A recently-published report from Cornerstone Research and the Stanford Law School Securities Class Action Clearinghouse analyzes securities class action litigation in 2020 and demonstrates both a continued focus by the plaintiffs’ bar on life science firms (including those in the pharmaceutical and biotechnology spaces), as well as specific trends in securities litigation affecting companies in

Biologic drugs, many of which are antibodies, represent an increasing share of the pharmaceutical market. In recent years, numerous broad functional patent claims directed at therapeutic antibodies have come under attack for failing to satisfy the written description and enablement requirements. The proper scope of these requirements has divided the biopharmaceutical industry. In its latest decision on this topic, Amgen Inc. et al. v. Sanofi, Aventisub LLC et al., ___ F.3d ___, No. 2020-1074 (Fed. Cir. Feb. 11, 2021), the Federal Circuit affirmed the invalidity of claims directed to therapeutic antibodies, noting that “functional claim limitations … pose high hurdles in fulfilling the enablement requirement.”

Continue Reading U.S. Federal Circuit Continues To Pressure BioPharma For More When It Comes To Functional Claims

George Lehmann, Insured Benefit Plans, Inc. v. Ohr Pharmaceutical, Inc., 2020 WL 5988517 (2nd Cir. Oct. 9, 2020)

On October 9, 2020, the Second Circuit affirmed the dismissal of an action brought against Ohr Pharmaceutical, Inc. and certain of its executives.  Plaintiffs alleged that the defendants made misleading statements concerning the efficacy of Ohr’s core product, a Squalamine-based treatment for wet age-related macular degeneration (WetAMD), a condition that can cause vision loss.

The complaint pleaded that in January 2018, Ohr announced the results of a phase III clinical trial of its WetAMD treatment, that the results of this trial showed that the treatment arm actually performed worse than the control arm, and that the Company’s stock price fell by over 80% as a result.


Continue Reading Second Circuit Affirms Dismissal of Action Regarding Clinical Trial Of Macular Degeneration Treatment

Nguyen v. Endologix, Inc., 2020 WL 3069776 (9th Cir. June 10, 2020)

On June 10, 2020, the Ninth Circuit affirmed the dismissal of a putative securities fraud class action brought against a medical device corporation, Endologix, Inc., and certain of its officers, regarding statements concerning the FDA’s likelihood of premarket approval of the Company’s aneurysm sealing product, Nellix. The Court held that plaintiff failed to allege facts giving rise to a strong inference of scienter (i.e., fraudulent intent) and thus failed to adequately plead a claim for securities fraud.


Continue Reading Ninth Circuit Affirms Dismissal of Action Regarding Statements Concerning Likelihood of FDA Premarket Approval of Aneurysm Sealing Device