Speaking Words of Wisdom: Let It Be the Reexamination of the Human Embryonic Stem Cell Patents

Article excerpt

"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.

I. 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. …