Eli Lilly v. Mylan Pharmaceuticals, 2015 FC 17 (de Montigny J.)
January 7, 2015
Jamie Mills/Chantal Saunders/Beverley Moore for Eli Lilly
Tim Gilbert/Sana Halwani/Zarya Cynader for Mylan
Eli Lilly brought an application for an order under s. 55.2(4) of the Patent Act and s. 6 of the PM(NOC) Regulations to prohibit issuance of a Notice of Compliance to Mylan for a generic version of tadalafil until after the expiration of CA 2,226,784 (see also 2015 FC 125).
Mylan's Notice of Allegation alleged that it did not infringe a number of the claims of the ‘784 Patent, and that claims 2, 4, 12, 14, 15, and 18 were invalid for lack of utility and for obviousness-type double patenting, though there was no allegation of non-infringement for these claims.
Mylan also referenced and quoted excerpts from documents alleged to have been filed by Eli Lilly in a European opposition proceeding in relation to a competing product, Viagra sildenofil. The documents were relied upon by Mylan for the fact that Eli Lilly took a particular position before the EPO regarding the general knowledge regarding erectile dysfunction and its treatment that was inconsistent with Eli Lilly’s current position.
Eli Lilly objected to inclusion of these documents. The Court, however, rejected Eli Lilly’s motion to strike the documents, and noted that it was open to Eli Lilly to call witnesses to test or impugn the documents if there was any reason to question their authenticity or clarify the statements made within them. The documents remained part of the evidence, but the weight given to them would be commensurate to the circumstances and the legal context in which they were drafted.
Mylan’s allegation of lack of utility was premised on the ‘784 Patent failing to establish a sound prediction for the utility of the claimed compounds, and argued that the promise of the patent required efficacy without undue side effects. Eli Lilly relied upon a published journal article which showed that sildenafil had no clinically significant effects on pulse rate, blood pressure, and laboratory safety tests on volunteers. The Court held that a person of skill in the art could have soundly predicted that tadalafil could be administered orally to treat ED, and as a result the promise of the ‘784 Patent was soundly predicted.
Regarding obviousness-type double patenting, the Court held that the allegation of obviousness-type double patenting was not justified as the references cited by Mylan were insufficient to conclude that it would be obvious to a person of skill in the art to administer tadalafil by way of oral administration to treat erectile dysfunction.
The application by Eli Lilly for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Mylan until the expiry of CA 2,226,784 was allowed, with costs payable to Eli Lilly.
By: Etienne de Villiers, Dimock Stratton LLP