An In-Depth Look At USPTO Patent Quality Problems

The comment period for the USPTO’s proposed patent quality initiatives is open until May 6, 2015, and the Office of Inspector General for the Commerce Department has given stakeholders plenty to think about in its final report on the USPTO’s quality assurance program. The OIG identified four areas of concern and made four recommendations for addressing its findings. Will stakeholders come forward with additional ideas for addressing these problems? Continue reading this entry

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