On December 1, 2015, a number of amendments to the Federal Rules of Civil Procedure took effect. The amendments primarily concern discovery. Below is an overview of the top three things you need to know. First, the amendments made a couple of changes to Rule 26(b)(1) regarding the scope of discovery. That revision added language […]
Shire has petitioned the Federal Circuit to rehear en banc its decision in Shire v. Amneal, where the Federal Circuit declined to hold an API manufacturer liable as an indirect infringer. Shire asked the court to address the question of whether a non-ANDA filer can be liable for future infringement under 35 U.S.C. § 271(e)(2) […]
The Federal Circuit held that the Administrative Patent Trial and Appeal Board’s (“PTAB”) decision to institute an Inter Partes Review Proceeding (“IPR”) is not reviewable by the Federal Circuit on appeal. See Achates Reference Publishing, Inc. v. Apple Inc. This decision arose from an appeal by the patentee, Achates, of the PTAB’s decision that several […]
In ruling on a “follow-on” inter partes review (IPR), the PTAB held that estoppel under 35 U.S.C. §315(e)(1) does not extent to grounds set forth in a petition that are denied as being redundant to a previous IPR proceeding. Apotex Inc. v. Wyeth LLC, IPR2015-00873, Paper 8 (P.T.A.B. Sept. 16, 2015). The Facts. Apotex filed […]
To prove infringement of a method of treatment claim under section 271(e), a patent owner must prove that the ANDA filer will induce infringement by another, typically a physician, who will directly infringe the asserted patent by carrying out the method according to instructions in the ANDA label. But what happens when the label instructs […]
Inter partes review became available on September 16, 2012. Since then, over 3,400 IPR petitions have been filed. The USPTO implemented a first set of changes, or “quick fixes,” in March, and now, the USPTO seeks to improve IPR via a host of additional proposed changes. But will they result in any real change? Only […]
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 […]
A recent filing in the Eastern District of Texas highlights the importance of investigating patent ownership issues before initiating a lawsuit or as part of defending against a lawsuit. Earlier this month, accused infringer Eli Lilly filed a motion to dismiss for lack of subject-matter jurisdiction under Fed. R. Civ. P. 12(b)(1), contending that Plaintiff […]
On July 22, 2015, the Patent Trial and Appeal Board rejected Amneal Pharmaceuticals LLC’s America Invents Act (AIA) challenge to Endo Pharmaceuticals’ patent related to Opana ER. The patent at issue (the ‘216 patent) relates to oral controlled-release pharmaceutical formulations comprising oxymorphone and methods of using it for sustained pain relief. In its Final Written […]
The Federal Circuit handed down a decision interpreting the Biologics Price Competition and Innovation Act (BPCIA) in a way that effectively grants branded biologics an additional six months of exclusivity. However, in a win for biosimilar applicants, the Federal Circuit also held that the statutory directive to disclose abbreviated application and manufacturing information to the […]