
On June 13, 2018, Senator Orrin Hatch (R-UT) introduced to the Senate Judiciary Committee an amendment to restore the careful balance sought in the Hatch-Waxman Act, which provided incentives for both pharmaceutical innovation and drug affordability. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would modify the IPR process for pharmaceuticals—under Hatch-Waxman and the BPCIA—and would amend sections of the Federal Food, Drug and Cosmetic Act that provide abbreviated pathways for generic drug and biosimilar product approval.
Continue Reading Proposed Hatch-Waxman Amendment Would Effectively Eliminate IPR Challenges by Generics
The Federal Circuit upheld the PTAB’s mixed decisions in IPRs filed by Google to challenge claims of two Personal Audio LLC patents asserted against Apple, Samsung, Amazon and Research in Motion, in addition to Google. Google LLC v. Personal Audio LLC, Nos. 2017-1162, -1166, -2110, -2111 (Fed. Cir. Aug. 1, 2018) (non-precedential).




Left in the wake of the Supreme Court’s SAS decision (discussed
Attempting to “swear behind” an alleged prior art reference has been common practice in IPRs, going back to the first IPR, Garmin Int’l, Inc. v. Cuozzo Speed Tech. LLC, IPR2012-00001 (PTAB 2013), aff’d sub nom. In re Cuozzo Speed Tech., LLC, 793 F.3d 1268 (Fed. Cir. 2015), aff’d sub nom., Cuozzo Speed Tech., LLC v. Lee, 136 S. Ct. 2131 (2016). In that case, Cuozzo was unsuccessful in swearing behind (for failure to exercise reasonable diligence toward reduction to practice), and as we have