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Alexion challenges constitutionality of Patented Medicine Prices Review Board price regulation provisions
by Kevin Siu »
On September 11, 2015, Alexion Pharmaceuticals Inc. (“Alexion”) filed a notice of application in the Federal Court, naming the Patented Medicine Prices Review Board (PMPRB) as a respondent, seeking a declaration that sections 83 to 86 and the words “in any proceeding under s. 83” in section 87(1) of the Patent Act, which provide a scheme for regulating the price of patented medicines in Canada, are ultra vires the Parliament of Canada and therefore unconstitutional.
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Canada concludes TPP free trade agreement
On October 5, 2015, the Government of Canada announced that the members of the Trans-Pacific Partnership (TPP) had successfully concluded negotiations on a free trade agreement (news release). While a draft text of the agreement has not been released, the Technical Summary of Negotiated Outcomes: Intellectual Property Chapter states as follows regarding pharmaceuticals:
- "Reflects Canada’s existing regimes, systems and laws on:
- Patent linkage;
- Protection for clinical trial data; and
- Early working exceptions.
- In line with outcomes secured in the Canada-EU Comprehensive Trade and Economic Agreement (CETA), Canada has retained the scope to meet its TPP obligations for patent term restoration for regulatory approval delays with a sui generis system. The TPP provision will have the necessary flexibility to allow Canada to retain its export exception and two year cap on additional protection.
- The TPP includes a strong regulatory review exception, reflecting Canada’s existing regime with respect to the availability of an early working exception. This will help ensure that generic drugs can continue to be introduced as soon as is practicable after the expiry of a patent across the region, as is the case now.
- As with other areas in the TPP, parties have retained the flexibility to determine the best means of implementing the patent linkage obligations within their domestic regimes. Canada’s existing linkage regime is TPP compliant".
Supreme Court of Canada leave applications
Construction of utility. As previously reported, the Federal Court of Appeal upheld the Federal Court’s finding that AstraZeneca’s patent for esomeprazole (AstraZeneca’s NEXIUM) was invalid for failure to meet a patent promise as of the date of the patent filing. On September 29, 2015, AstraZeneca filed for leave to appeal to the Supreme Court.
AstraZeneca Canada Inc et al v Apotex Inc et al (SCC Case No. 36654)
Court of Appeal decision – 2015 FCA 158
Federal Court decision – 2014 FC 638
Existence of non-infringing alternative defence. As previously reported, the Federal Court of Appeal upheld the Federal Court’s decision regarding the damages owed by Apotex to Merck for its infringement of Merck’s product-by-process patent for lovastatin (Merck’s MEVACOR). The Federal Court of Appeal recognized that the availability of a non-infringing alternative may be a relevant consideration when assessing damages for patent infringement but found that Apotex had failed to establish that it could and would have sold the non-infringing alternative. On September 29, 2015, Apotex filed for leave to appeal to the Supreme Court.
Apotex Inc et al v Merck & Co, Inc et al (SCC Case No. 36655)
Court of Appeal decision – 2015 FCA 171
Federal Court decision – 2014 FC 751
Health Canada News
Pilot project for step-wise review approach to subsequent entry biologic applications. Beginning September 14, 2015, Heath Canada is implementing a three-year pilot project to explore a step-wise review approach to complement the subsequent entry biologic (SEB) development process. The pilot stems from Health Canada’s experience with regulatory reviews of SEBs. An SEB sponsor may request a scientific advice meeting in order to receive advice from Health Canada on the sponsor’s comparability package early in the SEB development process. The pilot is open to any SEB sponsor that wishes to participate. One potential outcome of the scientific advice meeting is a recommendation to continue the approval process as a conventional drug.
Notice
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 (including non-prescription and disinfectant drugs), biologic and radiopharmaceutical drug submission review activity over five consecutive fiscal years (April 1 to March 31) from 2010-11 to 2014-15.
Therapeutic Products Directorate Report; Biologics and Genetic Therapies Directorate Report
Updates to Guidance Document: Labelling of Pharmaceutical Drugs for Human Use. As previously reported, on June 13, 2015, the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) were registered (SOR/2014-158, Canada Gazette Part II). The amendments aim to improve the safe use of drugs by making labels and packaging easier to read and understand and require the inclusion of a brand name assessment in all new drug submissions and Drug Identification Number applications where a new brand name or a change to an existing brand name is being proposed. On September 15, 2015, Health Canada published consequential updates to its Guidance Document: Labelling of Pharmaceutical Drugs for Human Use.
Notice - Updates to the Guidance Document: Labelling of Pharmaceutical Drugs for Human Use
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court of Appeal upholds orders in parallel Patented Medicines (Notice of Compliance) Regulations proceedings concerning moxifloxacin. On September 16, 2015, the Federal Court of Appeal dismissed Actavis’s appeal (2015 FCA 192) from a Federal Court prohibition Order (2014 FC 462) against Actavis’s moxifloxacin product (Alcon’s VIGAMOX). Actavis had alleged the claims to the compound moxifloxacin in Canadian Patent No. 1,340,114 were invalid for lack of sound prediction of utility and obviousness. The Court of Appeal determined that the Application Judge had not erred in finding that the claims in issue only promised potent antibacterial activity in vitro. The Application Judge’s “slight differences in wording” in construing the promise could be understood in a coherent manner and were therefore inconsequential. The Application Judge’s conclusion on sound prediction was open to him, in particular because the `114 patent disclosed the potent antibacterial activity of a compound structurally very similar to moxifloxacin. The Court of Appeal also found no palpable and overriding error that the inventive concept was neither obvious nor obvious to try. The `114 patent will expire on November 3, 2015.
In a parallel Patented Medicines (Notice of Compliance) Regulations proceeding, Alcon asserted Canadian Patent No. 2,342,211 (expiry date September 29, 2019). In the same decision (2014 FC 462), the Federal Court found that the inventive concept of the relevant claims of the `211 patent was obvious to try. On September 16, 2015, the Court of Appeal dismissed Alcon’s appeal (2015 FCA 191). The Court of Appeal rejected Alcon’s submission that the inventive concept – “composition for topically treating or preventing an ophthalmic infection, which comprises 0.1 to 1.0 wt% moxifloxacin” – included safety and efficacy in clinical practice. As a result, the prior art did not teach away from using moxifloxacin to treat eye infections. The Application Judge properly drew his own conclusions from the expert evidence, including that the antibacterial activity of 0.1 to 1.0 wt% moxifloxacin was known and that ophthalmic formulations containing other quinolone compounds (ciprofloxacin, ofloxacin) were on the market.
Alcon Canada Inc v Actavis Pharma Co, 2015 FCA 191
Actavis Pharma Co v Alcon Canada Inc, 2015 FCA 192
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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escitalopram orodispersible tablets (CIPRALEX MELTZ)
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Applicant:
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Lundbeck Canada Inc
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Respondents:
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The Minister of Health and Actavis Pharma Company
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Respondent/Patentee:
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H. Lundbeck A/S
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Date Commenced:
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September 23, 2015
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Court File No.:
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T-1611-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,612,827. Actavis alleges non-infringement and invalidity.
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Other proceedings
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Medicine:
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eculizumab (SOLIRIS)
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Plaintiff:
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Alexion Pharmaceuticals Inc
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Defendants:
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Patented Medicine Prices Review Board and Attorney General of Canada
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Date Commenced:
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September 11, 2015
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Court File No.:
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T-1537-15
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Comment:
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Application seeking a declaration that sections 83 to 86 and the words “in any proceeding under s. 83” in section 87(1) of the Patent Act exceed the powers granted to Parliament by the Constitution Act, 1867. See article above.
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Medicine:
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dorzolamide (TRUSOPT, Apo-Dorzolamide), dorzolamide/timolol (COSOPT, Apo-Dorzo-Timop)
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Plaintiff:
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Apotex Inc
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Defendant:
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Merck & Co, Inc
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Date Commenced:
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September 21, 2015
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Court File No.:
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T-1594-15
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Comment:
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Action for a declaration of invalidity of Patents Nos. 1,329,211 and 2,065,965 and an Order declaring that Apotex’s dorzolamide and dorzolamide/timolol formulations do not infringe these patents. Apotex was successful in proceedings under the PM(NOC) Regulations (2010 FC 1042 and 2010 FC 1043) and subsequently commenced two damages proceedings in the Ontario Superior Court. Apotex asserts that it is an interested person within the meaning of section 60(1) of the Patent Act as “Merck has suggested that the [patents] are valid” in the damages actions.
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Applicants:
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Apotex Inc, Apotex Pharmachem India PVT Ltd (APIPL) and Apotex Research Private Limited (ARPL)
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Respondents:
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The Minister of Health and Attorney General of Canada
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Date Commenced:
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September 29, 2015
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Court File No.:
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T-1653-15
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Comment:
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Application for judicial review of the Minister of Health’s decision to continue its “2015 ban” and refusal to vary its “2014 ban” (lawfulness subject of a judicial review application in Court File No. T-2223-14, heard September 15 to 17, 2015, with a decision under reserve). Both bans place restrictions on the sale and importation of drug products from applicants APIPL and ARPL.
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To check the status of Federal Court cases, please click here.
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