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Pharmaceutical and Life Sciences Litigation

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Overview

Our Clients

Katten provides intellectual property litigation 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.

Our Services

Using their wealth of legal and technical experience, our attorneys defend allegations of patent infringement and assert our clients' patents. Many members of our team have advanced degrees, ensuring a solid understanding of the complex scientific and medical issues at the heart of pharmaceutical and life sciences litigation.

While we look for ways to resolve a dispute outside the courtroom, we are experienced in litigation from complaint through trial and appeal. Our trial teams leverage the positions and arguments developed through the litigation process to achieve settlements and licenses with beneficial terms for our clients—such as early entry to the market or a low royalty rate.

We do not rush into litigation without considering the risks and potential rewards. Recognizing that, in certain situations, taking a primary role in a dispute is not warranted given the potential outcome, we recommend and negotiate litigation stays and dismissals without prejudice as appropriate.

Katten also has industry-specific corporate monitorship experience, including service as the independent Foreign Corrupt Practices Act (FCPA) compliance monitor for the world's largest manufacturer of generic pharmaceuticals.

Katten's Pharmaceutical and Life Sciences team pursues litigation with a mind toward our clients' overall business goals. As a result, we maximize the value of our clients' intellectual property assets and set the stage for continuing technological and business development and expansion.

Experience
  • Representation of a biopharmaceutical company in a 10b-5 securities class action in the US District Court for the District of New Jersey. The client’s lipid-lowering drug had been approved by the FDA for use in a small market of patients with extremely high cholesterol levels. When the FDA declined the client’s application to approve the drug for patients with moderately elevated levels, the stock price declined. Plaintiffs alleged that Katten's client misrepresented to investors the likelihood that it would obtain FDA approval for the broader indication by not revealing certain information to shareholders about a prior meeting with the FDA. The court dismissed the case as the allegations in the complaint were not specific enough to meet the bar for securities class actions, and some of the claims did not allege misconduct. Plaintiffs filed a second consolidated amended class complaint that was also dismissed; the US Court of Appeals for the Third Circuit affirmed the dismissal and denied a petition for rehearing en banc.
  • Representation of a pharmaceutical company in an antitrust and contract breach suit against Reckitt Benckiser over the right to sell generic Mucinex.
  • Lead counsel to Apotex, 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. Katten successfully established that the relevant patent was invalid, not infringed and procured by fraud.
  • Representation of a large Indian biopharmaceutical company in patent litigation.
  • Representation of a pharmaceutical corporation and certain of its officers and directors in connection with a securities class action brought by investors after the London Times published a story stating that our client was expected to restate its financial results; the company's stock price subsequently fell 5%. Following a meeting with Katten, lead counsel for the putative class agreed to voluntarily dismiss the case.
  • 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 MedTorque in patent litigation surrounding a medical device. Secured dismissal of one of three asserted patents in a motion to dismiss, and currently litigating the remainder.
  • Representation of a pharmaceutical company in three patent matters and its affiliate in two additional patent matters. Katten has also been engaged to represent the client with respect to a trademark infringement complaint filed in the US District Court for the District of Massachusetts.
  • Representation of a pharmaceutical company in a potentially litigious matter with respect to an ANDA it submitted seeking approval to sell a generic version of an ADHD drug.
  • Defense of a pharmaceutical company and certain of its officers against a putative securities class action lawsuit in the US District Court for the District of New Jersey. Plaintiff alleged that defendants previously misrepresented the likelihood that the FDA will approve the client's leading drug candidate for sale to the public, causing its stock price to be artificially inflated, but dropped the suit.
  • Representation of a British pharmaceutical company that markets and develops cannabis-based pharmaceuticals in a US District Court for the Southern District of New York securities class action lawsuit alleging failure to disclose internal control deficiencies. After proactively contacting and managing potential confidential witnesses, and presenting the results of an initial investigation into the merits of the case to lead counsel for the putative class showing that plaintiffs would be unable to identify either a false statement (no restatement was expected and the company had not previously certified the adequacy of its internal controls) or scienter (since there were no publicly reported stock sales), Katten obtained voluntary dismissal.
  • Representation of one of the largest generic pharmaceutical companies in Japan in litigation concerning patents listed in the FDA's Orange Book for an MS medication.
  • 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.
Pharmaceutical and Life Sciences Litigation

Recognition

U.S. News Best Lawyers "Best Law Firms" – Litigation – Patent (National)
Litigation – Patent (National), 2012–2018

Managing Intellectual Property IP Handbook

"Highly Recommended" firm for intellectual property in Illinois, 2013–2015

World Trademark Review 1000 – The World's Leading Trademark Professionals (Chicago)

2011, 2013–2014
Chambers USA – Intellectual Property (Illinois)
Intellectual Property (Illinois), 2006–2017

World Trademark Review 1000 – The World's Leading Trademark Professionals (National)

2011, 2013–2014

Trademarks Law Firm of the Year by Lawyer Monthly

2012

IAM Patent 1000

Patent Litigation, 2017
National Law Journal, Elite Trial Lawyers 2015

World Trademark Review 1000 – The World's Leading Trademark Professionals (New York)

2011, 2013–2014

World Trademark Review 1000 – The World's Leading Trademark Professionals (Washington, DC)

2011, 2013–2014
U.S. News Best Lawyers "Best Law Firms" – Litigation – Intellectual Property (National)
Litigation – Intellectual Property (National), 2012–2018
U.S. News Best Lawyers "Best Law Firms" – Litigation – Patent (Los Angeles)
Litigation – Patent (Los Angeles), 2014–2018
U.S. News Best Lawyers "Best Law Firms" – Litigation – Patent (Chicago)
Litigation – Patent (Chicago), 2012–2018
U.S. News Best Lawyers "Best Law Firms" – Litigation – Intellectual Property (Chicago)
Litigation – Intellectual Property (Chicago), 2012–2018
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Recognition

Litigation – Patent (National), 2012–2018

Managing Intellectual Property IP Handbook

"Highly Recommended" firm for intellectual property in Illinois, 2013–2015

World Trademark Review 1000 – The World's Leading Trademark Professionals (Chicago)

2011, 2013–2014
Intellectual Property (Illinois), 2006–2017

World Trademark Review 1000 – The World's Leading Trademark Professionals (National)

2011, 2013–2014

Trademarks Law Firm of the Year by Lawyer Monthly

2012

IAM Patent 1000

Patent Litigation, 2017

World Trademark Review 1000 – The World's Leading Trademark Professionals (New York)

2011, 2013–2014

World Trademark Review 1000 – The World's Leading Trademark Professionals (Washington, DC)

2011, 2013–2014
Litigation – Intellectual Property (National), 2012–2018
Litigation – Patent (Los Angeles), 2014–2018
Litigation – Patent (Chicago), 2012–2018
Litigation – Intellectual Property (Chicago), 2012–2018
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