In Search of Meaningful GAIN in Renewal of Prescription Drug Act
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capital markets that make it nearly impossible for small biotech companies—the true innovators in this therapeutic area—to finance the late-stage development of new antibiotics under current regulatory guidance.
While the GAIN Act provides advantages for antibiotic drug developers, will it truly accomplish the goal of stimulating the development of new antibiotics that work against drug-resistant pathogens? Such antibiotics are called “Qualified Infectious Disease Products” or QIDPs under the GAIN Act. Let’s look at some of the key provisions:
1. Market exclusivity. QIDPs would get an additional five-year period of market exclusivity beyond the standard periods of exclusivity for which they would qualify. In the U.S., new small molecule drugs are granted 5 years of Hatch Waxman market exclusivity, so this provision could convey a total of 10 years of market exclusivity to a sponsor with a new drug application (NDA) for a QIDP. What this means is that, for a period of 10 years from FDA’s approval of a sponsor’s NDA application, a potential competitor would not be able to use the data generated by a sponsor of the QIDP in a regulatory filing for a generic version of the sponsor’s antibiotic. While not the same as a patent term extension, an additional 5 years of market exclusivity would be advantageous for a drug with a current patent expiry within 10 years of NDA approval. Also, for a drug with a patent expiry currently beyond 10 years from approval, the additional 5 years of market exclusivity provides a safety net in the event of a patent challenge and invalidation. As an example, under this provision of the GAIN act, coupled with the current Hatch-Waxman extension, a new antibiotic approved in 2014 could have guaranteed market exclusivity through 2024 even in the absence of a valid patent.
2. Priority review. Under the GAIN Act, NDAs for QIDPs would qualify for Priority Review by the FDA. As the FDA’s current goal for Priority Review is six months, this provision could cut … Next Page »