Our Approach

Navigate the Hatch-Waxman Act.

A large measure of our success stems from a commitment to understand our clients' business and how patent litigation impacts their bottom line.

As one of the leading full-service Intellectual Property firms in the country, our team has the resources to counsel clients on all aspects of pharmaceutical drug development. That includes providing patent and FDA counseling prior to ANDA filing, and Hatch-Waxman litigation after ANDA filing. In the past five years, the Arent Fox team has represented multiple generic pharmaceutical companies in cases involving dozens of drugs.

Our litigation strategies are designed with a simple goal: get our pharmaceutical clients to the market as quickly as possible. We do that with: a) a team of experienced patent trial lawyers, b) cost-effective solutions, c) cutting-edge technology, and d) active client participation.

Who We Counsel

  • Brand and generic pharmaceutical companies
  • Foreign pharmaceutical companies entering the US market
  • Start-up brand-name and generic-drug companies
  • Companies operating in the food & drug and life sciences sectors

What We Do

  • ANDA litigation
  • Patent validity and infringement analyses
  • Patent certifications for ANDA applications
  • Patent term extension applications
  • Patent Office Proceedings

Our Work

Overcome the legal and regulatory barriers facing your business.

Over the past two decades, Arent Fox has litigated dozens of Hatch-Waxman cases in courts across the country. That includes both first-to-file and trailer ANDA litigation.

The group is led by Rich Berman, Janine Carlan, and Jay Deshmukh. Mr. Berman has represented pharmaceutical companies in dozens of Hatch-Waxman lawsuits, and advises chemical, pharmaceutical, and medical device companies on the acquisition, sale, in-licensing, and out-licensing of intellectual property. Ms. Carlan represents clients in bench and jury trials throughout the US. She has been the first chair in numerous federal district court cases, and has led teams on behalf of first-to-file generic drug manufacturers. Mr. Deshmukh is an experienced Hatch-Waxman litigator with significant experience counseling and litigating on behalf of many of the leading global generics companies. Prior to his work in private practice, Mr. Deshmukh was the head in-house lawyer for Ranbaxy during its most active period of Hatch-Waxman litigation (including first-to-file litigations regarding atorvastatin and esomeprazole).

Events

Issues of the day, broken down and explained by our team.

Our patent trial lawyers frequently speak about key issues in the generic drug industry. Upcoming events include:

Past Events

Rich Berman a Featured Panelist at ACI's 2017 Paragraph IV Disputes Master Symposium
Partner Rich Berman was a featured panelist at the American Conference Institute's Paragraph IV Disputes Master Symposium. The panel provided an obviousness update for Paragraph IV litigation, including the latest developments in the Federal Courts and at The Patent Trial and Appeal Board. The event took place April 24–26, 2017 at The Conrad Hotel in New York City, NY.

Rich Berman Moderates at ACI's 2016 Paragraph IV Disputes Master Symposium
Partner Rich Berman moderated a panel at the American Conference Institute's advanced forum on analyzing patent impediments caused by contract manufacturing and its impact on pharmaceutical product market access. The event took place April 25–26, 2016 at The Conrad Hotel in New York City, NY.

Janine Carlan Presents at ACI’s Post-Grant PTO Proceedings Forum
Partner Janine Carlan was a featured speaker at the American Conference Institute’s conference on ACI's Post-Grant PTO Proceedings. Bills presented by the US House and Senate would amend parts of the America Invents Act that affect Post-Grant Proceedings. The panel on which Ms. Carlan presented discussed the proposed measures and its effects. The presentation, titled “Analysis of New Patent Reform Legislation and Its Possible Impact on Post-Grant PTO Proceedings,” also discussed measures to curtail the abuses of non-practicing entities. The conference took place on March 14–15, 2016 in New York, NY.

Janine Carlan Presents at the 8th Annual ITC Litigation and Enforcement Forum
Partner Janine Carlan was a featured speaker at the American Conference Institute’s conference on ITC Litigation and Enforcement. The conference will examine best practices when bringing cases before the U.S. International Trade Commission. The conference took place on February 22–23, 2016 in Washington, DC.

Rich Berman a Featured Panelist at ACI's 2015 Paragraph IV Disputes Master Symposium
Partner Rich Berman will be a featured panelist at the American Conference Institute's advanced forum for brand name and generic counsel that will focus on the intricacies of pre-suit considerations, law suit commencement, motion practice, and final adjudication in Hatch-Waxman litigation. Rich will provide an update on the continued use of IPR, PGR and CBM review in the Hatch-Waxman Arena. The event takes place September 30–October 1, 2014 at The InterContinental Hotel in Chicago, IL.

Rich Berman Presents at ACI's Hatch-Waxman Series: Paragraph IV Dispute Conference
Partner Rich Berman was a featured speaker at the American Conference Institute's conference on Paragraph IV Disputes. The conference examines the consequences of the 2015 patent cliff escarpments which could result in some $32 billion dollars in patent losses for drugs. The conference took place on April 27-28, 2015 in New York, NY.

Yelee Kim Headlines ACI’s Panel on Life Sciences Patents
Partner Yelee Kim is a featured panelist at the American Conference Institute’s forum on patents in the life science industry. The discussion will focus on comprehensive and practical prosecution and non-Hatch-Haxman litigation strategies for biotechnology, pharmaceutical, and diagnostics companies. The event takes place January 13-14 at the DoubleTree Suites by Hilton Times Square in New York, NY.

Rich Berman a Featured Panelist at ACI’s 2014 Paragraph IV Disputes Master Symposium
Partner Rich Berman is a featured speaker at the American Conference Institute's advanced forum for brand name and generic counsel that will focus on the intricacies of pre-suit considerations, law suit commencement, motion practice, and final adjudication in Hatch-Waxman litigation. The event takes place September 30–October 1, 2014 at The InterContinental Hotel in Chicago, IL.

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