LSHC Horizons Brochure 2024 - Flipbook - Page 96
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
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Pharmaceutical patents in an era of increasing interagency scrutiny: Trends,
cross-currents and policies at the cross-section
Last year saw signs of increasing interagency
collaboration between the U.S. Food and
Drug Administration (FDA), the U.S. Federal
Trade Commission (FTC), and the U.S.
Patent and Trademark Office (USPTO).
2024 promises more. These issues have
important implications for pharmaceutical
and biotechnology companies, impacting the
development, prosecution, and enforcement
of patents. There are new initiatives afoot,
interagency cooperation, information sharing,
and new roles being played by FDA, USPTO
and FTC affecting the way patents will be
prosecuted, how and what information will
be listed by FDA in the Orange Book, and
enforcement risks.
These are not happenstance developments. In
July 2021, the White House issued an Executive
Order (EO) on Promoting Competition in the
American Economy, charging FDA to work
with the FTC and USPTO to “identify and
address any efforts to impede generic drug and
biosimilar competition” and “to help ensure
that the patent system, while incentivizing
innovation, does not also unjustifiably delay
generic drug and biosimilar competition
beyond that reasonably contemplated by
applicable law”.
Kristin Anne Connarn
Partner
Boston
To further this, FDA and USPTO set a goal to
create a formal mechanism of collaboration,
to include topics such as consistency in
representations made by drug sponsors to both
agencies, overlap in the agencies’ authorities
and responsibilities with respect to labeling
carve-outs, the connection between method of
use patents and associated use codes, and to
reach some accord on practices referred to as
“patent thickets”, “evergreening”, and “product
hopping”.
And last year saw a new front emerge for
Orange Book patent listings, with FTC taking
the helm. FTC issued a policy statement,
warning that it would crack down on allegedly
“improper” Orange Book patent listings,
and then issued a spate of warning letters,
challenging the listing of certain patents, using
FDA’s own patent listing dispute regulations
and procedures. In response, some sponsors
delisted patents, while others have stood firm.
This is likely to lead to further developments
in 2024.
These initiatives hold the potential to deeply
influence how patents are and can be used to
protect innovation and drive pharmaceutical
development. Like the agencies, we are
combining our expertise across practice areas
to respond to these new regulatory trends, to
ensure our clients protect their technology to
the full extent the law allows.
Jason F. Conaty
Counsel
Washington, D.C.
Ilana Kattan
Counsel
Washington, D.C.
