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United States Patent and Trademark Office › Generic Drugs

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 -
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

Wilson Sonsini Goodrich & Rosati

The PTAB Review - August 2024

Wilson Sonsini Goodrich & Rosati on

This issue of The PTAB Review begins by providing an analysis of how institution decisions consider declaration testimony submitted by a patent owner. Next, it summarizes proposed rulemaking from the United States Patent and...more

Foley & Lardner LLP

USPTO Aims to Mow Down Patent Thickets

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In a stunning Federal Register Notice published May 10, 2024, the U.S. Patent and Trademark Office (USPTO) proposes to impose a new requirement on terminal disclaimers filed to overcome obviousness-type double patenting...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

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

American Conference Institute (ACI) on

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

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

Legislative Efforts to Remove Impediments to Biosimilar Approvals and Marketing

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Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more

Goodwin

FDA Commissioner Delivers Remarks at FDA-U.S. Patent and Trademark Office Public Workshop

Goodwin on

On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA...more

Goodwin

An Interview with Rachel Goode, Ph.D, about Biological Patent Thickets

Goodwin on

Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...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

Foley & Lardner LLP

UPSTO Continues Discussion of Pharmaceutical Patents

Foley & Lardner LLP on

The USPTO will be hosting a “public listening session” on January 19, 2023, focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's Executive Order on “Promoting Competition in the American...more

Goodwin

Request for Comments on USPTO-FDA Collaboration Initiatives to Promote Generic Drug and Biosimilar Competition

Goodwin on

​​​​​​​On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more

Goodwin

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

Goodwin on

The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition. In July 2021, President Biden issued an Executive Order...more

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

Senators Urge Regulators to Block and Clear Patent Thickets

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

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

U.S. Senators Request PTO Action on Patent Thickets

Goodwin on

On June 8, 2022, a bipartisan group of U.S. Senators sent a letter to Kathi Vidal, Director of the U.S. Patent & Trademark Office, requesting that the PTO take action on patent thickets. According to the Senators, “large...more

Jones Day

Tillis Urges FDA, USPTO to Investigate Potential False Narrative by Drug Critics

Jones Day on

On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...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 - Life Sciences

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

Proskauer - Life Sciences on

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

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

Jones Day on

Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

Haug Partners LLP

FDA Acting Commissioner of Food and Drugs Seeks Collaboration Between FDA and USPTO to Address Pharmaceutical Patent-Related...

Haug Partners LLP on

On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of...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 - Health Care Viewpoints

Biden Administration Takes Aim at Rising Drug Prices through its Executive Order on Promoting Competition

Mintz - Health Care Viewpoints on

On Friday, July 9, 2021, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the "Order"). As part of this Order, the Biden...more

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

Getting Lost in the Thicket: AbbVie Wields Its Expansive Humira® Patent Portfolio Against Alvotech’s Adalimumab Biosimilar

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

In the most recent of a series of litigations by AbbVie against manufacturers seeking to market biosimilar versions of Humira®, the world’s most profitable drug, AbbVie initiated an action against Alvotech in the district...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

American Conference Institute (ACI)

[Webinar] Examining the COVID-19 Effect on the Business and Practice of Hatch-Waxman Litigation - June 2nd, 12:00 pm - 1:00 pm EST

American Conference Institute (ACI) on

The coronavirus global pandemic has ushered in extraordinary roadblocks for the pharmaceutical industry. To help you carve out a path forward, in-house senior executives and industry leaders will convene virtually at ACI’s...more

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

Kramer Levin Naftalis & Frankel LLP on

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

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