Latest 3 Cases This Week: Amgen Inc. v. Amneal Pharmaceuticals LLC (Fed. Cir.), Hospira, Inc. v. Fresenius Kabi USA, LLC (Fed. Cir.), Commonwealth ...

Senate Secrecy: Can the Votes of Senators on President Trump’s Impeachment be Withheld from the Voting Public?

VIKRAM DAVID AMAR, JASON MAZZONE

Illinois law dean Vikram David Amar and professor Jason Mazzone evaluate the suggestion made by some that the votes of senators on President Trump’s impeachment can and should be private. Amar and Mazzone argue that while the text of the Constitution alone does not foreclose secrecy, structural, prudential, and logistical considerations strongly disfavor a secret vote on the matter.

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Amgen Inc. v. Amneal Pharmaceuticals LLC

Court: US Court of Appeals for the Federal Circuit

Docket: 18-2414

Opinion Date: January 7, 2020

Judge: Alan David Lourie

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

Amgen holds an approved New Drug Application for Sensipar®, a formulation of cinacalcet hydrochloride used to treat secondary hyperparathyroidism in adult patients with chronic kidney disease who are on dialysis and to treat hypercalcemia in patients with parathyroid cancer and primary and secondary hyperparathyroidism. Amneal, Piramal, and Zydus each filed an Abbreviated New Drug Application (ANDA) seeking to enter the market with a generic version of Sensipar®. Amgen sued each ANDA filer, alleging that the proposed ANDA products would infringe its 405 patent, which is directed to a rapid dissolution formulation of cinacalcet. The district court entered a judgment of non-infringement. The Federal Circuit vacated in part, finding that the district court construed the claims incorrectly and erred in its analysis of infringement by Amneal. The court affirmed with respect to Piramal and Zydus, finding that the district court properly applied prosecution history estoppel to Amgen’s arguments regarding Piramal and otherwise did not err in its factual findings for Zydus.

Hospira, Inc. v. Fresenius Kabi USA, LLC

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1329

Opinion Date: January 9, 2020

Judge: Alan David Lourie

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

Farmos developed and patented Dexmedetomidine, a compound that is effective as a sedative, in the 1980s, and conducted human studies using intravenous administration of 20 µg/mL dexmedetomidine hydrochloride. Farmos abandoned its testing based on adverse effects. In 1994, Farmos’s successor granted Abbott an exclusive license to make, use, and sell dexmedetomidine in the U.S. In 1999, Abbott received FDA approval for “Precedex Concentrate,” a 100 µg/mL concentration too strong to be directly administered to patients; the label provides dilution instructions. In 2002, the European Medicines Evaluation Agency authorized the use of Dexdomitor, a ready-to-use 500 µg/mL formulation of dexmedetomidine hydrochloride. Hospira’s 106 patent, entitled “Dexmedetomidine Premix Formulation,” is directed to a liquid for parenteral administration, “wherein the composition is disposed within a sealed container as a premixture.” Fresenius sought FDA approval for a generic ready-to-use dexmedetomidine product. Hospira sued for infringement. Fresenius stipulated to infringement of the 106 patent. The Federal Circuit upheld a finding that a claim in that patent is invalid as obvious over prior art. The patent states that the invention was based on “the discovery that dexmedetomidine prepared in a premixed formulation . . . remains stable and active after prolonged storage.” It does not recite any manufacturing limitations related to stability or an added component that enhances stability; it recites a composition, with a “wherein” clause that describes the stability of that recited composition, a result that was inherent in prior art.

Commonwealth v. Stirlacci

Court: Massachusetts Supreme Judicial Court

Docket: SJC-12735

Opinion Date: January 8, 2020

Judge: Barbara A. Lenk

Areas of Law: Drugs & Biotech, Health Law, Insurance Law

In this case involving the indictments of Dr. Frank Stirlacci and his office manager, Jessica Miller, for violations of the Controlled Substances Act and for submitting false health care claims to insurance providers, the Supreme Judicial Court affirmed in part and reversed in part the superior court's judgment dismissing several of the indictments, holding that there was sufficient evidence to indict Shirlacci on twenty-six counts of improper prescribing and to indict both defendants on twenty of the twenty-two counts of submitting false health care claims. The charges against Defendants included twenty-six counts each of improper prescribing, twenty counts each of uttering a false prescription, and twenty-two charges each of submitting a false health care claim. The trial judge dismissed the indictments for improper prescribing and uttering false prescriptions and dismissed six of the indictments against each defendant for submitting false health care claims. The Supreme Judicial Court reversed in part, holding (1) the evidence was sufficient to indict Stirlacci on all counts of improper prescribing, but Miller's status as a nonpractitioner precluded her indictment on improper prescribing; (2) there was insufficient evidence to indict either defendant for uttering false prescriptions; and (3) there was sufficient evidence to indict both defendants on twenty counts of submitting false health care claims.