Anthony C. Tridico, Ph.D. AIPLA BIOTECHNOLOGY COMMITTEE Pinning Down a Moving Target: Patenting Biotech in Uncertain Times

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 IdenticalBiosimilar?Dissimilar? (New BLA) RP FOB RPFOBRPFOB Claim Scope Try to preserve DOE? Difficult to obtain generic claims in today’s environment.

Prosecution Strategies in Response to the BPCIA Timing BLA Approved 4 Years12 Years Patents for your portfolio… Cell lines, biomarkers, pharmacogenomic assays, second and subsequent indications, etc. Ref Prod. Patents Other patents.

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

TimingInformation Exchanged w/n 20 days after receiving notice from FDA that FOB application is accepted for review FOB applicant → reference product sponsor: Copy of FOB application Info describing manufacture of FOB w/n next 60 days 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 “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 – No “Orange Book”

TimingInformation Exchanged w/n next 60 days 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 “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” w/n next 60 days Reference product sponsor → FOB applicant: “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” Patent Information Exchange (cont’d)

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!

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