A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more
8/13/2020
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Commercial Marketing ,
Food and Drug Administration (FDA) ,
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Pharmaceutical Industry ,
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On June 26, 2020, Chief Judge Leonard Stark dismissed a Hatch-Waxman case without prejudice after Defendant Sandoz Inc. (“Sandoz”) converted its Paragraph IV certifications for certain asserted patents to Paragraph III...more
This October, the U.S. Food and Drug Administration (FDA) will be celebrating its 40th anniversary of the “Orange Book” as a resource for consumers, health care professionals, drug developers, and Hatch-Waxman litigants. ...more
Biologics are a fast-growing class of therapeutic compounds. In the United States, patent litigation between biologic manufacturers and biosimilar applicants occurs under the Biologics Price Competition and Innovation Act...more
What is Compulsory Licensing? Typically, a patent owner has the right to exclude others from practicing its patent, such as making, using, selling, or importing patented inventions. That, however, does not mean the patent...more
It’s the first day of trial and your team is ready to go. Typically, 48 citizens stream into the courtroom. A small subset of those people will determine your fate—and whether your business unit will be satisfied with two...more
The Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010 to provide an abbreviated regulatory pathway for biosimilars. One of the BPCIA’s key features is a patent dispute resolution process known as the...more
The market for insulin and certain other biological products may change in the coming months and years, as a provision in Biologics Price Competition and Innovation Act (BPCIA) goes into effect on March 23, 2020 changing how...more
This past week, FTC and FDA have taken further steps to encourage robust biosimilar competition in 2020 and beyond, this time with a particular focus on truthful and non-misleading advertising....more