The Practitioner’s Duty of Candor to the USPTO

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 […]

Section VIII Statement Does Not Create “a Case or Actual Controversy” to Establish Subject Matter Jurisdiction for Declaratory Judgment Counterclaim

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 […]

District Court Allows Infringement Claims to Proceed for Patent Issued After ANDA Approval

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 […]

Written Description Requirement for Negative Claim Limitations in Flux as Federal Circuit Panel Reverses Previous Panel Decision

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 […]

Antibody-Directed Inventions Require Robust Written Descriptions and Carefully Drafted Claims

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).  […]

Section VIII Carve-Outs Remain Viable in the Wake of GSK v. Teva

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 […]

Actual Filer of aBLA Not a Necessary Party in BPCIA Litigation

Recently, District Judge John Z. Lee of the Northern District of Illinois refused to dismiss a patent infringement suit brought under the Biosimilar Price Competition and Innovation Act (“BPCIA”) against a foreign parent company on the grounds that the domestic subsidiary was not a necessary party. See AbbVie Inc. v. Alvotech hf., No. 21-cv-02258 (N.D. […]

11th Circuit Rules that the Scope of Orphan Drug Exclusivity is Determined by the Rare Disease or Condition Designation, Not the Approved Indication

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 […]

Delaware Judge Finds Novel Induced Infringement Theory Directed at Health Insurance Provider Sufficiently Plead

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. […]

“Clever Labeling” of Prior Art Not Disclosed in Invalidity Contentions Insufficient to Satisfy District of New Jersey Local Patent Rules

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 […]