Richard J. Berman

Client Work

Rich leads ArentFox Schiff’s Hatch-Waxman litigation team, which has represented generic pharmaceutical companies in dozens of lawsuits over the past decade, including several high-profile, first-to-file suits. Rich has also litigated cases and led Inter Partes Review proceedings (IPRs) in the technical fields of computer software, biotechnology, medical and diagnostic devices, and herbal supplements.

Rich advises chemical, pharmaceutical, and medical device companies on the acquisition, sale, in-licensing, and out-licensing of intellectual property. Rich also advises manufacturing companies in the design-around process, including patent landscape and freedom-to-operate analyses.

Rich’s patent prosecution team counsels clients in a wide variety of technologies, such as new chemical entities, pharmaceuticals, medical and diagnostic devices, polymers, functional foods, herbal extracts, drug delivery systems, gene therapy, transgenic animals and plants, vaccines, antibodies, and imaging agents.

Publications, Presentations & Recognitions

Rich is a frequent speaker, and he is interviewed often about issues related to intellectual property law. His recent speeches include:

• “Recent Case Decisions on Paragraph IV and Pharmaceutical Patent Litigations,” Annual US PARA-IV & Global IP Litigation Symposium; March 3, 2023
• Intellectual Property & Technology Law Journal, “Premarket Testing of Diagnostic Medical Software Protected From Claims of Patent Infringement,” by § 271 Safe Harbor Defense; January 2021
• “Practical Advice for Overcoming USPTO Rejections and Asserting and Defending Against §101 Arguments in the Courts,” Paragraph IV Disputes Master Symposium, American Conference Institute; October 2, 2018
• “Mastering the Use of Experts in Parallel Proceedings,” Paragraph IV Disputes, American Conference Institute; April 23, 2018
• “Amgen v. Sandoz: An Update on Biosimilar Litigation for the Hatch-Waxman Litigator,” Paragraph IV Disputes Master Symposium, American Conference Institute; October 2, 2017
• “Obviousness Update for P-IV Litigation: Latest Developments in the Federal Courts and PTAB,” Paragraph IV Disputes, American Conference Institute; April 25, 2017
• “Deciphering the On-Sale Bar,” Paragraph IV Disputes Master Symposium, American Conference Institute; September 19, 2016
• “On Sale Bar in a Hatch-Waxman Setting,” Paragraph IV Disputes, American Conference Institute; April 25, 2016
• “PTO Proceedings Update: The Continuing Use of IPR, PGR and CBM Review in the Hatch-Waxman Arena,” Paragraph IV Disputes Master Symposium, American Conference Institute; September 30, 2015
• “Exploring Possible New Grounds Paragraph IV Invalidity Challenges: How 101 Rejections Under Myriad and Findings of 112 Indefiniteness Under Nautilus May Alter Paragraph IV Litigation,” Paragraph IV Disputes, American Conference Institute; April 27-28, 2015
• “Divided Infringement In Pharma Patent Cases,” Paragraph IV Disputes, American Conference Institute; October 1, 2014
• “Patents Ripe for Paragraph IV Challenge – Generic Considerations,” Paragraph IV Disputes – Master Symposium, American Conference Institute; October 3, 2013
• “Freedom To Operate Analysis: Managing Client’s Expectations,” Freedom To Operate, American Conference Institute; July 30, 2012
• “Exploring the Link Between FDA Approval and Drug Patenting,” Hatch-Waxman Boot Camp, American Conference Institute; June 25, 2012
• “Patent Challenge Strategies for ANDA Applicants,” Paragraph IV Disputes, American Conference Institute; April 24, 2012
• “The Paragraph IV Notice Letter: View From the Generic Side,” Paragraph IV Disputes, American Conference Institute; May 3, 2011
• “Pre-Litigation Patent Strategy for Generic Drug Manufacturers,” Paragraph IV Disputes, American Conference Institute; April 27, 2010
• “Outside Counsel: Your Due Diligence Traffic Cop,” Pharma/Biotech IP Due Diligence, American Conference Institute; January 28, 2009

Rich was noted in the inaugural edition of LMG Life Sciences in 2012 as a “Life Sciences Star” for his patent work. He was noted again in the 2013 and 2015 editions.