On behalf of the Public Interest Patent Law Institute, Professor Robin Feldman, patients Eliana Bookbinder and Brian Mahn, and ourselves, Niskanen submitted an amicus brief to the Court of Appeals for the Federal Circuit in Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals. Our brief argues the Federal Circuit should preserve the balance created by the United States’ patent laws and give narcolepsy patients more choice in medication by demonstrating how Jazz undermines both through its misuse of the patent and drug approval system.
Between 135,000 and 200,000 Americans suffer from narcolepsy. Jazz Pharmaceuticals sells Xyrem (and its low-sodium alternative Xywav, hereafter just “Xyrem”), which allows narcoleptics to get a restful night’s sleep and function during their waking hours. Without question, Xyrem hase improved the lives of the patients who take it. But there’s a drawback: it must be taken twice nightly. Patients taking medication to help them get a good night’s sleep must set an alarm to take the second dose four hours after the first, waking up between midnight and two o’clock in the morning.
We had the opportunity to speak to many patients currently taking Xyrem. They were grateful for the existence of a drug that treats their condition, but wished the dosing regimen was simpler and less disruptive. In fact, mistiming the second dose often led to oversleeping, which in turn resulted in professional and personal repercussions.
Avadel CNS Pharmaceuticals recognized there is room for improvement to this approach and developed a new drug, Lumryz, that comes in a once-nightly formulation. Avadel received tentative approval from the FDA pending certification that it did not violate any patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book.
Jazz sued Avadel for allegedly infringing on five of its patents, one of which is No. 8,731,963 (“the ‘963 patent”). The ‘963 patent is special because it is listed in the Orange Book, potentially granting Jazz the ability to stop the FDA from approving Lumryz for 30 months. But there’s a problem: the ‘963 patent covers nothing related to Xyrem itself, but rather with Xyrem’s special Risk Evaluation and Mitigation System (REMS), a computer screening protocol mandated by the FDA because Xyrem is a depressant with the potential for abuse (i.e., a “date rape” drug). Xyrem’s REMS protocol is thus not properly listed in the Orange Book, because it is not “a drug substance (active ingredient) patent[,] a drug product (formulation or composition) patent[, or] a method of using such drug for which approval is sought or has been granted in the application” as required by law.
After the district court unambiguously found the ‘963 patent “does not belong in the Orange Book” and ordered Jazz to delist the patent, Jazz appealed to the Federal Circuit.
Patents listed in the Orange Book come with a special set of rights created under the Drug Price Competition and Patent Term Restoration Act of 1984 and subsequent amendments, commonly known as the Hatch-Waxman Act. Hatch-Waxman’s primary focus was generic drug entry, but its general framework also covers the approval of new drugs. In exchange for creating an expedited process for generic drug approval and incentives to challenge invalid patents, Hatch-Waxman required those seeking approval to market a drug to certify that the new drug does not infringe on any patents already in the Orange Book or that the patents are invalid or enforceable.
Unlike changes to the law that generally beefed up patent rights, Hatch-Waxman, as amended, tried to create a balance. The 30-month stay of approval strengthened patent rights. Still, it was later rebalanced by allowing those sued for infringement to seek an order to delist with a further rebalancing to clarify Orange Book eligibility.
This balance is a crucial pillar of the brief’s argument: that injunctive relief for patents is granted “in accordance with the principles of equity,” essentially importing the general rules for injunctive relief from the common law. This was also affirmed in cases like eBay v. MercExchange, Takeda v. Mylan, and Apple v. Samsung. To preserve the balance intended by Hatch-Waxman, it is up to the judiciary to ensure that the powers granted to Orange Book patents are only granted to patents that belong there.
The issue before the court is not whether or not Avadel infringed on any of Jazz’s patents–that remains a question for the district court. The question is whether or not the Federal Circuit should help preserve the balance built into Hatch-Waxman by following the clear text of the statute and the district court’s finding. Upholding the district court’s order would ensure fidelity to Hatch-Waxman’s intent and help the public by making it possible for patients searching for improved drugs to have more choices in their narcolepsy treatment.