Pharmaceutical antitrust litigation

About

White & Case has an unmatched record in litigating antitrust matters for life sciences companies, often at the cutting edge of the law. We are market leaders in defending antitrust challenges to life-science patent settlements ("reverse payment" cases), product innovation strategies ("product-hopping" cases), cartel matters, as well as a range of pricing and distribution practices. We are also at the forefront of the application of antitrust in the newly developing area of biologics and biosimilars, representing clients in currently pending litigation in this important sector.

Our antitrust lawyers have been handling pharmaceutical antitrust cases since the very inception of the above theories decades ago. Our experience representing both brand and generic pharmaceutical companies provides our lawyers a unique perspective on avenues of defense for our clients, and we have extensive experience litigating claims brought by both private class action and opt-out plaintiffs, as well as the FTC and DOJ.

We believe we have the market-leading position in this type of litigation. Among other things, we believe we are the first law firm with two trial victories in the "reverse payments" area of antitrust law against the FTC (K-Dur®) and against class action plaintiffs (Hytrin®), the self-identified number-one priority of the FTC and the pharmaceutical class action plaintiffs.

 

Trial-ready

Our team begins preparing for trial from day one to ensure that it can take cases to the mat when necessary. Our Antitrust Practice is the only antitrust practice to handle at least one trial per year and has an unprecedented track record of trial victories in complex antitrust cases. But being a Firm that's known as "trial- ready" is about more than just trials: Our past successes in jury and bench trials along with our proven trial preparation strategies allow us to routinely achieve litigation off-ramps prior to trial, with favorable results for our clients ranging from settlement to the successful opposition of class certification and dispositive motion practice.

Our antitrust lawyers have achieved impressive results for our clients, often through innovative legal theories and creative approaches to issues of first impression. White & Case's innovative, energetic strategies have led to a long list of "firsts."

 

Innovative "firsts" in life sciences

  • First patent settlement agreement antitrust trial, a defeat for the FTC – FTC v. Upsher-Smith
  • First jury trial defeat of reverse-payment case – Kaiser v. Abbott
  • First defeat of a pharmaceutical consumer class action on Seventh Amendment grounds – Asacol
  • First defense-side product-hopping victory at summary judgment – Doryx
  • First and second reverse-payment case appellate wins – Valley Drug & Upsher-Smith
  • First defeat of a pharmaceutical antitrust claim on product market grounds – Doryx
  • First Third Circuit affirmation of summary judgment on product hopping defense and market definition – Mylan v. Warner Chilcott
  • First defeat of more than 200+ state law claims on a motion to dismiss – Aggrenox
  • First simultaneous co-promote patent settlement agreement – Kos Pharmaceuticals (Barr Labs)
  • First simultaneous merger-patent settlement agreement – Sepracor Pharmaceuticals (Arrow Pharma)
  • First forced patent license cases – IMS Health
  • First consent decree patent settlement agreement – In re: AndroGel Antitrust Litig.
  • First use of FRE 502 in helping to defeat sham patent litigation antitrust counterclaims – Shionogi v. Mylan
  • First federal district court loss for FTC's attack on "reverse payments" – In re: AndroGel Antitrust Litig.
  • First grant of "downstream discovery" (pass-on/sales information) from direct purchaser pharmaceutical class plaintiffs – Doryx
  • First grant of offensive discovery against pharmaceutical wholesaler plaintiffs – Doryx

 

View more information on Cartel investigations

View more information on Merger control

View more information on Antitrust litigation & class actions

View more information on Drug Pricing

View more information on Due process

View more information on European state aid

View more information on Competition compliance

View more information on Antitrust/Competition

 

 

AWARDS & RECOGNITION

Only team to win "Competition Group of the Year" 7 times
Law360

Top 3 in the "Global Elite"
GCR 100 2023

Tier 1
Antitrust/Competition
LMG Life Sciences 2023

"It seems like most of the winning defense strategies you see used in today's pharma antitrust matters can be traced back to arguments that the White & Case team came up with, and oftentimes won on, in some earlier litigation."
The Legal 500 US 2022

"The competition team is characterised by its sector expertise, which is hardly shown by its competitors."
Chambers Europe 2018

"The White & Case Antitrust team is a powerhouse in pharmaceutical antitrust litigation. They excel in their close understanding of the pharmaceutical industry, countless litigations in this space and actual experiences from which to draw, and mastery of relevant case law and trends."
The Legal 500 2021

"Particularly well suited to handling litigation at the cross-section of intellectual property and antitrust"
Chambers USA 2023

"White & Case is the leading defense firm for pharmaceutical companies facing pay-for-delay and product-hopping claims."
GCR 2018

"Puts a special emphasis on the pharmaceutical industry such as issues involving biosimilars, reverse payment patent settlements and product-hopping monopolization"
The Legal 500 US 2020

"They know which arguments the court will be most receptive to," says one source, explaining: "They have an insight into how the judges think and how the cases have developed."
Chambers Europe 2022

Experience

Life cycle management

Allergan/Warner Chilcott – Asacol: In a landmark victory for Allergan, 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. 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.

Warner Chilcott/Actavis – Doryx: 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."

 

Settling patent cases, patent fraud, inequitable conduct

Allergan/Warner Chilcott – Loestrin: 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.

Par Pharmaceuticals – Androgel: 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.

 

Loyalty contracting, price discrimination

Pfizer – Remicade: Representing Pfizer in major action against Johnson & Johnson asserting that Johnson & Johnson has improperly extended its patented monopoly on its multibillion-dollar biologic drug, Remicade.

 

Cartel, group boycott

Pfizer/Hospira – IV saline: Represented Pfizer/Hospira and ICU Medical in antitrust class action alleging conspiracy to create an artificial shortage of IV saline, securing dismissal on the pleadings.