Free to sell your biosimilar? The effect of the new FDA rules

1. © 2012, All rights reserved

2. Dr. D’vorah
About the Speaker –
Graeser
Founder & Partner Founder & CEO
IP consulting and business development, including
preparing and filing patent applications
PhD in Pharmacology, 4 years with the Human Genome
Project (post-docs)
Previously Vice President (Intellectual Property) of
Compugen (March 2004 – March 2006)

3. DISCLAIMER
Nothing in this presentation or in any
material provided, whether verbally or in
writing, constitutes legal or patent advice

4. Introduction

5. Free to Sell Your Biosimilar?
FTO (freedom to operate) –
submarine patents and process
patents
FTO – FDA process
Trade secrets

6. FTO- submarine/process
patents

7. What is FTO?
Freedom to operate – ability to make, sell,
use, export, import etc a product
Even if you have a patent, you may not have
FTO
FTO may be blocked by a single patent
or multiple patents
Enbrel- example of submarine patent
Process patents may expire later in US

8. Submarine patents
Last Enbrel patent issued in 2011
Not publicly available before that time
Delayed in patent process
Valid until 2018
No more submarines?
Law changed in 1995

9. Process patents – 271(e)(1)
Safe harbor – may infringe patent in
process of preparing submission to FDA
Only for approval - Classen v. Biogen IDEC
Also for post-approval activities - Momenta
Pharms. v. Amphastar Pharms
May go to US Supreme Court
Example – process patents covering
analytical methods

10. FTO – FDA process

11. Patents and FDA process
Originator provides list of relevant patents
that may be infringed by biosimilar applicant
No Orange Book
Applicant - patents invalid or not
infringed
Originator provides counter-arguments
Applicant notifies originator 180 days
before marketing

12. Trade secrets

13. What are trade secrets?
Commercially valuable information that a
company protects through secrecy
Example – Coca-Cola® formulation
Example – manufacturing process for a
biological drug
Analytical tests, purification process, etc
Patents vs trade secrets

14. Manufacturing Processes
and FDA – trade secrets I
Biosimilar applicant may include any
publicly available information
 Relevant law – section 351(k) of the PHS
FDA stated that public information
includes documents from BLA action
package (key documents)
But under FOIA, additional information
may be released

15. Manufacturing Processes
and FDA – trade secrets II
Biosimilar applicant’s trade secrets may be
released to originator through application
 Relevant law – BPCIA
 Biosimilar applicant must give copy of application to
originator within 20 days of notification of acceptance
by FDA
Applicant must state why patents are not
infringed or are invalid
Including manufacturing process patents

16. Conclusions

17. Conclusions
Current FDA process is unsettled
Effect of process patents unclear
Trade secret protection uncertain
Beware of submarines!

18. Looking forward to speaking
with you!
Feel free to contact us:
Graeser Associates International Inc
70 West Madison, Suite 1400, Chicago, IL
Tel: 312-214-3775
E-mail: dgraeser@gai-ip.com
Website: <http://www.gai-ip.com/>