News & Analysis as of

Patent Prosecution Abbreviated New Drug Application (ANDA) Pharmaceutical Industry

Rothwell, Figg, Ernst & Manbeck, P.C.

Breaking the Patent Thicket: Why the Proposed ETHIC Act Could Have Big Implications on Pharma Patent Law

On July 15, 2025, U.S. Senators Peter Welch (D‑VT), Josh Hawley (R‑MO), and Amy Klobuchar (D‑MN) introduced the ETHIC Act—the Eliminating Thickets to Increase Competition Act (S. 2276)—in the U.S. Senate. The bill is designed...more

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Robins Kaplan LLP

Azurity Pharms., Inc. v. Alkem Labs. Ltd.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: The ’948 patent claims non-sterile drinkable liquid formulations of vancomycin, an antibiotic used to treat Clostridium difficile infection. These formulations are particularly...more

MoFo Life Sciences

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

MoFo Life Sciences on

While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal...more

Knobbe Martens

The Sometimes Limiting Effect of "Wherein" Clauses

Knobbe Martens on

ALLERGAN SALES, LLC v. SANDOZ, INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of New Jersey. Summary: A “wherein” clause can be limiting if it is material to...more

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