We closed out July 2025 in Boston alongside several of our Axinn colleagues attending the American Conference Institute's 12th Annual Summit for Women Leaders in Life Sciences Law.

On October 31, 2023, FDA approved Amgen's Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen's Stelara (ustekinumab). Stelara has been selected by the Center...

It was a tough day for opposing patent damages experts in Ecolab Inc. v. Dubois Chemicals, Inc., as Judge Andrews of the District of Delaware granted Daubert motions directed to both experts' reasonable royalty opinions.

The continuing debate as to where to draw the line between encouraging innovation and lowering drug costs was front and center during a Senate HELP Committee confirmation hearing for NIH director...

According to Judge Gilstrap in the Eastern District of Texas, obligations to negotiate under fair, reasonable, and non-discriminatory (FRAND)...

Reflecting back on our time at the 13th Annual Pharma IPR Conference in Mumbai, there was a lively discussion during the panel that I moderated on Industry Insights...

Last week, the Seventh Circuit heard arguments in Motorola Solutions, Inc. v. Hytera Communications Corp. concerning when, if at all, civil claims under the Defend Trade Secrets Act ("DTSA")...

In a report by IPlytics, published today, they have confirmed what most in the business already presumed: that ownership of 5G standard essential patents (SEPs)...

The International Trade Commission has undergone a fundamental shift over the past 18 months, with new precedent on domestic industry requirements and dramatic changes in filing patterns. This analysis examines how recent Federal Circuit decisions, USPTO policy reversals, and shifting government priorities are reshaping IP enforcement strategy at the ITC.

A great thing about patent litigation is the vast array of legal doctrines, arguments, and defenses that can come up in any given case.

In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding...

On April 30, 2024, the U.S. Patent and Trademark Office (PTO) issued a Request for Comment on how AI technology could affect the PTO's evaluation of patentability...

The 2024 ABA/IBA International Cartel Workshop in Barcelona, Spain just wrapped up after three days full of demonstrations around a cartel hypothetical, substantive panels...

While on site at the 2025 Spring Meeting of the ABA Antitrust Law Section, managing partner Jeny Maier and partner James Hunsberger conducted one-on-one interviews for the Our Curious Amalgam podcast...

As we anticipated, the FTC has appealed Judge Kernodle's judgment in Chamber of Commerce v. Federal Trade Commission that vacated the FTC's new HSR Rule and Form.

FTC recently placed improper Orange Book patent listings squarely in its crosshairs. In its September 2023 policy statement, FTC announced that it would "scrutinize improper Orange Book listings"...

In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India...

After more than a year in effect, the FTC’s burdensome new rule for HSR filings has been suspended. Effective immediately, parties to HSR-reportable deals may comply with the HSR Act...

On October 1, 2025, the federal government shut down, causing non-essential government agencies to close temporarily due to a lapse in appropriations.

Last week, on February 3, 2026, Congress passed the Consolidated Appropriations Act ("the Act"), providing generic drug manufacturers much-needed clarity as to when inactive ingredients in an ANDA are qualitatively and quantitatively ("Q1/Q2") the same as those in the reference listed drug ("RLD").