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Federal Court of Appeal clarifies test for double-patenting, upholding prohibition order regarding Mylan’s tadalafil
As reported in our IP Update, the Federal Court of Appeal (FCA) issued its decision in Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc, 2016 FCA 119, upholding a prohibition order regarding Mylan’s tadalafil (Eli Lilly’s CIALIS). In doing so, the FCA clarified the test for obviousness-type double-patenting and addressed the relevant date for the double-patenting analysis. The FCA also made some important remarks on use of prior art, and on the distinction between prior art and common general knowledge.
New Case Management Guidelines for Patented Medicines (Notice of Compliance) Regulations Applications
The Federal Court has issued new Case Management Guidelines for NOC Applications. The guidelines set out the manner in which such proceedings are to be managed in the absence of exceptional reasons for departing from same. The guidelines address a number of matters to more closely manage such proceedings including:
- A case management conference presided by the case management and hearing judges should be held within 30 days after filing the requisition for hearing;
- On written request by the parties at least 120 days before the hearing date, the parties will submit claims charts at least 90 days before the hearing date, and a case conference meeting will follow with a view to limiting claim construction issues prior to the hearing;
- A hearing management conference presided by both the case management and hearing judges should be conducted after the respondent’s factum is filed;
- A further hearing management conference should be held at least 30 days prior to the hearing to discuss matters including which patents and claims remain in issue and any remaining claim construction disputes and provision of a statement of agreed facts and/or documents; and
- At least 15 days prior to the hearing, Compendia are to be filed and Outlines of Argument (up to 30 pages) if any are encouraged to be filed prior to the hearing.
Supreme Court News
Supreme Court dismisses Apotex’s application for leave to appeal in lovastatin damages proceeding regarding non-infringing alternative defence to damages claim – On April 14, 2016, the Supreme Court denied Apotex leave to appeal the FCA’s decision in Apotex Inc v Merck & Co, Inc, 2015 FCA 171, which concerned the quantification of Merck’s damages for Apotex’s infringing sales of lovastatin. As we previously reported, the FCA had held that the availability of a non-infringing alternative may be a relevant consideration when assessing damages for patent infringement. Apotex however had failed to meet its burden to show that it could and would have sold non-infringing lovastatin in place of infringing lovastatin.
Supreme Court docket.
Federal Court of Appeal decision — 2015 FCA 171.
Federal Court decision — 2013 FC 751.
Supreme Court dismisses Merck’s application for leave to appeal in PROPECIA and PROSCAR class certification – On April 14, 2016, the Supreme Court denied Merck leave to appeal the British Columbia Court of Appeal (BBCA)’s decision in Miller v Merck Frosst Canada Ltd, 2015 BCCA 353, in which the plaintiff had alleged that Merck had negligently failed to warn of the risk that sexual dysfunction may persist after discontinuation of treatment with either PROPECIA or PROSCAR (each of which contains finasteride as the active medicinal ingredient). The BCCA upheld the certification of a class proceeding, finding, inter alia, that there was a plausible way in which the plaintiff might establish, on a balance of probabilities, that finasteride caused the persistent sexual dysfunction common to the class as a whole.
Supreme Court docket.
B.C. Court of Appeal decision — 2015 BCCA 353.
B.C. Supreme Court decision — 2013 BCSC 544.
Patented Medicine Prices Review Board releases NEWSletter
The Patented Medicine Prices Review Board (PMPRB) released the April 2016 issue of its NEWSletter. Highlights include the anticipated spring release of the PMPRB Guidelines Modernization: Discussion Paper; an update on the Notice and Comment for amendments to the Compendium of Policies, Guidelines and Procedures; publication of Notices of Hearing relating to the Galderma Canada Inc. DIFFERIN, DIFFERIN XP, TACTUPUMP, and TACTUPUMP FORTE and Baxalta Canada Corp. ONCASPAR (pegaspargase) proceedings; an update on the Alexion SOLIRIS (eculizumab) proceeding; the approval of Voluntary Compliance Undertakings for MITOSOL (mitomycin; Labtician Opthalmics Inc.), NEORAL (Novartis Pharmaceuticals Canada Inc.), APPRILON (doxycycline monohydrate; Galderma Canada Inc.), and ANGIOMAX (bivalirudin; Sunovion Pharmaceuticals Canada Inc.); an update on The National Prescription Drug Utilization Information System’s engagement activities; and announcement of new and upcoming publications.
Health Canada News
Phase II of Health Canada’s Transparency Initiatives Underway: Expanded Listing of Regulatory Decision Summaries and Submissions Under Review.
Regulatory Decision Summaries (RDS) - Health Canada posts Regulatory Decision Summaries - Drugs and Regulatory Decision Summaries - Medical Devices for positive decisions for NDSs, SNDSs for new uses and new class IV licence applications after April 1, 2015; final negative decisions and cancellations for NDSs for new active substances for submissions accepted into review after April 1, 2015; and final negative decisions and cancellations for NDSs, SNDSs for new uses and new class IV licence applications for submissions accepted into review after May 1, 2016.
Submissions Under Review list - The SUR list lists new drug submissions (NDS) for new active substances (NAS) for both pharmaceuticals and biologics that were accepted into review on or after April 1, 2015 (Phase I), and SNDSs for new indications accepted into review on or after April 1, 2016 (Phase II). The list is updated monthly.
Notice: Regulatory Decision Summaries and the Submissions Under Review List.
On January 27, 2016, the Health Products and Foods Branch (HPFB) held a consultation with stakeholders regarding Health Canada’s Regulatory Transparency and Openness Framework. In addition to the RDS and SUR list, the initiatives under this framework include Summary Basis of Decisions, Summary Safety Reviews, the List of New Safety Reviews, the List of Advertising Complaints, and Draft Guide on Disclosure of Confidential Business Information under s. 21.1(3)(c) of the Food and Drugs Act.
Summary Report.
Changes to Health Canada’s comparative bioavailability requirements for Highly Variable Drug Products. On April 18, 2016, Health Canada issued a Notice advising of changes to its comparative bioavailability requirements for drug products which exhibit large pharmacokinetic within-subject variation in extent of absorption, as measured by area under the concentration versus time curve (AUC) (i.e., highly variable drug products).
Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products .
Notice of interim approach to drug safety updates initiated by Health Canada. With the coming into force of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)(see our prior article here), Health Canada is reconsidering how it manages post-market safety changes. On April 22, 2016, Health Canada issued a notice that informs how Health Canada is managing safety updates when a serious health risk is identified under Vanessa’s Law. In brief, when Health Canada identifies a label change (e.g., a new contraindication) necessary to prevent injury to health, the sponsor will receive an Advisement Letter requesting the filing of a S(A)NDS-labelling-only submission. In response, a sponsor may file the requested submission or may submit representations to Health Canada outside of the submission process. In the latter case, Health Canada will review the representations and decide whether to issue a label change order under s. 21.2 of the Food and Drugs Act, which would require the sponsor to file the requested submission.
In the interim, safety updates initiated by the sponsor will continue to be accepted as Notifiable Changes as outlined in the Post-NOC Changes: Safety and Efficacy Guidance Document. In the long term, it is anticipated that all Notifiable Changes will be phased out and addressed via the appropriate supplement.
Notice: How Health Canada is managing safety updates when a serious health risk is identified under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law).
Health Canada soliciting feedback from sponsors under the NOC/c policy regarding phasing out Dear Health Care Professional Letters. On April 15, 2016, Health Canada issued a notice soliciting feedback from sponsors of submissions that qualify under the Notice of Compliance with Conditions (NOC/c) policy on a proposal to no longer require Dear Health Care Professional Letters. Instead, the conditional market authorization would be communicated through Health Canada’s Health Product InfoWatch and would be posted on Health Canada’s website. Comments should be submitted within 60 calendar days.
Notice Regarding Dear Health Care Professional Letters for Notice of Compliance with Conditions.
Teva’s consent to sell two products following its acquisition of Allergan’s generic pharmaceuticals business resolves Competition Bureau’s concerns
The Competition Bureau reviewed Teva Pharmaceutical Industries Ltd. (Teva)’s proposed acquisition of the generic pharmaceutical business of Allergan plc (Allergan), and concluded that the proposed transaction would likely have resulted in substantial lessening or prevention of competition for the supply of two pharmaceutical products in Canada, due to the elimination of future competition between the parties. On April 4, 2016, the Bureau announced that it had reached a consent agreement with Teva, pursuant to which Teva must sell either its own or Allergan’s Canadian assets related to the two pharmaceutical products of concern: tobramycin inhalation solution and buprenorphine/naloxone oral tablets. These products must be sold to buyer(s) approved by the Commissioner of Competition. The Bureau stated that it is confident the implementation of the consent agreement will resolve the competition concerns it had with the transaction. In its statement, the Bureau explained that in order to assess the likelihood of future competition, the Bureau relied heavily on information obtained directly from competing drug developers regarding the status of their drug approvals and anticipated timing for their entry, and coordinated extensively with Health Canada.
Announcement; Competition Bureau statement; Consent agreement.
Court decisions
Motion for interim injunction to prevent sale of tear osmolarity-measuring device dismissed. On March 24, 2016, Justice Russell of the Federal Court dismissed a motion by TearLab Corporation for an interim injunction preventing the defendants from infringing certain claims of Patent No. 2,494,540 and from making, using, importing, marketing, offering for sale, or selling its i-Pen System pending the final disposition of an impending motion for an interlocutory injunction in the matter. The relevant patent generally relates to and claims fluid sample receiving chips, systems for measuring the osmolarity of sample fluids, and methods for measuring the osmolarity of sample fluids, which include tear fluids. In the underlying proceeding, the plaintiffs claim that the patent will be infringed by the defendant’s i-Pen System for measuring tear osmolarity, which had not yet launched in Canada at the time of the hearing.
Justice Russell’s decision is largely premised on the absence of irreparable harm to the plaintiffs absent the injunction. The plaintiffs’ evidence did not satisfy Justice Russell that they would suffer irreparable harm during the interim period for which the injunction was sought, as the affidavit evidence submitted by the plaintiffs did not speak to this time period and was not provided by individuals qualified to convince the Court that TearLab could not be compensated in damages for any harm incurred. Although he noted that the plaintiffs’ concerns regarding lost opportunities, lost sales, and lost goodwill were understandable, Justice Russell found that they lacked objective support. In contrast, the defendant provided the evidence of a qualified expert who attested that TearLab’s harm was quantifiable.
University of California v I-Med Pharma Inc, 2016 FC 350.
Federal Court dismisses Allergan’s prohibition application against Apotex’s gatifloxacin ophthalmic product; holds that factual basis and line of reasoning must be disclosed for sound prediction. In public reasons released April 1, 2016, the Federal Court dismissed Allergan’s application for a prohibition order regarding Apotex’s gatifloxacin ophthalmic product until after the expiration of Patent No. 2,307,632. Allergan failed to disprove Apotex’s allegations that Claim 10 of the 632 patent was obvious and lacked utility. Claim 10 covers an aqueous liquid pharmaceutical composition in the form of eye drops that comprises gatifloxacin or its pharmaceutically acceptable salt (0.1 to 1.0 w/v%) and disodium edetate (EDTA, 0.01 to 0.1 w/v%).
The Court preferred the evidence of Apotex’s expert witness, Dr. Sheardown, in part because she was blinded to the 632 patent when she opined on the common general knowledge and the prior art. The Court accepted Dr. Sheardown’s opinion that the inventive concept and the promise of Claim 10 included three stated advantages (relative to formulations without EDTA): increased corneal permeability of gatifloxacin, prevention of gatifloxacin precipitation, and prevention of gatifloxacin coloration. With respect to obviousness, the three stated advantages were “known to some degree” in the prior art and were “not an unexpected consequence of the combination.” The skilled person would have had a fair and reasonable expectation - to the level of being more or less self-evident - that combining gatifloxacin with EDTA would produce an effective ophthalmic composition with the three stated advantages. With respect to utility, the Court declined to adopt the holding in AstraZeneca Canada Inc v Apotex Inc, 2014 FC 638 (as previously reported) that disclosure of the factual basis and sound line of reasoning for a sound prediction is only required for new use patents. As a result, it could not be soundly predicted that the lower claimed concentrations of EDTA e.g., 0.01%) would have prevented precipitation of gatifloxacin, as the lowest EDTA concentration tested in the 632 patent was 0.05%. Allergan has appealed.
Allergan Inc v Apotex Inc, 2016 FC 344.
Federal Court issues order for mandamus to grant license for natural health product RESOLVE; finds reasonable apprehension of bias against Health Canada. On April 6, 2016, the Federal Court allowed the judicial review application of The Winning Combination Inc. (TWC) and issued an order for mandamus granting TWC a licence for its natural health product RESOLVE. At issue were two decisions of Health Canada’s National Health Products Directorate (NHPD, since renamed the Natural and Non-prescription Health Products Directorate) concerning TWC’s Product License Application (PLA) for RESOLVE. On July 19, 2007, the NHPD had refused the PLA based on safety and efficacy concerns. On August 21, 2007, the NHPD had refused the same PLA on the grounds that RESOLVE was a drug, not a natural health product.
The Court found that the July 19, 2007 decision was made after serious procedural fairness errors that supported a finding of reasonable apprehension of bias. Health Canada had conceded that there were no safety concerns with RESOLVE. With respect to efficacy, the Court found that s. 5(g) of the Natural Health Products Regulations requires an applicant “to provide ’information‘ that, reasonably speaking, supports some degree of efficacy in terms of the product claims set out in the PLA”. Health Canada’s interpretation of the NHP Regulations as “demanding ‘conclusive proof’ of efficacy in the form of unimpeachable human clinical studies” was unreasonable. TWC had clearly satisfied the efficacy requirement by providing “some objective and legitimate authoritative ‘information’ to ‘support’ that RESOLVE ‘may’ help with smoking addiction.”
The Court found that the August 21, 2007 decision was made without notice to TWC that classification of RESOLVE as a natural health product was a concern. In either law or in fact, the subsequent reconsideration process could not and did not rectify this lack of procedural fairness. Administrative decisions made without procedural fairness are void ab initio. But the Court went on to further find that the NHPD’s reconsideration was unreasonable, lacked procedural fairness, and provided further evidence of reasonable apprehension of bias.
With respect to remedy, the Court held that the conditions for mandamus were satisfied as there was nothing that could justify withholding a licence for RESOLVE. In the Court’s view, “it would be pointless to return this matter [to Health Canada] for further reconsideration”.
Canada has appealed (A-117-16); the Federal Court of Appeal has granted a stay pending appeal.
The Winning Combination Inc v Canada (Health), 2016 FC 381.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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drospirenone/ethinyl estradiol (YAZ)
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Applicants:
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Bayer Inc, Bayer Pharma Aktiengesellschaft, and Bayer Intellectual Property GmbH
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Respondents:
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Glenmark Pharmaceuticals Canada Inc and The Minister of Health
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Date Commenced:
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April 21, 2016
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Court File No.:
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T-639-16
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Comment:
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Application for Order of prohibition regarding Patents Nos.
2,382,426; 2,261,137; 2,432,151; 2,756,207. Glenmark alleges non-infringement of the 137, 151, and 207 patents, and invalidity of the 426 patent.
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Medicine:
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sevelamer carbonate tablets (RENVELA)
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Applicants:
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sanofi-aventis Canada Inc and Genzyme Corporation
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Respondents:
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Accel Pharma Inc and The Minister of Health
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Date Commenced:
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April 25, 2016
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Court File No.:
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T-650-16
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Comment:
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Application for Order of prohibition regarding Patent No. 2,586,023. Accel alleges non-infringement and invalidity.
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Medicine:
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naproxen/esomeprazole (VIMOVO)
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Applicants:
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AstraZeneca Canada Inc and Pozen Inc
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Respondents:
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Mylan Pharmaceuticals ULC and The Minister of Health
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Date Commenced:
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May 5, 2016
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Court File No.:
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T-719-16
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Comment:
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Application for Order of prohibition regarding Patent No. 2,449,098. Mylan alleges non-infringement and invalidity.
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Other proceedings
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Medicine:
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filgrastim (NEUPOGEN, GRASTOFIL)
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Applicants:
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Amgen Inc and Amgen Canada Inc
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Respondents:
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Apotex Inc
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Date Commenced:
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April 20, 2016
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Court File No.:
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T-633-16
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Comment:
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Infringement action regarding Patent No. 1,341,537.
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