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Pharmaceutical and Life Sciences

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Overview

Our Clients

Katten provides multidisciplinary services to a range of biotechnology and pharmaceutical companies. We represent companies with pharmaceutical products—both generic and brand-name—as well as companies with biologics, biosimilars, nutritional supplements and cosmetics.

Our Services

Katten's Pharmaceutical team has a deep understanding of the myriad of legal and business issues that pharma/biotech companies face. Our attorneys provide counsel on a variety of areas, including:

  • intellectual property litigation;
  • antitrust;
  • federal and state investigations;
  • commercial litigation; and
  • corporate and transactional issues.

Intellectual Property Litigation

We regularly represent companies defending allegations of patent infringement as well as those asserting patents. We have handled several multi-million dollar "at-risk" launch cases and have worked on matters involving more than 45 different drugs. Our team has particular experience in litigating pharmaceutical patent damages cases. We also counsel companies regarding Hatch-Waxman Act-related patent litigation, as well as US Patent & Trademark Office (PTO) trial proceedings, such as inter partes reviews. If necessary, we will argue related appeals to the Federal Circuit.

Our team includes several members with advanced degrees, which provides us with the insight necessary to handle complex scientific and medical issues related to pharmaceutical litigation. We understand the Food and Drug Administration's (FDA's) policies and procedures and have the resources to assist with regulatory issues and provide counsel on FDA exclusivities that can affect launch decisions. Whether by means of beneficial settlement terms or trial and appellate-level advocacy in court or the PTO, we seek to maximize the value of our clients' intellectual property assets while supporting their business development efforts and financial goals.

Antitrust

Our attorneys are highly experienced in handling a multitude of antitrust matters particular to the pharmaceutical industry. We advise on antitrust investigations, which often result from Hart-Scott-Rodino Act-related filings, by the Federal Trade Commission (FTC) and complaints filed by the plaintiffs' bar in relation to pharma mergers and acquisitions. We have a proven track record of negotiating successful settlements with the FTC and managing drug divestitures when necessary.

In addition, our attorneys litigate "pay for delay" matters between brands, generics and pharmacies; handle reimbursement-related disputes involving pharmacy benefit managers (PBMs); and advise on violations regarding "reverse payments," fraud on the PTO and price-fixing allegations.

Federal and State Investigations

With more than a dozen former Assistant US attorneys on our team, we provide comprehensive support for the broad range of investigative issues facing pharmaceutical companies, including:

  • Foreign Corrupt Practices Act (FCPA) matters;
  • False Claims Act litigation;
  • shareholder demand letters;
  • securities class action lawsuits;
  • off-label promotion allegations;
  • disclosure-related complaints;
  • average wholesale price (AWP) issues;
  • Stark Law and federal Anti-Kickback Statute investigations; and
  • various accounting-related matters.

In addition, our attorneys have represented corporations or served as pool counsel for government investigations.

Commercial Litigation

Katten regularly handles breach of contract cases resulting from pharma patent infringement cases, as well as matters involving vendor and supplier contracts. Our attorneys focus on the strategy that provides the best outcome for each individual client, whether it is a "bet the company" case or opting out of a class action case.

Corporate and Transactional

We advise on a variety of corporate transactions for pharma companies, including mergers, acquisitions, joint ventures, divestitures and the issuance of stock. We frequently draft development and licensing agreements, which include setting benchmarks throughout the trial and approval phases. We also coordinate the acquisition of rights to market and sell individual drugs on behalf of developers and distributors.

In addition, we have represented investment management companies and hedge funds in transactions involving pharma-related entities. We also handle senior secured credit facilities, acquisition of securities (e.g., common stock, convertible preferred stock, common stock warrants), and private investment in public equities (PIPEs).

Experience
  • Selection for a monitorship of one of the world's largest manufacturer of generic medicines as part of FCPA settlement, including the creation and implementation of a multi-jurisdictional DOJ compliance program.
  • Representation of several pharmaceutical company officers in a large, multi-jurisdictional DOJ investigation involving FDA issues and anti-kickback statutes related to nationwide sales practices of opioid painkiller products.
  • Representation of a pharmaceutical company and its affiliate in five new Hatch-Waxman patent litigations seeking to introduce generic pharmaceuticals into the market.
  • Representation of a pharmaceutical client in defense of a trademark infringement complaint filed in the US District Court for the District of Massachusetts, obtaining full dismissal of the claims.
  • Representation of Sagent Pharmaceuticals, a leading provider of affordable pharmaceuticals to the hospital market, in its $40 million acquisition of a portfolio of five ANDAs in the United States divested from Teva Pharmaceutical Industries' acquisition of Actavis (Allergan Generics), including working with FTC to qualify Sagent as a purchaser.
  • Representation of a biopharmaceutical company with a focus on the treatment of patients with rare and debilitating dermatologic and head and neck conditions in connection with its receipt of a $48 million investment from affiliates of Fidelity Investments.
  • Representation of a nutritional ingredients and medical foods developer and manufacturer, and its directors and officers, in a securities class action over an alleged failure to disclose that sales of one of its products would be greatly affected by changes in the Chinese regulations of infant formula manufacturers in its IPO and secondary offering documents.
  • Representation of a biopharmaceutical company in a securities class action over an alleged misrepresentation to investors regarding the likelihood of FDA approval for a broader indication.
  • Representation of a pharmaceutical company in an antitrust and breach of contract suit against a multinational consumer goods company over the right to sell a generic decongestant in which the consumer goods company agreed to sell the plaintiffs a generic form of the anti-congestion drug if they failed to obtain FDA approval for their own generic before a third party launched a similar version.
  • Representation of a global pharmaceutical drug company regarding antitrust and patent claims—including Walker Process fraud, the Therasense standard for inequitable conduct and reverse-payment liability theories—in relation to being illegally excluded from the billion-dollar-a-year market for a narcolepsy drug.
  • Representation of a privately held China-based company provider of pharmaceutical products in its sale to a U.S.-based, China-focused specialty pharmaceutical company valued at more than $100 million.
  • Representation of Hospira, a leading company in generic injectable pharmaceuticals, in a joint venture with a private equity fund for development, regulatory approval, commercialization and distribution of three biosimilar products.
  • Outside compliance counsel to an innovator of medical devices and solutions in orthopedics, spinal care and neuroscience; Katten provides regulatory compliance advice related to sales practices and physician relationships, conducts multiple internal investigations, and interfaces with the DHHS Office of Inspector General.
  • Representation of a developer of stem cell therapy in an alleged breach of contract regarding technology licensed to a Texas company for extraction, banking and reinjection of stem cells in the United States.
  • Representation of a former member of the board of directors of a pharmaceutical corporation in connection with an SEC and DOJ investigation of the company involving possible violations of the FCPA in connection with drug approval and price reimbursement in China as well as various restatements of the company's financials unrelated to any alleged FCPA violations.
  • Representation of an investment firm and its related funds in the purchasing of up to $36 million of convertible notes issued by a publicly held pharmaceuticals developer, involving the restructuring of our client's prior loan to the developer.
  • Defense of a biotechnology company in a putative class action brought in the US District Court for the District of New Jersey under Section 10(b) of the Securities Exchange Act of 1934. Plaintiffs also allege violations of Section 11 of the Securities Act of 1933 based on purportedly misleading statements made during a secondary stock offering. Katten successfully obtained dismissal based on failure by plaintiffs to state legally sufficient claims under the Exchange Act and Securities Act and scienter.
  • Representation of the president of a pharmaceutical company in a seven-week federal criminal jury trial in the US District Court for the Eastern District of New York. The case concerned the alleged importation of pharmaceuticals that were not approved by the FDA. The trial team successfully obtained acquittals on the most serious counts in the indictment; the US Court of Appeals for the Second Circuit erased all convictions and ordered a new trial.
  • Representation of a global pharmaceutical company in a patent dispute in a Hatch-Waxman litigation over an antibiotic drug; Katten sought and received an expedited proceeding that led to an optimal settlement structure after our summary judgment briefing was filed.
  • Representation of one of the largest generic pharmaceutical companies based in Japan in two Hatch-Waxman patent litigations seeking to introduce generic pharmaceuticals into the market.
Pharmaceutical and Life Sciences

Recognition

U.S. News Best Lawyers "Best Law Firms" – Litigation – Patent (Los Angeles)
Litigation – Patent (Los Angeles), 2016–2018

BTI Litigation Outlook 2018

IP Litigation Honor Roll
U.S. News Best Lawyers "Best Law Firms" – Litigation – Patent (Chicago)
Litigation – Patent (Chicago), 2016–2018

Managing Intellectual Property IP Stars – Patent Contentious (United States)

2017

Managing Intellectual Property IP Handbook

“Highly Recommended” firm for intellectual property (Illinois), 2013–2014
Chambers USA – Intellectual Property (Illinois)
Intellectual Property (Illinois), 2006–2018
U.S. News Best Lawyers "Best Law Firms" – Litigation – Intellectual Property (Chicago)
Litigation – Intellectual Property (Chicago), 2016–2019
U.S. News Best Lawyers "Best Law Firms" – Patent Law (Chicago)
Patent Law (Chicago), 2016

IAM Patent 1000

Patent Litigation, 2017
U.S. News Best Lawyers "Best Law Firms" – Litigation – Patent (National)
Litigation – Patent (National), 2016–2018
U.S. News Best Lawyers "Best Law Firms" – Litigation – Intellectual Property (National)
Litigation – Intellectual Property (National), 2016–2019
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Recognition

Litigation – Patent (Los Angeles), 2016–2018

BTI Litigation Outlook 2018

IP Litigation Honor Roll
Litigation – Patent (Chicago), 2016–2018

Managing Intellectual Property IP Stars – Patent Contentious (United States)

2017

Managing Intellectual Property IP Handbook

“Highly Recommended” firm for intellectual property (Illinois), 2013–2014
Intellectual Property (Illinois), 2006–2018
Litigation – Intellectual Property (Chicago), 2016–2019
Patent Law (Chicago), 2016

IAM Patent 1000

Patent Litigation, 2017
Litigation – Patent (National), 2016–2018
Litigation – Intellectual Property (National), 2016–2019
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