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Food and Drug Administration (FDA) › Pharmaceutical Industry › Patent Term Extensions

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

American Conference Institute (ACI) on

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

MoFo Life Sciences

Patent Term Extension For Biologics

MoFo Life Sciences on

Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S....more

Robins Kaplan LLP

Biogen Int’l GmbH v. Banner Life Sciences LLC

Robins Kaplan LLP on

Case Name: Biogen Int’l GmbH v. Banner Life Sciences LLC, No. 18-2054-LPS, 2020 U.S. Dist. LEXIS 3639 (D. Del. Jan. 7, 2020) (Stark, J.)....more

Fish & Richardson

Prodrugs – Federal Circuit Holds That A PTE Does Not Cover Their Metabolites

Fish & Richardson on

A. Introduction - A prodrug is a medication or compound that after administration is metabolized (i.e., converted in the body) into a pharmacologically active drug (e,g., a metabolite). Often, the prodrug has no function...more

Troutman Pepper

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

Troutman Pepper on

This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

Troutman Pepper

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

Troutman Pepper on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

Troutman Pepper

How to Obtain Multiple Patent Term Extensions for a Single Product

Troutman Pepper on

This is the second article in our five-part series on PTE. Everywhere you look, patent term extension (PTE) is described using the “Rule of Ones:” one patent, one product, one PTE. However, the Rule of Ones does not...more

Troutman Pepper

Patent Term Extension for Drugs Not Limited to New Chemical Entities

Troutman Pepper on

Patent term extension is a valuable tool that drug manufacturers should consider, even when their products are not new entities. Recent decisions from the U.S. Patent and Trademark Office, coupled with various court...more

McDonnell Boehnen Hulbert & Berghoff LLP

The Medicines Company v. Hospira (Fed. Cir. 2015)

McDonnell Boehnen Hulbert & Berghoff LLP on

There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more

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