Are Stem Cells Patentable?

POINT - Dr. Chris Centeno

The general idea of patentability comes from an understanding of what is novel and invented by individuals.  The US Patent Office uses this concept of novelty.  If someone were to envision something new and unexpected, such as a bicycle helmet with internet and GPS display, it would be considered novel and patentable.  However, if the idea is simply an evolution of something that already exists (a bicycle helmet designed with better aerodynamics), it is not a patentable idea.

The debate about stem cells centers around confusion about whether they are inventions or acts of nature. The belief that stem cells are drugs or biologic agents is based on the reasoning that they are tiny and not part of our everyday experience.  We don't observe our stem cells on a daily basis, so they seem like unique and mysterious objects.  However, they are a part of us as much as an arm or an elbow may be.  Scientists and researchers did not invent stem cells; they are naturally occurring parts of our bodies. Thus it makes no sense for these to be considered patentable objects.

Recently, this stance was further illustrated by a US district court decision which stated that genes (and by extension stem cells) are laws of nature and therefore cannot be patented [1]. This patent case creates clear precedence that the cells or genes in our bodies are not property of the biotech industry (devices or drugs) to be registered in the federal patent office or regulated by governments as new drugs. Rather, they are body parts no different than a knee or an elbow.  Nobody invented autologous stem cells, nor genes, nor knees or elbows [2].

Stem cells are acts of nature.  Patenting them only inhibits progress and the movement of the field of stem cell therapy forward.  Most of the research where new stem cell lines are discovered is federally funded (by us all through tax dollars), so we all should have unfettered access to this technology to help our patients.  However, having said that, if smart researchers are able to patent the backend biotechnology process that helps isolate, grow, or otherwise create a stem cell, this may be a novel finding that is patentable. 

1. Association for Molecular Pathology et. al. vs. United States Patent and Trademark Office. 2010, United States District Court; Southern District of New York.
2. The same holds true in a recent ruling by the U.S.P.T.O. in response to the challenge of an embryonic stem cell patent help by the alumni research foundation of the University of Wisconsin (WARF).  In this case, the embryonic stem cell line being used by Geron in spinal cord injury repair trials was patented by WARF and licensed by Geron.  U.S.P.T.O. decided that the stem cell patent was obvious and could have been anticipated by other discoveries.

 

COUNTER POINT - Dr. David Bonner

Patenting was established in the United States and in other countries in the early 1800’s to provide a limited monopoly to entrepreneurs. This limited monopoly, in principle, offers entrepreneurs an incentive to commercialize new technology, benefitting the economy.  In return for the limited monopoly, the inventor receiving allowance of patent claims must ‘teach’ the invention so that others may later use it.

In the last several decades, patenting has become hugely important in the world of stem cells and in other biological areas.  Unlike many other areas of invention in which patenting is traditionally involved, the biological area has raised two important new issues:  should it be legal to patent something found in nature and is there a moral conflict with restricting access (via the patent monopoly) to the use of inventive knowledge which could be used to improve or to save human life?

As is typical in the advance of science, scientific and commercial issues move into new areas not contemplated by current societal ethics.  That is where we find ourselves in patenting some stem cell advances.  The recent battles over Wisconsin Alumni Research Foundation (WARF) patents relating to embryonic stem cells are also supercharged by the views of segments of society that use of embryonic stem cells also involves religious issues relating to the beginning of life and whether or not use of embryonic stem cells in effect involves taking of life.

The ethical dilemmas relating to adult stem cells are, fortunately for the advance of clinical practice, devoid of the ethical/religious issues surrounding embryonic stem cells.  The issues for adult stem cell patenting relate more directly to the issue of whether patenting slows delivery of adult stem cell treatments to the patient in a clinical setting and to the doctor-patient relationship in choosing a means to treat a patient.  To the extent that there is a commercial need for profitability as a means of obtaining enough resources to ‘translate’ science from the laboratory to practice in the clinic, there is an argument for retention of the ability to patent in this area.

The re-examination and rejection of certain WARF patents revolves are the very complex issue of  ‘novelty’, i.e., has something new and unanticipated been conceived in exploring new areas or is the result simply ‘obvious to one skilled in the art’.  As a result, the rejection of the WARF patents, still subject to appeal in the U. S., does not really bear on the subject of the ethics of such patenting – or even the question of whether the commercial motive is useful in this area.

However, it is reasonable to conclude as a result of complex and numerous patent actions in court and in commerce that patenting stem cell results in the U. S. is far from certain.  The issue is even more complex in the European Union since the E. U. over the last decade has applied a ‘moral imperative’ standard to patenting.  This area of moral imperative is still evolving and is probably far from settled.  Nevertheless, applying the ‘moral imperative’ standard to patenting in the E. U. could mean that if there is a chance of saving human life with a new invention, then it shouldn’t be patented.  Such a standard may seem to have the impact of assuring greater patient access to new treatments, but whether treatments are more or less likely to arrive at the clinical properly tested and safe may depending upon the financial resources available to do so.  Whether this is enhanced or damaged by patenting is a complex issue that probably depends on a case-by-case analysis.

What we can be assured of is an increasingly complex patent scene in stem cells as time goes on.  The electronics industry has to some extent solved a similar problem (though without the ethical overtones involved in biological patenting) by evolving various concepts of open invention, a greater willingness among companies to ‘compete and collaborate’ and to ‘trade’ patent rights.  Some version of this may evolve in the world stem cells, but only time will tell.