IP Law Daily, PATENT—Fed. Cir.: Patents for narcolepsy drug Xyrem declared invalid based on obviousness, (Jul 13, 2018)

By Brian Craig, J.D.

The U.S. Court of Appeals for the Federal Circuit has affirmed a decision by the Patent Trial and Appeal Board concluding that claims for patents owned by Jazz Pharmaceuticals for the drug Xyrem, used to treat narcolepsy, are invalid based on obviousness. The Federal Circuit held that background materials and other information on the FDA website for the sensitive drug, which may also be used illicitly as a date-rape drug, were sufficiently accessible to the public to constitute prior art. The decision allows Amneal Pharmaceuticals, LLC to create a generic version of the drug (Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, July 13, 2018, Lourie, A.).

Jazz Pharmaceutical owns patents relating to the sensitive drug Xyrem, approved to treat symptoms associated with narcolepsy. The active ingredient in Xyrem, gamma-hydroxybutyrate ("GHB"), may also be illicitly used as a date-rape drug. As such, Xyrem is considered a sensitive drug subject to review by the FDA. The Board held that the background materials and the meeting minutes, transcript, and slides on the FDA website, called the Advisory Committee Art ("ACA") materials, constituted prior art, and declared the patent claims invalid based on obviousness. Jazz appealed the Board’s decision.

Public accessibility. The main issue on appeal was whether the ACA materials on the FDA website were sufficiently accessible to the public to constitute prior art.The Federal Circuit recognized that "public accessibility" is the touchstone in determining whether a reference constitutes a "printed publication" under 35 U.S.C. § 102. A reference is considered publicly accessible upon a satisfactory showing that the document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it. In re Wyer, 655 F.2d 221, 226 (CCPA 1981).

The FDA announced a public meeting to discuss the risk management issues for Xyrem. The Notice about the meeting, published in the Federal Register, included a hyperlink to an FDA website where background material from the drug sponsor and the FDA were posted before the meeting, and the meeting minutes, transcript, and slides would be posted after the meeting. The Federal Circuit held that that the Board properly concluded the ACA materials were publicly accessible printed publications.

Claim construction. The Federal Circuit then turned to whether the Board properly construed "periodic reports" and "information identifying" in the patent claims. Because the claim does not define the word "periodic," the Board considered dictionary definitions. The appeals court also examined the specification in interpreting the claims and the prosecution history. Based on the totality of the evidence, the Federal Circuit held that the Board properly construed the patent claims.

Obviousness. The Federal Circuit finally considered the Board’s obviousness analysis. Obviousness is a question of law with underlying factual issues, including the scope and content of the prior art, differences between the prior art and the claims at issue, the level of ordinary skill, and relevant evidence of secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). The Federal Circuit rejected the argument that the U.S. Supreme Court’s decision in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), requires that every finding of a motivation to combine be premised on subsidiary findings of (1) whether there was a problem to be solved; and (2) whether there was a finite universe of possible options. The Federal Circuit agreed with the Board that a person of ordinary skill would have been motivated to run the ACA materials’ distribution system over multiple computers. Therefore, the appeals court found that the Board properly analyzed obviousness.

The case includes Nos. 17-1671, 17-1673, 17-1674, 17-1675, 17-1676, 17-1677 and 17-2075.

Attorneys: Kathleen M. Sullivan (Quinn Emanuel Urquhart & Sullivan, LLP) for Jazz Pharmaceuticals, Inc. Steven Arthur Maddox (Maddox Edwards, PLLC) for Amneal Pharmaceuticals, LLC.

Companies: Amneal Pharmaceuticals, LLC; Jazz Pharmaceuticals, Inc.

Cases: Patent FedCirNews