In an opinion issued on March 6, 2023, the Federal Circuit affirmed the PTAB’s holding of unpatentability because the applications from which the patent claimed priority from lacked sufficient written description under 35 U.S.C. § 112. Regents of University of MN v. Gilead Sciences, Inc., No. 2021-2168 (March 6, 2021). Because the patent could not…
Section 112 written description requirements present a challenge for patentees claiming negative limitations, as the extent to which a specification needs to disclose the absence of a feature is not entirely clear, especially following the recent Federal Circuit case Novartis v. HEC Pharm Case No. 1:18-cv-01043-KAJ (Fed. Cir. June 21, 2022). In its review of negative…
Last week, in Novartis, et al., v. West-Ward Pharmaceuticals International Limited, the District of Delaware denied Defendant’s motion in limine seeking to exclude “post art” evidence, i.e. references published after the critical date, as irrelevant and prejudicial. In its order, the court remarked that though there are some limitations, post art can be offered for…
On January 5, 2016, Chief Judge Leonard P. Stark of the District of Delaware found the claim language of several patents covering Namenda XR®—Forest Laboratories, Inc.’s extended-release drug for treating Alzheimer’s-type dementia—indefinite. Forest Labs., Inc. et. al v. Teva Pharm. USA, Inc. et al., Civ. No. 14-cv-00121-LPS (D. Del. Jan. 5, 2016). Notably, the court…
After nearly five years of litigation with Par and Alkermes, TWi can finally launch its generic version of Megace ES® (megestrol acetate). On remand from the Federal Circuit following an initial finding of invalidity, the District of Maryland held that the asserted claims are invalid for obviousness and lack of enablement, and denied the plaintiffs’ motion…
Last week, in Virginia Innovation Sciences (“VIS”) v. Samsung, the Federal Circuit provided some indication of the circumstances under which it would defer to a district court’s evaluation of extrinsic evidence in the post-Teva world. We have previously written about the Supreme Court’s 2015 Teva v. Sandoz opinion, which overturned long-standing precedent, holding that while…
The Ruling. In a 6-2 decision issued Tuesday, the Supreme Court once again disagreed with the Federal Circuit and held that a defendant’s good-faith (but incorrect) belief that a patent is invalid is not a defense to an induced infringement claim. Commil USA, LLC v. Cisco Sys., Inc., No. 13-896. The Court also affirmed that induced…
Last week, an unconventional new player launched its first drug patent attack. The hedge fund Hayman Credes Master Fund, L.P., under the name Coalition For Affordable Drugs (ADROCA) LLC, filed an IPR petition against U.S. Pat. No. 8,663,685. (IPR2015-00720.) The patent, which covers the drug AMPYRA (dalfampridine), is owned by Acorda Therapeutics, Inc. This is…
A valid reissue patent must satisfy 35 U.S.C. § 251, which requires that there be an “error” in the original patent. On December 24, 2014, the Federal Circuit clarified this “error” requirement with its decision in Fleming v. Escort Inc., 2014 U.S. App. LEXIS 24419 (Fed. Cir. 2014). In Fleming, the patentee alleged that he…
A three judge panel of the Federal Circuit on November 18, 2014 affirmed the District of Delaware’s summary judgment decision that Warner Chilcott’s patents covering the osteoporosis drug Actonel were invalid for obviousness. Despite some uncertainty in the prior art regarding effective dosing of the drug, the Federal Circuit affirmed, stating that obviousness does not…