Eli Lilly v. Mylan Pharmaceuticals, 2015 FC 125 (de Montigny J.)
February 2, 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 2,371,684 (see also 2015 FC 17). The ‘684 Patent being directed towards a specific unit dosage form of tadalafil including for the treatment of erectile dysfunction.
Mylan’s Notice of Allegation alleged that the ‘684 Patent is a selection Patent and that its utility was neither demonstrated nor soundly predicted. Mylan also argued that, in the alternative, the ‘684 Patent was anticipated by CA 2,226,784 and clearly obvious.
The compound tadalafil was claimed and disclosed in CA 2,181,377, which was published in July 1995. The use of tadalafil for the treatment of erectile dysfunction was claimed and disclosed in the ‘784 Patent, which was published in February 1997, and the preferred route was oral administration of tadalafil with unit doses in range from 0.2 to 400 mg.
The evidence showed that preferred doses for tadalafil were lower than expected to provide a therapeutic dose. The ‘684 Patent claimed dosages in the range of 1 to 10 mg, a reduction in the range of doses previously claimed in the ‘784 Patent.
The Court held that the promise of the ‘684 Patent is to significantly minimize, or eliminate, the incidence of adverse side effects of sildenafil by using the claimed doses of 1 to 20 mg of tadalafil. On the basis of the evidence presented, however, there was no improvement of tadalafil over sildenafil and accordingly the ‘684 Patent failed to meet the promise.
Furthermore, the ‘684 Patent was anticipated by the ‘784 Patent as there was no evidence a person of skill in the art would have to go through prolonged experimentation to arrive at the 1 to 20 mg dosage range, after having reviewed the ‘784 Patent.
Interestingly, Justice de Montigny held that an adverse inference could be drawn from an amendment Eli Lilly made to the claims of the ‘684 Patent during prosecution. In particular, Eli Lilly tried to argue that the “daily maximum total dose” was an essential element of the claims, which they claimed differentiated the claims from the ‘784 Patent. During prosecution, however, Eli Lilly had removed reference to maximum total dose per day in order to overcome an Examiner objection that the claims were directed towards a method of medical treatment. Accordingly, since the term was removed during prosecution, the Court declined to read the limitation of a daily maximum dose into the claims.
Finally, the Court held that the ‘684 Patent was obvious as the claimed dosage range was encompassed by the range disclosed and claimed in the ‘784 Patent, and that it was more or less self-evident that lower and narrower doses of tadalafil would be effective at treating 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 2,371, 684 was dismissed, with costs payable to Mylan.
By: Etienne de Villiers, Dimock Stratton LLP