Pharmaceuticals & Healthcare
Global pharmaceutical and healthcare companies face a range of challenges: disputes over intellectual property (IP), adherence to evolving government regulation and parallel trade challenges, to name only a few. Great opportunity exists as well. Growth is possible through strategic acquisitions, joint ventures, licensing, distribution, supply agreements and international trade.
With our unique worldwide capabilities, including deep experience in the US, UK and EU regimes, we understand the business and legal intricacies that pharmaceutical and healthcare companies face on a daily basis. We work with many of the leading global players in the pharmaceutical and healthcare sector on their dispute resolution, corporate and transactional needs (major financings, M&A transactions, litigation, etc.).
We advise pharmaceutical multinationals on the full range of IP, antitrust, commercial litigation and M&A issues across the United States, Europe and Asia.
Our lawyers have litigated and won some of the biggest pharmaceutical cases in history. We successfully litigate high-profile patent cases, and advise on the full spectrum of IP-related work. In the US, we are the most experienced of any law firm in so-called "reverse payment" cases brought by the Federal Trade Commission and/or private plaintiffs. We try high-stakes pharmaceutical cases in the US and represent pharmaceutical clients in some of the most-watched matters of the day. In Europe, we have led the way on parallel trade and other issues in the sector.We also offer clients strong capabilities in other areas such as the Foreign Corrupt Practices Act, the False Claims Act, international arbitration, tax, environmental and international trade. We have deep connections with relevant national and international regulatory bodies in the pharmaceuticals and healthcare sector.
We offer clients unparalleled experience in defending branded, specialty, and generic pharmaceutical firms against antitrust-based challenges. Our experience includes government and private litigation, trials and appeals. Our work on behalf of pharmaceutical clients includes defending claims such as "product-hopping," Walker Process fraud before the United States Patent and Trademark Office (USPTO), "sham" IP enforcements and Food and Drug Administration (FDA) petitioning, and other allegations of improper conduct to delay or inhibit generic competition.
Our deep and longstanding connections with our clients ensure that our lawyers bring genuine commercial knowledge in the sector to each challenge. Our singular focus on understanding our clients' success and long-term strategies sets us apart. We commit to fully understanding our clients' businesses–their financial considerations and risk tolerance, as well as the competitive and regulatory environments in which they operate.
AWARDS & RECOGNITION
Only team to win "Competition Group of the Year" 7 times
Life Sciences Group of the Year
Law360 2018, 2016, 2014, 2013
Band 2 Belgium – EU Regulatory: Pharma, Medical Devices & Biotech
The Legal 500 2021
Consistently ranked in the top 10 for deal value in leading league tables.
Thomson Reuters, Mergermarket and Bloomberg
Antitrust Firm of the Year; Dimitrios Drivas inducted into Life Sciences "Hall of Fame"
LMG Life Sciences 2021
Dimitrios Drivas (2013, 2014), Rob Milne (2014, 2020), Jack Pace (2015) and Mark Gidley (2016) named to the "MVP" list of top lawyers in Life Sciences.
Several of our partners are noted for expertise in the pharmaceutical industry: "A prominent figure in the market whose considerable success has been founded on the impressive quality of…work." "Famed for…work in the pharmaceutical sector."
Pfizer and UCB, 2016
We achieved a significant victory for Pfizer and UCB at trial in a Hatch-Waxman patent case against Mylan concerning the drug Toviaz, which UCB developed and licensed to Pfizer, which markets the drug in the United States. Toviaz generates approximately US$200 million in annual US sales. The recent 4 day trial was against Mylan before Judge Gregory Sleet in the District of Delaware. Mylan claimed that it would present stronger invalidity arguments than those raised in the prior case, but the Court found Mylan's theories unconvincing in light of the persuasive and credible testimony from our chemistry experts. At the close of evidence, Judge Sleet issued a rare general verdict from the bench in favor of our clients on all five patents, concluding that Mylan failed to present even a prima facie case of invalidity. The Court's decision confirms that no generic will receive final FDA approval to market a generic version of Toviaz until 2022.
Anthem, Inc., US$54.2 billion acquisition of Cigna Corporation, 2015
We represented Anthem, Inc., one of the nation's largest health benefits companies, in its US$54.2 billion agreement to acquire Cigna Corporation, a combination that will create a premiere health benefits company with critical diversification and scale to lead the transformation of health care delivery for consumers.
Pfizer Inc., ongoing
We represent Pfizer on a broad range of intellectual property matters: patent infringement cases, cases involving antitrust claims based on patent settlements, and cases accusing Pfizer of copyright infringement. We also conduct US clearance investigations relating to branding of future US products.
We achieved a significant victory for Pfizer Inc. and its co-plaintiff Northwestern University in their patent infringement litigation against multiple generic drug companies involving patents covering Pfizer's blockbuster drug LYRICA® and certain of its therapeutic uses.
In an antitrust case (based on settlement of a patent case) involving the largest-selling pharmaceutical product in history, LIPITOR (US$125 billion per year), the trial court granted our motion to dismiss with prejudice in its entirety.
We represent UCB, a Belgium-based, global biopharma company, in US patent infringement cases. A recent significant victory, upheld by the US Court of Appeals for the Federal Circuit, involved defending UCB against patent infringement claims brought by Apotex, a generic drug manufacturer, in the US District Court for the Southern District of Florida. After a three-day bench trial on mostly equitable claims, the court held that Apotex's patent was unenforceable, in addition to other decisions favorable to UCB.
We represent Sandoz, a major pharmaceutical manufacturer, in the long-running Average Wholesale Prices (AWP) litigation, which has included numerous federal and state court cases brought by state Attorneys General and a qui tam relator alleging false claims act, fraud and consumer protection claims. Plaintiffs claim that pharmaceutical manufacturers reported false and inflated prices, which allegedly caused state Medicaid agencies to overpay for prescription drugs. We achieved significant wins in the two actions litigated to completion when, in each instance, the appellate court reversed substantial jury verdicts for the plaintiff state and issued a judgment in favor of Sandoz. These appellate victories combined to reverse more than US$100 million in judgments and set important precedents. Our counsel to Sandoz is ongoing.
Hikma Pharmaceuticals PLC, US$2.65 billion acquisition of generic drugs businesses, 2015
We represented Hikma Pharmaceuticals PLC in its US$2.65 billion acquisition of the US-based generic drugs businesses, Roxane Laboratories and Boehringer Ingelheim Roxane, from German drug maker Boehringer Ingelheim.
Zimmer Holdings, US$13.35 billion acquisition of Biomet, 2014
We represent Zimmer Holdings, Inc., a world leader in musculoskeletal health solutions, in its US$13.35 billion acquisition of Biomet, Inc., one of the world's leading medical device manufacturers.
Shenzhen Hepalink, acquisition of Scientific Protein Laboratories, 2014
We represented Shenzhen Hepalink Pharmaceutical Co., Ltd., a Chinese company listed on the Shenzhen Stock Exchange, and its US subsidiary, Hepalink USA Inc., in its US$337.5 million acquisition of Scientific Protein Laboratories, LLC, one of the leading global independent manufacturers and suppliers of active pharmaceutical ingredients. This transaction is one of a few acquisitions by a People’s Republic of China public company of a US privately held target and constituted a major reorganization for our client pursuant to the relevant Chinese listing rules, with the involvement of multiple consultants and agencies in the US and China.
Wellpoint, Inc., sale of 1-800 CONTACTS, 2014
We represented WellPoint, Inc., one of the nation's largest health benefits companies, in its sale of its 1-800 Contacts subsidiary to private equity firm Thomas H. Lee Partners and its related asset sale of 1-800’s glasses.com business to international optical conglomerate Luxottica.
Par Pharmaceuticals and Paddock Holdings
We represented Par Pharmaceuticals and Paddock Holdings in a Federal Trade Commission (FTC) challenge to settlement agreements regarding AndroGel®. The Eleventh Circuit forcefully reaffirmed the principle that brand-generic patent settlement agreements are not actionable if they do not exceed the scope of the patent, handing the FTC its first "payment for delay" loss on a motion to dismiss posture. White & Case was the only firm to have opposed the grant of certiorari among defense counsel; the others supported certiorari. On appeal to the Supreme Court, the court rejected the position of the FTC automatically condemning "reverse payment" settlement agreements as per se illegal (the Third Circuit position). The court held that challenges to such agreements are subject to the rule of reason, and we are currently handling cases for a variety of clients in the lower courts interpreting the Supreme Court's opinion.