News & Analysis as of

Pharmaceutical Patents Patent Litigation Federal Trade Commission (FTC)

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

Fenwick & West LLP

New Jersey Federal Court Weighs in on Orange Book Patent Listings

Fenwick & West LLP on

In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...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

McDermott Will & Emery

[Webinar] 2024 IP Outlook: Trends Affecting Patent, Trademark, Copyright and Trade Secret Holders - December 12th, 1:00 pm - 2:00...

McDermott Will & Emery on

As 2023 draws to a close, new developments continue to emerge across the patent, trademark, copyright and trade secret spaces. Join members of McDermott’s Intellectual Property Group for a year-end review that will explore...more

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more

American Conference Institute (ACI)

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

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

McDermott Will & Emery

Patent Law Principles Apply to Claim Scope: Orange Book Delisting and Listing and Regulations

The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method...more

McDonnell Boehnen Hulbert & Berghoff LLP

Mayor and City Council of Baltimore v. AbbVie Inc. (7th Cir. 2022)

A little over two years ago, U.S. District Court Judge Manish Shah sitting in the Northern District of Illinois held that AbbVie did not violate Sections 1 or 2 of the Sherman Antitrust Act by amassing a large number (132) of...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

Haug Partners LLP

California, Rest In Peace: Pharmaceutical Companies, Keep Your Settlement Discussions Out of California

Haug Partners LLP on

For nearly a decade, the Supreme Court’s FTC v. Actavis decision has guided pharmaceutical litigators and advisors exploring the antitrust risks inherent in settling pharmaceutical patent lawsuits, especially when such...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...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

Wilson Sonsini Goodrich & Rosati

Fifth Circuit Upholds Federal Trade Commission Ruling in Impax Laboratories, Inc. v. Federal Trade Commission and Grants...

On April 13, 2021, the U.S. Court of Appeals for the Fifth Circuit issued an opinion in Impax Laboratories, Inc v. Federal Trade Commission, affirming the Federal Trade Commission's (FTC) unanimous decision that Endo...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Prevails in Reverse Payment Case

The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange...more

Hogan Lovells

[Webinar] Antitrust today: Emerging issues affecting the life sciences industry - March 12th, 9:00 am - 10:00 am PST

Hogan Lovells on

Join the Hogan Lovells Antitrust and Competition team on Friday, March 12, 2021 to discuss hot antitrust topics in the life sciences industry, including: - What life sciences companies should expect with respect to...more

Robins Kaplan LLP

[Remote Event] Health Care Antitrust Under President Biden - What Health Care Companies May Expect By Way Of Antitrust Policy And...

Robins Kaplan LLP on

After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more

American Conference Institute (ACI)

[Virtual Event] 11th Summit on Biosimilars & Innovator Biologics - September 23rd - 24th, 7:45 am - 5:00 pm ET

This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more

American Conference Institute (ACI)

[Virtual Event] Paragraph IV Disputes - October 6-7, 8:00 am-6:00 pm EDT

For the past 13 years, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes conference to discuss, debate, and analyze the latest trends, judicial rulings and...more

White & Case LLP

FTC and FDA Announce Plans to Combat Anticompetitive Practices in the "Biologic Marketplace"

White & Case LLP on

On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive...more

WilmerHale

Unprecedented State Law on Pharmaceutical “Reverse Payments” Goes Into Effect

WilmerHale on

A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more

Fish & Richardson

Biosimilars 2018 Year in Review

Fish & Richardson on

Eight years have passed since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), and the biosimilars industry has continued to grow. In 2018, seven biosimilar drugs were approved by the U.S. Food...more

Cooley LLP

Alert: Agreements Involving Biosimilars Must Be Reported to FTC and DOJ Under New Law

Cooley LLP on

Biologic drug makers will soon have to alert the Federal Trade Commission and Department of Justice of agreements, including patent litigation settlements, they reach with biosimilar applicants. The new reporting requirement...more

Goodwin

President Signs Bill Requiring FTC and DOJ Review of Biosimilar Patent Litigation Settlements

Goodwin on

Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554). Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and...more

Goodwin

House Passes MMA Amendment Requiring FTC and DOJ Review of Biosimilar Patent Litigation Settlements

Goodwin on

On September 25, 2018, the House of Representative passed the “Patient Right to Know Drug Prices Act” (S.2554). As we previously reported, the Senate passed the bill on September 19, 2018....more

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