|
Federal Court of Appeal overturns Teva’s venlafaxine section 8 award for improper reliance on hearsay evidence
by Abigail Smith »
On May 31, 2016, the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) in relation to its venlafaxine hydrochloride product (Pfizer’s Effexor XR) on the basis that the judge had improperly relied on hearsay evidence (2016 FCA 161). The matter was remitted to the Federal Court for redetermination, excluding the hearsay evidence. The Court also provided guidance on a number of other issues, including how to determine lost sales in the “but-for” world and the burden of proof in section 8 actions.
Read more »
Federal Court grants Janssen close to $20 million against Teva for infringement of levofloxacin patent
by Kevin Siu »
The Federal Court on May 31, 2016 issued its public judgment in Janssen Inc v Teva Canada Ltd, 2016 FC 593, for the quantification of damages arising from infringement of Daiichi Sankyo’s Patent No. 1,304,080 for levofloxacin (LEVAQUIN). In the earlier liability phase of the action, Teva (then Novopharm) was held liable for damages for patent infringement (Janssen-Ortho Inc v Novopharm Ltd, 2006 FC 1234, aff’d 2007 FCA 217, leave to appeal refused [2007] SCCA No 442).
Read more »
Supreme Court dismisses application for leave in consumer class action regarding VIAGRA patent litigation
On June 9, 2016, the Supreme Court dismissed an application for leave to appeal in a consumer class action against Pfizer in relation to VIAGRA (news release, docket). As previously reported, the Court of Appeal for British Columbia dismissed a certification application for a proposed class action in which the plaintiff alleged that purchasers of sildenafil (Pfizer’s VIAGRA) had been overcharged as a result of Pfizer’s unsuccessful litigation under the PMNOC Regulations. The Court of Appeal found, inter alia, that the completeness of the patent regulatory regime forecloses parallel civil actions by consumers that are rooted in a breach of the Patent Act.
Eli Lilly NAFTA challenge hearing concluded
As previously reported, Eli Lilly filed suit under the North American Free Trade Agreement (NAFTA) seeking damages from the Government of Canada. Eli Lilly asserts that the Canadian judiciary's application of the promise doctrine to Eli Lilly's STRATTERA (atomoxetine) and ZYPREXA (olanzapine) patents contravenes Canada's obligations under NAFTA and the Patent Cooperation Treaty. The hearing was held May 30 to June 9, 2016.
Health Canada News
Highlights of 2015 new drug authorizations. On May 12, Health Canada published Health Canada New Drug Authorizations: 2015 Highlights. The publication details new active substances, subsequent entry biologics, and new generic pharmaceutical products authorized in 2015. In 2015, Health Canada authorized 37 new active substances, two subsequent entry biologics, and 128 new generic pharmaceutical products for the Canadian market.
Health Canada moves forward with mandatory reporting of drug shortages and discontinuances. On May 19, the Government of Canada announced that it has “moved a step closer to mandatory public reporting for drug companies experiencing shortages and discontinuances, by inviting prequalified contractors to submit proposals to develop and maintain a website for the reporting of this information.” The Government’s efforts to advance this initiative, including the current voluntary reporting approach, were previously reported.
Guidance regarding the preparation of drug submissions in eCTD format. Health Canada released Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the eCTD Format. The document provides a wealth of information regarding when a party can or must make submissions in eCTD format. For example, a sponsor is not yet required to provide an electronic regulatory activity in eCTD format, although it is strongly recommended. Sponsors not in a position to transition to the eCTD format may make submissions in “non-eCTD electronic-only” format. As previously reported, Health Canada issued notices in March indicating that for certain types of submissions, “non-eCTD electronic-only” format was available, and that as of June 1, paper copies (e.g. patent lists) would no longer be accepted.
Health Canada seeking feedback on regulatory framework for mandatory reporting of adverse drug reactions. In addition to other effects (e.g. as reported here and here), the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces a new power to require reporting of serious adverse drug reactions and medical device incidents by certain healthcare institutions. The requirement is intended to enable timelier identification and communication of emerging safety issues. Health Canada has prepared an Issue Identification Paper summarizing comments from stakeholder consultations in 2015-2016 that were meant to identify issues and potential challenges with implementing the new reporting requirement. Health Canada is now seeking feedback, by July 11, 2016, on the issues identified in the paper.
PMPRB releases report on Canadian public drug plan expenditures
The Patented Medicine Prices Review Board released (see announcement) its second edition of CompassRx, an annual report focusing on the 2013/2014 fiscal year that “monitors major developments in drug pricing and reimbursement in Canada, analyzes trends, and measures their impact on expenditure levels.”
Federal Court of Appeal dismisses appeal from listing case
As previously reported, by notice of motion dated March 6, 2015, Apotex sought an order under subsection 6(5)(a) of the PMNOC Regulations to dismiss Gilead’s prohibition application regarding emtricitabine and tenofovir disoproxil fumarate (TRUVADA) on the grounds that the asserted patent relating to tenofovir disoproxil and its salts was improperly listed on the Patent Register. The Federal Court rejected Gilead’s arguments that the amendments to the PMNOC Regulations regarding eligibility for listing of patents claiming only one of the active ingredients in a combination drug applied to the patent at issue in view of the filing date of Apotex’s motion having regard to the transitional provision, and granted Apotex’s motion. On May 4, 2016, the Federal Court of Appeal affirmed, with minimal reasons: Gilead Sciences, Inc v Apotex Inc, 2016 FCA 140, aff’g 2016 FC 231.
Acceptance of correspondence by XpresspostTM deemed receipt by CIPO
Biogen sought judicial review of a Commissioner’s decision that it had failed to respond to a requisition within set time limits and thus had abandoned claims in a conflict proceeding under the “old” (pre-October 1, 1989) Patent Act. On July 24, 2014, the same day it was due, Biogen’s patent agent sent affidavit evidence to the Commissioner by way of Canada Post’s Xpresspost™ service, not the Registered Mail Service of Canada Post. The latter is the name of the establishment designated by the Commissioner to accept correspondence which would be deemed received by the Commissioner on that day. The affidavit evidence was not physically received by the Canadian Intellectual Property Office (CIPO) until July 28, 2014. The Federal Court held that the Commissioner’s interpretation of “Registered Mail Service of Canada Post” was unreasonable, such that, by using Xpresspost™, delivery had been made to the designated establishment: Biogen Idec Ma Inc v Canada (AG), 2016 FC 517. In obiter, the Federal Court also found that the Commissioner’s refusal to grant an extension of time to accept the evidence on July 28, 2014 was unreasonable, and that the Commissioner lacked legislative authority to find Biogen had abandoned the conflict claims. In response to this decision, CIPO provided notice on May 24, 2016 that the XpresspostTM service of Canada Post will be recognized as a designated establishment or designated office to which correspondence addressed to the Commissioner of Patents, the Registrar of Trademarks, the Copyright Office or the Registrar of Topographies may be delivered.
FCA sets aside a Federal Court order enforcing a settlement agreement
After Allergan brought an action for patent infringement against Apotex related to gatifloxacin (Allergan's ZYMAR), settlement was discussed. Six months after negotiations fell apart, Allergan moved for an order enforcing the settlement agreement it thought it had reached. As previously reported, the Federal Court agreed, finding that the parties had settled the litigation and issued an order enforcing the settlement terms: 2015 FC 367. On appeal, the Federal Court of Appeal (FCA) set out five requirements for a settlement agreement to exist: (i) a mutual intention to create legal relations; (ii) consideration flowing in return for a promise; (iii) the terms of the agreement are sufficiently certain, such that that the parties were objectively ad idem; (iv) matching offer and acceptance on all essential terms; and (v) other requirements, such as legislative restrictions and whether lawyers bind their clients through the law of agency. The FCA found that the motions judge erred in principle in suggesting that the Court must adopt a subjective rather than objective standard when assessing whether these requirements were met. On the facts, the FCA found that the motion judge erred in finding that the scope of the restrictions upon Apotex – which had not been resolved during negotiations – was not an essential term of the contemplated agreement. The motion judge also erred in finding that an email from counsel for Apotex indicating a willingness to recommend acceptance of a draft agreement to his client constituted an acceptance of an offer. Counsel for Apotex had made it very clear that he did not possess authority to bind his client. The FCA therefore set aside the Federal Court’s order because the parties had not reached a settlement agreement: Apotex Inc v Allergan Inc, 2016 FCA 155.
Prothonotary summarily dismisses infliximab PMNOC proceeding regarding IBD indications against Celltrion
Celltrion received an NOC for INFLECTRA (infliximab) on January 15, 2014 for use in the treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis (RA conditions), as a subsequent-entry biologic to Janssen’s REMICADE. It did not have to address Patent No. 2,261,630 in connection with that submission, as the patent was listed after its filing date. Celltrion then filed a Supplemental New Drug Submission seeking approval for various forms of inflammatory bowel disease (IBD conditions–Crohn’s Disease, fistulising Crohn’s Disease, and ulcerative colitis). Celltrion was required to address the 630 patent in view of subsection 5(2) of the Regulations and Janssen commenced a prohibition proceeding. Celltrion brought a motion for summary dismissal on the basis that “the IBD indications cannot infringe the claims of the 630 Patent since all of the claims of the 630 Patent are directed to the treatment of the RA Indications”. On May 26, the Prothonotary dismissed the proceeding finding that “if a submission refers to uses of a drug that do not infringe and on the plain and ordinary meaning of the claims of the patent those uses do not infringe it should be the end of the matter”: Janssen Inc v Celltrion Healthcare Co, 2016 FC 525. Janssen has appealed to a Federal Court judge. 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.
Apotex's action for damages pursuant to the Trademarks Act and Statutes of Monopolies in the Ontario Superior Court survive motion to strike
As previously reported, Apotex is suing Sanofi and Schering in the Ontario Superior Court for additional damage claims arising from Sanofi's prohibition proceeding against Apotex regarding Apo-Ramipril. Apotex claims treble damages pursuant to the U.K. Statute of Monopolies and the Ontario Statute of Monopolies (Monopolies Act Claims), damages or an accounting of profits pursuant to s. 53.2 of the Trademarks Act (TM Act Claim), and disgorgement of Sanofi's profits generated from the sale of ramipril as a consequence of the improper issuance of a patent and/or the delay due to the prohibition proceeding (Unjust Enrichment Claim). The action had been stayed pending Sanofi's appeal to the Supreme Court, which addressed quantification of damages under section 8 of the PMNOC Regulations, which was dismissed in April 2015.
Sanofi and Schering brought motions seeking to strike, among other things, Apotex’s TM Act Claim and Unjust Enrichment Claim, while Schering also sought to strike the Monopolies Act Claims. On May 27, relying on earlier decisions on similar motions (such as Apotex Inc v Eli Lilly and Company, previously reported), and finding that the “legal issues raised [in the action] are insufficiently settled to be the object of a pleadings motion”, the Motions Judge dismissed the motions as they related to the Monopolies Act Claims and TM Act Claim: Apotex Inc v Schering Corporation — 2016 ONSC 3407. The Motions Judge did, however, strike Apotex’s Unjust Enrichment Claim based on binding jurisprudence (previously reported).
Commissioner's Decision demonstrates Patent Appeal Board's willingness to consider a sound prediction based on facts combined from the specification and the prior art
The claims of Patent Application No. 2,654,413 were directed to the use of VASCULAR ENDOTHELIAL GROWTH FACTOR B (VEGFB) for enhancing survival of motor neurons and treating Amyotrophic Lateral Sclerosis (ALS). The 413 application demonstrated that VEGF165, a homologue of VEGFB, functioned as a neuroprotectant, and that this function necessitated binding to neuropilin-1. However, the application provided no experimental evidence that VEGFB itself could function in the same manner. Moreover, the 413 application demonstrated that other VEGF homologues were not neuroprotectants. On this basis, the Final Action and Summary of Reasons concluded that the application did not provide a factual basis for a sound prediction that VEGFB could function as a neuroprotectant.
In response to the Summary of Reasons, the Applicant submitted an expert affidavit that pointed to a prior art publication for the missing link, namely that VEGFB was capable of binding the neuropilin-1 receptor. The affidavit further articulated a line of reasoning as to why a person in the field would have pieced the information from the prior art reference and the specification together to arrive at a reasonable prediction that VEGFB functions as a neuroprotectant.
Referring to Bell Helicopter Textron Canada Limitee v Eurocopter, 2013 FCA 219, Commissioner's Decision 1395 agreed that a "factual basis can rely on information disclosed in the specification as well as information forming part of the common general knowledge of the skilled person, the latter of which need not be explicitly disclosed in the specification". Relying heavily on a further prior art reference identified by the Patent Appeal Board panel itself, which corroborated the ability of VEFGB to bind neuropilin-1, the Commissioner agreed that the skilled person would see the ability of VEGFB to bind neuropilin-1 as a valid predictor of its ability to enhance motor neuron survival, and that the objection for lack of sound prediction was unjustified.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
|
Medicine:
|
lisdexamfetamine (VYVANSE)
|
|
Applicants:
|
Shire Pharma Canada ULC
|
|
Respondents:
|
Apotex Inc and The Minister of Health
|
|
Respondent/Patentee:
|
Shire LLC
|
|
Date Commenced:
|
May 6, 2016
|
|
Court File No.:
|
T-723-16
|
|
Comment:
|
Application for Order of prohibition regarding Patent No. 2,527,646. Apotex alleges non-infringement and invalidity. Apotex purported to withdraw the NOA on April 6.
|
|
Medicine:
|
lisdexamfetamine (VYVANSE)
|
|
Applicants:
|
Shire Pharma Canada ULC
|
|
Respondents:
|
Apotex Inc and The Minister of Health
|
|
Respondent/Patentee:
|
Shire LLC
|
|
Date Commenced:
|
May 20, 2016
|
|
Court File No.:
|
T-816-16
|
|
Comment:
|
Application for Order of prohibition regarding Patent No. 2,527,646. Apotex alleges non-infringement and invalidity. Apotex purported to withdraw the NOA on May 12.
|
|
Medicine:
|
dabigatran etexilate mesylate (PRADAXA)
|
|
Applicants:
|
Boehringer Ingelheim (Canada) Ltd and Boehringer Ingelheim Pharma GmbH & Co KG
|
|
Respondents:
|
Apotex Inc and The Minister of Health
|
|
Date Commenced:
|
May 20, 2016
|
|
Court File No.:
|
T-817-16
|
|
Comment:
|
Application for Order of prohibition regarding Patent No. 2,277,949. Apotex alleges non-infringement and invalidity.
|
|
Medicine:
|
tadalafil (CIALIS)
|
|
Applicants:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Laboratoire Riva Inc and The Minister of Health
|
|
Respondents/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
June 2, 2016
|
|
Court File No.:
|
T-877-16
|
|
Comment:
|
Application for Order of prohibition regarding Patent No. 2,226,784. Riva alleges non-infringement and invalidity.
|
|
Medicine:
|
dinoprost tromethamine (LUTALYSE)
|
|
Applicants:
|
Zoetis Canada Inc and Zoetis Services LLC
|
|
Respondents:
|
Ceva Animal Health Inc and The Minister of Health
|
|
Date Commenced:
|
June 3, 2016
|
|
Court File No.:
|
T-884-16
|
|
Comment:
|
Application for Order of prohibition regarding Patent No. 2,331,284. Ceva alleges non-infringement.
|
Judicial Review
|
Medicine:
|
unidentified
|
|
Applicants:
|
Teva Canada Limited
|
|
Respondents:
|
The Minister of Health and Attorney General of Canada
|
|
Date Commenced:
|
June 1, 2016
|
|
Court File No.:
|
T-872-16
|
|
Comment:
|
Application for judicial review in respect of the Minister of Health’s decision to release certain records relating to a Teva abbreviated new drug submission pursuant to the Access to Information Act.
|
To check the status of Federal Court cases, please click here. |
