Stephen R. 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, law firms, analysts, educators and others on his LinkedIn blog “Hatch Waxman ANDA Litigation Forum” or HALF, which has over 8,600 members worldwide.
He currently represents clients primarily in the areas of Paragraph IV design strategies, Hatch-Waxman litigation, and biosimilar market opportunities. Steve is a member of Taft’s Executive Committee.
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.
The second edition will be published in early 2018. He also served as an associate editor and chapter author for the second edition of ANDA Litigation: Strategies & Tactics for Pharmaceutical Patent Litigators, which is a must-have for drug patent litigators. His chapter, concerning declaratory judgment jurisdiction, was cited by Judge Andrews in a recent opinion.
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).
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.
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