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FCA finds Minister reasonable: cross-referenced drug submissions did not trigger section 5 of the PMNOC Regulations absent early working
by Abigail Smith »
On October 12, 2016, the Federal Court of Appeal allowed four appeals relating to decisions by the Minister of Health to issue a notice of compliance (NOC) to Teva for exemestane tablets (a generic version of Pfizer’s AROMASIN) and an NOC to Hospira for INFLECTRA, an infliximab powder for solution (a biosimilar of Janssen’s REMICADE): Teva Canada Limited v Pfizer Canada Inc et al, (2016 FCA 248).
Both NOCs resulted from administrative drug submissions, which Health Canada defines as submissions that do not require scientific review. Teva cross-referenced its submission regarding exemestane to Generic Medical Partners (GMP)’s abbreviated new drug submission (ANDS) for an exemestane product. GMP served a notice of allegation on Pfizer, but as GMP does not sell products in Canada, Pfizer did not start a prohibition application. Health Canada then issued an NOC to GMP. Hospira cross-referenced its submission for infliximab powder to Celltrion’s new drug submission (NDS) (an NDS, rather than an ANDS, was necessary because infliximab is a biologic). At the time the Celltrion NDS was filed, no patents were listed on the Patent Register against REMICADE. The Teva and Hospira submissions contained no scientific data, and both certified that their product would be identical to the cross-referenced product except for the name and manufacturer of the product.
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Supreme Court hearing on November 8
As previously reported the Supreme Court of Canada will hear an appeal of the Federal Court of Appeal decision affirming a trial decision invalidating AstraZeneca’s patent relating to esomeprazole (NEXIUM) for lack of utility. The hearing is scheduled for November 8, 2016.
Health Canada News
Annual Drug Submission Performance Reports released. The Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) have released their Drug Submission Performance Annual Reports. The reports contain information regarding pharmaceutical, biologic and radiopharmaceutical drug submission review activity over five consecutive fiscal years (April 1 to March 31) from 2011-12 to 2015-16.
Therapeutic Products Directorate Report
Biologics and Genetic Therapies Directorate Report
Final Guidance Document: Notice of Compliance with conditions (NOC/c) released. On September 16, 2016, Health Canada released the final version of the Guidance Document: Notice of Compliance with conditions (NOC/c). The Guidance Document replaces the “Dear Healthcare Professional Letter” with the “Notice of Market Authorization with Conditions”, which will be completed by Health Canada and appear in Health Canada’s monthly publication Health Product InfoWatch.
Notice
Guidance Document: Notice of Compliance with conditions (NOC/c)
Comment period for PMPRB modernization discussion paper extended
As previously reported, the PMPRB is seeking comments on its Guidelines Modernization Discussion Paper. The deadline for submitting comments has been extended to October 31, 2016.
Competition Bureau releases report questioning restrictions on health care advertising
On October 4, 2016, the Competition Bureau announced the release of its report on Advertising Restrictions in health care services. The Bureau analyzed advertising restrictions in some of Canada’s health care industries, and surveyed a broad cross-section of provincial regulations governing pharmaceutical, dental, and veterinarian services across Canada. It found that most regulators of these services tended to restrict advertising in some form, but that there is insufficient evidence to assess whether these restrictions are achieving their policy objectives. The report reviews economic literature that shows that reducing or removing advertising restrictions does not lead to consumers experiencing lower quality in services, and may allow consumers to benefit from lower prices. However, the Bureau found that the data necessary to conduct similar studies are not readily accessible in Canada. The report calls on governments and self-regulatory bodies to begin collecting and compiling information on marketplace outcomes in Canada’s health care markets, and to move toward greater emphasis on empirical evidence in decision-making. Such data could then be made available to researchers, which would allow evidence-based assessments to be made of the suitability of advertising restrictions.
Fresenius’ notice of allegation of non-infringement for moxifloxacin hydrochloride found defective
On July 5, 2016, the Federal Court granted an order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Fresenius for its moxifloxacin hydrochloride product (Bayer's AVELOX I.V) until expiry of Patent No. 2,192,418: Bayer Inc v Fresenius Kabi Canada Ltd, 2016 FC 581. The patent claims the monohydrate form of moxifloxacin hydrochloride having specified NMR and X-ray diffractogram characteristics. Fresenius alleged non-infringement in its notice of allegation (NOA), alleging its product is in solution form, which cannot contain the crystalline form required by Claim 1. Moreover, Fresenius alleged it would not use the monohydrate moxifloxacin specified by the patent in its manufacturing of Fresenius-moxifloxacin or in the manufacture of the active pharmaceutical ingredient (API) used in the manufacture of Fresenius-moxifloxacin.
Justice Brown held that Fresenius’ NOA failed to include a detailed statement of the legal and factual basis for the allegation of non-infringement, as required by the PMNOC Regulations. In particular, Fresenius’ NOA did not disclose that its product was to be manufactured offshore and imported to Canada, nor did it raise the legal principles relevant to infringement by importation. The NOA merely alluded to importation with “code words”; the relevant facts were disclosed only once the proceedings were commenced and a confidentiality agreement had been reached. The Court found that this was not “sufficient to make the patentee fully aware of the grounds on which the generic claimed that the relevant patent would not be infringed”. Though previous decisions have allowed (i) some later elaboration on allegations contained in the NOA, and (ii) certain confidential information (i.e. formulation details) to be produced subsequent to the delivery of an NOA, the Court rejected the argument that this matter fell within the scope of those decisions. The Court therefore granted an order of prohibition.
Justice Brown considered the allegation of non-infringement on the merits in the alternative and held that had he found the NOA to be sufficient, he would have concluded that the allegation of non-infringement was justified. The Court held that Bayer’s experts’ testing evidence on samples made by reproducing the API manufacturing process did not establish that the monohydrate appears in the manufacturing process. However, even if the Court had found presence of the monohydrate, the Court held that Bayer had not satisfied the Court that the Saccharin factors (see Pfizer Canada Inc v Canada (Health), 2007 FC 898) relevant to infringement by importation had been met.
Fresenius sought reconsideration of the decision on the basis that the prohibition order granted was inconsistent with the reasons. In particular, it argued that the Court concluded that the NOA was insufficient only in relation to the allegation of infringement by importation, but that the essence of its allegation – simple infringement – was justified. The Court found no inconsistency between the reasons and the prohibition order, reiterated that the NOA’s failure to include a detailed statement was a fatal defect, and thus dismissed the motion, 2016 FC 970. Fresenius’ appeal is pending (Court of Appeal File No. A-236-16).
Prohibition order denied against Apotex for generic tenofovir disoproxil/emtricitabine
The Federal Court dismissed Gilead’s prohibition application against Apotex for its tenofovir disoproxil fumarate (TDF) and emtricitabine fixed dose combination tablet (Gilead’s TRUVADA): Gilead Sciences, Inc v Apotex Inc, 2016 FC 856. Gilead sought to prohibit the issuance of a notice of compliance (NOC) until expiry of Patent No. 2,512,475, which claims a formulation comprising TDF and emtricitabine. The Court found Apotex’s allegations of invalidity to be justified on the basis of anticipation and obviousness. Apotex’s anticipation allegation was based on a transcript of an investor conference call held by Gilead prior to the claim date of the patent. The transcript was held admissible as an exception to the hearsay rule; it was found to be necessary as Apotex attempted to prove the document by serving a Direction to Attend and was found to be reliable. The Court held that the asserted claim was in fact disclosed during the conference call and that the disclosure was sufficient to enable a skilled person to make the invention, as development of the actual tablet required only routine tests once the combination was disclosed. Apotex’s obviousness allegation was also found justified, as the Court held that there were only a finite number of predictable solutions to develop a chemically stable co-formulation. On utility, the Court found Apotex’s allegation unjustified, as the invention was useful as a chemically stable co-formulation and was soundly predicted based on the testing disclosed in the patent.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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aripiprazole (ABILIFY)
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Applicants:
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Bristol-Myers Squibb Canada and Otsuka Pharmaceutical Co, Ltd
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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 21, 2016
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Court File Nos.:
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T-1566-16; T-1567-16; T-1568-16; T-1569-16; T-1570-16; T-1571-16; T-1572-16; T-1573-16; T-1575-16; and T-1576-16
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Comment:
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Individual applications for Order of prohibition until expiry of Patents Nos. 2,689,051, 2,689,052, 2,526,562, 2,511,619, 2,713,466, 2,700,314,
2,429,496, 2,688,915, 2,688,934, and 2,426,921. Apotex alleges non-infringement and invalidity (only for some patents).
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Medicine:
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prasugrel hydrochloride (EFFIENT)
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Applicants:
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Eli Lilly Canada Inc, Ube Industries, Ltd, and Daiichi Sankyo Company Limited
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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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October 14, 2016
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Court File No.:
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T-1734-16
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Comment:
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Application for Order of prohibition until expiry of Patent No 2,432,644. Apotex alleges non-infringement and invalidity.
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Other Proceedings
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Medicine:
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tadalafil (CIALIS)
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Plaintiffs:
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Eli Lilly Canada Inc, Eli Lilly and Company, Lilly Del Caribe, Inc, Lilly, SA and ICOS Corporation
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Defendants:
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Pharmascience Inc (PMS-Tadalafil), Laboratoire Riva (Riva-Tadalafil),
Jamp Pharma Corporation (Jamp-Tadalafil),
Mylan Pharmaceuticals ULC (Mylan-Tadalafil), Auro Pharma Inc (Auro-Tadalafil),
Pharmapar Inc (Priva-Tadalafil),
Teva Canada Limited (Teva-Tadalafil),
Apotex Inc (Apo-Tadalafil and Apo-Tadalafil PAH),
Mint Pharmaceuticals Inc (Mint-Tadalafil),
Marcan Pharmaceuticals Inc (Mar-Tadalafil),
Pro Doc Ltée (Tadalafil),
Ranbaxy Pharmaceuticals Canada Inc (Ran-Tadalafil),
Actavis Canada Inc (Act Tadalafil)
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Date Commenced:
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September 28, 2016
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Court File Nos.:
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T-1623-16; T-1624-16; T-1626-16; T-1627-16; T-1628-16; T-1630-16; T-1631-16; T-1632-16; T-1633-16; T-1636-16; T-1637-16; T-1638-16; T-1639-16
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Comment:
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Separate infringement actions regarding Patents Nos. 2,371,684, 2,379,948 and 2,492,540 (and Patent No. 2,226,784 against Apotex only) and passing off under the Trademarks Act (against JAMP, Apotex and Pro Doc only).
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Medicine:
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Various
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Plaintiffs:
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Apotex Inc, Apotex Pharmachem India PVT Ltd (APIPL) and Apotex Research Private Limited (ARPL)
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Defendants:
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Rona Ambrose, Julie Vaux, Clark Olsen, Nick Switalski, Cailin Rodgers, George Da Pont, Paul Glover, Anil Arora, Anne Lamar, Supriya Sharma, Robin Chiponski, Mary Morgan, Steven Schwendt, Sharon Mullin, Barbara Sabourin, Karen Reynolds, Craig Simon, Michelle Kovacevic, John Doe, Jane Doe, Her Majesty the Queen and the Attorney General of Canada
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Date Commenced:
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September 30, 2016
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Court File No.:
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T-1653-16
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Comment:
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Action seeking relief against the former federal Minister of Health, the former federal Deputy Minister of Health, and others (including damages and removal of “defamatory” content from Health Canada’s website) in connection with an import ban placed on APIPL and ARPL.
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