Latest 4 Cases This Week: In re Ocular Therapeutix Inc. (1st Cir.), Nevro Corp. v. Boston Scientific Corp. (Fed. Cir.), Valeant Pharmaceuticals ...

How Allen v. Cooper Breaks Important New (if Dubious) Ground on Stare Decisis

VIKRAM DAVID AMAR

Illinois Law dean and professor Vikram David Amar comments on language in a recent U.S. Supreme Court decision, Allen v. Cooperdiscussing constitutional stare decisis in the context of state sovereign immunity. Amar points out some of the problems with the Court’s jurisprudence on state sovereign immunity and Congress’s Section 5 power, and he questions the Allen majority’s embrace of a “special justification” requirement for constitutional stare decisis.

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In re Ocular Therapeutix Inc.

Court: US Court of Appeals for the First Circuit

Docket: 19-1557

Opinion Date: April 9, 2020

Judge: Stahl

Areas of Law: Drugs & Biotech, Securities Law

In this complaint alleging that Defendants intentionally or recklessly misled investors about Ocular Therapeutix, Inc.'s manufacturing problems the First Circuit affirmed the judgment of the district court dismissing Plaintiffs' complaint for failure to state a claim, holding that Plaintiffs failed to allege facts giving rise to a strong inference of scienter as required by the Private Securities Litigation Reform Act (PSLRA), 15 U.S.C. 78u-4, 78u-5. In 2015, Ocular submitted a new drug application to the FDA for approval of Dextenza. In 2017, the FDA published its observations of issues at Ocular's manufacturing facility, which resulted in a drop in the company's stock price. Plaintiffs, several shareholders, brought this securities fraud action on behalf of themselves and a putative class of investors alleging violations of section 10(b) of the Securities Exchange Act, 15 U.S.C. 78j(b) and section 20(a) of the Exchange Act, 15 U.S.C. 78t(a). The district court dismissed the complaint pursuant to Fed. R. Civ. P. 9(b) and 12(b)(6), the Exchange Act, and the PSLRA. The district court granted the motion and dismissed the complaint with prejudice. The First Circuit affirmed, holding that Plaintiffs did not allege facts giving rise to a strong inference of scienter as required by the PSLRA.

Nevro Corp. v. Boston Scientific Corp.

Court: US Court of Appeals for the Federal Circuit

Docket: 18-2220

Opinion Date: April 9, 2020

Judge: Kimberly Ann Moore

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

Nevro sued, alleging infringement of 18 claims across seven patents that are directed to high-frequency spinal cord stimulation therapy for inhibiting pain. Conventional spinal cord stimulation systems deliver electrical pulses to the spinal cord to generate sensations, such as tingling or paresthesia, that mask or otherwise alter the patient’s pain. The claimed invention purportedly improves conventional spinal cord stimulation therapy by using waveforms with high-frequency elements or components, which are intended to reduce or eliminate side effects. The district court issued a joint claim construction and summary judgment order, holding certain claims invalid as indefinite. As to the remaining six claims, found not indefinite, the court granted summary judgment of noninfringement. The Federal Circuit vacated and remanded. The district court erred in holding invalid as indefinite the “paresthesia-free” system and device terms and in holding indefinite the claims reciting the term “configured to.” The Federal Circuit construed “configured to” to mean “programmed to” and construed “means for generating” as a means-plus-function term, having a function of “generating” and a structure of “a signal/pulse generator configured to generate” the claimed signals. The district court erred in its claim construction but correctly determined that the term “therapy signal” does not render the claims indefinite; a “therapy signal” is “a spinal cord stimulation or modulation signal to treat pain.”

Valeant Pharmaceuticals International, Inc. v. Mylan Pharmaceuticals Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 18-2097

Opinion Date: April 8, 2020

Judge: Alan David Lourie

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

Valeant’s patent claims stable methylnaltrexone pharmaceutical preparations; methylnaltrexone, a quaternary amine opioid antagonist derivative, can be useful for reducing the side effects of opioids but is unstable in aqueous solution. The inventors discovered that when the pH of a methylnaltrexone solution is adjusted, the percentage of total degradants drops significantly. The patent is listed in the Orange Book for Relistor®, an injectable drug used to treat constipation as a side effect of taking opioid medication. Mylan filed an Abbreviated New Drug Application seeking FDA approval to market a generic version of Relistor®. Mylan conceded that its ANDA product would infringe claim 8 of the patent. The district court entered the parties’ stipulation to the construction of claim 8’s stability limitation: the phrase “the preparation is stable to storage for 24 months at about room temperature” means “the methylnaltrexone degradation products in the preparation do not exceed 2.0% of the total methylnaltrexone present in the preparation and the preparation is suitable for pharmaceutical use when stored for 24 months at room temperature” and granted summary judgment that claim 8 would not have been obvious. The court rejected Mylan’s expert testimony and cited references and Mylan’s theory that the claimed pH range would have been obvious to try. The Federal Circuit reversed. Mylar raised at least a prima facie case of obviousness. The district court’s obvious-to-try analysis is inconsistent with precedent.

Amgen Inc. v. Health Care Services

Court: California Courts of Appeal

Docket: B296563(Second Appellate District)

Opinion Date: April 9, 2020

Judge: Bendix

Areas of Law: Drugs & Biotech, Intellectual Property

This case arose when Amgen submitted a price increase notice to CCHCS and other registered purchasers. Reuters News made a request under the California Public Records Act, seeking the price increase notices. Amgen then filed a petition for writ of mandamus blocking disclosure. Amgen also moved for a preliminary injunction, which the trial court granted. While this appeal was pending, the trial court sustained CCHCS's demurrer to the mandamus cause of action with leave to amend, and then Amgen chose to dismiss the action instead. The Court of Appeal held that the appeal was not barred by the mootness doctrine where the issues raised are capable of repetition because there will be future price increase notices. Furthermore, the issues are likely to evade review because a pharmaceutical manufacturer has little reason to continue to prosecute a mandamus action after obtaining a preliminary injunction for the 60-day period before a price increase becomes public. On the merits, the court held that the trial court abused its discretion by concluding that Amgen had sufficiently shown that its price increase notice pursuant to Senate Bill No. 17 was a trade secret despite its disclosure to the registered purchasers. In this case, Amgen failed to explain how its purported trade secret maintained its confidentiality and concomitant value to Amgen when it was disclosed to over 170 purchasers who had the incentive to use the information to their benefit and Amgen's detriment, and were not subject to any restrictions on using or further disseminating the information. Likewise, the court held that the trial court abused its discretion in finding that the balance of harms favored Amgen. Therefore, the court reversed the trial court's order granting a preliminary injunction in favor of Amgen.