SCOTUS Decides on the Patentability of Genes

BY: ROSANGELY FRICK

According to the National Cancer Institute, in 2013, approximately 234,580 new cases of breast cancer will be diagnosed and 40,030 deaths will occur.[1. National Cancer Institute, The Genetics of Breast and Ovarian Cancer, (Last modified Mar. 03, 2013) http://www.cancer.gov/cancertopics/pdq/genetics/breast-and-ovarian/HealthProfessional/page1.]  In the midst of the staggering statistics, in April, The Supreme Court held arguments on whether genes (in this case, cancer causing genes) are patentable.[2. Adam Liptak, Justices Seem Wary of Bold Action in Gene Patent Case, NYTimes, (Apr. 15, 2013) http://www.nytimes.com/2013/04/16/business/justices-tackle-the-patenting-of-human-genes.html?_r=0.]  The Court’s decision could be a game changer for breast cancer research and detection.  Currently, Myriad Genetics (“Myriad”) owns the patents to genes that have been associated with increased risk of developing breast cancer.[3. Timothy Todd, Patenting the Fingerprint of God: How Gene Patents Violate the Products of Nature Doctrine, 5 Liberty U.L. Rev. 77, 78 (2010).] As such, it has in essence “monopolized” breast cancer research and restricted access to medical tests outside of its expensive laboratories.[4. Id. at 78.]  However, the countervailing interest in allowing genes to be patentable, at least according to Justice Scalia, is that removing the profit motive for companies will cause a chilling effect on research development.[5. Liptak, supra, note 2.]

Notwithstanding the policy arguments, the legal standard for patentability requires that the product or process in question have utility, be novel and non-obvious to a person having ordinary skill in the art or technical skill.[6. See 35 U.S.C. §112 (2006).]  The patent then grants the holder the right to preclude others from using the invention for a period of time.[7. Todd, supra, note 3 at 78.]  Customarily, only inventions or innovations were eligible for patents rather than the discovery of naturally occurring products such as DNA and bacteria.[8. Michael Specter, Can We Patent Life? The New Yorker, (Apr. 25, 2013), http://www.newyorker.com/online/blogs/elements/2013/04/myriad-genetics-patent-genes.html.]  However, in 1873 the first patent was issued for a naturally occurring substance when Louis Pasteur discovered that germs contaminated the yeast used to ferment beer.[9. Joseph Michelotti, Genes as Intellectual Property, 11 Mich. St. U.J. Med. & L. 71, 74 (2007).]  Since then, more than four thousand genes, covering approximately twenty percent of the human genome have been patented.[10. Specter, supra, note 8.] The genes patented include those associated with Alzheimer’s disease, colon cancer, asthma, and even the DNA that is altered to produce insulin to treat diabetes.[11. Id.]  The underlying rationale for allowing these genes to be patentable is the process of purifying and isolating the genes from their natural state.[12. Id.]  The problem is that the patent gives the owner broad rights to “exclude everyone from observing, characterizing or analyzing, by any means whatsoever, the product of Nature”.[13. See Specter, supra, note 8.]

Recently, the patentability of naturally occurring products and processes has come under higher judicial scrutiny.  In 2012 when The Supreme Court ruled that a patent held by Mayo Collaborative Services was invalid.[14. Mayo Collaborative Services v. Prometheus Labs., Inc., 130 S. Ct. 3543 (2012).] The patent concerned a method of specifying drug dosage to treat Chrohn’s disease.[15. Goldie Blumenstyk, Supreme Court Ruling Throws Doubt Over Countless Life-Sciences Patents, The Chronicle (Mar. 21, 2012) http://chronicle.com/article/Supreme-Court-Ruling-Throws/131264/.]  In the opinion, the Court explained that claims merely describing a naturally occurring phenomenon are not going to be patent eligible.[16. Id.]

In Myriad’s case, Justices have already echoed similar critiques in the oral arguments that took place on April 15th.  Justice Sotomayor and Chief Justice Roberts expressed misgivings about giving patent protection to the process of simply “snipping” gene sequences.[17. Association for Molecular Pathology, et. al., v. Myriad Genetics Inc., et al, No. 12-398 (Apr. 15, 2013).]  Concerns centered on whether the process of isolating a gene was sufficiently non-obvious to warrant patent protection.[18. Id.]  Justice Roberts analogized the process of snipping genes to trying to patent cutting a branch from a tree.[19. Id.]  Merely deciding where to cut the branches on the tree is not an innovation worthy of a patent.  However, cutting a branch from a tree and then improving on that branch enough to make baseball bat, would be patent eligible.  Similarly, deciding where to cut the genes in order to isolate them for research, might not be innovative or non obvious to merit patent protection.

Whether The Court affirms the patents held by Myriad or rules against the patentability of genes, the effect of the decision could have a sweeping impact in the field.  Ruling in favor of Myriad could hinder necessary research to be undertaken by other scientists while stripping Myriad of the patents, could slow down research as companies might be less willing to invest in a non-profitable endeavor.

Leave a Reply

Your email address will not be published.