Rakoczy Molino Mazzochi Siwik LLP

Over 30 full-time attorneys and technical advisors focused exclusively in the fields of pharmaceutical patent and regulatory counseling and litigation under Hatch-Waxman, the Medicare Modernization Act (MMA), and the Biologics Price Competition and Innovation Act (BPCIA).

RMMS is the only specialty litigation and counseling boutique in the United States devoted almost exclusively to the pharmaceutical industry, and our collective experience is second to none.

Small Molecules

To our knowledge, no firm has handled more complex Hatch-Waxman patent infringement actions in the past ten years. Since the firm’s inception in 2004, RMMS has handled over 200 Hatch-Waxman and related pharmaceutical litigation matters (including declaratory judgment, patent infringement, Administrative Procedure Act (APA), and commercial dispute matters) involving at least 130 different drug products for at least 20 pharmaceutical clients.

We understand that patent litigation is not an end-game, and that the business decisions made throughout the entire product and patent evaluation, regulatory review, litigation, and commercialization process are equally critical to the company’s strategic plans involving any one product or group of products. Our goals are aligned with those of our clients: to ensure that each client obtains value from its applications, whether through the eventual commercial marketing of the product, the sale or assignment of the asset, or relationship-building with other companies through joint development agreements, active pharmaceutical ingredient (API) and finished dosage form supply agreements, licensing agreements, and co-promotion and marketing agreements.

Biologics

RMMS attorneys have litigated patents related to life sciences and pharmaceuticals for over 20 years, and thus, are well prepared to adjust to the changing biosimilars industry. Our team is well-versed in all aspects of the Biologics Price Competition and Innovation Act (BPCIA), and regularly guides clients through the complex provisions of the BPCIA as well as resulting litigation.

In addition, RMMS regularly counsels clients on regulatory issues related to the Hatch-Waxman Act and the BPCIA, including expedited FDA review strategies for drugs and biological products, patent listing and certification issues, product labeling, agency review requirements, risk management programs, marketing exclusivities, and citizen petitions.

RMMS continues to expand its biosimilar practice, including consulting and strategy development in advance of application filing, as well as our involvement in cutting-edge, first-of-of their kind court decisions related to biosimilar products.