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IRS Treatment of Litigation Costs in ANDA Cases Affirmed
Posted at August 25, 2023 in 35 U.S.C. § 271(e)(2), ANDA Litigation, Hatch Waxman Action by Christopher Johnson
The Third Circuit Court of Appeals affirmed on July 27, 2023, that infringement-suit defense costs for ANDA filers who file Paragraph IV certifications are deductible legal expenses, not capital expenditures to obtain FDA approval. The Court of Appeals noted that legal defense costs for ANDA filers do...
Supreme Court Upholds Federal Circuit’s Full-Scope Enablement Test in Amgen Inc. v. Sanofi
Posted at June 8, 2023 in Enablement, Section 112, Supreme Court by R. Willets Ely
Recently, a unanimous Supreme Court issued its ruling in Amgen Inc. v. Sanofi, holding that Amgen’s challenged patents ran afoul of Section 112’s enablement requirement.
Recitation of Common Functional Groups for Genus Claims Fails Written Description Requirement
Posted at March 29, 2023 in Anticipation, Claimed Priority Date, Invalidity, Section 112, Written description by Katherine Chen
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 claim the benefit of the earlier priority date, the patent was anticipated by prior art, and therefore unpatentable. This...
Federal Circuit Upholds Decision to Delist System Patent from the Orange Book
Posted at March 9, 2023 in ANDA Litigation, Orange book, Paragraph IV, REMS by Seung Sub Kim
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 Pharms., LLC, Case No. 2023-1186 (Fed. Cir. Feb. 24, 2023). When Avadel CNS Pharmaceuticals, Inc. (“Avadel”) submitted an NDA...
Amici Weigh in on Enablement in Amgen Inc. v. Sanofi
Posted at February 20, 2023 in Enablement, Section 112, Supreme Court by R. Willets Ely
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 address the propriety of the Federal Circuit’s heightened enablement requirement for genus claims, which may also be referred to...
IRS Treatment of Litigation Costs in ANDA Cases
Posted at February 6, 2023 in 35 U.S.C. § 271(e)(2), ANDA Litigation, Hatch Waxman Action by Christopher Johnson
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 they are incurred. The IRS is seeking this result and Mylan opposes it, arguing the second category (b) should...
The Practitioner’s Duty of Candor to the USPTO
Posted at December 20, 2022 in FDA, PTO by Carlson Caspers
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 duty broadly applies to all individuals associated with the filing and prosecution of a patent application, individuals associated with...
Section VIII Statement Does Not Create “a Case or Actual Controversy” to Establish Subject Matter Jurisdiction for Declaratory Judgment Counterclaim
Posted at October 6, 2022 in Counterclaims, Declaratory Judgment, Section viii Carve-Out, Subject matter eligibility by Carlson Caspers
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 multidistrict patent litigation case concerns Novartis’ heart medication sold under the brand name Entresto (sacubitril/valsartan). After Plaintiffs received notice...
District Court Allows Infringement Claims to Proceed for Patent Issued After ANDA Approval
Posted at July 27, 2022 in Infringement, Motion to dismiss by Carlson Caspers
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 15, 2022, while AstraZeneca’s patent, U.S. Patent No. 11,311,558 (the ’558 patent), directed to its asthma and COPD treatment...
Written Description Requirement for Negative Claim Limitations in Flux as Federal Circuit Panel Reverses Previous Panel Decision
Posted at July 11, 2022 in Indefiniteness, Invalidity, Section 112 by Carlson Caspers
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 claim limitations, a split Federal Circuit panel reversed a prior split panel decision and ultimately found a pharmaceutical dosing...
Antibody-Directed Inventions Require Robust Written Descriptions and Carefully Drafted Claims
Posted at February 8, 2022 in Enablement by Christopher Johnson
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). The accused product was HEMLIBRA® directed to treating hemophilia A with antibody emicizumab-kxwh or ACE910. Baxalta sued in 2017,...
Section VIII Carve-Outs Remain Viable in the Wake of GSK v. Teva
Posted at January 14, 2022 in Inducement, Section viii Carve-Out by Nathan D. Louwagie
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 to sell a generic version of Vascepa® for the SH indication only based on a “section viii carve-out” of...