Amneal, Par, and Roxane Challenge Distribution Patent for Xyrem Under AIA Covered Business Method Review

In what appears to be the first time a drug patent has been so challenged, Amneal Pharmaceuticals LLC, Par Pharmaceutical Inc., and Roxane Laboratories Inc. have asked the U.S. Patent Trials and Appeals Board to invalidate U.S. Patent No. 7,895,059, assigned to Jazz Pharmaceuticals Inc., under the America Invents Act’s (AIA) covered business method (CBM) review program.  Jazz has sued Amneal, Par, and Roxane for infringement of, among others, the ’059 patent, in the District of New Jersey.

The AIA introduced new methods to challenge patent validity without going through the court system.  These include inter partes review, post-grant review, and covered business method review.  The PTO has defined a covered business method patent as “a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions.”  A CBM review may be brought on any ground that is a condition for patentability, including lack of patentable subject matter under 35 U.S.C. § 101.

The ’059 patent, entitled “Sensitive Drug Distribution System and Method,” relates to a method of distributing the drug Xyrem (gamma hydroxy butyric acid, or GHB), used to treat narcolepsy.  Because Xyrem has been classified as a “date rape” drug by the FDA, to prevent abuse it is only available through one central pharmacy.  The patent claims a computerized method for distribution of the drug.

Amneal, Par, and Roxane’s challenge relies on the recent Supreme Court decision in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, that held that computerization of an abstract idea does not make it patentable.  They argue that “Even in their best possible light, the claims are merely drawn to abstract ideas, and nothing more, artfully drafted in an effort designed to monopolize the abstract idea itself… For example, challenged claims 1-16 are directed to the abstract idea of centralizing distribution of hazardous or abuse-prone drugs to reduce the abuse risks associated with the drug without any meaningful limitations. And, the claimed steps can be performed by a human intermediary without any computer operation.”

The generics also assert that the ’059 patent is invalid as anticipated or obvious over certain “Advisory Committee Art” – a collection of materials used in FDA committee meetings on drug safety as a prerequisite to approval of Xyrem.  The generics argue that this collection of materials discloses every limitation of the challenged claims, and consequently, prior art existed that would have led a POSA to develop the centralized distribution systems claimed in the ’059 patent to minimize the risks associated with the distribution of hazardous prescription drugs.

Jazz has not yet made any comment on the CBM petition.  We will monitor this CBM petition and update this post as new developments materialize.