Latest Case This Week: GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir.)

“Might as Well Carry a Purse with That Mask, Joe”: COVID-19, Toxic Masculinity, and the Sad State of National Politics

JOANNA L. GROSSMAN, LINDA C. MCCLAIN

SMU Dedman School of Law professor Joanna L. Grossman and Boston University law professor Linda C. McClain comment on COVID-19, toxic masculinity, and the state of national politics today. Grossman and McClain contrast President Trump’s reckless bravado that endangers the lives of Americans with the empathy of Democratic presidential nominee former Vice President Joe Biden’s in asking people to be patriotic by doing their part by wearing masks to protect other Americans.

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Should Department of Justice Lawyers Defy William Barr?

AUSTIN SARAT

Austin Sarat—Associate Provost, Associate Dean of the Faculty, and William Nelson Cromwell Professor of Jurisprudence and Political Science at Amherst College—comments on an open letter addressed to the 100,000 professionals working in the U.S. Department of Justice and published by Lawyers Defending Democracy. In the letter, more than 600 members of the bar from across the United States call on their DOJ colleagues to refrain from “participating in political misuse of the DOJ in the elction period ahead.” Sarat argues that the letter rightly recognizes that Attorney General Barr’s blatant partisanship endangers the integrity of the DOJ itself and its role in preserving the rule of law.

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GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 18-1976

Opinion Date: October 2, 2020

Judge: Pauline Newman

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

GSK’s 067 patent for “carvedilol” issued in 1985. The FDA initially approved carvedilol for treating hypertension; the product was marketed with the brand name Coreg®. Scientists continued to study carvedilol. In 1997, the FDA approved carvedilol for the additional treatment of congestive heart failure. GSK’s 069 patent issued in 1998, describing and claiming treatment with a combination of carvedilol and an angiotensin-converting enzyme (ACE) inhibitor, a diuretic, and digoxin. The patent was listed in the FDA’s Orange Book. In 2003, the FDA approved this Coreg® combination for use by patients suffering from left ventricular dysfunction following myocardial infarction. In 2002, Teva applied for FDA approval of generic carvedilol, certifying in the ANDA that its product would not be launched until the 067 patent expired and that the 069 patent was “invalid, unenforceable, or not infringed.” Teva received FDA tentative approval “for treatment of heart failure and hypertension,” to become effective in 2007. GSK, in 2003, sought reissue of the 069 patent, 35 U.S.C. 251. The 000 patent issued in 2008. In 2011 the FDA required Teva to amend its carvedilol label to be “identical in content to the approved [GSK Coreg®] labeling.GSK sued for infringement. A jury found the 000 patent valid and infringed, assessed damages, and found the infringement willful. The district court granted Teva judgment of non-infringement as a matter of law. The Federal Circuit reinstated the jury verdicts as supported by substantial evidence.