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Apotex successful in establishing section 8 damages liability of Pfizer regarding azithromycin
On May 10, 2013, Justice O'Reilly allowed Apotex's claim for relief under section 8 in a proceeding regarding azithromycin tablets (Pfizer's ZITHROMAX). This was the first decision under section 8 to consider the interplay between the issues raised in a notice of allegation (NOA) and those that may be raised in a section 8 claim.
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Supreme Court of Canada news
Eli Lilly denied leave to appeal regarding olanzapine patent. On May 16, 2013, after an oral hearing to determine Eli Lilly's leave application regarding the patent claiming olanzapine (ZYPREXA), the Supreme Court denied leave to appeal a Federal Court of Appeal decision (as reported in the October 2012 issue of Rx IP Update) upholding the decision of Justice O'Reilly of the Federal Court invalidating Eli Lilly's patent. Justice O'Reilly had found that the utility promised by the patent had not been demonstrated and could not have been soundly predicted.
Eli Lilly Canada Inc v Novopharm Limited, May 16, 2013 (SCC Case No. 35067).
Federal Court of Appeal decision — 2012 FCA 232.
Federal Court decision — 2011 FC 1288.
Apotex denied leave to appeal decision upholding prohibition Order, addressing comity in PM(NOC) proceedings. On May 9, 2013, the Supreme Court denied Apotex leave to appeal a decision (as reported in the December 2012 issue of Rx IP Update) in which the Federal Court of Appeal dismissed Apotex's appeal of the Federal Court decision granting an Order prohibiting the Minister from issuing a notice of compliance (NOC) to Apotex for its ophthalmic drug combining brimonidine and timolol (Allergan's COMBIGAN). The Federal Court had found that Apotex's allegation of obviousness was justified (2012 FC 767) yet, despite this finding, issued a prohibition Order specifically to allow the Court of Appeal to address apparent "serious issues raised as to comity," which arose because of a prior decision of the Federal Court relating to the same patent. In dismissing the appeal, the Court of Appeal stated that "although the prohibition order was issued by the Federal Court for the wrong reason, it was nevertheless properly issued." The Court of Appeal held that Apotex's allegation of obviousness was not justified.
Apotex Inc v Allergan Inc et al, May 9, 2013 (SCC Case No. 35184).
Federal Court of Appeal decision — 2012 FCA 308.
Federal Court decision — 2012 FC 767.
Health Canada news
Amendments to Food and Drug Regulations to extend GMP requirements to active ingredients. On May 8, the Minister of Health announced that the Food and Drug Regulations have been amended, with the amendments coming into force on November 8, 2013. As reported in the November 2012 edition of Rx IP Update, the proposed amendments were published on September 29, 2012. These amendments will (i) extend Good Manufacturing Practices (GMP) requirements to active ingredients (AI); (ii) extend the drug establishment licensing (EL) requirements to all AI fabricators, packagers/labelers, testers and importers; and (iii) create a new record-keeping requirement to foster the traceability of AI from the original fabricator to the dosage-form drug manufacturer. A guidance document will be available on the Health Canada website.
Amendments and Regulatory Impact analysis statement. Government announcement.
New public database of clinical trials. On May 29, the Minister of Health announced several new government initiatives designed to assist Canadians in finding and understanding information about clinical trials, including:
- a public database of Health Canada-authorized drug clinical trials;
- completion of new standards for research ethics boards that oversee clinical trials;
- updated guidance on the inclusion of women in clinical trials; and
- a document for patients considering participating in trials.
Government announcement. Guidance document for Clinical Trial Sponsors.
Patented Medicine Prices Review Board news
Board is seeking comment on Initiatives to Reduce Regulatory Burden. As part of the Regulatory Burden Reduction Initiative, the Patented Medicine Prices Review Board (“PMPRB”) is seeking comments on proposed changes to the Consumer Price Index (CPI) Adjustment Methodology and Filing Requirements. Regarding the former, the Board proposes to maintain the current CPI Adjustment Methodology, with a replacement of the current use of the forecast CPI with an actual CPI in calculating the CPI Adjustment Factor for the forecast period. Regarding the latter, the Board proposes, among other things, to reduce the current bi-annual reporting obligations for existing drugs to annual filings. Comments should be provided on or before June 13, 2013.
Notice and comment. Feedback.
Voluntary Compliance Undertakings. The Board recently accepted a Voluntary Compliance Undertaking ("VCU") for Abbott Laboratories Limited's MAVIK.
VCU.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court dismisses Bayer's application for Order of prohibition for Cobalt's generic version of YASMIN. On May 29, 2013, the Federal Court dismissed Bayer Inc.'s application for an Order prohibiting the Minister of Health from issuing an NOC to Cobalt Pharmaceuticals for its generic version of Bayer's YASMIN (drospirenone). Cobalt alleged non-infringement of the patent at issue, which claimed drospirenone when made according to certain processes that included, and specifically claimed, oxidation by a ruthenium salt. The Federal Court disagreed with Bayer's arguments that (i) the product-by-process claim was directed to drospirenone irrespective of the process by which it was made, and (ii) the ruthenium salt in the process was inessential. As Cobalt's process did not use ruthenium salts, construed by the Court as an essential element of the claimed process, the Federal Court concluded that Bayer failed to show that Cobalt's allegation of non-infringement was unjustified.
Bayer Inc v Cobalt Pharmaceuticals Company, May 29, 2013.
Federal Court decision — 2013 FC 573.
Trademark decisions
Trademarks Opposition Board rejects Pfizer's application to register trademark for VIAGRA based on tablet shape and colour. Pfizer applied to register a trademark for VIAGRA, which consisted of the colour blue applied to a particular shape of tablet, in 2005 based on proposed use in association with "a pharmaceutical preparation for the treatment of sexual dysfunction." The Canadian Generic Pharmaceutical Association opposed the application. The Board rejected Pfizer's application on the ground of lack of distinctiveness. Specifically, the Board found that Pfizer had not established that the trademark was distinctive to physicians or pharmacists as of the relevant date as Pfizer had not "clearly established that a significant number of physicians and pharmacists relate the Mark to prescribing and dispensing of the Wares." Pfizer has sought judicial review.
Trademarks Opposition Board decision — 2013 TMOB 27.
Judicial review Court file no. — T-733-13.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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valganciclovir (VALCYTE)
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Applicant:
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Hoffmann-La Roche Limited
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Respondents:
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Teva Canada Limited and The Minister of Health
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Respondent/Patentee:
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F Hoffmann-La Roche AG
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Date Commenced:
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April 26, 2013
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Court File No.:
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T-734-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,154,721. Teva alleges non-infringement and invalidity.
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Medicine:
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ciclesonide nasal spray (OMNARIS)
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Applicants:
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Takeda Canada Inc and Takeda GmbH
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Respondents:
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The Minister of Health and Apotex Inc
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Date Commenced:
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May 3, 2013
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Court File No.:
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T-772-13
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,388,322, 2,388,325, and 2,538,419. Apotex alleges non-infringement and invalidity.
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Medicine:
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glatiramer acetate (COPAXONE)
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Applicants:
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Teva Pharmaceutical Industries Ltd and Teva Canada Innovation GP – SENC
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Respondents:
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Mylan Pharmaceuticals ULC, The Minister of Health and Yeda Research and Development Co, Ltd
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Date Commenced:
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May 17, 2013
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Court File No.:
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T-894-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,191,088. Mylan alleges non-infringement and invalidity.
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Other proceedings
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Medicine:
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solifenacin succinate/tamsulosin hydrochloride
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Plaintiff:
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Astellas Pharma Canada, Inc
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Defendant:
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Merus Labs Luxco SARL
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Date Commenced:
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April 26, 2013
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Court File No.:
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T-731-13
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Comment:
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Action seeking a declaration of invalidity regarding Patent No. 2,334,480.
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Medicine:
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ramipril (ALTACE)
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Plaintiff:
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Mylan Pharmaceuticals ULC
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Defendant:
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sanofi-aventis Canada Inc and sanofi-aventis Deutschland GmbH
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Date Commenced:
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May 7, 2013
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Court File No.:
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T-787-13
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Comment:
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Action for section 8 damages related to the prohibition proceeding in Court File No. T-1446-07.
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Medicine:
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brimonidine tartrate, timolol maleate (COMBIGAN, Apo-Brimonidine-Timop)
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Plaintiff:
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Apotex Inc
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Defendant:
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Allergan, Inc
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Date Commenced:
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May 10, 2013
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Court File No.:
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T-820-13
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Comment:
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Action seeking a declaration of invalidity regarding Patent No. 2,440,764 and a declaration that Apo-Brimonidine-Timop will not infringe the ’764 patent following issuance of an Order of prohibition: 2012 FC 767, aff'd 2012 FCA 308.
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Applicant:
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Bayer Inc
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Respondent:
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Health Canada and The Minister of Health
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Date Commenced:
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May 21, 2013
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Court File No.:
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T-899-13
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Comment:
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Application for judicial review of an Order prohibiting the Minister of Health from disclosing, in response to a request under the Access to Information Act, third party information belonging to Bayer.
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