IN THIS ISSUE:

Federal Court prohibits issuance of NOC to Teva for atazanavir sulfate, prior genus patent does not anticipate compound claim »

PMPRB begins consultations on modernizing pricing guidelines »

Health Canada News »

Regulatory amendments to require mandatory reporting of drug shortages and discontinuations »

Proposed Vanessa’s Law Amendments coming to the Food and Drug Regulations and Medical Devices Regulations »

2015-16 Statistical Report for PMNOC Regulations and Data Protection »

New Good Label and Packages Guides released »

Commissioner of Patents’ Decision clarifies support requirements for humanized antibodies, signalling change in CIPO practice »

Other Court Decisions »

Federal Court of Appeal upholds Federal Court’s finding that Teva’s proposed pleading amendments had no reasonable prospect of success »

Judge upholds summary dismissal of PMNOC proceeding relating to Celltrion’s submission for IBD Indications »

Alexion’s constitutional challenge of PMPRB provisions struck by Federal Court »

Federal Court of Appeal dismisses Amgen’s appeal of Apotex/filgrastim decision »

New Court proceedings »

Federal Court prohibits issuance of NOC to Teva for atazanavir sulfate, prior genus patent does not anticipate compound claim

by Kevin Siu »

On June 8, 2016, the Federal Court issued an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a notice of compliance to Teva for atazanavir sulfate (Bristol-Myers Squibb’s (BMS) REYATAZ) until expiry of Novartis AG’s Patent No. 2,250,840 (“840 patent”): Bristol-Myers Squibb Canada Co v Teva Canada Limited, 2016 FC 580. The Court dismissed the prohibition application relating to BMS’s Patent No. 2,317,736 (“736 patent”).

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PMPRB begins consultations on modernizing pricing guidelines

On June 24, 2016 the Patented Medicines Prices Review Board (PMPRB) launched the first phase of a consultation initiative intended to modernize and simplify the framework for determining when patented drug prices are excessive. According to the news release, “[the] PMPRB’s regulatory framework will be modernized and simplified to better protect Canadian consumers from excessive patented drug prices in today’s rapidly evolving pharmaceutical market”. As a first step, the PMPRB is seeking comments on its Guidelines Modernization Discussion Paper, regarding possible reform of its Compendium of Policies, Guidelines and Procedures. Comments must be submitted in writing to the PMPRB by October 24, 2016.

Health Canada News

Regulatory amendments to require mandatory reporting of drug shortages and discontinuations. The Government of Canada has announced publication of The Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) which were registered on June 14, 2016 (SOR/2016-139, Canada Gazette Part II). The amendments, which are to be implemented by spring 2017, and supported by a publically available third party reporting site (as previously reported), require industry to report on anticipated drug shortages and discontinuances of sales no less than 6 months in advance. Among other things, although not impacting the licence status of a drug, manufacturers will be required to “notify Health Canada if a drug has not been sold on the Canadian market for a period of 12 consecutive months”. A draft guidance document to assist industry in complying with the amended Regulations is expected to be made available for consultation shortly.

Proposed Vanessa’s Law Amendments coming to the Food and Drug Regulations and Medical Devices Regulations. On June 18, 2016, Health Canada provided notice that it intends to develop and propose amendments to the Food and Drug Regulations and Medical Devices Regulations as part of its implementation of Vanessa’s Law, reported most recently here. When Vanessa’s Law received royal assent on November 6, 2014, many provisions came into force (see overview here), but other provisions require supporting regulations, which will be developed in phases. The first phase, as per the notice of intent, will provide regulations relating to, among others:

• the Minister of Health’s power to make an order requiring assessment (section 21.31) and tests, studies, and other activities (section 21.32);
• the Minister of Health’s power impose or to amend terms and conditions on any therapeutic product authorization respecting a drug (section 21.7);
• the requirement of holders of a therapeutic product authorization to communicate certain information from outside of Canada (section 30.1(1.2)(d));
• the recall notification timing and strategy; and
• the clarification of paragraph 44(2)(b) of the Medical Devices Regulations, that a health care facility, other than hospitals, that distributes medical devices outside of its facility must obtain an establishment licence.

Comments on the notice of intent were due within 30 days of the notice. Comments on specific regulatory language will be invited once the full proposals are prepublished in the Canada Gazette, Part I, in phases beginning in fall 2016.

2015-16 Statistical Report for PMNOC Regulations and Data Protection. On June 28, 2016, Health Canada released the Therapeutic Products Directorate Statistical Report 2015/2016 providing an overview of administration under the Patented Medicines (Notice of Compliance) Regulations and data protection. The report includes information regarding trends in listing on the Patent Register and Register of Innovative Drugs, as well as related court activity. The Report shows an upward trend of both new patent listings on the Patent Register (644 in 2015/16 compared to 320 in 2014/15) and new drug listings on the Register of Innovative Drugs (40 in 2015/16 compared to 29 in 2014/15). The number of prohibition applications commenced fell sharply (18 in 2015/2016 compared to 53 in 2014/2015).

New Good Label and Packages Guides released. On June 30, 2016, as part of Health Canada’s Plain Language Labelling Initiative (as previously reported), Health Canada announced the release of the Good Label and Package Practices Guide for Prescription Drugs and the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products. The guides are intended to “provide industry with direction for designing clear and effective health product labels and packages” in order to “help improve the safe use of health products.”

Commissioner of Patents’ Decision clarifies support requirements for humanized antibodies, signalling change in CIPO practice

As reported in our IP Update, the Commissioner’s Decisions CD 1302 on monoclonal antibodies and the recent CD 1398 on humanized antibodies, indicate that the Canadian Intellectual Property Office (CIPO) is becoming more amenable to treating antibody inventions according to the same rules that apply to other molecules.

Other Court Decisions

Federal Court of Appeal upholds Federal Court’s finding that Teva’s proposed pleading amendments had no reasonable prospect of success. On June 10, 2016, the Federal Court of Appeal (FCA) dismissed Teva’s appeals from two decisions of the Federal Court dismissing its motions for leave to amend its statement of claim in a patent impeachment action relating to tenofovir (Gilead’s TRUVADA, ATRIPLA and VIREAD): Teva Canada Limited v Gilead Sciences Inc, 2016 FCA 175. In its first motion, Teva sought to add an allegation that the relevant patent was fraudulently obtained by misleading the Patent Office. In its second motion, Teva sought to add an allegation that the relevant patent is invalid on the basis that the invention disclosed in the specification is not the invention “as contemplated by the inventor” as required by subsection 27(3) of the Patent Act. The Federal Court Judge found that the motions were essentially duplicative and that the proposed amendments were not supported by the discovery evidence on which Teva purported to rely. He dismissed both for lacking a reasonable prospect of success.

In dismissing Teva’s appeals, the FCA reiterated that in determining whether to grant a proposed pleadings amendment, a threshold question is whether the proposed amendments have a reasonable prospect of success. The Court explained that this involves examining an amendment’s chances of success in the context of the law and the litigation process, taking a realistic view. The Court rejected Teva’s argument that in deciding the first motion, the Federal Court Judge had improperly applied the “reasonable prospect of success” test, endorsing his finding that the evidence did not support the proposed amendments, that Teva had misinterpreted the import of the scientists’ statements in discovery, and that an allegation as serious as fraud required very strong supporting evidence. With respect to the second motion, the Court found no error in the Federal Court Judge’s finding that the second motion was an improper relitigation of the first motion which had, in any event, no reasonable prospect of success for reasons similar to the first motion.

Judge upholds summary dismissal of PMNOC proceeding relating to Celltrion’s submission for IBD Indications. On June 9, 2016, the Federal Court affirmed a Prothonotary’s decision to strike Janssen’s prohibition application regarding Celltrion’s INFLECTRA (infliximab). As we previously reported, Celltrion had received a notice of compliance (NOC) for INFLECTRA in 2014 for treating rheumatoid arthritis and other conditions (RA indications) as a subsequent-entry biologic to Janssen’s REMICADE. Celltrion was not required to address Patent No. 2,261,630, as Celltrion had filed its submission before the 630 patent issued. Celltrion then filed a Supplemental New Drug Submission (SNDS) seeking approval for various forms of inflammatory bowel disease (IBD indications). By this time, the 630 patent had issued and been listed on Health Canada’s Patent Register, and Celltrion had to address it. The Prothonotary granted Celltrion’s motion for summary dismissal, finding that “[t]he Claims of the 630 Patent ... speak specifically and directly to and only to the RA Indications”, and thus “Celltrion, if it were to obtain an NOC for its SNDS, could not infringe the claims of the 630 Patent.”: 2016 FC 525. Considering the matter de novo, the Federal Court judge agreed, writing “where a patent claims a particular use of a drug it is that use that must be compared with the intended use by the generic and not just the drug”: Janssen Inc v Celltrion Healthcare Co, Ltd, 2016 FC 651. The Federal Court judge did not agree with the Prothonotary’s decision to stay the order for 30 days, citing a Federal Court of Appeal finding that dismissal of a prohibition application as unmeritorious “does not require anybody to do anything” (as the Minister is compelled to issue an NOC because of the Food and Drug Regulations not the Prothonotary’s order), making a stay not possible. Janssen’s separate infringement action regarding Celltrion, its RA indication, and the 630 patent (T-396-13) is scheduled to be heard starting in September. Janssen has appealed.

Alexion’s constitutional challenge of PMPRB provisions struck by Federal Court. Alexion Pharmaceuticals Inc, manufacturer of SOLIRIS (eculizumab), had previously brought an application to the Federal Court seeking a declaration that subsection 83-86 and the words “in any proceeding under s. 83” in section 87 of the Patent Act relating to the Patented Medicines Prices Review Board (PMPRB) were ultra vires the Parliament of Canada and therefore unconstitutional (as previously reported). The Attorney General (AG) moved to strike Alexion’s application on the basis that it was bereft of any chance of success. In particular, the AG argued that recent jurisprudence of the Federal Court of Appeal (FCA) was determinative of the issue, citing Canada (AG) v Sandoz Canada Inc, 2015 FCA 249 (as previously reported), leave to appeal pending, SCC Case No 36798. The Court granted the AG’s motion and struck Alexion’s application: Alexion Pharmaceuticals Inc v Canada (Attorney General), 2016 FC 716. In its reasons, the Court reviewed a line of cases upholding the constitutionality of the impugned provisions and found that the FCA’s decision in Sandoz was binding. The Court also noted that should leave to appeal be granted in the Sandoz matter, the issue of the constitutionality of the price control regime and the jurisdiction of the PMPRB would be open to consideration by the Supreme Court. Alexion has appealed.

Federal Court of Appeal dismisses Amgen’s appeal of Apotex/filgrastim decision. On July 15, 2016, the Federal Court of Appeal dismissed Amgen’s appeal from a decision (previously reported) declining to grant a prohibition order regarding Apotex’s filgrastim product GRASTOFIL (a subsequent entry biologic (SEB) to Amgen’s NEUPOGEN): Amgen Canada Inc v Apotex Inc, 2015 FCA 196. The Court relied on its prior decisions finding that once a notice of compliance has issued, an appeal from a failed prohibition application is moot. Amgen argued that the Court nevertheless ought to hear its appeal because if it succeeds in its appeal, it will not be exposed to section 8 damages, relying on Apotex’s section 8 action recently commenced. The Court rejected Amgen’s argument, pointing to prior authorities which all say “this Court should not entertain an appeal from a denial of prohibition where the patentee can bring an action for patent infringement and can assert its patent against the section 8 claim”.

New Court proceedings

Patented Medicines (Notice of Compliance) Regulations

Other Proceedings

To check the status of Federal Court cases, please click here.

RANKINGS AND RECOGNITIONS

Smart & Biggar honoured as the Canadian Patent Contentious Firm of the Year and Gunars Gaikis named Canadian Patent Litigation Attorney of the Year by LMG Life Sciences
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Smart & Biggar named Canada’s Intellectual Property Litigation Firm of the Year for two years in a row and ten leading IP litigators recognized in the area of intellectual property by Benchmark Canada
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Nancy Pei selected to be on Managing Intellectual Property’s IP Stars list of the Top 250 Women in IP for 2016
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Smart & Biggar honoured as one of only two Canadian firms selected as a ‘Band One’ firm in Canadian intellectual property law in the 2016 edition of Chambers Canada
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Smart & Biggar once again leads in Canadian IP law as the only firm chosen at the top of the rankings in Ottawa, Toronto, Montreal and Vancouver in the 2016 edition of The Canadian Legal Lexpert® Directory
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Smart & Biggar lauded at the “top level of the Canadian market” in the 2016 edition of IAM Patent 1000 — The World’s Leading Patent Practitioners
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Smart & Biggar chosen for the third year in a row as the Best Canadian IP Firm at The International Legal Alliance Summit & Awards
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Smart & Biggar honoured by Managing Intellectual Property as both the "Canadian Specialty IP Firm of the Year" and the "Canadian Trademark Contentious Firm of the Year"
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David Schwartz named the 2016 Biotechnology Law "Lawyer of the Year" in Ottawa by Best Lawyers
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The future is bright: Smart & Biggar dominates Canadian IP in LMG Rising Stars rankings
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26 Smart & Biggar lawyers recognized in the 2016 edition of The Best Lawyers in Canada
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