1. Subsequent Entry Biologics: IP Issues
Presentation by Adrienne Blanchard
October 11, 2012

2. Outline
Background to Guidance development
PM(NOC) Regulations and implications
Data Protection Regulations and implications
Where are we headed

3. Background re: Guidance Development
Guidance For Sponsor: Information and Submission Requirements for SEBs
IP is a critical component of the scheme
NOC Regulations: require NOA if direct or indirect comparison to product on Patent Register
Data Protection Regulations: require protection from competitors who compare to an “innovative drug”
First proposal to amend IP Guidances was 2010 3

4. Guidance re: NOC Regulations
If filing under the SEB pathway, that is a reference/direct or indirect comparison, as follows:
“New drug submissions submitted in accordance with the SEB Guidance that demonstrate similarity with a biologic drug marketed in Canada, and in respect of which there are patents listed on the Patent Register, are considered to make a comparison or reference within the meaning of section 5. Sponsors of such submissions will be required to fulfill the requirements for second persons under the PM(NOC) Regulations.” 4

5. Guidance re: NOC Regulations
When first SEB approved (OMNITROPE in 2009), no patent litigation
One NOC Regulations patent case commenced (involving Teva’s filgrastim) on May , 2012
Two years to litigate under NOC Regulations 5

6. Data Protection Guidance
Data protection rules
- Applies where a direct/indirect comparison to an “innovative drug” (medicinal ingredient never before approved in Canada)
- 8 years protection from date of innovative drug approval
- 6 years “no-filing”
Health Canada’s position: if SEB pathway, must respect the Data Protection Regulations.

7. Data Protection Guidance
“As described in the SEB Guidance, approval of an SEB is sought by filing a new drug submission in which the sponsor seeks to reduce the clinical and non-clinical study requirements by demonstrating similarity to a previously approved reference biologic drug … A submission as set out in the SEB Guidance containing a demonstration of similarity to a reference biologic drug will be considered to make a comparison within the meaning of subsection C (3). Such submissions will not be accepted for filing within the six-year period from the date of issuance of the NOC for the reference biologic drug.”

8. - No patent register U.S. Comparison
12 years of data protection/exclusivity
Non-Hatch Waxman system of patent disputes
- No patent register
- Exchange of patent information – all relevant patents
- No automatic stay

9. Intellectual Property: Outstanding Questions
Under NOC Regulations
- should broader range of patents be protected (no pure process patents under NOC Regulations)
- is the U.S. – style system preferable – or another model
- is a 2 year period for litigation reasonable
Under Data Protection Regulations
- what is a “medicinal ingredient” for a biologic
- what is the appropriate period of protection (12 years in the U.S.)

10. Possible Regulatory Amendments
Health Canada consulting on changing the Food and Drug Regulations
NOC Regulations will need to be amended to reflect new language
U.S. style system for biologics may be one option; others could be developed
Potential changes to data protection, possibly as a result of the Comprehensive Economic Trade Agreement (CETA)

11. Where are we headed?
Health Canada appears to be applying IP rules as proposed
As the U.S. biosimilars system develops, may see more SEBs in Canada too
Options on amendments to IP protections for innovative biologics will likely be considered in the context of regulatory modernization – a longer term process
CETA may also bring an opportunity for regulatory changes

12. THANK YOU Adrienne M. Blanchard Tel: 514.847.4750