Steve Auten Email & Phone Number

Chicago, Il, Us

Cincinnati, Oh, Us

Taft is a world-class, full-service firm with roots dating back to the 1800s. The firm has the right blend of scientific, patent and regulatory expertise to handle any Hatch-Waxman or patent litigation, including several Ph.D.s on staff. With over half of the firm's nearly 850 lawyers focusing on litigation, including experience before the U.S. Supreme Court, the firm has a deep bench to handle the needs of the world's leading generic drug and biosimilar companies. I am honored to chair its Pharmaceutical & Life Sciences Litigation Group. I have also served on the firm’s Executive Committee.

Basel, Basel-Stadt, Ch

As the IP head of Sandoz U.S., I reported directly to the U.S. President and Chief Executive Officer on all IP matters, particularly Hatch Waxman litigations, launch opportunities, and Paragraph IV design strategies. I was then promoted to lead the North America region.Notably, my team's contributions led to Sandoz being recognized as having the “second best track record for court outcomes” among all generic companies (RBC Capital Markets 1.15.10 Industry Comment at p. 4; found here -- http://goo.gl/XBH2xW).I managed the entire IP department in the US, including the attorneys, scientific advisors and other staff. Even though the ANDA litigation docket increased exponentially (a good thing in the generics business), we were very successful in controlling and reducing our expenses.

Basel, Basel-Stadt, Ch

I led the IP group for North America for Sandoz, growing the team five-fold during my tenure. My duties included selecting, developing and launching the company’s products, evaluating third-party patent rights, managing and settling all patent litigations (ANDA, 505(b)(2) and ANDS), recommending product-filing strategies, prosecuting patents and maintaining the IP estate, and negotiating and integrating new products and company acquisitions (e.g., Eon Laboratories, Ebewe Pharma, Oriel Therapeutics and Falcon Pharmaceuticals).In addition to managing countless patent litigations, I also authored several ground-breaking citizen’s petitions, trying to secure a market opportunity. Such petitions 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.Further, in a decision believed to be the only one of its kind, I led the charge in successfully persuading FDA to overturn its grant of New Chemical Entity exclusivity for TORISEL (temsirolimus) injection. See Torisel Exclusivity Determination, Administrative and Correspondence Documents, Part 2, dated June 21, 2012, publicly available at Drugs@FDA.

Chicago, Illinois, Us

Specialized in Hatch-Waxman counseling and litigation/trials for most major generic drug companies, as well as prepared freedom to operate opinions, patentability opinions and various patent applications.Advised clients on overall business strategies and opportunities, including filing/responding to citizen’s petitions and monitoring competitors through various sources. I left this position to pursue an opportunity at Sandoz.

Us

Counseled leading generic dug companies on Hatch-Waxman litigation and opinion issues, including trial responsibility on several patent cases.Argued as lead counsel before the BPAI, as well as authored all briefs, overturning the examiner’s final rejection to allow a patent to issue. I also prosecuted numerous other patents.Served as counsel to Baxter International in a secondment arrangement, advising management on Hatch-Waxman matters and patent prosecution strategies.

Chicago, Illinois, Us

I began my career as a trial lawyer, trying dozens of cases. See, e.g., Jones v. Fleetwood, 127 F. Supp.2d 958 (N.D. Ill. 2000) and Alvarez v. American Isuzu, 749 N.E.2d 16 (Ill. App. Ct. 2001). I also argued as lead counsel before the Illinois Appellate Court and arbitrated well over 100 cases. I was responsible for all aspects of the case, including signing the client, drafting pleadings, completing all fact and expert discovery (deposed hundreds of witnesses), and arbitrating and/or trying the case.

J.D., Law

B.S., Chemistry