What will be the effect of the Comprehensive Economic and Trade Agreement (CETA) between Canada and EU should it be ratified
CETA has two provisions concerning with availability and procurements of patents or patent-like (sui generis) protection. [Footnote: The consolidated CETA text is downloadable at http://goo.gl/cM4BE7, chapter “22. INTELLECTUAL PROPERTY” can be downloaded from our website here].
Article 9.1 – International Agreements
“The Parties shall make all reasonable efforts to comply with the Patent Law Treaty (Geneva, 2000).”
Article 9.2 – Sui Generis protection for Pharmaceuticals
“shall provide a period of sui generis protection in respect of a product that is protected by a basic patent … equal to the period which elapsed between the date on which the application for a patent was filed and the date of the first authorisation to place the product on the market of that Party as a pharmaceutical product reduced by a period of five years. .. the sui generis protection shall confer the same rights as conferred by the patent and shall be subject to the same limitations and obligations.”
At the EPO: The European Patent Organization, being an international organization independent of the European Union [Footnote: The European Patent Organization (EPOr) was established by the European Patent Convention (EPC) a treaty between certain european States. There is no link between the EPO and the EU. Not all Contracting States to the EPC are member of the EU; however, all EU members are Contracting States to the EPC and any new EU member will be required by to become a Contracting State to the EPC.] is not a party to the CETA, and therefore, is not bound by the CETA. However, Article 63(2)(b) of the EPC explicitly authorizes Contracting States to the EPC, “to extend the term of a European patent, or to grant corresponding protection which follows immediately on expiry of the term of the patent, under the same conditions as those applying to national patents … if the subject-matter of the European patent is a product or a process for manufacturing a product or a use of a product which has to undergo an administrative authorisation procedure required by law before it can be put on the market in that State.” And indeed, legislation in the form of the Supplementary protection certificate for medicinal products and Supplementary protection certificate for plant protection products already exists in the EU. [EU Regulation 1768/92 and 1610/96, respectively] and The Supplementary protection certificate offers the protection required by the CETA. [Footnote: Factsheet, http://goo.gl/WpZ1bK (“The EU wants to raise the level of protection and enforcement of intellectual property rights for its products in Canada to a comparable level to that of the EU. The EU is not aiming to go beyond rules that are already applied in the EU and in its Member States.”)] Consequently, such sui generis protection for pharmaceuticals is available in respect of a product that is protected by a european patent. However, applications for such protection must be filed and approved on a country-by-country basis at each Contracting State to the EPC that is also a member of the EU.
The European Patent Organization has revised the European Patent Convention in view of the Patent Law Treaty and the new European Patent Convention 2000 does comply with the Patent Law Treaty.
At the USPTO: None, the US also not being party to CETA. However, CETA may have model character for the current negotiation on a Transatlantic Trade and Investment Partnership (TTIP), establishing a transatlantic free trade area between the European Union and United States, or for other trade related agreements. The Hatch-Waxman Act introduced similar provisions to the sui generis protection for pharmaceuticals required by CETA which, subject to various exceptions and exemptions, extends the term of a patent by the time equal to the regulatory review period for the approved product that arose after the date the patent was issued. [35 U.S.156] The application for extension of patent term is to be filed at the USPTO. [35 U.S.C. 156(d)(1), see also MPEP 2750] Since both the US and EU already have sui generis protection for pharmaceuticals finalization of the TTIP will have to be awaited to see whether it would require changes to the sui generis protection in either US or EU.
The current laws and procedures as applied by the USPTO have been revised in view of the Patent Law Treaty and can be assumed to be in compliance.
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