Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Anor [2018] UKSC 56
(UKSC) Lords Mance, Sumption, Reed, Hodge, Briggs var’g [2016] EWCA Civ 1006 Floyd LJ:
Patten, Kitchin LLJ var’g [2015] EWHC 2548 (Pat) Arnold J
EP(UK) 0934061 / pregabalin / LYRICA
The decision of the UKSC in Warner-Lambert v Actavis is important in UK law both for its
discussion of the concept of “plausibility” and in respect of infringement in the context of a
second medical use patent. This post provides an overview and discusses the issue of
infringement, which raises a truly difficult problem, of how to balance the need for an incentive to
develop new indications of a known drug, against the need to allow unfettered availability of the
same drug for prior indication. I will argue that Warner-Lambert v Actavis does not provide a
solution; and it is unlikely to have much impact in Canadian law, except, perhaps, as a cautionary
tale about how the well-intentioned restriction on patentability of methods of medical treatment
has gone badly awry.
Overview
Pregabalin is indicated and marketed by Warner-Lambert for the treatment of epilepsy, general
anxiety disorder ("GAD") and neuropathic pain [Pat 2]. Warner-Lambert’s patent EP0641330
claimed pregabalin as such and for use in treating epilepsy and GAD. That patent expired in
2013. The key claims of Warner-Lambert’s 061 patent were Swiss-form claims to pregabalin for
the treatment of pain, inflammatory pain and neuropathic pain (Claims 1-3) [5]. Claim 3 was the
most important, as neuropathic pain is the most common type of pain for which pregabalin is
indicated [7], [13]. Mylan and Actavis, seeking to launch a generic pregabalin product, brought
separate actions for revocation of the 061 patent, which were consolidated [Pat 3]. After both
revocation actions had been started, Actavis decided to launch with a skinny label; that is, with
marketing authorization and corresponding product information targeting only the non-patented
uses. Warner-Lambert brought an action against Actavis in respect of that skinny label launch
[4]. The market at the time was something like 1/3 for unpatented uses, and 2/3 for patented uses
[Pat 399-407,425-42]. (The exact numbers are not important, except to establish that both
patented and unpatented uses were significant.) Note that Warner-Lambert is a company in the
Pfizer group [4], and Warner-Lambert markets pregabalin, under the brand name Lyrica, but
Pfizer holds the marketing authorization [Pat 2]. Nothing turns on this, but many of the facts
refer to steps taken by Pfizer rather than Warner-Lambert.
Showing posts with label Product-by-process claims. Show all posts
Showing posts with label Product-by-process claims. Show all posts
Friday, November 23, 2018
Thursday, May 30, 2013
A Product-by-Process Claim Is Not a Product Claim
Bayer Inc v Cobalt Pharmaceuticals Co / drospirenone (NOC) 2013 FC 573 O'Reilly J
YASMIN® / drospirenone / 2,261,137
In this application Bayer sought an order of prohibition preventing Cobalt from launching a generic version of YASMIN® until the expiry of the ‘137 patent. O’Reilly J refused to grant the order on the basis on non-infringement, and he did not reach Cobalt’s invalidity arguments. The infringement issue turned entirely on claim construction. Bayer’s claim construction argument were far-fetched, and were dismissed by O’Reilly J without difficulty.
Drospirenone is a old compound. The first 12 claims of the ‘137 patent are claims to a process for the production of drospirenone. The description (p 6) states that “a key reaction” in the process is ruthenium-catalyzed oxidation of certain compounds, and all the process claims incorporate that step. Claim 13, the only claim in issue, was to “A product according to the process of claim 12,” wherein the product comprises drospirenone of specified purity. Cobalt alleged that its product would not infringe because its process for the production of drospirenone would not use a ruthenium salt as an oxidizing agent.
Bayer argued that the use of a ruthenium salt as an oxidizing agent was not an essential element of the claims [30]. O’Reilly J rejected this argument [31]-[36]. While identification of the essential elements can sometimes be difficult, in this case O’Reilly J’s analysis is very straightforward and compelling. All the claims included ruthenium and the description identified its use as “key.” There were no alternatives mentioned apart from chromium, which was mentioned only to be avoided; part of the stated purpose of the invention (p 9) was to avoid the use of chromium, for environmental reasons.
Bayer also argued that the SCC decision in Hoffmann-La Roche [1955] SCR 414 stands for the proposition that product-by-process claims should be read as claims to the product alone [13], so that it does not matter how Cobalt’s product was produced, so long as it was of the required purity. As OReilly J pointed out, what Hoffmann-La Roche really says is that you cannot obtain a new patent for an old compound, even though a new process for making it has been invented [20].
Finally, Bayer argued that a skilled person would read Claim 13 as a claim for the purer form of drospirenone, regardless of how it was made [24]. It is not surprising that O’Reilly J rejected this submission, given that the first words of Claim 13 are “A product according to the process of claim 12.”
YASMIN® / drospirenone / 2,261,137
In this application Bayer sought an order of prohibition preventing Cobalt from launching a generic version of YASMIN® until the expiry of the ‘137 patent. O’Reilly J refused to grant the order on the basis on non-infringement, and he did not reach Cobalt’s invalidity arguments. The infringement issue turned entirely on claim construction. Bayer’s claim construction argument were far-fetched, and were dismissed by O’Reilly J without difficulty.
Drospirenone is a old compound. The first 12 claims of the ‘137 patent are claims to a process for the production of drospirenone. The description (p 6) states that “a key reaction” in the process is ruthenium-catalyzed oxidation of certain compounds, and all the process claims incorporate that step. Claim 13, the only claim in issue, was to “A product according to the process of claim 12,” wherein the product comprises drospirenone of specified purity. Cobalt alleged that its product would not infringe because its process for the production of drospirenone would not use a ruthenium salt as an oxidizing agent.
Bayer argued that the use of a ruthenium salt as an oxidizing agent was not an essential element of the claims [30]. O’Reilly J rejected this argument [31]-[36]. While identification of the essential elements can sometimes be difficult, in this case O’Reilly J’s analysis is very straightforward and compelling. All the claims included ruthenium and the description identified its use as “key.” There were no alternatives mentioned apart from chromium, which was mentioned only to be avoided; part of the stated purpose of the invention (p 9) was to avoid the use of chromium, for environmental reasons.
Bayer also argued that the SCC decision in Hoffmann-La Roche [1955] SCR 414 stands for the proposition that product-by-process claims should be read as claims to the product alone [13], so that it does not matter how Cobalt’s product was produced, so long as it was of the required purity. As OReilly J pointed out, what Hoffmann-La Roche really says is that you cannot obtain a new patent for an old compound, even though a new process for making it has been invented [20].
Finally, Bayer argued that a skilled person would read Claim 13 as a claim for the purer form of drospirenone, regardless of how it was made [24]. It is not surprising that O’Reilly J rejected this submission, given that the first words of Claim 13 are “A product according to the process of claim 12.”
Tuesday, March 20, 2012
Lovastatin Decision Affirmed on the Facts
Apotex Inc v Merck & Co Inc / lovastatin 2011 FCA 363, Gauthier JA: Evans, Stratas JJA aff’g
2010 FC 1265 Snider J
In a decision delivered last December, that has yet to be released on the FCA website, Gauthier J, writing for the court in what I believe is her first patent decision since being appointed to the FCA, has affirmed Snider J’s lovastatin decision in an appeal that essentially asked the FCA to reweigh the evidence. Leave to appeal to the SCC has been sought, but I would astonished if it were granted.
Legally, there are only two points of passing interest. First, Gauthier J’s opinion provides a brief but thorough discussion of the law related to the standard of appellate review. While this will not be a leading case in that it does not change the law, it will be a very useful reference decision on this issue.
Secondly, Snider J had interpreted s 55.1 (s 39(2) under the old Act), which provides that “In an action for infringement of a patent granted for a process for obtaining a new product, any product that is the same as the new product shall, in the absence of proof to the contrary, be considered to have been produced by the patented process,” as placing the persuasive burden of proving infringement on the patentee [FC 168- 184]. The FCA refused to endorse this interpretation, on the basis that the burden of proof was not determinative of the appeal, and Snider J did not have the benefit of full argument on the issue [9-10]. In my view, it is a wholly salutary principle that holdings of law are entitled to little weight if they are not essential to the case and are made without the benefit of full argument. Now, if only the SCC would take that principle to heart, and quit its bad habit of making new law in obiter on unargued points.
In a decision delivered last December, that has yet to be released on the FCA website, Gauthier J, writing for the court in what I believe is her first patent decision since being appointed to the FCA, has affirmed Snider J’s lovastatin decision in an appeal that essentially asked the FCA to reweigh the evidence. Leave to appeal to the SCC has been sought, but I would astonished if it were granted.
Legally, there are only two points of passing interest. First, Gauthier J’s opinion provides a brief but thorough discussion of the law related to the standard of appellate review. While this will not be a leading case in that it does not change the law, it will be a very useful reference decision on this issue.
Secondly, Snider J had interpreted s 55.1 (s 39(2) under the old Act), which provides that “In an action for infringement of a patent granted for a process for obtaining a new product, any product that is the same as the new product shall, in the absence of proof to the contrary, be considered to have been produced by the patented process,” as placing the persuasive burden of proving infringement on the patentee [FC 168- 184]. The FCA refused to endorse this interpretation, on the basis that the burden of proof was not determinative of the appeal, and Snider J did not have the benefit of full argument on the issue [9-10]. In my view, it is a wholly salutary principle that holdings of law are entitled to little weight if they are not essential to the case and are made without the benefit of full argument. Now, if only the SCC would take that principle to heart, and quit its bad habit of making new law in obiter on unargued points.
Friday, January 28, 2011
Fossilized Footprints of Section 39
Merck & Co Inc. v. Apotex Inc. / lovastatin 2010 FC 1265, Snider J
The invention at issue in the lovastatin decision related to a process for making lovastatin with the micro-organism A. terreus, and the patent (1,161,380), had both process and a product-by-process claims. A traditional fermented rice, Red Yeast Rice, was said by Apotex (and Wikipedia!) to contain lovastatin produced by a mold of the genus Monascus. The process claims are clearly unaffected, but Apotex argued that the product-by-process claims were therefore invalid as being anticipated by Red Yeast Rice. The obvious rebuttal to this that the product-by-process claims only encompass the product when made by the particular process, in this case by A. terreus; but as Apotex pointing out, Hoffmann-LaRoche Ltd. v. Canada (Commissioner of Patents), [1955] S.C.R. 414, 23 C.P.R. 1 clearly established that a product-by-process claim is to be treated as a product claim, in the sense that it will be anticipated if the product is known, even though made by different process. Snider J accepted this point as being established by the authorities, but with great reluctance, saying she had “considerable difficulty in understanding how the conclusion in Hoffmann-LaRoche 1955 can fit with the protection offered by the Patent Act,” and calling the result “illogical” [578] and even unprincipled [579].
In the end, Snider J held that the claims were valid as she was not satisfied that lovastatin was actually present in the Red Yeast Rice prior to the priority date [598], or, if it was, that it was adequately disclosed [608]. This raises some interesting questions as to the precise requirements for enabling disclosure.
However, I have a simpler question. What does it matter whether the process-by-product claims are valid? As Dr. Fox explained in his annotation to the Exchequer Court decision in Hoffmann-LaRoche, product-by-process claims, in principle at least, offer no advantage to the patentee as compared with simple process claims, because under the Saccharin doctrine, importation, use and sale in Canada of a product manufactured abroad using the patented process, is itself an infringement of the process patent (for recent affirmation see Eli Lilly Canada Inc. v. Apotex Inc. / cefaclor 2010 FCA 240 [17]-[20]). The evident difference between a product-by-process claim, and a process claim together with the Saccharin doctrine, relates to the burden of proof. Under the old s 39(1) the patentee was restricted to product-by-process claims in respect of the substances intended for food or medicine, but at the same time it was presumed by s 39(2) that any product of the specified composition was presumed to by produced by that process. While the SCC decision in Hoffmann-LaRoche is brief and somewhat cryptic, it appears to me, particularly from the decision of Rand J, that this presumption is what drove the result. It is a fair presumption if there is only a single method known for producing what is a novel compound, but if the compound is not new, it would be wrong to allow a patentee to take advantage of it when in fact the product might very well have been made by some other process. In that case, the patentee should be left to the protection of the Saccharin doctrine, where it would carry the burden of proof. If that is the real issue, then it was rendered largely moot in the lovastatin case, as Snider J interpreted s 39(2) as imposing only a very weak evidentiary burden which had been met by Apotex. And of course it is entirely moot under the current Act, with that entire section having been repealed.
So, it seems to me that the rule from Hoffmann-LaRoche, that a product-by-process claim amounts to a product claim for purposes of anticipation, is really just a vestige of the old s 39. With the repeal of s 39(2) that rule is no longer necessary; but on the other hand, with the repeal of s 39(1), product-by-process claims are themselves no longer necessary.
The invention at issue in the lovastatin decision related to a process for making lovastatin with the micro-organism A. terreus, and the patent (1,161,380), had both process and a product-by-process claims. A traditional fermented rice, Red Yeast Rice, was said by Apotex (and Wikipedia!) to contain lovastatin produced by a mold of the genus Monascus. The process claims are clearly unaffected, but Apotex argued that the product-by-process claims were therefore invalid as being anticipated by Red Yeast Rice. The obvious rebuttal to this that the product-by-process claims only encompass the product when made by the particular process, in this case by A. terreus; but as Apotex pointing out, Hoffmann-LaRoche Ltd. v. Canada (Commissioner of Patents), [1955] S.C.R. 414, 23 C.P.R. 1 clearly established that a product-by-process claim is to be treated as a product claim, in the sense that it will be anticipated if the product is known, even though made by different process. Snider J accepted this point as being established by the authorities, but with great reluctance, saying she had “considerable difficulty in understanding how the conclusion in Hoffmann-LaRoche 1955 can fit with the protection offered by the Patent Act,” and calling the result “illogical” [578] and even unprincipled [579].
In the end, Snider J held that the claims were valid as she was not satisfied that lovastatin was actually present in the Red Yeast Rice prior to the priority date [598], or, if it was, that it was adequately disclosed [608]. This raises some interesting questions as to the precise requirements for enabling disclosure.
However, I have a simpler question. What does it matter whether the process-by-product claims are valid? As Dr. Fox explained in his annotation to the Exchequer Court decision in Hoffmann-LaRoche, product-by-process claims, in principle at least, offer no advantage to the patentee as compared with simple process claims, because under the Saccharin doctrine, importation, use and sale in Canada of a product manufactured abroad using the patented process, is itself an infringement of the process patent (for recent affirmation see Eli Lilly Canada Inc. v. Apotex Inc. / cefaclor 2010 FCA 240 [17]-[20]). The evident difference between a product-by-process claim, and a process claim together with the Saccharin doctrine, relates to the burden of proof. Under the old s 39(1) the patentee was restricted to product-by-process claims in respect of the substances intended for food or medicine, but at the same time it was presumed by s 39(2) that any product of the specified composition was presumed to by produced by that process. While the SCC decision in Hoffmann-LaRoche is brief and somewhat cryptic, it appears to me, particularly from the decision of Rand J, that this presumption is what drove the result. It is a fair presumption if there is only a single method known for producing what is a novel compound, but if the compound is not new, it would be wrong to allow a patentee to take advantage of it when in fact the product might very well have been made by some other process. In that case, the patentee should be left to the protection of the Saccharin doctrine, where it would carry the burden of proof. If that is the real issue, then it was rendered largely moot in the lovastatin case, as Snider J interpreted s 39(2) as imposing only a very weak evidentiary burden which had been met by Apotex. And of course it is entirely moot under the current Act, with that entire section having been repealed.
So, it seems to me that the rule from Hoffmann-LaRoche, that a product-by-process claim amounts to a product claim for purposes of anticipation, is really just a vestige of the old s 39. With the repeal of s 39(2) that rule is no longer necessary; but on the other hand, with the repeal of s 39(1), product-by-process claims are themselves no longer necessary.
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