Anthony C. Tridico, Ph.D.

AIPLA BIOTECHNOLOGY COMMITTEE

Pinning Down a Moving Target: Patenting Biotech in Uncertain Times

Prosecution Strategies inResponse to the Biologics Price

Competition and Innovation Act BPCIA

1. Claim Scope

2. Timing

3. Numbers

Prosecution Strategies inResponse 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 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

Prosecution Strategies inResponse to the BPCIA

Identical Biosimilar? Dissimilar?(New BLA)

RP

FOBRP FOB RP FOB

Claim Scope

Try to preserve DOE?

Difficult to obtain generic claims in today’s environment.

Prosecution Strategies inResponse to the BPCIA

Timing

BLAApproved

4 Years 12 Years

Patents for your portfolio…

Cell lines, biomarkers, pharmacogenomic assays, second and subsequent indications, etc.

Ref Prod. Patents

Other patents.

Prosecution Strategies inResponse to the BPCIA

Numbers (more is better)

Patent Information Exchanges:

RP sponsor provides list of patents for whichinfringement by FOB could reasonably be

asserted

FOB applicant’s response: “detailed statement” describing on claim-by-claim basis

factual and legalbasis of opinion why patent claims are invalid, unenforceable, and would not be infringed by the

FOB

Timing Information 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”

Timing Information 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 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…

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