Christine J. Siwik

Christine J. Siwik is a partner of Rakoczy Molino Mazzochi Siwik LLP. Her practice focuses primarily on pharmaceutical regulatory litigation involving the U.S. Food and Drug administration (FDA), regulatory counseling, and patent litigation and counseling.

Ms. Siwik has assisted 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 a decade, 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 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 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). Her work in the emerging area of generic biologic products allows Ms. Siwik to provide clients value guidance and insight.

Ms. Siwik also has extensive 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. She also has more than a decade's experience of petitioning the agency to protect her client's right to prompt market access.

Ms. Siwik also has considerable experience working with the United States Pharmacopeia, 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.

Legislative Experience

For years, Ms. Siwik has worked on federal legislation, including legislation relating to the approval and marketing of generic pharmaceutical products. For example, she has worked extensively on various pieces of legislation involving the Patent Act in an effort to protect the interests of the generic pharmaceutical industry. 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." Ms. Siwik also has been a panelist at several Senate discussions regarding various pieces of pending patent legislation, and has delivered numerous presentations on the issues presented by such legislation. Additionally, she has submitted written statements on pending patent legislation to both the U.S. House of Representatives and U.S. Senate.

Ms. Siwik also has worked extensively on federal legislation seeking to establish a pathway for the approval of generic biological drug products. She has 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 establishes a workable generic biologic approval pathway.

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 new statutory scheme provides her with valuable insights into its operation, and 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.

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. Her litigation experience includes drugs such as Prozac® (fluoxetine hydrochloride), Zantac® (ranitidine hydrochloride), Provigil® (modafinil), Adderall XR® (mixed amphetamine salts), Remeron SolTab® (mirtazapine), Zofran® (ondansetron), 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.

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.