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).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
