Stephen R. Auten
STEVE AUTEN is head of Taft's Pharmaceutical & Life Sciences Litigation practice area. He 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 nearly 8,000 members worldwide. He currently represents clients primarily in the areas of Paragraph IV design strategies, Hatch-Waxman litigation, and biosimilar market opportunities.
He is currently counsel to a number of leading generics, including those who are first-to-file with an ANDA with a Paragraph IV Certification, and thus eligible for 180-days of market exclusivity. Though he has litigated scores of ANDA cases, his current cases include generic versions of the following products: ANGIOMAX (bivalirudin), AXIRON (testosterone), BELVIQ (lorcaserin), DALIRESP (roflumilast), ELIQUIS (apixaban), FANAPT (iloperidone), JEVTANA KIT (cabazitaxel), KYPROLIS (carfilzomib), POMALYST (pomalidomide), STIVARGA (regorafenib), TEFLARO (ceftaroline fosamil), VIIBRYD (vilazodone), XARELTO (rivaroxaban), and XELJANZ (tofacitinib).
A frequent author, Steve was an associate editor for Pre-ANDA Litigation: Strategies & Tactics for Developing a Drug Product and Patent Portfolio, a leading reference book published by the American Bar Association. He personally inked the chapter on "Citizen Petitions," sharing his knowledge about the intersection of FDA, patent, and Hatch-Waxman laws. He also served as an associate editor and chapter author for the second edition of ANDA Litigation: Strategies & Tactics for Pharmaceutical Patent Litigators, which was published in 2016 and is a must-have for drug patent litigators.
Prior to joining Taft, Steve was already well-known in the intellectual property community due to his long leadership run at Sandoz Inc., the generic drug division of Novartis and one of the largest in the world. At Sandoz, Steve figured prominently in seminal decisions by the Court of Appeals for the Federal Circuit and the Supreme Court concerning small molecule/patent law litigation. Steve was on the executive team and a critical contributor to the growth and long-term business strategy of the company. His final role was as Vice-President, Head of Intellectual Property for North America. Under Steve's leadership, Sandoz was recognized as having “second best track record for court outcomes” among all generic drug companies (RBC’s Industry Comment, Jan. 15, 2010, at p. 4).
As part of his regulatory practice, Steve has authored several ground-breaking citizen’s petitions, trying to secure a market opportunity for his client, which argued that:
- Select competitors were required to submit new patent certifications relating to generic ACTOS (pioglitazone), thereby causing the related thirty month stay to restart;
- FDA should not permit certain label carve-outs for generic LYRICA (pregabalin);
- the first applicant’s 180-days of market exclusivity is forfeited when the sponsor voluntarily adopts a packaging change from the reference listed product for generic HECTOROL (doxercalciferol); and
- the first applicant’s exclusivity for generic NEXIUM (esomeprazole) was forfeited for failure to obtain tentative approval in good time, even if just by one day, an argument which was reported by The Wall Street Journal and other top sources.
Further, in a decision believed to be the only of its kind, Steve led the charge in successfully persuading FDA to overturn its grant of New Chemical Entity exclusivity for TORISEL (temsirolimus) injection, thus allowing for generic entry many years before previously estimated.
Steve earned his J.D. from the Chicago-Kent College of Law, where he was a member of moot court and earned the highest grade in legal writing, later serving as a teacher’s assistant in that course. He received his Bachelor of Science in chemistry from University of Illinois at Urbana-Champaign with high distinction, authoring a senior thesis on enantiomeric separation under the supervision of Dr. William H. Pirkle, a recognized pioneer in the field. Steve is recognized by his peers in The Best Lawyers in America for IP Litigation, as a Leading Lawyer, a selection limited to less than five percent of Illinois attorneys (and is by nomination only), as an Illinois Super Lawyer in IP Litigation and is recognized as a "World's Leading Patent Practitioner" by Intellectual Asset Management Magazine. Steve is also a registered patent attorney.
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