AIPPI 2014 – Workshop Pharma 3PATENT TERM EXTENSION IN CANADAKristin WallPartnerNorton Rose Fulbright Canada LLPSeptember 16, 2014
Docstor # 3099400
2
OVERVIEW
I. Introduction – The Pharmaceutical Exclusivity Regime in Canada
II. Background – CETA
III. Patent Term Extension Proposed in Canada
IV. Timeline for Implementation
I. The Pharmaceutical Exclusivity Regime in Canada
PHARMA PATENT/
PRODUCT
PM(NOC) Regulations
Data Protection
Patent Act
Patent Term Extension
3
4
II. Background – Comprehensive Economic and Trade Agreement (CETA)
3 pharmaceutical IP reforms were on the table:
1. Provide patentees with an effective right of appeal in PM(NOC) Proceedings
2. Extend the term and scope of data protection3. Implement patent term extension
5
II. Background – Comprehensive Economic and Trade Agreement (CETA) cont.
What pharmaceutical IP reforms appear likely?
CETA Agreement-in-Principle (released October 2013)
1. Effective innovator right of appeal in PM(NOC) Proceedings
2. “End the practice of dual litigation”3. Patent term extension (capped at 2 years)
6
III. Patent Term Extension
Official Source: CETA Agreement-in-Principle
Limited to eligible patents
Period of protection calculated by reference to the patent application filing date and product approval date (i.e., Notice of Compliance)
Period of protection capped at 2 years
Canadian-made generic export exceptions
No retroactivity
CGPA is disappointed by the inclusion of a patent
term extension in CETA, but welcomes the
Government of Canada’s commitment to cap the
maximum length of extension at two years and
include other essential safeguards.
CETA also sets an international precedent as the
first trade agreement that permits an exception
under the period of patent extension for the
production and other activities related to the
export of generic medicines.
Canadian Generic Pharmaceutical Association Statement Regarding CETA Agreement-in-Principle (October 18, 2013)
Patent Term Restoration will offer research-based
pharmaceutical companies the potential to
recover up to two years of time lost on their
patent as a result of lengthy regulatory and
government approval processes. Canada is the
only G7 nation that does not provide any form of
patent term restoration.
Canada’s Research-Based Pharmaceutical Companies Regarding CETA Agreement-in-Principle (October 18, 2013)
9
III. Patent Term Extension cont.
***Unofficial Source: DRAFT Agreement Text
August 2014 – Final text is announced, but not released to the public.
Definition of “Product”
Definition of “Basic Patent”
Time limits for application
Formula for calculating the period of exclusivity
Export exception
10
IV. Timeline - Patent Term Extension
EU-Canada Summit
(commitment)
2007
EU-Canada Summit
(joint study)
2008
EU-Canada Summit (launch of negotiations)
May 6, 2009
Agreement-in-Principle
Oct 18, 2013
Full-text completed
Aug 5, 2014
Ratification and
implementation?
2015/2016
Scoping Report
March 2009
Final legal review,
translation
CETA Timeline
11
Questions?
DisclaimerNorton Rose Fulbright LLP, Norton Rose Fulbright Australia, Norton Rose Fulbright Canada LLP, Norton Rose Fulbright South Africa (incorporated as Deneys Reitz Inc) and Fulbright & Jaworski LLP, each of which is a separate legal entity, are members (“the Norton Rose Fulbright members”) of Norton Rose Fulbright Verein, a Swiss Verein. Norton Rose Fulbright Verein helps coordinate the activities of the Norton Rose Fulbright members but does not itself provide legal services to clients.
References to “Norton Rose Fulbright”, “the law firm”, and “legal practice” are to one or more of the Norton Rose Fulbright members or to one of their respective affiliates (together “Norton Rose Fulbright entity/entities”). No individual who is a member, partner, shareholder, director, employee or consultant of, in or to any Norton Rose Fulbright entity (whether or not such individual is described as a “partner”) accepts or assumes responsibility, or has any liability, to any person in respect of this communication. Any reference to a partner or director is to a member, employee or consultant with equivalent standing and qualifications of the relevant Norton Rose Fulbright entity.
The purpose of this communication is to provide information as to developments in the law. It does not contain a full analysis of the law nor does it constitute an opinion of any Norton Rose Fulbright entity on the points of law discussed. You must take specific legal advice on any particular matter which concerns you. If you require any advice or further information, please speak to your usual contact at Norton Rose Fulbright.
Kristin WallPartnerNorton Rose Fulbright Canada LLPToronto, [email protected]