In a recent federal court hearing, two pharmaceutical giants – Jazz Pharmaceuticals and another unnamed – challenged the U.S. Food and Drug Administration (FDA). It came into light, that they alleged the FDA for approving a narcolepsy drug that competes directly with Jazz’s own treatment, in spite of the fact that Jazz holds exclusive rights given by the Orphan Drug Act.
Narcolepsy, a neurological disorder affecting sleep-wake cycles, is considered a rare or orphan disease. Jazz Pharmaceuticals, has exclusivity rights under the Orphan Drug Act, which directly led to the face-off.
The Orphan Drug Act, a law in place since 1983, extends a seven-year market exclusivity to pharmaceutical companies developing treatments for rare, or “orphan,” diseases, impacting fewer than 200,000 people in the U.S. With such a law in force, corporations are given incentives that result in the development of treatments for these diseases which otherwise would be financially nonviable to pursue.
However, the question here is whether this narcolepsy drug approved by the FDA, directly violates Jazz’s exclusivity rights by being considered as the ‘same drug.’ This case puts into perspective a debate that calls for a clear definition of what constitutes being the ‘same’ in the context of orphan drugs.
Legal professionals worldwide are watching this case with bated breath as its outcome could potentially impact the growth of the pharmaceutical industry in significant ways, particularly those dedicated to rare disease treatments, and could also lead to revisions of the laws surrounding orphan drugs.
For swifter understanding of the ongoing debate, the unfolding proceedings of the case can be followed up at
Law360.