The document discusses developments in 2017 regarding biosimilars and the written description requirement for antibody patents, and previews what may lie ahead in 2018. It summarizes the establishment of an abbreviated pathway for biosimilar approval via the Biologics Price Competition and Innovation Act (BPCIA) and ongoing litigation over requirements in the "patent dance" process. It also discusses recent court decisions invalidating broad antibody patents for lack of written description and making it more difficult to protect new antibodies without genus claims describing the antibody structure. Looking to 2018, it raises questions around participation in the patent dance process, how political pressure may affect patent litigation doctrines, and implications for pricing models as biosimilars are approved and seek interchange

1. Life Sciences IP
2017 … and 2018 in Preview
Claire Laporte
December 12, 2017

2. © 2017 Foley Hoag LLP. All Rights Reserved. 1
Agenda
Biosimilars
Written description

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Biologics Price Competition &
Innovation Act (BPCIA)
Generic equivalents of biologic drugs
For small molecules, Hatch-Waxman Act provides
an abbreviated approval pathway
Until BPCIA, there was no abbreviated pathway for
biologics

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Biologics
Complex biomolecules such as antibodies
Manufactured in genetically modified
living cells
High price, high profit
Costly to develop

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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.

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And Now, the IP Dimension …
Statute sets up a “patent dance” to define scope of
patent litigation:

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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.

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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.”

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The Supreme Court Decides
Supreme Court in Amgen, Sandoz cases:
 Requirement to participate in the patent dance is not
enforceable by injunction.

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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.

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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?

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Agenda
Biosimilars
Written description

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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

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Target-Based Research
Research focus has been on targets
Construction of antibodies to targets has been
routine
Patent Office training materials recognized that
applicants would obtain patents covering a genus of
all antibodies to a particular target
Many Federal Circuit cases did too.

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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.

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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!

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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 patents
Difficulty of protecting new antibodies without
genus claims

18. © 2017 Foley Hoag LLP. All Rights Reserved. 17
Questions?

19. Life Sciences IP
2017 … and 2018 in Preview
Claire Laporte
December 12, 2017