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Pharmaceutical Industry › Patent Term Extensions › Biologics

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FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision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As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more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

Mintz - Intellectual Property Viewpoints

New revised USMCA trade deal affects intellectual property rights, but not exclusivity period for biologics

Mintz - Intellectual Property Viewpoints on

On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”). The USMCA, if ratified by each respective country, would replace the...more

Troutman Pepper

We Received a Patent Term Extension - Now What?

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This is the final article in our five-part series on PTE. Obtaining a patent term extension (PTE) is extremely valuable to an innovator. By design, PTE extends the patent term to recoup time lost to the rigorous...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

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Obama Administration Releases Much Anticipated Text of the Trans-Pacific Partnership Agreement

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

This client alert examines intellectual property proposals in the Trans-Pacific Partnership from the perspective of biotechnology, pharmaceutical, and chemical industries. On November 5, 2015, the U.S. trade...more

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