Christine J. Siwik, a former named partner of Rakoczy Molino Mazzochi Siwik LLP and now Of Counsel (effective January 13, 2011), has a practice focusing primarily on pharmaceutical regulatory counseling and litigation involving the U.S. Food and Drug administration (FDA), pharmaceutical patent litigation and counseling, and federal legislative issues involving the pharmaceutical industry.
Ms. Siwik assists clients in developing long-term legal and business strategies for developing, obtaining regulatory approval for, and launching pharmaceutical products. She has worked almost exclusively in the pharmaceutical arena for over seventeen years, gaining a wide-range of knowledge and experience in all facets of the pharmaceutical industry.
Regulatory Litigation and Counseling
Ms. Siwik has extensive experience litigating pharmaceutical regulatory issues. Relevant cases include Nostrum Pharmaceuticals v. FDA , Wyeth v. FDA and aaiPharma Inc. v. Thompson et al. , in which she successfully prevented a competitor from blocking her client's market entry, and TorPharm v. Shalala , in which she obtained a preliminary injunction forcing FDA to permit her client's market entry. Ms. Siwik also has secured for her clients the right to marketing exclusivity for generic versions of multiple drug products.
Ms. Siwik also has extensive regulatory counseling experience. She, for example, works closely with clients that have drug applications pending before FDA, including working with FDA to resolve issues involving such things as product labeling, patent listing disputes, designing and implementing risk management programs, issues pertaining to new drug and marketing exclusivities, and responses to agency deficiency letters. Her experience includes work on both abbreviated new drug applications (ANDAs) and 505(b)(2) applications filed pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).
Ms. Siwik also has experience with biological products approved under the Public Health Service Act (PHSA), and offers her clients unique insight into the biosimilar legislative approval pathway enacted by Congress in 2010. Her extensive work in the emerging area of generic biologic/biosimilar products allows Ms. Siwik to provide clients valuable guidance and direction.
Ms. Siwik also has more than nineteen years of experience with FDA's formal citizen/stay petition process. She, for instance, regularly submits responses to petitions designed to delay her client's market entry and routinely petitions the agency to protect her client's right to prompt market access.
Ms. Siwik also has considerable experience working with the United States Pharmacopeia (USP), a standards setting organization. She has, for example, assisted clients by addressing proposed product monographs that can present obstacles to the marketing of generic drug products.
Intellectual Property Litigation and Counseling
Ms. Siwik has been helping clients develop legal strategies and litigating generic pharmaceutical patent cases since 1995. She has extensive experience with all aspects of litigation, from pre-suit strategy development through trial and the appellate process, and with a wide assortment of pharmaceutical products, including solid oral dosage forms and a variety of topical dosage forms. Her litigation experience includes drugs such as Prozac® (fluoxetine hydrochloride), Mucinex® (guaifenesin), Razadyne® (galantamine), Monistat® (miconazole), Zantac® (ranitidine hydrochloride), Provigil® (modafinil), Adderall XR® (mixed amphetamine salts), Prozac® Weekly (fluoxetine hydrochloride), Remeron SolTab® (mirtazapine), Zofran® (ondansetron), Olux® (clobetasol foam), Olux E® (clobetasol foam), Evoclin® (clindamycin foam), Men's Rogaine® (minoxidil foam), Clobex® shampoo (clobetasol shampoo), Clobex® spray (clobetasol spray), Vanos® (fluocinonide cream), Androgel® (testosterone gel), Astepro® 0.15% (azelastine nasal spray), Epiduo® (adapalene and benzoyl peroxide gel), Acanya® (clindamycin and benzoyl peroxide gel), and a variety of oral birth control products.
Many of these cases have involved best-selling drugs and resulted in high-profile decisions. For instance, Ms. Siwik successfully represented her client in challenging the validity of the patent protecting Eli Lilly's Prozac® product from generic competition. As a result of this victory, the client obtained 180 days of generic marketing exclusivity. During its exclusivity period, the client's sales exceeded several hundreds of millions of dollars. Ms. Siwik also was involved in a case involving a generic version of 3M's drug Tambocor®. In less than six months, she obtained a summary judgment ruling of non-infringement from the district court. The Federal Circuit's affirmance of the decision resulted in a leading opinion on the proper application of the Hatch-Waxman Amendments to the FFDCA.
In addition to considerable patent litigation experience, Ms. Siwik also has experience with trademark, trade dress, and copyright matters.
For years, Ms. Siwik has worked on federal legislation, including legislation relating to the approval and marketing of generic pharmaceutical products. Notably, Ms. Siwik worked extensively on federal legislation seeking to establish a pathway for the approval of generic biological/biosimilar drug products, including considerable involvement reviewing and negotiating the generic biological product provisions enacted into law in 2010. She participated in numerous debates and presentations before Congressional members and staff, in both the U.S. Senate and House, in an effort to ensure that Congress established a workable biosimilar approval pathway. Ms. Siwik's intimate involvement with this important legislation allows her to provide clients with unique and valuable insights into this emerging area of law.
Ms. Siwik also has considerable experience with various pieces of legislation involving the Patent Act, including the America Invents Act, where she has worked to protect the interests of the generic pharmaceutical industry. For example, in July 2005, Ms. Siwik testified before U.S. Senate, Committee on the Judiciary, Subcommittee on Intellectual Property, at a hearing entitled 'Perspective on Patents: Harmonization and Other Matters .' She also has been a panelist at several U.S. Senate discussions regarding various pieces of pending patent legislation, and has delivered numerous presentations on the issues raised by various legislative proposals. Additionally, she has submitted written statements on various pieces of patent legislation to both the U.S. House of Representatives and U.S. Senate.
Additionally, Ms. Siwik worked extensively on the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA includes provisions that dramatically altered the generic pharmaceutical approval procedures first set forth in the 1984 Hatch-Waxman Amendments to the FFDCA. Given the divergent interests involved in the drafting process, these statutory provisions often are complex. The generic exclusivity forfeiture provisions, for example, are lengthy and dense. They present a particular challenge to companies trying to formulate business and litigation strategies. Ms. Siwik's extensive involvement with reviewing and negotiating the final provisions of this statutory scheme gives her a unique ability to advise clients on the intricacies of these new laws and to help clients develop business models.
Other relevant federal legislative matters include bills involving the regulation of settlements between brand and generic drug companies, generic FDA user fees, and federal citizen petition reform.
Ms. Siwik's involvement with pending federal legislation allows her to provide clients with critical information about how such measures could impact current and future business and litigation strategies.
Complex Commercial Litigation Counseling
Ms. Siwik has experience in complex-commercial litigation. For instance, she successfully represented a client in connection with over 30 consolidated putative class action lawsuits brought against the client as a result of its settlement of a patent infringement case. The plaintiffs alleged that the settlement violated state and federal antitrust laws, as well as various state consumer protection statutes. The plaintiffs sought an injunction preventing the parties from continuing under the settlement agreement and significant monetary damages. Ms. Siwik obtained dismissal at the district court level and the U.S. Court of Appeals for the Second Circuit affirmed that decision.
Ms. Siwik has worked closely with clients on contracts relating to raw material acquisitions, litigation settlements, and strategic business alliances. She also has experience responding to Civil Investigation Demands and inquiries from various governmental agencies.
Prior to joining Rakoczy Molino Mazzochi Siwik LLP, Ms. Siwik was a partner at Winston & Strawn LLP.
Testimony to United States Senate: Committee on the Judiciary, Subcommittee on Intellectual Property, 'Perspective on Patents: Harmonization and Other Matters ' (July 2005).
International Generic Pharmaceutical Alliance—Presentation, 'Subsequent Entry Biologics/Biosimilars ' (October 2009).
Generic Pharmaceutical Association Annual Policy Conference—Presentation, 'Patent Challenge Process: Pros and Cons Within Biogeneric Legislation ' (September 2009).
Generic Pharmaceutical Association Annual Meeting—Panelist, 'Biogenerics ' (February 2009).
Federal Trade Commission—Roundtable Participant, 'Follow-On Biologic Drugs: Framework for Competition and Continued Innovation ' (November 2008).
Generic Pharmaceutical Association Annual Policy Conference—Presentation, Patent Reform Issues and Update (September 2007).
United States House of Representatives—Debate, Generic Biologics Legislation (May 2007).
United States House of Representatives—Presentation, Generic Biologics Legislation (May 2007).
United States House of Representatives—Presentation, Brand/Generic Settlement Legislation (April 2007).
United States House of Representatives—Debate, Generic Biologics Legislation (April 2007).
United States Senate—Presentation, Patent Reform Legislation (October 2006).