The Fed. Circ. In June: More Liability For Generic-Drug Makers

The Federal Circuit’s June ruling in Amarin v. Hikma will likely result in more allegations of induced infringement by generic drugs postapproval, with more of those cases proceeding to at least the summary judgment stage instead of being cut off at the outset, say Jeremiah Helm and Sean Murray at Knobbe Martens.

Proposed NIL Deal Leaves NCAA Antitrust Liability Door Open

The proposed House v. NCAA settlement filed in California federal court creates the possibility of significant direct payments to student-athletes for the first time, but the resulting framework is unlikely to withstand future antitrust scrutiny because it still represents an agreement among competitors to limit labor cost, says Yaman Desai at Lynn Pinker.

Opinion

Expert Witness Standards Must Consider Peer Review Crisis

For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.

USPTO Must Anticipate 'Black-Box Problem' For AI Inventions

The U.S. Patent and Trademark Office's recent guidance allows patents for inventions created with artificial intelligence, but inventors need to address the so-called black-box problem to ensure others can recreate the invention, thus meeting the enablement requirement, say Mark Basanta and Georg Reitboeck at Haug Partners.

Irish Businesses Should Act Now To Prepare For EU AI Act

Artificial intelligence is increasingly transforming the Irish job market, and proactive engagement with the forthcoming European Union AI Act, a significant shift in the regulatory landscape for Irish businesses, will be essential for Irish businesses to responsibly harness AI’s advantages and to maintain legal compliance, say lawyers at Pinsent Masons.

How To Grow Marketing, Biz Dev Teams In A Tight Market

Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.

Considerations For Federal Right Of Publicity As AI Advances

Amid rapid advances in generative artificial intelligence technology, Congress should consider how a federal right of publicity would interact with the existing patchwork of state name, image and likeness laws, as well as other issues like scope, harm recognized and available relief, says Ross Bagley at Pryor Cashman.

What Patent Litigators Should Know About CHIPS Act Grants

With the U.S. Department of Commerce now actively awarding grants under the CHIPS and Science Act, recipients should ensure they understand the implications of promises to construct new semiconductor manufacturing facilities, especially in jurisdictions with active patent litigation dockets, say Gabriel Culver and Peter Hillegas at Norton Rose.

Patent Lessons From 5 Federal Circuit Reversals In June

A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

Series

Rock Climbing Makes Me A Better Lawyer

Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.

Think Like A Lawyer: Dance The Legal Standard Two-Step

From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.

Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance

A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.

Recent Settlement Shows 'China Initiative' Has Life After Death

Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.

How Orange Book Antitrust Scrutiny Is Intensifying

Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.

Trending At The PTAB: 1 Year Of Denials Of Institution

An analysis of Patent Trial and Appeal Board denials of institutions between May 2023 and May of this year highlights the board’s common reasons for denial, which can provide insight to both petitioners and patent owners in future proceedings, say Kevin Rodkey and Victor Palace at Finnegan.