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Patent Applications Food and Drug Administration (FDA) Patents

Fish & Richardson

Preparing Your Company for Hatch-Waxman

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The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more

Womble Bond Dickinson

Codifying the Experimental Use Exception? USPTO Seeks Public Input

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The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms Obviousness of Rifaximin Polymorph Patents and Denial of Motion to Modify Judgment After Post-Trial...

In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...more

Goodwin

USPTO Emphasizes Searches of FDA Databases for Pharmaceutical Patent Applications

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In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...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

Fenwick & West LLP

FTC Employs New Tactic in Effort Against Drug Makers Alleged to Have Improperly Listed Patents in the FDA’s Orange Book

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On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...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

Dechert LLP

Initiatives to Increase Communication Between the USPTO and the FDA Concerning Pharmaceutical Patent Applications

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President Biden, in July 2021, issued an Executive Order (“E.O.”) observing that “too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and...more

Knobbe Martens

Description Prescription

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REGENTS OF THE UNIVERSITY OF MINNESOTA V. GILEAD SCIENCES, INC. Before Lourie, Dyk, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: For drug patents, adequate written description of a broad genus...more

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

How to Effectively Use Patent Counsel to Navigate the USPTO’s Duty of Candor Guidance Regarding FDA Submissions

The United States Patent and Trademark Office (USPTO) issued updated guidance on the duty of candor and duty to disclose in relation to submissions made to other government agencies, particularly the Food and Drug...more

Goodwin

USPTO and FDA Continue to Focus on Patent Quality in the Pharmaceutical Industry

Goodwin on

​​​​​​​After a recent reminder from the U.S. Patent and Trademark Office (USPTO) regarding the duties of disclosure and reasonable inquiry during examination of a patent application and a Request for Comments (RFC) on the...more

Procopio, Cory, Hargreaves & Savitch LLP

Expedited Examination Programs at the USPTO: What To Know to Secure Your Patent Promptly

From the moment a new invention or technology is realized, the race to patent the invention has begun. Anyone can apply for a patent to protect their inventions, discoveries and technologies at the U.S. Patent and Trademark...more

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

Senators Urge Regulators to Block and Clear Patent Thickets

Patent thickets, particularly those involving pharmaceutical patents, appear to have caught the ire of many U.S. senators. Within the past few weeks, two separate letters have urged action to find ways to prevent issuance of...more

Knobbe Martens

Federal Circuit Review - September 2021

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Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more

WilmerHale

PTAB/USPTO Update - October 2021

WilmerHale on

USPTO News - On September 9, 2021, Senators Patrick Leahy and Thom Tillis wrote a letter to Acting Director Andrew Hirshfeld requesting that the USPTO “take steps to reduce patent applicants’ making inappropriate...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2021

Belcher Pharmaceuticals, LLC v. Hospira, Inc., Appeal No. 2020-1799 (Fed. Cir. Sept. 1, 2021) - In an appeal from the United States District Court for the District of Delaware, the Federal Circuit affirmed the district...more

Perkins Coie

Updates on the Implementation of the Newly Amended PRC Patent Law

Perkins Coie on

The China National Intellectual Property Administration (CNIPA) and the National Medical Products Administration (NMPA) in the People’s Republic of China (PRC) issued measures to facilitate the implementation of the newly...more

Robins Kaplan LLP

ANDA Approvals - Fall 2020

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This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

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

Patent Prosecution Tool Kit: Patenting the Product Label

When the U.S. Food and Drug Administration approves a new drug, it also approves a package insert of the drug, known as a “product label.” A pharmaceutical company marketing a generic product is required to package their...more

Fox Rothschild LLP

USPTO Launches COVID-19 Prioritized Patent Application Examination Pilot

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After offering to expedite review of trademark applications for COVID-19 products and services, the USPTO has now launched a prioritized examination pilot program for certain patent applications “that claim products or...more

Sheppard Mullin Richter & Hampton LLP

USPTO Announces a New Initiative to Expedite Examination of COVID-19 Related Patent Applications

The USPTO has authorized an initiative to prioritize examination of patent applications having COVID-19 uses that would require FDA approval. A pilot program only for small and micro entities has been implemented effective...more

Weintraub Tobin

PTO Fast Tracks COVID-19 Patent And Trademark Applications

Weintraub Tobin on

The United States Patent and Trademark Office has established a new program for prioritized examination for patent applications for inventions related to COVID-19 and for trademark applications for marks used for certain...more

Cole Schotz

COVID-19 Prioritized Examination Pilot Program

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Small business efforts to patent technology which deals with the COVID-19 outbreak will be getting a boost thanks to the United States Patent and Trademark Office (USPTO)...more

Snell & Wilmer

U.S. Patent Office Implements COVID-19 Pilot Program for Prioritized Examination

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The United States Patent and Trademark Office (USPTO) has introduced a pilot program to provide prioritized patent examination for patent applications that cover a product or process related to COVID-19. The product or...more

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