AIPPI 2014 – Workshop Pharma 3PATENT TERM EXTENSION IN CANADAKristin WallPartnerNorton Rose Fulbright Canada LLPSeptember 16, 2014

Docstor # 3099400

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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

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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

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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)

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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)

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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

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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

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Questions?

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Kristin WallPartnerNorton Rose Fulbright Canada LLPToronto, Canada416-216-3964kristin.wall@nortonrosefulbright.com

International

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