Keeping Up With Kyle Bass

In the few weeks since I first wrote about Kyle Bass and the Coalition for Affordable Drugs he formed to challenge Orange Book-listed patents that he believes “have little value other than to drive up prescription drug prices,” he has been busy. Here, I review the patents he has challenged with Inter Partes Review (IPR) petitions, and identify whether there are other Orange Book-listed patents for the pharmaceutical product at issue.  Continue reading this entry

Why The Grace Period Restoration Act Is A Bad Idea

Representatives Sensenbrenner (R-WI) and Conyers (D-MI) have introduced the “Grace Period Restoration Act of 2015″ (H.R. 1791) to “correct the drafting problem in the Leahy-Smith American Invents Act relating to the grace period,” and “maintain the position of leadership of the United States in educational, technological, and scientific programs.” After giving some thought to the proposed legislative “fix,” I can think of at least five reasons why it could do more harm than good. Continue reading this entry

Biosig Claims Pass Reasonable Certainty Test

In its decision on remand from the Supreme Court, the Federal Circuit once again held the Biosig patent claims not indefinite, reversing the district court decision to the contrary. The decision came in Biosig Instruments, Inc. v. Nautilus, Inc., and applied the Supreme Court’s “reasonable certainty test” rather than the Federal Circuit’s previous “insolubly ambiguous test.”  Continue reading this entry

Amicus Briefs On Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. (I wrote about the court’s decision in this article.) The appeal is on an expedited briefing schedule at the Federal Circuit, and three amicus briefs have been filed. All of the amicus briefs argue for reversal of at least some of the district court’s decision regarding the biosimilar patent litigation framework of the BPCIA.  Continue reading this entry

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