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Competition Food and Drug Administration (FDA)

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Get Their Colleagues to Agree on Drug Patent Litigation Legislation

Recent history of Congress's performance as a legislative body has been, to be kind, mixed, and a great many bills, resolutions, and other activities have appeared to be more for show than to accomplish anything worthwhile. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Get Their Colleagues to Agree on Drug Patent Litigation Legislation

Recently the Senate passed S.150 entitled the Affordable Prescriptions for Patients Act. Those paying attention might recall that Senator Cornyn (R-TX) introduced this bill (joined by Senator Blumenthal (D-CT) and seven other...more

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

Foley Hoag LLP

FTC Challenges More Patent Listings in the FDA’s Orange Book

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The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - April 2024

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This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more

Proskauer - Health Care Law Brief

Public Portal to Promote Healthy Competition

Past long-standing chair of Proskauer’s Health Care Department, Ed Kornreich is a recognized authority on the legal, regulatory and business issues related to health care… Past long-standing chair of Proskauer’s Health Care...more

Hogan Lovells

FTC continues to highlight FDA Orange Book patent listings

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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

Sheppard Mullin Richter & Hampton LLP

FTC's Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - January 2024

WilmerHale on

Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision.  On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more

Morgan Lewis - As Prescribed

FTC Policy Statement on Orange Book Listings Brings More Clarity (Sort Of)

With the J.P. Morgan Healthcare Conference taking place in San Francisco this week, what better time for an update on the Orange Book? The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration...more

Sheppard Mullin Richter & Hampton LLP

The March on Pharmaceutical Patents?

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...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

Foley & Lardner LLP

How is Patent Term Extension Calculated For a Reissued Patent?

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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

Proskauer - Minding Your Business

Ozempic Gains Popularity, Its Maker Loses First Legal Fight

With Hollywood celebrities speaking out both in favor of and against the use of drugs like Ozempic and Wegovy for weight loss, it was only a matter of time before demand outpaced supply. Although most might believe that...more

Morrison & Foerster LLP

FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents

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In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more

Fish & Richardson

FTC Challenges More Than 100 Patents as Improperly Listed in Orange Book

Fish & Richardson on

On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The...more

Axinn, Veltrop & Harkrider LLP

FTC Takes Up the Battle Against Improper Orange Book Patent Listings

Attempting to put some teeth into the policy statement that it issued last month, the FTC sent letters to 10 pharmaceutical companies, asserting that their listing of over 100 patents in FDA's Orange Book for a variety of...more

Axinn, Veltrop & Harkrider LLP

FTC Throws Down the Gauntlet on Improper Orange Book Listings

The FTC recently issued a policy statement warning drug manufacturers that it “intends to scrutinize improper Orange Book listings” and “use its full legal authority” to “tak[e] actions against companies and individuals that...more

BakerHostetler

AD-ttorneys@law - January 2023 #2

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Introducing Our Secret Plan to Fight Inflation - It’s simple: Don’t fall afoul of the FTC - ’Twas Ever Thus - Every year, like the swallows returning to Capistrano, the Perseid meteor shower, or a Real Housewives...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

MoFo Life Sciences

The USPTO And The FDA Join Hands To Promote Competition

MoFo Life Sciences on

On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration...more

BakerHostetler

AD-ttorneys@law - November 2022 #2

BakerHostetler on

Made-in-USA Shootout Leads to Jury Trial, $3.1 Million Judgment Novelty glassware manufacturer weaponizes FTC guidance against rival - Is Half Bulletproof Really a Thing? For the uninitiated, the shot glass in...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

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

Cozen O'Connor

The State AG Report – 1.20.2022

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Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Student Loan Servicer Agrees to Cancel $1.7...more

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