In Janssen-Ortho Inc. v. Canada (Minister of Health) (2010 FC 42), the Federal Court of Canada (“Federal Court”) denied Alza Corporation and Janssen-Ortho’s (“the Applicants”) application for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Novopharm Ltd. for its generic methylphenidate drug until the expiration of Canadian Patent No. 2,264,852 (” ’852 patent”). Novopharm had submitted an Abbreviated New Drug Submission (ANDS) for methylphenidate, used to treat Attention Deficit Hyperactivity Disorder (ADHD).
Methylphenidate’s previous immediate-release formulation required multiple doses to ensure an effective amount of methylphenidate remained present. Later, a sustained-release formulation sold under the brand name Ritalin was developed to reduce the need for multiple doses. The Applicant’s alleged this approach was less effective due to the development of tolerance, a claim disputed within the scientific community. The Applicants claimed the ascending methylphenidate plasma concentration profile described in the ’852 patent overcame the tolerance issues. Continue Reading
In Merck & Co. Inc. v. Pharmascience Inc. (2010 FC 510), the Federal Court (FC) dismissed Merck & Co. Inc.’s (Merck) application to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Pharmascience Inc. The FC found Canadian Patent No. 2,173,457 (the ’457 patent) invalid on the basis of double patenting and anticipation. Significantly, the FC held that, despite its finding of anticipation, the ’457 Patent was not obvious because prior art subsequent to the anticipating art would have discouraged any inquiry in to the relevant field of research.
Pharmascience had sought a NOC to market a generic version of the medicine finasteride, used in the treatment of male pattern baldness. Only dependent claim 5 of the ’457 Patent remained in issue, and the FC summarized it as follows: “the use of finasteride for the preparation of a medicament adapted for oral administration useful for the treatment of male pattern baldness in a person and wherein the daily dosage is about 1.0mg.” Continue Reading
In Sanofi-Aventis Canada Inc. v. Ratiopharm Inc. (2010 FC 230), the Federal Court (“FC”) denied Sanofi-Aventis Canada’s (Sanofi) application to prohibit the Minister of Health from issuing a Notice of Compliance (“NOC”) to Ratiopharm Inc. pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations“). The FC held Sanofi’s Canadian Patent No. 2,177,772 was invalid for overbreadth, lack of utility and in any case was not infringed by the use of Ratiopharm’s proposed composition.
Ratiopharm’s NOC application was for irbesartan, a drug for treatment of cardiovascular ailments such as hypertension and heart failure. Canadian Patents 2,177,772 (“’772 patent”) and 2,057,913 had been listed by Sanofi on the patent register in respect of irbesartan pursuant to section 4 of the PMNOC Regulations. Ratiopharm accepted that no NOC would issue prior to expiry of the ’913 patent, so only the ’772 patent remained for consideration. The ’772 patent claims pharmaceutical compositions containing irbesartan, preferably in the form of tablets with a high relative amount of the active ingredient that allowed for a rapid dissolution and release. Continue Reading
In Apotex Inc. v. Merck & Co., Inc (2010 FC 287), the Federal Court of Canada (FC) held that Apotex is entitled to obtain compensation from Merck for having been kept out of the norfloxacin market for several years while the parties litigated Apotex’s Notice of Compliance (NOC) application.
Apotex tried to market a generic version of norfloxacin in the early 1990s, a drug patented by Merck. Merck filed an order to prohibit Apotex from obtaining a NOC. The Supreme Court of Canada set aside the prohibition order on July 9, 1998 in Merck Frosst Canada v. Canada. Apotex sought relief under s.8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (“the 93 Regulations”), as amended by SOR/98-166 (“the ’98 Regulations”), for delayed market entry caused by Merck’s prohibition order application. Continue Reading
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