Latest 3 Cases This Week: C R Bard Inc. v. AngioDynamics, Inc. (Fed. Cir.), Ferring B.V. v. Allergan, Inc. (Fed. Cir.), Quidel Corporation v. ...

Update on Trump’s Coup: Do Not Think That This Is Guaranteed to End Well

NEIL H. BUCHANAN

UF Levin College of Law professor Neil H. Buchanan explains why “being patient with Trump” is a recipe for disaster, why there are still reasons to be guardedly optimistic, and why this all could still end very badly. Buchanan argues that the present situation is not guaranteed end badly, but he cautions that a Trump coup is eminently possible.

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C R Bard Inc. v. AngioDynamics, Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1756

Opinion Date: November 10, 2020

Judge: Jimmie V. Reyna

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

Bard and AngioDynamics both manufacture vascular access ports, devices implanted underneath a patient’s skin that allow the injection of fluid into the patient’s veins on a regular basis without starting an intravenous line each time. Vascular access ports were traditionally used to administer injections at low pressure and flow rates. Certain procedures, like computed tomography (CT) imaging, required the injection of fluids into patients at high pressure and high flow rates (power injection). As of 2005, vascular access ports were not FDA-approved for power injection but certain medical providers were using existing ports for power injection; in some cases, the pressure ruptured the port, seriously injuring the patient. Bard obtained FDA approval for PowerPort as the first vascular access port labeled for power injection and obtained the patents-in-suit. AngioDynamics then obtained FDA approval to market its own vascular access port products as suitable for power injection. Bard sued AngioDynamics for infringement. During the trial, the court granted judgment that the asserted claims were not infringed, were not willfully infringed, and were invalid as directed to printed matter. The Federal Circuit reversed. There was substantial evidence to support a jury finding of infringement and willfulness; the asserted claims are not directed solely to printed matter and are patent-eligible under 35 U.S.C. 101. A genuine dispute of material fact precludes summary judgment as to anticipation.

Ferring B.V. v. Allergan, Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 20-1098

Opinion Date: November 10, 2020

Judge: O'Malley

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

Fein was a consultant for Ferring Pharmaceuticals, involved in a project involving desmopressin, a synthetic analog of the naturally occurring hormone arginine vasopressin, which regulates the body’s retention of water. Fein suggested administration as a waterless orodispersible form to improve the bioavailability of the desmopressin. In 2002, Ferring filed a Great Britain Patent Application, covering an orodispersible desmopressin formulation but did not list any inventors. When Ferring experienced production delays, it undertook another clinical study with an intravenous desmopressin formulation. Fein was selected to oversee the U.S. study and suggested certain changes. After Ferring terminated Fein’s consulting agreement, both parties continued to test various formulations. Both Ferring and Fein filed patent applications. Fein’s company sold the right to commercialize a low-dose desmopressin intranasal spray. Ferring unsuccessfully requested reexamination of Fein’s patent, then filed a complaint asserting state law claims and claims for correction of inventorship of the Fein patents under 35 U.S.C. 256. The district court granted the defendants summary judgment, finding that conduct occurring before the issuance of Fein's patents could give rise to equitable estoppel of claims for correction of inventorship. The court noted Ferring’s inaction for over seven years following letters from Fein’s attorney. On counterclaims for correction of inventorship of Ferring’s patents, the court granted Ferring judgment. The Federal Circuit vacated and remanded for further development of the record, noting the fact-laden equitable issue and the need to avoid a rush to judgment.

Quidel Corporation v. Super. Ct.

Court: California Courts of Appeal

Docket: D075217A(Fourth Appellate District)

Opinion Date: November 6, 2020

Judge: Richard D. Huffman

Areas of Law: Antitrust & Trade Regulation, Business Law, Civil Procedure, Drugs & Biotech

Quidel Corporation (Quidel) petitioned for a writ of mandate and/or prohibition to direct the trial court to vacate its order granting summary adjudication. Quidel contended the trial court incorrectly concluded a provision in its contract with Beckman Coulter, Inc. (Beckman) was an invalid restraint on trade in violation of Business and Professions Code, section 16600. Quidel argued the trial court improperly extended the holding from Edwards v. Arthur Andersen LLP, 44 Cal.4th 937 (2008) beyond the employment context to a provision in the parties’ 2003 BNP Assay Agreement (the Agreement). In its original, published opinion, the Court of Appeal concluded it was not, granted the petition and issued a writ instructing the trial court to vacate the December 2018 order granting summary judgment on the first cause of action. The California Supreme Court then granted review of the Court of Appeal's opinion and ordered briefing deferred pending its decision in Ixchel Pharma, LLC v. Biogen, Inc., S256927. On August 3, 2020, the Supreme Court issued Ixchel Pharma, LLC v. Biogen, Inc., 9 Cal.5th 1130 (2020), which held “a rule of reason applies to determine the validity of a contractual provision by which a business is restrained from engaging in a lawful trade or business with another business.” The Quidel matter was transferred back to the Court of Appeals with directions to vacate its previous opinion and reconsider the case in light of Ixchel. The appellate court issued a new opinion in which it concluded the trial court’s decision was incorrect. The trial court was directed to vacate the December 7, 2018 order granting summary adjudication on the first cause of action.