The Federal Court of Appeal has clarified that there must be a “high threshold of consistency” between the content of a new drug submission and a patent’s claims in order for the patent to be listed on the patent register pursuant to section 4(2)(a) of the PM(NOC) Regulations.
This decision, Gilead Sciences Canada Inc. v. The Minister of Health and The Attorney General of Canada, 2012 FCA 254 (Gilead), presents additional challenges for innovative pharmaceutical companies seeking to protect new innovations by listing patents on the patent register.
The Facts of Gilead
On October 4, 2010, Gilead filed a new drug submission (NDS) with the Minister for the drug Complera, to be used for the treatment of HIV infections. As described in the NDS, Complera contains three medicinal ingredients: (1) tenofovir disoproxil fumarate (tenofovir); (2) emtricitabine; and (3) rilpivirine. Health Canada issued an NOC in respect of this NDS which triggered the listing provisions of the PM(NOC) Regulations.
Gilead submitted eight patents for listing. On October 26, 2010, the Minister advised Gilead that one of these patents (the ‘475 Patent) was not eligible for listing on the patent register because it did not contain a specific claim for all three of the medicinal ingredients described in the NDS. Rather, the ‘475 Patent claimed a combination of tenofovir and emtricitabine with a third unnamed antiviral agent, selected from various classes of agents including non-nucleoside reverse transcriptase inhibitors (NNRTIs). Rilprivirine (the third medicinal ingredient in Complera) is an NNRTI.
Therefore, the patent specifically claimed two of the medicinal ingredients described in the NDS, along with the class of compounds to which the third medicinal ingredient belonged.
History of the Dispute
The issue in the appeal was whether the ‘475 Patent was eligible for listing on the patent register in respect to Gilead’s NDS. The Minister held that it was not, as the patent needed to match the approved formulation in the NOC, and it could not do so unless both “explicitly contain all of the same medicinal ingredients”. This decision was upheld on judicial review by the Federal Court.
The Decision of the Federal Court of Appeal
The Court of Appeal held that the concept of “product specificity” was a key feature of the 2006 amendments to the PM(NOC) Regulations, and that this requires the subject matter of the patent to reflect the subject matter of the approved drug submission to qualify for listing on the patent register. The Court of Appeal referred to its own decision in Purdue Pharma v. Canada (Attorney General), 2011 FCA 132 (Purdue), which held that “absent precise and specific matching between the patent claims and the approved NOC, the patent was not eligible for listing [under section 4(2)(c) of the PM(NOC) Regulations]”. In Gilead, the Court of Appeal applied the reasoning in Purdue to section 4(2)(a), and held that:
The wording of the PM(NOC) Regulations, as well as their object and purpose, suggest that the product specificity requirement sets a high threshold of consistency. Thus, in the case at bar, “the” medicinal ingredients, i.e. tenofovir, emtricitabine, and rilpirivine, must be set out in the patent claims and the NOC for the patent to be eligible on the register.
The Court of Appeal dismissed Gilead’s appeal because not all of the medicinal ingredients in the submission were explicitly found in the claims.
As noted above, this decision presents additional challenges for innovators seeking to protect new innovations by listing patents on the patent register. Because patent applications and drug submissions may be filed years apart, it is challenging for innovators to ensure that their patents meet the specificity requirements set out by the Court of Appeal.
This decision may also result in increased litigation at the Federal Court. Typically, a single application is brought in respect of every patent listed on the patent register for a drug. This provides for a summary adjudication of validity and non-infringement allegations, which may settle the patent dispute relating to the drug (subject to potential section 8 liability). However, if Gilead results in a new class of patents – plainly relevant but not listable – such patents may be appropriate choices for subsequent separate infringement actions.
* with the assistance of Brooke MacKenzie