Bristol-Myers Squibb & Gilead Sciences, LLC, et al v. Teva Canada Limited, et al., 2015 FCA 3, (Eleanor R. Dawson J.A., David Stratas J.A., David G. Near J.A.)
January 9, 2015
Patrick Kierans, Jordana Sanft and Amy Grenon for Bristol-Myers Squibb & Gilead Sciences, LLC and Merck Sharp & Dohme Corp.
Jonathan Stainsby and Leslie Caswell for Teva Canada Limited
Bristol-Myers, Gilead and Merck appealed from a judgement of the Federal Court made under the PM(NOC) Regulations. In the application, the appellants sought an order of prohibition relating to an NOC for a generic version of the appellant’s drug Atripla.
On appeal, two issues were raised by the appellants. First, the appellants submitted that the Federal Court failed to apply the proper evidentiary standard. Second, the Federal Court failed to draw an adverse inference against Teva for refusing to produce its tablets to the appellants for testing.
With respect to the initial burden on a generic or second person in a PM(NOC) proceeding, the Federal Court of Appeal distinguished between allegations of invalidity and non-infringement. The effect of the presumption of validity found in s. 43(2) of the Patent Act is that, without any evidence from the second person, the legal position is that the patent is valid. Therefore, some evidence from the second person is needed to put invalidity into play. However, when the allegation is non-infringement, there is no presumption in play and, thus, no initial onus on the second person to put forward evidence.
The Federal Court of Appeal stated:
I agree with Teva’s submission that once it alleged in its NOA that “[t]he Teva Product will not contain Form I nor is Form I used in the manufacture of the Teva Products”... there was no further evidentiary burden on it; its allegation of non-infringement was “in play.”
The Federal Court of Appeal also rejected the submission that any adverse inference should have been drawn by the failure of Teva to produce its tablets, finding that there were various facts which supported the opposite finding, and that production is not required under s. 6(7) of the PM(NOC) Regulations.
By: Peter W. Choe, Gowling Lafleur Henderson LLP