No Collateral Challenge Of Patent Application Revival

In Exela Pharma Sciences, LLC v. Lee, the Federal Circuit held that the USPTO’s decision to revive a patent application “is not subject to third party collateral challenge” under the Administrative Procedures Act (APA). In so doing, it affirmed the district court’s dismissal of Exela’s action challenging the revival of Cadence’s patent application, but on different grounds. Continue reading this entry

Patent Term Adjustment In The Post-RCE Period

We know from Novartis v. Lee  that a patent application does not earn “B delay” type Patent Term Adjustment (PTA) from the time an RCE is filed until a Notice of Allowance is issued, but an application still can earn PTA for “A delay” when the USPTO takes more than four months after the RCE is filed to act on the application. However, the USPTO has been charging “Applicant Delay” when the applicant files any paper between the RCE and the next Office Action or Notice of Allowance, even though no PTA statute or rule expressly governs the post-RCE period. Continue reading this entry

Judge Finds Biosimilar Patent Procedures Optional

Judge Seeborg of the U.S. District Court for the Northern District of California issued an order in Amgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA) are optional. If this interpretation is upheld, will any parties go through the complicated biosimilar patent dance of 42 USC § 262(l)? Continue reading this entry

The Remicade Biosimilar Patent Dispute

While Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio™ (filgrastim-sndz) is a biosimilar of Amgen’s Neupogen® (filgrastim) product), another biosimilar patent dispute is brewing between Janssen Biotech, Inc. and Celltrion Healthcare Co., Ltd. over Remicade® (infliximab). On March 6, 2015, Janssen filed a complaint against Celltrion in the Massachusetts district court, alleging violations of the BCPIA, and infringement of six patents. Like the pending litigation between Amgen and Sandoz, the Remicade biosimilar case highlights how the carefully orchestrated patent dispute resolution processes of the BCPIA can fall apart when the parties cannot even agree on what the law requires.  Continue reading this entry

STRONG Patents Act Would Fix Micro Entity Gap

Senator Coons (D-Del) has introduced patent reform legislation that is similar to but different from the Goodlatte Innovation Act pending in the House. One section of S. 632 that does not have a parallel in H.R. 9 relates to micro entity status, and would fix the problem with 35 USC § 123 that left universities out of the definition of micro entities. Continue reading this entry