Arrow Pharmaceuticals Ltd v Merck & Co Inc

Link copied
Case Copied 78 min read

FEDERAL COURT OF AUSTRALIA

Arrow Pharmaceuticals Limited v Merck & Co., Inc. [2004] FCA 1282

PATENTS – application for revocation – attempt to ‘evergreen’ pharmaceutical patent – validity – whether new dosing regime for administering known substance for known purpose by known method without new pharmaceutical properties constitutes a manner of manufacture or an invention

PATENTS – application for revocation – novelty – whether claimed invention anticipated by information in commercial magazine – magazine distributed internationally to existing and potential customers of commercial corporation – recipients of magazine free in law and equity to make use of information contained therein – no evidence magazine available on request or for inspection in any public library – evidence of publication of contents of magazine via the internet – whether information ‘publicly available’ so as to constitute ‘prior art information’ for the purposes of the Patents Act 1990 (Cth)

PATENTS – application for revocation – novelty – dosage regime for administering alendronate – whether method anticipated by prior art information – application of reverse infringement test – prior art information suggested testing of claimed invention – whether suggestion that disclosed invention be tested prevented disclosure from constituting anticipation – whether suggestion of specific doses anticipated claimed invention

PATENTS – application for revocation – false suggestion – patent specification contained statements alleged to misrepresent conclusions drawn from published article – no finding that any such misrepresentation intended to mislead – whether patent obtained by fraud, false suggestion or misrepresentation

WORDS AND PHRASES – ‘made publicly available’

Patents Act 1990 (Cth), ss 7, 18, 40, 80–87, 138

Adhesive Dry Mounting Co Ltd v Trapp & Co (1910) 27 RPC 341 referred to
Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171 considered
Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1 followed
Azuko Pty Ltd v Old Digger Pty Ltd (2001) 52 IPR 75 cited
Bristol-Myers Squibb Co v Baker Norton Pharmaceuticals Inc [2001] RPC 1 referred to
Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 97 FCR 524 followed in part; distinguished in part
Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232 applied
Fomento Industrial SA v Mentmore Manufacturing Co Ltd [1956] RPC 87 cited
ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc (2000) 106 FCR 214 cited
Kimberley-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 cited
Merck & Co., Inc’s Patents [2003] EWCA Civ 1545; [2004] FSR 16 referred to
Merck & Co., Inc’s Patents [2003] EWHC 5 (Pat); [2003] FSR 29 referred to
Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 applied
National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 considered
NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 applied
Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 applied
PLG Research Ltd v Ardon InternationalLtd [1993] FSR 197 cited
Re Bristol-Myers Co’s Application [1969] RPC…

CaseChat AU logo

Keep reading for free

Create a free CaseChat account to read Arrow Pharmaceuticals Ltd v Merck & Co Inc and more:

  • Read every judgment in full
  • Ask AI and get answers linked to paragraphs
  • See how each paragraph was cited in later cases
  • Download judgments as PDF or Word
Continue with Google

One click creates your free account or signs you in.

By continuing you agree to the Terms and Privacy Policy.

Details
Case
[2004] FCA 1282
Decision Date

CaseChat Overview and Summary

In the case of Arrow Pharmaceuticals Ltd v Merck & Co Inc, the dispute centred on the validity of certain patent claims related to the use of alendronate, a bisphosphonate compound used in the treatment of bone resorption diseases such as osteoporosis. The primary legal issues addressed by the court involved the assessment of inventive step and novelty of the patent claims, specifically focusing on the method of administration and the dosage forms of alendronate. The court was tasked with determining whether the claims related to the administration of alendronate in tablet or liquid form, or at specific dosages, involved any inventive step that was not already part of the common general knowledge at the priority date of the patent.

The court reasoned that the patent specification did not demonstrate any inventive step in formulating the composition for administration, as it only referenced standard mixing and formulation techniques. The court further noted that even if the dosage regime was novel, it did not inherently confer novelty on the method of administration or the substance itself. The evidence presented indicated that tablets containing up to 40 mg of alendronate were already available in the market by the priority date, thereby negating the novelty of higher dosage formulations. Consequently, the court concluded that the claims concerning the specific formulations and dosages were invalid.

The court ordered that the proposed claims 1, 2, 3, 5, 6, 9, and 10 be deemed invalid. The proceeding was adjourned to allow the parties to prepare formal orders. The court indicated that Merck should bear the costs of the proceeding for Arrow Pharmaceuticals, excluding those related to particulars of invalidity on the ground of novelty that were not pursued at trial. The court invited the parties to bring any omissions or significant live issues to its attention.

Orders

Orders of the court

The proceeding stand over for the making of orders.

Background

Background to the litigation

The claims included:‘20.A method of treating or preventing a disease of bone resorption comprising administering to a person in need of such treatment an effective amount of the compound of any one of claims 14, 15, 16, or 17, or the composition of claim 18 or 19.21.The method of claim 20, wherein said disease is hypercalcemia of malignancy, Paget’s disease or osteoporosis.22.The method of claim 20, wherein said disease is osteoporosis.…25.A method of treating or preventing a disease of bone resorption comprising administering to a person in need of such treatment an effective amount of the compound of claim 23, or the composition of claim 24.26.The method of claim 25, wherein said disease is hypercalcemia of malignancy, Paget’s disease or osteoporosis.27.The method of claim 25, wherein said disease is osteoporosis.’Narrative of Facts The narrative of the facts which follows is largely drawn from the chronologies prepared by the parties and much of it is not controversial. Some of it is reflected in the extracts from the specification of the patent in suit already set out. Bisphosphonates have been known since the 1970s to be inhibitors of bone resorption. The clinical application of bisphosphonates including their use, effectiveness and side effects in the treatment and prevention of osteoporosis was well known. Gastrointestinal (GI) side effects were well known. Etidronate and clodronate were each bisphosphonates developed for clinical use. Pamidronate followed. It was the first aminobisphosphonate compound developed for clinical use in the treatment of osteoporosis. Clinical trials were organised by Ciba-Geigy in 1989–1990. The trials of oral administration of pamidronate were discontinued because of GI side effects. The trial experience was published in November 1994 in Vol 4 of the periodical Osteoporosis International in an article by Lufkin et al entitled ‘Pamidronate: An Unrecognised Problem in Gastrointestinal Tolerability’. The 1995 edition of Bisphosphonates in Bone Disease by Professor Fleisch reported (at p 152) that:‘Oral pamidronate as well as other aminobisphosphonates can give rise to dose-related gastrointestinal disturbances that may be severe’.That report related to oral doses of 300 mg or more daily. In about 1987 or 1988, Merck acquired the rights to the base Gentili patents for alendronate and set about exploiting them. It was necessary to satisfy the Food and Drug Administration (FDA) of the United States of efficacy and safety pursuant to the US regulatory regime concerning drugs for the treatment of humans. Phase II clinical trials commenced in 1991 with the Harris study of six weeks on 65 healthy post-menopausal women. It was followed by the two year Chesnut study in 1992–1993 as to 5, 10, 20, and 40 mg orally daily on 188 post-menopausal women with osteoporosis. That study was reported in September 1995 in the periodical American Journal of Medicine, Vol 99 in an article by Chesnut et al ‘Alendronate Treatment of the Postmenopausal Osteoporotic Woman: Effect of Multiple Dosages on Bone Mass and Bone Remodeling’ (the Chesnut article).

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

GYLES J
I can, however, deal with the composition claims. I have held that it is plain on the face of the specification that there is no inventive step involved in formulating the composition in a form appropriate for administration – whether in tablet or liquid form. Reference is only made to standard mixing and formulation techniques. I have pointed out that, even if the dosage regime is novel, that of itself does not confer novelty on the manner of administration or the substance involved. It was clearly part of common general knowledge by the priority date that tablets of up to 40 mg active ingredient of alendronate were on the market. That answers the description in claims 5 and 6 in substance. Even if one 70 mg tablet were contemplated by claims 9 and 10 (contrary to the United Kingdom decisions), there is no evidence to suggest that there is any inventive step in formulating a 70 mg tablet or the equivalent liquid.Conclusion Proposed claims 1, 2, 3, 5, 6, 9 and 10 are invalid. I will hear the parties upon the formal orders to be made. Arrow should bring in short minutes of order. As to costs, my present view is that Merck should pay Arrow’s costs of the proceeding, excluding costs relating to particulars of invalidity on the ground of novelty which were not pursued at trial. The parties should draw to my attention any omission to deal with any significant live issue in these reasons.

Ratio Decidendi

Legal Principle Established

Established by: GYLES J

The following exchanges of emails took place on 12 June 1997:‘From: Browne, PeterTo: DiCesare, Elizabeth A.Cc: Barbara Senich; Katdare, Ashok V.Subject: Today’s Alt Form Task ForceDate: Thursday, June 12, 1997 10:32AMPriority: HighBeth,Some quick thoughts on today’s Alternative Formulations Task Force meeting:Marketing is in agreement with HHPAC decisions on dosing/formulations. For each of the options, I’ll list our thoughts:·Once weekly dosing – Very promising, important enough to start in clinical ASAP if we go with 40mg tablet, however, we recommend a 35 mg dose to make registration simpler (more directly substitutable for 5 mg and 10 mg given daily.…For the new product image, we will be doing the forecasts and marketing pros/cons in preparation for the results of the market research, to support the decision which will need to be made after full market research results are received. As you know, this is the one option that we can place into the market faster than risedronate and possibly tiludronate. Timelines discussed at recent DDST indicate that 1Q99 is fastest possible date. ANYTHING that can be done to accelerate this timing will be a major victory. I am assuming that we can gain internal sign-off by late August, or early September at the latest.For once/twice weekly dosing, WHHM strongly supports the safety assessment program in dog model, and as stated earlier, we’d like to see 35mg over 40mg. We’d also like to file with 6 months BMD, if this has a REASONABLE probability of success. What are the tradeoffs in sample size, prob of success, etc. …’(emphasis added)‘From: Santora, Arthur C.To: Holland, Sherry D.Cc: DiCesare, Elizabeth A.Subject: MORE bioavailability studies for FOSAMAX?Date: Thursday, June 12, 1997 4:17PMSherry,After you left the Alternative Formulations meeting today a topic was raised about the need to look at the bioavailability of a 70 or 80 mg dose if that were chosen for the new program. Beth and I recalled that the Bioavailability Dose-proportionality study went up to 80 mg. Ashok thought it was 40 mg. Either way, the biobatches only went to 40 mg, so a complete CMC package would be required. Your opinion is needed on whether a bioavailability study would be needed for a 70 or 80 mg dose if we chose to register the dose. The plan for clinical development includes a comparison to the 10 mg dose administered daily (our standard) so there would be data to support an equivalent BMD and bone biochemical effect of 10 daily and 70 or 80 weekly. Would any additional bioavailability studies be needed to support the application?Art’‘From: Holland, Sherry D.To: Santora, Arthur C.Cc: DiCesare, Elizabeth A.Subject: RE: MORE bioavailability studies for FOSAMAX?Date: Thursday, June 12, 1997 4:53PMArt: What 70- or 80-mg dose? for what program? Last I heard we were looking at 35- or 40-mg dose 1x/week for prevention and 2x/week for treatment. The dose proportionality study with capsules went up to 80 mg. The FMI dose proportionality with the tablet went up to 40 mg (35 mg not included, but would arguably be in that range). The 35-mg tablet would probably require a PK study vs a registered dose (10 or 40) to confirm its performance (i.e. dose-adjusted GMR of AUC within (0.8, 1.25). To register a 70- or 80-mg tablet would require a PK study compared at least to 10 mg (also 5?, 40?) with the same type of relative bioeavailability [sic] question and perhaps also dose-proportionality. Are you looking at 70- or 80-mg once a week? Or 35- or 40-mg twice a week? Sherry’‘From: Santora, Arthur CTo: Holland, Sherry D.Cc: DiCesare, Elizabeth A.; Katdare, Ashok V.Subject: RE: MORE bioavailability studies for FOSAMAX?Date: Thursday, June 12, 1997 6:47 PMSherry,Osteoporosis treatment. The potentially patentable claim is that the same total dose for alendronate (and related bisphosphonates) given once a week is less toxic to the esophagus (at least in dogs) than one-seventh the dose given once a day. Of course, it would be similarly efficacious. It would be less desirable to use 35 or 40 mg twice a week than to use double the dose once a week. Twice-a-week dosing would also greatly complicate the convenience claim (“I thought you said only one day a week,” remarked the lady with the kyphosis.) and muddle the patent claim.Nobody could recall anyone actually “killing” a 70 or 80 mg dose at the T-pac or technical review. Although it may by [sic] “killed” at the next higher level review, its still in for now - - along with 35 to 40 twice a week in treatment.Thanks for the info.Art.’(emphasis added)