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.
"Agency coordination could facilitate biosimilar development, reduce market exclusivity periods by promoting earlier patent filings, and ensure that patients have earlier access to lower-cost therapies..."
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