Human Gene Patenting, White Paper

This is a Policy White Paper I wrote on a topic of my choice, assigned for my sociocultural genetics course at PSU.  Thought it was interesting enough to share here.  Enjoy if you're into this sort of thing.

Human Gene Patenting

1. Introduction / Background

            The debate over gene patenting questions whether genes can be owned and how best to encourage innovation in this relatively new field.  This debate has grown especially contentious over the last year due to a few high-profile court cases, most notably against biotech companies Myriad Genetics Inc. and Monsanto Inc. (1). Since patent scope is determined not by the United States Patent & Trademark Office (USPTO) but instead by the judicial branch (5), these cases have been closely watched by the biotechnology industry, researchers, and the public for who will have access to which resources: private industry, the public, and/or scientific researchers.

2. Abstract / Business Case

            Gene patenting has become the focus of societal discourse over the developing biotechnology industry. Biotechnology promises treatments for many common genetic maladies, as well as potential enhancement of common genetic traits (2). This paper will explore some of the economic and ethical problems with gene patents and attempt to provide a solution that will best encourage innovation in the future. Arguments for and against gene patenting will be explored. Approaches attempted by foreign nations will be presented, as will a solution for the current debate in the United States.

3. Problem Statement / Introduction

            Gene patenting problems center on ethics and access to resources. Primarily, it is questionable that genes should be patented in the first place.  There has been much debate in the United States ever since the 1980 Supreme Court decision, Diamond v. Chakrabarty (3).  This landmark case stated that is was legal to patent “genetically modified organisms” (4). However, this has lead to the patenting of genes and gene fragments, based on the legal argument that genes are modified if isolated from the human body. There is no longer a clear distinction between naturally occurring and scientifically isolated, as articulated by the recent Myriad case.  Seven patents held by Myriad were invalidated on the basis that they involved laws of nature (3). To further confuse matters, USPTO uses suspect language in qualifying gene patents, such as “Step 1: Identify novel genetic sequence.”(4) If the sequence were truly new then it should be considered synthetic, and not something found naturally as a part of the human genome.

Private biotechnology industries such as Myriad and Monsanto argue gene patents retain exclusivity to their genetic product. For example, Myriad owns gene patents used to predict if women have an increased risk of developing breast and ovarian cancer. These industries say patents ensure profitability, and thus, attract initial capitol investment necessary for research and development (3).  However, attracting initial investment is a risk with any emerging industry, and the large initial research and development necessary to many biotechnology products and services, does not make the problem unique. The biotechnology industry claims that consumer demand may not answer industry investment, and therefore must be protected by exclusivity. Today, after thirty years of development, there is clearly no shortage of demand for the services of genetic testing and treatment. The exclusivity of these industries is being challenged by public interest for better and cheaper access to the technology, so there is clearly demand for the product.  Private interests argue that without the guarantee of the protection of such a patent, investors would not fuel future innovation. “The competition among researchers to find diagnostic mutations for cystic fibrosis and other common diseases flourishes, even though no company has exclusivity.” (2) Most scientific research is also funded publicly in the United States.  It is up to industry to compete in the free market; neither exclusivity, nor economic success can be guaranteed in a capitalist society.

            Public interest organizations, such as the American Civil Liberties Union (ACLU), are the largest opponent of gene patents, and also argue against inhibiting innovation.  They argue that the ability to patent genes keeps prices exorbitant and prevents free market competition of obtaining a second opinion on a person’s genetic test results (1).  In addition, patents on genes and patents on gene fragments impede future scientific discovery.  Gene fragments include expressed sequence tags (ESTs) and single nucleotide polymorphisms (SNPs). “Diagnostic laboratories are moving away from a dependence on individual gene patenting and towards multiple-genome analyses, with prominent articles (published as early as March, 2010) reporting that: ‘when hundreds or thousands of genes are being tested at once, patents on each individual gene can become a hindrance to innovation rather than a spur’” (2) Royalties on such “patent stacking” creates multiple barriers to free access to knowledge and therefore become costs that are likely passed on to consumers.  Advocacy organizations claim that private biotechnology firms who own certain sets of patents can effectively monopolize certain gene test markets, which then stifles innovation.  

4. Proposed Solution

4.1 Introduction of Solution   

            There are many different solutions to these complex and historically unique problems.  Many countries have addressed these issues in different ways.  The United States is unique in its “Patent first, ask questions later” approach (5).  Notably, both the European Union and Australia have also seen a recent resurgence of this political and ethical debate (2).  Thanks to peer countries examples of how this problem could be approached, there is a wealth of solutions.

4.2.a One solution is to simply maintain the status quo.

4.2.b Especially in today’s complex and quickly changing economy, many ethical and technological problems presented by other new technologies have been solved or become moot by the snowball effect of further development. However, like many arguments by industry that attempt to maintain the exclusivity of the status quo, there is little research to support the idea that gene patents actually promote innovation more than without patents (5).  Limiting patents might even increase competition and innovation. For example, a company cannot patent bottled water, but this remains a lucrative and competitive market.

4.3.a Another option would be to simply ban all gene patents on the basis of being naturally occurring.

4.3.b However, this too is inadvisable, since such a change would upset a 30-year precedent, and thereby set back the development of the biotechnology field (2).  With the accelerating pace of technological development and so much promise on the horizon, it is unlikely that banning all gene patents would put a complete end to the biotechnology industry.

4.4.a The third solution recommended is patenting only processes and not genes themselves to solve both of the ethical and economic problems.

4.4.b There are two core arguments against gene patenting: one economic and one ethical. The infringement of innovation (primarily due to cost, but also to institutional knowledge) is argued on both sides of the patent issue.  Gene patenting is also argued against because of its attempt to patent the natural world. Patenting only the process of gene isolation and manipulation, as has been proposed in Australia and the European Union (2), will continue to encourage the development of multiple approaches to the same gene, and not an exclusive monopoly to that one natural element. Some care would have to be considered so that this policy does not run rampant, thereby patenting common scientific practices.  The “non-obviousness” clause of USPTO patenting standards would continue to protect basic scientific processes from over-patenting as industry “trade secrets.” This clause states that patents should only be issued to “non-obvious” inventions that are “not an improvement easily made by someone trained in the relevant area” (4).

5. Results / Conclusion

            Since the sequencing of the human genome in 2003, genetic testing and treatment has become more widespread around the world. As with any burgeoning field, innovation is to be encouraged to promote growth and economic prosperity as well as population health and freedom from genetic disease.  Innovation requires a complex cooperation of research and industry. Problems of innovation and ethics have centered on gene patents, and the ability of private industry to own genes and gene fragments.  Private interests hold that patents spur innovation by encouraging investment in research and development, while others maintain that the patents inhibit progress, by creating unnecessary barriers to existing scientific knowledge.  At the core of the debate, a new area of policy consideration has developed: as technological capacity increases, the lines between natural and synthetic biological processes become blurred.

Patenting of scientific processes such as isolation, identification, and modification instead of patenting of natural genetic material would solve these problems.  Patenting processes instead of genes would eliminate the need for excessive bureaucratic oversight of patent enforcement and royalty extortion currently propagated by the exclusivity granted by gene patents.  Both oversight and royalties have been charged with inhibiting innovation. If only processes were patented, innovation could proceed to develop new methods for isolation and identification without fear of infringement.  In addition, patenting only processes would effectively end the debate of whether or not gene patents are actually patents on naturally occurring elements.

6. Bibliography

1. American Civil Liberties Union. (2011, December 07). ACLU Asks Supreme Court to Hear Gene Patents Case. Retrieved from http://www.aclu.org/blog/free-speech-womens-rights/aclu-asks-supreme-court-hear-gene-patents-case
2. Goh, R. (2010, February 24). Gene Patenting: Information on Gene Patenting. Retrieved from http://genepatents.info/
3. Schwartz, J., & Pollack, A. (2010, March 29). Judge invalidates human gene patent. New York Times. Retrieved from http://www.nytimes.com/2010/03/30/business/30gene.html?scp=1&sq=judge sweet myriad gene&st=cse
4. U.S. Department of Energy. (2010, July 07). Genetics and Patenting. Retrieved from http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml
5. Yu, P. (2007). Intellectual property and information wealth: Issues and practices in the digital age. (Vol. 2). Westport, CT: Praeger Publishers. Retrieved from http://books.google.com/books?id=z_tYraycQRAC&pg=PA239&lpg=PA239&dq=do patents necessarily lead to wealth&source=bl&ots=5Pfb_NTAqu&sig=Q7SffqU1ERCHkYgQOReqQTNFDU4&hl=en&sa=X&ei=ung9T5zlOsfq2AWnz9GQCA&ved=0CCIQ6AEwAA

Lent

It's sunny in Portland today.  Which means that people are walking around looking at the ground because they can't see with all of the brightest around that they're not used to.

I'm not Catholic but I've always liked the idea of Lent.  Mary Helen says that it is about giving something up so that you can then be free to go after something you want.  It sounds to me like a more realistic version of New Year's Resolutions: there's a trial period, if it doesn't work out, you can always come back to what you gave up at the end of the 40 days, and there is a fundamental understanding that to get something, you've got to give something up in return.

In thinking about and preparing to apply to med schools this spring, I'm thinking a lot about what I want.  It's simultaneously humbling, daunting, and empowering to realize that, where I am right now, the only thing standing in between me and getting into A medical school, even not the one of my dreams, is me.  If I buckle down and do everything that I know needs to be done and I throw myself into it, there is no way that I will fail.

Yesterday during Fat Tuesday I got a slap-in-the-face reminder of that when I got a lower grade on a paper than I wanted.  But during Fat Tuesday the world is supposed to be turned upside down, to remind us which way is up and why we want to keep it that way normally.  That's why I'm giving up video games for Lent this year.  So I can go after what I want, and not stand in my way.

Whistle While You Work

ben's rules of making drudgery bearable:

1. work 45, take 5-15.  Personally I can only go through three hours of this before I need at least a 15 minute, if not 30 minute break, or switching subjects/projects.  hold yourself to this.  ONLY reward yourself with a 5-15 min break if you stayed focused and on task the whole 45.

2. breaks should not involve the same medium as the work: if the 45 was working outside, go inside, and vice versa.  if the 45 was spent looking at a computer, sitting in a chair, get up and walk around, and go look at something that's not on a computer screen for your break.

3. as often as possible, make it a game: if i can get X done in this 45, let's see if i can get Y done in this 45. if i can get X done in this 45 I'll buy myself a pastry with my coffee, if not, only the coffee

4. STOP at the 45!  this can be hard, because maybe you're right in the middle of something, but stopping when you're supposed to (within reason), will keep you in a better mood, and better organized.

5. As often as you can, eliminate distractions and listen to music that helps you concentrate (unless this is a contradiction for you).  either way, figure out what works best for you and stick to it.