Product-Specificity Strikes Back: Minister of Health Rejects CSP Application

Recently, ViiV Healthcare ULC brought one of the the first applications for judicial review from a decision of the federal Minister of Health (the “Minister”) to deny a certificate of supplementary protection (“CSP”).[1]

The Minister held that ViiV’s drug JULUCA was ineligible for a CSP because the basic patent at issue claimed only one of its two medicinal ingredients.

The Minister’s decision and the Federal Court proceeding may have a significant impact on future CSP applications.

Background: the CSP Regime Extends Patent Protection for Qualifying Drugs

Unlike most products, pharmaceuticals require marketing authorization before they can be sold. Seeking government approval often consumes much of the term of any patents protecting a drug, leaving little time to exploit the hard-earned patent.

In 2015, drug patent term extensions were negotiated between Canada and the European Union as part of the Canada-European Union Comprehensive Economic and Trade Agreement (“CETA”). As a part of the CETA negotiations, Canada agreed to restore, in part, the term of patent rights covering medicinal ingredients contained in drugs that are delayed to market due to pending Health Canada safety and efficacy reviews.

Canada ratified the CETA patent term extension obligation by enacting the CSP regime, which is encoded in the Patent Act and the Certificate of Supplementary Protection Regulations (the “CSP Regime”).[2] Under the CSP Regime, a patentee may apply to the Minister for a CSP. The Minister will then assesses whether to issue a CSP based on the eligibility criteria set forth in the CSP Regime. If granted, a CSP extends the term of a patent covering medicinal ingredients (with respect to making, constructing, using, and selling the qualifying drug) by up to two additional years.

Among other things, to be eligible for a CSP, one criterion is that the patent forming the basis for the CSP application (a “basic patent”) must “pertain to a medicinal ingredient, or combination of medicinal ingredients, contained in a drug for which an authorization for sale…was issued”.[3]

Under the CSP Regime, a patent pertains to a medicinal ingredient or combination if it “contains a claim for the medicinal ingredient or combination of all the medicinal ingredients contained in a drug”.[4]

The Minister’s Decision in JULUCA Revives Product-Specificity Reasoning

ViiV applied for a CSP extending the term of Canadian Patent No. 2,606,282 (the “282 Patent”). The 282 Patent claimed the medicinal ingredient dolutegravir, one of the two medicinal ingredients in ViiV’s combination antiviral drug JULUCA.

Even though JULUCA fell within the scope of the 282 Patent’s dolutegravir claims, the Minister denied the CSP. The Minister concluded that, while the 282 Patent “contains claims directed toward one of the medicinal ingredients contained in JULUCA…namely dolutegravir”, it did not “pertain to the combination of medicinal ingredients dolutegravir and rilpivirine”, the other medicinal ingredient in JULUCA. Essentially, the Minister held that the patent was required to claim both ingredients by name for JULUCA to qualify for a CSP.

The Minister’s reasoning risks reducing the term of protection for patents that would necessarily be infringed by generic versions of JULUCA and other combination drugs, and mirrors prior decisions of the Minister denying patent listing under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”).

Product-Specificity under the PM(NOC) Regulations

Under the PM(NOC) Regulations, generic drug companies are required to address patents listed against innovative drugs — by agreeing to await expiry, or by challenging infringement or validity — as a condition of drug approval.

Historically, the Minister routinely denied applications to list patents that specifically claimed only a subset of the medicinal ingredients in a combination drug, on the basis that they were not product-specific, because they did not claim all of the medicinal ingredients by name.

For instance, in another decision involving ViiV, the Minister refused to list a patent that claimed the medicinal ingredient abacavir in combination with another unnamed medicinal ingredient against ViiV’s combination drug KIVEXA, which contained the medicinal ingredients abacavir sulfate and lamivudine. As held by the Federal Court Prothonotary at first instance, it “is not enough that [the patent] encompasses the medicinal ingredient lamivudine (among others) in combination with abacavir…[t]he requisite degree of product specificity [requires that] [t]he medicinal ingredient, formulation, dosage form or use of the medicinal ingredient claimed in the patent sought to be listed must match that in the drug submission that was approved through the issuance of the NOC.”[5]

The reasoning in these decisions was problematic because often a generic version of the drug at issue could not be marketed without infringing the particular patent. Since the purpose of the PM(NOC) Regulations was to make generic drug approval contingent on patent clearance and since only listed patents are required to be addressed, this reasoning left relevant patents unaddressed.

This issue was resolved by amendments to the PM(NOC) Regulations that explicitly overruled these decisions, even mentioning the ViiV KIVEXA decision by name.[6]

Our Courts May Find Guidance in UK or European Authorities

The European legislation, creating the equivalent supplementary protection certificate (“SPC”) regime, came into force in 1993 and is similarly worded.[7] This issue — whether an SPC may be obtained for a combination drug, given a basic patent claiming only one medicinal ingredient — has previously been considered in the UK and European courts. Two different approaches have emerged:

  • The infringement test. This test simply asks whether the drug would infringe the basic patent. If so, the drug is eligible for SPC protection, assuming the other criteria are met.
  • The identification test. This test is narrower. To be eligible for an SPC, the drug must not only be claimed by the basic patent, but also be specifically identifiable in the patent specification. This appears to be similar to the test applied by the Minister in respect of JULUCA.

In 1999, the Court of Justice of the European Union (“CJEU”) was asked to set criteria for determining whether or not a product is protected by a basic patent, but declined to rule on that question because “provisions concerning patents have not yet been made the subject of harmonisation at [the European] level”.[8] Instead, the CJEU held that “to determine…whether a product is protected by a basic patent, reference must be made to the [domestic] rules which govern that patent”,[9] suggesting that the issue should be determined at the national level.

In the United Kingdom, Justice Kitchin (as he then was), writing for the High Court in England, considered this issue in Gilead Sciences v Comptroller of Patents.[10] He rejected the identification test, holding that whether the drug was “‘identifiable with the invention’ of the basic patent” or whether there was “‘a clear pointer’ to the specific combination authorised” in the basic patent are “neither precise nor find any foundation in the [legislation]”, and may “produce a harsh result”.[11]

The Federal Court of Canada has not yet considered this issue in the CSP/SPC context. While the Court’s decision in ViiV’s CSP application will be based on administrative law principles and the Canadian CSP Regime, the Court’s reading of CETA will animate how the CSP Regime is interpreted,[12] and foreign jurisprudence on parallel issues may be persuasive.

 

[1] Federal Court File No. T-353-19. See also Federal Court File No. T-1603-18.

[2] See Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, SC 2017, c 6.

[3] Patent Act, RSC 1985, c P-4, s 106(1)(c).

[4] Certificate of Supplementary Protection Regulations, SOR/97-165, s 3(2).

[5] Viiv Healthcare ULC v Canada (Minister of Health), 2014 FC 328 at paras 28-29, aff’d 2014 FC 893, aff’d 2015 FCA 93. See also Purdue Pharma Canada v Canada (Attorney General), 2011 FCA 132; Gilead Sciences Canada Inc v Canada (Minister of Health), 2012 FCA 254; Novartis Pharmaceuticals Canada Inc v Canada (Attorney General), 2012 FC 836; and Eli Lilly Canada Inc v Canada (Attorney General), 2014 FC 152, rev’d 2015 FCA 166.

[6] Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, SOR/2015-169, s 3.

[7] EC, Council Regulation (EEC) 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, [1992] OJ, L 182/1, art 1, 3(a). See also EC, Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products, [2009] OJ, L 152/1 (current law codifying SPC regime amendments unrelated to product-specificity); CETA, art 20.27 (using some language identical to the European regulation in respect of “a product that is protected by a basic patent in force”).

[8] Farmitalia Carlo Erba Srl’s SPC Application, C-392/97, [1999] ECR I-5572 at para 26.

[9] Farmitalia Carlo Erba Srl’s SPC Application, C-392/97, [1999] ECR I-5572 at I-5584.

[10] Gilead Sciences v Comptroller of Patents, [2008] EWHC 1902 (Pat).

[11] Gilead Sciences v Comptroller of Patents, [2008] EWHC 1902 at paras 28, 32-33 (Pat).

[12] National Corn Growers Assn v Canada (Import Tribunal), [1990] 2 SCR 1324 at 1371 (“reasonable to make reference to an international agreement at the very outset of the inquiry to determine if there is any ambiguity, even latent, in the domestic legislation”). See also Takeda Canada Inc v Canada (Health), 2013 FCA 13 at paras 71-102 (per Stratas JA, dissenting).

Authors

Subscribe

Stay Connected

Get the latest posts from this blog

Please enter a valid email address