News & Analysis as of

United States Patent and Trademark Office › Abbreviated New Drug Application (ANDA)

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
Rothwell, Figg, Ernst & Manbeck, P.C.

Selective Readings of Cellect: Federal Circuit Carves out First Exception to Burgeoning Double Patenting Challenges

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

Last year, the Federal Circuit surprised many observers of patent law in In re Cellect LLC, 81 F.4th 1216, 1228–29 (Fed. Cir. 2023) when—for the first time—it affirmed a U.S. Patent & Trademark Office decision cancelling an...more

McDonnell Boehnen Hulbert & Berghoff LLP

United Therapeutics Corp. v. Liquidia Technologies Inc. (Fed. Cir. 2024)

McDonnell Boehnen Hulbert & Berghoff LLP on

Zealous advocacy is a hallmark of adversarial proceedings, whether in district court or before the USPTO, where the opportunities for such advocacy have multiplied with the establishment by the Leahy-Smith America Invents Act...more

WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

WilmerHale on

Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

Foley & Lardner LLP

USPTO Publishes Drug Patent and Exclusivity Study Report

Foley & Lardner LLP on

The U.S. Patent and Trademark Office (USPTO), in conjunction with the Food and Drug Administration (FDA) and in response to January 2022 and April 2022 letters from Senator Thom Tillis (R-NC), has published a report examining...more

Axinn, Veltrop & Harkrider LLP

Hatch-Waxman Overview

Axinn, Veltrop & Harkrider LLP on

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2024 #3

Schwabe, Williamson & Wyatt PC on

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

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Venable LLP

USPTO Rejects "Contingent" Terminal Disclaimer

Venable LLP on

On January 18, 2024, the USPTO rejected a "contingent" terminal disclaimer filed by Acadia Pharmaceuticals Inc. (Acadia) for a patent it owns that is being challenged in a pending litigation as invalid for obviousness-type...more

Foley & Lardner LLP

How is Patent Term Extension Calculated For a Reissued Patent?

Foley & Lardner LLP on

Share on Twitter Print Share Back to top The Patent Term Extension (PTE) provisions of 35 U.S.C. 256 were enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984. PTE partially compensates...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

Foley & Lardner LLP

Trends In Orange Book and Biologic PTAB Trials

Foley & Lardner LLP on

The USPTO has released an updated report on Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book or biologic patents, taking into account data through March 31, 2023. Highlights of the...more

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries

Sheppard Mullin Richter & Hampton LLP on

We are excited to share Sheppard Mullin’s inaugural quarterly report on key Federal Circuit decisions. The Spring 2023 Quarterly Report provides summaries of most key patent law-related decisions from January 1, 2023 to March...more

Foley & Lardner LLP

USPTO Discusses Duty of Disclosure and Duty of Reasonable Inquiry

Foley & Lardner LLP on

On February 23, 2023, the U.S. Patent and Trademark Office (USPTO) held a virtual panel discussion on the duty of disclosure and duty of reasonable inquiry. While both duties apply regardless of technology area, the...more

Dechert LLP

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

Dechert LLP on

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

Foley & Lardner LLP

Senate Judiciary Committee Pushes Pharma Patents and Pricing Bills Forward

Foley & Lardner LLP on

It is hard to predict whether a given bill will gain traction, but when the Senate Judiciary Committee reports out five bipartisan bills targeting pharmaceutical patents and pricing, it seems likely they are determined to get...more

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

MarkIt to Market® - January 2023

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

Thank you for reading the January 2023 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss an ongoing trademark dispute between the band OK Go and cereal company Post, how to stay vigilant about...more

MoFo Life Sciences

Recent Biden Administration Efforts On Drug Pricing: USPTO Notice Focuses On Eliminating Inconsistencies In USPTO/FDA Statements

MoFo Life Sciences on

On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the...more

McDermott Will & Emery

PTO Issues Notice on Duties of Disclosure and Reasonable Inquiry

McDermott Will & Emery on

The US Patent & Trademark Office (PTO) issued a notice on July 29, 2022, titled “Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and...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

McDermott Will & Emery

Silence May Be Sufficient Written Description Disclosure for Negative Limitation

McDermott Will & Emery on

Addressing the issue of written description in a Hatch-Waxman litigation, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that the patent adequately described the claimed daily dose and...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Mintz - Intellectual Property Viewpoints

PTAB statistics show interesting trends for Orange Book and biologic patents in AIA proceedings

Mintz - Intellectual Property Viewpoints on

The Patent Trial and Appeal Board (“PTAB”) regularly tracks statistics regarding administrative trials conducted under the processes created by the America Invents Act (“AIA”), which provide insight into recent trends...more

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2020 Decisions

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

[co-author: Kathleen Wills] Last year, the global COVID-19 pandemic created unprecedented challenges for American courts. By making several changes, however, the U.S. Court of Appeals for the Federal Circuit was able to...more

American Conference Institute (ACI)

[Virtual Event] Paragraph IV on Virtual Trial - COVID-19 Edition - August 20th, 8:45 am - 6:00 pm EDT

American Conference Institute (ACI) on

Join us for a one-day virtual event for Counsel for Hatch-Waxman Litigators. While COVID-19 prevented us from meeting in person this April in NYC, we are pleased to announce a special one-day virtual event Paragraph IV on...more

Robins Kaplan LLP

Duke Univ. v. Akorn, Inc.

Robins Kaplan LLP on

THE COURT GRANTED PLAINTIFFS’ MOTION TO DISMISS DEFENDANT’S ANTITRUST AND PATENT MISUSE COUNTERCLAIMS AND RELATED AFFIRMATIVE DEFENSES. Case Name: Duke Univ. v. Akorn, Inc., Civ. No. 3:18-cv-14035-BRM-TJB, 2019 U.S. Dist....more

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