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The Use Of The Hatch-Waxman Safe Harbor In Patent Infringement Cases | Caldwell Intellectual Property Law

The Use Of The Hatch-Waxman Safe Harbor In Patent Infringement Cases | Caldwell Intellectual Property Law
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FDA Solicits Feedback on Drug Products Approved Under Abbreviated New Drug Applications Before the Enactment of the Hatch-Waxman Amendments

The FDA has established a   public docket   to solicit comments on several issues related to FDA’s regulation of certain drug products approved under abbreviated new drug applications before the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments.

Pfizer and BioNTech Lawsuit Provides Insight into Research Tools

Tuesday, July 20, 2021 Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement complaint filed by Allele Biotechnology and Pharmaceuticals, Inc. (“Allele”) in the Southern District of California. The patent at the center of the case is U.S. Pat. No. 10,221,221 (“the ’221 Patent”) which covers Allele’s mNeonGreen, a monomeric yellow-green fluorescent protein notable for its intense brightness. On May 4, 2021, the court denied the motion to dismiss, leaning heavily of the Federal Circuit’s 2008 decision  Proveris Science Corp. v. Innovasystems, Inc. As this case continues to develop it could help shed light on an unsettled issue – are “research tools” categorically excluded from the 35 U.S.C. § 271(e)(1) Safe Harbor?

A Guiding Light for the Research Safe Harbor and Research Tools ? | Proskauer - Life Sciences

A Guiding Light for the Research Safe Harbor and Research Tools ? | Proskauer - Life Sciences
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