The provisional application of CETA takes effect in Canada today, ushering in a new era for pharmaceutical patent litigation. As part of this implementation, amendments to the Patent Act, the Patent Rules and the PM(NOC) Regulations, as well as the new Certificates of Supplemental Protection (CSP) Regulations, came into force today. See our previous posts on the new PM(NOC) Regulations and CSP Regulations for key details about these new schemes.
As a part of its obligations under CETA, Canada plans to introduce patent term restoration for up to two years when research or regulatory delays have consumed part of the 20-year term of a pharmaceutical patent. Patent term restoration will occur via the grant of a so-called certificate of supplementary protection (“CSP”).
On July 15, 2017, the government of Canada published its proposed Certificate of Supplementary Protection Regulations (“CSP Regulations”) which, in conjunction with amendments to the Patent Act, will create the framework for the issuance of CSPs which will be administered by Canada’s Minister … Continue Reading
On July 15, 2017, the Canadian government published (link) its proposed amendments to the NOC Regulations. These amendments will implement sweeping changes to pharmaceutical patent litigation in Canada pursuant to obligations imposed under CETA. There will be a 15-day comment period, after which, the amendments will be published in final form. The finalized amendments are expected to be in force around late September 2017. These revamped NOC Regulations will apply to Notices of Allegation (“NOAs”) served on or after the date the revamped NOC Regulations come into force.
Overall, the revamped NOC Regulations… Continue Reading
Canada’s latest trade deal is set to expand the protection of geographical indications to a wide array of agricultural products.
On October 30, 2016, Canada and the European Union signed the Comprehensive Economic and Trade Agreement (“CETA”). A day later, the Government of Canada tabled Bill C-30 (the “Bill”) for the purpose of implementing CETA into the country’s legislative landscape. One of the primary operative effects of CETA, as a trade agreement, is that it will eliminate 95% of all existing tariffs applied to goods traded between the two jurisdictions. Apart from the direct economic impact … Continue Reading
Changes are coming swiftly, as the federal government moves to implement the Comprehensive Economic and Trade Agreement (“CETA”) just days after it was signed by Prime Minister Trudeau in Brussels at the end of October 2016.
These changes will significantly impact biologic/pharma patents in two major ways. First, they will implement, for the first time, a Canadianized version of patent-term restoration. Second, they will revamp the current framework for linkage between patents and the approval of biosimilar/generic drugs in Canada by giving innovators the right of appeal, by changing the nature of the PM(NOC) proceedings to a more U.S.-style approach, … Continue Reading
Business Capabilities Sourcing
Edward Smythe opened the panel with an interesting discussion on the increasing integration of IT outsourcing (ITO) services and business process outsourcing (BPO), which have traditionally been distinct offerings. He explained that the combination of ITO and BPO would form into either:
- a business capability outsourcing service, where the vendor is in charge of supporting