Compound patent held to be not soundly predicted for the level of promised utility found by the Court
Eli Lilly Canada Inc. v. Hospira Healthcare Corporation, 2016 FC 47
Drug: pemetrexed ALIMTA®
The Federal Court has dismissed an application for prohibition concerning the drug ALIMTA®. Although the parties joined issue on a significant number of evidentiary and legal issues the Court declined to address them all and only addressed the issue of sound prediction of utility.
The 794 Patent was filed by Takeda in Canada on March 23, 1989 and issued more than a decade later on October 19, 1999. As an "Old Act" patent, it will expire on October 19, 2016. Lilly had previously obtained a license to sell pemetrexed covered under a different patent until it expired on December 10, 2010.
The Court asked whether the person of skill in 1989 could have soundly predicted the promised utility of the untested compounds falling within Claims 7 and 9 from the test data reported in the Patent and from what was known in the art.
The vast majority of the compounds covered by Claims 7 and 9 (including pemetrexed and said to be in the thousands) were not specifically disclosed nor were they made or tested by Takeda before the filing date. The Court did not allow Lilly to rely on in-house test data or upon a sound line of reasoning that cannot be found in the Patent.
The Court dismissed Lilly's arguments that there was no promise of utility in the compound claims. The Court held that when a compound claim is silent as to use, the person of skill must resort to the specification to determine the utility promise of the claim. The Court relied on statements such as, "This invention relates to the novel pyrrolopyrimidine derivatives which are useful as anti-tumor agents, the production and utilization thereof" in finding a promise of in vivoactivity in relation to abnormal tissue.
In the result, the Court found that the patent was an overreaching attempt to monopolize a huge class of compounds on the strength of its highly discrete test data.
Order granting an election of an accounting of profits or all damages sustained is upheld on appeal
Philip Morris Products S.A. v. Marlboro Canada Limited, 2016 FCA 55
This is an appeal by Philip Morris Products S.A. and Rothmans, Benson & Hedges Inc. (the appellants) from a discretionary Order of a judge of the Federal Court (2015 FC 364). The Order provided that Marlboro was entitled to elect an accounting of profits or all damages sustained as a result of the infringement of their rights in the registered trademark MARLBORO.
The appellants unsuccessfully argued four grounds of appeal:
- that because they had not actually used the respondents' property, they were not unjustly enriched;
- the Judge erred in his conclusion that the complexity of an accounting of profits is neutral as a factor because the calculation of damages could be as complex as an accounting of profits;
- there was no causal link between the damages suffered by the respondents and the use of their property by the appellants;
- they will be prejudiced if the respondents elect an accounting of profits, in view of the parallel litigation that has been initiated by the respondents alleging infringement of their MARLBORO trademark further to the introduction in July 2012 of the appellants' redesigned ROOFTOP packaging.
The Court of Appeal did not find a reviewable error in the first three grounds of appeal. For the fourth, the Court of Appeal held that when either the infringement proceeding or the reference is ready to be heard, the other proceeding may be stayed until a decision is rendered. This was said to effectively avoid potential prejudice posed by the parallel proceedings.
The appeal was dismissed with costs.
Supreme Court Leave to Appeal
The Supreme Court has granted Google leave to appeal (Court No. 36602) from the judgment of the Court of Appeal for British Columbia (Vancouver), Number CA41923, 2015 BCCA 265, dated June 11, 2015. The Supreme Court provides the following summary:
The plaintiffs sued their former distributors for unlawful appropriation of trade secrets, alleging that the distributors designed and sold counterfeit versions of their products. The plaintiffs obtained injunctions against the distributors, prohibiting them from carrying on any business online. When this proved ineffective, the plaintiffs sought a court order against Google, to prohibit it from displaying search results that included the distributors' websites.
The Supreme Court of British Columbia granted a worldwide injunction against Google, finding that it had territorial competence over Google and that it possessed an inherent jurisdiction to maintain the rule of law and protect its processes, which in appropriate circumstances may include an injunction against non-parties. In this case, the balance of convenience favoured granting an injunction. The Court of Appeal agreed that the court held jurisdiction over Google with respect to the injunction application. It also concluded that it was permissible to seek interim relief against a non-party. The power to grant injunctions is presumptively unlimited, and injunctions aimed at maintaining order need not be directed solely at the parties involved in litigation. In this case, an injunction with worldwide effect was justified.
Other Industry News
Health Canada has released the revised Post-Notice of Compliance (NOC) Changes — Quality Guidance.
Health Canada has released the revised form Post-Notice of Compliance (NOC) Changes: Level III.
Health Canada has announced the Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q10: Pharmaceutical Quality System.