What Form Is It? Lessons from 13 Polymorph Pharmaceutical Cases

Price: $224 OnDemand

Brian J. Sodikoff
Partner, Katten Muchin Rosenman LLP
Martin S. Masar III
Associate, Katten Muchin Rosenman LLP


Now that generic pharmaceutical companies are required to address all Orange Book-listed patents when filing an Abbreviated New Drug Application, either through acquiescence or challenge. Increasingly, these companies are forced to consider patents covering polymorphic forms of the active ingredient. Under Federal Drug Administration regulations, different polymorphs of an active substance are considered the ‘‘same’’ drug under the federal Hatch-Waxman Act. This provides generic manufacturers with the option of trying to design around polymorph patents, in addition to pursuing a traditional invalidity challenge.

To assess the risks and rewards for generic and brand firms alike, this webinar is designed to introduce the current landscape of polymorph patent litigation and attempt to provide insight for future strategy.

Educational Objectives:
• Review Abbreviated New Drug Application requirements
• Explore patent requirements covering polymorphic forms of active ingredients
• Discuss Federal Drug Administration regulations
• Analyze the federal Hatch-Waxman Act as it pertains to generic drugs
• Introduce the current landscape of polymorph patent litigation and attempt to provide insight for future strategy

Who would benefit most from attending this program?
Legal practitioners interested in the Abbreviated New Drug Application, Federal Drug Administration regulations, patents, and/or the federal Hatch-Waxman Act.



Brian J. Sodikoff is a partner at Katten Muchin Rosenman LLP. With extensive experience litigating patents in the pharmaceutical industry, Brian has developed a strong understanding of the legal issues surrounding Abbreviated New Drug Application litigations, including the intricacies of Federal Drug Administration approval, exclusivity periods under the Hatch-Waxman Act and the antitrust implications stemming from settlements. Brian advises clients on patent, trademark, copyright and trade secret matters. He devotes a significant part of his practice to complex patent litigation and has worked on all phases of cases involving a diverse array of technologies, including thermoplastic air bag covers, automated truck transmissions, DVD technology and hard disk drives. A registered patent attorney, Brian prosecutes and secures patents, partnering with clients to design and implement customized strategies to create strong patent protection that transforms ideas into competitive business advantages. He also helps clients to develop their brands through trademark prosecution and protect proprietary information through trade secret protection. Brian is a member of the Illinois bar.


Martin S. Masar III, PhD is an associate at Katten Muchin Rosenman LLP. Martin has varied experience in patent prosecution and litigation, with emphasis in the scientific fields of chemistry, pharmaceutical arts, nanotechnology and biotechnology. Martin has prepared and prosecuted patent applications for a number of clients from an array of technical fields, including nanotechnology-based mass spectrometry methods and apparatus, nanotechnology-based computer chip coolers, radiation therapy methods for cancer treatment, breathable polymers, fire detection systems, medicine dispensing systems and methods and dietary supplements. Martin has experience in pharmaceutical patent litigation relating to the Hatch-Waxman Act and other pharmaceutical and cosmetic contexts, including participating in four trials, arguing motions, deposing fact and expert witnesses and preparing opinions, briefs and Paragraph IV Notice letters for more than two dozen pharmaceutical or cosmetic products. He has also been involved in antitrust and unfair competition litigations. Martin is a member of the Illinois bar.