LS&HC Horizons 2022 - Flipbook - Page 5
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
5
Precision and Regenerative Medicine
CTGT transactions: Beware the ripples in the safe harbor
We increasingly encounter research and
development collaboration partners relying
on various research tools, cell lines, and other
technologies to develop products and therapies
within the cell, tissue, and gene therapy (CTGT)
field. These research tools, cell lines, and other
technologies, many of which are patented, are
useful for but separate from the product or
therapy being developed. When the question
of third-party patent rights is raised with
respect to such patented technologies, many
partners dismiss the concern on the ground
that the development of the product or therapy
is being conducted in support of a Biologics
License Application to the FDA, and therefore
is immune from an infringement suit pursuant
to the development safe harbor.
Indeed, in the United States, Section 35 USC ยง
271(e)(1) expressly exempts certain otherwise
infringing acts if conducted solely for uses
reasonably related to the development and
submission of information under a Federal law
which regulates the manufacture, use, or sale of
drugs or biological products.
Cullen Taylor
Partner, Northern Virginia
Similar exemptions exist under the laws of
many other jurisdictions. Historically, this safe
harbor, also known as the Bolar exemption, has
been broadly construed in the U.S. However,
as recent case law indicates, where a patented
research tool, such as a cultured host cell useful
in the manufacture of a gene therapy product
or a fluorescent protein, is itself not subject to
FDA premarket approval, the safe harbor may
not apply.
As additional patented research tools
become available, developers of CTGT
products would be prudent to include any
potential development technologies as part
of their freedom-to-operate analysis moving
forward. And in development collaboration
arrangements, companies should ensure that
their partners engaged in development work
have secured the appropriate licenses for the
conduct of such development activities.
Anishiya Abrol
Counsel, Washington, D.C.
