Lex Machina Out With Legal Analytics for Big Pharma
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Drug manufacturers and their counsel get legal analytics for litigation in new drug applications
Lex Machina, a provider of legal analytics from publicly available data sources, announced on Sept. 23 a new service for the pharmaceutical industry. The new service allows drug patent holders and generic drug manufacturers and their counsel to use the company’s data analytics to decide about case strategy and litigation tactics around the 1984 Drug Price Competition and Patent Restoration Act, commonly known as the Hatch-Waxman Act.
The Hatch-Waxman Act amended the Federal Food, Drug, and Cosmetic Act and established an abbreviated new drug application (ANDA) process that requires generic manufacturers to demonstrate a generic drug is “bioequivalent” to an approved brand drug. Under ANDA, the generic manufacturer must file a certification regarding drug patents in the Orange Book aka Approved Drug products with Therapeutic Equivalence Evaluations.
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