Munger, Tolles & Olson’s broad spectrum of life sciences representations covers:

Antitrust
Our firm has handled groundbreaking antitrust pharmaceutical matters, including “reverse payment” claims, sham litigation claims, Orange Book listing challenges, Walker Process claims, Robinson-Patman claims, resale price maintenance claims and pharmaceutical bundling claims. Our representations include:

• Solvay Pharmaceuticals, now part of AbbVie, as lead counsel in the landmark FTC v. Actavis, Inc. matter, where the U.S. Supreme Court ruled that “reverse payment” patent settlements between brand-name pharmaceutical companies and generic manufacturers are not presumptively unlawful, but should be evaluated under the “rule of reason.”
• AbbVie in defeating antitrust claims brought by GlaxoSmithKline when AbbVie repriced Norvir®, a HIV treatment commonly used to increase the potency of a GSK drug. The jury rejected GlaxoSmithKline’s $571 million damages claim, which would have been subject to automatic trebling under antitrust laws, and GSK abandoned those claims on remand from the Court of Appeals.
• AbbVie in defeating the FTC’s claims that AbbVie improperly brought and settled patent litigation to maintain a monopoly over the testosterone replacement drug AndroGel®.
• AbbVie Inc. and Solvay Pharmaceuticals in a decade-long, multi-part antitrust litigation brought by wholesalers and indirect purchasers alleging “sham litigation” in patent settlements concerning the testosterone drug AndroGel®. Trial is expected in 2025.

Patents
Our attorneys have litigated numerous important life sciences patent cases, including:

• Abbott Laboratories, later AbbVie, in TheraSense v. Becton Dickenson, in winning an en banc Federal Circuit ruling that fundamentally altered the standards for determining inequitable conduct before the U.S. Patent and Trademark Office.
• Takeda Pharmaceuticals and its affiliates in obtaining judgments of patent infringement and validity, as well as injunctive relief, in a bench trial against three companies seeking to market generic versions of Takeda’s acid reflux drug, Dexilant®.
• Abbott Laboratories, later AbbVie, in obtaining dismissal of a patent infringement suit filed by Bayer Corp. alleging that Abbott’s largest product, the antirheumatic drug Humira®, infringed Bayer’s patents.
• Amgen in defending a patent infringement lawsuit related to Mvasi®, a biosimilar version of Genentech’s Avastin®. We helped the parties reach a confidential settlement that allowed Amgen’s biosimilar drugs to stay on the market.

Licensing and Payments

We have helped our clients obtain awards and multi-year licensing agreements. Our representations include:

• Amgen, in obtaining a favorable settlement from Coherus Biosciences, including a multi-year royalty, on the eve of a lengthy trial to resolve a trade secret dispute regarding a Coherus treatment that is biosimilar to Amgen’s oncology drug Neulasta®.
• Abbott Laboratories in successfully resolving a claim for milestone royalties and trade secret counterclaims relating to DNA amplification technology.

Class Actions

Our attorneys routinely obtain dismissals of class actions at the pleading stage or denials of class certification. If matters should proceed to trial, we are equally adept at bringing them to swift and favorable resolutions. Our putative class action representations include:

• Takeda Pharmaceuticals in defeating certification of two proposed classes of indirect purchasers who alleged that Takeda’s conduct in licensing and enforcing patents delayed the market entry of a generic version of its muscle relaxant, Skelaxin®.
• AbbVie, in obtaining a denial of class certification for third-party payers of the drug Niaspan®, who allege that AbbVie and Teva engaged in a “reverse-payment” settlement to delay marketing of a generic version of the treatment. The Third Circuit’s affirmance of that ruling is the leading precedent on how the Circuit’s class action ascertainability requirement applies in pharmaceutical industry litigation.

False Claims Act
We have investigated and defended individuals and companies against a broad array of white collar charges. Our representations for pharmaceutical clients include:

• Genentech in a False Claims Act investigation by U.S. Attorney’s Office for the District of Massachusetts relating to Lucentis®, a macular degeneration drug. In August 2023, after the government declined to intervene, the private plaintiff voluntarily dismissed the complaint.

Case Studies

We specialize in challenging matters that set important precedents, which is why clients turn to us when the stakes are high and they need a knowledgeable, experienced partner to help guide matters to an efficient resolution. Our work includes:

Kite Pharma: Overturning a $2 billion medical patent infringement ruling

Munger, Tolles & Olson and co-counsel helped Kite Pharma, Inc., a subsidiary of Gilead Sciences, defeat a patent infringement complaint filed by Juno Therapeutics (now a subsidiary of Bristol Meyers Squibb) and its licensor, the Memorial Sloan Kettering Cancer Center, regarding competing cancer treatments. The plaintiffs alleged that Kite Pharma’s drug, Yescarta®, infringed their patent and claimed more than $1.2 billion in damages, plus ongoing royalties – estimated at $500 million annually – for several years.

The case went to trial in district court in December 2019 and the jury returned a verdict in favor of Juno. Kite appealed to the U.S. Court of Appeals for the Federal Circuit. In August 2021, the Federal Circuit found for our client, reversing the district court’s judgment and agreeing with our argument in the district court that the asserted patent claims were invalid for lack of adequate written description.

Media Coverage: Fed. Circ. Wipes Out $1.1B Juno IP Win On Cancer Drug

AbbVie: Establishing the leading precedent on application of the class certification “ascertainability” requirement

Munger, Tolles & Olson represents AbbVie, Inc., in long-running putative class actions by direct and indirect purchasers of the dyslipidemia treatment drug Niaspan®, In Re: Niaspan Antitrust Litigation. Plaintiffs allege that settlement agreements between two predecessor companies, now owned by AbbVie and Teva, improperly delayed generic versions of Niaspan® from entering the market.

In August 2021, a Pennsylvania federal judge denied certification of a class of end-payor plaintiffs, finding that the plaintiffs had failed to establish that they met the ascertainability requirement for class certification. The plaintiffs appealed to the Third Circuit, where MTO conducted the oral argument on behalf of all defendants. In May 2023, a Third Circuit panel upheld the district court’s denial of class certification. The Third Circuit’s affirmance of that ruling is the leading precedent on how the Circuit’s class action ascertainability requirement applies in pharmaceutical industry litigation.

Media Coverage: 3rd Circ. Rejects Rehearing Bid From Niaspan Buyers

Contact:

Stuart N. Senator

Rohit K. Singla