The Patent Trial and Appeals Board (PTAB) denied the request to review four Orange Book-listed patents owned by Jazz Pharmaceuticals, Inc. under the covered business method (CBM) review procedure. The CBM petitions filed by Amneal Pharmaceuticals, Par Pharmaceutical, and Roxane Laboratories (collectively “Petitioners”) were the first attempt to use the CBM procedure on pharmaceutically related patents.
Amneal Pharmaceuticals, a generics company, petitioned for Inter Partes Review of three Orange Book patents owned by Supernus Pharmaceuticals in petitions filed June 20, 2013. Galderma Labs, a subsidiary of Supernus, makes the drug. These are the first IPRs involving Orange Book patents to end in final written decisions.
As noted in our June 27, 2014 post, the PTAB had requested comments on a number of procedures, including amendments. The rules had made it so difficult to make amendments, that to date there was only one successful amendment, and it was uncontested. The PTAB has responded with new guidelines for amendments, which are set forth in the order linked below. The main improvement is allowing the claims themselves in an appendix.
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.
In a recent message posted on its America Invents Act (AIA) Blog, Patent Trial and Appeal Board (PTAB) judges give guidance on what discovery is allowed, which is very limited. A number of cases with specific examples are cited. Those include allowing discovery of lab notebooks relied on in expert testimony, emails between experts, and discovery related to real party-in-interest and privity issues. Discovery requests denied include those regarding commercial success and copying of the product by the petitioner to show non-obviousness.
On Sept. 26, 2014 the Patent Trial and Appeal Board (PTAB) designated 7 decisions over the last year as “informative.” The decisions deny multiple petitions using the same prior art, or prior art that wasn’t shown to be unknown at the time of the first petition. The decisions also say including better arguments doesn’t justify a new petition. In short, the petitioner is expected to pick the best prior art and arguments in the initial filing.
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Our goal is to keep our clients up to date on the latest practice tips. Since its enactment in 2011, the American Invents Act and its implications have changed for practitioners and set up new challenges. Click below for our latest post-grant proceedings practice tips and resources.