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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
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
Appropriations Update. On March 3, Congress released bill text for the CAA, 2024, which includes funding for six of the 12 appropriations bills: Agriculture-FDA, Military Construction-VA, Energy-Water, Transportation-HUD,...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
Ballard Spahr attorneys from the firm’s Life Sciences and Health Care Industry Teams were on the ground for the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) from January 7-10. While still less crowded than...more
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
In a recent speech, a senior official at the U.S. Department of Justice Antitrust Division noted that “in U.S. antitrust enforcement and competition policy, there is no more important question than what can we do to safeguard...more
This marks the second issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more
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
On February 13, 2023, U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, sent a letter to the Antitrust Division of the Department of Justice (DOJ) and the Federal Trade Commission (FTC)...more
The 2022 midterms have concluded, but the Republican underperformance is not expected to dampen Congressional enthusiasm for Pharmacy Benefit Manager (PBM) reform. The issue remains at the forefront of the healthcare pricing...more
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
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
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
On Friday, July 9, 2021, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the "Order"). As part of this Order, the Biden...more
On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more
The ACCC 47th Annual Meeting & Cancer Center Business Summit (AMCCBS) took place virtually, March 1-5. The Summit serves the prominent thought leadership forum and annual conference on matters of policy, business strategies,...more
Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
Recent amendments to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), titled the Patient Right to Know Drug Prices Act, require parties to inform regulatory authorities of executed settlement...more
Earlier this month, the President signed into law the Patient Right to Know Drug Prices Act (Public Law 115-263). The Act mainly focuses on eliminating so-called “gag clauses” that prevent pharmacists from telling patients...more
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
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
Congress - Senate - Senate Vote Fails to Block Trump Administration’s Short-Term Health Plans - On Oct. 10, the Senate failed to block the Trump administration’s expansion of short-term insurance plans. The...more
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