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.

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