Stricter Standing For Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject matter. While the costs of IPR proceedings may prevent casual challenges, now that hedge fund manager Kyle Bass has filed several IPR petitions to challenge pharmaceutical patents and possibly short the stocks of pharmaceutical companies, some are calling for stricter standing requirements for IPR petitioners.  Continue reading this entry

Apotex Has Standing Despite Benicar Patent Disclaimer

In Apotex Inc. v. Daiichi Sankyo, Inc., the Federal Circuit held that Apotex has standing to seek a declaratory judgment that it does not infringe Daiichi Sankyo’s patent, even though Daiichi Sankyo has disclaimed the patent such that there can be no infringement as a matter of law. The court reached this decision because only a judgment of non-infringement could open the door for Apotex to enter the market earlier than it otherwise could as a subsequent ANDA filer.  Continue reading this entry

Waiting On Sequenom

As I write this there’s a voice in my head saying, “Be careful what you wish for!” but it has been five months since Sequenom was argued at the Federal Circuit, and the court has yet to issue its decision. (You can read my summary of the oral arguments here.) In the meantime, neither the USPTO nor stakeholders know whether or when diagnostic methods and personalized medicine methods can be patented. Continue reading this entry

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