Merck & Co Inc v Arrow Pharmaceuticals Ltd

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FEDERAL COURT OF AUSTRALIA

Merck & Co Inc v Arrow Pharmaceuticals Limited [2006] FCAFC 91

PATENTS – bisphosphonates known to inhibit bone resorption – oral administration of bisphosphonates known to cause gastrointestinal side effects – administration of bisphosphonates at high relative dosage and low relative dosing frequency found to reduce side effects

PATENTS – manner of manufacture – new dosage regime for known substance to treat known condition – high dosage weekly as opposed to regimens of low dosage daily or cyclic treatments

PATENTS – novelty – industry journal distributed via mailing list – whether to be ‘publicly available’ a publication must be catalogued or identified in a way which would enable anybody to find it – articles suggest dosage regime ‘needs to be tested’ – whether articles nonetheless constitute an anticipation

WORDS AND PHRASES – ‘publicly available’

Patents Act 1903 (Cth) s 47
Patents Act 1952 (Cth) s 100(1)(g)
Patents Act 1990 (Cth) ss 7(1), 18, 138, 186, 40

Arrow Pharmaceuticals Limited v Merck & Co Inc [2004] FCA 1282 overruled
Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1 cited
Bristol-Myers Squibb Company v F H Faulding & Co Ltd (2000) 97 FCR 524 applied
Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232 cited

National Research Development Corporation v Commissioner of Patents (1950) 102 CLR 252 applied

N V Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 considered

Sunbeam Corporation v Morphy-Richards (Aust) Pty Ltd (1961) 180 CLR 98 cited
Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171 at 191-192 cited
Fomento Industrial SA v Metmore Manufacturing Co Ltd [1956] RPC 87 cited
Re Bristol Myers and Co’s Application[1969] RPC 146 cited

Morgan & Co v Windover & Co [1890] 7 RPC 131
Elias v Grovesend Tinplate Company [1890[ 7 RPC 455 approved

Stanway Oyster Cylinders Pty Ltd v Marks (1996) 35 IPR 71 at 74-75 cited

Vallance v The Queen (1961) 108 CLR 56 at 76 cited
Hill v Evans (1861) 4 De G F & J 288, 45 ER 1195 followed
C Van Der Lely NV v Bamfords Limited [1963] RPC 61 followed
Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 applied

Industrial Property Advisory Committee, ‘Patents, Competition and Innovation in Australia’, 29 August 1984

MERCK & CO INC v ARROW PHARMACEUTICALS LIMITED

NSD 1563 OF 2004

HEEREY, KIEFEL & DOWSETT JJ
15 JUNE 2006
BRISBANE (HEARD IN SYDNEY)


IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

NSD 1563 OF 2004

ON APPEAL FROM A SINGLE JUDGE OF THE FEDERAL COURT OF AUSTRALIA

BETWEEN:

MERCK & CO INC
APPELLANT

AND:

ARROW PHARMACEUTICALS LIMITED
RESPONDENT

JUDGES:

HEEREY, KIEFEL & DOWSETT JJ

DATE OF ORDER:

15 JUNE 2006

WHERE MADE:

BRISBANE (HEARD IN SYDNEY)

THE COURT ORDERS THAT:

1.        The appeal be dismissed.

2.        The appellant pay the respondent’s costs, including reserved costs.

Note:    Settlement and entry of orders is dealt with in…

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Details
Case
[2006] FCAFC 91
Decision Date

CaseChat Overview and Summary

Merck & Co Inc appealed against the decision of the primary judge, who held that claims 1-3 of the patent were invalid. Arrow Pharmaceuticals Ltd sought to revoke claims of the patent, which was related to a method of inhibiting bone resorption by administering an effective amount of alendronic acid to a patient. The dispute centred on the validity of the claims of the patent, which related to the administration of alendronate for the treatment of osteoporosis. The Full Court of the Federal Court of Australia was tasked with determining the validity of claims 1-3 of the patent. The court needed to decide whether the claims were novel and involved an inventive step, and whether they were a manner of manufacture as required by statute.

The Full Court held that the appeal should be dismissed. The court found that the claims did not involve an inventive step, as they were based on known substances and methods. The court also held that the claims did not constitute a manner of manufacture, as they were directions for use of a known substance for a known purpose. The court further found that the claims were not novel due to prior publication of articles in Lunar News, which anticipated the claims. The Full Court held that the primary judge's decision was correct, and that the claims were invalid. The appeal was dismissed, and the appellant was ordered to pay the respondent's costs, including reserved costs.

Orders

Orders of the court

1. The appeal be dismissed.

2. The appellant pay the respondent’s costs, including reserved costs.

Background

Background to the litigation

The respondent (‘Arrow’) commenced proceedings in the Court under s 138 of the Act seeking orders that each of the claims of the Patent be revoked. Merck did not defend the claims of the Patent as granted but proposed and secured amendments to the claims such that only ten claims were finally pursued. Arrow asserted the invalidity of seven of those claims, all of which were held by the primary judge to be invalid: Arrow Pharmaceuticals Limited v Merck & Co Inc [2004] FCA 1282. Merck appeals to the Full Court from that decision. The Notice of Appeal is now pressed only with respect to claims 1 – 3, the terms of which are set out later in these reasons.Background A variety of disorders in humans and other mammals involve or are associated with abnormal bone resorption (loss of substance). Such disorders include osteoporosis, Paget’s Disease, periprosthetic bone loss or osteolysis and hypercalcemia of malignancy. The most common of those disorders is osteoporosis, which in its most frequent manifestation occurs in post-menopausal women. Bisphosphonates have been known to be inhibiters of bone resorption since the 1970’s. Alendronate is a potent bisphosphonate compound. In about 1983 patents were granted in various countries (but not in Australia) containing claims relating generally to a method of inhibiting bone resorption by administering an effective amount of alendronic acid to a patient in need thereof. In about 1987 or 1988, Merck acquired the rights to these patents for alendronate and set about exploiting them. In 1990 Merck filed a patent application claiming priority back to 1989 that was granted as Australian Patent 625704, which is currently in force and is due to expire on 8 June 2010. That Australian Patent includes claims directed to the specific alendronate monosodium trihydrate species, compositions containing the same, a process for preparing alendronic acid or salts and methods for treating or preventing osteoporosis by administering the same. Despite their therapeutic benefits, biphosphonates are poorly absorbed from the gastrointestinal tract. Gastrointestinal (‘GI’) side effects are well-known. By October 1995 alendronate was approved for sale and was on sale by Merck in the United States under the trade name ‘Fosamax’ on the basis of a dosage of 10 mg per day for the treatment of osteoporosis and 40 mg per day for the treatment of Paget’s Disease. Fosamax was initially registered in Australia pursuant to the Therapeutic Goods Act 1989 (Cth) in July 1996 on the basis of the same dosages. On 1 October 1996 Fosamax was released for sale in Australia for the treatment of osteoporosis and Paget’s Disease at the dosages indicated. Lunar Corporation is a US company with a business that specialises in bone densitometry. The principal was Dr Mazess (whose qualifications and experience were in the fields of radiology and medical physics). It did business with Merck from time to time. Several times a year it published a magazine entitled Lunar News which contained articles on topics of interest related to its business. The issues of Lunar News for April 1996, July 1996 and April 1997 contained articles in relation to bisphosphonates in general, and alendronate in particular, which were found by the primary judge to anticipate claims 1, 2 or 3 of the Patent or some of them. It will be necessary to return, in due course, to the details of these publications and as to whether the information contained in them was ‘publicly available’ before the priority date.The Patent

Evidence

Evidence Before The Court

In the April 1997 issue under the heading ‘Update: Bisphosphonate’ it is said:‘One way to reduce the relatively high cost, and the potential side effects, of potent oral bisphosphonate may be to dose only two or three times a week rather than daily. In pigs, the bisphosphonate dose can be reduced without adverse effect on skeletal response by giving a standard ‘daily dose’ every fourth day or for 5 days out of 20. In the human, there is little difference between 5 and 10 mg/day of alendronate, so the 10 mg dose theoretically could be given only 3X a week or the 40 mg dose once per week. Serum biochemical markers could be used to titrate dose downward. If turnover remains low after three months at 3X/week, the dose could be reduced to 2X/week or lower. These new clinical approaches to dosing need to be tested in at least short-term trials.’Evidence as to publication of Lunar News From the late 1980s until 2000 Dr Mazess was the author and editor of Lunar News. The aim of this publication was to provide a summary of other articles in the bone area and in particular the treatment of bone diseases and bone densitometry and his opinion on various developments in these areas. In the second half of the 1990s Lunar News was published three times a year. There were two main mailing lists, a select mailing list which was sent by first class or airmail to approximately 1000 priority contacts around the world and the conventional mailing list which was distributed as printed matter mail in the United States. International copies were often sent as packages to distributors who in turn mailed copies locally in the countries they represented. In all about 9,000 to 10,000 copies went to US recipients including Lunar Corporation customers, potential customers and libraries and the remainder of about 8,000 went to recipients outside the United States. Lunar News was also available on the Lunar website. Among the recipients of Lunar News were Dr Santora and Dr Yates of Merck. Dr Mazess identified from a mailing list four Australian recipients. Mr Lyndon Davies of West Pennant Hills New South Wales at relevant times provided consultancy services to Lunar Corporation for its activities in the Asia Pacific region. He received copies of Lunar News and a client distribution list for Australia and New Zealand from the international marketing support department of Lunar Corporation. The total number of listed recipients of Lunar News in Australia and New Zealand in about 1996 was approximately 150, of which 100 were associated with clients of Lunar Corporation and the remainder were potential clients including universities and hospitals or other individuals interested in receiving the publication. Mr Davies attended medical conferences dealing with pain research, bone density and bone research in 1996 and 1997 and distributed the current editions of Lunar News to conference attendees. Dr Terrence Diamond is a Senior Consultant at St George’s Hospital in Sydney. His evidence was that he did not see the first or second issues of Lunar News in question. He does not discuss the third. As to the general availability of the publication at his hospital he says:‘I did not have the time or opportunity to read every edition of “Lunar News”, nor did they all find their way to me from the nuclear medicine department.’The statutory test for novelty

Decision

Reasons for decision

These claims are to a method of treatment (or prevention) of a particular disease with an amount (specified in claims 1 and 2 but not in claim 3) of a known chemical or drug (alendronate) already known to treat that disease, with the sole asserted novelty being that the amount of the drug (claims 1 and 2) or the drug per se (claim 3) is taken weekly. An issue arises in relation to claim 3 as to whether on its proper construction the reference to a ‘pharmaceutically effective amount’ should be read as signifying 35 mg or 70 mg as the case may be, although the primary judge declined to construe claim 3 in that way.The judgment appealed from The primary judge held (pursuant to ss 138(3)(b) and 18(1)(a) of the Act) that claims 1 – 3 were invalid because they did not claim a manner of new manufacture within the meaning of s 6 of the Statute of Monopolies. A method of medical treatment of the human body is patentable: Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1; Bristol-Myers Squibb Company v F H Faulding & Co Ltd (2000) 97 FCR 524. Arrow accepted that the primary judge was bound by those decisions and that this Court would follow them whilst reserving its right to argue that those decisions are wrong should the matter proceed to the High Court of Australia. However, his Honour held that in substance, each claim relates to the use of a known substance with known properties for a known purpose in a known manner. There is no claim of any new process or method of the administration of such. There is no claim of discovery of new physical properties in the compound. Guided by the decisions of the High Court in Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232, National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 and N V Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655, and having regard only to the disclosures in the specification itself, the primary judge held that each of the so-called method claims was one way of utilising alendronate and its known qualities for the known purpose of preventing or treating osteoporosis by a known method of oral administration. They are in the nature of directions for use. That does not constitute an invention or a manner of manufacture. The second ground on which his Honour found that claims 1, 2 and 3 were invalid is that the claims were not novel by reason of the prior publication of the Lunar News articles. His Honour found that the information contained in these publications was ‘publicly available’ and that the April 1996 issue of Lunar News anticipated claim 3, the July 1996 issue anticipated claims 1, 2 and 3, and the April 1997 issue anticipated claims 1 and 3. One of the grounds upon which Arrow asserted the invalidity of the Patent was that when compared with the prior art base as it existed before the priority date, the claims did not involve an inventive step: s 18(1)(b)(ii). In the light of his other conclusions, it was not necessary for the primary judge to deal with this ground, and he did not do so as he said that it would involve grappling with a considerable body of evidence and the exercise would have an air of unreality having regard to his conclusion that the invention lacked subject matter. By its Amended Notice of Contention Arrow asserts that the primary judge should have found that the invention as claimed did not involve an inventive step when compared with the prior art base as it existed before the priority date.The issues on appeal

Ratio Decidendi

Legal Principle Established

Full text does not contain this section.