Life Sciences and Pharmaceuticals
Handling high-stakes antitrust and patent matters
Life sciences and pharmaceuticals clients retain Munger, Tolles & Olson to help them navigate, resolve and litigate their most important matters. We have long had a leading life sciences practice, focusing on advising on and leading litigation regarding antitrust, patents, licensing and trade secrets, including jury and bench trials as well as appellate work. To each matter, we bring not only technical and scientific backgrounds and a deep understanding of the pharmaceutical industry, but also our reputation as trial lawyers. Our experience in large-scale litigation makes us a formidable force in the courtroom and we have achieved favorable outcomes for our clients in high-stakes civil and criminal cases and regulatory actions.
We have a particular focus on landmark matters at the intersection of antitrust and patent laws, such as challenges to patent settlements, allegations of sham patent litigation and Walker Process claims. We were the lead defense counsel at every stage of the precedent-setting FTC v. Actavis matter, including before the U.S. Supreme Court, and continue to break ground in pharmaceutical antitrust litigation.
Our Life Sciences and Pharmaceuticals practice includes the following service areas:
- Patent Litigation and Strategy
- Class Actions
- Antitrust Litigation and Counseling
- Licensing and Royalty Disputes
- Trade Secret and Employment Mobility
Our life sciences clients have included many of the leading companies in the industry, such as:
- Abbott Laboratories
- Novartis Pharmaceuticals
- Takeda Pharmaceuticals
- Gilead/Kite Pharma
Our attorneys draw on deep experience in precedent-setting matters, including FTC v. Actavis, and the first denial of class certification of a direct purchaser class in a reverse payment case. Our team includes:
Munger, Tolles & Olson’s broad spectrum of life sciences representations covers:
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. Examples of such matters 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.
- AbbVie in defeating antitrust claims brought by GlaxoSmithKline when AbbVie repriced Norvir®, a HIV treatment commonly used to increase the potency of a GlaxoSmithKline drug. The jury rejected GlaxoSmithKline’s $571 million damage claim, which would have been subject to automatic trebling under the antitrust laws.
- 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®.
Our attorneys have litigated numerous important life sciences patent cases, including:
- Abbott Laboratories, in TheraSense v. Becton Dickenson (Fed. Cir. 2011), where our team persuaded the Federal Circuit en banc to fundamentally change the standards for determining inequitable conduct before the U.S. Patent and Trademark Office.
- Takeda Pharmaceuticals 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, 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, including a multi-year royalty from Coherus Biosciences, to resolve a trade secrets dispute involving the oncology drug Neulasta®.
- American Hospital Association (AHA), in successfully challenging a major reduction in Medicare reimbursements to AHA members under the 340B Drug Pricing Program. The U.S. Supreme Court ruled that the Department of Health and Human Services improperly denied $4 billion in past reimbursements and required the agency to change its policies.
- Abbott Laboratories in successfully resolving a claim for milestone royalties and trade secret counterclaims relating to DNA amplification technology.
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 twice defeating class certification of third-party payors of the dyslipidemia treatment drug Niaspan®. Plaintiffs alleged that a patent infringement settlement by a predecessor company violated antitrust laws by delaying the marketing of generic versions of the drug.
- Halyard Health, Inc., in dismissing a class action suit and reversing a $100 million judgement on the basis that the plaintiff lacked standing.
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 $1 billion medical patent infringement ruling
MTO 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 two prominent start-ups’ competing cancer treatments. The plaintiffs alleged that Kite Pharma’s drug, Yescarta®, infringed their patent and claimed more than $1.2 billion in damages.
The case went to trial 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 reversed the district court’s judgment, agreeing with our argument that the asserted patent claims were invalid for lack of adequate written description. The Federal Circuit rejected Juno’s petition for rehearing. Juno filed a petition for certiorari with the Supreme Court, which was rejected in November 2022. Juno filed a petition for reconsideration, which was denied in January 2023.
Media Coverage: Fed. Circ. Wipes Out $1.1B Juno IP Win On Cancer Drug
- AbbVie: Protecting past patent settlements from claims of “sham litigation"
A Munger, Tolles & Olson team led by Rohit K. Singla and Stuart N. Senator represents AbbVie Inc. and Solvay Pharmaceuticals, Inc., in a more than decade-long, multiple-part antitrust litigation relating to various patent litigations and patent settlements concerning the testosterone drug AndroGel®. The various private claimants have sought $3 billion in damages and the FTC sought extensive conduct remedies.
In prior phases of the matter, MTO defeated certain claims of “sham litigation” at summary judgment and another such claim in the Court of Appeals, defeated direct purchaser class certification, persuaded indirect purchasers to abandon their claims, and obtained very favorable settlements from retailer plaintiffs, certain wholesalers and the FTC. MTO was also lead appellate counsel for the defense group when one of the FTC’s cases proceeded to the U.S. Supreme Court, leading to the landmark FTC v. Actavis opinion, which ruled that pay-for-delay agreements are not presumptively illegal and that defendants are allowed to justify their actions under the rule of reason.
MTO currently represents AbbVie on multiple fronts, including against individual claims brought by the major pharmaceutical wholesalers following a district court ruling that AbbVie delayed generic forms of AndroGel® through “sham litigation.” The wholesalers’ case challenges three patent settlements as illegal “pay for delay” arrangements and three patent assertions as “sham.” This is one of the first such cases brought by direct purchaser wholesalers on an individual basis.In March 2022, MTO defeated the plaintiffs’ efforts to obtain summary judgment based on the alleged collateral estoppel effect of prior litigation. The case remains in discovery.