The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex's generic version of Lilly's EFFIENT® (prasugrel hydrochloride). While the Court rejected Apotex's allegations of overbreadth, insufficiency, and non-patentable subject matter, it held that the claims were obvious.

Background

The claims of Canadian Patent No. 2,432,644 (the 644 Patent) relate to pharmaceutical compositions comprising prasugrel and aspirin. Prasugrel is a member of the thienopyridine family of compounds. The asserted claims of the patent claimed the use of prasugrel for simultaneous or sequential, separate administration with aspirin and the compound prasugrel for use in combination with aspirin, in preventing or treating a disease caused by thrombus or embolus.

Obviousness

In its obviousness analysis, the Court accepted the Applicants' construction of the inventive concept: the combination of prasugrel plus aspirin with an antithrombotic effect that is greater than the sum of the effects of each agent alone. The Court also found that this inventive concept had not previously been disclosed and therefore differed from the state of the art.

However, in applying the "obvious-to-try" test, the Court held that the claims were obvious finding that there was a motivation in the art to try the combination of prasugrel with aspirin and that there was a "reasonable expectation" that combining prasugrel, a thienopyridine, simultaneously or sequentially with aspirin would produce a beneficial, complementary mechanism of action.

The Court acknowledged that:

Central to the Court's analysis was evidence that the prior art had shown that the substitution of one thienopyridine (ticlopidine) for another (clopidogrel) to use in combination with aspirin had been positive.

Despite finding that one of only two thienopyridines approved for sale did not consistently demonstrate synergy with aspirin and that there was no information in the state of the art regarding the mechanism by which clopidogrel and aspirin had developed a synergy, the Court nevertheless concluded that there was a reasonable expectation that the combined use of prasugrel and aspirin could reasonably be expected to achieve a synergy similar to the combination of clopidogrel with aspirin.

This analysis minimizes the well-known unpredictability of structural changes on biological effect. In combination with the "obvious to try" test, this may create a low bar to obviousness that disproportionately impacts pharmaceutical inventions.

Patentable Subject Matter

The Court held that the patent disclosed that the use of prasugrel combined with aspirin results in an effect on platelet aggregation that is new, useful, and more than the mere sum of the effects of the two agents taken alone. The Court accepted as sufficient, data showing that the combination produced a numerically greater inhibition rate than prasugrel or aspirin alone and did not require a more formal statistical analysis.

Insufficiency & overbreadth

The Court rejected Apotex's argument that the patent failed to disclose how to administer prasugrel and aspirin sequentially. Although time intervals were not specified in the patent, the experts were able to determine an appropriate interval using the patent and common general knowledge. The Court similarly rejected the argument that claim 29 of the 644 Patent was overly broad for failing to include a maximum time interval.

Link to Decision:

Eli Lilly Canada Inc., Ube Industries, Ltd. and Daiichi Sankyo Company, Limited v. Apotex Inc., 2018 FC 736


About Norton Rose Fulbright Canada LLP

Norton Rose Fulbright is a global law firm. We provide the world's preeminent corporations and financial institutions with a full business law service. We have 3800 lawyers and other legal staff based in more than 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.

Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.

Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.

For more information about Norton Rose Fulbright, see nortonrosefulbright.com/legal-notices.

Law around the world
nortonrosefulbright.com

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.