Last week the Northern District of Illinois found it lacked personal jurisdiction over foreign patentee Daiichi Sankyo Co., Ltd. and its U.S. subsidiary, Daiichi Sankyo, Inc.. Torrent Pharma. Ltd. v. Daiichi Sankyo Co., Ltd., No. 16-C-2988 (N.D. Ill. July 25, 2016). The First Benicar® Case. Daiichi holds the NDA for Benicar® and markets the blood…
A recent order from the Federal Circuit serves as a good reminder that a party’s statements in its ANDA may be used against the party in litigation. Intendis GmbH v. Glenmark Pharms. Inc., 822 F.3d 1355 (Fed. Cir. 2016). The Court relied on statements in the ANDA about the function of the claimed excipients to…
Companies currently holding the exclusive rights to biologics should be celebrating the Federal Circuit’s decision released earlier this week. In Amgen v. Apotex, the Court held that all biosimilar applicants must provide a 180-day notice to owners of the NDA for the referenced biologic before engaging in commercial marketing of their biosimilars. Amgen Inc. v.…
Last week, in Genzyme v. Biomarin, the Court of Appeals for the Federal Circuit held petitioners may introduce new evidence after an institution decision in IPR proceedings as long as the opposing party received notice of the new evidence and an opportunity to respond. In its final written decision, the PTAB relied on references beyond…
Yesterday in Cuozzo Speed Techs., LLC v Lee, the Supreme Court clarified two aspects of inter partes review procedure: (1) the Patent Trial and Appeal Board (PTAB) may continue to use the broadest reasonable claim construction standard for construing the claims of unexpired patents; and (2) the PTAB’s decision to institute (or not institute) an…
On May 24th 2016, a panel consisting of Federal Circuit Court of Appeals Judges Kathleen O’Malley, Jimmie Reyna, and Raymond Chen, as well as Minnesota District Court Judge Joan Erickson, offered guidance for practice before the Federal Circuit. Some of the insight and advice the judges shared is provided below. Focus on the Issues Do…
The Patent Trial and Appeal Board (PTAB) recently denied motions by Teva to amend the filing dates of two petitions to institute IPRs related to patents covering Suboxone, a drug used to help patients suffering from opioid addiction. Teva’s deadline for filing these petitions was December 3, 2016, but due to technical difficulties in filing,…
In Merck & CIE v. Watson Laboratories, Inc., No. 2015-2063, 2016 U.S. App. LEXIS 8782 (Fed. Cir. May 13, 2016), the Federal Circuit reversed a District of Delaware Paragraph IV decision, and held that the patent-in-suit was invalid under the on-sale bar of pre-AIA Section 102(b). The sole asserted claim was directed to crystalline calcium…
A recent order the District of New Jersey highlights the importance of diligence in establishing good cause to amend a party’s contentions, and that a claim construction ruling is a not a free pass to amend infringement contentions. Takeda Pharmaceutical Co. Ltd., et al. v. Sun Pharma Global FZE et al., Case No. 14-cv-4616 (D.N.J.)…
Last Wednesday we commented on a Delaware decision (Andrews, J.) applying the Federal Circuit’s Mayo analysis to find that a patent on a new dosing regimen for an old drug lacked patentable subject matter under 35 U.S.C. § 101. Alice in Pharma Land. Two days later, the Federal Circuit affirmed another Delaware decision (Stark, J.)…