AIPLA
BIOTECHNOLOGY COMMITTEE
Pinning Down a Moving Target: Patenting
Biotech in Uncertain Times
Anthony C. Tridico, Ph.D.
Prosecution Strategies in
Response to the Biologics Price
Competition and Innovation Act BPCIA
1. Claim Scope
2. Timing
3. Numbers
Prosecution Strategies in
Response to the BPCIA
Follow-on Biologics (FOB) get to market under BPCIA if:
1. >12 years from approval of BLA on Reference
Product [“RP”]
2. FOB is “biosimilar” or “interchangeable” with RP;
and
3. No infringement of a valid and enforceable claim
(at risk launch can occur).
Preliminary injunctions?
Prosecution Strategies in
Response to the BPCIA
Claim Scope
FOB applicant wants to design around the claims, but
in doing so not end up with a molecule that is so
changed that it is no longer “biosimilar”
Innovator: prevent design around by claiming the
“biosimilar” landscape
Prosecution Strategies in
Response to the BPCIA
Claim Scope
RP
FOB
Identical
RP
FOB
Biosimilar?
RP
FOB
Dissimilar?
(New BLA)
Try to preserve DOE?
Difficult to obtain generic claims in today’s environment.
Prosecution Strategies in
Response to the BPCIA
Timing
BLA
Approved
4 Years
12 Years
Ref Prod. Patents
Other
patents.
Patents for your portfolio…
Cell lines, biomarkers, pharmacogenomic assays, second and
subsequent indications, etc.
Prosecution Strategies in
Response to the BPCIA
Numbers (more is better)
Patent Information Exchanges:
RP sponsor provides list of patents for which
infringement by FOB could reasonably be asserted
FOB applicant’s response: “detailed statement”
describing on claim-by-claim basis factual and legal
basis of opinion why patent claims are invalid,
unenforceable, and would not be infringed by the FOB
Patent Information Exchange – No “Orange Book”
Timing
Information Exchanged
w/n 20 days
FOB applicant → reference product sponsor:
after receiving notice from FDA
that FOB application is accepted
for review
• Copy of FOB application
• Info describing manufacture of FOB
Reference product sponsor → FOB applicant:
• “a list of patents for which the reference product sponsor
believes a claim of patent infringement could reasonably be
asserted” and
w/n next 60 days
• “identification of the patents . . . that the reference product
sponsor would be prepared to license to the” FOB applicant
• Ongoing duty to supplement lists
• Failure to identify a patent – may not sue on patent
Patent Information Exchange (cont’d)
Timing
Information Exchanged
FOB applicant → reference product sponsor:
• “a detailed statement that describes, on a claim by claim basis, the factual and legal
basis of the opinion . . . that [each listed] . . . patent is invalid, unenforceable, or will
not be infringed” by the FOB; or
w/n next 60 days
• “a statement that the . . . [FOB] applicant does not intend to begin commercial
marketing of the biological product before the date that such patent expires;” and
• a response regarding any licensing offer
• optionally, “a list of patents for which the . . . [FOB] applicant believes a claim of patent
infringement could reasonably be asserted”
Reference product sponsor → FOB applicant:
w/n next 60 days
• “a detailed statement that describes . . . on a claim by claim basis, the factual and legal
basis of the opinion . . that [each listed] patent will be infringed” by the FOB; and
• “a response to the statement concerning validity and enforceability”
Preparing a Follow-On Biologic
Preparation for Patent Information Exchange
 FTO Search: Identify potentially relevant patents/applications
(not just reference product sponsor)
– Emphasis on patents and patent applications relating to key
elements
 Biosimilar application must be for:
– Same indication or condition of use
– Same route of administration, dosage form, and strength as
reference product
 FTO must consider
– Compositions
– Methods of use
– Methods of making
– Formulations
– Dosage forms, administration…
Strategic Options to Consider
 Patent life and launch date
 Design around and cost analysis (e.g.: cost to license
alternative technology)
 Prepare defenses for litigation
– Basis for opinions at patent information exchange
 Proactive measures
– Patentee’s enforcement history (i.e. license, litigate, etc.)
– Options for third party attack
• Opposition in future??
• Interference
• Third party submission (37 CFR 1.99)
For the Reference Product Sponsor….
 Conduct your own due diligence
–
–
–
–
(Be Prepared!)
How to establish infringement
Understand weaknesses in portfolio
Prepare for attacks (reexam/reissue)
Any new IP to in-license ?
• Additional protection of reference
product.
• Block possible FOB applicant from
accessing technology.
GOAL
No surprises at the patent information exchange!
Thanks to our Sponsors!!
Bird & Bird LLP
Engel & Novitt, LLP
Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP