Speaking words of wisdom: let it be the reexamination of the human embryonic stem cell patents.

• Author: vom Wege Dovi, Julia
• Position: COMMENTS

"Science is a first-rate piece of furniture for a man's upper chamber, if he has common sense on the ground-floor." (1)

INTRODUCTION I. WHAT ARE STEM CELLS? II. THE STEM CELL PATENTS III. REEXAMINATION IV. SHOULD THE PATENTS REMAIN VALID? A. Obviousness B. The Validity of the Stem Cell Patents Is Consistent with the Purpose of Patent Law C. Disclosure D. Not Research but Profit-Making Is Limited by the Patents E. The Upstream Technology Argument F. WARF Is Not "Keeping It All to Itself" G. The Cost Is More Than Reasonable H. California v. Wisconsin? I. Scientists Are Not Moving Abroad to Conduct Their Research CONCLUSION INTRODUCTION

On July 17, 2006, the Foundation for Taxpayer and Consumer Rights (FTCR) filed a request for reexamination of the three stem cell patents owned by the Wisconsin Alumni Research Foundation (WARF) through the Public Patent Foundation. The consumer groups argue that the patents hinder the progression of research. (2) The United States Patent and Trademark Office (USPTO) granted the request in September 2006. Such reexamination could result in narrowing or canceling of some or all of the claims. This Comment will outline why the USPTO should not invalidate or significantly narrow the patents. Specifically, this Comment will explain that the patents should remain valid. First, this Comment will outline what stem cells are and what the patents at issue cover. This Comment will then briefly explain the applicable law and policy considerations. Finally, this Comment discusses why the patents should withstand their current challenge.

1. WHAT ARE STEM CELLS?

   There is no single definition of what a stem cell is or what its characteristics are. (3) However, there are a number of properties the scientific community agrees upon being innate to stem cells. Stem cells are undifferentiated precursor cells to other cells of the body. (4) They have the ability to propagate themselves, through proliferation, essentially indefinitely without loosing their undifferentiated character. (5) This key characteristic significantly distinguishes stem cells from somatic cells. (6) Somatic cells undergo only a finite number of replications in culture because of a sequential shortening of the chromosome ends (telomeres) during each cell division. (7) Stem cells, in contrast to human somatic cells, express a protein (telomerase) that permits for the maintenance of chromosome ends and thereby allows for indefinite replication. (8)

   Embryonic stem cells (ES cells) retain the ability to form "all three embryonic germ layers even after prolonged culture." (9) Adult stem cells, those that are found in an individual's tissues, are typically limited in their ability to differentiate into only those cells inherent to the tissue in which they reside. (10) For example, adult stem cells in the brain (neural stem cells) can differentiate into nerve cells, astrocytes, and oligoddendrocytes, all of which reside in brain tissue. (11) However, adult stem cells that can differentiate into cells of tissues other than the one in which they reside have been isolated and are currently under investigation. (12)

   The great hope for ES cells rests in their use as replacements for human tissues and organs that failed as a result of accidents, disease, or age. (13) For example, scientists speculate that ES cells could alleviate or cure the insulin insufficiency in individuals suffering from diabetes. (14) If the ES cells could integrate into the pancreatic islets and become insulin-producing cells, they would effectively ameliorate or even completely cure the diseased phenotype. (15) Similar hope exists in the field of degenerative disorders, such as Alzheimer's and Parkinson's diseases. (16) In addition, stem cells are important study objects to discern the human developmental process as well as biological processes. (17) However, it is important to note that this technology is still in its infancy and its true value is unclear. (18)

   Currently, federal funds are available only for work with defined, already-existing human embryonic stem cell lines, i.e. federal funding may not be used to generate or work with new human embryonic stem cell lines. (19)

2. THE STEM CELL PATENTS

   A patent grants the "right to exclude others from making, using, offering for sale, or selling the invention." (20) The three stem cell patents that are being reexamined are U.S. Patent numbers 5,843,780 ("Primate embryonic stem cells," "the '780 Patent"), (21) 6,200,806 ("Primate embryonic stem cells," "the '806 Patent"), (22) and 7,029,913 ("Primate Embryonic Stem Cells," "the '913 Patent"). (23) The '780 Patent issued in 1998 and claims "purified preparation of primate embryonic stem cells." (24) The '806 Patent issued in 2001 and claims "purified preparation of pluripotent human embryonic stem cells." (25) The '913 Patent issued in 2006 and claims "methods of obtaining human hematopoietic cells from human pluripotent embryonic stem cells using mammalian stromal cells." (26) All three patents list Dr. James Thomson as the inventor, are assigned to WARF, and are licensed to Geron Corporation. (27) This California biotechnology company "has an exclusive license to the WARF patents for heart, pancreas and neural cells." (28) Geron had provided significant financial support for Dr. Thomson's research. (29)

3. REEXAMINATION

   "A patent shall be presumed valid." (30) To challenge the validity of a patent, any person can apply for reexamination with the USPTO. (31) The grounds for which such reexamination may be requested are limited to new questions of patentability raised by prior art, i.e. a printed publication or patent. (32) The requestor must make his request in writing and explain the relevance of the cited prior art with regard to every claim to be reexamined. For such a reexamination request to be granted, the examiner has to find that the cited prior art raises "a substantial new question of patentability." (33) Prior art raises a substantial new question of patentability if "there is a substantial likelihood that a reasonable examiner would consider the prior art ... important in deciding whether or not the claim is patentable." (34)

   While a patent owner could potentially lose his patent, a requestor has nothing to lose because the USPTO refunds a large portion of the reexamination application fee should the request for reexamination not be granted. (35) Requestors cannot appeal the USPTO's decision not to grant the request for reexamination. (36)

   The Public Patent Foundation, on behalf of the FTCR, filed a request for reexamination of the three stem cell patents in July, 2006. (37) The FTCR cited five sources, only four of which were deemed by the USPTO to raise "a substantial new question of patentability." (38) The fact that the FTCR's request for reexamination was granted is not unusual. The USPTO grants between 90% (ex parte) and 98% (inter partes) of reexamination requests. (39) The claims at issue were changed in some way in nearly two-thirds of the ex parte proceedings, but all claims were cancelled in only 10% of the proceedings. (40) The challenged claims remained unaltered in more than one-fourth of the proceedings. Since 90% of all reexamination proceedings resulted in either modified or unaltered claims and only 10% in cancellation, the USPTO history makes it unlikely that the FCTR will prevail in its desired cancellation of the '780 Patent and the '806 Patent. In contrast, for the '913 Patent, an inter partes proceeding was granted. In inter partes proceedings, less than one-third of the claims remained unaltered or were modified, while over 70% were cancelled. (41)

   On April 3, 2007, the USPTO issued a preliminary rejection of the stem cell patents due to obviousness. (42) This is not unusual, however, and signifies only the first of many steps. (43) In its response filed on May 31, 2007, WARF refutes the USPTO's preliminary rejection. (44) Further proceedings are likely to take months, if not years.

4. SHOULD THE PATENTS REMAIN VALID?

   The WARF patents should remain valid because the prior art cited by the requestors does not render the inventions obvious. Also, the patents should remain valid because they do not stifle but rather promote the progress of science by allowing access to those who want it for a reasonable fee (or no fee at all). Finally, the patents should remain valid to foster investors' confidence in investing in embryonic stem cell research so that such research can continue despite current restrictions on available federal funding.

   1. Obviousness

      To be patentable, an invention must be novel and useful (45) as well as nonobvious. (46) "Nonobviousness ... means that an invention must not have been obvious to one with ordinary skill in the art to which the subject matter of the invention pertains at the time of the invention and in the light of ... the prior art." (47) In contrast to novelty, an invention can be obvious even in the absence of a single prior reference as long as all components are described in prior references and "some motivation or suggestion to combine the references is provided by the prior art taken as a whole." (48) It should be noted that this general standard of nonobviousness was recently rejected by the Supreme Court. (49) It is not entirely clear yet how this decision will impact biotechnological inventions. However, it is speculated that "the impact of the Supreme Court's ruling may not be as profound on life-science patents." (50) This notion is supported by the fact that "[w]ith life science inventions, 'we can extrapolate and guess, but until we conduct an experiment, we don't know if it's going to work.'" (51)

      When dealing with biotechnological inventions, the standard for obviousness has been more difficult to define. In 1995, Congress amended 35 U.S.C. [section] 103 with subsection (b) to include a provision specific to biotechnology. (52) This subsection "has been interpreted as requiring...