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…
Recently, the Eleventh Circuit sided with Florida-based Catalyst Pharmaceuticals Inc., holding that the U.S. Food and Drug Administration’s interpretation of the Orphan Drug Act is contrary to the plain language of the statute. Catalyst Pharm., Inc. v. Becerra. The court found that the FDA unlawfully infringed on an exclusivity period it awarded to Catalyst for…
Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (“Amarin”) sued ANDA-holder Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals PLC (“Hikma”) and health insurance provider Health Net, LLC (“Health Net”) for induced infringement of three patents covering methods of use for Amarin’s drug Vascepa®. Notably, the complaint asserts a novel theory of induced infringement against Health Net.…
A Special Discovery Master in Celgene Corp. v. Hetero Labs Ltd., No. 17-3387 (D.N.J. Mar. 29, 2021)1 recently issued a Report and Recommendation requiring defendants to move to amend their invalidity contentions to add dozens of prior art references that defendants’ experts relied on, but which defendants failed to disclose in their invalidity contentions. The court…
In a nonprecedential opinion issued on June 25, 2021, the Federal Circuit upheld the PTAB’s rule against incorporation of evidence by reference. 3M Company v. Evergreen Adhesives, Inc., No. 2020-1738 (Fed. Cir. June 25, 2021). 3M filed an IPR against Evergreen Adhesives Inc. (formerly Westech Aerosol Corp.), asserting that its aerosol adhesive patent was invalid…
Judge Bryson, sitting in the District of Delaware invalidated four patents owned by Lipocine, Inc., finding that the patents did not meet the written description and enablement requirements of 35 U.S.C. § 112. Lipocine Inc. v. Clarus Therapeutics, Inc., No. 19-622 2021 (D. Del. 2021). Lipocine’s patents were directed to methods for treating men deficient…
Last week, the Eastern District of Kentucky declined to stop a third-party company from importing a key pharmaceutical compound on behalf of a generic drug developer, holding that the company was protected by the Hatch-Waxman Act’s “safe harbor” provision. Although the importer itself was not developing the generic drug, its actions were “in furtherance” of…