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Einar Stole specializes in complex pharmaceutical and chemical patent litigation in the US district courts, including numerous cases involving generic drug approvals and the Hatch-Waxman Act.  Dr. Stole’s litigation and counseling experience has focused on matters involving pharmaceuticals, chemicals, chemical processes, and biotechnology such as genetically-engineered enzymes and DNA-based diagnostic methods.  He counsels clients on a range of intellectual property and litigation matters, including patent infringement, validity, and enforceability.

  • Represented major pharmaceutical company in multi-defendant Hatch-Waxman litigation relating to a multi-billion dollar drug.
  • Represented major producer of industrial chemicals in procuring patents related to wood treatment technology.
  • Coordinating non-US patent litigation, involving pharmaceutical patents in over 50 worldwide actions.
  • Represented drug manufacturer in an ANDA litigation related to sublingual formulations of drug compounds.
  • Represented biotechnology company in patent litigation relating to methods for manufacturing DNA microarrays.
  • Represented biotechnology company in patent litigation relating to genetically-engineered enzymes used in genetic engineering.
  • Represented major manufacturer of DNA-based diagnostics in declaratory judgment action relating to diagnostic DNA probes.
  • Represented biotechnology company in patent litigation involving synthesis and use of DNA libraries.
  • Defended biotechnology company against claims of unlawful patent marking in U.S. District Court and Court of Appeals for the Federal Circuit.
  • Provided strategic advice to a manufacturer of industrial chemicals on worldwide patent portfolio development and patent enforcement.

Previous Experience

  • Dr. Stole was a patent examiner in the United States Patent & Trademark Office (1996-2000) where he examined patent applications in the areas of recombinant proteins, enzymes and other areas biotechnology.
  • Dr. Stole was a post-doctoral fellow at Johns Hopkins University (1992-1996) where he conducted research on enzymes involved in reactions with and repair of DNA and other nucleic acids.