Pharmaceuticals

The pharmaceutical industry is characterized by unique regulation, unusual marketing practices, and an abundance of useful – but often poorly understood – data. Effective expert testimony in pharmaceutical cases requires a strong grasp of all three. Few industries have spawned more academic and governmental interest, or a wider array of empirical studies, and familiarity with these resources is a prerequisite to informed analyses. As specialists in the industry, our staff work daily with all of these resources and many have spent decades understanding the nuances of pharmaceutical development, approval, marketing and sales. These skills are applied not only to human pharmaceuticals, but to veterinary and biological products as well.

OnPoint’s experts and staff are thoroughly familiar with the FDA’s operations, patent examination procedures, and the complex laws and regulations that govern drug approval, including, most notably, the Hatch-Waxman Act. Our analysts keep abreast of academic literature and government and private studies on pharmaceutical promotion, sales and competition. They are thoroughly conversant with all available third-party pharmaceutical data, and the interpretation and use of that data. This knowledge, together with a strong grasp of the commercial realities faced by both brand and generic pharmaceutical firms, has made us one of the country’s preeminent economic consulting firms in the pharmaceuticals field.

OnPoint performs a broad range of pharmaceutical analyses, including:

  • Blocking (through delayed generic entry, patent acquisition or development termination)
  • Profits lost due to patent infringement
  • Reasonable royalties
  • Secondary indicia of patent validity
  • Drug development contracting
  • Effect of product representations
  • Drug pricing and marketing practices and their economic effects
  • Definition of competitor sets and relevant markets
  • Order of entry effects
  • Generic competition
  • Regulation of biosimilars

OnPoint has been engaged with scores of important drugs used to treat medical conditions including ADHD, allergic rhinitis, blood clotting, cancer, chronic obstructive pulmonary disease (COPD), contraception, depression, dermatitis, diabetes, gastric reflux, high blood pressure, hormone deficiencies, infection, nausea and weight loss, organ transplants, pain, and others. Many of the world’s largest blockbuster drugs are included within this list. OnPoint provides its services to both brand and generic firms. Recent successes involve a damage verdict of $548 million plus punitive damages in favor of Asahi Kasei Pharmaceuticals on the basis that development of its drug, Fasudil, had been willfully blocked through corporate acquisitions. OnPoint has provided support to both brand and generic companies in patent infringement cases where damage claims exceed $1 billion (e.g., In Re: Gabapentin Patent Litigation). Based on their unique facts, our pharmaceutical engagements include both support for class certification (e.g., Class v. Smithkline Beecham Corporation D/B/A Glaxosmithkline plc (Flonase)) and opposition to class certification (e.g., James Weiss, Patricia Vogt, et al. v. AstraZeneca Pharmaceuticals LP and Zeneca, Inc. (Nexium)). We frequently analyze branded drug performance for the purpose of determining commercial success, or the lack thereof (e.g., Santarus, Inc. and The Curators of the University of Missouri v. Par Pharmaceutical, Inc.). Our experts have been relied upon in seminal competition cases that have helped shape the pharmaceutical industry (e.g. In Re: Brand Name Prescription Drugs Antitrust Litigation).