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Patent Applications United States Patent and Trademark Office Food and Drug Administration (FDA)

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

Sterne Kessler’s Reissue, Reexamination, and Supplemental Examination Practice Tips – March 2025

In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more

ArentFox Schiff

Federal Circuit Affirms ImmunoGen Patent Obviousness

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In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...more

Fish & Richardson

Preparing Your Company for Hatch-Waxman

Fish & Richardson on

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

Womble Bond Dickinson on

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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2024 #3

Luv N’ Care, Ltd. v. Lindsey Laurain, Appeal Nos. 2022-1905, -1970 (Fed. Cir. Apr.12, 2024) - In this week’s Case of the Week, the Federal Circuit affirmed the district court’s bench trial decision that unclean hands...more

Goodwin

USPTO Emphasizes Searches of FDA Databases for Pharmaceutical Patent Applications

Goodwin on

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

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

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

Goodwin

The USPTO’s Increasing Focus on FDA Submissions and the Duty of Disclosure

Goodwin on

​​​​​​​The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application...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

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Proskauer - The Patent Playbook

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Knobbe Martens

Federal Circuit Review - September 2021

Knobbe Martens on

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

Foley & Lardner LLP

USPTO Announces New Program To Promote Publication Of COVID-19 Innovation

Foley & Lardner LLP on

In an effort to both promote innovation against COVID-19 and promote dissemination of information about innovation against COVID-19, the USPTO is launching a new “deferred fee” pilot program for certain provisional patent...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

Harris Beach Murtha PLLC

COVID-19 Patent Applications Offered Prioritized Examination by the U.S. Patent Office

Starting in May of 2020, the United States Patent and Trademark Office (U.S. Patent Office) has initiated a pilot program for prioritized examination of non-provisional patent applications which cover inventions related to...more

Cole Schotz

COVID-19 Prioritized Examination Pilot Program

Cole Schotz on

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

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