Pharmaceuticals

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Overview

In a market of constant change that is complex, competitive, and highly regulated, Rothwell Figg serves as IP law counsellors and strategic advisors to the pharmaceutical industry. We focus on navigating beyond the specific challenges associated with protecting unique and sophisticated IP, building strategic partnerships, launching new products and services in the U.S. and abroad, and proactively safeguarding existing product lines.

Our pharmaceutical industry clients include both brand name innovators and generic drug manufacturers, which we believe gives us an advantage over firms that handle only brand name companies. We work with our generic drug clients to navigate the legal landscape and bring their products to market with greater surety. As a result, we provide insight into the generic side’s objectives and viewpoint strengthening our approach to strategic development for brand name innovators while keeping their goals in mind.

IP rights, especially patents, are the foundation of the pharmaceutical industry—which is why our firm has developed one of the most agile and results-driven pharmaceutical patent prosecution practices in the country. We have successfully prosecuted patents involving traditional pharmaceutical small molecule active ingredients, biologics, excipients and formulations, drug-related delivery systems, synthetic methods, drug metabolites, discovery tools, screening methods, and bioinformatics, including genomics and proteomics. Moreover, we are called upon to identify and assess the value of pharmaceutical IP in M&A transactions and negotiate and close licensing and collaboration agreements that are global in scale.

Our firm is a recognized leader in resolving litigation arising out of the Drug Price Competition and Patent Term Restoration Act, referred to as Hatch-Waxman litigation. We have handled 60+ such cases in federal district courts and before the U.S. Court of Appeals for the Federal Circuit involving advanced legal and scientific theory. Because many of our litigators have scientific degrees in areas related to pharmaceuticals, including biomedical engineering, chemical engineering, biology, zoology, chemistry, biochemistry, and pharmacy, our advocates function at the intersection where scientific and legal erudition converge.

For more than four decades, our litigators have invalidated scores of pharmaceutical patents and successfully pursued antitrust cases arising out of the improper listing of patents in the Orange Book. Our firm has handled 60+ IPRs earning a depth of knowledge and skill before the PTAB that is unique, as many of our attorneys have substantial experience handling interference proceedings and reexaminations. We are well-versed in the PTAB’s rules and strategies, and we use this insight to our advantage when helping clients formulate a successful strategy on attack or defense.

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