The Federal Trade Commission filed a brief as Amicus Curiae in the U.S. District Court for the District of Delaware in a case related to Sage Chemical Inc. and its marketing partner TruPharma, LLC’s efforts to sell a lower-cost alternative to Apokyn. Apokyn is an injectable drug used to treat patients with symptoms of advanced Parkinson’s Disease. Apokyn’s cost per patient to the Medicare Part D program in 2020 was close to $100,000.
As detailed in the brief, plaintiffs Sage and TruPharma allege that multiple defendants including Supernus Pharmaceuticals Inc. have engaged in numerous unlawful strategies to delay or block entry of a generic version of the branded apomorphine drug, Apokyn. Many of Supernus’ alleged strategies leverage their control over the Apokyn pen injector, a device the FDA requires be used with both branded and generic apomorphine cartridges. The plaintiffs claim that without access to the pen injectors, consumers cannot use their FDA-approved generic version of Apokyn.
According to the FTC’s brief, “This case may have significant implications for patients who rely on apomorphine to treat debilitating symptoms of advanced Parkinson’s Disease. Moreover, because the strategies alleged here are similar to strategies used by other branded pharmaceutical companies to block generic competition, there is a broader public interest in the legal issues this case presents.” The brief describes four important antitrust issues raised by Supernus’s motion to dismiss the case in its entirety.
The brief states that: 1) exclusion of a generic competitor not only harms that competitor, but also competition and consumers more generally; 2) Sage and TruPharma’s development of a generic apomorphine cartridge to substitute as a refill for branded cartridges is not improper “free riding” within the meaning of antitrust law; 3) exclusive agreements like the one between Supernus and the manufacturer of the injectable pen can be unlawful when they foreclose a competitor’s access to a key input, even if the potential competitor could theoretically develop an alternative version; and 4) defining a relevant antitrust market requires assessing which products are available to consumers if prices are raised above a competitive level and single-brand or single-manufacturer markets may be appropriate when there are no adequate substitutes.
In summary, the brief urges the court to consider these four points in determining whether to grant Supernus’s motion to dismiss, reiterating that “in the pharmaceutical industry, the exclusion of lower-cost generic drug competition typically causes significant harm to consumers and to competition.”
The Commission vote approving the filing of the amicus brief was 3-0-1, with Commissioner Christine S. Wilson not participating. It was filed in the U.S. District Court for the District of Delaware.