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IN THIS ISSUE: Federal Court finds PLAVIX patent invalid » Supreme Court of Canada news » Patented Medicine Prices Review Board news » Court of Appeal affirms unavailability of unjust enrichment claim in section 8 action » Takeda denied data protection for DEXILANT » Court of Appeal affirms CGPA's lack of standing to challenge data protection » Court of Appeal affirms infringement by Apotex regarding lovastatin » Regulations prohibiting private label generic drugs found valid » Federal Court finds PLAVIX patent invalid On December 6, 2011, Justice Boivin of the Federal Court held that Apotex infringed the patent that claims clopidrogel bisulfate (sanofi-aventis's PLAVIX) but that the patent was invalid: Apotex Inc. v. sanofi-aventis, 2011 FC 1486, appeal pending.
Court of Appeal finds Merck liable under 1998 version of section 8 regarding lovastatin and remits case back to Trial Judge On December 19, 2011, the Court of Appeal reversed the Trial Judge's finding that the 1993 version of section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") applied to Apotex's claim against Merck relating to a prohibition proceeding regarding lovastatin (Merck's MEVACOR) (Apotex Inc. v. Merck & Co., Inc. et al., 2011 FCA 364, rev'g 2010 FC 1264).
Supreme Court of Canada news Ratiopharm denied leave to appeal decision refusing to set aside Order of prohibition following declaration of invalidity. The Supreme Court has dismissed ratiopharm's application for leave to appeal the Federal Court of Appeal's decision refusing to set aside a 2006 Order of prohibition against ratiopharm for amlodipine besylate (Pfizer's NORVASC). The relevant patent had been declared invalid in an impeachment action. Ratiopharm sought to set aside a 2006 Order of prohibition so that it would be entitled to compensation pursuant to section 8 of the Regulations. The Court of Appeal held that the declaration of invalidity was not a new matter that would warrant setting aside the 2006 Order, and that it could not be said that the 2006 Order was induced by and resulted from misrepresentation. The Supreme Court had previously denied ratiopharm's application for leave to appeal the 2006 Order (SCC Case No. 31607). Ratiopharm Inc. v. Pfizer Canada Inc. (SCC Case No. 34464). Eli Lilly denied leave to appeal holding of invalidity of atomoxetine use patent. As reported in the August 2011 issue of Rx IP Update, the Federal Court of Appeal affirmed the Federal Court decision that the patent claiming the use of atomoxetine (Eli Lilly's STRATTERA) to treat attention deficit hyperactivity disorder was invalid on the bases of inutility and lack of sound prediction. The Supreme Court has dismissed Eli Lilly's application for leave to appeal. Eli Lilly and Company v. Teva Canada Limited (SCC Case No. 34396).
Patented Medicine Prices Review Board news NPDUIS releases report on wholesale up-charge policies of Canada's public drug plans. In December 2011, the National Prescription Drug Utilization Information System ("NPDUIS") released a new analytical report regarding wholesale up-charge policies across the NPDUIS participating jurisdictions to better understand the instruments available in controlling related costs.
Recent Court decisions Patented Medicines (Notice of Compliance) Regulations Court of Appeal affirms unavailability of unjust enrichment claim in section 8 action. On December 16, 2011, the Court of Appeal held that Apotex could not pursue unjust enrichment claims in actions relating to raloxifene (Eli Lilly's EVISTA) and pantoprazole (Nycomed's PANTALOC) as no cause of action independent of the operation of section 8 was alleged. Apotex Inc. and Eli Lilly Canada Inc., December 16, 2011. Other decisions Takeda denied data protection for DEXILANT. On December 9, 2011, the Federal Court upheld the Minister of Health's decision that Takeda was not entitled to data protection for DEXILANT (dexlansoprazole) as it is an enantiomer of the previously approved racemate lansoprazole (currently marketed as PREVACID). The Court also did not find that there was any breach of the duty of fairness owed to Takeda in refusing to consider the data submitted. Takeda has appealed. Takeda v. Canada (Health), December 9, 2011. Court of Appeal affirms CGPA's lack of standing to challenge data protection. On December 15, 2011, the Court of Appeal affirmed the finding of the Federal Court, which held that the Canadian Generic Pharmaceutical Association ("CGPA") does not have standing to challenge data protection for the GlaxoSmithKline product AVAMYS (fluticasone furoate). The Court affirmed that the CGPA is not directly affected by the Minister's decision not to remove the drug from the Register of Innovative Drugs as CGPA does not manufacture generic drugs, submit drug submissions, obtain notices of compliance, or sell drugs in Canada. The Court also noted that none of the CGPA members had filed a drug submission for the drug or expressed any interest to manufacture the drug. The Court further affirmed that the CGPA lacks public interest standing. Canadian Generic Pharmaceutical Association v. The Minister of Health, December 15, 2011. Court of Appeal affirms infringement by Apotex regarding lovastatin. On December 19, 2011, the Court of Appeal affirmed the Trial Judge's finding of infringement of certain batches of lovastatin (which is marketed by Merck as MEVACOR) by Apotex and Apotex Fermentation. Merck & Co Inc. v. Apotex Inc., December 19, 2011. Regulations prohibiting private label generic drugs found valid. In February 2011, the Ontario Divisional Court held that certain provisions of the Regulations made under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act, which effectively prohibited the sale of private label generic drugs in the public and private markets in Ontario, are invalid. On December 23, 2011, the Ontario Court of Appeal reversed the Divisional Court decision and held that the impugned Regulations are intra vires and remain in full force and effect. The Court of Appeal did not accept the regulation/prohibition dichotomy articulated by the Divisional Court and noted that the Regulations are regulation, not prohibition, as they do not preclude the pharmacies from engaging in the purchase and sale of drugs in Ontario as long as they do so in accordance with the legislative and regulatory scheme. The Court of Appeal found that the Divisional Court erred in overemphasizing the effect of the Regulations on profits by manufacturers and pharmacies and underemphasizing the potential of the Regulations to influence market dynamics, incentives and drug costs in the long term. The Court of Appeal also found that the Divisional Court failed to recognize that the regulatory regime was intended not only to reduce drug costs to consumers but to ensure that pharmacists were compensated as professional service providers and not from profit in the dispensing of drugs. It held that it was not for the Court to second-guess the Ontario government. It could be reasonably concluded that private-label generics could reduce competition in ways that would adversely affect long-term pricing. Finally, the Court of Appeal held that the Regulations are not an improper restraint on trade and they did not discriminate against the pharmacies. Shoppers Drug Mart Inc. v. Ontario (Health and Long-Term Care), December 23, 2011.
New Court proceedings Patented Medicines (Notice of Compliance) Regulations
Other proceedings
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