Federal Court of Appeal finds summary trial appropriate, upholds dismissal of ViiV’s action for patent infringement re: Gilead’s BIKTARVY

Update: On February 7, 2022, ViiV’s application to the Supreme Court of Canada for leave to appeal was discontinued (ViiV Healthcare Company, et al v Gilead Sciences Canada, Inc, Docket No 39823).

The Federal Court of Appeal dismissed an appeal by ViiV from a decision of the Federal Court granting Gilead’s motion for summary trial and dismissing ViiV’s patent infringement action that claimed Gilead infringed Patent No.  2,606,282 (the 282 Patent) by selling bictegravir as one of three medicinal ingredients in BIKTARVY (see our article here): ViiV Healthcare Company v Gilead Sciences Canada, Inc,  2021 FCA 122. The Court of Appeal also dismissed appeals from three interlocutory orders of the Federal Court, including the dismissal of ViiV’s motion to quash the motion for summary trial. In its reasons, the Court of Appeal provided commentary on the summary trial process, including whether a motion to quash can be brought.

Summary Trial

The Court of Appeal outlined the three basic operative principles concerning the practice and procedure of the Federal Courts:

1. The practice and procedure of the Federal Courts draws upon two sources: the Federal Courts Rules (Rules) and the plenary powers that the Courts possess by virtue of being Courts under section 101 of the Constitution Act.
2. The general default position in the Federal Courts system is that litigation is party-run.
3. Rule 3 is central in interpreting the Rules, requiring that the Rules be interpreted and applied so that “every proceeding” is determined “on its merits” in “the just, most expeditious and least expensive” way.

Taking into account these basic operative principles, the Court of Appeal reasoned that in rare circumstances, motions to quash or adjourn a motion can be brought “when brought early and dealt with quickly,” such motions can “proactively advance the objectives of Rule 3.” Additionally, the Court on its own initiative may “refuse to entertain a problematic motion, i.e., one where the time and the expense it will cause is disproportionate to its benefit,” but should not be quick to do so, and should always respect the principles of procedural fairness.

The Court of Appeal also commented on Rules 213-216, which provide the prerequisites for motions for summary judgment and summary trial. Referring to previous cases, the Court of Appeal pointed out that the Federal Court has developed useful factors relevant to whether the prerequisites for summary judgment or summary trial have been met. While in some cases such summary proceedings add to the cost and duration of litigation, in other cases summary proceedings can improve access to speedy, cost-efficient justice. “It all depends. The wise exercise of judicial discretion is called for: taking the words of the Rules, viewing them in light of the objectives of Rule 3 and examples in the case law, and applying them to the particular circumstances of the case.”

Applying the above principles to the appeal at hand, the Court of Appeal held that the Federal Court was wrong to conclude that it had no authority to consider the motion to quash. However, the appeal from that motion was dismissed as ViiV had not established that the Federal Court made a reviewable error. The Court of Appeal also dismissed ViiV’s appeal of the Federal Court’s finding that a summary trial was appropriate.

Claim Construction

Each of the claims at issue of the 282 Patent (the Claims) refers to a genus of compounds and their pharmaceutically acceptable salts or solvates that are of a general structure including a ring described as “Ring A”. The Federal Court found that bictegravir falls outside the scope of the Claims because it includes a “bridged” ring at the Ring A position whereas the Claims were construed to only encompass “fused” or “spiro” rings. As such, bictegravir did not infringe the Claims and the Federal Court therefore granted Gilead’s motion for summary trial and dismissed ViiV’s action.

On appeal, ViiV alleged a number of legal grounds for reversal, each of which was dismissed by the Court of Appeal.

1. ViiV argued that the Federal Court erred in law by referring to the patent disclosure when construing the claims. However, the Court of Appeal disagreed, stating “[i]t is trite law that a patent must be read contextually in light of the entire patent and all of the necessary expert evidence”.
2. ViiV also argued that the Federal Court erred in law by resorting to the disclosure even though it found the claims “clear and unambiguous”. The Court of Appeal again disagreed, holding that a reading of the whole paragraph in which this phrase was situated shows the Federal Court found it necessary to go beyond the terms of the claim.
3. The Court of Appeal also rejected arguments that the Federal Court erred by construing the patent without biology/virology evidence from Gilead and improperly limited the Claims to the preferred embodiments.
4. Finally, ViiV argued that even if bictegravir does not fall within the scope of the Claims, it infringes the 282 Patent because it is a mere variation of a non-essential element of the patent. However, during the summary trial, ViiV conceded that Ring A is essential. The Court of Appeal held this concession meant the variant argument is not open to ViiV and that its arguments smacked of the now-discredited “spirit of the invention” approach to patent infringement.

ViiV would need leave from the Supreme Court of Canada to appeal the Court of Appeal decision.

Should you have any questions, please do not hesitate to contact a member of the  Pharmaceutical Litigation Group.

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