Drug manufacturers and their counsel get legal analytics for litigation in new drug applications
By Sean Doherty. This article originally appeared on Law Technology News, September 29, 2014.
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.
The generic manufacturer’s certification includes a notice to the original drug manufacturer, stating that an Orange Book drug patent is invalid or that the generic does not infringe the patent. A patent owner has 45 days after receiving an ANDA notification to sue the generic manufacturer for patent infringement.
The new service available in the Lex Machina platform includes “hundreds of thousands of docket entries and documents from more than 2,500 ANDA cases filed since January 1, 2000,” according to the press release. Like Lex Machina’s content for patent litigators, pharma industry and legal professionals can review ANDA cases on drug patents and generic equivalents in particular jurisdictions, before certain judges, and brought by particular parties and their attorneys to benchmark case strategies and review possible litigation outcomes.
Lex Machina identifies patent infringement filings under ANDA from pleadings and docket entries gleaned from PACER (Public Access to Court Electronic Records). The company also references keywords and plaintiff and defendant information related to brand and generic drug manufacturers to create a unique data set for the pharmaceutical industry.
Lex Machina’s technology was created from Stanford University’s computer science department and law school. The company is headquartered in Menlo Park, Calif.