Procopio Life Sciences IP Litigators Recognized for ANDA Litigation
Procopio’s growing Life Sciences practice has been named a highly active ANDA litigation firm by intellectual property research firm Patexia, in part with the addition earlier this year of two seasoned Washington, D.C., IP litigators, Steve Maddox and Jeremy Edwards.
ANDA stands for “abbreviated new drug application,” which is filed with the U.S. Food and Drug Administration for approval of a generic drug product. As the FDA explains: “Generic drug applications are termed ‘abbreviated’ because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product performs in the same manner as the innovator drug.” The ability to get FDA approval through the ANDA process arose from an amendment to a key law governing the pharmaceutical industry, the Hatch-Waxman Act. The law also permits litigation against an ANDA applicant, which can often be high-stakes.
Patexia analyzed 267 law firms and 1,857 attorneys involved in ANDA litigation in their determination to list Procopio among highly active ANDA firms. It noted the addition of Steve and Jeremy to Procopio as significant, naming Steve’s move one of the top lateral law firm moves of the last year.
Steve and Jeremy joined Procopio in February 2022 and opened the firm’s Washington, D.C., office, which is now growing. Their many legal successes include earning a complete victory for Amneal Pharmaceuticals over Noven Pharmaceuticals in connection with Amneal’s ANDA for a generic version of the Minivelle® estrogen patch; persuading a unanimous Federal Circuit panel to affirm the decision of the U.S. Patent Trial and Appeal Board that all claims of six patents by Jazz Pharmaceuticals were invalid as obvious, paving the way for Amneal’s bid to market a therapeutic equivalent of Xyrem® for the treatment of narcolepsy; persuading the Federal Circuit to vacate a trial decision rendered against Actavis after being brought on for the appeal; securing a complete victory for Allergan in first-to-file litigation over Beyaz® and Safyral® (Merck and Bayer), persuading a unanimous Federal Circuit panel to reverse and invalidate the patents under the on-sale bar; and scoring a complete non-infringement victory for Watson before the U.S. District Court for the District of Delaware, obtaining a rare, expedited trial culminating in a rare announcement from the bench of the judge’s decision immediately after the close of evidence, before any post-trial briefing.
Procopio’s active Life Sciences practice brings clients decades of law firm and in-house counsel experience, from life-saving pharmaceuticals to breakthrough biotechnologies. Whether for an emerging company or an established multinational, Procopio attorneys provide life sciences clients a wide range of legal services including corporate formation, financing and venture capital, intellectual property counseling and litigation, licensing, real estate, mergers and acquisitions, and joint ventures.