Fleming, Teresa V.

Lara FitzSimmons is a partner at Rakoczy Molino Mazzochi Siwik LLP and is involved in all areas of the firm's regulatory and litigation practice. She concentrates on statutory and regulatory issues arising under the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act; the Medicare Prescription Drug, Improvement and Modernization Act; and FDA's implementing regulations; with particular emphasis on matters relating to abbreviated new drug applications (ANDAs), and section 505(b)(2) applications, and their associated regulatory and marketing exclusivity rights.

Ms. FitzSimmons has been involved in Hatch-Waxman patent infringement suits involving prescription pharmaceutical drugs, as well as APA actions brought against the FDA-both at the trial and appellate levels. Her work in this area has given her experience in litigation involving such drugs as Neurontin® (gabapentin), Paxil® (paroxetine hydrochloride), Pravachol® (pravastatin sodium) and Accupril® (quinapril hydrochloride). Ms. FitzSimmons was part of the team that obtained a final judgment and permanent injunction against the FDA that preserved Apotex's lucrative 180-day marketing exclusivity for generic Paxil®-which was threatened when FDA awarded so-called "shared exclusivity" to several other companies. The day before the launch of one of Apotex's competitors, the FDA's shared exclusivity decision was set aside and a declaration was entered stating that Apotex is entitled to sole 180-day marketing exclusivity for generic Paxil® and enjoining the FDA from approving any other generic Paxil® products until the expiration of Apotex's exclusivity. The decision preserved Apotex's exclusivity and more than $50 million in additional generic Paxil® sales.

Ms. FitzSimmons has experience working with the national trade association for the generic drug industry, the Generic Pharmaceutical Association, on preparing and filing amicus curiae briefs in the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court. In addition, she has been involved in the arbitration of other intellectual property matters, such as copyright infringement, unfair competition and licensing disputes.

Ms. FitzSimmons also has represented clients in complex commercial litigation matters in state and federal courts. She has handled all aspects of litigation, including investigative and written discovery, motions practice, and merits briefing at both the trial and appellate levels, and has worked with clients in numerous emergency injunction proceedings.

Ms. FitzSimmons is actively involved in the DRI Women in the Courtroom Committee and is a co-author of the DRI publications "A Career in the Courtroom: A Different Model for the Success of Women Who Try Cases" and the Women in the Courtroom Best Practices Guide.

Previous Experience

Prior to joining Rakoczy Molino Mazzochi Siwik LLP, Ms. FitzSimmons was an associate with Lord, Bissell & Brook LLP and Jenner & Block LLP. Before entering the legal profession, Ms. FitzSimmons worked with a Philadelphia-based law firm in its Business Development Department.