'Purple Book' Patent Listing Under Biological Product Patent Transparency Act: What Is Required, and What to Expect?

摘要

At the end of the day, it remains to be seen whether and how the new regime of "Purple Book" patent listing under the BPPT will impact the strategic approaches of biologies innovators and biosimilars to litigation and regulatory and commercial strategy. Given the tight listing timelines under the BPPT, though, we should start to see data points pertaining to these questions in relatively short order.Reference product sponsors and biosimilars alike should also keep an eye out for the FDA's forthcoming solicitation of public comments "regarding the type of information, if any, that should be added to or removed from the list required"34 under the BPPT by new Section 351 (k) (9) (A) of the PHS Act.