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The Biden administration is exploring the use of "march-in" rights established in the 1980 Bayh-Dole Act, which... Read More »
In August, our much-anticipated fourth annual ANDA Litigation Intelligence Report made its entrance into the world of pharmaceutical litigation... Read More »
In a groundbreaking legal development, Eli Lilly has secured a remarkable victory in a high-stakes patent... Read More »
We are proud to announce that tomorrow marks the release of the fourth edition of our ANDA Litigation Intelligence Report. This year's report... Read More »
In the intricate world of pharmaceuticals, where innovation meets regulation, ANDA litigation stands as a... Read More »
In the realm of pharmaceuticals, the approval process for generic and brand-name drugs holds significant importance. The Hatch-Waxman Act, ... Read More »
Abbreviated New Drug Application (ANDA) litigation stands at the crossroads of pharmaceutical innovation and ... Read More »
British drugmaker GlaxoSmithKline (GSK) has taken American pharmaceutical giant Pfizer to court, alleging a... Read More »
In the world of pharmaceuticals, access to affordable generic drugs is crucial for ensuring cost-effective... Read More »
When it comes to generic medications, the Abbreviated New Drug Application (ANDA) process plays a crucial... Read More »
The landscape of patent litigation is ever-evolving, and the first half of 2023 has been no exception. The dynamics of patent litigation are... Read More »
When it comes to preparing an Abbreviated New Drug Application (ANDA), there are several common pitfalls that applicants often encounter... Read More »
Written by: Rhett D. Ramsey & Michael L. Fuller
In Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981, the... Read More »
The Abbreviated New Drug Application (ANDA) process plays a vital role in the pharmaceutical industry, enabling generic drug manufacturers ... Read More »
Written by: Brianne M. Kingery & Eric Furman, Ph.D.
On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government... Read More »
Promosome LLC, a biotech firm represented by law firm Susman Godfrey, has just filed a patent infringement lawsuits against Moderna... Read More »
The Hatch-Waxman Act, officially known as the Drug Price Competition and Patent Term Restoration Act, revolutionized the pharmaceutical... Read More »
In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market... Read More »
The Oncomouse patent stands as a remarkable milestone in the field of biotechnology patents, revolutionizing the way we approach... Read More »
Written by:Nima Zargari, Ph.D. & Joseph Mallon, Ph.D.
On April 26, 2023, the European Commission proposed a pharmaceutical law... Read More »