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In
This Issue:
· Amgen Obtains $70M Damages Award
Against Hospira For Infringement Of Amgen’s
Erythropoetin Patent
· FDA Releases Draft Guidance on
Statistical Approach for Determining whether Biosimilar is Highly Similar to Reference Product
Contact Us:
Walter
Schlapkohl, Ph.D., Esq.
wschlapkohl@gbpatent.com
703-716-1191 (phone)
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Amgen
Obtains $70M Damages Award Against Hospira For Infringement Of Amgen’s Erythropoetin Patent
On September 22, 2017, a federal jury awarded Amgen $70
million in damages for Hospira’s infringement of Amgen’s patent covering the
manufacture of Epogen® (EPO).
Hospira filed an abbreviated Biologics License Application
(aBLA) with the FDA in early 2015 for a biosimilar version of EPO. Amgen
subsequently filed suit in the District of Delaware asserting infringement of
two of its patents related to the manufacturing of EPO. One patent covered
specific EPO isoforms and methods of selecting them, and the other patent
covered a cell line suitable for making EPO. At the time the lawsuit was
filed, the cell line patent had already expired, and the isoform patent was
about to expire.
At issue during the trial were 21 batches of EPO that
Hospira had manufactured between the years 2013 and 2015. Hospira asserted
that the manufacture of these batches of EPO was protected under the “safe
harbor” of 35 U.S.C. §271(e)(1), which provides that uses of a patented invention
that are solely reasonably related to the development and submission of
information under a Federal law that regulates the manufacture, use, or sale
of drugs or veterinary biological products is not an act of infringement.
Amgen countered that Hospira’s manufacture of the 21 batches of EPO was not
reasonably related to obtaining FDA approval, but instead was intended to
create a stockpile of commercial product that was worth nearly $1 billion
ahead of its anticipated regulatory approval by the FDA.
The jury agreed that seven of the 21 batches in question
fell under the protection of the safe harbor because they were shown to have
been used in testing for regulatory purposes, but found that the other 14
batches were not protected by the safe harbor and infringed Amgen’s isoform
patent, and that the patent was not invalid. The jury awarded Amgen $70
million in reasonable royalty damages.
This is the first verdict award of significant
infringement damages to a patent owner under the Biologics Price Competition
and Innovation Act (BPCIA). Even more remarkable is the size of the award in view of the fact that Hospira had not yet obtained FDA
approval for its biosimilar product and thus had not marketed or sold any of
the product in the United States.
--By
Jeffrey R. Bousquet
FDA Releases Draft Guidance on Statistical Approach for
Determining whether Biosimilar is Highly Similar to
Reference Product
Under the Biologics Price Competition and Innovation Act
(BPCIA), a first manufacturer to produce the biologic (the sponsor) may
obtain a license from FDA if it can demonstrate that the biologic is “safe,
pure, and potent.” 42 U.S.C.
§262(a)(2)(C)(i)(I). Subsequent manufacturers of a biologic may piggy-back on
the first license, via an abbreviated showing that the second product (the
biosimilar) is “highly similar” to the first-licensed product (the reference
product) and that there are no “clinically meaningful differences” in terms
of “safety, purity, and potency.” 42 U.S.C. §§262(i)(2)(A), (B), and §262(k)(2)(A)(i)(I).
On September 22, 2017, FDA released draft guidance
entitled Statistical Approaches to Evaluate Analytical Similarity Guidance
for Industry. The guidance provides a
framework for evaluating whether the biosimilar is highly similar and does not
exhibit clinically meaningful differences in safety, purity, and
potency. As proposed, the analysis
should be risk-based, testing a minimum of 10 biosimilar lots and 10
reference product lots. The reference
product lots should be from U.S.-licensed supplies and represent the
reference product variability including a range of expiration dates. The biosimilar lots should also be
manufactured with different processes or scales.
To conduct the Analytical Similarity Plan under the draft
guidance, the biosimilar applicant will have to:
1)
Determine the quality attributes that
characterize the reference product in terms of structural/physiochemical and
functional properties,
2)
Rank these attributes according to risk and
potential clinical impact, and then
3)
Evaluate these attributes based on the
following three tiers of statistical approaches,
a.
For the attributes having the highest
potential clinical impact, formal statistical equivalence testing should be
conducted,
b.
For the attributes having a moderate or
medium-clinical impact, acceptable ranges should be set, and
c.
For those attributes that have the lowest risk
of potential clinical impact or are not amenable to formal tests or
quantitative evaluation, subjective observations and assessments should be
made.
Reinforcing the previous guidance entitled “Scientific
Considerations in Demonstrating Biosimilarity to a Reference Product,” once
evidence under this analytical framework has been submitted, FDA will then
assess whether the biosimilar is highly similar to
the reference product based upon the totality of the evidence rather than by
evaluating whether the biosimilar passes each and every statistical
tier. The comment period for the draft
guidance, ends November 21, 2017.
--By
Christopher L. Wright
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