We all know that policymakers are increasingly focused on
lowering drug costs. From the Inflation Reductions Act’s
Medicare price negotiations (aka price controls) to the recent
proposals directed at pharmacy benefit managers
(“PBM’s”), there have been many efforts aimed at
reigning in the costs of pharmaceuticals and biologics.

But, is the patent system also being abused by drugmakers? And,
if so, will coordination between the PTO and FDA ensure that the
patent system is not being gamed to improperly reduce competition
by biosimilars and generics? Two recent research letters published
in JAMA suggest that the answers may be yes and yes.

The first study focused on the use of what the
authors call “ancillary patents” on biologics. According
to the authors, these patents are directed to features of the
biologic that enable it to act on the therapeutic target, such as
oxidation levels, glycan profiles, or other physiochemical
properties. The authors assert that innovator companies withhold
such information as trade secrets during the initial patent
prosecution, only filing for patents on such features later in time
in order to extend patent life and further delay biosimilars from
entering the market. The authors go on to argue that FDA should
release such information to the PTO in order to ensure that these
tactics are not used to inappropriately extend patent life and
delay biosimilar competition.

The second study examined inequitable conduct
cases decided by the Federal Circuit from 2004 to 2021, focusing
particularly on cases involving FDA-regulated products. Inequitable
conduct renders a patent unenforceable and often involves arguments
that the patent holder made a material omission of prior art or
other information when prosecuting the patent application, which
may have led the PTO to mistakenly issue the patent. Of course, the
study found that inequitable conduct findings by the Federal
Circuit dropped significantly after the court’s 2011 decision
in Therasense, Inc. v. Becton, Dickinson & Co. in
which the Federal Circuit raised the bar to prove inequitable
conduct. Nevertheless, the authors argue that coordination between
FDA and the PTO during patent prosecution may ensure that all
relevant information is presented to the patent office in a timely
manner.

Although these studies only paint a limited section of a much
broader mosaic, they certainly communicate a strong-held opinion of
the authors as to the misuse of the patent system by drugmakers to
reduce competition. As FDA and the PTO continue their collaboration, it will be interesting to see
if there will be any impact on the quality and quantity of patents
that are issued.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.