News & Analysis as of

Competition Drug Pricing

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

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

Lowenstein Sandler LLP

Antitrust Agencies’ Health Care RFI Signals Increased Scrutiny of PE Deals

Lowenstein Sandler LLP on

On March 5, the Federal Trade Commission (FTC), U.S. Department of Justice’s Antitrust Division (DOJ), and Department of Health and Human Services (HHS) jointly issued a Request for Information on Consolidation in Health Care...more

Troutman Pepper

FTC Promotes Next Front in Administration's Efforts to Lower Pharmaceutical Prices: Bayh-Dole Act's "March-In" Rights

Troutman Pepper on

The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more

Knobbe Martens

Draft Framework for Exercise of March-In Rights under Bayh-Dole Act Targets High Drug Pricing

Knobbe Martens on

The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more

Epstein Becker & Green

President Seeks More Antitrust Scrutiny of Health Care Transactions

Epstein Becker & Green on

On December 7, 2023, the Biden-Harris administration announced new initiatives it believes will “lower health care and prescription drug costs by promoting competition.”...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

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

Hogan Lovells

A Survey of President Biden’s Executive Order on Promoting Competition in the American Economy

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It has been one year since President Biden signed a far-reaching, industry-spanning Executive Order on Promoting Competition in the American Economy.  The Executive Order outlines a “whole-of-government” approach to...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

Mintz - ML Strategies

Look Ahead: Upcoming Congressional Work Period – July 2022

Mintz - ML Strategies on

The next three weeks will be full of activity in Washington D.C., as the House of Representatives and Senate are working to push their legislative agendas to garner support from their constituents ahead of an August recess...more

Faegre Drinker Biddle & Reath LLP

FTC Issues Policy Statement Putting PBMs on Notice

On June 16, 2022, the FTC unanimously voted to issue an enforcement policy statement putting Pharmacy Benefit Managers (PBMs) on notice that the payment of rebates and fees by drug manufacturers to PBMs resulting in the...more

Mintz - Antitrust Viewpoints

DOJ and FTC Virtual Workshop: Agencies Discuss Novel Approaches to Address Competition Issues in Pharmaceutical Mergers

On June 14 and 15, 2022, the Department of Justice Antitrust Division (“DOJ”) and the Federal Trade Commission (“FTC”) hosted a virtual workshop to discuss antitrust analysis of pharmaceutical mergers and anticipated focal...more

Tarter Krinsky & Drogin LLP

The Federal Trade Commission Launches Investigation into Pharmacy Benefit Managers

The Federal Trade Commission (FTC) has launched an inquiry into the largest Pharmacy Benefit Managers (PBMs) in the United States, with the goal of scrutinizing the PBMs’ practices and influence on the pharmaceutical...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

Proskauer - Life Sciences

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

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

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

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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

Vinson & Elkins LLP

Biden’s Competition Council Holds Inaugural Meeting to Discuss Competition Policy Priorities

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On September 10, the newly-formed White House Competition Council (the “Council” or “Competition Council”) held its inaugural meeting, bringing together eight cabinet members and the leaders of seven independent agencies, to...more

White & Case LLP

HHS Report Reiterates Biden Administration Support for Wide-Ranging Action to Address Drug Prices

White & Case LLP on

On September 9, 2021, the Department of Health and Human Services ("HHS") released its widely anticipated "Comprehensive Plan for Addressing High Drug Prices." The HHS report supports far-reaching legislative and...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

Vinson & Elkins LLP

Three Takeaways from “Navigating the New Antitrust Enforcers”

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Corporate acquirers accustomed to government inertia in antitrust reform are navigating a sea change in Washington, according to Craig Seebald, a Washington, D.C.-based Partner and leader in the global Antitrust Group at...more

Sheppard Mullin Richter & Hampton LLP

Executive Order on Promoting Competition in the American Economy: The Biden Administration Considers Drug Pricing Strategies While...

On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020...more

Proskauer - Health Care Law Brief

Pass Go and Collect Regulatory Scrutiny: The Biden Administration Takes Aim at Consolidation & Anti-Competitive Business Practices...

Given the current political dynamic within Congress, the chances of the Biden Administration enacting significant, substantive health care legislation appear slim in the short-term. Thus, the Biden Administration has sought...more

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