Patent Found Valid and Infringed Even if the Method of Infringement Was Not in the Minds of the Inventors
Drug: LOSEC® omeprazole
AstraZeneca sued Apotex for infringement of its patent relating to the formulation of the drug omeprazole. Apotex argued invalidity and non-infringement. The Court found several claims valid and infringed. The patent described that omeprazole needed to be protected from the acid in the stomach, but an enteric coating would degrade the omeprazole. The invention included an inert subcoating that was applied between the omeprazole and the enteric coating.
The construction of claim 1 was a key issue. AstraZeneca argued that as long as all the elements were present and formed a viable formulation, it does not matter how the inert subcoating is formed. So, AstraZeneca said that a subcoating that forms in situ from a reaction between the core and the enteric coating is a matter of process that does not circumscribe or limit the claim to the product. Apotex disagreed.
The Court found that although an in situ subcoating may not have been in the minds of the inventors, all they had to do was disclose one viable method of manufacture and not limit their claim drafting to a single embodiment. The Court further stated that a patentee is not obligated to teach its competitors how to avoid infringing.
As for infringement, Apotex criticized AstraZeneca's testing, but did not perform any testing of its own. The criticism was not found to sway the Court. Also, while the testing was performed ex parte, the work was found to be appropriately recorded and the results were subject to review and criticism. Furthermore, where the work could be easily reproduced, the Court rejected any suggestion the results he obtained were anything other than he has reported.
Some additional issues were discussed, including: whether AstraZeneca had standing to bring the claim (it did); whether foreign issue estoppel should be applied (it was not); whether Apotex had deceived AstraZeneca in the NOC application where it put forward a formulation that was not ultimately used (no deception found); the applicable statute of limitations (the Federal 6 years was allowed over Ontario's 2 years); and the allowance for AstraZeneca to claim an accounting of profits.
This decision only related to liability, as the proceeding was bifurcated. The issue of costs and the accounting of profits remains to be decided.
Although Moot, Minister of Health is Found to be Wrong to Issue NOCs to Generic Companies Without First Requiring Them to Serve a Notice of Allegation
Drug: TRACLEER® bosentan
Actelion has persuaded the Court to quash the NOCs provided to two generic companies after they were awarded by the Minster of Health. However, the patent at issue had expired by the time this decision was reached, and so the relief was arguably moot. Actelion had the option to continue to seek to quash the NOCs, but the court docket indicates that Actelion decided not to pursue this course of action. Instead, Actelion was awarded declatory relief that the OPML failed to comply with the PM(NOC) Regulations by failing to require Cobalt and Sandoz to address the 193 Patent before issuing them NOCs for their bosentan products.
This litigation arose when Pharmascience settled PM(NOC)litigation with Actelion, and then cross-licenced its NOC for bosentan with Cobalt and Sandoz. The Minister of Health issued the two additional NOCs to the licensees without requiring them to address the requirements of the PM(NOC) Regulations. The Minister had previously amended its Guidance Document to provide for such an allowance, but this Guidance Document was found to contravene the PM(NOC) Regulations.
This reasoning was first applied in Pfizer Canada Inc. v The Attorney General of Canada and Teva Canada Limited, 2014 FC 1243, and was summarized here.
Statements in a Generic's Product Monograph Were Not Found to Amount to an Inducement to Infringe
Drug: AVELOX® I.V.® moxifloxacin
The Court has allowed a motion to strike portions of an application pursuant to paragraph 6(5)(b) of the PM(NOC) Regulations. The generic respondent sought to strike portions of Bayer's application in regards to the '424 Patent, for being scandalous, frivolous and vexatious or is otherwise an abuse of process.
Bayer conceded there was no evidence of direct infringement, but Bayer maintained that health practitioners would infringe as a direct result of PPC's representations in its Product Monograph and its attempts to have PPC-Moxifloxacin substituted for AVELOX®I.V.
The Court held that there is no infringement of a patent in selling an article which does not in itself infringe the patent, even when the vendor knows that the purchaser buys the article for the purpose of using it in the infringement of the patent. The Court found that whether the Product Monograph instructed others to infringe was a question of fact, not opinion, and there was no evidence that PPC will be seeking to sell its product in combination with sodium chloride.
Application for an Order of Prohibition is Dismissed
Drug: VELCADE® bortezomib
The Court found that Teva's allegation of obviousness was justified. As a result, the application was dismissed.
CREMANT DE GLACE for Apple Cider Found to be Deceptively Misdescriptive
Verger du Mino appealed a decision of the TMOB pursuant to section 56 of the Trade-marks Act to the Federal Court. The TMOB allowed the respondent's opposition to the proposed trademark CREMANT DE GLACE as being deceptively misdescriptive of the character or quality of the services in association with which they are proposed to be used.
The appellant makes apple cider. The respondent opposed the mark by stating that "crémant de glace" implies the product is a slightly sparkling wine, fermented from fruit exposed to a period of natural freezing. The Court held it was not unreasonable that the TMOB found that the proposed mark was deceptively misdescriptive, and dismissed the appeal.
Note: This decision was originally published in French last year, and the English translation of this decision has only now become available.
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