 |
|||||||||||||||||||||||||||||
|
In this issue: PMPRB orders ratiopharm Inc. to pay over $65M to offset excess revenues » Supreme Court of Canada news » Patented Medicine Prices Review Board news » Federal Court dismisses appeal of Registrar's decision refusing to expunge TABASTOP trademark » Federal Court of Appeal affirms Trial Judge's dismissal of ramipril infringement claims » |
|||||||||||||||||||||||||||||
|
PMPRB orders ratiopharm Inc. to pay over $65M to offset excess revenues As reported in the July 2011 issue of Rx IP Update, a Panel of the Board found that the Board had jurisdiction over ratiopharm Inc.'s sales of ratio-Salbutamol HFA ("ratio HFA"). The Panel had ordered the Board Staff to determine the amount to be paid to the Crown for excessive revenues generated by the sales of ratio HFA from September 2002 to January 2010 based on ratio HFA's maximum non-excessive price at introduction, as adjusted for the Consumer Price Index in accordance with the Board's Guidelines, without taking into account any reduction for rebates. Further to that Order, the Panel has issued an Order requiring that ratiopharm pay the Crown, after the determination by the Federal Court of ratiopharm's application for judicial review of the Panel decision (Court File No. T-1058-11), an amount of $65,898,842.76 to offset excess revenues for ratio HFA from July 2002 to June 2010. This amount is the highest the PMPRB has ordered to date. Board decision – PMPRB-08-D3-ratio-Salbutamol HFA; Order for repayment. Supreme Court of Canada news Ratiopharm seeks leave to appeal decision refusing to set aside Order of prohibition following declaration of invalidity. As reported in the August 2011 issue of Rx IP Update, the Federal Court of Appeal refused to set aside a 2006 Order of the Court of Appeal (2006 FCA 214) prohibiting the Minister of Health from issuing a Notice of Compliance to ratiopharm for amlodipine besylate (Pfizer's NORVASC) until the expiry of Pfizer's ’393 patent. The ’393 patent had been declared invalid in a 2009 judgment (2009 FC 711), which was affirmed by the Court of Appeal (2010 FCA 204). Ratiopharm sought to set aside the 2006 Order so that it would be entitled to compensation pursuant to section 8 of the Regulations. Ratiopharm submitted that the 2006 Order of prohibition should be set aside by reason of a matter that was discovered subsequent to the Order and because the Order was obtained by fraud. 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 the misrepresentation later found in the impeachment proceedings made to obtain the patent. 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). Pfizer seeks leave to appeal decision setting aside Order of prohibition re. latanoprost (Pfizer's XALATAN). As reported in the September 2011 issue of Rx IP Update, the Federal Court of Appeal set aside the Federal Court's Order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex for latanoprost. The Court of Appeal held that when the promise of the patent was properly construed, the promised utility was not soundly predicted. Pfizer Canada Inc. v. Apotex Inc. (SCC Case No. 34497). Health Canada news Health Canada releases clarifications to Data Protection Guidance Document. Health Canada announced the publication of clarifications to its Guidance Document: "Data Protection under C.08.004.1 of the Food and Drug Regulations." The clarifications were published in light of inquiries regarding the interpretation of the definition of "innovative drug" for veterinary and human drugs. The clarification explains that the prior approval of a medicinal ingredient in a drug for veterinary use does not preclude the granting of data protection to a drug for human use containing the identical medicinal ingredient or a variation thereof and vice versa. Further minor corrections/clarifications were also made. The clarification to the Guidance Document is effective October 11, 2011. Clarification to Guidance Document. Patented Medicine Prices Review Board news Voluntary Compliance Undertakings. The Board recently accepted Voluntary Compliance Undertakings for Merck Canada's NASONEX (mometasone furoate) (Notice) and ORGALUTRAN (ganirelix acetate) (Notice), as well as Eli Lilly Canada's EFFIENT (prasugrel) (Notice). NPDUIS releases three new analytical reports. The National Prescription Drug Utilization Information System ("NPDUIS"), a partnership between the PMPRB and the Canadian Institutes for Health Information, is an initiative that aims to provide analyses of drug price, utilization and cost trends in Canada to support drug plan policy decision-making for participating levels of government. On September 30, 2011, NPDUIS released three new analytical reports. In "Generic Drugs in Canada: International Price Comparisons and Potential Cost Savings," NPDUIS conducted a comparison of Canadian and foreign prices of the 105 top-selling molecules for 2008, and reports that foreign prices of the leading generic drugs were typically lower than the corresponding Canadian prices. The aim of the study in "The Impact of Generic Entry on the Utilization of the Ingredient" was to identify the impact of generic entry on the utilization of the ingredient itself in respect of seven top-selling drugs that lost patent protection in recent years. The study reports that the main implication of the findings is that the only savings that can be expected from generic entry are those related to the generic price discount. In the third report, "Public Drug Plan Dispensing Fees: A Cost-Driver Analysis, 2001/02 to 2007/08," NPDUIS collected data from nine public drug plans over a six-year span and identifies and quantifies factors that drove dispensing fee expenditures to increase at an average annual growth rate of 9.1% in the studied time period. Recent Court decisions Federal Court dismisses Shire's appeal to amend defence to section 8 claim to add patent infringement as a defence/counterclaim. Shire was denied an Order of prohibition against Apotex regarding modafinil (Shire's ALERTEC), and Apotex subsequently commenced an action pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations. As reported in the May 2011 issue of Rx IP Update, a Prothonotary denied leave to Shire to amend its pleadings to plead infringement as a defence and counterclaim. Justice Near dismissed Shire's appeal of the Prothonotary's decision. Justice Near held that Shire should have raised the issue of infringement much sooner, that the proposed amendments would cause significant delays and the loss to Apotex of having the matter dealt with expeditiously cannot be fully remedied with costs. Shire had also previously been denied leave to amend its defence to plead that Apotex should be precluded from recovering damages pursuant to section 8 in the event that there is a finding of infringement of the relevant patent in another proceeding, brought by the patentee (Cephalon) against Apotex (reported in the September and November 2010 issues of Rx IP Update). Apotex Inc. v. Shire Canada Inc., April 7, 2011. Trademark decisions Federal Court dismisses appeal of Registrar's decision refusing to expunge TABASTOP trademark. The decision of the Registrar of Trademarks refusing to expunge the trademark TABASTOP pursuant to section 45 of the Trademarks Act was upheld on appeal. The Federal Court held that the Registrar's decision was reasonable in light of the affidavit evidence submitted by the trademark owner, Les Laboratoires Bio-Santé Inc, which was sufficient to show that the owner was using the trademark in the normal course of trade. Fasken Martineau Dumoulin S.E.N.C.R.L., S.R.L. v. Les Laboratoires Bio-Santé Inc. Other decisions Federal Court of Appeal affirms Trial Judge's dismissal of ramipril infringement claims. On November 2, 2011, the Court of Appeal dismissed sanofi-aventis and Schering's appeals from the Judgment of Justice Snider, which dismissed their infringement claims against Apotex and Teva (formerly Novopharm) regarding a patent covering ramipril (sanofi-aventis's ALTACE). As reported in the August 2009 issue of Rx IP Update, Justice Snider found that the relevant claims were invalid for lack of sound prediction and, in the alternative, as obvious. The Court of Appeal concluded that the Trial Judge properly cited the legal principles applicable to sound prediction, applied those principles to the evidence before her and arrived at her conclusions. In particular, the Court noted that the appellants' submissions "ignore the fundamental factual finding" that "in the stereochemistry context, even a small change to a molecule can yield profound effects on activity," which underpinned and informed the Judge's analysis. The Court also noted that the Judge's obviousness analysis was obiter and therefore, it did not address obviousness. sanofi-aventis Canada Inc. v. Apotex Inc., November 2, 2011. |
Rankings and recognitions Smart & Biggar/ Smart & Biggar/ Smart & Biggar/ Firm dominates rankings in The 2011 Lexpert/American Lawyer Guide to the Leading 500 Lawyers in Canada Smart & Biggar/ Firm recognized in The International Who's Who of Life Sciences Lawyers 2011 Smart & Biggar/ |
New Court proceedings Patented Medicines (Notice of Compliance) Regulations
Other proceedings
To check the status of Federal Court cases, please click here.
|
For more information or to request a copy of any decision, pleading or legislation, please contact: Case-law briefs prepared by: Litigation contacts: Prosecution contacts: Regulatory contacts: Disclaimer The preceding is intended as a timely update on Canadian intellectual property and regulatory law of interest to the pharmaceutical industry. The contents of this newsletter are informational only and do not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly. To join the Rx IP Update mailing list, be removed from the mailing list or make changes to contact information, please send an e-mail to rxip.update@smart-biggar.ca.  | ||||||||||||||||||||||||||