Pharma Forum Dialogues

Court Decision Clarifies Hatch-Waxman Data Exclusivity

Posted by New York Pharma Forum Inc. on Jul 30, 2015 2:00:00 PM

By: Clark G. Sullivan and Sujatha VathyamTroutman Sanders LLP

A pharmaceutical patent lawsuit against the Food and Drug Administration (“FDA”) earlier this year has clarified when 3-year Hatch-Waxman data exclusivity will prevent the United States Food and Drug Administration (“FDA”) from approving an application filed under section 505(b)(2) of the Food Drug and Cosmetic Act (the “FD&C Act”). In the case, Veloxis Pharmaceuticals, Inc. v. FDA, a United States District Court held that reliance on an earlier approval was not necessary for three year data exclusivity to delay the later filed 505(b)(2) application. Exclusivity arose solely because the later application was for the same drug as the earlier approval and would be approved for the same conditions of use.

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Topics: Hatch-Waxman Litigation, patent law, FDA guidance

Background on and Trends in Ethnic Bridging Studies

Posted by New York Pharma Forum Inc. on May 28, 2014 11:14:00 AM

An ethnic group is defined as a group of people who identify with each other based on intrinsic factors, such as genetic similarities due to common ancestry, and extrinsic factors, such as shared cultural experiences or environment.  Therefore, one’s ethnicity is a fundamental aspect of life that defines a person, and that differentiates that person from others. 

Ethnic differences have become important in the field of clinical drug development because they may impact the absorption, distribution, metabolism, or excretion (ADME) of drugs, and may be relevant to an understanding of a drug’s efficacy and safety.        

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Topics: patent law, Clinical Trials

Inter Partes Review Adds
Another Twist To Hatch-Waxman Litigation

Posted by New York Pharma Forum Inc. on Apr 22, 2014 4:17:00 PM

Inter Partes Review (IPR), introduced by the America Invents Act (AIA), opens the door to another venue and procedure to challenge the validity of a patent. IPR on pharmaceutical patents is drawing increasing attention as an additional threat for a research-based (brand) pharmaceutical company facing or already involved in Hatch-Waxman litigation—the most common type of patent litigation between brands and generics seeking to market copies of branded products. 

Overview of Hatch-Waxman
Litigation and IPR 

Hatch-Waxman litigation typically occurs between a brand company, which holds a New Drug Application (NDA) to sell a drug, and a generic, which files an Abbreviated New Drug Application (ANDA) requesting FDA approval to market a generic copy of the NDA holder’s drug.

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Topics: Hatch-Waxman Litigation, Generics, patent law, Inter Partes Review

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