Stat D.C. Diagnosis: Clearing thick patent brush

A small but diverse and bipartisan group of House lawmakers is urging the U.S. Patent and Trademark Office to take a new tack in the fight against drug patent gaming that delays generic and biosimilar competition.

Pharma has long argued that patents for even incremental improvements to drugs are good, even if there are several dozens of them for the same drug, but a study released last fall makes the case that brand drug makers often file several patents for the same drug feature. When patent examiners reject patents as “non-patentably distinct,” brand drug makers are allowed to keep those patents on the books as long as they don’t run longer than the patents that they duplicate. That means makers of generics and biosimilars must challenge all duplicate patents, which takes a lot of time and money. Reps. Jodey Arrington (R-Tex.), Michael Burgess (R-Tex.), Lloyd Doggett (D-Tex.) and Ann McLane Kuster (D-NH) are asking the Patent and Trademark Office to institute a policy that would cause all duplicate patents to fall when the original patent that they’re based on is invalidated.

“In other words, non-distinct patent claims could ‘rise or fall together,’” according to a March 24 letter from the lawmakers to the patent office.