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Apotex's non-infringing alternative defence rejected; ordered to pay over $61 million in perindopril profits reference
by Cameron Weir »
On June 18, 2015, the Federal Court ordered Apotex Inc. and a related company to pay over $61 million arising from the infringement of ADIR's patent for perindopril (COVERSYL): ADIR et al v Apotex Inc et al, 2015 FC 721.
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Health Canada issues interim policy re: interpretation of "medicinal ingredient"
by Nancy Pei »
One of the requirements under the Food and Drug Regulations for an abbreviated new drug submission (ANDS) is that the generic manufacturer's drug be the "pharmaceutical equivalent" of the innovator's drug (the Canadian reference product), defined under s. C.08.001.1 as:
"pharmaceutical equivalent" means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; [Emphasis added.]
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PMNOC Regulations amendments re: listing claim for single medicinal ingredient against fixed-dose combination now registered and published
As we previously reported, Regulations Amending the Patented Medicines (Notice of Compliance) Regulations were registered on June 19, 2015 and therefore came into force on that date. The amendments were published on July 1, 2015 (HTML; Bilingual PDF), together with a Regulatory Impact Analysis Statement (RIAS).
The RIAS indicates that "the interpretation by the Federal Court [in Gilead Sciences Canada Inc v The Minister of Health and The Attorney General of Canada (Gilead), 2012 FCA 254 and Viiv et al v Teva et al (Viiv), 2014 FC 328 and 2014 FC 893, aff'd 2015 FCA 93] is inconsistent with the policy intent of the PM(NOC) Regulations of allowing the listing of patents that claim one or more, but not all, of the medicinal ingredients contained in an approved combination drug... These amendments would restore the intent of the original and amended PM(NOC) Regulations, and clarify ambiguities regarding the listing requirements as they relate to patents containing a claim for the medicinal ingredient and combination drugs."
As noted previously, if the Minister deleted a patent from the Register or refused to add a patent to the Register between October 18, 2014 and June 19, 2015 on the basis of Viiv Health Care ULC v Teva Canada Limited, 2014 FC 893, the first person may resubmit the patent list for addition to the Register within 30 days after the date on which the amendments come into force, i.e. by July 19, 2015. The Regulations only provide this one opportunity to resubmit. The RIAS confirms, "It is intended that the Regulations, as amended, will apply to the remaining patents on the patent register, even if they were not considered under ViiV."
Federal Court releases Notice to the Parties and the Profession aiming to increase proportionality in complex litigation
On June 24, 2015, the Federal Court released a Notice to the Parties and the Profession titled "Case Management: Increased Proportionality in Complex Litigation before the Federal Court." The Notice sets out the initial recommendations of the Federal Court Case Management Working Group, composed of judges and prothonotaries, which resulted from consultations with the Bar. The overall aim of the Notice is to increase proportionality in proceedings before the Court, including proceedings relating to pharmaceutical patents.
There were ten recommendations. Highlights include:
- Earlier involvement of the trial judge in the pre-trial case management process, to implement procedures that will allow early resolution of interlocutory motions and appeals to ensure readiness for fixed trial dates.
- Limits on documentary discovery to ensure proportionality of cost and time to the nature and complexity of the dispute.
- Limits on oral discovery, including guidelines on the number of days of discovery based on the number of days fixed for trial.
- Limits on refusal motions, including one hour per motion per day of discovery and increased cost sanctions against unsuccessful/unreasonable parties. Further, the Notice mandates that questions on discovery should be answered unless clearly improper or prejudicial, or would require the disclosure of privileged information.
- Consideration of amendment to the Federal Courts Act and Federal Courts Rules to impose limits on appeals of prothonotaries' interlocutory orders.
The remaining recommendations relate to a short notice wait list for earlier trial dates, limits on demonstrative aids at trial, stricter enforcement of the limits on numbers of experts, potential of a science and technology primer prior to trial, and early consideration of mediation in all actions.
Health Canada news
Health Canada restricts import of some drugs, requests quarantine of other drugs. On June 12, 2015, Health Canada announced that it is restricting the import and marketing of drugs from Hospira SPA in Liscate, Italy, because of data integrity concerns identified by a trusted regulatory partner (Advisory; list of drugs affected). Medically necessary products from this site must be tested by an independent third-party in order to be released to the Canadian market. Products from this site which are not medically necessary are banned from import and release to the Canadian market until the data integrity concerns are resolved.
Additionally, in two separate alerts, Health Canada has also requested the quarantine of drugs manufactured or tested by Polydrug Laboratories, from Ambarnath, Maharashtra, India (Advisory) and Zhejiang Hisun Pharma Company Ltd., in Zhejiang, China (Advisory). Both quarantines stem from concerns with data integrity raised by a trusted regulatory partner.
Proposed regulatory amendments to require mandatory reporting of drug shortages and discontinuations. On June 20, 2015, proposed amendments to the Food and Drug Regulations were published which would, among other things, "mandate reporting of drug shortages by authorization holders to a third-party Web site for certain categories of drugs that have the potential, in a shortage or discontinuation situation, to adversely affect the health of Canadians and the health system." The proposed regulations are posted for a 75 day comment period ending September 3, 2015.
Announcement; Proposed Regulations Amending the Food and Drug Regulations (Shortages and Discontinuation of Sale of Drugs)
Proposed changes to Health Canada's comparative bioavailability requirements for HVDPs. On June 26, 2015, Health Canada issued a Notice advising of its proposed policy on bioequivalence standards for highly variable drug products ("HVDPs"), i.e. drug products which exhibit large pharmacokinetic within-subject variation in extent of absorption, as measured by area under the concentration versus time curve (AUC).
Health Canada has proposed "to adopt an average bioequivalence approach to HVDP with expanding limits based on the within-subject variability of the reference product." The Policy "would permit widening of the bioequivalence interval for AUC, with a point estimate constraint." The Notice is posted for a 60 day comment period ending August 25, 2015.
Notice: Proposed Policy on Bioequivalence Standards for Highly Variable Drug Products
CIPO Releases guidance for examination of diagnostic claims
As we reported in an IP Update, the Canadian Intellectual Property Office (CIPO) released guidance for examination of diagnostic method claims on June 29, 2015: Practice Notice: Examination Practice Respecting Medical Diagnostic Methods – PN 2015-02.
Novartis succeeds on prohibition application regarding Teva's deferasirox
On June 19, 2015, the Federal Court granted Novartis' application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Teva for its deferasirox product, (Novartis' EXJADE). The decision considered and rejected each of Teva's allegations of inutility, obviousness and insufficiency:
- Inutility: Rather than finding a single, overarching "promise of the patent," Justice O'Reilly distinguished between the promise of the compound claims and the promise of the use claims. The promise for the compound claims was found to have been either demonstrated or soundly predicted.
- Obviousness: Rejecting Teva's obviousness attack, Justice O'Reilly found the inventive concept to be consistent with the promise of the compound claims, and found that the gap between the prior art and patent required inventive ingenuity.
- Insufficiency: Justice O'Reilly held that Novartis did not 'hide' the real invention by failing to identify deferasirox as the compound that was chosen as the commercial compound. Further, the patent met the requirements for s. 27(3) of the Patent Act: the patent described how to synthesize the claimed compounds, which all had at least soundly predicted utility, and the patent referred to publications regarding tests used to assess utility in animal studies.
Teva may appeal as of right.
Novartis Pharmaceuticals Canada Inc v Teva Canada Limited, 2015 FC 770
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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bortezomib mannitol boronic ester (VELCADE)
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Plaintiff:
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Teva Canada Limited
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Defendants:
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Janssen Inc and Millennium Pharmaceuticals, Inc
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Date Commenced:
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June 5, 2015
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Court File No.:
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T-944-15
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Comment:
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Action for section 8 damages related to the prohibition proceedings in Court File No. T-2194-12 (decision reported as 2015 FC 247).
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To check the status of Federal Court cases, please click here.
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