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Anthony C. Tridico, Ph.D.

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. Claim Scope Timing Numbers.

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Anthony C. Tridico, Ph.D.

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

  2. Prosecution Strategies inResponse to the Biologics Price Competition and Innovation Act BPCIA Claim Scope Timing Numbers

  3. Prosecution Strategies inResponse to the BPCIA Follow-on Biologics (FOB) get to market under BPCIA if: • >12 years from approval of BLA on Reference Product [“RP”] • FOB is “biosimilar” or “interchangeable” with RP; and • No infringement of a valid and enforceable claim (at risk launch can occur). Preliminary injunctions?

  4. Prosecution Strategies inResponse 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

  5. Prosecution Strategies inResponse to the BPCIA Claim Scope RP RP FOB RP FOB FOB Identical Biosimilar? Dissimilar? (New BLA) Try to preserve DOE? Difficult to obtain generic claims in today’s environment.

  6. Prosecution Strategies inResponse 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.

  7. Prosecution Strategies inResponse 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

  8. Patent Information Exchange – No “Orange Book”

  9. Patent Information Exchange (cont’d)

  10. Preparing a Follow-On BiologicPreparation 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…

  11. 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)

  12. 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.

  13. GOAL No surprises at the patent information exchange!

  14. Thanks to our Sponsors!! Bird & Bird LLP Engel & Novitt, LLP Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

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