This question was recently considered in the Reasons for Order and Order released today in relation to HOSPIRA HEALTHCARE CORPORATION v THE MINISTER OF HEALTH AND ATTORNEY GENERAL OF CANADA (a copy of the Order can be found at http://decisions.fct-cf.gc.ca/fc-cf/decisions/en/70967/1/document.do)
Canada’s Data Protection Regime “aims to protect the data submitted in support of an application for approval to market innovative drugs containing a new chemical entity, by preventing others from using the innovator’s data in support of their own applications for drug approval. When a drug is placed on the Register of Innovative Drugs, the Minister is precluded from receiving from another manufacturer an application for a Notice of Compliance entitling it to market that drug in Canada for a period of six years, where that application is based on or refers to the data provided by the innovator. The Minister may not, either, issue an NOC for such an application for a further period of two years.” (see paragraph [3]).
Sanofi-Aventis Canada Inc.’s drug Eloxatin (which contains the active ingredient oxaliplatin) was found to be an innovative drug in accordance with Canada’s Data Protection Regime and was listed on the Register of Innovative Drugs (the “Register”) on June 15, 2007.
Prior to oxaliplatin’s listing on the Register, Hospira filed a New Drug Submission (NDS) for a drug containing “Chemical Entity A” that was reasonably assumed to be oxaliplatin. During examination of the NDS, Hospira responding to a request for additional information by the Minister of Health “made reference to the product monograph for Eloxatin. The Minister considered that Hospira had thereby made “direct or indirect comparison” between its drug and Eloxatin, and advised Hospira that, pursuant to section C.08.004.1, it would not issue Hospira’s NOC for the drug until the expiration of the data protection period, even though Hospira’s ANDS was otherwise approvable.” (see paragraph [5] of order].
Hospira sought a judicial review of this decision stating that (1) “the data protection provisions do not apply to its NDS because it was filed before Eloxatin was entered on the Register” and (2) “it did not directly or indirectly compare its product to Eloxatin, that if it did, the reference did not appear in its initial NDS and that post-filing amendments are excluded from the scope of the relevant section, and that the reference was mandated by the Minister without due notice that it would be deemed to trigger the application of data protection” (see paragraph [6]).
Sanofi was not named or served the notice of application for judicial review by Hospira. Sanofi argued “that it is a person directly affected by the order sought by Hospira in this judicial review application, and that as such, Hospira ought to have, and should be ordered to, name it as a party respondent”. Madam Prothonotary Tabib agreed with Sanofi and found that “it is clear that an order reversing the Minister’s determination that the data protection regime was engaged and ordering the issuance of an NOC to Hospira would prejudicially affect Sanofi in a direct way, and not merely because it would suffer economic or competitive prejudice” and order Hospira to amend its Notice of Application to add Sanofi.
Claire Palmer, Ph.D.
Tuesday, April 15, 2014
Members of the Congress of the United States Express Concern Regarding Canada’s “Lack of Adequate and Effective Intellectual Property Rights”
Last week, members of the Congress of the United States wrote the United States Trade Representative “to express [their] strong concerns about lack of adequate and effective intellectual property (IP) rights in Canada.” This group further states “we believe that Canadian courts have significantly weakened patent standards through a unique misinterpretation of the international accepted utility standard, directly harming the competitiveness and economic growth of U.S. innovators.” This group requested elevation of Canada to the Intellectual Property Priority Watch List.
See http://freepdfhosting.com/06e4637b68.pdf
Kay Palmer, Ph.D.
See http://freepdfhosting.com/06e4637b68.pdf
Kay Palmer, Ph.D.
Thursday, April 10, 2014
LANGUAGE POLITICS AND FRENCH SIGN WARS IN QUEBEC - REVISITED QUEBEC COURT CONFIRMS FRENCH LANGUAGE WATCHDOG CANNOT BITE ENGLISH TRADEMARKS
LANGUAGE POLITICS AND FRENCH SIGN WARS IN QUEBEC - REVISITED
QUEBEC COURT CONFIRMS FRENCH LANGUAGE WATCHDOG CANNOT BITE ENGLISH TRADEMARKS
By Scott Miller, April 10, 2014
On April 9, 2014, the Superior Court in Quebec in Best Buy Stores Ltd. et al v. Quebec (Attorney General) (2014) QCCS 1427, confirmed that the Quebec language watchdog, the Office Québécois de la langue française (OQFL) attempt to cause retailers to modify their brand names to include French signage was contrary to the existing language laws of Quebec.
This case is a huge victory for all businesses that wish to maintain brand recognition by using English trademarks in Quebec (ie. Best Buy, The Gap, Costco, Toys R Us, Wal-mart) and not be forced to translate them into French.
Section 58 of the Charter of the French Language (French Charter), reads, "public signs and posters and commercial advertising must be in French". However, there are exceptions in the French Charter Regulations (sections 7(4) and 25(4)) which permit English only packaging and signage for "a recognized trade mark within the meaning of the Trade Marks Act, unless a French version has been registered".
Justice Michel Yergeau refused the OQFL argument that retailers should use French signage because section 63 of the French Charter reads, "The name of an enterprise must be in French". The Court was not persuaded by political arguments and recognized that for the last 37 years the French Charter has kept a balance of encouraging French language rights with the need to encourage multinational companies to carry on business in Quebec. Simply put, the use of the signage in issue was recognized as trademarks and not as business (trade) names.
This case may be appealed but the political tide is changing in Quebec. The minority Parti Québécois government elected in September 2012 was defeated in a landslide election on April 7, 2014 with a new majority Liberal Government being put in place. The likelihood of the French language being used to divide the people of Quebec over the next 4 years is doubtful.
The Federal Trade-Marks Act 'recognizes' both common law (unregistered) and registered trademarks. Nonetheless, it still remains an open question whether the OQFL will recognize unregistered trademarks or argue such marks are actually trade names not subject to the English use exception. As a precautionary measure, it may still be advisable to file for English trademarks to avoid the OQFL. If threatened about the legitimacy of whether an English word is a recognized trademark, it is answerable by noting that the English word is the subject of a pending trademark application.
For more information please contact Scott Miller or Jahangir Valiani.
Scott Miller, Partner
E: smiller@mbm.com