It's Time to Stop the Hypocrisy over Stem Cell Patents - Part I

    By Kevin E. Noonan --

The recent first Office Action in the re-examination of the Thomson stem cell patents before the U.S. Patent and Trademark Office (see "WARF Stem Cell Patent Claims Rejected in Re-examination") has predictably resulted in press releases and commentary regarding these patents.  However, while the Patent Office has initially rejected the claims for the three patents-in-reexamination, the issue is far from resolved, and the rejections per se do not establish that the patents are invalid.

Since the reexaminations were requested, however, the issue has been less over the validity of the patents than it has been over avoiding royalty payments by commercial interests, particularly those hoping to benefit from the windfall expected from California's support for stem cell research (see "Stem Cells a Go! in California").  Rest assured, California expects to make a profit from its investment, and the Thomson patents are in the way.

Thus, we have the PR campaign that these are "bad" patents, and that it is the patents, rather than the Bush administration's ban on Federal support, that is "driving" stem cell research abroad.  There is, of course, no mention that the patent-holder, the Wisconsin Alumni Research Foundation (WARF) licenses its stem cell patents to scientific researchers for substantially less than it licenses these patents to commercial interests, or that in return for the license, WARF provides support and training in working with cells well-recognized as being difficult to grow.

One of the latest salvos in this PR war comes from the San Diego Union Tribune, in an article about Singapore researcher Ariff Bongso.  It is cast as an apocryphal story of the pure scientific researcher out merely for the glory of discovery, untainted by thoughts of profiting by patenting his invention.  No doubt, Dr. Bongso has admirably pursued his research in Singapore (where the government has spent a great deal of money on its own stem cell industry).  However, the facts don't support the conclusion that Dr. Thomson either does not deserve his patents or that he should not have obtained them.  Indeed, the article merely establishes once again that the understanding of the scientific and legal issues contained in the popular press is severely wanting, and that the public is in fact less informed, or more misinformed, for their efforts.

The crux of the matter is, fortunately, set forth in the article itself.  Speaking about his work, Dr. Bongso explains that he created in vitro fertilized embryos in the laboratory and determined how to extend the time the embryos could grow outside the womb before implantation.  At that time, he was able to extract embryonic stem cells from the inner cell mass and have them survive in culture for a short time.  However, by his own admission, Dr. Bongso was unable to get the cells to grow for enough time or to sufficient numbers to be useful.  That was Thomson's patentable contribution.

Quoted extensively in the article is Dr. Jeanne Loring, a scientist whose expert declaration, opining on both the science of embryonic stem cells and the law of obviousness, was rejected by the U.S. patent examiner in the Thomson patent reexamination.  Although pointed in its rhetoric about the "public injury" occasioned by the Thomson patents, the examiner condemned this declaration and refused to consider it, since it was improper to submit such a declaration in a re-examination.  In the Union Tribune article, Dr. Loring opines that the Thomson work was "an advance, not an invention," providing no legal or logical reasons for the distinction.

While it is certainly Dr. Loring's opinion these days that stem cell patents (or at least Dr. Thomson's stem cell patents) are a bad thing, it has not always been so.  In 2002, Dr. Loring submitted her own U.S. patent application on stem cells, published as U.S. Publication No. 2002/0188963.  In this application, Dr. Loring claimed "an isolated population of non-mouse embryonic stem cells," a claim much broader than any of Dr. Thomson's claims (that are limited not only to primate and human stem cells, but recite particular properties those cells must possess).  Indeed, Dr. Loring's claims are so broad that they undoubtedly encompassed the cells produced by Dr. Bongso.  If Dr. Thomson's claims occasion "public injury," imagine the result should Dr. Loring's claims have ever issued.  In what must be viewed as a fortunate outcome for the public good (in view of the current rhetoric about stem cells), the U.S. Patent and Trademark Office refused to issue Dr. Loring a patent on her "invention."

A decision as to whether Dr. Thomson's patents are properly granted, valid, and enforceable is expected from the Patent Office later this year (subject to court appeal).  Until then, it does the public no service for the press to publish politically-motivated fairy tales.

For additional Patent Docs coverage concerning stem cells, please see:

• "NIH Chief Dissents on Federal Stem Cell Funding Ban" - March 20, 2007
• "Limitations on the Usefulness of Adult Stem Cells" - February, 28, 2007

Comments

[Lawrence B. Ebert]

Note the April 16 post on IPBiz titled:

Somers on Bongso work as prior art to Thomson patents

available: http://ipbiz.blogspot.com/2007/04/somers-on-bongso-work-as-prior-art-to.html

An email criticizing the article by Somers was sent to both Somers and the San Diego Union-Tribune, but (to date) no response was made.