lipid levels may help prevent vision loss associated with retinal hard exudate. Preservation of vision may be an additional motivating factor for lowering serum lipid levels in persons with diabetes in whom they are elevated.
As expressed in the abstract to ETDRS 22:
These data demonstrate that elevated serum lipid levels are associated with an increased risk of retinal hard exudate in persons with diabetic retinopathy. Although retinal hard exudate usually accompanies diabetic macular edema, increasing amount of exudate appear to be independently associated with an increased risk of visual impairment. Lowering elevated serum lipid levels has been shown to decrease the risk of cardiovascular morbidity. The observational data from the Early Treatment Diabetic Retinopathy Study suggest that lipid lowering may also decrease the risk of hard exudate formation and associated vision loss in patients with diabetic retinopathy. Preservation of vision may be an additional motivating factor for lowering serum lipid levels in persons with diabetic retinopathy and elevated serum lipid levels.
It should be noted that ETDRS 22 did not itself demonstrate the effect of using lipid-lowering agents on retinal hard exudates or demonstrate a causative link between serum lipid levels and the development or progression of hard exudates. It did, however, make the association, and proffered the suggestion, quoted above, that lipid-lowering may decrease the risk of hard exudate formation and associated vision loss in patients with diabetic retinopathy.
ETDRS 22 is relevant to Grounds 10 – 15 of the appeal. It was central to the primary judge’s finding that the invention as claimed lacks an inventive step. His Honour was satisfied that ETDRS 22 was common general knowledge in that it would have formed part of a consulting ophthalmologist’s background knowledge as at 10 November 2005, the priority date of the claims in suit.
We mention ETDRS 22 in this part of our reasons because his Honour also found that, if he was wrong in his conclusion that ETDRS 22 was common general knowledge, he was nonetheless satisfied that it was prior art information which, for the purposes of s 7(3) of the Act, the person skilled in the art, as at 10 November 2005, would have ascertained, understood and regarded as relevant.
The 711 patent: Grounds 5 – 7
The primary judge’s reasons
The primary judge found that the claims in suit of the 711 patent were invalid on the ground that the invention, as claimed, was not novel in light of the publication of the ACCORD Protocol. He rejected Sun Pharma’s case that the claims were not novel having regard to the conduct of the ACCORD Study and the FIELD Study. Grounds 5 – 7 concern Mylan’s appeal in relation to the primary judge’s findings on lack of novelty in light of the prior publication of the ACCORD Protocol. As pressed, only claims 5, 10 and 11 are relevant to these grounds.
The primary judge commenced his consideration of the question of lack of novelty by referring to a number of the leading cases on that question. His consideration included AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; 226 FCR 324 (AstraZeneca v Apotex) which included reference to Bristol-Myers Squibb Company v FH Faulding & Company Limited [2000] FCA 316; 97 FCR 524 (BMS v Faulding), and Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91; 154 FCR 31 (Merck v Arrow). We mention BMS v Faulding and Merck v Arrow in particular because both cases featured prominently in Mylan’s submissions on appeal.
The primary judge analysed the ACCORD Protocol which, he found, had been made publicly available before the priority date of the claims in suit. There is no appeal from that finding. The primary judge noted the aim and the hypothesis, which we have quoted at [47] and [48] respectively, and recorded Mylan’s submission that the ACCORD Protocol did no more than articulate an hypothesis which may or may not be correct.
In that latter connection, the primary judge said:
160In support of their submission the applicants referred to the evidence of Professor O’Brien and Professor Mitchell who said that on a reading of the Protocol as a whole, they would not have been directed to use fenofibrate in the prevention or treatment of retinopathy. This is because, as I understood their evidence, neither regarded the hypothesis articulated in the Protocol as likely to produce to a positive result. Professor O’Brien said that he would not have been confident that lipid lowering therapy could reduce the risk of microvascular complications such as diabetic retinopathy. He said that he would not have prescribed fenofibrate for that purpose even if he was aware of the Protocol prior to November 2005 and would have awaited the outcome of the Eye Study before considering the use of fenofibrate therapy in patients with diabetic retinopathy. Professor Mitchell’s evidence was to a similar effect.
161I think this evidence is answered by the Full Court’s observation in Bristol-Myers at [72]:
Prudent practitioners might well take the view that they would prefer to await the final outcome of the trials, both as to efficacy and as to safety, before rushing to embrace the proposed method. But, in our view, there can be no serious doubt that the abstract teaches the [invention].
The primary judge then made the following findings:
162In my view the Protocol suggested to the skilled addressee who read it prior to November 2005 that fenofibrate could be used in daily doses of 160 mg for the prevention and treatment of diabetic retinopathy. The fact that Professor O’Brien and Professor Mitchell would not have acted on this suggestion, preferring instead to await the outcome of clinical trials, is no answer to the proposition that the Protocol discloses the precise method of treatment that was later claimed. Nor is it an answer to say that the disclosure was made in the context of a proposed clinical trial aimed at testing a hypothesis.
…
164I am satisfied that the Protocol clearly discloses a method of administering fenofibrate in a daily dose of 160 mg to patients suffering from type 2 diabetes who were already taking a statin in the expectation that this would reduce the risk of development or progression of diabetic retinopathy in those patients beyond what it would be were they to have continued to take a statin alone. Use of fibrate in accordance with this method would clearly infringe each of the method of treatment claims which are therefore invalid for lack of novelty. Further, since the novelty of the Swiss-style claims depends upon the use described being new, those claims are also invalid for lack of novelty in light of the use it is proposed in the Protocol for fenofibrate in 160 mg dosages.
In light of Sun Pharma’s notice of contention, it is convenient to record, at this juncture, the primary judge’s findings and conclusions with respect to the conduct of the ACCORD Study and the FIELD Study. In relation to those studies, which were advanced as public acts, the primary judge held:
181The acts of investigators administering fenofibrate during the course of the Eye Study were also relied upon by the respondent as novelty defeating. This aspect of the novelty case, which received little attention in closing submissions, appears to have assumed that the Eye Study was an open label study which enabled the investigators to know whether or not they were administering fenofibrate. However, this would not be possible in a double blind study in which neither the investigator nor the participant would know whether fenofibrate or placebo was being administered. The Protocol states at page 3 that the participants would be randomly assigned in “a double masked fashion to either placebo or fenofibrate” which clearly indicates that the Eye Study was double blinded.
182The FIELD Study was also a double blind study. What I have just said in relation to the Eye Study applies to the FIELD Study as well.
The primary judge therefore concluded that Sun Pharma’s lack of novelty case, based on prior public use, failed.
The appeal
As developed in oral submissions, Grounds 5 – 7 of the appeal repeat, in substance, Mylan’s submission at trial that the ACCORD Protocol could not anticipate the invention as claimed because it advanced no more than a reasoned hypothesis for treatment, not a method of treatment as such. Mylan developed its submission by the following argument.
For a documentary disclosure to be anticipatory, it must contain a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim: General Tire & Rubber Co Ltd v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 (General Tire) at 485 – 486. Correspondingly, a method of treatment claim (involving the administration of a pharmaceutical compound for the treatment of the specified medical condition) can only be infringed if there is a deliberate administration of the compound for that purpose: Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50; 253 CLR 284 (Apotex v Sanofi) at [172], [289] and [294]. Therefore, a prior art disclosure which merely teaches the administration of a compound for the purpose of evaluating its safety and efficacy for a claimed therapeutic purpose will neither infringe nor, correspondingly, anticipate, such a method of treatment claim because that would not be a disclosure of the deliberate administration of the compound for the purpose, aim or object of the claimed therapy. As Mylan put the argument in its written submissions with respect to the ACCORD Protocol:
The Protocol might have anticipated the method of treatment claims of the 711 Patent if it had given a clear description of the deliberate administration of fenofibrate for the purpose, aim or object of preventing and/or treating retinopathy, or if it had given clear instructions to do so. The Protocol might also have anticipated the Swiss-style claims of the 711 Patent if it had disclosed that the fenofibrate was efficacious for the prevention and/or treatment of retinopathy. But the Protocol did neither of these things. Rather, it disclosed the administration of fenofibrate for the purpose of evaluating its efficacy for the claimed therapeutic purpose.
Adopting the language of the cases, Mylan submitted that the disclosure of a reasoned hypothesis that is yet to be evaluated does not constitute “clear and unmistakable directions” to perform the method (Flour Oxidizing Company Ltd v Carr & Company Ltd (1908) 25 RPC 428 (Flour Oxidizing) at 457); it does not “teach” the invention (BMS v Faulding at [67] and [72]); and is akin to a “proposition not true to its full extent” which will “not prejudice a subsequent statement which is limited and accurate, and gives a specific rule of practical application”: Hill v Evans (1862) 31 LJ Ch 456; 4 De GF & J 288; 45 ER 1195 at 1200 (Hill v Evans).
Mylan called in aid the analysis in InterPharma Pty Ltd v Hospira, Inc (No 5) [2019] FCA 960; 149 IPR 182 (InterPharma) of an allegedly anticipatory disclosure of a method claim directed to sedating a patient in an intensive care unit (ICU) with dexmedetomidine, and a corresponding Swiss type claim, by the publication of a patient consent form (the 249 Form). In that case, the trial judge extensively analysed the 249 Form against the backdrop of a Phase II clinical trial and found that it was not an anticipatory disclosure because it disclosed only the possibility of the use of dexmedetomidine as an ICU sedative and that a study was to be conducted to evaluate that possibility—in other words, an hypothesis to be tested in order to establish if it was well-founded. Further, in the context of considering a submission based on the doctrine of anticipatory disclosure by “inevitable result” (General Tire at 485 – 486), the trial judge found that the 249 Form did not contain clear instructions to do or make something that would infringe the patent.
In this appeal, Mylan noted that, in finding that the ACCORD Protocol anticipated the invention as claimed, the primary judge relied, in part, on a statement by the Full Court in Merck v Arrow (at [110]) that the characterisation of an alleged anticipation as a “suggestion” in relation to the invention, is “not necessarily fatal to a novelty argument”. We will return to consider Merck v Arrow. For present purposes, it is sufficient to note that Mylan submitted that, properly understood, this observation by the Full Court did not countenance “mere speculation” or “the presentation of no more than a reasoned hypothesis” as an anticipatory disclosure. Here, Mylan said, the ACCORD Protocol advanced no more than a reasoned hypothesis for treatment.
Mylan further submitted that if Merck v Arrow did countenance such a disclosure as anticipatory, then it was wrongly decided and should not be followed because it was contrary to the statement of principle established by the Full Court in BMS v Faulding that, in order to be anticipatory, the earlier documentary disclosure must “teach” that which the patent claims. According to Mylan, presenting a reasoned hypothesis does not amount to “teaching” in the requisite sense.
For the avoidance of doubt, we record that Mylan does not contend that the ACCORD Protocol did not disclose the administration of one of the dosages of fenofibrate referred to in claims 5 and 11 of the 711 patent.
Discussion
Relevantly to this appeal, s 7(1)(a) of the Act provides that an invention will be taken to be novel unless it is not novel in light of prior art information made publically available in a single document. In BMS v Faulding, the question was whether seven, separate prior documentary disclosures anticipated the invention, which was a method of administering a pharmaceutical compound (taxol) to a patient suffering from cancer, comprising infusing from 135 to 175 mg/m2 of taxol over a duration not exceeding six hours. Five documents were reports of (or articles on) Phase I clinical trials of taxol, which the evidence showed were trials to establish a safe dosage limit of the compound. The sixth document was an editorial in December 1991 by Rowinsky and Donehower in the Journal of the National Cancer Institute entitled “Taxol: Twenty Years Later, the Story Unfolds” (Rowinsky and Donehower). The seventh document was an abstract by Dr W W ten Bokkel Huinink of the Netherlands Cancer Institute entitled “Taxol the First Available of Taxanes, a New Class of Anti Cancer Drugs” (the Huinink abstract).
The trial judge (Bristol-Myers Squibb Co v FH Faulding & Co Ltd (1998) 41 IPR 467) had held that each document anticipated the invention as claimed because each satisfied the test expressed in Hill v Evans (45 ER at 1200):
… the information as to the alleged invention given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent. The invention must be shewn to have been before made known. Whatever, therefore, is essential to the invention must be read out of the prior publication.
In expressing his conclusion, the trial judge made a number of preliminary observations, including (at 482):
… it is not to the point that the information in the prior publication does not recommend to the skilled reader the utility of the method disclosed. The test is not whether such a reader would be persuaded by what is disclosed in the prior publication to work the invention. As already noted, there was much evidence from Bristol-Myers’ witnesses to the effect that there was not enough data publicly available at the priority date to confirm that a three hour infusion period of taxol was safe. But disclosure of an invention is not a matter of scientific proof, nor warranty of effectiveness.
It is apparent that, in this passage, the trial judge was using the word “recommend” in its primary sense of favourably considering the information or presenting it as worthy of acceptance. His Honour’s observation was that there could be anticipatory disclosure without recommendation in this sense. However, his Honour was not saying that a recommendation, in this sense, could not be part of a disclosure that is anticipatory.
The trial judge also remarked (at 483) that:
… publication of a method of medical treatment is none the less a disclosure because it takes the form of a report of clinical trials. Such trials are not solely experiments. It is to be assumed that the medical practitioners involved are also treating their patients with a rational and ethical objective of alleviating their condition and would only continue treatment if there was a reasonable prospect of success. (The side effects of taxol are at the very least unpleasant.)
On appeal, the Full Court (Black CJ and Lehane J, with whom Finkelstein J expressed general agreement) found that only the seventh document—the Huinink abstract—was an anticipation. While all the Phase I reports literally disclosed the administration of taxol at dosages falling within some or all the claims in suit, they were trials directed to, and reporting on, dosage safety, with the limited exception that two reports noted some clinical responses. As to these, one reported on responses to dosages that were not in the claimed range; the other (Cancer Treatment Reports, Donehower et al., December 1987) recorded only partial clinical responses in two cases, stating:
The frequency and severity of acute reactions to taxol were similarly decreased, making further clinical development of this drug more realistic and worthwhile based on the antitumour activity seen. It does, however, seem prudent that initial Phase II studies of taxol with this or other schedules be conducted in institutions familiar with its use, and facilities should be readily available for the management of severe type I hypersensitivity reactions.
In reasoning to their conclusion that the five Phase I reports were not anticipatory disclosures, Black CJ and Lehane J posed this question:
60… The substantial question, however, is whether the mere disclosure, in the context which we have described at some length, that in the course of the trials doses had been administered literally according to the claims of the petty patents, deprived the claimed invention of novelty. …
This passage is important because it presages their Honours’ concern as to whether the prior documentary disclosure of mere dosages of taxol, within the range claimed in the invention, in reports on dosage safety, was enough to amount to an anticipatory disclosure of the invention that was claimed, which was a method of administering taxol to treat cancer.
This caused their Honours to turn to a number of the accepted case authorities in this area of discourse. Thus, like the trial judge, their Honours referred to the “reverse infringement” test articulated by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 (Meyers Taylor) at 235 and to the test stated by Lord Westbury in Hill v Evans, quoted above. As to the latter, their Honours also quoted the following further passages (45 ER at 1200):
Apparent generality, or a proposition not true to its full extent, will not prejudice a subsequent statement which is limited and accurate, and gives a specific rule of practical application.
The reason is manifest, because much further information, and therefore much further discovery, are required before the real truth can be extricated and embodied in a form to serve the use of mankind. It is the difference between the ore and the refined and pure metal which is extracted from it.
Again, it is not, in my opinion, true in these cases to say, that knowledge, and the means of obtaining knowledge, are the same. There is a great difference between them. To carry me to the place at which I wish to arrive is very different from merely putting me on the road that leads to it. There may be a latent truth in the words of a former writer, not known even to the writer himself; and it would be unreasonable to say that there is no merit in discovering and unfolding it to the world.
Upon principle, therefore, I conclude that the prior knowledge of an invention to avoid a patent must be knowledge equal to that required to be given by a specification, namely, such knowledge as will enable the public to perceive the very discovery, and to carry the invention into practical use.
The combined passages from Hill v Evans speak of the need for a prior documentary disclosure to provide information that is equal to the invention that is claimed, if the prior documentary disclosure is to be anticipatory and thereby deprive the invention of novelty. As Hill v Evans makes clear, equality in this context refers to both the specificity of the information and its completeness. Unless these twin qualities are present, the prior disclosure will not be sufficient to deprive the invention of novelty.
Thus, a prior documentary disclosure will not be anticipatory if it merely provides information at a level of generality which, while encompassing that which is claimed as the invention, nevertheless fails to identify the invention with sufficient specificity. The notion was explained by Parker J in Flour Oxidizing (at 457):
But where the question is solely a question of prior publication, it is not, in my opinion, enough to prove that an apparatus described in an earlier Specification could have been used to produce this or that result. It must also be shown that the Specification contains clear and unmistakable directions so to use it.
In General Tire the Court of Appeal, in a similar vein, said (at 485-486):
When the prior inventor's publication and the patentee's claim have respectively been construed by the court in the light of all properly admissible evidence as to technical matters, the meaning of words and expressions used in the art and so forth, the question whether the patentee's claim is new … falls to be decided as a question of fact. If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee's claim is carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would be at least as likely to be carried out in a way which would not do so, the patentee's claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee's claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented: Flour Oxidizing Co. Ltd. v. Carr & Co. Ltd. (1908) 25 R.P.C. 428 at 457, line 34, approved in B.T.H. Co. Ltd. v. Metropolitan Vickers Electrical Co. Ltd. (1928) 45 R.P.C. 1 at 24, line 1). A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.
As the Full Court explained in AstraZeneca v Apotex at [294], the Court of Appeal’s metaphor of planting the flag has been taken up in this Court. In ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc [2000] FCA 1349; 106 FCR 214, the Full Court at [51], after noting the metaphor, remarked that, in that case, the appellant’s argument involved the skilled addressee rummaging through a “flag locker” to find a flag which the prior art possessed and could have planted. In Apotex Pty Ltd v Sanofi-Aventis [2008] FCA 1194; 78 IPR 485, Gyles J at [91] adopted a different metaphor when remarking that:
… anticipation is deadly but requires the accuracy of a sniper, not the firing of a 12 gauge shotgun.
As the Full Court in AstraZeneca v Apotex remarked, each metaphor underlines the importance of the specificity required in order for a prior art document to anticipate an invention as claimed.
But even if the information given in a prior documentary disclosure is, in terms, sufficiently specific—at least as to part of what is claimed as the invention—it might not go far enough to disclose all the essential features of the invention. If the information fails to go far enough, the prior documentary disclosure will not be anticipatory so as to deprive the invention of novelty. Thus, in Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 528, Gummow J said:
There was some discussion before us as to the significance of the reverse infringement test as a criterion for judging anticipation. In the Meyers Taylor case, supra, Aickin J was dealing with alleged anticipation of a combination patent; none of the alleged anticipations incorporated all the integers of any one of the claims. Therefore, as his Honour said (137 CLR at 235) none of them “could therefore possibly constitute an infringement”. In such a situation, the adequacy of the reverse infringement test will be readily apparent, given the fatal effect upon an infringement suit of omission from the alleged infringement of an essential integer. But Aickin J described this test only as “generally” applicable. Where the alleged anticipation is a paper publication, particularly a prior patent specification, there may be ground for debate in a comparison with the specification in suit as to the presence of inessential integers and mechanical equivalents. King J pointed this out in his judgment at first instance in Werner's case, supra (IPR at 536; ALR at 702). There may also be dispute whether what has been disclosed sufficiently reveals an essential integer, in the light of the principles in Hill v Evans (1862) 4 De GF & J 288: see Werner's case (ALR at 683) per Lockhart J.
In BMS v Faulding, after discussing several authorities on anticipatory disclosure (including, as we have noted, Meyers Taylor and Hill v Evans, and also Flour Oxidizing and General Tire) Black CJ and Lehane J remarked:
67What all those authorities contemplate, in our view, is that a prior publication, if it is to destroy novelty, must give a direction or make a recommendation or suggestion which will result, if the skilled reader follows it, in the claimed invention. A direction, recommendation or suggestion may often, of course, be implicit in what is described and commonly the only question may be whether the publication describes with sufficient clarity the claimed invention or, in the case of a combination, each integer of it. But in this case medical practitioners hardly needed to be told that it was possible to infuse a particular dose of taxol over three hours, or how to do it. Nor, equally obviously, is that the point of the claims. The claims of the earlier of the petty patents are for a method for administration of taxol to a patient suffering from cancer; the claims of the later one are for a method of treating cancer. In each case the method involves a particular regimen for the infusion of taxol. The context was that great difficulties had been encountered in using taxol, despite its known anti‑carcinogenic properties, in the treatment of cancer, because of the drug’s side effects. Each of the trials reported in the articles referred to was an investigation directed towards finding a solution of the difficulties: directed, particularly, to ascertaining safe dosage levels. But, though methods falling within the claims of the patents were used in each trial, none of the reports can be said to teach (a word which in this context encompasses direct, recommend and suggest) that which the petty patents claim.
Two things should be noted about this passage. First, when using the language of “teach”, “direct”, “recommend” and “suggest”, Black CJ and Lehane J were not using—indeed, were not purporting to use—the statutory language of s 7(1)(a) of the Act which, relevantly to the present question, speaks of prior art information that is made publicly available in a single document. Thus, their Honours were not stating a statutory test. Rather, they were seeking to capture and explain the notion, conveyed by the cases, of the sufficiency of the disclosure that a prior art document must make before it can deprive an invention of novelty. This notion is not elucidated by exploring the linguistic limits of “teach”, “direct”, “recommend” and “suggest” as ordinary English words. Indeed, it would be a distraction to do so. Nor would it assist to add to the catalogue of English words other words that might equally be used aptly to explain the sufficiency of the disclosure that must be made before a prior document can deprive an invention of novelty.
Secondly, the reason why, in their Honour’s judgment, the reports of the Phase I trials were not anticipatory disclosures was because they were disclosures about finding a solution to the difficulties of ascertaining safe dosage levels of taxol. In short, in their Honours’ view, the disclosures did not go far enough to disclose all the essential integers of the invention as claimed, which was directed to use of taxol, by means of a particular form of administration, to treat cancer. The challenge to novelty did not fail simply because the reports were about Phase I trials as such.
Having found that none of the reports of the Phase I trials were anticipatory disclosures, Black CJ and Lehane J turned to consider the two remaining publications—Rowinsky and Donehower, and the Huinink abstract. Their Honours summarised Rowinsky and Donehower as recording:
70… a decision by the National Cancer Institute that future trials should utilise 24-hour infusions, together with pre-medication, and mentioned that the trials, leading to the claimed invention, were in progress: it mentioned them as trials the results of which might indicate whether a 24-hour infusion was indeed necessary and throw some light on the optimum therapeutic dose of taxol, particularly in patients who had previously received other therapy …
As to that disclosure, their Honours said:
70… Applying the principles which we have discussed, that article is no more an anticipation than are the reports of the Phase I trials: it teaches the method no more than they do.
Their Honours then turned to consider the Huinink abstract from which their Honours quoted the following:
71Toxicity of taxol so far consists of dose limiting neutropenia, general malaise, muscle cramps, alopecia and hypersensitivity reactions, maybe related to the carrier in so far used formulations: Cremophor. Due to these side effects and based on preclinical screening antitumor continues [sic] infusions of 24 hours have been used so far. Phase I and II studies revealed activity against cisplatin refractory ovarian cancer, breast cancer and lung cancer. Further studies to evaluate the feasibility of shorter infusion time, 3 hours versus 24 hours and a lower 135mg/m2 versus a maximum tolerated dose of 175mg/m2 are now in progress in relapsing ovarian cancer patients both in Canada and in Europe. Already more than 200 patients have been entered into this four‑arm randomized, NCIC guided international study. Indeed, the 3 hours infusion time administration schedule proved to be feasible, if given concomitantly to profylactic [sic] measures as high dose dexamethasone, cimetidine and difenhydramine. This makes even outpatient treatment with this first available representative of this new class of antitumor agents possible. Major steps forward in medical oncology are rare. After doxorubicine in the seventies, and cisplatin and carboplatin in the eighties, taxol and its European pendant Taxotere ranks high to become the outstanding drugs of the nineties.
Their Honours found:
72It was submitted that it was necessary to decide the question of anticipation by reference to what the skilled reader would have drawn from the abstract; and we were taken to evidence that skilled readers would have treated the words “feasibility” and “feasible” in the abstract as referring to safety, not efficacy. Even if that is right, however, other aspects of the abstract must be taken into account. We are told that earlier studies had revealed taxol’s “activity against” certain forms of cancer; that the point of the studies then underway was to evaluate the “feasibility of shorter infusion time” and a lower dose “versus a maximum tolerated dose of 175mg/m2”. We are told (apparently) that what the tests have already revealed “makes even outpatient treatment with this first available representative of this new class of antitumour agents possible”. In other words, it is already known that taxol is effective against certain cancers; it is known that 175mg/m2 is a maximum tolerated dose; the purpose of the trial is to test the feasibility of a three hour infusion of that dose and a smaller dose; and the three hour infusion has already proved feasible, so that outpatient treatment has been demonstrated to be possible. Prudent practitioners might well take the view that they would prefer to await the final outcome of the trials, both as to efficacy and as to safety, before rushing to embrace the proposed method. But, in our view, there can be no serious doubt that the abstract teaches the shorter infusion period, with premedication, as a “treatment” of cancer. The necessary consequence, as it was conceded that the abstract was published in Australia before the priority date, is that the claimed invention lacked the novelty required by s 18(1)(b)(i). We note that that conclusion is consistent with the decision of the English Patents Court (to which we were not referred) concerning a similar European Patent (though on rather different evidence and under legislation which differs in significant respects from ours): Bristol‑Myers Squibb Co v Baker Norton Pharmaceuticals Inc [1999] RPC 253.
We do not read BMS v Faulding as laying down any new or modified principle of anticipatory disclosure by the publication of prior art documents. Rather, the reasons for judgment must be taken as explaining, by reference to existing authority, why their Honours’ factual conclusions differed from those reached by the trial judge in respect of the disclosures of six of the seven documents in question. Indeed, their Honours proceeded on the basis that they were undertaking an orthodox application of long-accepted legal principles. Importantly, we also note their Honours’ acceptance (at [60]) that publication of a method of medical treatment may be an anticipatory disclosure even when it takes the form of a report of clinical trials.
In Merck v Arrow, the trial judge had found that certain articles published in Lunar News anticipated one or more claims of a patent directed to a method of treating or preventing osteoporosis in a human by administering specified doses of alendronate according to specified dosage schedules. One such article was published in the April 1996 issue of Lunar News, which included the following:
One of the difficulties with alendronate is its low oral bioavailability. When taken with water in a fasting state, only about 0.8% of the oral dose is bio available. Even coffee reduces this by 60 % and a meal reduces it by > 85%. Alendronate must be taken, after an overnight fast, 30-60 minutes before breakfast. Subjects should remain seated or standing; a very small group of patients have reported some upper gastrointestinal distress if this is not done. This regime may be difficult for the elderly to maintain chronically. An intermittent treatment program (for example, one per week, or one week every three months), with higher oral dosing, needs to be tested. A sustained response has been demonstrated to intravenous administration of high dose alendronate.
(Emphasis added.)
The words “needs to be tested” in the penultimate sentence of this passage provided a focus of attention for the patentee (Merck) which argued at trial, purportedly on the authority of BMS v Faulding, that “something that needs to be tested is not to anticipate that which is suggested”. The trial judge dealt with that contention by reference to the passage from BMS v Faulding at [67], which we have quoted at [88] above. Specifically, the trial judge said:
107… That statement of principle was based upon a review of certain of the authorities. Those authorities stand for the proposition that the claimed invention must be disclosed as such and not simply as a possibility. If the Lunar News article had said ‘in view of these problems a continuous dosing schedule with various intervals greater than one day should be tested’ it would not anticipate claim 3, even though a weekly dosage interval would be both technically and practically contemplated by that suggestion. On the contrary, here, the disclosure is quite precise and accords with the gist of the claimed invention. I do not accept the submission on behalf of Merck that the passage in question from Faulding adds an additional requirement for anticipation, namely that the publication should recommend the use of the invention as disclosed. That is not what the passage from Faulding says and it does not follow from the authorities analysed in that judgment. The essential difference in the treatment of the prior publications in Faulding lay in the view that one publication pointed clearly to one solution which was the invention rather than other publications which did not so point. That was a factual rather than a legal judgment and cannot be translated to the present circumstances.
108In my opinion, the mere fact that a test of a defined solution to a problem is suggested does not avoid the disclosure being an anticipation. A drawing of a mechanical device with a caption ‘should be tested for speed’ would be an anticipation of a claim for that mechanical device. This point has particular cogency in relation to the present field. No invention can be used in the treatment of humans without extensive testing. In the present case, the patent was applied for before that testing had even commenced. The same reasoning is an answer to the argument advanced on behalf of Merck that the disclosure could not amount to an anticipation as no sensible medical practitioner would have acted upon it without adequate testing for safety. Even if that were correct (and it is contrary to some of the expert evidence led on behalf of Arrow) it would not affect the fact of disclosure having been made and being publicly available.
On appeal, Merck raised two contentions. First, the information in the articles in Lunar News did not form part of the prior art base because, in the language of s 7(1)(a) of the Act, they were not “publicly available”. For the purposes of this appeal, that contention can be put to one side. Secondly, Merck contended that the articles did not provide a sufficient disclosure of the invention that was claimed in the relevant claims.
As to this matter (the sufficiency of the disclosures), the Full Court said (at [104]) that the contemplation of further experiments and testing was not necessarily fatal to a finding of anticipation. Their Honours also noted that Merck had approached the appeal by relying, by way of analogy, on a detailed examination of the various publications which the Full Court in BMS v Faulding held to be or, perhaps more importantly, held not to be, anticipations. As to this, the Full Court said:
109Merck’s argument sought to rely by way of analogy on a detailed examination of the various publications which the Full Court in Faulding held were or were not anticipations. But, as the primary judge in the present case pointed out, these were questions of fact. We do not read Faulding as support for any proposition of law that, in the case of pharmaceutical patents, no publication can amount to an anticipation unless clinical trials have been actually conducted.
110In any event, Faulding at [67] speaks of a requirement that an alleged anticipation ‘teach’, in the sense of ‘direct, recommend or suggest’, that which is claimed. So a characterisation of an alleged anticipation as suggestion is not necessarily fatal to a novelty argument. Nor is it necessary that a reader, or even all readers, agree with the suggestion. Thus the fact that a Merck medical witness said that he would not have followed the Lunar News article for fear of side effects, does not if itself mean that disclosure was insufficient.
Importantly, the Full Court added:
111As Hill v Evans … long ago established, equality of disclosure, anticipation as against patent, is the essential element …
The Full Court explained (at [112]) that the claimed method was “clearly conveyed” in the Lunar News articles and that “nothing additional” was required in order to deprive the invention of novelty.
The Full Court’s understanding of BMS v Faulding accords with our own understanding. We do not accept, therefore, that Merck v Arrow was wrongly decided. BMS v Faulding was a case dealing with the sufficiency of particular disclosures as anticipations of the invention that was claimed. It turned on an evaluation of the facts of the case, not (as we have said) on any new or modified principle of anticipatory disclosure. We read both cases as proceeding on the acceptance and application of well-established principles that are not in doubt.
As we have noted, the substance of Mylan’s submission in this appeal is that the ACCORD Protocol could not anticipate the invention as claimed because it advanced no more than a reasoned hypothesis for treatment, not a method of treatment as such.
We do not accept that a documentary disclosure containing an hypothesis cannot be an anticipatory disclosure that deprives an invention of novelty. In such a case the question, simply put, remains: what does the prior document disclose? The occasion on which, or the context in which, a particular documentary disclosure is made may well inform the interpretation of the document’s content. But if, as a matter of interpretation, the document nonetheless discloses that which is later claimed as an invention, that disclosure will anticipate the invention and deprive it of novelty.
Having reviewed previous clinical data, the authors of the ACCORD Protocol arrived at the primary hypothesis that a therapeutic strategy that uses a fibrate to lower triglyceride levels and raise HDL-C levels in patients already receiving a statin drug for treatment of LDL-C levels will reduce the rate of development or progression of diabetic retinopathy compared to a strategy in which a statin alone is used. It is, of course, true that a study based on the ACCORD Protocol was to be conducted to test the hypothesis. But it is equally true that, by proposing the study, according to the Protocol and its hypothesis, there was a disclosure that fenofibrate was to be deliberately administered with a statin with the aim of preventing or treating diabetic retinopathy in patients in need of such treatment. That is, plainly, the method of treatment that the ACCORD Protocol instructed practitioners participating in the study to carry out. Equally clearly, that was a method of treatment claimed in claim 7 and, more specifically, the method of treatment claimed in claim 10 of the 711 patent. It was also a method of treatment claimed in claim 11 of the 711 patent (there being no issue taken on appeal that the ACCORD Protocol also disclosed one of the particular dosages referred to in that claim). Therefore, the ACCORD Protocol disclosed the claimed method. Nothing additional was required in order for the Protocol to function as an anticipatory disclosure. The disclosure of the Protocol’s instruction to carry out the purposeful administration of fenofibrate at the claimed dosages and with a statin was not diminished because a trial to validate the hypothesis was in contemplation.
It is important to stress that validation of the ACCORD Protocol’s hypothesis was certainly not required in order to achieve the equality of disclosure referred to in Hill v Evans. Looked at from a different perspective, it is not a requirement for a patentable invention that the invention, as claimed, be based on scientific proof or substantiation: Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2018] FCAFC 183; 267 FCR 428 at [135]. That being so, no greater requirement is imposed on a prior documentary disclosure in order for it to be anticipatory. What is required is that the prior document discloses that which is subsequently claimed as an invention. If that is disclosed, the invention cannot be new. If it should also be proved that the invention is not useful (for example, a claimed method of medical treatment is wholly or partly ineffective), then the patent can be challenged on that basis as well. But that raises a separate and distinct ground of invalidity.
Here, the method of treatment claimed in claims 7, 10 and 11 was not new because the prior-published ACCORD Protocol disclosed it. We mention claim 7 because, even though Mylan does not seek to support claim 7 under these grounds of appeal, the method of treatment claims it does seek to support—claims 10 and 11—are dependent on claim 7. Mylan does not suggest that the other claim it seeks to support under these grounds—claim 5 (the Swiss type claim)—should be treated differently from claims 10 and 11 in this respect.
As we have noted, Mylan called in aid the analysis in InterPharma, which found that the patient consent form used in Phase II trials—the 249 Form—was not an anticipatory disclosure of the use of dexmedetomidine to sedate a patient in an ICU. There are certainly passages in that analysis which support the way in which Mylan couched its submissions in this case. For example, the trial judge in that case referred (at [419]) to the fact that the 249 Form recorded a proposal for a trial to evaluate an hypothesis, namely whether use of dexmedetomidine in ICU sedation was safe, effective and dose titratable. The trial judge also referred (at [422]) to the fact that the 249 Form disclosed only the possibility of the use of dexmedetomidine as an ICU sedative and that a study was to be conducted to evaluate that possibility. The trial judge considered the disclosures of the 249 Form to be different in substance, and hence in legal effect, from the disclosures in BMS v Faulding and Merck v Arrow that were found to be anticipations. The correctness of that factual conclusion is not before us.
While comparisons with other case examples can be instructive, at root is the evaluation of particular evidence, and the consequent findings of fact based on that evidence, in each case. For the reasons we have given, we are not persuaded that the primary judge erred in the conclusion to which he came as to the substance and legal effect of the disclosures in the ACCORD Protocol. Therefore, Grounds 5 – 7 of the appeal fail.
Before departing from these grounds of appeal, we record that, in the course of oral argument, and after inquiry by the Full Court, Mylan also referred to two United Kingdom authorities which, it submitted, supported its position that the ACCORD Protocol could not anticipate the invention as claimed because it advanced no more than a reasoned hypothesis for treatment, not a method of treatment as such: Regeneron Pharmaceuticals Inc v Genentech Inc [2012] EWHC 657 (Pat); Hospira UK Limited v Genentech Inc [2015] EWHC 1796 (Pat); [2016] RPC 1. Mylan’s written submissions also referred to Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat). Leave was granted to the parties to file written submissions dealing with these cases following the hearing of the appeal.
Sun Pharma says that given the formulator’s desire to obtain the smallest possible particle size, it would have been obvious to try and maintain the particle size of 50 to 300 nm described in the 704 patent as transiently stable by treating the surface of the drug particles to facilitate dissolution in water. This would be done by choosing a surface active agent that was not hydrophobic.
Further, Sun Pharma says that because the 704 patent revealed that the phospholipid formulations were only transiently stable at 50 to 300 nm (see at [0026], [0040], [0069]), this provided motivation to the skilled team not merely to accept the formulations of the 704 patent, but to try to improve them through the processes of routine trial and error which was accepted to be part of common general knowledge.
Sun Pharma says that on the basis of the evidence and the primary judge’s findings of fact, it would have been obvious to a skilled addressee in light of common general knowledge and armed with the 704 patent to formulate a stable fenofibrate composition for oral administration comprising particles of fenofibrate having a D50 particle size of less than about 500 nm to improve dissolution and therefore bioavailability, and at least one surface stabilizer which was not a phospholipid and was most likely a combination such as HPMC and SLS that would complement each other.
Sun Pharma says that the skilled addressee would understand that by reducing particle size and using a surface active agent, the food effect could be substantially eliminated, and the composition would redisperse in biorelevant media.
On that basis, Sun Pharma says that each of the asserted claims of the 807 patent was also obvious in light of common general knowledge considered together with the 704 patent.
We reject Sun Pharma’s notice of contention point.
In our view, the primary judge correctly rejected Sun Pharma’s lack of inventive step case based on the 704 patent ([428]). This was on the basis, inter alia, of the expert evidence referred to by the primary judge at [440] to [442], which his Honour correctly summarised and recorded in part.
Further, after referring to this evidence, the primary judge found (at [443]) that:
In my opinion the evidence does not establish that a skilled team endeavouring to apply the teachings of the 704 Patent with a view to producing a fenofibrate composition containing small particles of fenofibrate, could produce a stable formulation of particles of about .5 μm (500 nm) or less in size using a phospholipid as the surface stabilizer.
Not only has that conclusion not been shown to be in error, but in our view, based upon our own review of the 704 patent and the evidence, it is quite correct.
Further, we reject the conditionality of Sun Pharma’s notice of contention by reference to “if”. Sun Pharma has mischaracterised the primary judge’s finding at [445]. The primary judge’s finding that the 704 patent would not tell the notional team anything more than what it would already know from common general knowledge was only in one respect, namely, “by reducing the size of fenofibrate particles in a fenofibrate composition suitable for oral administration, it may be possible to eliminate or substantially eliminate the food effect”. That finding did not refer to the solubility, dissolution profile or bioavailability of fenofibrate or the use of surface stabilizers in formulating fenofibrate.
Further, the primary judge did not find that, in light of the 704 patent, the notional team would be directly led to trying to produce a fenofibrate composition containing a stable formulation of particles of 500 nm or less using any stabilizer other than a phospholipid. Indeed, the evidence adduced before the primary judge included evidence of the skilled addressee’s understanding that the inventors had already attempted to optimise the fenofibrate compositions disclosed. Moreover, the lead formulations all included phospholipids.
Further, it is important not to overlook Professor Roberts’ evidence concerning the melting and cooling steps in the 704 patent. One of his uncertainties concerned obtaining a stable formulation of particles having a size of 500 nm or less in addition to the selection of a stabilizer(s). Professor Roberts’ evidence was that the selection of a different stabilizer(s) alone may not yield stable particles having a particle size of 500 nm or less. Moreover, there was no detailed evidence of what steps Professor Roberts would have taken instead of the melting and cooling steps.
The notional team would not likely have employed the melting and cooling steps in the 704 patent. Indeed, Professor Roberts explained that he would have avoided the heating step described in the 704 patent so as to avoid forming an undesirable crystalline form. He would have made this change because he would have wanted fewer steps or steps that were less likely to go wrong. It is worth setting out his evidence:
MR MURRAY: Thanks very much. Just a minute, please, your Honour. Based on your May 2002 knowledge, Professor Roberts, you would regard it as – sorry. You would be optimistic certainly – let me make it clear what I mean by optimistic. Not certain but optimistic that you could, by taking what you’re told in the 704 patent and optimising the formulation that was used to obtain the tablets in example 20, that by varying the use of surfactant or surface stabiliser such as by using SLS and HPMC, you would have been optimistic that you could have stabilised that particle size at around the 300 nanometre range that had been obtained at step B.
PROF ROBERTS: Can [I] express a real concern I have with all of this?
MR MURRAY: Yes.
PROF ROBERTS: I don’t know what physical form will end up with a fenofibrate, so if we end up with a crystalline form which is actually terribly insoluble - - -
MR MURRAY: Yes.
PROF ROBERTS: - - - we could be in a worse situation than we had before we started.
MR MURRAY: Yes.
PROF ROBERTS: So the process of melting – I just don’t know – because there’s a number of cooling steps.
MR MURRAY: Yes.
PROF ROBERTS: If you slow down the cooling, you can end up with, in fact, a more robust crystal which will dissolve even as an intrinsic dissolution rate - - -
MR MURRAY: Yes.
PROF ROBERTS: - - - which is actually much slower than another crystalline form - - -
MR MURRAY: Yes.
PROF ROBERTS: - - - and I’m just not certain what I would end up with - - -
MR MURRAY: Thank you.
PROF ROBERTS: - - - so I would prefer to be cautious and actually avoid that step.
MR MURRAY: Avoid which step?
PROF ROBERTS: The molten step. The actual, sort of, molten and then, sort of, trying to bring it back into some crystalline form.
MR MURRAY: Thanks.
PROF ROBERTS: I just don’t know what the outcome would be.
MR MURRAY: Thank you. And so that was a view you reached on the 704 patent without the benefit of the 807 patent?
PROF ROBERTS: Correct.
MR MURRAY: Thanks. And so as a matter of your chemical chemistry instincts, you thought that it would be sensible, in taking the learning of 704, not to use the heating step.
PROF ROBERTS: I would feel much more comfortable with less steps and with ones that are less likely to go wrong.
MR MURRAY: And if you had taken that approach, can I put my earlier question to you about being optimistic that you would have stabilised at around that 300 nanometre range?
PROF ROBERTS: Well, I think the hindsight were the 807 – it was 807, I think it is - - -
MR MURRAY: Yes.
PROF ROBERTS: - - - actually shows that is the case.
MR MURRAY: Yes. Are you able to express an opinion as to your level of optimism putting the 807 aside?
PROF ROBERTS: It’s a gamble. I mean, a whole – all sorts of developments are gambles. Sometimes they work; sometimes they don’t. I think I would be very – what’s the word? – foolhardy to suggest to you that I would be sure it would work.
Further, the 704 patent did not report on the Cmax for fenofibrate when the formulations of the 704 patent were administered under fed and fasted conditions. Contrastingly, asserted claims 1, 2, 3 (and dependent claims 4 to 39), and 40, 41, 42 (and dependent claims 43 to 80) of the 807 patent claim Cmax values at a 90% confidence interval for Cmax which is between 0.80/80% and 1.25/125%.
In summary, for all these reasons his Honour correctly rejected Sun Pharma’s case based upon both common general knowledge and the 704 patent as s 7(3) information. Sun Pharma’s point of contention must be rejected.
The 964 patent: background
The issue
The primary judge held that claims 12 and 13 of the 964 patent were not fairly based on the matter described in the specification for that patent and, accordingly, that the claims were invalid. Mylan contends that the primary judge erred in so finding: grounds 22 to 25 of the amended notice of appeal. Mylan seeks a declaration that Sun Pharma threatens to infringe claims 12 and 13 of the 964 patent and a certificate of validity which includes those claims.
Claims 12 and 13
Claims 12 and 13 need to be considered in the context of, amongst other claims, claim 1. The claims are as follows:
1. An immediate-release fenofibrate composition comprising:
(a) an inert hydrosoluble carrier covered with at least one layer containing fenofibrate in a micronized form having a size less than 20 μm, a hydrophilic polymer and, optionally, a surfactant; said hydrophilic polymer making up at least 20% by weight of (a); and
(b) optionally one or several outer phase(s) or layer(s).
…
12. A composition comprising fenofibrate having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or with 0.025M sodium lauryl sulfate.
13. The composition according to any one of the preceding claims, in the form of a tablet.
In short, the primary judge found that the specification only disclosed a composition comprising fenofibrate in a micronized form having a size less than 20 μm and did not disclose any composition comprising fenofibrate having the dissolution profile in claim 12: [287]. To understand the primary judge’s reasoning it is necessary to consider the terms of the specification.
The specification
The specification identifies at p 1 lines 5-37 that:
The present invention relates to a novel pharmaceutical composition having high bioavailability through improved dissolution, and a method for preparing it. The invention more particularly relates to a pharmaceutical composition for administration by oral route, containing an active ingredient of poor aqueous solubility.
Numerous active ingredients suffer from the disadvantage of being poorly soluble in an aqueous medium, thus having an insufficient dissolution profile and, consequently, poor bioavailability within the organism, following oral administration. The therapeutic dose required to be administered must thus be increased in order to obviate this disadvantage. This particularly applies to numerous hypolipemiant active ingredients, such as those belonging to the fibrate family.
Fenofibrate is a well-known hypolipemiant from the family of fibrates, which is commercially available in various doses (100 and 300 mg for example Secalip®) but in a form leading to poor bioavailability of the active ingredient. Indeed, due to it [sic] poor hydrosolubility, fenofibrate is poorly absorbed in the digestive tract and consequently its bioavailability is incomplete, irregular and often varies from one person to another.
To improve the dissolution profile of fenofibrate and its bioavailability, thereby reducing the dose requiring to be administered, it would be useful to increase its dissolution so that it could attain a level close to 100%.
Moreover, for patient comfort, it is advantageous to seek a dosage form that only requires the medicament to be taken once daily while giving the same effect as one administered several times daily.
Page 2 lines 1-33 describe the prior art in these terms:
EP-A-0330532 discloses a method for improving bioavailability of fenofibrate. This patent describes the effect of co-micronizing fenofibrate with a surfactant, for example sodium laurylsulfate in order to improve fenofibrate solubility and thereby increase its bioavailability. This patent teaches that co-micronizing fenofibrate with a solid surfactant improves fenofibrate bioavailability to a much greater extent than the improvement that would be obtained either by adding a surfactant, or through solely micronizing the fenofibrate, or, yet again, through intimately mixing the fenofibrate and surfactant, micronized separately. The dissolution method employed is the conventional rotating blade technique (European Pharmacopoeia) : product dissolution kinetics are measured in a fixed volume of the dissolution medium, agitated by means of a standardized device; a test was also carried out with an alternative technique to the European Pharmacopoeia, using the continuous-flow cell method.
The process of EP-A-0330532 leads to a new dosage form in which the active ingredient, co-micronized with a solid surfactant, has improved fenofibrate dissolution, and thus increased bioavailability, which makes it possible, for a given level of effectiveness, to decrease the daily dose of the medicament: respective 67 mg and 200 mg instead of 100 mg and 300 mg.
However, the preparation method in that patent is not completely satisfactory inasmuch as it does not lead to complete bioavailability of the active ingredient, and suffers from several disadvantages. The technique of co-micronizing fenofibrate with a solid surfactant does, it is true, improve dissolution of the active ingredient, but this dissolution remains, however, incomplete.
The specification continues in these terms at p 2 line 34 to p 3 line 12:
There is thus a need to improve fenofibrate bioavailability in order to attain, over very short periods of time, a level close to 100% (or, in any case, better than the following limits: 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes in a medium consisting of 1200 ml water to which 2% Polysorbate 80 is added, or of 1000 ml of water to which 0.025M sodium lauryl sulfate sodium [sic] is added, with a blade rotation speed of 75 rpm), and this even when dissolution media having a low surfactant content are used.
Applicant has found that, surprisingly, it is possible to resolve this problem by a new method for preparing a pharmaceutical composition by spraying a suspension of the active ingredient onto an inert hydrosoluble carrier. The present invention also relates to pharmaceutical compositions thus prepared.
After a further discussion of the prior art the specification includes consistory statements as follows at p 5 line 1 to p 6 line 4:
Thus, the present invention provides an immediate-release fenofibrate composition comprising:
(a) an inert hydrosoluble carrier covered with at least one layer containing a fenofibrate active ingredient in a micronized form having a size less than 20 μm, a hydrophilic polymer and, optionally, a surfactant; said hydrophilic polymer making up at least 20% by weight of (a); and
(b) optionally one or several outer phase(s) or layer(s).
In one embodiment, a surfactant is present with the active ingredient and the hydrophilic polymer
The invention also provides a composition comprising fenofibrate having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or in a dissolution medium constituted by water with 0.025M sodium lauryl sulfate.
A method for preparing a pharmaceutical composition is also provided, comprising the steps of:
(a) preparing a fenofibrate suspension in micronized form with a particle size below 20 μm, in a solution of hydrophilic polymer and, optionally surfactant;
(b) applying the suspension from step (a) to an inert hydrosoluble carrier;
(c) optionally, coating granules thus obtained with one or several phase(s) or layer(s).
Step (b) is preferably carried out in a fluidized-bed granulator.
The method can comprise a step in which products obtained from step (b) or (c) are compressed, with or without additional excipients.
The invention also provides a suspension of fenofibrate in micronized form having a size less than 10 μm, in a solution of hydrophilic polymer and, optionally, surfactant.
At p 8 lines 16-25 the specification provides that:
The compositions according to the invention comprise, in general, based on the total composition weight excluding the outer phase or layer, an inert hydrosoluble carrier making up from 10 to 80% by weight, preferably 20 to 50% by weight, the fenofibrate representing from 5 to 50% by weight, preferably from 20 to 45% by weight, the hydrophilic polymer representing from 20 to 60% by weight, preferably 25 to 45% by weight, the surfactant making up from 0 to 10% by weight, preferably 0.1 to 3% by weight.
At p 9 lines 12-27 the specification states:
The composition according to the invention is prepared by a novel process comprising spraying a suspension of the active ingredient in a micronized form in a solution of a hydrophilic polymer and, optionally, a surfactant, onto the inert cores.
When a surfactant is present, the active ingredient can be co-micronized with the surfactant. One will then use with advantage the teachings of EP-A-0330532.
The method according to the invention consists in using the fluidized bed granulation principle, but with specific starting materials, in order to arrive at an improved dissolution profile and thus, at elevated bioavailability. In particular, the invention employs a suspension of the micronized active ingredient in a solution of a hydrophylic polymer and, optionally, a surfactant.
At p 10 lines 13-15 the specification notes that:
The compositions according to the invention can also be prepared by other methods, for example by spraying a solution of the micronized active ingredient onto the hydrosoluble inert carrier.
The specification then provides at p 11 lines 15-21 that:
The invention also covers this novel suspension.
Without wishing to be tied down to a specific theory, applicant believes that this novel method, through the use of a micronized active ingredient suspension in a hydrophilic polymer solution, enabled a novel composition to be obtained in which the active ingredient is in a non-re-agglomerated form.
The specification continues by providing four examples which are said at p 11 lines 22-23 to “illustrate the invention without limiting it”.
The 964 patent: Grounds 22 - 25
The primary judge’s reasons
The primary judge identified that:
277Section 40(3) of the Act, as it stood prior to its amendment by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth), states that a claim must be (inter alia) “fairly based on the matter described in the specification”.
The primary judge then explained the relevant principles stating:
278In Lockwood Security Products Pty Limited v Doric Products Pty Ltd (No 1) (2004) 217 CLR 274 (“Lockwood No 1”) the High Court (Gleeson CJ, McHugh, Gummow, Hayne and Heydon JJ) referred with approval to a passage in the judgment of Barwick CJ in Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 (and also approved Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 at [15]) in which the Chief Justice said at 240:
The question whether the claim is fairly based is not to be resolved … by considering whether a monopoly in the product would be an undue reward for the disclosure. Rather, the question is a narrow one, namely whether the claim to the product being new, useful, and inventive, that is to say, the claim as expressed, travels beyond the matter disclosed in the specification.
The primary judge continued at [279] to the effect that s 40(3) requires a “real and reasonably clear disclosure” of what is claimed, but that this question is not answered solely by reference to the preferred embodiments. The primary judge noted that the High Court said:
[68] Erroneous principles. The comparison which s 40(3) calls for is not analogous to that between a claim and an alleged anticipation or infringement. It is wrong to employ “an over meticulous verbal analysis”. It is wrong to seek to isolate in the body of the specification “essential integers” or “essential features” of an alleged invention and to ask whether they correspond with the essential integers of the claim in question [CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 281, per Spender, Gummow and Heerey JJ].
[69] “Real and reasonably clear disclosure”. Section 40(3) requires, in Fullagar J’s words, “a real and reasonably clear disclosure” [Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5 at 11]. But those words, when used in connection with s 40(3), do not limit disclosures to preferred embodiments.
“The circumstance that something is a requirement for the best method of performing an invention does not make it necessarily a requirement for all claims; likewise, the circumstance that material is part of the description of the invention does not mean that it must be included as an integer of each claim. Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.” [Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 95, per Gummow J]
Fullagar J’s phrase serves the function of compelling attention to the construction of the specification as a whole, putting aside particular parts which, although in isolation they might appear to point against the “real” disclosure, are in truth only loose or stray remarks.
At [280] the primary judge said that Lockwood No 1 is “authority for the proposition that a consistory clause may provide a fair basis for a claim which mirrors its language but not if there are other matters disclosed in the specification which show that the invention is narrower than the consistory clause suggests”. The primary judge referred in particular to Lockwood No 1 at [99] that:
… the correct position is that a claim based on what has been cast in the form of a consistory clause is not fairly based if other parts of the matter in the specification show that the invention is narrower than that consistory clause. The inquiry is into what the body of the specification read as a whole discloses as the invention [Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 at 612-613]. An assertion by the inventor in a consistory clause of that of which the invention consists does not compel the conclusion by the court that the claims are fairly based nor is the assertion determinative of the identity of the invention. The consistory clause is to be considered by the court with the rest of the specification.
The primary judge observed at [281] that the invention described in the specification for the 964 patent has a number of aspects. His Honour said:
282 One aspect of the invention described is an immediate release fenofibrate composition containing (inter alia) fenofibrate in a micronized form having a size less than 20 μm. I will refer to this as the immediate release formulation. The immediate release formulation is the subject of independent claim 1.
283 Another aspect of the invention described is a method of preparing the formulation of the invention. This method comprises a number of steps the first of which is the preparation of fenofibrate in micronized form with a particle size below 20 μm suspended in a solution of hydrophilic polymer and, optionally, a surfactant. This is the method claimed in independent claim 14. The form and size of the fenofibrate as used in the method corresponds with the form and size of the fenofibrate referred to in the immediate release formulation.
284 A further aspect of the invention described is the suspension that is prepared as the first step of the method. This is the suspension claimed in independent claim 17.
The primary judge posed the question for resolution in these terms:
286The question is whether the specification also contains a real and reasonably clear disclosure of an invention consisting of “[a] composition comprising fenofibrate” with a particular dissolution profile as claimed in independent claim 12 that need not contain fenofibrate in micronized form.
The primary judge answered the question as follows:
287In my view, when read as a whole, the specification discloses an invention comprising a fenofibrate composition that includes fenofibrate in micronized form having a size less than 20 μm, an inert hydrosoluble carrier and a hydrophilic polymer. It does not disclose an invention (or an aspect of an invention) comprising any composition of fenofibrate that has the improved dissolution profile.
The primary judge said at [288] and [289]:
(a)The passage at p 2 line 34 to p 3 line 6 of the specification (commencing with the words “There is thus a need to improve fenofibrate bioavailability…”) does not describe the invention, but the problem which is said to have been solved.
(b)The problem is said to have been solved by making the product most broadly described at p 5 lines 1-10 (the consistory clause which refers to an immediate release fenofibrate composition including fenofibrate in a micronized form having a size less than 20 μm) using the method described at p 5 lines 21-34 (the consistory clause for a method for preparing a pharmaceutical composition comprising the steps of, inter alia, preparing a fenofibrate suspension in micronized form with a particle size below 20 μm).
(c)The dissolution profile at p 5 lines 13-20 (the consistory clause for claim 12 commencing “The invention also provides a composition comprising fenofibrate having a dissolution of at least…”), in the primary judge’s words, “is not a statement of the invention but a statement of an advantage of the invention”. The primary judge then said:
To the extent that the consistory statement at page 5 lines 13-20 of the specification may suggest otherwise, I regard it as inconsistent with what is disclosed elsewhere in the document including at page 8 lines 16-25, page 9 lines 12-27 (when read with page 10 lines 13-15), page 11 lines 15-21, and, I would add, other parts of the consistory clause.
Those parts of the specification are set out above.
(d) The formulations used in the Examples include particles of micronized fenofibrate that are less than 20 μm in size, and an inert hydrosoluble carrier and a hydrophilic polymer. While the specification makes clear that the invention described is not limited by the Examples, the “description of the composition of the formulations used in the Examples form part of the matter disclosed and must be taken into account when seeking to characterise the invention described in the specification when read as a whole”.
The appeal
Mylan submitted that the primary judge fell into error by construing the invention described in the specification too narrowly. In particular, his Honour construed the specification as requiring the invention to involve a composition or a method of preparing a formulation containing fenofibrate in a micronized form having a size less than 20 μm. While these are embodiments of the invention, the invention is more broadly described in the specification so as to provide a fair basis for claims 12 and 13.
According to Mylan, the invention is a novel pharmaceutical composition comprising fenofibrate having high bioavailability through improved dissolution, and a method of preparing the same. After describing the need to improve fenofibrate bioavailability at p 2 line 34 to p 3 line 6, the specification describes various embodiments of the invention which are subsequently claimed including the embodiment for claim 12. In a non-limiting way, the specification then exemplifies embodiments of the invention by reference to Figures 1 and 2 and the Examples. Although the primary judge recognised the Examples to be non-limiting at [289], he appears to have read down the invention by reference to the Examples.
Mylan submitted that:
Contrary to the primary judge’s finding (J [286], [287], Pt A Tab 15, 78-79), the specification does not require the composition of the invention to contain fenofibrate in a micronised form of less than 20 μm. Rather, the specification requires a pharmaceutical composition comprising fenofibrate having high bioavailability through improved dissolution, which had not been achieved by the prior art. The improved dissolution is reflected in the dissolution profile claimed in claim 12. As the specification makes clear, this may be achieved by a pharmaceutical composition of claim 1, made in accordance with the method of claim 14.
According to Mylan, it is not possible to read the references in the consistory clause for the invention claimed in claim 12, that the invention “also” provides “a” composition with the relevant dissolution profile, as mere stray words. As Mylan put it, nothing in the text of that consistory clause limits the composition to the composition which is contained in the immediately preceding consistory clause for the invention claimed in claim 1. Contrary to the primary judge’s approach, this is not a mere statement of the advantage of the invention described in the immediately preceding consistory clause, but is a statement of another embodiment of the invention separate and distinct from the invention earlier described.
Sun Pharma submitted that Mylan had suggested no error in the primary judge’s exposition of the relevant principles, including to the effect that a consistory clause could not provide a fair basis for a claim where other matters disclosed in the specification showed that the invention is narrower than the consistory clause suggests: see, in addition to Lockwood No 1, Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132; (2011) 119 IPR 194 at [90], [91], [94], [95], [98], [99], [169], [170], [240]-[250] and AstraZeneca v Apotex at [413]-[421].
According to Sun Pharma, the primary judge’s construction of the 964 specification was correct. The specification discloses a particular immediate release fenofibrate composition, and a method for preparing it. It employs a suspension of fenofibrate in micronized form in a solution of a hydrophilic polymer sprayed onto an inert hydrosoluble carrier. The concentration of polymer used in the composition disclosed is essential to secure the increased dissolution rate and bioavailability.
Sun Pharma stressed that after identifying the need to improve fenofibrate bioavailability on p 3 line 34 to p 4 line 6, the specification stated as follows (Sun Pharma’s emphasis):
Applicant has found that, surprisingly, it is possible to resolve this problem by a new method for preparing a pharmaceutical composition by spraying a suspension of the active ingredient onto an inert hydrosoluble carrier. The present invention also relates to a pharmaceutical composition thus prepared.
Sun Pharma noted that the specification discloses:
(a) p 5 lines 3 -10: that the invention relates to an immediate release fenofibrate composition comprising: (a) an inert hydrosoluble carrier coated with at least one layer containing a fenofibrate active ingredient in a "micronized form" having a size less than 20 μm, a hydrophilic polymer, and optionally, a surfactant, with the hydrophilic polymer making up 20% of the weight of (a) and (b) optionally one or more outer phases or layers; and
(b)p 5 lines 21-35, p 9 lines 12-16, p 10 lines 3-16: a method for preparing a pharmaceutical composition, comprising the steps of preparing a fenofibrate suspension in micronized form with a particle size below 20 μm, in a solution of hydrophilic polymer and optionally a surfactant, applying the suspension to an inert hydrosoluble carrier (preferably in a fluidised bed granulator), and optionally coating granules thus obtained with one or several phases or layers.
Sun Pharma continued, submitting:
The specification states that "the applicant believes that this novel method, through the use of a micronized active ingredient suspension in a hydrophilic polymer solution, enabled a novel composition to be obtained in which the active ingredient is in a non-re-agglomerated form" (page 11lines 16 to 21 (Pt A Tab 2, 11)). It is clear that use of the particular approach to formulating fenofibrate described is essential to avoiding re-agglomeration of the micronized drug particles, and thereby achieving increased dissolution rate and bioavailability.
With respect to the consistory clause for the invention claimed in claim 12, Sun Pharma submitted:
The specification explains that the invention also provides a composition comprising fenofibrate having a specified dissolution profile (page 5 lines 13 to 20 (Pt A Tab 2, 5)). However, this dissolution profile is characteristic of and achieved by the composition which is described. The specification does not identify any other means of obtaining this dissolution rate profile.
According to Sun Pharma:
This is a paradigm example of the principle to which the High Court referred in Lockwood (No. 1) at [99]. Consideration of the 964 specification as a whole makes clear that the invention disclosed is narrower than that identified at page 5 lines 13-20 (Pt A Tab 2, 5). The primary judge was correct in finding at PJR [288] (Pt A Tab 15, 71) that the dissolution profile specified at page 5 lines 13-20 (Pt A Tab 2, 5) is not a statement of the invention but a statement of an advantage of the invention, and that neither claims 12 nor claim 13 is fairly based.
Discussion
Sun Pharma’s submissions to the effect that the reasoning of the primary judge about claims 12 and 13 of the 964 patent involve no error should be accepted.
First, the consistory clause on which Mylan relies (p 5 lines 13 to 20) must be read in the context of the specification as a whole, including what immediately precedes and follows it on p 5 lines 1 to 12 and p 5 lines 21 to 34. When read in context, it is apparent that it is not necessary to treat the words “also” (“The invention also provides…”) and “a” (“…a composition comprising fenofibrate”) as stray words. The better reading of p 5 lines 13 to 20 of the specification is that the invention to which reference is made is “the present invention [which] provides an immediate release fenofibrate composition” described at p 5 lines 1 to 12 and made in accordance with the method described at p 5 lines 21 to 34. It is this invention which also provides a composition comprising fenofibrate with the relevant dissolution profile. The words “a composition”, on their natural and ordinary meaning, do not suggest any composition at large. Rather, they are linked to the invention which has already been described, being the immediate release fenofibrate composition. It is this composition which provides the relevant dissolution profile.
Mylan’s submission that the words “also” and “a” indicate a separate and distinct embodiment of the invention does not readily conform to the natural and ordinary reading of the relevant part of the specification in context. The statement is that the invention “also provides something”. In other words, the statement assumes that the invention has already been described. And the invention which has already been described is the immediate release fenofibrate composition. Nor is it necessary for the definite article “the” to be used, so as to refer to “the composition”, to confine the description to the immediate release fenofibrate composition. What is being conveyed is that the invention, being the immediate release fenofibrate composition, also provides a composition which has the relevant dissolution profile. As the primary judge put it at [288], the passage on which Mylan relies is not a statement of the invention but a statement of an advantage of the invention.
The other parts of the specification on which the primary judge relied are consistent with this construction of the specification. They all involve the fenofibrate in a micronized form. In particular, the passage on which Mylan relies at p 5 lines 13 to 20 sits between two statements of the invention both of which involve fenofibrate in micronized form having a size less than 20 μm. As Sun Pharma put it, there is no disclosure of any other method of obtaining the relevant dissolution profile. The dissolution profile is achieved by the composition which is described.
The primary judge did not read down the invention by reference to the Examples. The Examples are all consistent with the specification construed as a whole in which the dissolution profile is an advantage achieved by the composition which is disclosed, being the immediate release fenofibrate composition. The inconsistency which the primary judge had in mind at [288] is inconsistency between the fact that the disclosure elsewhere in the specification makes clear that the invention is to the immediate release fenofibrate composition and a method for preparing it, and Mylan’s construction of the passage on p 5 lines 13 to 20 to the effect the invention extends to any composition of fenofibrate which satisfies the dissolution profile. As Sun Pharma submitted, this is a paradigm example of claims which travel beyond the matter disclosed in the specification.
For these reasons, the primary judge was correct to conclude that claims 12 and 13 of the 964 patent are not fairly based on matter described in the specification. Grounds 22 to 25 of the amended notice of appeal must be dismissed.
Conclusion and disposition
For these reasons, Mylan’s appeal and Sun Pharma’s notice of contention should be dismissed. Mylan should pay Sun Pharma’s costs.
I certify that the preceding five hundred and eighty-eight (588) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justices Middleton, Jagot, Yates, Beach and Moshinsky. Associate:
Dated: 3 July 2020
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