RX IP Update - January 2017

by Smart & Biggar
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Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld

As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the validity of AstraZeneca’s Patent No. 1,292,693. The patent covered AstraZeneca’s successful product, LOSEC, for inhibiting gastric acid secretion and treating gastrointestinal diseases such as stomach ulcer.


Supreme Court of Canada News

SCC denies Teva leave to appeal venlafaxine section 8 hearsay decision. As previously reported, Teva filed leave to appeal a decision of the Federal Court of Appeal (reported here) setting aside the Federal Court’s award of damages under section 8 of the PMNOC Regulations to Teva for its venlafaxine hydrochloride product (Pfizer’s Effexor XR). The Federal Court of Appeal found that the Federal Court had improperly admitted and relied on hearsay evidence. The matter was remitted to the Federal Court for redetermination, excluding that evidence. On January 19, 2017, the Supreme Court dismissed Teva’s application for leave to appeal (docket no. 37162).

Apotex seeks leave on obviousness-type double-patenting decision. As previously reported, on November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA 267 and upheld the Federal Court’s Order of prohibition for tadalafil (Eli Lilly’s CIALIS). In doing so, the Federal Court of Appeal did not depart from its decision in Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc, 2016 FCA 119 (reported here), holding that the relevant date for obviousness-type double-patenting is an open question. On December 28, 2016, Apotex applied to the Supreme Court for leave to appeal (docket no. 37368).


CETA Implementation Act completes second reading

As previously reported, on October 31, 2016, the day following the signing of CETA (see our article here), Bill C-30, An Act to implement the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union and its Member States and to provide for certain other measures, was tabled in Parliament. On December 13, 2016, Bill C-30 completed second reading and was referred to the Standing Committee on International Trade for consideration. Bill C-30 includes provisions for restoration of patent term to account for marketing delays resulting from the time required to obtain regulatory approval in the form of supplementary protection certificates.


CIPO: Revisions to antibody sections of Manual of Patent Office Practice

On January 9, 2017, the Canadian Intellectual Property Office (CIPO) announced that it has revised sections 17.07 and 17.08 concerning antibodies in chapter 17 of the Manual of Patent Office Practice. A list of the changes is available online.


PMPRB finds it has jurisdiction over Galderma’s DIFFERIN

On December 21, 2016 (see announcement here), the Patented Medicine Prices Review Board (PMPRB) issued its Reasons relating to allegations that Galderma failed to report pricing and sales information in relation to its acne medicines DIFFERIN and DIFFERIN XP. Although the Hearing Panel dismissed the application with respect to two of the three patents at issue, it found the third patent pertained to DIFFERIN and therefore ordered Galderma to provide the PMPRB with pricing and sales information regarding DIFFERIN. Galderma has sought judicial review.


Competition Bureau approves Abbott’s acquisition of St Jude Medical

On December 28, 2016, the Competition Bureau announced the signing of a consent agreement with Abbott Laboratories related to its proposed US$25 billion acquisition of St. Jude Medical. The Board found that the majority of medical devices offered in Canada by Abbott and St. Jude are largely complementary. Abbott and St. Jude are, however, the largest suppliers in Canada of vessel closure devices (VCDs). Under the terms of the consent agreement, St. Jude’s VCDs business will be sold to Terumo Corp. The Bureau cooperated with the U.S. Federal Trade Commission to reach a coordinated resolution in both jurisdictions.


CIHI releases reports on Canada’s health and prescribed drug spending

On December 15, 2016, the Canadian Institute for Health Information (CIHI) announced the release of its reports, National Health Expenditure Trends, 1975 to 2016 and Prescribed Drug Spending in Canada, 2016.


Court Decisions

Application regarding Pharmascience’s zolpidem tartrate dismissed. On December 9, 2016, the Federal Court dismissed Valeant and Meda’s PMNOC proceeding regarding Pharmascience (PMS)’s zolpidem tartrate tablets (Valeant/Meda’s SUBLINOX) and Patent No. 2,629,988. Justice Manson held that PMS’s allegation of non-infringement was justified and its allegation of invalidity on the basis of overbreadth was justified only with respect to claim 1. PMS’s remaining allegations of invalidity (anticipation, obviousness, and utility) were not justified: Meda AB v Canada (Health), 2016 FC 1362. Justice Manson found that claim 1 was overbroad as the positioning of the bio/mucoadhesion agent is an essential feature of the invention and while this limitation was present in claim 2 and all subsequent claims, it was not a limitation in claim 1.

Court grants Order prohibiting issuance of notice of compliance for Actavis’s methylphenidate. On January 9, 2017, the Federal Court granted Janssen’s application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Actavis for its methylphenidate product (Janssen’s CONCERTA): Janssen Inc v Actavis Pharma, Canada (Health), 2016 FC 1361. Janssen had previously been unsuccessful on the same patent, 2,264,852, when the Court had found that Novopharm’s allegations of non-infringement were justified (Janssen-Ortho Inc v Canada (Health), 2010 FC 42; previously reported here). In the present case, Justice O’Reilly followed the prior Court’s construction of the claims, but found that Janssen established that most tablets tested showed the release methylphenidate at a sustained-ascending rate for the claimed period of time. Justice O’Reilly also held that Actavis’s allegations of obviousness, lack of soundly predicted or demonstrated utility, overbreadth and inutility were unjustified.


PMNOC proceedings

Medicine:

bupropion hydrochloride (WELLBUTRIN XL)

Applicants:

Valeant Canada LP/ Valeant Canada SEC

Respondent/Patentee:

Valeant Pharmaceuticals Luxembourg SARL

Respondents:

Ranbaxy Pharmaceuticals Canada Inc. and the Minister of Health

Date Commenced:

December 22, 2016

Court File No.:

T-2224-16

Comment:

Application for Order of prohibition until expiry of Patent No. 2,524,300. Ranbaxy alleges non-infringement.

Other Proceedings

Medicine:

ciclesonide (OMNARIS)

Plaintiff:

Apotex Inc

Defendant:

Takeda Canada Inc

Date Commenced:

December 14, 2016

Court File No.:

T-2159-16

Comment:

Action seeking damages pursuant to section 8 of the PMNOC Regulations based on the dismissal of Takeda’s prohibition application in Court File No. T-772-13 (2015 FC 570).

Medicines:

Apo-Sitagliptin and Apo-Varenicline

Applicant:

Apotex Inc

Respondents:

Minister of Health and Attorney General of Canada

Date Commenced:

December 20, 2016

Court File No.:

T-2200-16

Comment:

Application for Order to quash a decision by the Minister of Health to continue prohibition on granting NOCs for products manufactured by Apotex Research Private Limited or having API sourced from Apotex Pharmachem India Private Limited unless Apotex provided data integrity packages.

Medicine:

adapalene (DIFFERIN)

Applicant:

Galderma Canada Inc

Respondents:

Patented Medicine Prices Review Board and Attorney General of Canada

Date Commenced:

January 18, 2017

Court File No.:

T-83-17

Comment:

Application for judicial review of the PMPRB’s finding that the Board had jurisdiction over DIFFERIN as a result of Patent No. 2,478,237. See Decision above.

To check the status of Federal Court cases, please click here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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