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Bayer prevails in drospirenone/ethinyl estradiol infringement action against Apotex and Cobalt
by Urszula Wojtyra »
On September 9, 2016, Justice Fothergill of the Federal Court released a decision finding that Apotex Inc. and Cobalt Pharmaceuticals Company each infringed Bayer’s valid patent for an oral contraceptive composition combining drospirenone and ethinyl estradiol (Bayer’s YAZ and YASMIN) (2016 FC 1013). Apotex markets MYA (approved on the basis of a comparison to YAZ) and ZAMINE (approved on the basis of a comparison to YASMIN) and Cobalt marketed ZARAH (approved on the basis of a comparison to YASMIN).
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Federal Court of Appeal affirms prohibition order regarding Teva’s deferasirox; affirms principle of claim differentiation in assessing utility
As previously reported the Federal Court granted an order of prohibition regarding Teva’s deferasirox product (Novartis’ EXJADE). On September 15, 2016, the Federal Court of Appeal dismissed Teva’s appeal of this order:Teva Canada Limited v Novartis Pharmaceuticals Canada Inc , 2016 FCA 230. Utility, in particular, Justice O’Reilly’s construction of the promise of the patent, was the only issue on appeal.
The Court of Appeal held that the Federal Court was correct to reject Teva’s argument that there was (i) an explicit promise that the patented compounds had been tested in humans and had been found to be both non-toxic and valuable in the therapeutic treatment of iron-excess disorders in humans by virtue of the compounds’ capacity to bind markedly to iron; and (ii) this promise applies to all of the patent’s claims, including the compound claims.
While the Court of Appeal held that the Federal Court erred in considering the patent’s abstract in construing the promise of the patent, this was found to be immaterial. The Court adequately supported its construction of the promise by construing the key passage of the disclosure textually and contextually, and by referencing passages of the disclosure that described testing in animals and in vitro (the latter in reference to the prior art) rather than in humans.
The Court of Appeal also rejected Teva’s argument that because every formula II compound is a subset of the formula I compounds, there was no basis to exempt the formula II compounds from the utility in humans promised for the formula I compounds. The Court of Appeal held that given the manner in which the patent disclosure and claims expressly differentiate between the formula I compounds (whose novelty rested in their use as some of the compounds were known) and novel formula II compounds, the statements of use at issue could only relate to certain claims, and not the compounds of formula II claimed in other claims. The Court of Appeal affirmed that at law, different claims can have different utilities for the same compound.
As previously reported the Supreme Court of Canada will hear an appeal regarding the promised utility doctrine on November 8.
Supreme Court of Canada News
Supreme Court leave sought in venlafaxine section 8 hearsay decision. As previously reported the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva close to $125 million in damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations in relation to its venlafaxine hydrochloride product (Pfizer’s EFFEXOR XR). The Court of Appeal held that the trial judge erred in his reliance upon inadmissible hearsay evidence, and remitted the matter to the Federal Court for redetermination. Teva filed an application for leave to appeal to the Supreme Court of Canada on August 30, 2016. The scheduled redetermination by the trial judge has been adjourned while the leave application is pending, and if leave is granted, until the appeal is determined. Separately, in the Federal Court of Appeal, Pfizer had brought a motion for return of payment made to Teva. The Court of Appeal dismissed the motion finding that it was not possible to expand the notice of appeal to seek such relief after the judgment had been rendered, noting that when the matter is remitted to the Federal Court, it will be bound to take into account any payments that Teva might have received to which it is not entitled:2016 FCA 218.
Teva Canada Limited v Pfizer Canada Inc (SCC Case No. 37162)
Federal Court of Appeal decision - 2016 FCA 161
Federal Court decision 2014 FC 248, further reasons 2014 FC 634
Application for leave to appeal regarding PMPRB jurisdiction over generic manufacturers is discontinued. As previously reported, Sandoz and ratiopharm sought leave to appeal from the Federal Court of Appeal’s decision that Sandoz and ratiopharm are subject to the Patented Medicine Prices Review Board (PMPRB)’s jurisdiction. The Federal Court of Appeal held that the PMPRB did not err in finding that Sandoz and ratiopharm are “patentees” within the meaning of subsection 79(1) of the Patent Act overturning two decisions of the Federal Court (reported here). The leave application was discontinued on September 8, 2016, with the parties advising that they had “reached a settlement”.
The Federal Court of Appeal had referred two issues back to the Federal Court: (i) the propriety of the $65 million pricing adjustment directed against ratiopharm to offset excess revenues realized on the sale of ratio HFA and (ii) the question in each case whether the respective patents pertain to the medicines in issue. Ratiopharm and Sandoz discontinued the judicial review applications on September 9, 2016.
Sandoz Canada Inc, et al v Attorney General of Canada, et al (SCC Case No. 36798)
Federal Court of Appeal decision - 2015 FCA 249
Federal Court decision - 2014 FC 501
PMPRB decision PMPRB-10-D2-SANDOZ
Health Canada approves sixth SEB: BRENZYS, Samsung Bioepis’ SEB version of ENBREL
On August 31, Health Canada issued a notice of compliance for Samsung Bioepis’ BRENZYS, a subsequent-entry biologic (SEB) version of Amgen’s ENBREL (etanercept). Amgen had commenced an application for a prohibition order on July 31, 2015 (Court File No. T-1283-15), which was discontinued on February 22, 2016. A proceeding against Sandoz (Court File No. T-1057-16) remains pending. This is the sixth SEB approved by Health Canada, following OMNITROPE, 2009, REMSIMA/INFLECTRA, 2014, BASAGLAR, 2015, and GRASTOFIL, 2015.
PMPRB releases annual report
On August 17, 2016, the Federal Minister of Health tabled the 2015 Annual Report of the Patented Medicine Prices Review Board (PMPRB) with the Clerks of the House of Commons and the Senate. The report indicates that Canadian patented drug prices remain the third-highest among the seven comparator countries against which the PMPRB reviews prices, behind Germany and the United States. Sales of patented drug products in 2015 totalled $15.2 billion, 15.8% of which stemmed from general anti-infective drugs, including breakthrough treatments for Hepatitis C. Research and development spending in 2015 was reported to be 4.4% of sales revenues. At the end of 2015, 93 investigations into possible excessive patented drug pricing were ongoing
Recent Court Decisions
Five-judge panel of the Federal Court of Appeal adopts new standard of review for appeals of prothonotaries’ orders. On August 15, 2016, a five-member panel of the Federal Court of Appeal unanimously overturned the standard of review applicable to discretionary orders of prothonotaries articulated in Canada v Aqua-Gem Investments Ltd, [1993] 2 F.C. 425, adopting instead the general appellate standard established by the Supreme Court of Canada in Housen v Nikolaisen, 2002 SCC 33. This decision marks the first time that the Federal Court of Appeal has sat as a panel of five since the Aqua-Gem decision itself. The appeal arose in the context of litigation relating to the drug infliximab (INFLECTRA ).
Appeals of prothonotaries are heard by Federal Court judges. Under the Aqua-Gem standard, discretionary orders of prothonotaries would not be disturbed on appeal unless (1) the order was clearly wrong, in the sense that it was based on a wrong principle or a misapprehension of the facts, or (2) the relevant question was vital to the outcome of the case, in which case the reviewing judge would consider the matter de novo. Consistent with Housen, questions of law arising from the decisions of prothonotaries will now be subject to a correctness standard, while questions of fact and mixed fact and law will be reviewed for palpable and overriding error.
Hospira Healthcare Corporation v Kennedy Institute of Rheumatology, 2016 FCA 215
Prohibition orders granted regarding Apotex’s tenofovir disoproxil products. The Federal Court granted Gilead Sciences Canada Inc. orders prohibiting the issuance of notices of compliance (NOCs) to Apotex Inc. for its tenofovir disopropoxil fumarate (TDF) tablets (Gilead’s VIREAD) and combination of emtricitabine and TDF tablets (Gilead’s TRUVADA) until the expiry of Patent No. 2,261,619: 2016 FC 857. The 619 patent has been and continues to be the subject of litigation between Gilead and Teva Canada Limited: the Federal Court had previously granted orders of prohibition in respect of the 619 patent (reported here) and Teva has sued to impeach the 619 patent (trial starts November 28, 2016). In the present decision, the Court held that it was not bound by the prior Teva decision, and that comity only applied in the limited context of patent construction or another question of law. In considering the expert evidence, the Federal Court considered whether to give greater weight to Apotex’s evidence on the basis that its experts were blinded. The Court found that the blinding issue is a question of relevance, reliability and weight rather than a doctrinal matter, and therefore approached the evidence on a case-by-case basis. The Federal Court found Apotex’s allegations of invalidity, including on the basis of anticipation, obviousness and lack of soundly predicted or demonstrated utility, unjustified.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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deferasirox (EXJADE)
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Applicant:
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Novartis Pharmaceuticals Canada Inc
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Respondents:
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Apotex Inc and The Minister of Health
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Date Commenced:
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September 9, 2016
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Court File No.:
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T-1484-16
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Comment:
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Application for Order of prohibition regarding Patent No. 2,255,951. Apotex alleges non-infringement and invalidity.
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Other Proceedings
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Medicine:
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Unidentified
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Applicant:
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Teva Canada Limited
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Respondant:
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Minister of Health
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Date Commenced:
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September 7, 2016
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Court File No.:
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T-1468-16
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Comment:
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Application for Order to quash a decision by the Minister of Health to release certain records in Teva’s regulatory submission for an unnamed drug product pursuant to an Access to Information Act request.
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