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Federal Court grants prohibition Order regarding celecoxib against Mylan
On January 28, 2014, Justice Harrington allowed Pfizer's application for an Order of prohibition regarding celecoxib (Pfizer's CELEBREX).
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Supreme Court of Canada matters
Apotex seeks leave to appeal re: motion to dismiss prohibition proceeding following subsequent declaration of invalidity (olanzapine). Apotex has sought leave to appeal a Federal Court of Appeal decision declining to: (i) set aside a prohibition Order (which had been affirmed on appeal) and (ii) dismiss the application seeking the prohibition Order regarding the patent claiming olanzapine (Eli Lilly's ZYPREXA). Apotex brought the motion on the basis of a declaration of invalidity of the patent at issue, subsequent to issuance of the Order of prohibition. The Court of Appeal decision was reported in the January 2014 issue of Rx IP Update.
Apotex Inc v Eli Lilly Canada Inc, SCC Case No. 35714
Federal Court of Appeal decision — 2013 FCA 282.
Federal Court decision — 2010 FC 952.
Patented Medicine Prices Review Board news
PMPRB accepts Voluntary Compliance Undertaking regarding Teva's COPAXONE Syringe and concludes the redetermination proceeding. As reported in the May 2013 edition of Rx IP Update, the Federal Court had set aside a decision of the PMPRB wherein it ordered Teva to pay the government $2,801,285 for having sold COPAXONE Syringes (glatiramer acetate) at an "excessive price" between 2004 and 2010. This was the second time the Federal Court had overturned the PMPRB's decision regarding COPAXONE Syringes. On February 14, 2014 the PMPRB accepted a Voluntary Compliance Undertaking ("VCU") filed by Teva and Board Staff which proposed to resolve all issues in the redetermination proceeding. The PMPRB underscored that the acceptance of the VCU is premised on the specific and unique facts presented in this case, and that the parties accept the approach and methodology set out in the Board's February 23, 2012 decision (reported in the April 2012 edition of Rx IP Update).
PMPRB-13-D1-COPAXONE Redetermination 2013 — Board Order.
VCU by Teva Canada Innovation G.P.-S.E.N.C.
Health Canada news
Pursuant to the recent amendments to the Food and Drug Regulations extending the requirements of drug establishment licensing and Good Manufacturing Practices (GMP) to active ingredients used in pharmaceutical drugs for human use only (reported in the December 2013 edition of Rx IP Update), Health Canada has published a Guidance Document regarding Good Manufacturing Practices (GMP) for APIs.
Federal Court releases Notice to the Profession regarding experimental testing in patent disputes
On February 27, 2014, Chief Justice Crampton released a Notice to the Profession concerning actions for infringement or validity of a patent where a party intends to establish any fact in issue by experimental testing conducted for the purpose of litigation. The Notice states that the party relying on the testing shall, no later than two months before the scheduled service of the expert report(s) in chief, advise the other parties as to:
- the facts to be proven by such testing;
- the nature of the experimental procedure to be performed;
- when and where the adverse parties' counsel and representative(s) can attend to watch the experiment(s); and
- when and in what format the data and test results from such experiment(s) will be shared with the adverse parties.
The Notice states that "Unless a party intending to rely on such experiments has so advised the other parties, the party shall not, without leave of the Court, lead evidence at the trial or hearing as to any experiments conducted by or for it for the purpose of the litigation."
Notice to the Profession — Intellectual Property (experimental testing).
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court upholds Minister's refusal to list Eli Lilly's TRIFEXIS. The Minister refused to list a patent specifically claiming spinosad for listing against the new drug submission for Eli Lilly's TRIFEXIS, a combination product containing spinosad and milbemycin oxime, finding that it did not meet the product specificity requirement of subsection 4(2)(b) of the Regulations. Eli Lilly brought an application for judicial review, challenging the Minister's decision. Justice Bédard considered: (1) whether the Minister correctly construed the '329 Patent; (2) whether the Minister correctly interpreted subsection 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations ("Regulations"); and (3) whether the Minister's decision to not list the patent was reasonable.
Regarding construction of the patent, the Court held that the Minister had interpreted the patent too restrictively. The claims referred to a formulation that was defined to include spinosad alone or in combination with certain other active ingredients, including milbemycins, of which milbemycin oxime was part. Justice Bédard construed the terms in accordance with established principles of construction, holding that the claims were directed to formulations including spinosad alone but also to formulations with other active ingredients "such as, but not restricted to, milbemycin oxime."
Regarding subsection 4(2)(b), Justice Bédard held that a "perfect match" between the claimed formulation and what has been authorized is required by the Regulations.
Finally, Justice Bédard found that, despite the Minister's error in construction, the decision at the third step was reasonable. In her view, and based on the reasoning of the Court of Appeal in the Gilead Sciences Canada Inc v Canada (Minister of Health), 2012 FCA 254 claims covering formulations that could, but that do not necessarily, comprise milbemycin oxime are not sufficient to meet the strict matching requirement of the Regulations. Although the claims could extend to a formulation containing milbemycin oxime, a reference to the general family of milbemycins is not specific enough to "match" the formulation in the product.
Eli Lilly Canada Inc v Canada (Attorney General), February 17, 2014
Federal Court decision — 2014 FC 152.
Court of Appeal upholds validity of Notice of Allegation (NOA) but disqualifies Cobalt's in-house counsel. In 2002, Valeant received a NOA from Cobalt in respect of patents relating to diltiazem hydrochloride (Valeant's TIAZAC XC). Valeant learned that a law firm purported to represent Cobalt and that it was involved in preparing the NOA. However, the same law firm had acted for Valeant's predecessor, Biovail, in five proceedings before the Federal Court relating to the same medicinal ingredient. Valeant objected and the law firm resigned as Cobalt's counsel and further undertook not to assist in any way in the application. Valeant objected to one of Cobalt's in-house counsel, who was employed as a student-at-law and lawyer by the firm during the time it represented Biovail. Valeant also objected to the NOA, which it asserted was a direct product of the firm's improper use of confidential information gathered from its earlier retainer with Biovail. The Court of Appeal upheld the disqualification of the in-house counsel, noting that he had received confidential information of Valeant's predecessor while he was at the firm. As a result, his disqualification was automatic. The Court of Appeal declined to invalidate the NOA, noting that on the record before it, the Court was not persuaded that the NOA is the product of the misuse of information and an improper conflict of interest.
Valeant Canada LP v Canada (Health), February 24, 2014
Federal Court of Appeal decision — 2014 FCA 50.
Federal Court dismisses Cobalt's motion to dismiss an application as an abuse of process. Valeant sought a prohibition Order regarding two patents relating to diltiazem hydrochloride (Valeant's TIAZAC XC). Cobalt brought a motion to dismiss regarding one of the patents, relating to formulations as an abuse of process having regard to the construction of certain claims in a 2005 proceeding against a different generic manufacturer, Rhoxalpharma. In dismissing Cobalt's motion, the Court held that Valeant's argument regarding a different construction, despite the principle of judicial comity, has more than a mere possibility of success. The Court noted that this was not a case where Valeant failed "to put its best case forward in the first instance; rather, it is a situation where it is alleged that an error of law was made. It is noteworthy in this respect, that Biovail attempted to appeal to the Federal Court of Appeal, but its appeal was dismissed as moot." Accordingly, in the Court's view, fairness in permitting Valeant an opportunity to prove its case overcomes consistency.
Valeant Canada LP v Canada (Health), December 16, 2013
Federal Court decision — 2013 FC 1254.
Federal Court dismisses Alcon's application. On February 14, 2014, Justice Gleason of the Federal Court dismissed Alcon's application for an Order of Prohibition relating to 0.2% olopatadine ophthalmic solution (Alcon's PATADAY). The patent at issue was a formulation patent. Justice Gleason held that Cobalt's allegations of obviousness, ambiguity and insufficiency were not justified, but that the allegations of lack of utility and overbreadth were justified.
Alcon Canada Inc v Cobalt Pharmaceuticals Company, February 14, 2014
Federal Court decision — 2014 FC 149.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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abacavir sulfate — lamivudine (KIVEXA)
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Applicant:
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ViiV Healthcare ULC, ViiV Healthcare UK Limited and Glaxo Group 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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January 31, 2014
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Court File No.:
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T-333-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,289,753. Apotex alleges non-infringement and invalidity.
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Medicine:
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abacavir sulfate — lamivudine — zidovudine (TRIZIVIR)
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Applicant:
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ViiV Healthcare ULC, ViiV Healthcare UK Limited and Glaxo Group 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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January 31, 2014
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Court File No.:
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T-335-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,289,753. Apotex alleges non-infringement and invalidity.
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Medicine:
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abacavir sulfate (ZIAGEN)
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Applicant:
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ViiV Healthcare ULC, ViiV Healthcare UK Limited and Glaxo Group 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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January 31, 2014
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Court File No.:
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T-336-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,289,753. Apotex alleges non-infringement and invalidity.
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Medicine:
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rivastigmine (EXELON PATCH)
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Applicant:
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Novartis Pharmaceuticals Canada Inc
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Respondents:
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Mylan Pharmaceuticals ULC and the Minister of Health
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Respondent/Patentee:
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Novartis AG and LTS Lohmann Therapie-Systeme AG
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Date Commenced:
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February 6, 2014
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Court File No.:
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T-365-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,315,784. Mylan alleges non-infringement.
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Medicine:
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pemetrexed disodium (ALIMTA)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Hospira Healthcare Corporation and the Minister of Health
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Respondent/Patentee:
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Takeda Pharmaceutical Company Limited
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Date Commenced:
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February 6, 2014
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Court File No.:
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T-366-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 1,340,794. Hospira alleges non-infringement (certain claims only) and invalidity.
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Other proceedings
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Medicine:
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latanoprost (XALATAN)
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Plaintiff:
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Apotex Inc
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Defendants:
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Pfizer Inc, Pharmacia Aktiebolag and Pfizer Canada Inc
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Date Commenced:
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February 12, 2014
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Court File No.:
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CV-14-498386
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Comment:
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Action for damages pursuant to the Ontario and English Statutes of Monopolies, as well as a disgorgement of the Defendants' revenues. Apotex asserts that, in the event that Patent No. 1,339,132 is declared to be invalid by the Federal Court, it is entitled to the relief it seeks.
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To check the status of Federal Court cases, please click here.
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