Taft Chicago Pharmaceutical and Life Sciences Litigation attorneys Andrew Alul, Stephen Auten, Jane Berman, Richard Ruzich, and Roshan Shrestha, Ph.D., contributed to the fourth edition of ANDA Litigation, a comprehensive guide examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation.
Alul, Ruzich, and Shrestha authored Chapter 8, “Use of Reissue Proceedings in Hatch-Waxman Litigation.” This chapter addresses the reissue application process, the risks associated with reissues among other related topics.
Auten and Berman authored Chapter 10, “Examining Subject-Matter Jurisdiction over Declaratory Judgment Claims Filed in Combination with Patent Infringement Claims under Section 271(e)(2)(A).” This chapter explores the background on subject-matter jurisdiction over declaratory judgment claims, analyzes pertinent decisions and addresses related legal considerations
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Alul focuses his practice on intellectual property litigation and counseling, particularly pharmaceutical drug patent litigation and regulatory litigation involving the FDA. He has extensive experience litigating cases brought under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act for pharmaceutical products and under the Administrative Procedures Act.
Auten is a widely recognized and seasoned attorney in Hatch-Waxman and biosimilar matters, including related patent litigation, and is followed by key industry leaders (brand and generic alike), law firms, analysts, educators, and others on his LinkedIn blog “Hatch Waxman ANDA Litigation Forum” or HALF, which has over 14,000 members worldwide. He regularly represents clients in the areas of Paragraph IV design strategies, Hatch-Waxman litigation, and biosimilar market opportunities.
Berman is a registered patent attorney and a member of Taft’s Intellectual Property group. She has broad experience in the prosecution, enforcement, licensing, and transfer of intellectual property, including patents, trade secrets, trademarks and copyrights. Berman also has experience advising on the intellectual property aspects of complex corporate and financial transactions, including acquisitions, licensing, commercial lending, private equity finance and restructuring.
Ruzich is an internationally recognized patent attorney who focuses on complex patent litigation, representing generic pharmaceutical companies in ANDA litigation under the Hatch-Waxman statutory framework. An accomplished trial and appellate advocate, registered patent attorney, and a frequent lecturer and author, he is known worldwide for his legal work on behalf of his generic clients, including biosimilar sponsors. His experience covers the entire lifecycle spectrum from product selection, Paragraph IV development, and through to market entry, including at-risk launches.
Shrestha focuses his practice on all aspects of intellectual property law, including patent litigation, prosecution, and opinion work in the chemical, pharmaceutical, and electronic material arts. He has a broad scope of pharmaceutical and life sciences capabilities, including Hatch-Waxman litigation and inner parts review proceedings at the USPTO. Shrestha has been recognized by Super Lawyers and Leading Lawyers Network and was named to Law Bulletin’s “40 Illinois Attorneys Under 40 to Watch.”