Four Orange Book-listed U.S. patents owned by Jazz Pharmaceuticals, Inc. have been challenged in petitions for covered business method (CBM) patent review filed at the U.S. Patent and Trademark Office by Amneal Pharmaceuticals, Par Pharmaceuticals, and Roxane Laboratories. These actions appear to be the first time that Orange Book patents, or indeed any pharmaceutically related patents, have been challenged under CBM post-grant review that was designed to cover financial services related patents. 

The America Invents Act defines a CBM patent as one 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. The Patent Trial and Appeal Board will have to decide whether the CBM framework applies to patents such as these. A decision is expected in December 2014. 

The challenged patents are related to distribution of sodium oxybate (Xyrem®), also known as gamma hydroxy butyrate (GHB), which is used to treat excessive daytime sleepiness and cataplexy associated with narcolepsy (commonly called the “date rape” drug). Two of the patents claim “A computerized method of distributing a prescription drug under exclusive control of an exclusive central pharmacy…,” and the other two claim “A method of treatment of a narcoleptic patient with a prescription drug,” comprising steps that utilize a computer database and processor to address potential misuse or abuse of the drug. The broadest claims do not recite a particular drug, and dependent claims recite the prescription drug is GHB. 

All four CBM petitions allege the patents claim nonstatutory subject matter under 35 U.S.C. §101 as directed to “mere abstract ideas,” where the claims “only impliedly reference a general purpose computer,” citing the Alice and Mayo decisions by the Supreme Court. The petitions further argue that the claims are anticipated and obvious over the prior art. 

The patent family was acquired by Jazz Pharmaceuticals when it purchased Orphan Medical in 2005. The patents are U.S. Patents No. 7,895,059 (CBM2014-00149, filed June 24, 2014); 8,457,988 (CBM2014-00150, filed July 7, 2014); 7,668,730 (CBM2014-00151, filed July 9, 2014); and 8,589,182 (CBM2014-00153, filed July 9, 2014).