Recently, Canada has concluded negotiations on two international treaties whose terms will have an effect on patent rights for patentees in Canada.
The Comprehensive Economic and Trade Agreement (CETA) was negotiated between Canada and the European Union. It covers the broad trade relationship Canada has with Europe. Canada's Minister of International Trade released a joint statement with the European Commissioner for Trade, indicating that they expect CETA to be signed in 2016 and enter into force in 2017.1
The Trans-Pacific Partnership (TPP) was negotiated between Australia, Brunei Darussalam, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States, Viet Nam and Canada. Canada's Minister of International Trade has released a statement indicating that it is still too soon to endorse the TPP, but also too soon to close the door. Canada has signed the agreement. However, the Minister maintains that the text will be tabled in Parliament for debate before any final decision is made.2
CETA will change how pharmaceutical patents are dealt with in two major respects. First, a "sui generis" protection is being provided. Essentially, patent term restoration can be granted to a single, specific type of patent for a new pharmaceutical product. This restoration is to address delays faced in obtaining marketing approval. The agreement states that this will be for a maximum of 2-5 years. However, the Canadian government has indicated that 2 years will be the maximum period in Canada. Furthermore, there will be exceptions granted for generic pharmaceuticals that are exported. This restoration period will only apply to new marketing authorizations granted after it comes into force.
The second item arising from CETA is that the government is to ensure that all parties to a patent linkage system will have an equal and effective right of appeal. This specifically applies to innovators who use the Patented Medicines (Notice of Compliance) Regulations. Currently, if an innovator is unsuccessful in the proceeding brought pursuant to those Regulations, that innovator loses any right of appeal as soon as the generic company is granted its marketing authorization for a product at issue. The generic company always has a right of appeal. This marketing authorization grant can, and does often, occur shortly after the innovator loses the proceeding. However, the Canadian Government, during the CETA negotiations, promised the Canadian Generic Pharmaceutical Association that it will also address what it termed "excessive and duplicative litigation by ending the practice of dual litigation."3 Currently, for a number of reasons, including the lack of a right of appeal for innovators under the Regulations, the losing party in a case brought pursuant to the Regulations can sue for either patent infringement or to impeach the validity of the patent. This is the dual litigation the Government has promised to end. Thus, the "Right of Appeal" provision in CETA may become meaningless.
The TPP does not appear to add any new provisions specifically directed at implementing changes to the pharma and biotech industry. It contains a number of provisions with which Canada is already compliant. Furthermore, it reiterates the patent term restoration found in CETA. Of most interest, however, is the additional type of patent term restoration found within the text; this one for delays in the patent office.
In particular, the TPP indicates that if there are unreasonable delays in the issuance of patents, a means to adjust the term of the patent to compensate for that delay shall be provided to the patent owner. Unreasonable delay is defined as more than five years from the filing date or more than three years from the request for examination of the patent. However, there is an exception provided for periods of time that are not directly attributable to the granting authority and for periods of time that are attributable to the patent applicant.
The Canadian Government has not provided any indication of how long this restoration period will be. Furthermore, it has not indicated how the exceptions will be codified. However, this does give some hope to patentees who have seen their applications mired in policy changes at the office.
1 Joint statement by European Commissioner for Trade and Canada's Minister of International Trade on Canada-EU trade agreement, February 29, 2016, (http://news.gc.ca/web/article-en.do?mthd=index&crtr.page=1&nid=1036759) last accessed April 28, 2016.
2 Open Letter to Canadians on the Trans-Pacific Partnership from the Honourable Chrystia Freeland, Minister of International Trade, January 25, 2016, (http://www.international.gc.ca/trade-agreements-accords-commerciaux/agr-acc/tpp-ptp/open_letter-lettre_ouverte.aspx?lang=eng) last accessed April 28, 2016.
3 Canadian Generic Pharmaceutial Association Statement Regarding Agreement in Principle in CETA Negotiations, October 18, 2013, (http://www.canadiangenerics.ca/en/news/docs/10.18.13_CGPA_Statement_re_CETA_FINAL.pdf) last accessed April 28, 2016.
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