Federal Court Issues Order Prohibiting NOC for Mylan Tadalafil

In Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC, 2015 FC 17 (January 7, 2015), Justice de Montigny of the Federal Court allowed the application of Eli Lilly Canada Inc (Lilly) for a order prohibiting the Minister of Health from issuing a notice of compliance to Mylan Pharmaceuticals ULC (Mylan) for a generic version of Lilly’s erectile dysfunction (ED) drug CIALIS® (tadalafil) until the expiry of Canadian Patent No. 2,226,784 (the 784 Patent). The 784 Patent relates to the use of certain tetracyclic derivatives, including tadalafil, as potent and selective inhibitors of PDE V in the treatment of ED. Justice de Montigny found that Mylan’s allegations of lack of utility and obviousness-type double patenting were not justified.

Utility

Justice de Montigny held that the promise of the patent related to the effectiveness of the compounds to treat ED, but not to the specific route of administration. Since the utility of the claimed compounds to treat ED were not demonstrated as of the Canadian filing date, Justice de Montigny considered whether the promised utility was instead soundly predicted. He concluded that in light of the experiments disclosed in the 784 Patent and the common general knowledge, the 784 Patent taught a skilled person that the claimed compounds inhibit the PDE V potently and selectively, causing penile erection. Even if construing the promise to include oral administration, Justice de Montigny found that the promised utility would be soundly predicted.

Obviousness-Type Double Patenting

Mylan argued that if the promise of the patent did not include oral administration, then the 784 Patent was invalid for obviousness-type patent over an earlier patent that claimed the same compounds. Justice de Montigny rejected this argument, holding that while both patents claim tadalafil, they claimed different uses of this compound. In particular, the earlier patent did not contemplate the use of tadalafil to treat ED.

Justice de Montigny also clarified that the correct date for assessing obviousness-type double patenting is the priority date of the earlier patent.