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 […]
Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware granting a motion for an injunction to delist Jazz Pharmaceuticals, Inc.’s (“Jazz”) REMS patent from the Orange Book, as the patent covers neither the drug itself nor a method of using it. Jazz Pharms., Inc., v. Avadel CNS […]
On Friday, February 10, 2023, the latest round of amicus briefs in Amgen Inc. v. Sanofi poured in. The case, set to be argued on March 27 before the U.S. Supreme Court, asks the Court to wrestle with the enablement requirement of Section 112 of the Patent Act. Specifically, the Court has been asked to […]
The Third Circuit Court of Appeals will decide whether the IRS can force Mylan (and by extension other ANDA filers) to treat a) legal expenses to prepare notice letters and b) legal expenses to defend against infringement suits after paragraph IV certification both as capital expenditures that may not be deducted entirely in the year […]
The United States Patent and Trademark Office (“USPTO”) issued a notice to clarify disclosure duties owed to it entitled Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board (“the Notice”). Parties have a duty of candor and good faith to the USPTO. This […]
Judge Richard Andrews of the District of Delaware dismissed counterclaims lodged by two generic drug manufacturers, finding that no justiciable declaratory judgment controversy arises for an ANDA filer who only submits statements pursuant to 21 U.S.C. § 355(j)(2)(A)(viii) (“Section viii statements”). In re: Entresto (Sacubitril/Valsartan) Patent Litigation, No. 20-md-02930 (D. Del. Sept. 27, 2022). This […]
In a recent order, Judge John Bailey from the Western District of Virginia denied Defendant Mylan’s 12(b)(6) motion to dismiss § 271(e) infringement claims despite the USPTO issuing Plaintiff AstraZeneca’s patent after the FDA approved Mylan’s ANDA. AstraZeneca AB v. Mylan Pharmaceuticals Inc_, 2022 U.S. Dist. LEXIS 123111. Mylan’s ANDA application was approved on March […]
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 […]
In a recently unsealed opinion from the District of Delaware, Judge Dyk of the Federal Circuit sitting by designation, held a patent in the “inherently unpredictable” field of antibodies invalid on summary judgment for failing to satisfy the enablement requirement. Baxalta Inc. v. Genentech Inc. Delaware Opinion, Case No. 17-cv-509-TBD (D. Del. Jan. 13, 2022). […]
Last week, Judge Andrews from the District of Delaware granted Defendant Hikma’s motion to dismiss Plaintiff Amarin’s induced infringement claims related to the drug Vascepa®. Amarin Pharma, Inc. v. Hikma Pharm. USA Inc. Amarin sells Vascepa® for two indications: severe hypertriglyceridemia (the “SH indication”) and cardiovascular risk reduction (the “CV indication”). Hikma received FDA approval […]