Pharmaceuticals & Healthcare

AbbVie
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.

Actavis/Warner Chilcott
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."

ADVANZ PHARMA
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.

Allergan/Warner Chilcott/Watson
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.

Anthem
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.

Bayer
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.

Carlyle Group
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.

COBEPA
Representation of Cobepa in its Reaction Biology Corporation, an industry-leading provider of drug discovery services, as well as the financing of the transaction.

Enzymotec Ltd.
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).

Kite
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.

LOTTE
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.

Par Pharmaceuticals
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.

Pfizer
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.

Takeda
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.

Vertex
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.