Madam Justice Snider of the Federal Court has rendered judgment in the long-standing patent infringement action between Merck & Co. Inc. and Merck Frosst Canada Ltd. (collectively "Merck") and the defendants Apotex Inc. ("Apotex") and Apotex Fermentation Inc. ("AFI") concerning lovastatin (Merck’s MEVACOR) (Merck v. Apotex, 2010 FC 1265). Justice Snider found that the patent at issue was valid and infringed by the defendants regarding certain lots through the manufacture of lovastatin by AFI and the importation of lovastatin produced by Blue Treasure, a Chinese joint venture with AFI. In a separate judgment, Justice Snider dismissed Apotex’s action under section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") regarding the same patent (Apotex v. Merck, 2010 FC 1264).
In 1993, Merck commenced a proceeding under the Regulations. The statutory stay expired in 1996 without a hearing on the merits. Merck’s application for an extension of the stay was denied in 1997, the notice of compliance ("NOC") was issued to Apotex in 1997, and Merck’s appeal was dismissed in 1999. Merck sued Apotex and AFI for patent infringement in 1997, and Apotex subsequently sued Merck under section 8. The actions were heard together.
Infringement action. The patent at issue claims lovastatin and three other compounds in process-dependent form. Justice Snider concluded that the patent was infringed. In particular, she reviewed extensive circumstantial evidence and found that Blue Treasure was manufacturing lovastatin using the infringing process, and that one batch of lovastatin made by AFI was infringing on the basis of direct DNA testing evidence.
Justice Snider rejected all of Apotex’s validity attacks. She concluded that Apotex’s overbreadth argument was more properly a question of sound prediction. Regarding utility, Justice Snider found that Apotex had failed to demonstrate that the claims included embodiments which would not achieve the promised result, as Apotex relied on a construction and promise of the ’380 patent with which she did not agree. She further found that Apotex had failed to demonstrate that the promised utility, namely "useful as antihypercholesteremic agents for the treatment of atherosclerosis, hyperlipemia and like diseases in humans," was not soundly predicted by the inventors. Apotex pointed to the lack of testing on humans. Justice Snider found that the inventors had an adequate factual basis for their predictions, including the inventors’ experimentation and laboratory results, their knowledge of the cholesterol biosynthesis pathway and the information drawn from the prior art. She also found that there was an articulable line of reasoning, and that sufficient information was disclosed in the patent to allow the skilled person to soundly predict that the compounds of the invention would have the utility promised by the patent. She noted that the jurisprudence does not teach "that the patent specification must disclose absolutely everything that the inventor knew up to the relevant date." Justice Snider also rejected Apotex’s argument of prior inventorship, finding there was no missed conflict.
Finally, Justice Snider rejected Apotex’s argument of anticipation by prior use. Apotex argued that lovastatin was known and used in traditional Red Yeast Rice, a substance known for centuries. Justice Snider accepted that Hoffmann-La Roche Ltd. v. Canada (Commissioner of Patents), [1955] SCR 414 supports the proposition that a product-by-process claim can be anticipated by prior disclosure of the product and not the process. However, she found that Apotex had not established that Red Yeast Rice contained lovastatin before the priority date, and the disclosure requirement for anticipation had not been met as Red Yeast Rice does not necessarily produce lovastatin.
While Justice Snider agreed with Merck’s argument that it had not committed any inequitable conduct that would disentitle it from the equitable remedy of profits, balancing the factors in this case (including the time to trial and complexities in accounting for non-infringing production and settlement with a third party), she declined to exercise her discretion to permit Merck to elect an accounting of profits. Merck may seek its damages on a separate reference.
Section 8 action. Justice Snider held that the 1993 version of section 8 applied and that Apotex is not entitled to any compensation under this provision, as the cause of any delay in issuing the NOC to Apotex was not that the patent had "expired."
Apotex and AFI have appealed Justice Snider's judgment in the infringement action. Apotex has also appealed Justice Snider's judgment in the section 8 action.
Junyi Chen, Toronto
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