Rosanna K. McCalips

Partner

Washington + 1.202.879.3898

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Rosanna McCalips has more than 15 years of experience defending pharmaceutical companies against antitrust lawsuits alleging a variety of exclusionary conduct. These proceedings have included sham Citizen Petition filings with the United States Food and Drug Administration (FDA), sham Hatch-Waxman Act patent infringement litigation, fraud on the United States Patent and Trademark Office (USPTO), abuse of FDA Risk Evaluation and Mitigation Systems (REMS) programs, product hopping, and improper Orange Book listing. She was a member of the defense team in one of the few pharmaceutical antitrust cases to go to trial, helping to obtain a full defense jury verdict for Sanofi-Aventis US LLC against a claim of monopolization based on the filing of an allegedly sham Citizen Petition with the FDA.

In addition to monopolization cases, Rosanna has experience defending companies against allegations of price-fixing conspiracies. Her other litigation experience includes cases involving claims against federal agencies under the Freedom of Information Act (FOIA) and the Administrative Procedure Act (APA), claims arising from credit card security breaches, claims of professional negligence related to Pap smear testing, and False Claims Act violations.

Representative clients include Sanofi-Aventis US LLC and BioMarin.

Rosanna is active in pro bono activities. She has represented residential tenants in obtaining compensation from their landlords for housing code violations. She also provides pro bono representation in guardianship and custody cases in the Domestic Relations Branch of the D.C. Superior Court and supervises junior lawyers who are serving as guardians ad litem in disputed custody matters.

Erfahrung

  • Sanofi defends proposed class action alleging improper Orange Book listings and sham patent litigationJones Day is defending Sanofi-Aventis U.S. LLC against a proposed class action alleging that Sanofi improperly listed certain patents in the FDA's Orange Book and engaged in sham patent litigation to forestall competition for its diabetes drug, Lantus.
  • Mattel and Fisher-Price defeat putative nationwide consumer class action  lawsuitsOn February 2, 2016, Mattel, Inc. and Fisher-Price, Inc. defeated plaintiffs' motion for class certification of dozens of consumer protection claims under the laws of several different states pending in the Northern District of Alabama.
  • BioMarin files antitrust suit against Dr. Reddy'sJones Day represented BioMarin Pharmaceutical Inc. ("BioMarin") in an antitrust suit against Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. ("Dr. Reddy's") stemming from Dr. Reddy's request that BioMarin provide samples of its FDA-approved Kuvan® product to support Dr. Reddy's efforts to obtain FDA approval for a generic version of Kuvan®.
  • Gosselin wins second favorable post-trial judgmentOn December 24, 2014, the Eastern District of Virginia issued a favorable judgment to Jones Day clients Gosselin Worldwide Moving N.V. and its CEO, Marc Smet, overturning a jury verdict against them under the False Claims Act (FCA).
  • Aventis Pharmaceuticals successfully defends against monopolization claims based on fraud on the Patent Office theoryJones Day resolved class action claims that Aventis Pharmaceuticals, the exclusive licensee of patents covering DDAVP (a treatment for certain water metabolism disorders), knew that the licensor obtained those patents by fraud before the Patent and Trademark Office.
  • American Airlines merges with US Airways in $11 billion dealJones Day represented American Airlines in the antitrust investigation and federal court challenge to its $11 billion merger with US Airways, which closed after the Department of Justice and State attorneys general agreed to settle their lawsuit that sought to block the deal.
  • Jones Day secures third party custody for long time foster parentJones Day obtained a custody order awarding primary physical custody and joint legal custody of a four year old child to our client who had raised the child essentially from birth.
  • Tenants facing substandard housing conditions in the District of Columbia obtain a favorable settlementAs part of Jones Day's initiative to ensure decent and affordable housing in Washington, D.C., Jones Day attorneys represented a group of tenants facing substandard housing conditions and closure of their apartment building in settlement negotiations with their landlord.
  • sanofi-aventis wins unanimous jury verdict in Arava antitrust litigationJones Day defended sanofi-aventis in an antitrust jury trial involving the claims of a class of drug wholesalers that sanofi had unlawfully blocked generic competition for its rheumatoid arthritis drug Arava.
  • Tenant association obtains relief for substandard living conditionsAs part of Jones Day's effort to assist in the preservation of decent and affordable housing in Washington, D.C., John Majoras, Rosanna McCalips, and Miguel Eaton represented a group of tenants in settlement negotiations with their landlord to recover for past rent paid despite the existence of substantial housing code violations.
  • Onyx prevails in ICC arbitrations claiming breach of representations and warranties for waste facility purchased in MexicoJones Day represented Onyx S.A., a French subsidiary of Veolia Environnement involved in international waste management, with regard to a dispute that arose after it acquired a hazardous waste landfill in Mexico in 2000.
  • Sherwin-Williams resolves antitrust class action litigation involving automotive paint refinishingOn behalf of Sherwin-Williams, Jones Day served as national coordinating and trial counsel in connection with multiple related federal and state class actions alleging price fixing of automotive refinishing paint sold in the U.S.
    •

    October 2021 White Paper

    Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

    April 2021 Commentary

    FTC Notches Win in Fifth Circuit Reverse Payment Patent Settlement Case

    October 2018 Alert

    Antitrust Alert: New Law Requires Disclosure of Biologic Patent Settlement Agreements to Antitrust Authorities

    • September 18, 2017
      Aspen Skiing: Do you have to have danced before?, ABA Webinar
    • June 1, 2017
      Antitrust Issues Arising from Pharmaceutical Drug Product Litigation
    • January 19, 2017
      REMS Abuse: Balancing Generic Competition, Innovation, and Safety Concerns in the Pharmaceutical Industry, California Lawyers Association Webinar
    • May 16, 2013
      New Antitrust Challenges for U.S. Companies Around the Globe

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