A Medical Device Daily

Geron (Menlo Park, California) reported that the U.S. Patent and Trademark Office has upheld the validity of a key patent for human embryonic stem cells.

The patent is assigned to the Wisconsin Alumni Foundation (Madison) and is one of three related patents challenged through re-examination proceedings. Geron holds an exclusive license under these patents to develop and commercialize therapies based on three types of cells derived from human embryonic stem cells: neural cells, cardiomyocytes and pancreatic islet cells.

In communicating its decision, the USPTO issued an 82-page Action Closing Prosecution in the inter-partes re-examination of U.S. patent No. 7,029,913. The USPTO rejected the arguments made by the party that requested the re-examination and found the expert declarations it submitted to be “flawed by hindsight reasoning.” The claims of the patent cover replicating cultures of human embryonic stem cells.

“This is clearly the correct outcome,” said David Earp, PhD, Geron’s chief patent counsel and senior VP of business development. “In the course of the re-examination proceeding, the USPTO conducted a thorough evaluation of relevant scientific and patent publications, considered extensive legal arguments and reviewed several expert declarations. The decision explains in precise detail why this pioneering technology is entitled to patent protection. We are, of course, pleased with the holding.”

The re-examination proceeding was initiated in October 2006 at the request of the Public Patent Foundation (New York) and the Foundation for Taxpayer & Consumer Rights (Santa Monica, California).

Two parallel re-examination proceedings involving U.S. patent nos. 5,843,780 and 6,200,806 which claim preparations of, respectively, primate and human embryonic stem cells and methods for their isolation, still are pending.

Geron is developing biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes.