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. Dr. Stole also has experience prosecuting chemical and biotechnology patent applications in the U.S. Patent and Trademark Office, including appeals and interferences before the Board of Patent Appeals and Interferences.
- 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.
- 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.