Carlos Angulo

Partner

Office
Washington, DC
Tel.
202.778.1811
Fax.
202.822.8106
Others
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One of the country’s foremost voices on generic pharmaceuticals and biosimilars, Carlos Angulo focuses his practice on food and drug law.

As a litigator and former congressional aide, Carlos represents clients before the FDA, in federal and state trial and appellate courts, including the United States Supreme Court, and in arbitrations and mediations.


Generic drug manufacturers and the generic drug trade association rely on Carlos to represent their interests before the FDA and in the courts. He has extensive experience in matters arising under the Hatch-Waxman generic drug approval law and the Biosimilars Price Competition and Innovation Act (BPCIA). Carlos also represents anti-smoking groups, medical device manufacturers, and other clients in the food and drug field.

Carlos also has litigated complex commercial cases, including securities and consumer class actions and antitrust cases. His legislative and policy practice emphasizes health-related issues. He also has performed numerous due diligence reviews in connection with corporate transactions involving FDA-regulated companies. He also has extensive experience in corporate compliance matters under the Foreign Agents Registration Act (FARA) and Lobbying Disclosure Act (LDA).

Carlos joined Zuckerman Spaeder as an associate in 1999 and became a partner in 2004; he left the firm in 2007 to serve as legislative director (and later acting chief of staff) for Sen. Sheldon Whitehouse, returning to Zuckerman Spaeder in 2010.

Before joining Zuckerman Spaeder, Carlos served as legislative counsel to Sen. Paul Sarbanes and as staff counsel to Sen. Paul Simon on the Senate Judiciary Committee’s Subcommittee on the Constitution.


Education
  • Yale Law School, J.D., 1989
    • Finalist, Thurman Arnold Moot Court Prize Argument
    • Finalist, Cardozo Moot Court Brief-writing Prize
    • Member, Moot Court Board
       
  • Haverford College, B.A., magna cum laude, 1986
    • Phi Beta Kappa
    • Chairman, Haverford College Honor Council
Bar admissions
  • District of Columbia
  • New York
Court admissions
  • U.S. Supreme Court
  • U.S. Court of Appeals, Federal Circuit
  • U.S. Court of Appeals, District of Columbia Circuit
  • U.S. District Court, District of Columbia
Clerkships
  • Hon. Phyllis A. Kravitch, U.S. Court of Appeals, Eleventh Circuit
Government service
  • Legislative Director
    • Sen. Sheldon Whitehouse (D-RI)
    • U.S. Congress
       
  • Legislative Counsel
    • Sen. Paul Sarbanes (D-MD)
    • U.S. Congress
       
  • Staff Counsel
    • Sen. Paul Simon (D-IL)
    • Senate Judiciary Committee, Subcommittee on the Constitution
    • U.S. Congress
       
Professional leadership
  • Member, Food and Drug Law Institute (FDLI)

Representative matters
  • Authored multiple amicus curiae briefs in Amgen v. Sandoz case arising under the BPCIA, including in the U.S. Supreme Court and U.S. Court of Appeals for the Federal Circuit, on behalf of the Generic Pharmaceutical Association, the Biosimilars Council and America’s Health Insurance Plans. 
  • Obtained summary judgment on behalf of Ranbaxy Laboratories, Inc. that preserved the generic manufacturer’s eligibility for Hatch-Waxman 180-day marketing exclusivity for a generic version of the blood pressure/heart medication Diovan®. In 2012, a generic competitor had sought a preliminary injunction in federal district court to block the FDA’s determination that Ranbaxy was eligible for 180-day of exclusivity for its generic Diovan® product. Ranbaxy, represented by Zuckerman Spaeder, intervened on the FDA’s behalf and filed a motion for summary judgment (as did the FDA). Carlos briefed and argued the preliminary injunction and summary judgment motions. The district court denied the competitor’s motion for a preliminary injunction and granted Ranbaxy’s and the FDA’s motions for summary judgment.
  • Obtained summary judgment upholding FDA’s approval of a generic version of Lovenox® (enoxaparin sodium) developed by Momenta and its business partner, Sandoz. The Federal District Court for the District of Columbia granted summary judgment to FDA and Sandoz, as intervenor, in a case brought by the manufacturer of branded Lovenox®, Sanofi-Aventis, challenging FDA’s approval of the generic product [Sanofi-Aventis v. FDA, Civ. No. 10-01255 (D.D.C. Feb. 7, 2011)]. We advised Momenta and Sandoz in connection with the summary judgment briefing and argument and with Sanofi’s earlier, unsuccessful efforts to obtain a preliminary injunction blocking FDA’s approval.
  • Filed an amicus brief for Rep. Henry Waxman in the U.S. Supreme Court case, Caraco et al. v, Novo Nordisk et al., No. 10-844, urging the Court to reverse the U.S. Court of Appeals for the Federal Circuit’s decision undermining the Hatch-Waxman law’s “Section VIII” generic approval process. In 2012, the Supreme Court unanimously reversed the Federal Circuit’s decision.
  • Defeated a “citizen petition” seeking the FDA’s ruling that a generic pharmaceutical company forfeited its right to 180-day generic exclusivity.
  • Defended a generic pharmaceutical’s right to FDA approval of a generic version of a multimillion dollar allergy drug against a federal court challenge by the manufacturer of the brand version of the product. The district court granted the brand company’s motion for temporary restraining order, but we successfully defeated the company’s motion for a preliminary injunction, and FDA’s approval was upheld.
  • Defended a generic pharmaceutical company’s right to 180-day exclusivity for a generic version of a blockbuster cholesterol product in litigation brought by a generic competitor in federal district court.
  • Represents anti-smoking groups in matters before the FDA and in federal courts with a focus on the 2009 tobacco law.
  • Provided FDA-related due diligence counseling to a major investment bank in connection with the bank’s financing of a completed multibillion-dollar acquisition of one pharmaceutical company by another pharmaceutical company.
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Carlos Angulo_bio

Carlos Angulo

Partner

Office
Washington, DC
Tel.
202.778.1811
Fax.
202.822.8106
Others
Send an Email
vCard