News & Analysis as of

Competition Prescription Drugs Patents

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

Hogan Lovells

FTC continues to highlight FDA Orange Book patent listings

Hogan Lovells on

With the recent filing of an amicus brief in a private pharmaceutical patent infringement case, the Federal Trade Commission (FTC) has continued its focus on allegedly “improperly listed” patents in the Food and Drug...more

Knobbe Martens

The Federal Trade Commission Put Brand Drug Manufacturers on Notice About Improperly Listing Patents in the Orange Book and Then...

Knobbe Martens on

The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

A&O Shearman on

The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more

Fish & Richardson

Biosimilars 2022 Year in Review

Fish & Richardson on

2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Goodwin

USPTO Outlines New Initiatives Regarding Drug Pricing

Goodwin on

On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more

Robins Kaplan LLP

[Webinar] Health Care Antitrust Under President Biden 2.0 - Almost One Year In: What Have We Learned About The Democrats’ Approach...

Robins Kaplan LLP on

In March 2021, our experienced intellectual property, antitrust, and health care litigation lawyers shared some predictions on antitrust policy and enforcement in the health care sector. In “Health Care Antitrust under...more

MoFo Life Sciences

Skinny Labels Back In Focus After HHS Report On Addressing Drug Prices

MoFo Life Sciences on

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more

Goodwin

FDA’s Woodcock Reviews Patents Practices as a Way to Effect Drug Pricing

Goodwin on

On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...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

Jones Day

FDA Launches Review of Orange Book Patent Listing Practices

Jones Day on

Citing its priority to facilitate the timely development and approval of generic drugs, the U.S. Food and Drug Administration ("FDA") solicits stakeholder input on the types of patents that should be listed in the Orange...more

Haug Partners LLP

FDA And FTC To Scrutinize Biologics Competition

Haug Partners LLP on

On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

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On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

The Volkov Law Group

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

The Volkov Law Group on

This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more

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