GAO on com­bo prod­uct patents: Stake­hold­ers split on need for Or­ange Book tweaks

The Gov­ern­ment Ac­count­abil­i­ty Of­fice (GAO) late Thurs­day re­leased a re­port eval­u­at­ing whether Or­ange Book patent list­ings re­lat­ed to drug-de­vice com­bi­na­tion prod­ucts might be ham­per­ing gener­ic com­pe­ti­tion, with stake­hold­ers of­fer­ing dif­fer­ing views on whether the FDA should do more or stay out of the Or­ange Book list­ings of cer­tain types of patents.

The GAO’s re­port didn’t turn up too many an­swers, as stake­hold­ers in­ter­viewed by the of­fice of­fered a wide va­ri­ety of in­clu­sion and ex­clu­sion cri­te­ria on which de­vice-re­lat­ed patents should be list­ed in the Or­ange Book. Both sides made their case that more com­pre­hen­sive list­ings could help gener­ic firms, or how ex­clud­ing more of these patents could lessen the amount of time it takes for the gener­ic prod­ucts to hit the mar­ket.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER