The following are highlights of developments in Canadian pharmaceutical intellectual property and regulatory law in 2014.
1. Health Canada approves first antibody SEBs
On January 15, Health Canada approved Celltrion's REMSIMA and INFLECTRA (NOC now in the name of Hospira), each containing the monoclonal antibody, infliximab. They were filed as subsequent entry biologics to Janssen's REMICADE and did not receive approval for all of its indications.
2. Court of Appeal issues first section 8 quantification decisions (ramipril); Supreme Court grants sanofi-aventis leave
On March 14, the Federal Court of Appeal reversed in part the first two decisions quantifying section 8 damages, employing different hypothetical models from that of the trial judge. The cases relate to ramipril (sanofi-aventis' ALTACE, Apo-Ramipril and Teva-Ramipril). The Supreme Court subsequently granted sanofi-aventis leave to appeal the Apotex decision.
3. Federal Court finds PMPRB does not have jurisdiction over ratiopharm and Sandoz
On May 27, the Federal Court decided that ratiopharm (selling an authorized generic version of VENTOLIN HFA) and Sandoz, a subsidiary of the patentee Novartis, are not "patentees" and are therefore not subject to the Board's pricing jurisdiction. The PMPRB has appealed.
4. Heightened matching requirement for patent listing; Regulations to be amended
On September 18, the Federal Court upheld a Prothonotary's finding that a patent explicitly claiming one medicinal ingredient was not eligible for listing on the Patent Register against the fixed-dose combination products KIVEXA and TRIZIVIR. Viiv has appealed. Industry Canada will be amending the Patented Medicines (Notice of Compliance) Regulations.
5. Competition Bureau releases white paper on patent litigation settlements
On September 23, the Competition Bureau released a white paper providing the Bureau's preliminary views on how the Competition Act may apply to both entry-date settlements (limited to generic entry prior to patent expiry) and "pay-for-delay" agreements.
6. CETA: Text released, patent term restoration coming to Canada
On September 26, the text of CETA (the Comprehensive Economic and Trade Agreement between Canada and Europe) was released and includes patent term restoration and an innovator right of appeal under the Patented Medicines (Notice of Compliance) Regulations. The agreement must still be ratified and domestic laws amended.
7. Health Canada imposes import ban on products from sites in India; Apotex sues
On September 30, Health Canada commenced action to stop the import of health products from Apotex Pharmachem India Pvt Ltd (APIPL), Apotex Research Private Limited (ARPL), and IPCA Laboratories (the Department in India), noting "serious doubts about the quality and safety of finished products and APIs produced at these sites." Apotex brought applications challenging this decision (T-2223-14) and Health Canada's decision refusing a NOC for Apo-Rasagiline stemming from this import ban (T-2411-14).
8. Court of Appeal permits Janssen to amend its plea, dissolves STELARA injunction and orders new trial
On October 28, the Federal Court of Appeal granted Janssen's appeal of a pre-trial Order denying its request to plead further prior art references, consequently set aside the lower Court's decision declaring Abbvie's patent valid and infringed by Janssen's antibody drug STELARA (ustekinumab), and remitted the matter back for a new trial before a new judge. The injunction was also set aside. The new trial has been scheduled for January 2016. Abbvie has sought leave to appeal from the Supreme Court.
9. Utility: Apotex discontinues PLAVIX appeal on eve of SCC hearing
On November 3, Apotex discontinued its appeal to the Supreme Court of Canada regarding the validity of sanofi-aventis' patent claiming clopidogrel bisulfate (PLAVIX). Had the appeal proceeded, the Supreme Court was expected to provide guidance on Canada's "promise" doctrine of utility and the test for sound prediction of utility.
Separately, on October 30, the Federal Court of Appeal provided further clarity regarding the "promise" doctrine, upholding prohibition Orders regarding celecoxib (Pfizer's CELEBREX). Addendum: On December 23, Apotex and Mylan sought leave to appeal from the Supreme Court.
10. CHEO challenges validity of gene patents
On November 3, the Children's Hospital of Eastern Ontario ("CHEO") brought a Claim seeking a declaration of invalidity and non-infringement of five Canadian patents relating to nucleotide and amino acid sequences of genes and proteins implicated in Long QT syndrome, an inherited cardiac disorder.
11. Vanessa's Law: Health Canada has heightened powers to address adverse drug reporting
On November 6, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) received royal assent. The Act strengthens oversight of drugs, devices and drug-device combinations post-approval, and provides Health Canada with new powers to compel and disclose information, order changes to labels and packages and recall products that present serious or imminent risk of injury to health.
12. Health Canada found negligent in handling of Apo-Trazodone regulatory submission
On November 18, the Federal Court found the Minister of Health liable to pay damages to Apotex for misfeasance in public office and negligence for its failure to abide by a settlement agreement relating to use of a foreign reference product, which delayed the approval of Apotex's generic trazodone product. The Queen has appealed.