Biosimilar Update – Shall We Dance?

By: Emily A. Curtis  |   April 20, 2016

On April 5, 2016, the U.S. Food and Drug Administration (“FDA”) approved Inflectra, Celltrion Inc.’s biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab). Inflectra was approved as therapy for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis. This is the second biosimilar approved by the FDA following the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Although the FDA just approved Inflectra, Janssen and Celltrion have already begun patent litigation related to the biosimilar. Litigation is related to Janssen’s patents and Celltrion’s statutory requirements under BPCIA.

Purdue Pharma v Epic Pharma

By: Gideon Eckhouse & Andreas Baltatzis  |   February 29, 2016

In Purdue Pharma L.P. v. Epic Pharma, LLC, the Court of Appeals for the Federal Circuit reviewed the validity of multiple patents with claims directed toward pain-relieving dosage forms. In particular, the claims at issue were directed toward formulations containing the opioid analgesic oxycodone with a low amount of a specified impurity. The Court held that the patents are invalid as obvious or anticipated, despite the fact that there was no proof that the source of the impurity was known in the prior art. The Court also found that the hardness of the abuse-deterrent dosage form was inherent in the prior art. 

PTAB Setting New Precedents

By: Emily A. Curtis  |   February 2, 2016

The U.S. Patent and Trademark Office Patent Trial and Appeal Board (“PTAB”) recently designated two of its decisions as precedential. The cases relate to restrictions on filing cases at the PTAB specifically with regard to estoppel and time limits.

Enhanced Damages: An Inevitable Shift?

By: Emily A. Curtis  |   December 11, 2015

After overturning Federal Circuit precedent regarding the standards required to award attorney fees in patent cases, the highest court has agreed to hear additional patent cases related to awarding damages. See Halo Electronics, Inc. v. Pulse Electronics, Inc., 769 F.3d 1371 (Fed. Cir. 2014). The Supreme Court granted certiorari for Halo Electronics, Inc. v. Pulse Electronics, Inc.and Stryker Corp. v. Zimmer, Inc., 782 F.3d 649 (Fed. Cir. 2014), both concerning the standards applied by district courts and the Federal Circuit when treble damages for patent infringement are requested under 35 U.S.C. § 284. Given recent jurisprudence with respect to an analogous two-prong test in awarding attorneys’ fees in patent cases, has the Supreme Court already revealed how it will decide Halo and Stryker?

Alice In Wonderland - Court Decisions For Patentability

By: Sandra King; Yoni Torchman; Patrick Wamsley  |   September 8, 2015

Please check out the entire article here: Download the Alice article now!