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Pharmaceutical Industry Department of Justice (DOJ) Patents

Axinn, Veltrop & Harkrider LLP

Will the PTO's Proposed Expansion of Filing Settlement Agreements Help to Reduce Drug Prices?

In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding, even if such agreement occurs prior to a decision to institute an inter partes review...more

Polsinelli

Regeneron v Novartis and Vetter: Walker Process Client Update

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In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...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

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

Ballard Spahr LLP

Life Sciences Landscape: 2023 Mid-Year Industry Update

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The Inflation Reduction Act (IRA), signed into law in August 2022, impacted a wide range of tax laws and touched many aspects of government. Significantly, part of the IRA provides Medicare with the ability to negotiate the...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

Robins Kaplan LLP

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

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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

White & Case LLP

FTC Publishes Annual MMA Report—Continues to Scrutinize Pharma Patent Settlements

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On December 3, 2020, the Federal Trade Commission (FTC) published its annual report on pharmaceutical patent settlements filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for October 2018?

This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more

Cooley LLP

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

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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

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

Goodwin on

Yesterday, the Senate overwhelmingly (98-2) passed the “Patient Right to Know Drug Prices Act” (S.2554), which includes amendments to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) that...more

Holland & Knight LLP

Healthcare Law Update: June 2017

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Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

McGuireWoods LLP

More on Patent Settlements Including Litigation at the European Courts

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Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

Carlton Fields

Expect Focus – International, Summer 2015

Carlton Fields on

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

K&L Gates LLP

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

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AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

Goodwin

Federal Appeals Court Upholds FTC HSR Rule on Pharma Patent Licenses

Goodwin on

Background – the HSR Act: Under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act), acquisitions of voting securities, assets and other commercial interests which exceed certain monetary thresholds...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Antitrust and Competition: Nonmerger Enforcement Activity Heats Up on Both Sides of the Atlantic"

U.S. and European antitrust agencies had similar enforcement priorities last year, a trend we expect to continue in 2014. Nonmerger enforcement will continue to focus on intellectual property, financial services and...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Antitrust and Competition: Surveying Global M&A Enforcement Trends"

US: Agencies Continue Aggressive Enforcement - Despite changes in leadership at the U.S. Department of Justice’s (DOJ) Antitrust Division and the Federal Trade Commission (FTC) (collectively, the Agencies) in 2013, the...more

Orrick, Herrington & Sutcliffe LLP

Antitrust and Competition Newsletter - December 2013

Japan’s METI Submits Amicus Brief in the TFT-LCD Litigation Seeking to Limit the Extraterritorial Reach of U.S. Antitrust Laws - On Oct. 31, 2013, Japan’s Ministry of Economy, Trade and Industry submitted a brief in...more

Holland & Knight LLP

FTC Announces Amendments to Hart-Scott-Rodino Rules Regarding Pharmaceutical Patent Licenses

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The Federal Trade Commission (FTC) has announced revisions to the rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) that will apply to certain transactions involving the transfer of patent rights in...more

Bracewell LLP

FTC Broadens Notification Requirements for Transfers of Pharmaceutical Patent Rights

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The Federal Trade Commission (FTC) has revised the rule for determining when a transfer of exclusive rights to a patent in the pharmaceutical industry (including biologics and medicine manufacturing) results in a potentially...more

Ballard Spahr LLP

FTC Issues Premerger Notification Review Changes for Pharmaceutical Patent License Transfers

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The Federal Trade Commission (FTC) issued final changes to the premerger notification rules to expand the circumstances that require pharmaceutical industry companies to report proposed acquisitions of exclusive patent rights...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2013 Insights: Global Litigation

New legal ground is expected to be broken this year in areas of importance to companies and their directors, officers and executives. We see those developments coming from around the globe and defining the litigation...more

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