Latest 2 Cases: Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd. (Drugs & Biotech), DAI Global, LLC v. Administrator of United States ...

Taking Stock: A Review of Justice Stevens’s Last Book and an Appreciation of His Extraordinary Service on the Supreme Court

RODGER CITRON

Rodger D. Citron, the Associate Dean for Research and Scholarship and a Professor of Law at Touro College, Jacob D. Fuchsberg Law Center, comments on the late Justice John Paul Stevens’s last book, The Making of a Justice: Reflections on My First 94 Years. Citron laments that, in his view, the memoir is too long yet does not say enough, but he lauds the justice for his outstanding service on the Supreme Court.

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Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd.

Docket: 18-2361

Opinion Date: December 27, 2019

Judge: Jimmie V. Reyna

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

Persion’s 760 and 499 patents, both entitled “Treating Pain in Patients with Hepatic Impairment” share a common written description and priority date and are directed to methods of treating pain in patients with mild or moderate compromised liver functionality, using extended-release hydrocodone-only formulations. Hydrocodone is an opioid, widely used to treat pain, and has been FDA-approved since 1943. The patents cover the formulation for Zohydro ER.4. Persion sued, alleging that Alvogen infringed the patents by filing an Abbreviated New Drug Application seeking to market a generic version of Zohydro ER.4. The Federal Circuit affirmed a finding that the patents are invalid as obvious. The district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims. Regardless of whether the court’s consideration of the FDA’s statement was proper, there was no clear error in the court’s finding that there was a motivation to combine prior art in light of the evidence as a whole. The district court considered Persion’s evidence of objective indicia together with the other evidence on the issue of obviousness and there is no inconsistency between the district court’s findings underlying its obviousness and lack of written description determinations.

DAI Global, LLC v. Administrator of United States Agency for International Development

Docket: 19-1330

Opinion Date: December 27, 2019

Judge: Kimberly Ann Moore

Areas of Law: Government & Administrative Law, Government Contracts

In 2006-2010, the U.S. Agency for International Development (USAID) awarded DAI developmental services contracts for Afghanistan. DAI subcontracted with EI, which employed over 1,000 individuals to provide security services. Afghanistan imposed a $2 million fine on EI based on the size and composition of EI’s private security workforce. EI paid the fine, allocating the expense among DAI’s contracts. In May 2017, DAI submitted EI’s claims to USAID. DAI’s cover letter characterized itself as a certification. DAI also included EI’s certifications stating that each claim was in good faith; 70 days after DAI submitted its claims, the contracting officer notified DAI that the submission did not contain a contractor certification. DAI filed appeals. The Board dismissed DAI’s claims for lack of jurisdiction based on DAI’s failure to certify the claims (41 U.S.C. 7103(a)(1)), stating that DAI’s May 2017 certification bore no resemblance to the required statutory language, that DAI made its certification with reckless disregard for the requirements, and that nontechnical mistakes in the certification and DAI’s recklessness rendered DAI’s purported certification unsalvageable. The Federal Circuit reversed. The statute provides that “[a] defect in the certification of a claim does not deprive a court or an agency board of jurisdiction over the claim.” EI’s certifications, which mirror the certification language of 48 C.F.R. 33.207(c), evidence an intent to certify the claims. Because the contracting officer failed to issue a decision within the statutory period, DAI’s claim was deemed denied and became appealable, 41 U.S.C. 7103(f)(5).