High fees, restrictive guidelines have objectors seeking reversal

The San Diego Union-Tribune (California)

The U.S. Patent and Trademark Office has agreed to re-examine patents that give the University of Wisconsin’s Alumni Foundation the exclusive rights to all human embryonic stem cells used for research.

In granting the re-exam, the patent office said it found that consumer groups raised substantial questions as to whether the three patents on embryonic stem cells should have been issued.

The consumer advocates contend the patents require all researchers in the United States working with embryonic stem cells — whether at a university, private research lab or drug discovery company — to pay exorbitant fees and adhere to such restrictive guidelines that researchers are effectively being handcuffed.

The groups also argue that Wisconsin’s science was not unique enough to have been worthy of a patent. They submitted previously published papers documenting the research of other scientists who worked on embryonic stem cells before University of Wisconsin scientist James Thomson filed for his first patent.

“We’re pleased the (patent office) has decided to re-examine these patents,” said John M. Simpson, of the Foundation for Taxpayer and Consumer Rights in Santa Monica. “The patents should never have been issued in the first place.”

Joining in the request for a re-examination are the New York-based Public Patent Foundation and Jeanne Loring, a stem cell researcher at the Burnham Institute in La Jolla.

The patents at issue were granted to University of Wisconsin researcher James A. Thompson in 1998, 2001 and last April. The patents cover the scientific recipe for pulling embryonic stem cells out of days-old primate embryos that are a cluster of 100 to 200 cells. These embryonic stem cells eventually morph into all cell types in the body, including nerve, blood and bone.

The hope and hype are that these cells can be used to test new drugs that are problematic to test on people, and that they might eventually be used to produce new cells to cure diseases such as diabetes, Parkinson’s and Alzheimer’s.

Beth Donley, executive director of WiCell Research Institute, which was formed to commercialize the Wisconsin patents, said the institute has provided a free license and stem cells to 324 research groups, Donley said.

“(The) stem cell patents do not inhibit research; in fact, they support and encourage it,” she said.

The consumer advocates say the patents, and the fees being charged to use the science they cover, are driving researchers and philanthropic funding overseas, where the patents are not legally recognized.

For instance, the Juvenile Diabetes Research Foundation is giving more money to researchers overseas because its philanthropic dollars go further where scientists are unfettered by the patents, Richard Goldstein, the organization’s chief scientific officer, said earlier this year.

Many scientists and biotech insiders contend that this brain drain is giving other countries an advantage in the research that may one day lead to a lucrative industry providing treatments for some of the most devastating diseases.

Although there are 1.5 million patents active in the United States, the patent office receives only 400 to 500 requests annually to re-examine patents, said Brigid Quinn, a spokeswoman for the office. A re-examination can result in no change to the patent or a dismissal of all or part of a patent.

She said about 90 percent of re-examination requests are granted.

In each of the three Wisconsin patents to be re-examined, there are several scientific elements, also known as “claims.”

Some of the claims are for a method of deriving the stem cells and keeping them alive in different types of culture. Others are “composition of matter” claims, which seek ownership of all embryonic stem cells no matter what method is used to derive them and keep them alive.

It is the composition of matter claims that give the patents such sweeping control, said biotechnology patent lawyer John Wetherell, of Pillsbury Winthrop Shaw Pittman in San Diego. If a scientists develops another method for deriving embryonic stem cells and keeping them alive, the right to the cells would still be owned by the Wisconsin foundation under the composition of matter claim, Wetherell said.

The consumer groups asked the patent office to review all of the claims in each of the foundation’s embryonic stem cell patents, and the patent office has agreed to do so.

Third-party requests for patent re-examination, like the ones filed challenging the Wisconsin patents, are successful in having the patent either changed or completely revoked about 70 percent of the time, Simpson said.

It can take up to a year for the patent office to complete the re-examination and decide whether to change the patent.
————–
Contact Terri Somers at: (619) 293-2028 or [email protected]