|
Competition Bureau's draft Intellectual Property Enforcement Guidelines (IPEGs) address PMNOC Regulations litigation settlement
by Urszula Wojtyra »
On June 9, 2015, the Competition Bureau released draft updated Intellectual Property Enforcement Guidelines (IPEGs) for comment. The IPEGs describe how the Bureau will determine whether conduct involving IP raises an issue under the Competition Act (Act). This latest release follows the Bureau's September 2014 release of the present IPEGs. Also in September 2014, the Bureau released a white paper titled Patent Litigation Settlement Agreements: A Canadian Perspective, as previously reported here and here.
Read more »
Federal Court of Appeal confirms sound prediction elements self-evident to skilled person need not be disclosed in patent
by Andrew Mandlsohn »
On June 3, 2015, the Federal Court of Appeal dismissed Apotex's appeal from a prohibition Order relating to bimatoprost (Allergan's LUMIGAN RC): Apotex Inc v Allergan Inc, 2015 FCA 137. As we previously reported, Justice O'Reilly held that Apotex's allegations of invalidity on the bases of obviousness, lack of utility and anticipation were not justified: 2014 FC 567.
Read more »
Patented Medicine Prices Review Board (PMPRB) releases NEWSletter
The PMPRB released the April 2015 issue of its NEWSletter which published the appointments to the Human Drug Advisory Panel, staffing changes, and the anticipated summer release of the PMPRB's 2015-2018 Strategic Plan and The National Prescription Drug Utilization Information System (NPDUIS) report on generic drugs in Canadian private plans.
Plain Language Labelling Amendments for prescription drugs, including requirement for Look-Alike/Sound-Alike assessment, in force on June 13, 2015
As reported previously, the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) were registered on June 13, 2014 (SOR/2014-158, Canada Gazette Part II). The amendments will apply to submissions filed on or after June 13, 2015 for prescription products and those administered or obtained through a health professional; non-prescription products will be subject to the amended Regulations on June 13, 2017. Health Canada's Guidance Document Questions and Answers: Plain Language Labelling Regulations effective June 13, 2015 provides guidance on how Health Canada will apply the amendments in force as of that date.
The amendments will require the inclusion of a brand name assessment (also referred to as Look-alike sound-alike (LASA) assessment) in all new drug submissions and Drug Identification Number applications where a new brand name is being proposed or where a change to an existing brand name is being proposed. The sponsor must assess "whether there is a likelihood that the drug will be mistaken for any of the following products [including a drug that has a drug identification number] due to a resemblance between the brand name that is proposed to be used ... and the brand name, common name or proper name of any of those products." See Health Canada's: Guidance for Industry: Review of Drug Brand Names and Frequently Asked Questions — Guidance Document for Industry — Review of Drug Brand Names.
Quebec's Bill No. 28 providing listing agreements passed on Aril 21
As previously reported, in November 2014, the Quebec legislature introduced Bill No. 28, An Act mainly to implement certain provisions of the Budget Speech of June 4, 2014 and return to a balanced budget in 2015-2016. The Act permits Quebec's Minister of Health and Social Services to negotiate listing agreements with manufacturers before a medication is added to the basic prescription drug insurance plan. The Act also provides the framework for Quebec to participate in the pan-Canadian Pharmaceutical Alliance negotiations. Bill No. 28 was assented to on April 21, 2015.
Federal Court summarily dismisses portions of applications relating to Gilead's VIREAD and TRUVADA
On May 8, 2015, Justice Barnes summarily dismissed Gilead's prohibition applications against Apotex relating to emtricitabine and tenofovir disoproxil fumarate (Gilead's TRUVADA) and tenofovir disoproxil fumarate (Gilead's VIREAD) as regards to Patent No. 2,298,059 (two other patents remain in the applications). Apotex sought the dismissal, arguing abuse of process on the basis of a prior decision, Gilead Sciences, Inc v Teva Canada Limited, 2013 FC 1272 ("Teva applications"; previously reported here), finding certain claims of the same patent invalid for obviousness. Gilead opposed the motion on several grounds, including that a different evidentiary record would be before the Court as Gilead has asserted all of the claims of the subject patent, whereas in the Teva applications, it asserted only two of the claims (Teva had alleged invalidity of claims 1-7). The Court held that "A patentee cannot avoid an abuse of process finding by asserting the validity of only a select number of claims in an initial NOC [Notice of Compliance] proceeding, only to assert the validity of different claims in a subsequent NOC proceeding involving a different generic challenger ... If it were otherwise, the patentee could effectively split its case and unilaterally compel subsequent generic challengers to litigate claims, the invalidity of which the patentee had effectively conceded. This would amount to a manipulation of the system and it would violate the principle that the patentee is required to put its strongest case forward in the first instance." However, the Court noted, "The situation may well be different where the initial generic challenger declines to put the validity of certain claims in issue in its NOA [Notice of Allegation], perhaps relying solely on an allegation of non-infringement."
Gilead Sciences, Inc et al v Apotex Inc et al, 2015 FC 610.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
|
Medicine:
|
bortezomib for subcutaneous injection (VELCADE)
|
|
Applicant:
|
Janssen Inc
|
|
Respondents:
|
Actavis Pharma Company and Minister of Health
|
|
Respondent/Patentee:
|
Millennium Pharmaceuticals, Inc
|
|
Date Commenced:
|
May 7, 2015
|
|
Court File No.:
|
T-747-15
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,203,936. Actavis alleges non-infringement and invalidity.
|
|
Medicine:
|
bortezomib for intravenous injection (VELCADE)
|
|
Applicant:
|
Janssen Inc
|
|
Respondents:
|
Teva Canada Limited and Minister of Health
|
|
Respondent/Patentee:
|
Millennium Pharmaceuticals, Inc
|
|
Date Commenced:
|
May 8, 2015
|
|
Court File No.:
|
T-756-15
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,203,936. Teva alleges non-infringement (certain claims only) and invalidity.
|
|
Medicine:
|
bupropion hydrochloride (WELLBUTRIN XL)
|
|
Applicant:
|
Valeant Canada LP/Valeant Canada SEC
|
|
Respondents:
|
Actavis Pharma Company and the Minister of Health
|
|
Respondent/Patentee:
|
Valeant International Bermuda
|
|
Date Commenced:
|
May 20, 2015
|
|
Court File No.:
|
T-830-15
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,524,300. Actavis alleges non-infringement and invalidity.
|
Other proceedings
|
Medicine:
|
travoprost ophthalmic solution (TRAVATAN Z, TEVA-Travoprost Z)
|
|
Plaintiffs:
|
Alcon Canada Inc, Alcon Laboratories, Inc, Alcon Pharmaceuticals Ltd and Alcon Research, Ltd
|
|
Defendant:
|
Teva Canada Limited
|
|
Date Commenced:
|
April 27, 2015
|
|
Court File No.:
|
T-662-15
|
|
Comment:
|
Action for infringement of Patent No. 2,606,370.
|
|
Medicine:
|
glycerol phenylbutyrate (RAVICTI)
|
|
Applicant:
|
Horizon Pharma PLC
|
|
Respondents:
|
Minister of Health and the Attorney General of Canada
|
|
Date Commenced:
|
May 20, 2015
|
|
Court File No.:
|
T-823-15
|
|
Comment:
|
Application for judicial review of Minister's decision to refuse to grant data protection for RAVICTI. While the Minister had initially advised that RAVICTI was eligible for data protection, before issuance of the notice of compliance, Medunik Canada received a NOC for PHEBURANE (sodium phenylbutyrate), a generic version of Horizon's BUPHENYL (which had only been sold in Canada under the Special Access Programme), based on data for BUPHENYL. The Minister denied data protection for RAVICTI on the basis that it is "an ester variation of sodium phenylbutyrate [PHEBURANE], or an ester of phenylbutyric acid which was previously approved as its sodium salt."
|
To check the status of Federal Court cases, please click here.
|
