by Dennis Crouch
In the pharmaceutical industry, there is a lot of interplay between the patents and FDA regulation. A party with an approved drug product will often list related patents in the Orange Book. Jazz’s approved drug is sodium gamma-hydroxybutyrate (“GHB”). GHB is an infamous date-rape drug and the FDA conditioned its approval on Jazz developing “Risk Evaluation and Mitigation Strategies” (REMS). Jazz created a set of strategies, and also obtained a patent covering the strategy. US8731963. The patent basically overs a computer system that keeps track of prescriptions and inventory using a “single-pharmacy system” as well as a focus on whether the drug was purchased by a cash-payer. Jazz listed this REMS patent in the Orange Book as covering its drug product. And, although the patents covering the drug use itself expired in 2022, the REMS patent is still in force. But, the FDA is actually no longer requiring Jazz to use the system.
In my view, this is a pretty weak patent, and a court will probably eventually hold that it is ineligible. But, the “beauty” of the orange book listing is that patent quality often does not really matter. As the Federal Circuit explained Orange Book listing “arm[s] the patent owner with the ability to trigger a presumptive, thirty-month suspension of the FDA’s approval of a competitive product.” In other words, if a competitor wants to enter the market, the mere existence of a listed Orange Book patent creates a 2.5 years delay in approval of their product. The law also makes it an act of infringement for a third party to submit a NDA alleging that it is either not infringing or that the patent is invalid/unenforceable.
In this case, Avadel is wanting to market its own GHB drug and has its own proposed REMS using multiple pharmacies. After Avadel filed its NDA, Jazz sued. Avadel responded with a counterclaim seeking a court order to delist the patent.
Orange Book listing is proper when the patent either (1) covers the approved drug; or (2) covers an approved method of using the drug. The Federal Circuit appeared ready to allow this type of REMS patent as an Orange Book Listing. But, here is the rub for Jazz — its patent doesn’t claim a method, but rather claims a computer system.
Each of the ’963 patent’s three independent claims describes a ‘computer-implemented system’ that comprises ‘one or more computer memories’ and a ‘data processor.’ . . . That the claimed systems can be used in the course of treating patients suffering from narcolepsy does not alter the fact that these are system claims.
Slip Op. Jazz unsuccessfully argued that the FDA required submission of a “system,” and that should alter the method requirement. In fact, the FDA does not directly review the submitted patents and has never definitively stated that REMS patents can be listed.
Thus, the Federal Circuit affirmed the lower court order to delist the patent.
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My key struggle with this case is the background law that a “system” claim automatically covers both the system itself and using the system. This stems from the definition of patent infringement that covers making, using, selling, etc. 35 USC 271(a).