The following is a mid-year review of the top IP and regulatory law developments in life sciences in Canada.
As we previously reported, in November 2014, Apotex discontinued its appeal to the Supreme Court of Canada (SCC) on the eve of the hearing of its appeal regarding the validity of sanofi-aventis' patent claiming clopidogrel bisulfate (PLAVIX). Had the appeal proceeded, the SCC was expected to provide guidance on the "promise" doctrine of utility and the test for sound prediction of utility. Apotex and Mylan subsequently sought leave to the SCC in the celecoxib (CELEBREX) litigation which also raised issues of utility, including "promise" of the patent. The SCC denied leave on April 23, 2015.
On April 20, the Supreme Court dismissed sanofi-aventis' appeal in a section 8 damages case. The Federal Court of Appeal had affirmed, in large part, a decision granting damages to Apotex regarding ramipril (ALTACE). Issues considered by the Court of Appeal included the methodology to be applied in determining the hypothetical market during the section 8 liability period.
3. Patent infringement actions: Apotex ordered to pay over $100 million to Eli Lilly in cefaclor damages reference; Apotex ordered to pay $61 million to Servier in perindopril profits reference; Apotex unsuccessful in omeprazole infringement action
On January 23, the Federal Court ordered Apotex to pay Eli Lilly over $100 million in damages for infringing sales of cefaclor (Eli Lilly's CECLOR) and on June 18, the Federal Court ordered Apotex and Apotex Pharmachem Inc. to pay over $61 million to Adir and Servier for infringing sales of perindopril (Servier's COVERSYL). In both cases, the Court rejected Apotex's non-infringing alternative arguments. In the only Federal Court infringement decision issued this year to date, the Federal Court on March 16 found AstraZeneca's omeprazole (LOSEC) formulation patent valid and infringed by Apotex. AstraZeneca's reference is pending. Apotex's appeals in all three cases are pending.
Following pre-publication on May 2, Regulations Amending the Patented Medicines (Notice of Compliance) Regulations came into force on June 19 and were published on July 1 to address Court decisions that were inconsistent with the policy intent of the PMNOC Regulations: Gilead Sciences Canada Inc v The Minister of Health and The Attorney General of Canada, 2012 FCA 254 and Viiv et al v Teva et al, 2014 FC 328 and 2014 FC 893, aff'd 2015 FCA 93.
On March 18, the Canadian Intellectual Property Office (CIPO) issued revised practice guidelines for the examination of patent applications respecting medical use claims following the Federal Court's decision in AbbVie Biotechnology Ltd v The Attorney General of Canada, 2014 FC 1251. On June 29, CIPO issued guidance for examination of diagnostic method claims.
On June 9, the Competition Bureau released draft updated Intellectual Property Enforcement Guidelines (IPEGs) for comment. The IPEGs describe how the Bureau will determine whether conduct involving IP raises an issue under the Competition Act. A new subsection would address settlements of proceedings under the PMNOC Regulations. Comments may be submitted until August 10, 2015.
On June 24, the Federal Court released a Notice to the Parties and the Profession titled "Case Management: Increased Proportionality in Complex Litigation before the Federal Court."
8. Health Canada updates
Several Health Canada developments have occurred including.
- Launch of two initiatives related to November 2014 Vanessa's Law amendments to the Food and Drugs Act (April 14); proposed amendments to Food and Drug Regulations not yet released.
- New/expanded databases:
- List of therapeutic products with paediatric information available in their labelling (February 12)
- New online tool for drug safety information (February 12)
- New online access to information on inspections of companies that manufacture and sell drug products (April 13
- Drug Product Database scope expanded (effective June 18)
- Further quarantines of products from foreign sites (January 6, June 12; Apotex's court application (T-2223-14) seeking to quash the import ban on drugs from Apotex Pharmachem India Pvt Ltd and Apotex Research is scheduled to be heard this Fall.
- Release of Final Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience) (May 1)
- New requirement for brand name assessments for prescription drugs (for submissions filed on or after June 13
- Interim policy re: interpretation of "medicinal ingredient" (June 16)
- Proposed changes to Health Canada's comparative bioavailability requirements for highly variable drug products (HVDPs) (comments will be accepted until August 25)
- Proposed regulatory amendments to require mandatory reporting of drug shortages and discontinuations (comments will be accepted until September 3)