FDA Closeout Letter Suggests Relaxing Stance On Wearables

The U.S. Food and Drug Administration's recent decision not to pursue enforcement action against Whoop's wearable blood pressure tracker, read together with guidance released earlier this year, suggests a softer shift in the FDA's approach to regulating wearables, say attorneys at Arnold & Porter.

Fed. Circ. Dental IP Ruling Reinforces Prior Art Framework

The Federal Circuit's recent decision in Dental Monitoring v. Align Technology reaffirms the necessity of substantive written description support for establishing an earlier effective prior art date under the America Invents Act, and aligns Patent Trial and Appeal Board practice with district court litigation, say attorneys at Morgan Lewis.

Justices' Hikma Reasoning May Extend Well Beyond Pharma

The active steps framework announced by the U.S. Supreme Court in its Hikma v. Amarin decision, finding that Amarin failed to plausibly allege inducement of infringement, has the potential to reshape how courts evaluate inducement claims across patent, copyright and other doctrines, say attorneys at BCLP.

Teva MDL Loss Shows DPAs Can Return To Haunt Civil Suits

Teva’s recent partial summary judgment loss in antitrust multidistrict litigation reinforces the importance of carefully scrutinizing any statement of facts a company admits to in a deferred prosecution agreement, and illustrates the potential costs of resolving a criminal investigation this way, say attorneys at Sheppard.

An Inside Look At Squires' Discretionary Denials

A deep dive into the discretionary denials issued by U.S. Patent and Trademark Office Director John Squires since he took over last year identifies trends in commonly asserted arguments and how they correlate with institution outcomes, say attorneys at Kirkland & Ellis.

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Ballet Makes Me A Better Lawyer

A lifetime of learning and performing ballet taught me that success — whether in dance or practicing law — comes only through hours of thorough preparation, boundless energy and relentless effort, says Sharon Katz-Pearlman at Greenberg Traurig.

Fed. Circ. In July: Meeting The Enablement Requirement

The Federal Circuit's decision in Wyeth v. AstraZeneca last month exemplifies when a generalized conception of an invention is insufficient to enable the full scope of asserted patent infringement claims, and may lead to more enablement challenges, say attorneys at Knobbe Martens.

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Taekwondo Makes Me A Better Lawyer

Taekwondo has taught me to recognize when to fight for a position and when to focus on finding a solution, and that the best outcomes are often achieved by solving problems — all of which has improved my work as a bankruptcy lawyer, mediator and Subchapter V trustee, says Amy Denton Mayer at Berger Singerman.

Why AI Diligence Is Especially Key In IP Practice

In light of recent federal court sanctions against intellectual property litigators for filing work product generated by artificial intelligence without verification, it's important to consider the unique risks and consequences that can arise from overreliance on AI, which poses less visible risks in IP matters, says Stephen Ball at Husch Blackwell.

How 'Most Favored Nation' Regime Affects Biopharma Deals

As M&A activity surges in the biopharma space, companies will need to account for the Trump administration's most-favored-nation pricing proposals — durable in concept, if unsettled in detail — when drafting deals, say attorneys at Gibson Dunn.

What To Know As Legal Duty To Consider AI Takes Shape

While the U.K. Jurisdiction Taskforce’s recent statement on liability for artificial intelligence harms is nonbinding for both U.K. and U.S. lawyers, it highlights the importance of being able to distinguish between the availability of a tool and a professional obligation to use it, say Jonny Frank and Michael Costa at StoneTurn.

NC Dental Review Change Counters Tougher National Trend

North Carolina’s elimination of its prior review requirement for dental management agreements departs sharply from the national trend toward expanded corporate practice of medicine oversight, but stakeholders should not view this regulatory shift as a relaxation of compliance expectations, say attorneys at Holland & Knight.

NY Bill Would Boost Litigation Risk For Cosmetics Cos.

The Beauty Justice Act, now pending in the New York Legislature, would not only present compliance challenges for companies making cosmetics and personal care products, but could also be used by private plaintiffs to bring consumer fraud, false advertising, toxic exposure and product liability claims, says Kadeejah Kelly-Previl at Faegre Drinker.

How To Structure Protective Order AI Provisions In IP Disputes

A survey of protective orders in recent intellectual property litigation reveals best practices for drafting provisions on artificial intelligence use that maximize IP protection while balancing enforceability with efficient discovery, say Matthew Stephens and Bryce Tabbut at MoFo.

Appellate Vape Rulings May Expand State Regulation Powers

Two recent federal appeals courts decisions rejecting Federal Food, Drug and Cosmetic Act preemption challenges to state electronic nicotine delivery systems directory laws signal an emerging appellate consensus that could significantly expand states' power to regulate vaping product sales where federal enforcement falls short, say attorneys at Troutman.