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If at first you don’t succeed, you may not be permitted to try again

Justice Barnes’ decision in Gilead Sciences, Inc. v. Minister of Health is a cautionary note to applicants in PM(NOC) Proceedings to think carefully when choosing to limit the claims asserted during the proceeding. In his decision, Justice Barnes granted Apotex’ 6(5)(b) motion to dismiss Gilead’s application as an abuse of process on the basis that it was an improper attempt to relitigate the validity of the relevant patent in light of an earlier decision involving the same patent against Teva.

The underlying basis for Apotex’ motion was Justice Barnes’ earlier decisions involving the same patent and Teva (2013 FC 1270, and 2013 FC 1272), where Gilead only asserted claims 3 and 4 of Canadian Patent No. 2,298,059.

In the motion before Justice Barnes, Apotex argued that Gilead’s attempt to relitigate the validity of the 059 Patent on grounds of obviousness should not be permitted. In response, Gilead argued that it intended to fill in an evidentiary gap from the Teva proceeding and, unlike the Teva matter, it intended to put all claims in play. Justice Barnes held that Gilead’s attempt amounted to a clear abuse of process:

[13] It seems to me that an abuse of process finding in the NOC context is not dependant on the evidence to be called but, rather, on the issues presented to the Court for determination. Once the second person puts a validity issue into play, the patentee proceeds at its subsequent peril by not fully responding. In other words, it must live with the consequences of not fully joining issue in the first proceeding.

[14] A patentee cannot avoid an abuse of process finding by asserting the validity of only a select number of claims in an initial NOC proceeding, only to assert the validity of different claims in a subsequent NOC proceeding involving a different generic challenger. Where the initial NOA puts in issue the validity of certain patent claims, it is not open to the patentee to concede some of the claims but later resile from that position. If it were otherwise, the patentee could effectively split its case and unilaterally compel subsequent generic challengers to litigate claims, the invalidity of which the patentee had effectively conceded. This would amount to a manipulation of the system and it would violate the principle that the patentee is required to put its strongest case forward in the first instance.

Justice Barnes went on to hold that there was no merit to Gilead’s argument that the Court should exercise its discretion to deny the relief requested by Apotex, as this would amount to a waste of judicial resources. If Gilead was aggrieved by his earlier finding in the Teva proceeding it had the option of commencing an infringement action.

Justice Barnes’ decision is available here.