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Gilead prevails in SOVALDI appeal
by: Kevin P. Siu
The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the Court declared Idenix’s Patent No. 2,490,191 invalid on the basis of insufficiency of disclosure and inutility, while upholding the validity of Gilead’s Patent No. 2,527,657 (657 patent).
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Proposed amendments to the Canadian Patent Rules published for public consultation
As previously reported, the government is conducting a public consultation on proposed amendments to the Patent Rules until September 8, 2017. Details regarding the proposed amendments were reported here, and relate primarily to pending amendments to the Patent Act intended to bring it into compliance with the Patent Law Treaty.
Patented Medicine Prices Review Board releases July 2017 NEWSletter
The Patented Medicine Prices Review Board released the July 2017 issue of its NEWSletter. Highlights include:
- an update on the status of proposed amendments to the Patented Medicine Regulations (Regulations) in respect of changes to the regulations of patented drug prices;
- a reminder that patentees are required under the Regulations to properly complete Block 5 information by filing “publicly available ex-factory prices for each dosage form, strength and package size in which their product is sold to each class of customer in each country set out in the schedule”; and
- notice of recent and forthcoming publications, including: CompassRx, 3rd edition, which reports on prescription drug expenditures by Canada’s public drug plans; the first of three reports on Canadian public drug plan formularies to be released in fall 2017; Generics360, which focuses on generic drug pricing in Canada and internationally; and a report entitled Potential savings from biosimilars in Canada.
CADTH issues Common Drug Review Update Newsletter
The Canadian Agency for Drugs and Technologies in Health (CADTH) issued a Common Drug Review (CDR) Update on August 1, which includes the following highlights:
- commencing September 1, 2017, CADTH will no longer seek individual permissions from patient groups and will be sharing all patient input submissions online (subject to patient groups requesting that personal identifying information be redacted in their initial submissions and summary of patient input);
- CADTH invited stakeholders to provide comments and feedback on its proposed revisions to the biosimilar review process;
- CADTH initiated stakeholder consultation on its proposed revisions to CDR and pan-Canadian Oncology Drug Review resubmission eligibility criteria; and
- CADTH extended its deadline for stakeholder comments and feedback on the consultation for Revising Common Drug Review Recommendations in the CADTH Therapeutic Review Process to September 15, 2017 at 5 pm EDT.
2016-17 Statistical Report for PMNOC Regulations and Data Protection
On July 14, 2017, Health Canada released the Therapeutic Products Directorate Statistical Report 2016/2017 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 new patent listings on the Patent Register (769 in 2016/17 compared to 644 in 2015/16) and a decline in new human drug listings on the Register of Innovative Drugs (31 in 2016/17 compared to 40 in 2015/16). The number of prohibition applications substantially increased from 18 in 2015/2016 to 32 in 2016/2017 (as of March 31, 2017).
TPD and BGTD Annual Drug Submission Performance Reports released
The Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) have released their Drug Submission Performance Annual Reports. The reports contain information regarding pharmaceutical, biologic and radiopharmaceutical drug submission review activity over five consecutive fiscal years (April 1 to March 31) from 2012-13 to 2016-17, including approval times.
Court Decisions
Federal Court permits quia timet pleading to stand. Otsuka has sued Apotex for patent infringement, claiming that Apotex infringes several patents relating to aripiprazole (ABILIFY) based on Apotex's ongoing manufacture and export of aripiprazole tablets for consumption by patients outside of Canada and on the basis that Apotex intended to sell its aripiprazole tablets to patients in Canada. Apotex brought a motion to strike Otsuka’s statement of claim, alleging that the claim ought to be struck as a quia timet claim and was not supported by sufficient material facts. The Court dismissed Apotex’s motion. The Prothonotary held that the action was quia timet and therefore required material facts relating to Apotex having a deliberate intention to engage in infringing acts; that the infringing activity must be imminent and not speculative; and that the damages suffered by Otsuka must be substantial if not irreparable. The Court held that the claim was not speculative and the facts pleaded were stronger than those in other cases in which quia timet claims have been struck. In particular, it was sufficient to plead that: (1) a lengthy notice of allegation was served and Patented Medicines (Notice of Compliance) proceedings had commenced, (2) damages in excess of $50,000 would be suffered, and (3) Apotex was continuing to manufacture aripiprazole tablets, although presently for use outside of Canada.
Otsuka Pharmaceutical Co, Ltd v Apotex Inc, Order of Proth. Aalto dated 15 June 2017 (Court File T-200-17), appeal pending
PMNOC proceedings
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Medicine:
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tapentadol hydrochloride (NUCYNTA IR)
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Applicants:
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Endo Ventures Ltd, Paladin Labs Inc and Grünenthal GmbH
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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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July 14, 2017
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Court File No.:
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T-1033-17
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,680,771. Apotex alleges non-infringement and invalidity.
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Medicine:
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tapentadol hydrochloride (NUCYNTA IR)
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Applicants:
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Endo Ventures Ltd, Paladin Labs Inc and Grünenthal GmbH
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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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July 14, 2017
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Court File No.:
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T-1034-17
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,572,147. Apotex alleges non-infringement and invalidity.
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Medicine:
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tapentadol hydrochloride (NUCYNTA IR)
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Applicants:
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Endo Ventures Ltd, Paladin Labs Inc and Grünenthal GmbH
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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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July 14, 2017
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Court File No.:
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T-1035-17
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,683,779. Apotex alleges non-infringement and invalidity.
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Medicine:
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ticagrelor (BRILINTA)
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Applicants:
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AstraZeneca Canada Inc and AstraZeneca AB
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Respondents:
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Teva Canada Limited and The Minister of Health
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Date Commenced:
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July 20, 2017
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Court File No.:
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T-835-17
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,351,709; 2,408,596; and 2,659,328. Teva alleges non-infringement and invalidity.
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Medicine:
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lenalidomide (REVLIMID)
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Applicants:
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Celgene Inc and Celgene Corporation
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Respondents:
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Dr. Reddy’s Laboratories Ltd and The Minister of Health
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Date Commenced:
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July 27, 2017
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Court File No.:
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T-1143-17
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,476,983 ("983 patent"); 2,477,301; 2,537,092; 2,687,924; 2,687,927; 2,688,694; 2,688,695; 2,688,708; 2,688,709; 2,741,412; and 2,741,575. Dr. Reddy’s Laboratories alleges non-infringement of all patents and invalidity of the 983 patent.
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Other Proceedings
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Medicine:
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15-valent pneumococcal capsular polysaccharide conjugate vaccine (PREVNAR 13, V114)
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Plaintiffs:
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Merck Sharp & Dohme Corp and Merck Canada Inc
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Defendant:
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Wyeth LLC
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Date Commenced:
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August 1, 2017
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Court File No.:
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T-1184-17
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Comment:
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Action for a declaration of invalidity of Patents Nos. 2,604,363, 2,650,056, and 2,803,111.
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