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Life Sciences › Biosimilars › Abbreviated New Drug Application (ANDA)

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

Personal Jurisdiction Over Foreign Companies that File an ANDA or aBLA in the U.S.

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

On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more

Axinn, Veltrop & Harkrider LLP

More Skinny-Label Drama or Just Your "Run-Of-The-Mill" Induced Infringement Case?

Axinn, Veltrop & Harkrider LLP on

The Federal Circuit's recently issued decision in the Amarin/Hikma case continues the drama around skinny labeling for generic and biosimilar products, but the panel certainly went out of its way to couch its analysis as an...more

Sheppard Mullin Richter & Hampton LLP

FTC's Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

Sheppard Mullin Richter & Hampton LLP on

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

American Conference Institute (ACI) on

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Proskauer - Life Sciences

GSK v. Teva: Federal Circuit Issues New Opinion Analyzing Induced Infringement

Proskauer - Life Sciences on

On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more

Haug Partners LLP

Next-Generation Antibodies: Antibody-Drug Conjugates

Haug Partners LLP on

Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...more

Wilson Sonsini Goodrich & Rosati

FDA Releases Final Guidance: Transition of Previously Approved Drugs to Being "Deemed Licensed" Biologics

Wilson Sonsini Goodrich & Rosati on

U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons....more

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - June 2018

McDonnell Boehnen Hulbert & Berghoff LLP on

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Fresenius Kabi USA, LLC v. Eurohealth International...more

Seyfarth Shaw LLP

Innovation In Hatch-Waxman And ANDA Litigation

Seyfarth Shaw LLP on

The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and development; and (2) to help generic drugs reach the market more quickly. Through...more

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