Federal Court examines "good faith" in patent prosecution

In Lundbeck Canada Inc.  v. Ratiopharm Inc., 2009 FC 1102 (F.C. Nov. 23, 2009), the Federal Court provided guidance on the requirement to deal in good faith with the Patent Office during patent prosecution. Since 1996, s. 73(1)(c) of the Patent Act has required that applicants reply in “good faith” to any request by a patent examiner. However, until now the scope of that requirement had been somewhat uncertain.

Justice Mactavish took this opportunity to clarify that an applicant must not provide information that could mislead the Patent Office. The case involved a patent for a combination of drugs used in treating dementia. To meet the requirement of non-obviousness, it was necessary to show that this combination of drugs led to a result that was new and unexpected in light of the state of knowledge of researchers at the time. Lundbeck, in support of the patent, indicated to the patent agent that prior articles taught that this combination was ineffective. However, Lundbeck did not point out that one significant study (of which they were aware) stated that only certain subsets of the combinations in question were ineffective, but that others could be. Mactavish J. held that the omission of this information was misleading and thus a breach of the duty of good faith. In addition, Mactavish J. equated this obligation to the Patent Office with obligations to the court in an ex parte proceeding.

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.

Draft Code of Conduct for the Credit and Debit Card Industry

A proposed Code of Conduct for the Credit and Debit Card Industry was released by the Federal Government of Canada today for a 60 day comment period. Its purpose is to improve merchant cost-transparency and allow merchants to provide flexible pricing options to consumers. It is proposing to accomplish this by allowing merchants to provide discounts depending on what cards consumers use, and by allowing merchants to cancel contracts without penalty after a fee change.

U.S. federal agencies publish final model GLBA privacy form

On November 16, 2009, the Office of the Comptroller of the Currency, Treasury; the Board of Governors of the Federal Reserve System; the Federal Deposit Insurance Corporation; the Office of Thrift Supervision, Treasury; the National Credit Union Administration; the Federal Trade Commission; the Commodity Futures Trading Commission; and the Securities and Exchange Commission (collectively, the Agencies) published a final rule amending the rules that implement the privacy notice obligations under the Gramm-Leach-Bliley Act (GLBA). Pursuant to the final rule, the Agencies are adopting an optional model privacy form that financial institutions may rely on as a safe harbour and that will satisfy their privacy notice obligations under the GLBA. The final rule will come into effect on December 31, 2009.

The model form replaces the “sample clauses” previously contained in the Agencies’ privacy rules and used by many financial institutions in their GLBA notices as a safe harbour. The Securities and Exchange Commission is eliminating the guidance associated with, and the other Agencies are eliminating the safe harbour permitted for, notices based on the sample clauses if the notice is provided after December 31, 2010.

The final rule includes three versions of the model form: (1) a model form with no opt-out; (2) a model form with opt-out by telephone and/or online; and (3) a model form with opt-out by telephone, online and/or mail-in.

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).

CRTC follows the money, concludes Globalive does not satisfy Canadian ownership and control requirements

Gregory Kane Q.C., Sean Vanderpol and Colin Yao

Canada's federal telecommunications regulator, the Canadian Radio-television and Telecommunications Commission (CRTC or Commission), has recently released the stunning decision that Globalive Wireless Management Corporation (Globalive) is not currently eligible to operate as a telecommunications common carrier (TCC). According to the CRTC, Globalive, which recently purchased 30 advanced wireless spectrum licences at auction from Industry Canada, may not act as a TCC because it does not meet the requirements set out in section 16 of the Telecommunications Act (the Act).

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