The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2015, updating our 2015 mid-year highlights.
1. Still no clarification from Supreme Court on utility
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. Following dismissal by the Court of Appeal of its appeal of a Federal Court decision invalidating its patent for esomeprazole (NEXIUM) for lack of demonstrated/sound prediction of utility, on September 29, AstraZeneca sought leave to appeal from the SCC; a decision remains pending. The Federal Court’s finding in NEXIUM that the patent disclosure requirement for sound prediction only applies to new use patents was followed by the Federal Court in an October 9 decision relating to sofosbuvir (SOVALDI).
2. Supreme Court dismisses sanofi-aventis’ section 8 appeal; Ontario Court of Appeal dismisses Apotex’s unjust enrichment appeal; Ontario Court dismisses Eli Lilly’s motion to strike Apotex’s claim for damages under almost 400-year-old Statute of Monopolies; BC Court of Appeal dismisses consumer class action based on invalidation of VIAGRA patent
Following unsuccessful enforcement of its patents under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), patentees have been sued in a variety of actions on various grounds:
- On April 20, the SCC dismissed sanofi-aventis’ appeal in a section 8 damages case. The Federal Court of Appeal (FCA) had affirmed, in large part, a decision granting damages to Apotex regarding ramipril (ALTACE).
- On May 5, the Ontario Court of Appeal dismissed Apotex’s appeal from a Divisional Court decision that struck Apotex’s claim for unjust enrichment relating to atomoxetine (Eli Lilly’s STRATTERA). Apotex has sought leave to appeal from the SCC; a decision remains pending.
- On August 28, the Ontario Superior Court of Justice dismissed Eli Lilly’s motion to strike Apotex’s claim for treble damages and double costs pursuant to the almost 400-year old British Statute of Monopolies and its 118-year-old Ontario re-enactment in an action relating to atomoxetine (STRATTERA).
- On December 8, the British Columbia Court of Appeal (BCCA) reversed a judge’s ruling that a proposed class action relating to sildenafil (VIAGRA) disclosed a cause of action sufficient for the purposes of certification under the province’s Class Proceedings Act.
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 their profits from infringing sales of perindopril (Servier's COVERSYL). In both cases, the Court rejected Apotex’s non-infringing alternative arguments. However, on July 23, in a case relating to lovastatin (Merck’s MEVACOR), the Federal Court of Appeal held that the availability of a non-infringing alternative may be a relevant consideration when assessing damages for patent infringement. As the defence was rejected on the facts, the lower Court’s award of over $119 million in damages to Merck (previously reported here) was upheld. On September 29, Apotex sought leave to appeal from the SCC in lovastatin; a decision remains pending. Apotex’s appeals in cefaclor and perindopril are pending.
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 appeal is pending. On October 9, in the only other pharmaceutical patent action decision on the merits, the Federal Court invalidated an Idenix patent and dismissed attacks on a Gilead patent claiming sofosbuvir (SOVALDI); Idenix has appealed.
4. PMNOC Regulations amended to permit listing patent with claim for single medicinal ingredient against fixed-dose combination; FCA permits listing patent with formulation claim naming single medicinal ingredient against a fixed-dose combination product (TRIFEXIS)
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. On July 17, the Court of Appeal held that a patent with a claim for a formulation naming one medicinal ingredient (spinosad) was eligible for listing against a fixed-dose combination product containing spinosad and milbemycin oxime (TRIFEXIS).
On August 10, the Court dismissed Photocure’s application, challenging the Minister of Health’s denial of data protection for hexaminolevulinate hydrochloride (HAL HCl) (CYSVIEW) on the basis that HAL HCl was an “ester” of a previously approved medicinal ingredient, aminolevulinic acid hydrochloride (LEVULAN KERASTICK). On November 6, the Federal Court upheld the Minister’s decision to not issue a notice of compliance (NOC) for Hospira’s OXALIPLATIN FOR INJECTION pending expiry of the data protection term for ELOXATIN. While Hospira’s new drug submission (NDS) was filed before sanofi-aventis’s NDS for ELOXATIN was filed, the Court found that the Minister was correct that post-filing amendments to a NDS can trigger data protection.
6. Alexion challenges constitutionality of Patented Medicine Prices Review Board price regulation provisions; Federal Court of Appeal finds that Sandoz and ratiopharm are subject to jurisdiction of PMPRB
On September 11, Alexion Pharmaceuticals filed an application, seeking a declaration that the Patent Actscheme for regulating the prices of patented medicines is unconstitutional. On November 6, the FCA reversed Federal Court decisions and found that Sandoz and ratiopharm are “patentees” for the purpose of the PMPRB provisions of the Patent Act. In December, the PMPRB released it strategic plan for 2015-2018.
On October 5, the Government of Canada announced that the members of the Trans-Pacific Partnership (TPP) had successfully concluded negotiations on a free trade agreement and the text was released on November 5. The agreement will require that parties provide a patent term adjustment to compensate for the “unreasonable curtailment of the effective patent term as a result of the marketing approval process”. Canada has already committed to providing such protection in the Canada-EU Comprehensive Trade and Economic Agreement (CETA). CETA remains to be ratified.
On October 14, the Federal Court quashed the Minister of Health’s Import Ban against Apotex and certain related companies on the basis that the Minister issued it for an improper purpose and denied Apotex procedural fairness.
On November 10, in the first decision on a subsequent entry biologic (SEB) product in an application brought under the PMNOC Regulations, the Federal Court dismissed Amgen’s application for an order prohibiting the issuance of a NOC to Apotex for its proposed filgrastim product (GRASTOFIL), which relied on a comparison to Amgen’s NEUPOGEN. Apotex was successful in its allegation of obviousness and Amgen appealed. Apotex received its NOC on December 7, which is the fifth SEB approved in Canada (after OMNITROPE, 2009, REMSIMA/INFLECTRA, 2014, and BASAGLAR, 2015). Separately, Amgen’s prohibition proceeding relating to Samsung Bioepis’s version of the recombinant antibody etanercept (Amgen’s ENBREL) remains pending.
10. PMNOC Regulations and data protection statistics
Based on the 14 Federal Court PMNOC Regulations decisions reported by year-end, the patentee was successful on the merits regarding 3 patents in 4 cases and the generic manufacturer was successful regarding 11 patents in 10 cases. The FCA affirmed all 6 PMNOC Regulations appeals (patentee on 3 patents; generic manufacturer on 4 patents). See summary table here. See also the Therapeutic Products Directorate report providing a statistical overview of Health Canada’s administration of the PMNOC Regulations and data protection; and the Therapeutic Products Directorate and the Biologics and Genetic Therapies Directorate’s Drug Submission Performance Annual Reports.