08/07/2022
On Wednesday, the USPTO announced a joint initiative with the Food and Drug Administration (FDA) to reduce drug prices and encourage competition. The new undertaking, a response to President Biden’s Executive Order 14036 on “Promoting Competition in the American Economy” that was issued one year ago, will curb certain practices that pharmaceutical companies engage in.
Last year, the FDA stated it was especially concerned that some “uses of the patent system” let companies delay the introduction of generic and biosimilar drugs. For example, continuation patent practices, “which may allow the filer to obtain follow-on patents directed to inventions disclosed in earlier patents,” creating “patent thickets,” “product-hopping,” and the practice of “evergreening,” in which patents are obtained on “‘post-approval’ or ‘secondary’ changes to previously approved drug products such as new formulations of the same drug, new delivery systems, or patents claiming various additional methods of use.” The FDA cited one study that found “78 percent of the drug products for which new patents were listed in the Orange Book from 2005-2015 were existing drug products, not new drugs entering the market.”
In response, the USPTO announced five broad changes that will “strengthen our patent system for all technologies.” It will work to improve public participation, for example by adding public interest representatives to the Patent Public Advisory Committee. In addition, it will strengthen its collaboration with the FDA and other fellow federal agencies by providing them with resources and providing examiners with training on FDA assets that can be utilized in searches.
Most importantly, the USPTO will evaluate proposals for ways to minimize the delay of generics and biosimilar drugs, while still “incentivizing and protecting the investment essential for bringing life-saving and life-altering drugs to market.” It will also “improve procedures for obtaining a patent so that the USPTO issues robust and reliable patents,” which includes introducing more examination time into the examination system, considering whether changes should be made to reduce the effects of obviousness-type double patenting practices, and reviewing other countries’ practices of examining and issuing pharma and bio patents in order to identify ways to strengthen the U.S. system.