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Pharmaceutical Industry › Regulatory Requirements › Preliminary Injunctions

Robins Kaplan LLP

United Therapeutics Corp. v. Liquidia Techs., Inc.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: UTC’s ’782 patent claims a method for treating pulmonary hypertension (“PH”). PH manifests in different varieties, including pulmonary arterial hypertension (“PAH”) and pulmonary...more

Jenner & Block

A Secured Reversal of Preliminary Injunction in High-Stakes Pharmaceutical Battle

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In a significant victory for pharmaceutical competition and access to generic drugs, Jenner & Block secured a key litigation win on behalf of client MSN Pharmaceuticals. A federal judge denied a pharmaceutical company’s...more

Troutman Pepper Locke

Trade Dress Disputes Continue To Be a Bitter Pill in Pharma

Troutman Pepper Locke on

A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more

Knobbe Martens

District Court Finds the FDA Reasonably De-listed Eli Lilly’s Weight Loss Drug From Drug Shortage List

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Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage. For example, a determination of...more

Foley & Lardner LLP

Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is...

Foley & Lardner LLP on

On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more

Wilson Sonsini Goodrich & Rosati

FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

Wilson Sonsini Goodrich & Rosati on

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

Polsinelli

Personal Jurisdiction Considerations for International Biosimilars Companies

Polsinelli on

The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more

Herbert Smith Freehills Kramer

Biosimilars in 2020: What’s Ahead

Herbert Smith Freehills Kramer on

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

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