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
Adam Acosta (2022), 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."
Secured complete dismissal with prejudice of all reverse-payment antitrust claims filed by nationwide class-action plaintiffs (direct and indirect purchasers) as well as nationwide retailers Walgreens and CVS concerning hypertension drug Bystolic®. The case challenged patent litigation settlements that allowed entry by multiple generics prior to patent expiry and were done in parallel with commercial business deals. White & Case is lead counsel in the Second Circuit appeal.
Successfully defended against claims of monopolization based on alleged "product hopping" brought by manufacturer of generic version of Doryx. The Third Circuit affirmed dismissal on summary judgment, finding that Warner Chilcott did not exclude competition by reformulating, introducing and marketing new versions of Doryx, or even by withdrawing old versions, key issues in the increasing number of cases regarding pharmaceutical "product hopping."
Representation of ADVANZ PHARMA on its acquisition of the ex-US business of Intercept Pharmaceuticals. This investment will give ADVANZ PHARMA the rights to commercialize Ocaliva, a drug treatment for primary biliary cholangitis, a form of liver disease, outside the US and thereby establish it as a leading provider of specialty and hospital pharmaceuticals in Europe.
In a landmark victory for Allergan concerning its Asacol treatment, we successfully reversed the District Court's end-payor class certification at the First Circuit. The far-reaching ruling bans the widespread use of aggregate proof and post-trial affidavits as a substitute for fact-finding by juries under the Seventh Amendment. The Asacol plaintiffs challenged Allergan's alleged "product hopping": the development of new dibutyl phthalate-free Asacol, despite the FDA's insistence that Allergan develop this phthalate-free version. On remand from the First Circuit, the District Court denied leave for plaintiffs' smaller class, and the First Circuit upheld that decision by denying a Rule 23(f) appeal. This successfully ended the Asacol class action.
Defended Warner Chilcott and Watson in antitrust class actions asserting Walker Process fraud, sham litigation, "reverse payment" patent settlements and product-hopping monopolization. After a three-day mini-trial on class certification, which showed that a massive number of consumers were uninjured and that there was no manageable way to identify and exclude these uninjured consumers at trial, the District Court eliminated the consumers from the Loestrin antitrust class action completely, expressly following the First Circuit Asacol class certification reversal that White & Case had secured only a few months earlier.
White & Case achieved a landmark victory on behalf of Anthem (now Elevance Health), in one of the hardest-fought broken deal disputes in US history, resulting from the failed US$54 billion acquisition of Cigna Corporation. Over four years of litigation, two weeks of trial, and one appeal, our aggressive strategy from day one allowed Anthem to choose the grounds and define the playing field for their eventual trial success.
Representation of Bayer in a broad range of complex IP issues involving pre-litigation investigations and PTAB proceedings related to their patent portfolios directed to various drug/crop science candidates in development to identify potential arguments that third-party challengers may deploy in litigation; strategic counseling on how to mitigate such risks and strengthen the existing portfolios worldwide for stronger patent coverage; as well as due diligence support, providing opinions on third-party patent risks, and advice relating to cross-border contested proceedings in the US and Europe.
Representation of Carlyle Group (NASDAQ: CG) and the existing promoters of SeQuent Scientific Limited in the acquisition of a majority stake in SeQuent Scientific Limited ("SeQuent"), the largest pure-play animal healthcare company in India.
Representation of Cobepa in its Reaction Biology Corporation, an industry-leading provider of drug discovery services, as well as the financing of the transaction.
Representation of Enzymotec Ltd., a developer, manufacturer and marketer of innovative bio-active lipid ingredients and nutritional products, in its acquisition by Frutarom, an Israeli company (LSE:FRUT) (TASE:FRUT).
Representation of Kite, a Gilead Company, in its global strategic collaboration to co-develop and co-commercialize Arcellx, Inc.'s lead late-stage product candidates, CART-ddBCMA.
Representation of South Korean multinational conglomerate LOTTE Corporation (LOTTE) on its US$160 million acquisition of a biological drug manufacturing facility in New York from Bristol Myers Squibb. The transaction represents LOTTE's first acquisition of a pharmaceutical technology asset to launch its business in the US. The new plant will serve as the LOTTE Center for North America Operations for its new biologics contract development and manufacturing organization business in the US.
Defeated direct-purchaser plaintiffs' motion for class certification in a "reverse payment" case, only the second time that a putative class of direct purchasers has been denied class certification in a pharmaceutical antitrust case. The denial signaled a significant vulnerability for such hoped-for direct purchaser class actions in pharmaceutical and other cases going forward.
We have been IP counsel to Pfizer for the past 20 years and have handled numerous District Court litigation, Federal Circuit appeals and PTAB matters.
Representation of Pfizer in major action against a branded competitor asserting that the company improperly extended its patented monopoly on its multibillion-dollar biologic drug, Remicade.
Representation of Pfizer/Hospira and ICU Medical in antitrust class action alleging conspiracy to create an artificial shortage of IV saline, securing dismissal on the pleadings.
Pharmaceutical licensing dispute
We obtained a victory for a US biotechnology company that had developed a revolutionary device for the long-term treatment of a chronic disease, in an ICC arbitration against a major European pharmaceutical company arising out of disputes over a licensing and know-how agreement.
Representation of Takeda Pharmaceutical Company Limited on its strategic divestitures of over-the-counter and non-core assets worth over $3 billion to various purchasers in various jurisdictions, including Russia, Latin America, Europe, China, and Asia Pacific.
Representing Vertex in Hatch-Waxman patent infringement cases pending in the District of Delaware concerning Vertex's KALYDECO® tablets, a treatment for cystic fibrosis.
Zimmer Biomet spin-off of dental and spine business
Representation of Zimmer Biomet Holdings, Inc., a global medical technology leader, and ZimVie Inc. in the spin-off of ZimVie, Zimmer Biomet's former dental and spine businesses.