News & Analysis as of

Patents Patent Trial and Appeal Board Drug Pricing

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Unveils Examiner Guidance on Searching Drug-related Applications

Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to...more

Axinn, Veltrop & Harkrider LLP

Will the PTO's Proposed Expansion of Filing Settlement Agreements Help to Reduce Drug Prices?

In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding, even if such agreement occurs prior to a decision to institute an inter partes review...more

American Conference Institute (ACI)

[Event] 20th Paragraph IV Disputes - April 25th - 26th, New York, NY

Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more

Ballard Spahr LLP

Life Sciences Landscape: 2023 Mid-Year Industry Update

Ballard Spahr LLP on

The Inflation Reduction Act (IRA), signed into law in August 2022, impacted a wide range of tax laws and touched many aspects of government. Significantly, part of the IRA provides Medicare with the ability to negotiate the...more

Goodwin

USPTO Publishes Notice Calling Out Pharmaceutical Industry

Goodwin on

President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more

Goodwin

USPTO Outlines New Initiatives Regarding Drug Pricing

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On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Key Members of Congress Urge USPTO to Curtail Discretionary Denials of IPR Petitions to Help Lower Drug Costs by Breaking Patent...

On September 16, 2021, eleven congressional leaders (“the Signors”) sent a letter to Andrew Hirshfeld, the acting director of the United States Patent and Trademark Office (“USPTO”), requesting the USPTO to reevaluate the...more

Goodwin

FDA’s Woodcock Reviews Patents Practices as a Way to Effect Drug Pricing

Goodwin on

On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...more

Goodwin

Legal Developments to Keep an Eye Out for in 2020

Goodwin on

Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s...more

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