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BC Court of Appeal dismisses consumer class action based on invalidation of VIAGRA patent
by Lynn Ing »
On December 8, 2015, the British Columbia Court of Appeal (BCCA), reversed a judge’s ruling that a proposed class action relating to sildenafil (VIAGRA), based on Pfizer’s unsuccessful litigation under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), disclosed a cause of action sufficient for the purposes of certification under the province’s Class Proceedings Act (CPA): Low v Pfizer Canada Inc, 2015 BCCA 506. (See our article regarding the BC Supreme Court’s August 5, 2014 decision here.)
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Prohibition application against Mylan’s generic SENSIPAR dismissed; Court finds Amgen did not have a valid selection patent
by Paul Jorgensen »
The Federal Court released reasons, dated November 3, 2015, for dismissing Amgen’s application for an order prohibiting the Minister of Health from issuing a notice of compliance to Mylan for its cinacalcet tablets (Amgen’s SENSIPAR): Amgen Canada Inc v Mylan Pharmaceuticals ULC, 2015 FC 1244. Mylan alleged that Canadian Patent No. 2,202,879 (879 patent) was not a valid selection patent and was anticipated, obvious, and invalid for double-patenting. The Court issued a judgment dismissing the application on October 19, 2015, with reasons to follow, so as to avoid any lack of jurisdiction arising from the expiry of the 879 patent on October 23, 2015. The Court held that none of Mylan’s allegations were disproven by Amgen.
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PMPRB dismisses Alexion’s motion to disqualify PMPRB counsel
As reported previously, the Patented Medicine Prices Review Board (PMPRB or the Board), issued a notice of pricing regarding Alexion’s SOLIRIS (eculizumab) on January 22, 2015 and as reported separately, Alexion has challenged the constitutionality of the PMPRB provisions of the Patent Act in the Federal Court. On October 5, 2015, the Board dismissed Alexion’s motion to quash the notice of hearing based on a reasonable apprehension of bias of the Board’s Chairperson, Mary Catherine Lindberg. Alexion had submitted that Ms. Lindberg’s position as a director of Green Shield raises a reasonable apprehension of bias; the Board held that Alexion failed to establish the requisite standard of impartiality has not been met. The Board also dismissed Alexion’s motion to disqualify Isabel Raasch, Director, Legal Services and General Counsel for the Board from participating in the proceeding. The Board rejected Alexion’s submissions that confidential Alexion information possessed by the law firm representing Alexion was imputed to Ms. Raasch at the time she was a partner at the law firm and as a former partner at that law firm, she owes a duty of loyalty to Alexion, including as Ms. Raasch was not involved in the representation of Alexion and had no confidential information from Alexion. Alexion has sought judicial review.
Board Decision – October 5, 2015
Recent Court decisions
Court upholds Minister’s finding that CYSVIEW not entitled to data protection On August 10, 2015 (public reasons released December 2, 2015), the Court dismissed Photocure’s application, challenging the Minister’s denial of data protection for hexaminolevulinate hydrochloride (HAL HCl) (CYSVIEW) on the basis that HAL HCl was an “ester” of a previously approved medicinal ingredient, aminolevulinic acid hydrochloride (LEVULAN KERASTICK). The Court struck Photocure’s expert evidence as being more detailed than the evidence before the Minister and opining on the very issue the Minister was asked to determine, and held that the Minister’s decision was reasonable.
Photocure ASA v the Minister of Health, 2015 FC 959
Federal Court grants Leo Pharma’s application against Teva relating to DOVOBET On November 18, 2015, the Federal Court granted Leo Pharma’s application for a prohibition order against Teva’s generic version of DOVOBET, finding that Teva’s obviousness, lack of utility and insufficiency allegations in respect of Patent No. 2,370,565 were not justified. The patent generally relates to a formulation combining calcipotriol and betamethasone (two psoriasis drugs) and a solvent (limited to POP-15 in claim 17), resulting in a stable formulation of two drugs that were not previously combined due to pH incompatibility. The Court construed the claims as including stability as one of the characteristics of the claimed compositions.
With respect to obviousness, the Court held that the “patented combination was not obvious to try in light of the many other possible combinations that might also be tried.” In rejecting Teva’s argument of lack of sound prediction, including based on Leo’s acknowledgement that it has never understood why the patented combination was stable, the Court noted the evidence that all of the claimed alternatives are based on the same chemical scaffold, that “Leo need not establish anything close to certainty that all combinations would be useful”, and held that the skilled person would have understood the factual basis and line of reasoning based on the successful example in the patent. In dismissing Teva’s insufficiency allegation, the Court found that a “skilled person would be able to make the claimed formulation based on his or her own knowledge, possibly through some non-inventive trial and error”.
Teva has appealed to the Federal Court of Appeal.
Leo Pharma Inc v Teva Canada Limited et al, 2015 FC 1237
Settlement agreement between Pfizer and ratiopharm does not preclude Teva from pursuing section 8 damages against Pfizer for Teva-sildenafil On November 18, 2015, the Federal Court of Appeal dismissed Pfizer’s appeal of O’Keefe J.’s decision denying its motion for summary judgment in Teva’s action against Pfizer under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for Teva-sildenafil.
O’Keefe J. found that a settlement agreement between Pfizer and ratiopharm (which later merged with Novopharm, subsequently becoming Teva) which precluded a section 8 action against Pfizer for ratio-sildenafil did not prevent Teva from pursuing section 8 damages against Pfizer in relation to Novo-sildenafil (now Teva-sildenafil). O’Keefe J. simultaneously granted Teva’s parallel motion for summary judgment, finding that Pfizer could not assert the agreement to reduce or otherwise affect Teva’s claims in the action.
Gauthier J.A. (Near and Webb J.J.A concurring) rejected Pfizer’s arguments relating to O’Keefe J.’s interpretation of the settlement agreement. Although it did not endorse O’Keefe J.’s reasoning, the Court agreed with his ultimate conclusion. The words of the relevant contractual provision, when read in light of the entire agreement and its factual context at the time it was executed, did not show that the parties intended to encompass damages arising from lost sales of Novo-sildenafil, a different drug, covered by an abbreviated new drug submission filed by what was then a different company. While Teva is bound by the settlement agreement by virtue of its amalgamation with ratiopharm, the Court found that “this does not mean that one can go back in time and rewrite the Agreement to apply it to claims arising from litigation excluded under a proper construction of the Agreement”.
Pfizer Canada Inc v Teva Canada Inc, 2015 FCA 257
Federal Court decision, 2015 FC 760
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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moxifloxacin (AVELOX)
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Applicant:
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Bayer Inc and Bayer Intellectual Property GmbH
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Respondent:
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International Pharmaceutical Generics Ltd and the Minister of Health
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Date Commenced:
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October 29, 2015
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Court File No.:
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T-1837-15
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 1,340,114 and 2,192,418. International Pharmaceutical Generics will await expiry of the 114 patent and alleges non-infringement and invalidity of the 418 patent.
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Other proceedings
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Medicine:
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Not identified
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Plaintiff:
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Apotex Inc
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Respondents:
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Minister of Health and Attorney General of Canada
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Date Commenced:
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October 22, 2015
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Court File No.:
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T-1782-15, T-1783-15
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Comment:
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Applications for judicial review of two decisions of the Minister of Health to release certain records relating to an Apotex NDS in response to requests received by Health Canada pursuant to the Access to Information Act. Apotex asserts that Health Canada’s decisions are stated to be the same as the decision relating to a separate request, which is the subject of a separate judicial review application (T-1511-15).
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Medicine:
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eculizumab (SOLIRIS)
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Applicant:
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Alexion Pharmaceuticals Inc
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Respondent:
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Attorney General of Canada
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Date Commenced:
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November 03, 2015
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Court File No.:
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T-1855-15
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Comment:
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Application for judicial review of a decision of the Patented Medicine Prices Review Board that was made in a proceeding arising from excessive pricing allegations relating to Alexion’s drug SOLIRIS (see brief of decision above).
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Medicine:
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tenofovir disoproxil fumarate (VIREAD), emtricitabine/tenofovir disoproxil fumarate (TRUVADA), efavirenz/emtricitabine/tenofovir disoproxil fumarate (ATRIPLA)
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Plaintiff:
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Gilead Sciences, Inc, Gilead Sciences Canada, Inc, and Bristol-Myers Squibb & Gilead Sciences LLC
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Defendant:
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Teva Canada Limited
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Date Commenced:
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November 09, 2015
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Court File No.:
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T-1888-15
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Comment:
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Infringement action relating to Patent No. 2,298,059, related to Teva’s action to impeach the 059 patent and Patent No. 2,261,619 in T-1529-12.
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Applicant:
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Apotex Inc
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Respondents:
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Minister of Health and Attorney General of Canada
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Date Commenced:
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November 12, 2015
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Court File No.:
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T-1915-15
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Comment:
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Application for judicial review of the decision of the Minister of Health to refuse to end its prohibition on granting NOCs and reviewing ANDSs and SANDs for products manufactured at Apotex Research Private Limited or having active pharmaceutical ingredient sourced from Apotex Pharmachem India Private Limited, in the face of the Federal Court’s judgment in T-224-14 (2015 FC 1161). For a complete list of the products that Apotex pleads are affected, see Apotex’s pleading here (para 38).
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