Protecting Biotech Innovation In The Platform Knowledge Era

Following the U.S. Food and Drug Administration's recent shift toward leveraging prior and platform knowledge in biotechnology, companies should protect their innovations by guarding against obviousness challenges and treating the entire development pipeline as a source of patentable innovation, says Aisha Hasan at Barnes & Thornburg.

Series

Judges On AI: Examining Administrative, Organizational Uses

U.S. District Judge Alan Albright of the Western District of Texas examines how artificial intelligence could transform a court's ability to deal with administrative work and organize materials when preparing for hearings or drafting opinions, thereby affording judges more time to resolve contested issues.

USPTO-Fed. Circ. Split Complicates Machine Learning Patents

The wide chasm between the USPTO's and the Federal Circuit's approach to eligibility for machine learning patents means that patent drafters must avoid functional claiming and specifications if they hope to avoid invalidation of a machine learning patent at the appellate court, says attorney Michael Kiklis.

How 9th Circ. 'Shadow Trading' Case May Affect Private Credit

Private credit firms should not wait for a result in the Ninth Circuit appeal in U.S. Securities and Exchange Commission v. Panuwat to address material nonpublic information exposure under existing statutes and take steps to ensure their internal policies and surveillance are ready for increased regulatory scrutiny, says Steve Brown at StarCompliance.

AG Watch: Ohio AG Joins State Antitrust Enforcement Trend

Amid the recent reprioritization in the federal government's competition enforcement agenda, two recent cases provide critical insight into how the Ohio attorney general will proceed in the relatively unprecedented trend of state attorneys general aggressively pursuing antitrust matters, say attorneys at BakerHostetler.

Series

Being A Singer Makes Me A Better Lawyer

Before law school, I spent seven years trying to make it as a professional singer in Los Angeles, and nearly everything I learned about preparation, humility, confidence and more has followed me into my legal practice, says Jessica Caterina at Moses & Singer.

Mass. UHC Fraud Suit Signals States' Medicaid FCA Push

Massachusetts' recently filed False Claims Act suit alleging UnitedHealthcare misrepresented the health status of enrollees in a Medicaid senior care organization plan it managed pushes forward a new phase of state-level scrutiny of managed care data and Medicaid payment mechanisms, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwendolyn Stamper at Vogel Slade.

FDA Draft Guidance Maps Payor Strategy For Psychedelics

Recently revised guidance from the U.S. Food and Drug Administration will operationalize a framework permitting drug developers to share product information with insurance companies, giving psychedelic therapeutics developers a road map for building a successful payor infrastructure before approval, says Kimberly Chew at Husch Blackwell.

How 2nd Circ. Raised The Bar For Pleading Securities Fraud

In Huey v. Anavex, the Second Circuit recently appeared to increase the burden on securities fraud plaintiffs in pleading loss causation where no immediate share price decline follows the corrective disclosure, generating new questions that district courts must grapple with, say attorneys at Skadden.

Quantifying Damages In Product Launch Delay Allegations

In delayed generic-drug entry cases that have generated substantial settlements in recent years, damages are often measured by profits lost during the delay window, but this model can fail to account for potentially significant economic harm that occurs after that window, say analysts at Kroll.

3rd Circ. ERISA Ruling Stresses Process Over Perfect Returns

The Third Circuit's recent decision in Quest Diagnostics affirms that a sound fiduciary process — not perfect investment returns — defeats Employee Retirement Income Security Act claims, signaling that courts will keep scrutinizing how fiduciaries decide, and sponsors who can show their work should remain protected, say attorneys at Nixon Peabody.

Fed. Circ. Licensing Rulings Shed Light On Patentee Standing

Two recent decisions from the Federal Circuit provide a useful framework for evaluating whether a patent license agreement preserves a sufficient exclusionary interest to support future patent infringement claims, say attorneys at Venable.

Series

Being A Magician Makes Me A Better Lawyer

The skills I've developed as a lifelong magician have translated directly into tangible benefits in the courtroom because performing magic and trying cases both live at the intersection of psychology, storytelling, timing and disciplined rehearsal, says Mark Dombroff at Fox Rothschild.

How Pfizer Won Fed. Circ. Patent Dispute By 1 Carbon Atom

The Federal Circuit's recent refusal to revive a patent in Enanta Pharmaceuticals v. Pfizer over an alleged typo creating a one-atom difference in a COVID-19 treatment application hands defendants a template for potentially converting a triable fact question into an early dispositive ruling, say attorneys at Polsinelli.

What Data Says About Biologics-Related Ex Parte Challenges

An analysis of the 67 ex parte reexaminations used to challenge biologics patents over the last 13 years reveals that reexamination may emerge as an alternative to inter partes review and postgrant review, despite facing a number of procedural disadvantages, say attorneys at Steptoe.