Attorneys
Partner

Practice Focus

Clerkships

Hon. Phyllis A. Kravitch, U.S. Court of Appeals, Eleventh Circuit

Education

Yale Law School, J.D., 1989

  • Finalist, Moot Court Competition
  • Finalist, Moot Court Brief Writing Competition
  • Member, Moot Court Board

Haverford College, B.A., magna cum laude, 1986

  • Phi Beta Kappa
  • Chairman, Haverford College Honor Council
Photo of Carlos  Angulo

Carlos Angulo

Overview
Experience
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Affiliations

Carlos Angulo focuses his practice on food and drug law, including litigation; administrative practice before the U.S. Food and Drug Administration (FDA); and legislative policy matters. He has represented generic drug manufacturers and the generic drug trade association in multiple matters before the FDA and in federal trial and appellate courts and has extensive experience in matters arising under the Hatch-Waxman generic drug approval law. He also represents anti-smoking groups, medical device manufacturers, and other clients in the food and drug field. He also has litigated complex commercial cases, including securities and consumer class actions and antitrust cases. His legislative and policy practice emphasizes civil rights and health-related issues, and he has extensive experience on corporate compliance matters under the Foreign Agents Registration Act (FARA) and Lobbying Disclosure Act.

Mr. Angulo was an associate at Zuckerman Spaeder LLP from 1999 to 2003 and a partner from 2004 to 2007; he returned to the firm in 2010 after serving as legislative director for Sen. Sheldon Whitehouse. Before joining Zuckerman Spaeder, Mr. Angulo 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. Before working on Capitol Hill, Mr. Angulo was a law clerk to the Hon. Phyllis A. Kravitch of the U.S. Court of Appeals for the Eleventh Circuit, and a trial attorney in the Civil Division of the U.S. Department of Justice.

Professional Highlights

  • In 2012, a competitor sought a preliminary injunction in federal district court to block the FDA’s determination that Ranbaxy Laboratories was eligible for 180 days of market exclusivity for a generic version of the blood pressure/heart failure medication Diovan®. Ranbaxy, represented by Zuckerman Spaeder, intervened on the FDA’s behalf and filed a motion for summary judgment (as did the FDA). We briefed and argued the preliminary injunction and summary judgment motions, and the district court denied the competitor’s motion for a preliminary injunction and granted Ranbaxy’s and the FDA’s motions for summary judgment, preserving Ranbaxy’s eligibility for a generic exclusivity valued at $200 million.
  • Zuckerman Spaeder assisted Momenta Pharmaceuticals in connection with its successful efforts to uphold the FDA’s approval of a generic version of Lovenox® (enoxaparin sodium) developed by Momenta and its business partner, Sandoz. In 2012, the U.S. 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 the FDA’s approval of the generic product. Mr. Angulo advised Momenta and Sandoz in connection with the summary judgment briefing and argument, in addition to providing counsel after Sanofi’s earlier, unsuccessful efforts to obtain a preliminary injunction blocking the FDA’s approval.
  • In 2011, Zuckerman Spaeder filed an amicus curiae 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.
  • The firm successfully 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.
  • We successfully 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.
  • Zuckerman Spaeder filed an amicus curiae brief for Rep. Henry Waxman in the U.S. Supreme Court case, Caraco et al. v, Novo Nordsik et al. No. 10-844, urging the court to reverse the U.S. Court of Appeals, Federal Circuit’s decision undermining the Hatch-Waxman law’s “section viii” generic approval process. The Supreme Court unanimously reversed the Federal Circuit’s decision (132 S.Ct. 1670).
  • Zuckerman Spaeder assisted Momenta Pharmaceuticals in connection with its successful efforts to uphold 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.
  • In 2012, a competitor sought a preliminary injunction in federal district court to ‎block the FDA’s determination that Ranbaxy Laboratories was eligible for 180 ‎days of market exclusivity for a generic version of the blood pressure/heart ‎failure medication Diovan®. Ranbaxy, represented by Zuckerman Spaeder, ‎intervened on the FDA’s behalf and filed a motion for summary judgment (as did ‎the FDA). We briefed and argued the preliminary injunction and summary ‎judgment motions, and the district court denied the competitor’s motion for a ‎preliminary injunction and granted Ranbaxy’s and the FDA’s motions for summary ‎judgment, preserving Ranbaxy’s eligibility for a generic exclusivity valued at ‎‎$200 million.
  • The firm counsels the Reagan-Udall Foundation, a 501(c)(3) corporation created by Congress to assist the FDA in its mission.
  • Represents anti-smoking groups in matters before the FDA and in federal courts, with a focus on the 2009 tobacco law.
  • Advised a generic drug trade association on issues relating to generic drug approval and was the lead presenter for generic interests at a daylong FDA symposium on the subject.
  • In 2012, Zuckerman Spaeder filed comments on behalf of an unnamed client in opposition to an as-yet undecided FDA citizen petition filed by Abbott Laboratories calling on the FDA to suspend the biosimilars approval program on Fifth Amendment takings grounds.
  • In 2013, Zuckerman Spaeder 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.
  • In 2011, Zuckerman Spaeder provided FDA- and USDA-related due diligence counseling to the acquirer in connection with the completed acquisition of a national food company.
  • In 2014, Zuckerman Spaeder provided FDA-related due diligence counseling to a major food company in connection with a proposed joint venture.
  • In 2013, Zuckerman Spaeder provided regulatory advice to a foreign food manufacturer regarding FDA regulatory and U.S. food importation requirements.
  • In 2013, Zuckerman Spaeder represented a foreign medical device company in connection with claims by one of its competitors that the client had violated the Lanham Act.
  • Our attorneys testified before the Senate Committee of Health, Education, Labor and Pensions and the Senate Judiciary Committee regarding patent and exclusivity provisions in proposed bioterrorism legislation.
  • Zuckerman Spaeder has helped coordinate an international generic drug manufacturer’s efforts to assess and ensure regulatory compliance in foreign markets. In 2012, we negotiated a consent decree with the FDA, settling concerns that presented potential obstacles to drug approval. The consent decree strengthened Ranbaxy’s data integrity policies and its manufacturing practices, paving the way for the company to bring its products to market in the United States.

Mentioned & Quoted

Appearances

Publications

Bar Admissions

Court Admissions

Professional Affiliations

  • Member, Food and Drug Law Institute (FDLI)
    • Member, FDLI Tobacco Committee
    • Member, FDLI Writing Awards Committee

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