claire laporte, "health ip"

Life Sciences IP2017 … and 2018 in Preview

Claire LaporteDecember 12, 2017

© 2017 Foley Hoag LLP. All Rights Reserved. 1

Agenda

Biosimilars Written description


Biologics Price Competition & Innovation Act (BPCIA)

Generic equivalents of biologic drugsFor small molecules, Hatch-Waxman Act provides

an abbreviated approval pathwayUntil BPCIA, there was no abbreviated pathway for

biologics


Biologics

Complex biomolecules such as antibodiesManufactured in genetically modified

living cellsHigh price, high profitCostly to develop


BPCIA Establishes Biosimilars Pathway

Biosimilar applicant must establish that its drug is “biosimilar” to a “reference product” based on analytical, animal, and clinical studies.FDA cannot approve a biosimilar under the BPCIA

pathway until 12 years after it licenses the reference product. But a biosimilar applicant can obtain a new biologics

license.

8 biosimilars are now approved But most are not yet on the market because of patent

litigation.


And Now, the IP Dimension …

Statute sets up a “patent dance” to define scope of patent litigation:


Patent Dance

But when it was time for Sandoz to put on its dancing shoes …Sandoz did not want to dance.But it did want to go to the Supreme

Court.


Patent Dance?

Sandoz (and others) asserted that patent dance is OPTIONAL. What do you think? BPCIA (42 U.S.C. §262(l)(2)(A)): Biosimilar applicant

“shall provide to the reference product sponsor a copy of the application … and such other information that describes the process or processes used to manufacture the biological product.” But BPCIA (§262(l)(9)(C)): “If a [biosimilar] applicant

fails to [initiate the patent dance], the reference product sponsor, … may bring an action … for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.”


The Supreme Court Decides

Supreme Court in Amgen, Sandoz cases: Requirement to participate in the patent dance is not

enforceable by injunction.


And There’s More

Reference product gets 12 years of exclusivity…. BUT:BPCIA (l)(8)(A): “The [biosimilar] applicant shall

provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” Amgen argued that the biosimilar could only

“provide notice” after the FDA licensed its product.Amgen lost on this point too.


What Lies Ahead in 2018 and Beyond

Will any applicants join in the patent dance?How will political

pressure for cheaper drugs affect doctrines of patent litigation?How will approval of

biosimilars affect pricing models?Will biosimilars obtain

“interchangeable” status?


Agenda

Biosimilars Written description


The Antibody Problem

Most biologics are engineered antibodies An antibody “binds” to its “target,” an “antigen.”Once target is determined, antibodies are made by: Using genetically engineered mice “Immunizing” the mice with the target antigen Screening resulting antibodies for Strong binding Inhibition of target


Target-Based Research

Research focus has been on targetsConstruction of antibodies to targets has been

routinePatent Office training materials recognized that

applicants would obtain patents covering a genus of all antibodies to a particular targetMany Federal Circuit cases did too.


The Antibody Problem: AbbVie v. Janssen

AbbVie v. Janssen (2014): Invalidated AbbVie antibody patent covering all human

antibodies that bound to human IL-12 at or above a particular affinity

Basis for invalidation: written description requirement means that one must have a specific, structural description of one’s invention.Nobody noticed.


Battle Over PCSK9 Antibodies

Blocking enzyme PCSK9 can lower LDL (“bad” cholesterol) Amgen developed evolocumab (Repatha®) Sanofi/Regeneron developed alirocumab (Praluent®) Amgen had obtained a broad patent covering antibodies

to PCSK9. And then it got a preliminary injunction against

Praluent. People noticed!


Federal Circuit Doubles Down:Amgen v. Sanofi

Federal Circuit reverses and vacates preliminary injunction.Federal Circuit distinguishes its prior cases

validating the target-based approach: they’re all dicta!Fully characterizing a target does not give you any

rights to anti-target antibodies.No more broad antibody patentsDifficulty of protecting new antibodies without

genus claims


Questions?

Life Sciences IP2017 … and 2018 in Preview

Claire LaporteDecember 12, 2017

claire laporte, "health ip"

Health & Medicine