Subsequent Entry Biologic Litigation Set to Take Off in Canada

Subsequent Entry Biologic Litigation Set to Take Off in Canada

The Canadian pharmaceutical industry is entering a new era as Subsequent Entry Biologic (SEB) litigation begins to emerge in the Canadian pharmaceutical landscape. Biologic drugs are derived through the metabolic activity of living organisms and tend to be significantly more variable and structurally complex then chemically synthesized drugs.

Biologics play an important role in the Canadian health care system through their use in treating numerous diseases and medical conditions. Examples of biologic drugs include antibodies and growth factors.

Patents and data protection covering biologic drugs in Canada are beginning to expire thereby creating opportunities to bring more affordable SEB versions to the market. It is important to distinguish between traditional generic pharmaceutical products and SEBs. The term SEB was specifically chosen by the Canadian government to clearly distinguish between the regulatory process and product characteristics for SEBs and traditional generic drug products.

A SEB is a drug that enters the market subsequent to a version previously authorized in Canada and with demonstrated similarity to a reference biologic drug. A SEB relies in part on prior information regarding safety and efficacy that is deemed relevant due to the demonstration of similarity to the reference biologic drug and which influences the amount of and type of original data required.

Because of the significant differences between SEBs and traditional generic drug products Canadian health authorities created new guidelines to govern the approval of new SEBs. Guidance from Health Canada is particularly prudent since the Food and Regulations do not contain specific regulatory mechanisms for approval of SEBs. In March 2010, Health Canada released its framework for the approval of SEBs in a document entitled “Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)”. These guidelines indicate that manufacturers seeking approval of a SEB must file a new drug submission as opposed to an abbreviated new drug submission as is the case with traditional generic drug products. While SEBs require a new drug submission they may still rely in part on data from the reference product but may not state that the SEB and the reference product are bioequivalent or are clinically equivalent. The Patented Medicine (Notice of Compliance) Regulations also include SEBs within their scope thus linking patent protection to the approval process and opening the door to patent litigation.

The Canadian pharmaceutical industry is no stranger to patent litigation under the Patented Medicine (Notice of Compliance) Regulations and it appears SEBs will be no different. In early 2012 Teva Pharmaceutical Industries Ltd. (Teva) applied for a Notice of Compliance in order to market a SEB consisting of the protein filgrastim. In their application, Teva made reference to a reference biologic product owned by Amgen Inc. (Amgen).  Amgen commenced a proceeding (Court File T-989-12) under the Patented Medicines (Notice of Compliance) Regulations against Teva seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance for Teva’s filgrastim product prior to the expiry of Canadian Patent No. 1,341,537 (the “537 Patent). The 537 Patent is listed on the patent register against Amgen’s biologic filgrastim product. The 537 Patent will expire on July 31, 2024. According to Amgen’s Notice of Application, Teva has made a number of allegations against the 537 Patent including:

  • Invalidity of certain claims due to (1) double patenting (2) invalid selection (3) material misrepresentation (4) anticipation (5) obviousness (6) missed conflicts and (7) lack of utility and lack of sound prediction;
  • The 537 Patent is not entitled to claim priority from a United States application;
  • Claim 43 is the only relevant claim; and
  • Claims 12, 16-24, 26, 27, 29-42 and 48-82 will not be infringed.

This proceeding represents the first SEB litigation in Canada. While this litigation will only determine the issue of whether the Court should prohibit the Minister of Health from granting Teva a Notice of Compliance, it will be interesting to see if any novel legal issues arise regarding SEBs. Given that Canadian SEB litigation is in its infancy, this proceeding may have important implications for the future of SEBs in Canada. For an interesting article on Canada’s SEB market the reader is directed to the following website.

Sean Jackson is a JD candidate at Osgoode Hall Law School and is currently enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program.  As part of the program requirements, students are asked to write a blog on a topic of their choice.