ANDA Hatch-Waxman Litigation

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ANDA Hatch-Waxman Litigation


Intellectual Property
Pharma/Biotech/Med Devices
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King & Spalding’s Hatch-Waxman litigation team has a proven record of success on behalf of innovator pharmaceutical companies. Our focus is always on protecting our clients’ patent rights effectively and efficiently. In a recent case, for example, we defended the patents in suit so effectively that the generic dropped its Paragraph IV challenge – converting to Paragraph III – at the close of fact discovery. This gave the client the same result as a judgment of validity and infringement but without the cost of expert discovery, pretrial proceedings, and trial.

Pharmaceutical and Litigation Expertise

Beyond our core team of Hatch-Waxman experts, King & Spalding has more than 125 lawyers and other professionals who devote all or a substantial portion of their practices to pharmaceutical clients. This includes over 20 professionals with PhDs, MDs, and other advanced degrees in pharmacology, chemistry, molecular biology, and related fields, ensuring that we have the expertise to handle the most difficult technical issues.

Our Hatch-Waxman team is part of a larger patent litigation group that over the last 10 years has tried more than 100 cases to decision, had more than 200 cases decided on summary judgment, and conducted more than 60 Markman hearings.

Our patent litigators have been recognized in publications such as Chambers USA, Legal 500, America’s Leading Business Lawyers, The Best Lawyers in America, The International Who’s Who of Business Lawyers, Euromoney Publications’ Guide to the World’s Leading Patent Law Experts, Georgia Super Lawyers, New York Super Lawyers, Texas Super Lawyers, IAM Patent 1000: The World’s Leading Patent Practitioners, and Montclair Who’s Who Directory of Industry Leaders from Around the World.

ANDA Pre-Litigation Evaluations

We conduct Hatch-Waxman pre-litigation early case assessments (ECAs) to help prepare clients for the inevitable ANDA challenges to their portfolios. In these engagements, we identify potential patent weaknesses/attacks, evaluate which patents to assert, and develop litigation strategy, including formulating trial themes and invention story, collecting core documents, identifying key witnesses and experts, evaluating alternative regulatory product protection strategies and potential anti-competitive allegations, and conducting early communication with management/business teams. The net result: enhanced “litigation readiness” and an ability to proceed efficiently upon receipt of a Paragraph IV Notice.


  • Successfully protected Schering’s Noxafil® antifungal drug from Paragraph IV challenge.

  • Successfully protected Roche’s Valcyte® antiviral drug from Paragraph IV challenge; case settled on favorable terms for Roche after trial and during pendency of appeal, with defendants stipulating to the validity and infringement of the asserted patent.

  • Successfully blocked launch of generic version of Roche’s immunosuppressant drug CellCept®.

  • Successfully protected Merck’s Propecia® male pattern baldness drug from Paragraph IV challenge; cases settled favorably for Merck.
John H. Barr Jr. 
T: +1 713 276 7369 HOUSTON
Kenneth H Sonnenfeld PHD 
T: +1 212 556 2324 NEW YORK