Are Drugmakers Gaming The Patent System?

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