2021 LS&HC Horizons - Flipbook - Page 44
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Hogan Lovells
Synergistic use of patent litigation, patent prosecution, and regulatory
counsel to maximize commercial value
Unquestionably, the biggest asset an innovator
pharmaceutical company has is its intellectual
property protecting its commercially valuable
drug products and its product pipeline.
Unfortunately, in patent enforcement
proceedings, many life sciences innovators
unexpectedly find themselves facing particularly
difficult challenges in attempting to meet their
infringement proofs. Troubling is that these
difficulties could easily have been obviated
by early planning by a multi-discipline team
– patent litigation, patent prosecution, and
regulatory counsel – working together in a
holistic fashion. Many in the industry are yet
to fully appreciate and embrace this holistic
approach, but those innovators who have,
considering and utilizing opportunities offered
by regulatory and other means, have managed
time and again to maximize their chance to meet
the potentially burdensome proofs required for
an infringement determination.
This approach is becoming more and more
relevant as generic companies are attempting
to find ways to avoid providing relevant
information through discovery, and in doing
so, hamper the ability of patentees to meet
their burden of proving infringement. We have
seen an increased use of third party research
companies by generic Abbreviated New Drug
Application (ANDA) filers, which conduct all the
generic product development, in part, to limit
discovery during Hatch-Waxman litigations.
These third party research companies are
often based in countries that do not provide
easy access to third party discovery. During
subsequent patent litigation, that ANDA filer will
then attempt to argue it has little more than the
actual final ANDA document to produce, because
all the research and development and other
potentially relevant information is in the hands
of a third party. The problem portrayed in this
example can be mitigated by obtaining patent
claims and drafting NDAs such that most, if not
all, the claim elements can be established by
reference to information that will likely need to
be included in an approvable ANDA submission.
Conversely, this example demonstrates the
shortcomings of failing to fully appreciate the
potential limitations of litigation discovery by
patent prosecution counsel working in isolation
and/or the failure of regulatory counsel to
consider what aspects of the regulatory pathway
can be utilized to ensure generic applicants fairly
include information encompassed by the patent
claims in their regulatory filings.
Simon Roberts
Partner, New York
simon.roberts@hoganlovells.com
