Capabilities
Life Sciences Industry

Antitrust

Arnold & Porter's Antitrust/Competition practice enjoys an international reputation for effective antitrust and competition advocacy in the life sciences sector in the US and EU. We coordinate multidisciplinary teams of lawyers, economists, and industry experts to craft creative business-responsive solutions that address our clients' local and international regulatory and litigation needs. Our team has handled numerous engagements representing life sciences clients over many decades. The firm's antitrust attorneys have assisted life sciences clients in the full range of competition-related engagements, including transactions, government criminal and civil investigations, litigation, and counseling. Our team includes lawyers who have held significant senior government positions in Europe and the US, including Chair of the Federal Trade Commission (FTC), Director of the FTC's Bureau of Competition, Deputy Assistant Attorney General of the Department of Justice Antitrust Division, and Head of the Food and Pharmaceuticals and Financial Services Units in the European Commission's Competition Directorate General.

Representative Experience

  • Hikma Pharmaceuticals in its $2 billion acquisition of the Roxane Laboratories generic drug business from Boehringer Ingelheim. In describing the importance of the transaction, Said Darwazah, Chief Executive Officer of Hikma, has commented: "This transaction has significant strategic value for us, transforming our position and scale in the US generics market. Roxane's impressive portfolio, attractive pipeline and R&D expertise, focusing on higher value, niche and differentiated products, will create a platform for sustainable long-term growth."
  • Hikma Pharmaceuticals' $300 million acquisition of the Bedford generic injectable drug business from Boehringer Ingelheim. Regarding the transaction, Said Darwazah, Chief Executive Officer of Hikma, commented: "Bedford's impressive product portfolio and deep pipeline will significantly increase the scale and scope of our rapidly growing US Injectables business. The large number of high value, niche and differentiated products we are acquiring will strengthen our market position in the US and will benefit patients by bringing back products to the market that are currently in short supply."
  • Aduro Biotech, Inc. in the negotiation of a major collaboration with Novartis for the worldwide research, development, and commercialization of novel immuno-oncology products. Under the terms of the agreement, Novartis has paid $200 million to Aduro and, if development milestones are met, Aduro is eligible to receive up to an additional aggregate amount of $500 million.
  • General Electric in a putative class action filed by PharmaRx against GE and Cardinal Health alleging anticompetitive conduct relating to radiopharmaceutical distribution. Our motion to dismiss the amended complaint with prejudice was granted in January 2013. The Ninth Circuit affirmed the judgment for GE in March, 2015.
  • Boston Scientific Corporation in its acquisition of American Medical Systems' urology portfolio from Endo for $1.6 billion. The transaction required filings in the US, Spain, Germany, and Colombia. As stated by Mike Mahoney, President and CEO of Boston Scientific, "The combination of Boston Scientific's Urology and Women's Health and AMS' urology portfolios will create a business with nearly $1 billion in annual sales and enable significant synergies and strong future growth prospects through portfolio innovation and international market expansion."
  • American Capital, Ltd. in the sale of Scientific Protein Labs, a manufacturer of pancreatic enzymes, heparin, and its analogs, to Shenzhen Hepalink Pharmaceuticals. The firm counseled both American Capital and Scientific Protein Labs on antitrust issues related to the transaction and represented them before US and French regulators.
  • Boston Scientific Corporation in its $415 million acquisition of Bayer AG's Interventional business.
  • General Electric in connection with the Federal Trade Commission (FTC) investigation of Thermo Fisher Scientific's acquisition of Life Technologies and GE's $1.06 billion acquisition of the cell culture, gene modulation, and magnetic bead businesses from Thermo Fisher. Those businesses were divested as part of Thermo Fisher's acquisition of Life Technologies pursuant to an FTC consent decree and other regulatory requirements around the world.
  • Celgene Corporation, a multinational biopharmaceutical company, in connection with its $2.9 billion acquisition of Pharmion Corporation. Although both Celgene and Pharmion marketed medicines used in the treatment of certain cancers of the blood, the team was able to demonstrate that the drugs were not in head-to-head competition through an in-depth exploration of the drugs' mechanisms of action and their therapeutic usage. In the US, the FTC cleared the transaction without a Second Request under the Hart-Scott-Rodino Act. In Germany, the Federal Cartel Office approved the transaction without requiring a Phase 2 investigation.
  • Laboratoires Fournier (a subsidiary of the Belgian company Solvay) at trial in November 2008. The case involved the cholesterol medication TriCor and alleged that Fournier and its licensing partner Abbott had foreclosed competition through the introduction of successive formulation changes to TriCor making it more difficult for generic companies to compete effectively in the market. Plaintiffs in the District of Delaware case included generic manufacturers, Impax Laboratories, Teva USA, Teva Pharmaceutical, and Novopharm, along with a class of direct purchasers of TriCor. Over the course of the trial, each plaintiff group eventually agreed to settle for a fraction of their demand just before trial with the last settlement coming during the testimony of the final witness.
  • Defending generic drug manufacturer in several direct and indirect purchaser actions claiming that it and other generic manufacturers conspired to fix prices in certain generic dermatological products (S.D.N.Y.).
  • Pfizer and Warner-Lambert against claims brought by the State of Louisiana that Pfizer and Warner-Lambert delayed the introduction of generic versions of Neurontin® by bringing alleged "sham" litigation to enforce patents, causing the State Medicaid Agency to overpay for branded Neurontin®, allegedly in violation of Louisiana anti-monopoly and other laws. State of Louisiana v. Pfizer Inc. and Warner-Lambert Company, LLC (19th Judicial Dist. Ct., Parish of East Baton Rouge).
  • Brand name pharmaceutical manufacturer against third-party payor health plans claims that it brought so-called "sham" litigation to enforce patents in an effort to impede generic competition. United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund, et al. v. Novartis Pharmaceuticals Corporation, et al. (US District Court, D. Mass.).
  • King Pharmaceuticals LLC in several federal and state class actions alleging that manufacturer conspired with a potential generic entrant to delay or block generic entry in violation of Section 1 of the Sherman Act and certain state antitrust, unfair trade practices, and related laws. Defeated motions for class certification by plaintiffs seeking to represent classes of Indirect Purchasers for Resale (e.g., pharmacies) and End Payor Indirect Purchasers (e.g., health insurers, pharmacy benefit managers, consumers); successfully resolved remaining "opt-out" plaintiffs cases and currently defending related actions in state court.
  • Novartis AG with respect to the competition law issues associated with its July 2012 $1.5 billion acquisition of a competing dermatologics company, Fougera Holdings, Inc., and represented the company before the Federal Trade Commission to obtain clearance for the acquisition. Novartis Acquisition of Fougera Holdings, Inc.
  • Brand name prescription drug manufacturer in obtaining summary judgment on behalf of it and its codefendants, dismissing on the merits an action by California retail pharmacies alleging a conspiracy to fix prices in violation of the Cartwright Act, California's state antitrust law. Summary judgment was affirmed by the California Court of Appeal and, on November 28, 2012, the California Supreme Court denied plaintiffs' Petition for Leave to Appeal. On June 3, 2013, the United States Supreme Court denied plaintiffs' Petition for a Writ of Certiorari. Clayworth, et al. v. Pfizer Inc, et al. (Superior Court of California, Alameda County).
  • Novartis AG in connection with competition and regulatory approval aspects of its February 2010 acquisition of Corthera, Inc., a privately held biopharmaceutical company engaged in the research and development of Relaxin, for $120million, with Corthera's shareholders being eligible for additional payments of up to $500 million contingent upon successful development and commercial milestones; assisted the company in obtaining early termination of Federal Trade Commission review of the transaction. Novartis Acquisition of Corthera, Inc.
  • Pfizer Inc. and its codefendants in obtaining summary judgment, dismissing all damages claims by representative plaintiffs in price discrimination actions brought by several thousand independent pharmacies against a group of major brand name prescription drug manufacturers. Drug Mart Pharmacy Corp., et al. v. American Home Products Corp., et al. (US District Court, EDNY).
  • Together, Rx LLC and its founding members, in obtaining voluntary dismissal of horizontal antitrust claims asserted in private third-party payor and Medicare beneficiary class actions as well as all consumer fraud and Medicaid fraud claims against the firm's client asserted by the same plaintiffs. In re Pharmaceutical Industry Average Wholesale Price Litigation (US District Court, D. Mass).
  • Major pharmaceutical company in putative class actions alleging price-fixing among manufacturers of generic drugs. Sergeants Benevolent Association Health & Welfare Fund, et al. v.Fougera Pharmaceuticals, Inc., et al.
  • Major pharmaceutical company in putative antitrust class actions alleging that defendants procured patent by fraud and engaged in sham patent litigation. United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund, et al. v. Novartis Pharmaceuticals Corp., et al.
  • Major pharmaceutical company in case brought by state attorney general alleging that defendants violated state law by engaging in sham patent litigation with prospective generic competitors. State of Louisiana v. Pfizer Inc. and Warner Lambert LLC.
  • Major pharmaceutical company in antitrust class actions challenging a patent litigation settlement agreement between branded and generic pharmaceutical companies. In re Lamictal Antitrust Litigation.
  • GSK in a case brought by Santa Clara County on behalf of all California citizens alleging violations of California's false advertising law. County of Santa Clara v. GlaxoSmithKline.
  • Major pharmaceutical company in a landmark case brought by the Federal Trade Commission challenging the settlement of patent cases brought against manufacturers of generic drugs. After a two-month hearing, the administrative law judge ruled in the client's favor, and the FTC was unsuccessful on appeal. Schering-Plough v. Federal Trade Commission.
  • Manufacturer of orthodontic appliances in a case alleging monopolization under Section 2 of the Sherman Act. The case resulted in a directed verdict on behalf of the client at the close of the plaintiff's case. Viazis, et al. v. GAC International, Inc.
  • Novartis International AG in connection with competition and regulatory approval aspects of its acquisition of Corthera, Inc.
  • Pfizer in its worldwide enforcement of patents covering its blockbuster drug Viagra®. Most significantly, after assisting Pfizer through a lengthy reexamination proceeding, we succeeded in preserving Pfizer's still ongoing exclusivity for Viagra, defeating a challenge by Teva Pharmaceuticals which sought FDA approval to sell a generic version of the drug. After a twelve-day bench trial, the US District Court for the Eastern District of Virginia ruled that Pfizer's patent claiming use of the drug to treat erectile dysfunction would be infringed by Teva's proposed copy. The court rejected Teva's arguments that Pfizer's patent is invalid and unenforceable. The case settled on appeal to the Federal Circuit. We also represented Pfizer in additional ANDA litigations concerning Viagra brought in the US District Court for the Southern District of New York. Those cases likewise settled. Our outstanding work on Viagra was recognized by The American Lawyer which recognized Aaron Stiefel and Daniel DiNapoli as "Litigators of the Month."

Experience

Boston Scientific Corporation Acquisition of Symetis
Obtained antitrust clearances associated with the company’s $435 million acquisition of Symetis, a Swiss structural heart company focused on minimally-invasive transcatheter aortic valve implantation devices.
Generic Drug Manufacturer In re Generic Pharmaceuticals Pricing Antitrust Litigation
Defending the company in several direct and indirect purchaser actions relating to certain dermatological products.
Pfizer and Warner-Lambert State of Louisiana v. Pfizer Inc. and Warner-Lambert Company, LLC
Defended the company against claims brought by the State of Louisiana that they delayed the introduction of generic versions of Neurontin® by bringing alleged “sham” litigation.
General Electric Company Acquisition of certain biosciences businesses
Obtained antitrust clearance for the client's US$1.06 billion acquisition of cell culture, gene modulation, and magnetic bead businesses divested by Thermo Fisher Scientific.
Novartis Acquisition of Fougera Pharmaceuticals
Represented client and its generics division Sandoz on its $1.525 billion all-cash purchase of Fougera Pharmaceuticals.
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