Lex Machina Adds Orange Book Data to Its Patent Litigation Analytics Platform

ANDA litigators now have access to patent and use code data for litigated pharma patents

Menlo Park, CA — June 6, 2016 — Lex Machina, a LexisNexis company, today announced it has integrated the Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations data – commonly known as the Orange Book – into its award-winning Legal Analytics® platform. The new data enables attorneys to search through, and gain historical insights from, patent and use code data for FDA-approved drugs that have been the subject of federal patent litigation.

The Orange Book contains information related to Abbreviated New Drug Applications (ANDAs), including the patents covering a drug, as well as a description of any patented uses – the so-called ”use code” – of the drug. The FDA updates the online Orange Book every month. Although the FDA describes the updates as cumulative, the Orange Book sometimes removes records for older, expired patents. But Lex Machina captures all data that has appeared in the Orange Book since March 2014, making it a more comprehensive, valuable and easy-to-use reference for ANDA lawyers than the published version.

“Now that Lex Machina is a part of LexisNexis, we have access to incredible amounts of new data and information that can be used to enrich our products and make them inherently more strategic and valuable to litigators,” said Owen Byrd, General Counsel and Chief Evangelist at Lex Machina. “The Orange Book has been one of the most requested data sets, especially among ANDA attorneys and their pharma company clients. Lex Machina is the only entity that captures historical Orange Book data, integrates it with other litigation data and makes it easily searchable.”

Lex Machina is used by pharmaceutical companies such as Apotex, Impax Laboratories, AbbVie and many others, as well as law firms with significant ANDA practices such as Winston & Strawn, Fish & Richardson, and Wilson Sonsini Goodrich & Rosati.

Lex Machina’s platform includes information on more than 45,000 litigated patents, including more than 1,600 pharma patents that now contain integrated Orange Book data. The new information appears as a tab on the patent’s page, and includes such data as:

  • Applicant: The applicant holder of the New Drug Application.
  • Application Number: The New Drug Application number as assigned by the FDA.
  • Application Approval Date: The date the product was approved by the FDA. Products approved before January 1, 1982 are shown with an approval date of 1982-01-01.
  • Product: Trade name as shown on the product label.
  • Patent Expiration: The patent’s expiration date, as claimed by the applicant.
  • Litigated Patents and Unlitigated Patents: Other patents referenced in the application, in addition to the page’s current patent. Litigated Patents are patents in Lex Machina’s database, meaning that they have been litigated in District Court, PTAB or the ITC.
  • Active Ingredient(s): The product’s active ingredient(s).
  • Strength: Potency of the product’s active ingredient(s).
  • Dosage: Form and route (e.g. tablet, oral).
  • Type: RX, OTC or DISC.

About Lex Machina
Lex Machina’s award-winning Legal Analytics® platform is a new category of legal technology that fundamentally changes how companies and law firms compete in the business and practice of law. Delivered as Software-as a-Service, Lex Machina provides strategic insights on judges, lawyers, parties, and IP, mined from millions of pages of legal information. This allows law firms and companies to predict the behaviors and outcomes that different legal strategies will produce, enabling them to win cases and close business.

Lex Machina was named one of the “Best New Legal Services” by readers of The Recorder in 2014 and 2015, and received the “Best New Product of the Year” award in 2015 from the American Association of Law Libraries.

Based in Silicon Valley, Lex Machina is part of LexisNexis, a leading information provider and a pioneer in delivering trusted legal content and insights through innovative research and productivity solutions, supporting the needs of legal professionals at every step of their workflow. By harnessing the power of Big Data, LexisNexis provides legal professionals with essential information and insights derived from an unmatched collection of legal and news content—fueling productivity, confidence and better outcomes.