Supreme Court issues clear warning of need to respect the "Patent Bargain"

Ian P. Goodman -

On Thursday, November 8, 2012, a unanimous Supreme Court of Canada issued a decision with significant implications for those wishing to obtain or enforce Canadian patent rights.  Owners of issued patents seeking to enforce such rights should carefully scrutinize the disclosure and claims of their issued patents in light of this decision, and patent applicants should consider this decision when drafting the specifications of new applications.

The case of Teva Canada Ltd. v. Pfizer Canada Inc.  arose out of a Patented Medicines (Notice of Compliance) [PMNOC] proceeding in which Novopharm Limited (now, Teva Pharmaceuticals Limited) sought approval from Health Canada to market and sell a generic version of Pfizer’s Viagra-branded sildenafil tablets.  To obtain such approval, the decision-maker had to be convinced that Pfizer’s patent (the ‘466 Patent) was invalid. However, Teva was unsuccessful at both the Federal Court of Canada and the Federal Court of Appeal, each of which held that Teva’s allegations of invalidity were not justified.

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Federal Court finds Apotex infringed Merck's product-by-process patent for Lovastatin

In Merck & Co. Inc. v. Apotex Inc., the Federal Court found Apotex to have infringed Merck’s Canadian Patent No. 1,161,380 (‘380 Patent), a product-by-process patent for the medicine lovastatin.

In arriving at its decision, the Court addressed key questions regarding standing, infringement and patent validity. The decision provides an interesting example of a plaintiff’s successful use of DNA and circumstantial evidence in establishing two separate sources of infringement. In addition, readers should take note of the Court’s finding that a pre-existing process will invalidate a product-by-process patent only where it necessarily produces the relevant product.  

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The Genetic Information Nondiscrimination Act (GINA) Comes into Force in the U.S.

In 2008, the U.S. enacted the Genetic Information Nondiscrimination Act of 2008 (GINA) to prohibit discrimination in health coverage and employment based on genetic information. While many states have already enacted legislation that prohibitions discrimination based on genetic information, the degree of protection provided by state laws varies widely and the federal act provides a minimum baseline of protection. GINA prohibits health insurers or administrators from requesting or requiring genetic information from an individual or an individual’s family members. GINA also prohibits employers from using genetic information on any decisions regarding employment.

Federal Court Upholds Constitutionality of Drug Data Protection Rules

In Canadian Generic Pharmaceutical Association v. The Minister of Health et al., (2009) FC 725, Justice Mandamin of the Federal Court upheld the constitutional validity of the data exclusivity protection rules found in the Food and Drug Regulations (Data Protection Rules). The Data Protection Rules were enacted pursuant to subsection 30(3) of the Food and Drugs Act in 2006 and provide new drugs with a guaranteed minimum period of market exclusivity of eight years. The Data Protection Rules also provide that a generic manufacturer, seeking to copy an innovative drug, will not be permitted to file a new drug for a period of six years. The Federal Court found the enactment of the Data Protection Rules to be a valid exercise of the federal power to regulate trade and commerce in that the Data Protection Regulations are “adjunct” to the federal regulatory scheme for marketing drugs in Canada and bring the approval of generic drugs into conformity with Canada’s data protection obligations in NAFTA and the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).