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Comprehensive Economic and Trade Agreement between Canada and Europe to result in greater protection for pharmaceutical patentees
As reported in our October 30, 2013 IP Update, the Canadian government tabled a Technical Summary report on October 29, 2013 which contained details concerning the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union (EU). An agreement in principle was reached on October 18, 2013, concluding more than four years of negotiation.
The Technical Summary contains the following outcomes with respect to pharmaceuticals and intellectual property protection. The EU had requested (i) an innovator right of appeal under the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations), (ii) patent term restoration, and (iii) an extended data protection term. Canada agreed to (i) and (ii). The future amendments are welcome, as they will bring Canada's regime not only closer to that of the EU, but the U.S. as well.
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Health Canada news
Health Canada releases revised Post-Notice of Compliance (NOC) Changes — Quality Guidance. In September 2009, Health Canada released the revised Post-Notice of Compliance (NOC) Changes — Quality Guidance, which outlines the conditions for the categorization of a given post authorization change and recommendations for supporting documentation. Revisions were made in September 2011 to eliminate Level II (Notifiable Changes), moving higher risk submissions to Level I and lower risk ones to Level III. On October 15, 2013, Health Canada released a further revised Guidance Document, containing further clarifications/additions. The changes became effective upon release.
Guidance document
CADTH sought shareholder comments on formulary review procedure and process for drugs for rare diseases. Drugs for rare diseases ("DRDs") are "small molecule drugs or biologics used to treat rare diseases," which are life-threatening, seriously debilitating, or serious chronic conditions that only affect a very small number of patients (source: An Orphan Drug Framework for Canada by Health Canada, reported in the October 2012 issue of Rx IP Update). The Canadian Agency for Drugs and Technologies in Health ("CADTH") currently assesses DRDs through its Common Drug Review ("CDR") process. It recently sought shareholder comments on the future direction of a formulary review procedure and process for DRDs (deadline was November 4, 2013). A decision is anticipated by end of the current fiscal year (i.e. March 31, 2014). Until then, all DRDs will continue to be reviewed through the current CDR process.
CDR Update — Issue 94
Background on DRDs — Drugs for Rare Disease — Evolving Trends in Regulatory and Health Technology Assessment Perspective
Patented Medicine Prices Review Board news
New CPI Initiatives for 2015. As reported in the June 2013 edition of RxIP Update, the Patented Medicine Prices Review Board ("PMPRB") sought comments from stakeholders on proposed changes to the Consumer Price Index (CPI) Adjustment Methodology and Filing Requirements from May 16 to June 13, 2013. The PMPRB has posted the stakeholder submissions online.
On October 18, 2013, the PMPRB announced that for 2014, the existing CPI-Adjustment Methodology will be applied, and the new CPI initiative will be implemented for 2015. The actual lagged 2013 CPI (to be announced in January 2014) will be used to calculate the CPI-Adjustment Factors.
The PMPRB has invited written submission on the new CPI Initiatives by November 15, 2013.
Notice of Comment. Side-by-Side Comparison of Current and Proposed Text.
PMPRB tables 2012 Annual Report. On October 16, 2013, the Minister of Health tabled the PMPRB's 2012 Annual Report before Parliament. The report contains compliance and enforcement statistics, including that 1,328 patented drug products for human use were under the PMPRB's jurisdiction in 2012 and that the Board approved 15 Voluntary Compliance Undertakings (to the end of May 2013) and completed two price hearings. The Board also reports that the sales of patented drug products in Canada decreased slightly from $13.1 billion to $12.8 billion in 2012 and that the R&D expenditures reported by patentees were $894.8 million in 2012, a decline of 9.8% over 2011.
The Board has also published a summary of key information this year in the Annual Report 2012: In Brief.
Communiqué . Annual Report 2012 . Annual Report 2012: In Brief.
Hearing date for review of PMPRB Sandoz decision. As reported in the October 2012 edition of RxIP Update, on August 1, 2012, the PMPRB held that the generic manufacturer Sandoz Canada Inc. is a "patentee" and thus falls within the Board's jurisdiction for reporting purposes. Sandoz was therefore ordered to file information relating to five medicines: Sandoz Cyclosporine, – Famciclovir, – Azithromycin, – Estradiol and – Terbinafine.
Sandoz brought an application for judicial review (Court File No. T–1616–12). The hearing for the judicial review has been set down for November 19 and 20, 2013.
PMPRB-10-D2-SANDOZ — Merits reasons and order.
New NEWSletter released. The PMPRB released the October 2013 issue of its NEWSletter.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court of Appeal upholds Order of prohibition for Teva's generic version of zoledronic acid IV infusion. On October 15, 2013, the Federal Court of Appeal dismissed Teva's appeal from the Order of prohibition of Justice Hughes of the Federal Court regarding zoledronic acid IV infusion (Novartis' ZOMETA and ACLASTA). As reported in the April 2013 issue of Rx IP Update, Justice Hughes allowed Novartis' application for an Order of prohibition, holding that Teva's allegations of obviousness, lack of utility and insufficiency with respect to one patent (including a claim specific to zoledronic acid) were not justified. Teva appealed only with respect to Justice Hughes' obviousness analysis. The Court of Appeal dismissed Teva's appeal, finding that Justice Hughes did not err in law in his approach to his factual findings in respect of obviousness, nor did he make an overriding and palpable error in his appreciation of the evidence.
Teva Canada Limited v Novartis Pharmaceuticals Canada Inc, October 15, 2013.
Federal Court of Appeal decision — 2013 FCA 244
Federal Court decision — 2013 FC 283.
Federal Court allows Bayer's application for prohibition Order re: Cobalt's generic version of YAZ. On October 22, 2013, Justice Hughes prohibited the Minister of Health from issuing a notice of compliance ("NOC") to Cobalt for its proposed generic version of Bayer's YAZ (drospirenone and ethinyl estradiol), until the expiry of one of two patents at issue.
The first patent claims a pharmaceutical composition comprising drospirenone particles with certain characteristics, including a specified dissolution rate, and ethinyl estradiol. The Court rejected Cobalt's allegations of non-infringement, obviousness, inutility, lack of sound prediction, overbreadth, insufficiency and ambiguity. Cobalt argued that the claims at issue were limited to the micronized form of drospirenone. Justice Hughes preferred Bayer's interpretation that the claims were not limited to micronized drospirenone but instead to any form with the specified dissolution rate. Regarding the non-infringement allegation, Justice Hughes held that as Cobalt was obliged to provide sufficient information in its Notice of Allegation for Bayer to "come to grips with the allegations made" and Cobalt provided no sample tablets or any evidence about the dissolution parameters of its tablets, the allegation of non-infringement was not justified.
The second patent claims the use of an oral dosage form comprising an estrogen and a gestagen for contraception. Apart from one claim, a range of dosages of both estrogen and gestagen are claimed. One claim provides for a fixed dose of ethinyl estradiol and drospirenone of "an equivalent dose" of "75 µg of gestodene." Justice Hughes held that there was "no certainty as to what precise dosage" this would be, but that the most likely amount is 2 mg. Based on his construction, Cobalt's allegation of non-infringement was justified. He found that Cobalt's allegations of obviousness, double patenting, lack of utility and sound prediction were not justified.
Cobalt had also alleged that the patent claimed a method of medical treatment. Citing his decision in Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, 2013 FC 985 (reported in the October edition of RxIP Update) regarding methods of medical treatment, Justice Hughes found certain claims of the patent were not proper subject matter as "they provide for a choice to be made by those prescribing or providing contraceptive drugs to choose between a variety of components and a variety of dosage ranges." One claim directed at a single dosage of each of two compounds was held to be patentable subject matter.
Bayer Inc v Cobalt Pharmaceuticals, October 22, 2013.
Federal Court decision — 2013 FC 1061.
Other decisions
Subsection 53(2) of the Patent Act cannot be used alone to correct involuntary error. On September 30, 2013, the Federal Court dismissed Hoffmann-La Roche's ("Roche") judicial review application under subsection 53(2) of the Patent Act for a declaration amending a page from the disclosure of a patent, or in the alternative, for a declaration striking such language. Roche expressed the concern that an allegation could be made that the disclosure overstates the promised utility of all the claimed compounds. Roche was out of time to seek a reissue patent and did not want to use the disclaimer provision given that it found it too drastic in the circumstances. Justice Roy found that subsection 53(2) saves a patent that would otherwise be void by subsection 53(1) (void for material misrepresentation), but cannot be used alone as a remedy to correct an involuntary error if the conditions of subsection 53(1) are not met.
F Hoffmann-La Roche AG v Commissioner of Patents, September 30, 2013.
Federal Court decision — 2011 FC 1001.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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celecoxib (CELEBREX)
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Applicant:
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Pfizer Canada Inc and GD Searle & Co
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Respondents:
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Teva Canada Ltd and the Minister of Health
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Date Commenced:
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September 20, 2013
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Court File No.:
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T-1551-13
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Comment:
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Application for Order of Prohibition until expiry of Patent No. 2,177,576. Teva alleges invalidity.
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Medicine:
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tadalafil (CIALIS; ADCIRCA)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Apotex Inc and the Minister of Health
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Respondent/Patentee:
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Icos Corporation
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Date Commenced:
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Sept 27, 2013
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Court File No.:
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T-1597-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,181,377. Apotex alleges non-infringement (certain claims only) and invalidity.
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Medicine:
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tadalafil (CIALIS)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Apotex Inc and the Minister of Health
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Respondent/Patentee:
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Icos Corporation
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Date Commenced:
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Sept 27, 2013
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Court File No.:
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T-1598-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,226,784. Apotex alleges non-infringement (certain claims only) and invalidity.
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Medicine:
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tadalafil (CIALIS; ADCIRCA)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Apotex Inc and the Minister of Health
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Respondent/Patentee:
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Icos Corporation
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Date Commenced:
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Sept 27, 2013
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Court File No.:
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T-1599-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,379,948. Apotex alleges non-infringement and invalidity.
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Medicine:
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tadalafil (CIALIS; ADCIRCA)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Apotex Inc and the Minister of Health
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Respondent/Patentee:
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Icos Corporation
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Date Commenced:
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Sept 27, 2013
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Court File No.:
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T-1600-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,371,684. Apotex alleges non-infringement and invalidity.
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Medicine:
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clarithromycin (BIAXIN XL)
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Applicant:
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Abbott Laboratories and Abbott Laboratories Limited
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Respondents:
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The Minister of Health and Ranbaxy Pharmaceuticals Canada Inc
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Date Commenced:
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Oct 7, 2013
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Court File No.:
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T-1661-13
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,258,606; 2,386,527; 2,387,361; 2,387,356; 2,261,732; 2,471,102; 2,419,729; 2,386,534; 2,277,274; 2,209,714; 2,285,266; 2,358,395.
Ranbaxy alleges non-infringement and invalidity.
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Medicine:
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exemestane (AROMASIN)
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Applicant:
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Pfizer Canada Inc
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Respondents:
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The Minister of Health and Teva Canada Limited
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Date Commenced:
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Oct 16, 2013
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Court File No.:
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T-1703-13
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Comment:
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Application for judicial review of the issuance of a notice of compliance (NOC) to Teva on October 1, 2013, without requiring Teva to first serve a notice of allegation (NOA) addressing Patent No. 2,409,059. Teva's first NOC (subject of an earlier judicial review application, Court File No. T-1321-13) was rescinded by Health Canada on August 14, 2013. Pfizer pleads that Teva's submission was cross-referenced to Generic Medical Partners Inc (GMP) ANDS; an NOC issued to GMP on October 1, 2013; Teva has never served an NOA addressing the 059 patent. Pfizer also challenges Health Canada's Guidance Document: Patented Medicines (Notice of Compliance) Regulations insofar as it provides that a person that files an Abbreviated New Drug Submission (ANDS) cross-referenced to another ANDS approved on the basis of a comparison to an innovative drug is not required to separately address patents on the Patent Register.
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Other proceedings
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Medicine:
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dexmedetomidine hydrochloride (PRECEDEX)
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Plaintiffs:
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Hospira Inc, Orion Corporation, Hospira Healthcare Corporation
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Defendants:
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Sandoz Canada Inc, Sandoz International GmbH, and Sandoz Inc
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Date Commenced:
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September 26, 2013
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Court File No.:
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T-1589-13
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Comment:
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Patent infringement action relating to Patent No. 2,326,339. Hospira alleges that Sandoz is eligible to receive final FDA approval for Sandoz Dexmedetomine on January 15, 2014 and that Sandoz will make, market, use and sell Sandoz Dexmedetomidine manufactured and formulated by Sandoz Canada at its Boucherville plant, for the purposes of export and sale in the United States on or immediately after January 15, 2014.
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To check the status of Federal Court cases, please click here.
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