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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
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Carlos Angulo

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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.

Carlos 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.

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 for Sen. Sheldon Whitehouse, returning 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.

  • Obtained a favorable summary judgment on behalf of Ranbaxy that preserved the generic manufacturer’s eligibility for marketing exclusivity, valued at $200 million. In 2012, a competitor had 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Provided FDA- and USDA-related due diligence counseling to the acquirer in connection with the completed acquisition of a national food company.
  • Provided FDA-related due diligence counseling to a major food company in connection with a proposed joint venture.
  • Provided regulatory advice to a foreign food manufacturer regarding FDA regulatory and U.S. food importation requirements.
  • Represented a foreign medical device company in connection with claims by one of its competitors that the client had violated the Lanham Act.
  • 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.
  • 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 the client’s data integrity policies and its manufacturing practices, paving the way for the company to bring its products to market in the United States.

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Professional Affiliations

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

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