Posts Tagged ‘NOC’
In AstraZeneca Canada Inc. v. Apotex Inc. (2010 FC 714), the Federal Court (“FC”) denied AstraZeneca Canada’s (“AstraZeneca”) application under s. 6 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations“) prohibiting ththe issuance of a Notice of Compliance (“NOC”) to Apotex Inc. until the expiration of Canadian Patent No. 2,139,653 (” ’653 patent”). The FC held Apotex’s allegations against the ’653 patent regarding obviousness and lack of sound prediction as to utility were justified, and denied AstraZeneca’s prohibition application.
Apotex’s Abbreviated New Drug Submission (ANDS) was for esomeprazole magnesium tablets, a drug useful in the treatment of conditions where a reduction of gastric acid secretion is necessary. The ’653 patent, entitled “Optically Pure Salts of Pyridinylmethyl Sulfiny – IH – Benzimidazole Compounds”, claimed optically pure salts of esomeprazole, process claims and use claims. The issue at way was limited to whether Apotex’s allegation that claim 8 of the ’653 patent was invalid was justified. Claim 8 is for a salt of esomeprazole having an optical purity of 99.8% or greater.
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 Apotex Inc. v. Pfizer Canada Inc. (2009 FC 631), the Federal Court (FC) dismissed Pfizer Canada Inc.’s (Pfizer) motion for summary judgment. Due to the complicated statutory interpretations of s.8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOCR), summary judgment had never been granted in the past. The issue was whether Apotex’s Statement of Claim failed to disclose a genuine issue for trial so that summary judgment should be granted. In particular, whether Pfizer’s application for an order of prohibition caused any damages allegedly suffered by Apotex, such that Pfizer is liable under s.8 of the PMNOCR. The question of whether the outcome of any proceeding could be considered when determining whether Pfizer’s had wrongly delayed Apotex’s generic drug approval weighed against summary judgment. Continue Reading
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