LS&HC Horizons 2023 - Flipbook - Page 40
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Patents, Litigation, and Beyond
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Generic labeling carve-outs
Extensive debate surrounds the practice of
generics omitting, or “carving out”, patent
or exclusivity-protected information from
pioneer drug labeling, to get approved and
on the market prior to the expiration of the
protections. While typically identical to the
pioneer labeling, generic labeling that omits
efficacy or safety information often leads
to questions about the adequacy of the
remaining instructions or whether the labeling
must retain the protected information to
be considered safe and effective. Conversely,
there is a question of whether the generic
product remains inherently infringing even
without this information. FDA’s recent
denial of generic applications seeking to
omit important dosage and administration
information (e.g., LONSURF®), and the Federal
Circuit’s decision in GSK v. Teva, finding a
generic liable for induced patent infringement
despite its “carve-out” of the protected use,
continue to place a spotlight
on the practice.
importance, implications, and scope of the
protection that patents and exclusivities afford
to theses uses. Recent developments highlight
the importance of: (1) how information,
especially safety information, is conveyed
in approved labeling, (2) how omission or
removal of information from the labeling
impacts the safe and effective use of the generic
product, and (3) how patents are described
when submitted to FDA for listing in the
Orange Book.
We continuously study these developments
at the agency and court level on behalf of our
pioneer clients, carefully monitoring for shifts
and fault lines in law and policy to ensure
generic drugs are as safe and effective as the
products they copy.
Pioneer sponsors investing resources into
discovering new uses that improve the efficacy
or safety of their products understand the
David M. Fox
Partner, Washington, D.C.
Jason F. Conaty
Counsel, Washington, D.C.
Bryan Walsh
Associate, Washington, D.C.
