Free to sell your biosimilar?
18
© 2012, All rights reserved
-
Upload
biosimilars -
Category
Documents
-
view
140 -
download
0
description
Free to sell your biosimilar? The effect of the new FDA rules
Transcript of Free to sell your biosimilar?
© 2012, All rights reserved
About the Speaker –
PhD in Pharmacology, 4 years with the Human Genome Project (post-docs)
Previously Vice President (Intellectual Property) of Compugen (March 2004 – March 2006)
Dr. D’vorah Graeser
Founder & Partner Founder & CEO
IP consulting and business development, including preparing and filing patent
applications
DISCLAIMER
Nothing in this presentation or in any material provided, whether verbally or in writing, constitutes legal or patent advice
Introduction
Free to Sell Your Biosimilar?FTO (freedom to operate) –
submarine patents and process patents
FTO – FDA processTrade secrets
FTO- submarine/process patents
What is FTO?Freedom to operate – ability to make, sell,
use, export, import etc a productEven 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 patentProcess patents may expire later in US
Submarine patentsLast Enbrel patent issued in 2011
Not publicly available before that timeDelayed in patent processValid until 2018
No more submarines?Law changed in 1995
Process patents – 271(e)(1)Safe harbor – may infringe patent in
process of preparing submission to FDAOnly for approval - Classen v. Biogen IDECAlso for post-approval activities - Momenta
Pharms. v. Amphastar Pharms
May go to US Supreme CourtExample – process patents covering
analytical methods
FTO – FDA process
Patents and FDA processOriginator provides list of relevant patents
that may be infringed by biosimilar applicantNo Orange Book
Applicant - patents invalid or not infringed
Originator provides counter-argumentsApplicant notifies originator 180 days
before marketing
Trade secrets
What are trade secrets?Commercially valuable information that a
company protects through secrecyExample – Coca-Cola® formulation
Example – manufacturing process for a biological drugAnalytical tests, purification process, etc
Patents vs trade secrets
Manufacturing Processes and FDA – trade secrets I
Biosimilar applicant may include any publicly available informationRelevant 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
Manufacturing Processes and FDA – trade secrets II
Biosimilar applicant’s trade secrets may be released to originator through applicationRelevant law – BPCIABiosimilar 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 invalidIncluding manufacturing process patents
Conclusions
ConclusionsCurrent FDA process is unsettled
Effect of process patents unclear
Trade secret protection uncertain
Beware of submarines!
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: [email protected]
Website: <http://www.gai-ip.com/>
