News & Analysis as of

Patents Patent Term Extensions Prescription Drugs

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

Hatch-Waxman Requires Patent Term Extension for Reissued Patents To Be Based on Original Patent

The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more

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FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision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As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more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

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

Wilson Sonsini Goodrich & Rosati

Federal Circuit Holds That Claims of a Patent Asserted During a Patent Term Extension Are Not Infringed by the Carboxylic Acid...

Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more

Hogan Lovells

Proposed changes to draft patent law further strengthen incentives to bring new drugs to China

Hogan Lovells on

On 6 July, China’s National People’s Congress (NPC) published additional amendments to its draft patent law, which was first released in January 2019. As we reported at that time here, the proposed Chinese Patent Law...more

Harris Beach Murtha PLLC

Federal Circuit Holds That Patent Term Extension Under The Hatch-Waxman Act Does Not Apply to De-Esterified Metabolite of the...

In a recent decision, the issue before the Federal Circuit was the meaning of the term “product” in a patent term extension statute. Biogen Int'l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351 (Fed. Cir. 2020). Section 156 of...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

American Conference Institute (ACI)

[Event] Pharmaceutical Patent Term Extensions – The Only Specialized Forum on SPCs and Patent Protection in Europe and Around the...

This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Mintz - Intellectual Property Viewpoints

Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize...more

Troutman Pepper Locke

We Received a Patent Term Extension - Now What?

Troutman Pepper Locke on

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 Locke

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

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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 Locke

Patent Term Extension for Drugs Not Limited to New Chemical Entities

Troutman Pepper Locke 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

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