Industry

Life Sciences and Pharmaceuticals

Handling high-stakes antitrust and patent matters before regulators, judges and juries

Life sciences clients retain Munger, Tolles & Olson to help them navigate, resolve and, if necessary, litigate their most important matters. We have long had a leading pharmaceutical practice, focusing on antitrust matters, patents, licensing disputes and trial work, and we bring not only an understanding of the unique dynamics of the pharmaceutical industry, but also our reputation as trial lawyers to bear on every matter. With deep experience in large-scale litigation, we are a formidable force in the courtroom and 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. In the precedent-setting FTC v. Actavis matter, we were lead defense counsel at every stage, including before the U.S. Supreme Court. Similarly, we obtained the first denial of class certification of a direct purchaser class in a reverse payment case, which helped us develop the roadmap for challenging indirect purchaser classes. We also successfully tried the first reverse payment case to go to trial and have substantial experience in litigation involving class actions, mergers & acquisitions, trade secrets and related issues. 

Services

Our Life Sciences practice includes the following service areas:

Patents

  • Infringement
  • Licensing

Antitrust

  • “Pay for Delay” Claims
  • “Sham” Litigation Claims

Licensing and Payments

  • Royalties
  • Settlements

Class Actions

  • Direct/Indirect Purchasers
  • Appeals

Clients

From pharmaceuticals firms to industry executives, we have represented life sciences clients that include:

  • AbbVie
  • Novartis Pharmaceuticals
  • Abbott Laboratories
  • Solvay Pharmaceuticals
  • Gilead/Kite Pharma
  • Takeda Pharmaceuticals
  • Halyard Health

Team

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:

Related Practices

Experience

Munger, Tolles & Olson’s broad life sciences capabilities cover: 

  • Antitrust
    ​​​​​​​Our firm has handled groundbreaking antitrust matters as well as cases alleging Robinson-Patman violations, resale price maintenance and pharmaceutical bundling. Our work includes:
    • Representing Solvay Pharmaceuticals (now part of AbbVie) as lead counsel in the landmark FTC v. Actavis, Inc. matter, regarding the testosterone replacement drug AndroGel®. Here, the U.S. Supreme Court ruled that “reverse payment” patent settlements between brand-name pharmaceutical companies and generic manufacturers are not presumptively unlawful.
    • Winning a defense jury verdict for AbbVie in an antitrust case involving Abbott and GlaxoSmithKline, two of the world’s largest pharmaceutical companies. The jury rejected GlaxoSmithKline’s $571 million damage claim, which was subject to automatic trebling.
    • Winning a summary judgment decision for Abbott Laboratories in an antitrust suit brought by a competitor challenging long-term contracts for supply of blood screening products as well as the legal standard for evaluating predatory pricing claims based on bundled pricing. On appeal, the judgement was affirmed by the Second Circuit Court.
  • Patents
    Our attorneys have deep experience at the intersection of antitrust and patent laws, such as challenges to patent settlements, allegations of sham patent litigation and Walker Process claims.
    • Winning a high-profile appeal in the Third Circuit to overturn a district court decision that AbbVie brought so-called “sham” litigation to maintain a monopoly over their testosterone replacement drug, AndroGel®.
    • Obtaining a judgment in favor of Takeda Pharmaceuticals after a trial on patent infringement and validity claims by three companies seeking to market generic versions of Takeda’s acid reflux drug, Dexilant®.
    • Obtaining dismissal of a patent infringement suit filed by Bayer Corp. alleging that Abbott Laboratories’ largest product, the antirheumatic drug Humira®, infringed its patents.
    • Obtaining reversal of an adverse jury verdict that found Vysis, Inc.’s patents for DNA-based diagnostic tests were non-infringed and invalid. A Federal Circuit court held the district court lacked jurisdiction to determine claims by a licensee in good standing.
    • Defending Amgen in 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.
    • Winning an en banc Federal Circuit ruling for AbbVie that fundamentally altered the national standards for determining inequitable conduct before the U.S. Patent and Trademark Office.
  • Licensing and Payments
    We have helped our clients obtain awards resulting in settlements and multi-year licensing agreements. Our experience includes:
    • Obtained an award in arbitration of an international licensing dispute concerning the calculation of royalties for HIV diagnostic tests, on behalf of Abbott Laboratories.
    • Obtaining a favorable settlement for Amgen, including a multi-year royalty from Coherus Biosciences, resolving a trade secrets dispute involving the oncology drug Neulasta®.
    • Bringing a challenge to a major Medicare reimbursement rule change to the U.S. Supreme Court on behalf of American Hospital Association. The case will be argued in the term ending June 2022.
  • Class Actions
    Our attorneys routinely obtain dismissals of class actions at the pleading stage or denials of class certification. If a matter should proceed to trial, we are equally adept at bringing matters to a swift and favorable resolution. Our work includes:
    • Obtaining denial of class certification to two proposed classes of indirect purchasers alleging that Takeda Pharmaceutical’s conduct in licensing and enforcing patents delayed the market entry of a generic version of its muscle relaxant, Skelaxin®.
    • Dismissing for the second time long-running putative class actions by third-party payors and wholesalers of the dyslipidemia treatment drug Niaspan® on behalf of AbbVie. Plaintiffs alleged a patent infringement settlement by AbbVie violated federal and state antitrust laws by delaying the marketing of generic versions.
    • Achieved dismissal of a class action suit against Halyard Health, Inc., reversing a $100 million judgement on the basis that the plaintiff lacked standing. 

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:

  • Reversing a court-ordered disgorgement of $448 million and dismissing FTC claims
    Client: AbbVie

Munger, Tolles & Olson and its co-counsel convinced the Court of Appeals for the Third Circuit to reverse a district court-ordered disgorgement of $448 million against two pharmaceuticals manufacturers, our client AbbVie and Besins Healthcare, for allegedly delaying generic forms of the testosterone treatment AndroGel® through “sham litigation.” Presaging a subsequent Supreme Court decision, the court set a precedent by concluding that while Section 13(b) of the Federal Trade Commission Act authorizes a court to “enjoin antitrust violations,” the statute does not authorize a court to order defendants to disgorge profits to the FTC. 

The Third Circuit also reversed the district court’s finding that AbbVie and Besins’ infringement suit against Teva Pharmaceuticals USA Inc. was a sham intended to delay Teva’s generic form of AndroGel, affirming a similar finding with respect to Perrigo Company. The panel said the companies could have reasonably believed the Teva suit could succeed. The panel said that while AbbVie and Besins have monopoly power in the relevant market for similar treatments, the commission “has not shown the monopolization entitles it to any remedy,” including injunctive relief. Although the panel held that a claim of an alleged reverse-payment settlement agreement with Teva Pharmaceuticals could proceed in the district court, on remand the Federal Trade Commission voluntarily dismissed that claim with prejudice.

Media Coverage: Law360 - 3rd Circ. Wipes Out FTC's $448M AbbVie Win; Law360 - FTC Drops AndroGel Antitrust Case Against AbbVie

 

  • Defending an innovative cancer treatment against allegations of patent infringement
    Client: Gilead Sciences, Inc. (through its subsidiary, Kite Pharma, Inc.)

As co-counsel, Munger, Tolles & Olson 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 (“MSK”). Juno and MSK alleged that Kite’s cancer treatment drug, Yescarta, infringes on their patents for chimeric antigen receptor T cell (“CAR T”) therapy, a treatment that reprograms a patient’s immune system to kill cancer cells. Juno and Kite were the two most prominent start-ups developing this groundbreaking treatment in the mid-2010s. In the suit, Juno claimed damages of approximately $1.2 billion.

The case went to trial in December 2019, with the jury returning a verdict in favor of Juno. Kite appealed to the U.S. Court of Appeals for the Federal Circuit, and, in August 2021, the Federal Circuit reversed the district court’s judgment, holding that every asserted claim in Juno’s patent is invalid for lack of written description and dismissing the damages. A pending request for rehearing en banc will be decided in 2022.

Media Coverage: JD Supra - Federal Circuit Court of Appeals Reverses $1.2 Billion Verdict in Juno v. Kite Pharma, Invalidating Genus Claims to a Three-Part Chimeric Antigen Receptor

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