Pharmacia LLC v Juno Pharmaceuticals Pty Ltd

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FEDERAL COURT OF AUSTRALIA

Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92

File number: NSD 1370 of 2019
Judgment of: BURLEY J
Date of judgment: 15 February 2022
Catchwords: PATENTS – standard patent claiming reconstitutable powder composition containing a cyclooxygenase-2 inhibitor for parenteral administration – infringement – validity
PATENTS – infringement – where respondents manufacture and sell competitor product to applicants – where respondents provided applicants with representative documents relating to six batches of parecoxib sodium product – claim construction – meaning of “about”, “therapeutic agent” and “essentially” as used in claims – whether claims include or exclude residual water from the composition – whether omnibus claim infringed – certain batches found to be within scope of asserted claims
PATENTS – validity – lack of inventive step – where respondents put forward eight-step development pathway leading to claimed invention – composition of hypothetical skilled team – whether prior art information could be reasonably expected to have been ascertained – where parties accepted that hypothetical team would first attempt to formulate as a “ready to use” composition before moving to consider a lyophilised formulation – whether hypothetical team would persist with “ready to use” formulation – whether hypothetical team would use a bulking agent in lyophilised formulation – lack of inventive step challenge rejected
PATENTS – validity – lack of clarity and definition – whether word “essentially” rendered claim unclear – grounds of invalidity not established
PATENTS – relief – where patent expires within two months of delivery of judgment – whether injunction restraining exploitation of invention appropriate – injunction appropriate in circumstances
Legislation:

Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)

Patents Act 1952 (Cth)

Patents Act 1990 (Cth) ss 7(2), 7(3), 18(1)(b)(ii), 40(2)(b), 40(3) and 117

Patents Amendment Act 2001 (Cth)
Cases cited:

Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411

Albany Molecular Research Inc v Alphapharm Pty Ltd [2011] FCA 120; 90 IPR 457

Aristocrat Technologies Australia Pty Limited v Konami Australia Pty Limited [2015] FCA 735; 114 IPR 28

Aspirating IP Ltd v Vision Systems Limited [2010] FCA 1061; 88 IPR 52

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; 226 FCR 324

AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30; 257 CLR 356

Britax Childcare Pty Ltd v Infa-Secure Pty Ltd [No 3] [2012] FCA 1019

Calidad Pty Ltd v Seiko Epson Corporation (No 2) [2019] FCAFC 168; 147 IPR 386

CCOM Pty Ltd v Jeijing Pty Ltd [1994] FCA 396; 51 FCR 260

Commissioner of Patents v Emperor Sports Pty Ltd [2006] FCAFC 26; 149 FCR 386

Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86; 277 FCR 267

Flexible Steel Lacing Co v Beltreco Ltd [2000] FCA 890; 49 IPR 331

GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Ltd [2016] FCAFC 90; 120 IPR 406

Hood v Bush Pharmacy Pty Ltd [2020] FCA 1686; 158 IPR 229

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Details
Case
[2022] FCA 92
Decision Date

CaseChat Overview and Summary

Pharmacia LLC sued Juno Pharmaceuticals Pty Ltd for patent infringement, validity, and relief in the Federal Court of Australia. The dispute centred on a standard patent for a reconstitutable powder composition containing a cyclooxygenase-2 inhibitor intended for parenteral administration. Juno Pharmaceuticals manufactured and sold a competitor product, leading to the infringement claim. The validity of the patent was challenged on several grounds, including lack of inventive step and clarity. The court had to determine whether Juno Pharmaceuticals' products infringed the patent claims and whether the patent was valid.

The court addressed several legal issues, including the interpretation of terms such as "about," "therapeutic agent," and "essentially" in the patent claims. It also considered whether the claims included or excluded residual water from the composition and whether the omnibus claim was infringed. Regarding validity, the court assessed whether there was a lack of inventive step and clarity in the patent claims. The hypothetical skilled team's approach to formulating the composition was also examined.

The court found that three batches of Juno Pharmaceuticals' products fell within the scope of the asserted claims, while the other three did not. It rejected the challenges to the validity of the claims, including the lack of inventive step and clarity. The court determined that Pharmacia LLC was entitled to injunctive relief to restrain infringement, considering the patent's impending expiration.

The court's detailed analysis included the examination of expert evidence, the hypothetical skilled team's approach, and the properties of the active pharmaceutical ingredient (API) and excipients. It concluded that the claims were clear and that the hypothetical skilled team would have reasonably arrived at the claimed invention. The injunctive relief was deemed appropriate to prevent prejudice to the proper administration of justice.

Orders

Orders of the court

1. Pursuant to s 37AI of the Federal Court of Australia Act 1976 (Cth) and on the ground that it is necessary to prevent prejudice to the proper administration of justice, the text of the reasons for judgment published today may be published and disclosed only to the persons listed in order 1(a) of the orders made on 26 April 2021.

2. The parties confer and, by 1 March 2022, provide to chambers:

(a) an agreed form of the reasons for judgment that is suitable for publication, with redactions noted; and

(b) short minutes of order giving effect to these reasons marked-up to indicate any areas of disagreement.

3. The proceedings be listed for a case management hearing at 9.30am on 17 March 2022.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

In his first affidavit, Dr Mokdsi reports that he conducted a search using the PubMed online database as if it were April 2001 according to a search strategy provided to him by the solicitors for the respondents, and exhibits the results. In his second affidavit, Dr Mokdsi responds to the evidence of Mr Cruise. He refers to receiving supplementary instructions for the conduct of a search and annexes the results of that search, both of which he had omitted to include in his first affidavit. He responds to the criticisms made by Mr Cruise by conducting further searches. Dr Mokdsi was not cross-examined. 3. BACKGROUND COMMON GENERAL KNOWLEDGE The following background information is extracted from the formulation primer and the pain primer. The parties agree that it forms part of the background common general knowledge as at the priority date. In the case of the formulation primer, there were some limited areas of disagreement or differences in emphasis between Professor Winter and Dr Robertson (the formulation experts). To the extent necessary, in what follows I have included my findings as to the (limited) areas of dispute. 3.1 Formulation primer In the pharmaceutical industry, as the drug molecule moves through its development it is often described as the active ingredient, the drug substance or active pharmaceutical ingredient (API) and these terms are often used interchangeably. The API may be defined as the therapeutically active ingredient in a pharmaceutical drug product and is the chemical entity that provides the clinical benefit. One of the important preclinical aspects of testing a new drug molecule is to determine its ADMET properties. ADMET refers to Absorption, Distribution, Metabolism, Excretion and Toxicity. The ADMET team generally consists of experts in drug metabolism, pharmacokinetics and toxicology and involves the analysis of the drug in various biological matrices. The purpose of ADMET testing is to obtain information that will allow the API to proceed into clinical trials in humans (hence the name "preclinical development stage"). ADMET testing provides an initial view of the API’s toxicity compared with its efficacy. It therefore serves as a means of selecting the starting dosage in healthy volunteers in Phase I clinical trials. The objective of a Phase I clinical trial is to determine if the drug can be delivered safely and engage with its target. The formulation used in the Phase I clinical trials is preferably, but not invariably, the same as that used in the Phase II and Phase III clinical trials and in the commercial product. Because of this, the formulator is typically involved in the preclinical stage. The formulator's role is to formulate the API into a commercially viable formulation that can be used in clinical trials and then to market. The formulation stage is described further below. There is generally a considerable amount of time between the Phase I trials and the commercial product being finalised and changes in the formulation are commonly made during that time due to various reasons. For example, a liquid formulation might be changed to a lyophilisate due to a realisation that the liquid formulation does not remain stable for a sufficient amount of time for a commercial product.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

In their amended particulars of invalidity the respondents additionally pleaded lack of novelty, lack of utility and lack of fair basis. However, in their opening submissions at the hearing they indicated that they did not press the first of these and part of the second and in closing submissions they shed the balance. 1.3 Summary of conclusions For the reasons set out in more detail below, I have found that three of the exemplar batches of the Juno products fall within the scope of claims 1, 4, 5, 11, 14, 15, 17, 18, 19, 20, 21, 24, 34, 35, 36, 37, 38, 39, 40 and 41 but not claims 7, 26, 27, 28, 30 or 42. I have found that the other three exemplar batches do not fall within the scope of any of the relevant claims. I have rejected the challenges to the validity of the relevant claims. I have also determined that the applicants are entitled to injunctive relief to restrain infringement. 2. THE WITNESSES Seven witnesses gave evidence for the purposes of the proceedings, six of whom were expert witnesses. Five of the expert witnesses were cross-examined. No challenges were made to the credit of any of the witnesses and I generally found them to be good witnesses who gave evidence in accordance with their obligations as experts to assist the court. In general, the expert witnesses were well qualified to give evidence on the subjects that they addressed. The parties made submissions as to the relative weight to be given to their evidence from time to time. I address specific aspects of those submissions, where relevant, during the course of my reasons. 2.1 The applicants’ witnesses Gerhard Johannes Winter is a professor and chair of Pharmaceutical Technology and Biopharmaceutics in the Department of Pharmacy at Ludwig-Maximilians-University, Munich. He studied pharmacy at the University of Heidelberg and graduated in 1982. He was awarded a PhD by the University of Heidelberg in 1987. From 1987 to 1988 he worked for Merck KGaA leading a laboratory for solid dosage form development, after which he worked at Boehringer Mannheim (which later became Roche) from 1988 until 1999. There he was responsible for parenteral (including freeze-dried parenteral) and liquid dosage form development across every step in the development process from pre-formulation through to the completion of the product for regulatory submission. During this period he led a large scale aseptic pilot plant to supply worldwide clinical studies with parenteral lyophilisates (freeze-dried products) and sterile injectable solutions. He was also involved in drug delivery research. From 1993, he was promoted to head the department for parenteral and liquid dosage form development and became responsible for overseeing a group of about five PhD level scientists who each oversaw their own teams. In 1997 he was promoted to become the deputy head of pharmaceutics development where he oversaw the formulation department, a group working on solid dosage forms and a group dealing with clinical supplies, manufacturing and managing the packaging of supplies to support clinical studies. While with Boehringer Mannheim/Roche he was involved in the development of a number of major drug products, including erythropoietin (EPO), reteplase (rPA), various antibodies and small molecular weight drugs such as ibandronate (a bisphospohonate), all of which became marketed formulations. In addition, Professor Winter worked on over 50 formulation candidates that did not make it to market, including small and large molecular weight drugs and liquid and lyophilised parenteral dosage forms.

Ratio Decidendi

Legal Principle Established

Injectable routes of administration typically include, but are not limited to, the subcutaneous (under the skin), intramuscular and intravenous. Reasons for choosing an injectable route over an oral route for example include drugs with low oral bioavailability, patients who are unable to take the drug by mouth (e.g., it irritates the GI tract), the need for immediate effect (e.g., emergency situations), the patient is unconscious or otherwise not able to swallow or there is a desire to control the rate of absorption and duration of effect. When commencing a formulation task, the formulator seeks to understand the properties of the API (having regard to the selected route of administration). Where the drug development involves the formulation of a known drug molecule, the formulator will acquire publicly available information about the relevant properties of the API, for example, from a search of relevant medical or chemical databases. Where the drug is a new drug molecule the formulator will attempt to acquire any information about the relevant properties of similar APIs from a search of relevant medical or chemical databases. In both instances, the formulator will give consideration to the chemical structure of the drug molecule. Properties of the API in which the formulator will be interested include the solubility of the API in aqueous solutions, dissolution rate (which is the speed at which the API can go into dissolution), ionisation potential (which is relevant to the ability of the API to form salts and the pH of the resulting drug substance solution, which may require adjustment of buffering), stability of the API and its salts if any and any excipient interactions with the API. It is generally critical that injectable formulations, particularly formulations prepared for intravenous use, do not contain any particulate matter, and that precipitation of either the API or added excipients does not occur during or following injection. Solid particulate matter can in many cases cause thrombosis and the formation of blood clots that can be dangerous to the subject receiving the injection. For any dosage form and route of administration, a minimum desired stability for a commercial pharmaceutical product is generally about two years. For some vaccines, for example, it can be shorter. Excipients are substances other than the API that may be included in a formulation. Ideally, excipients have no biological activity in their own right and are only included in any given formulation of an API if they are required to solve a particular problem. Consideration which may lead to the use and types of excipients will vary depending upon the form of the drug product (e.g. solid or liquid) and its route of administration. A particular excipient will only be added to a formulation if it achieves a particular purpose. The purposes of adding an excipient to a formulation may include, for example:(a)to enhance stability, bioavailability or patient acceptability;(b)to assist in the effectiveness of delivery; and(c)to assist in maintaining the integrity of a drug product during storage.