The Claim Game

In 2011, the case Mayo v. Prometheus was argued in front of the Supreme Court. The case concerned patented diagnostic technology that assessed the appropriate dosage of drug treatments for various gastrointestinal diseases such as Crohn's disease.

Prometheus laboratories sued Mayo Clinic, when Mayo attempted to use its own test, claiming patent infringement. A federal judge invalidated Prometheus Laboratories' patents on the grounds that patents cannot claim a body's reaction to drugs. This lower court decision was appealed toe the U.S. Court of Appeals of the Federal Circuit, which overturned the decision. This appellate decision was then appealed to the Supreme Court.

Sources:
(1) https://www.oyez.org/cases/2011/10-1150
(2) http://en.citizendaily.net/wp-content/uploads/2015/02/drugs.jpg
(3) http://www.ipwatchdog.com/2012/03/20/supreme-court-mayo-v-prometheus/id=22920/

Diamond v. Chakrabarty is a landmark Supreme Court decision in regards to life science patents. In 1971, microbiologist Ananda Chakrabarty genetically engineered Pseudomonas bacteria to metabolize oil by using plasmids to transform bacteria with genes necessary for oil metabolism. Though before his work, oil metabolizing bacteria existed, Chakrabarty discovered a genetic crosslinking method that significantly improved upon the metabolism of oil by two orders of magnitude. Chakrabarty's genetically engineered bacteria could metabolize roughly 66% of the hydrocarbons in an average oil spill. 



Chakrabarty applied for a utility patent on his genetically modified microorganisms, but was denied intellectual property rights on the grounds that U.S. patent law precludes living organisms. Chakrabarty appealed this decision and the U.S. Court of Customs and Patent Appeals overturned the decision, granting Chakrabarty patent rights. This appeals decision was then appealed by the Commissioner of Patents and Trademarks, Sydney Diamond, reaching the Supreme Court in 1980. 

The legal question at hand would set landmark precedent for biotechnology patents: 

Does Section 101 of Title 35 of the United States Code include living organisms as patentable subject matter?

In a 5-4 decision, the court decided that yes, living organisms can be patented under U.S. patent law, affirming the decision of the U.S. Court of Customs and Patent Appeals, and granting Chakrabarty patent rights. The court detailed that though the discovery of naturally occurring phenomena and substances is not patentable, the creation of modified, non-naturally occurring substances is indeed eligible. 

This is an interesting decision in that it points towards the limits of patent law in that the law does not necessarily foresee significant fields of innovation. That said, case law alone may not be sufficient for optimal patent law in biotechnology and pharmaceuticals. There are many challenges unique to innovation in the life sciences, one of them being regulatory hurdles and costs such as clinical trials. This provokes a couple of questions - should the law be tailored towards industry? How can we make make patent law more adaptable to the dynamic nature of innovation and ensure that it continues to facilitate innovation despite being blind to future developments?

Sources:
https://www.oyez.org/cases/1979/79-136
http://davidhuerta.typepad.com/.a/6a01347ff0d110970c0168e508841b970c-500wi

Patenting has shifted from purely and industry practice to one that has become adopted by universities. This comes at no surprise with the passage of the Bayh-Dole Act of 1980 (which allows universities to claim ownership of inventions) as well as the emergence and growth of start-ups, incubators, and university technology transfer offices. However, ownership rights regarding university research can get tricky. There are often various sources of funding that drives university research - from government funding to funding by the private sector. With these multiple stakeholders involved, once an invention is invented, who should receive the intellectual property rights of the invention.

Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (Stanford v. Roche) is a Supreme Court case situated in the realm of university licensing and patents. Stanford v. Roche presents the question as to whether patent rights over inventions that result from federally funded research must be awarded to the university at which inventors work at.



This case emerged over a licensing dispute between Stanford University and the pharmaceutical company Roche regarding the patent on Roche's HIV testing kits. The HIV testing kits at hand were developed by Mark Holodniy, a professor at Stanford School of Medicine who had signed a collaborative research contract with Cetus Corp, a company later acquired by Roche. Stanford sued Roche in an attempt to claim intellectual property rights over the HIV testing kit technology.



In 2009, the U.S. Court of Appeals decided this case in favor of Roche, on the grounds that Stanford had no standing to claim patent infringement. In 2011, the Supreme Court decided in favor of Roche in a 7-2 decision. The court argued that

"The Bayh-Dole Act does not automatically vest title to federally funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions" (1).

I personally find this case interesting because there is a lot of research going on at universities that results in inventions, and this research is sometimes funded by the private sector. The decision in Stanford v. Roche shows that as a researcher at a university, the technology transfer may not be a smooth, clear process.

Sources:
(1) https://www.oyez.org/cases/2010/09-1159
(2) http://www.ipwatchdog.com/2011/06/06/supreme-court-affirms-cafc-in-stanford-v-roche-on-bayh-dole/id=17594/
(3) http://static01.nyt.com/images/2011/06/07/business/07bizcourt-inline/07bizcourt-inline-popup.jpg
(4) http://www.ipeg.com/wp-content/uploads/2010/11/University-professor_19287067_M1.jpg

One of the more recent, significant patent litigation cases within biotechnology is the Association for Molecular Pathology v. Myriad Genetics decided by the Supreme Court in 2013.

In this case, the Association for Molecular Pathology challenged Myriad Genetics for its patents relating to BRCA1 and BRCA2 genes and particular mutations in these genes that are strongly associated with the development of breast cancer. As noted by the majority opinion in this case,

"the average American woman has a 12- to 12-percent risk of developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer (2)."

The specific patents in question regard mutation diagnostic methods that allowed Myriad to exclusively control diagnostic testing and scientific research on the BRCA genes. Myriad received these patents based on its research

The plaintiff, the Association for Molecular Pathology, argued that the patents on the BRCA1/2 genes are patents on products of nature. Since Section 101 of Title 35 of the United States Code defines patentable subject matter as

"any new and useful process, machine, manufacture, or compositions of matter, or any new and useful improvement thereof"

if the genes claimed are merely products of nature, they are not patent eligible. Therefore, the plaintiffs claimed that Myriad Genetics' patents are invalid based on Section 101. Myriad's defense is based on the argument that its patents are valid because once a gene is isolated, it is distinguishable from other genes.

Additionally, the plaintiffs noted that Myriad's exclusivity in regards to BRCA research is an impediment to further scientific research.


This case originated at the district court, which ruled in favor of the Association for Molecular Pathology, invalidating Myriad Genetics BRCA patents. Myriad appealed this case to the U.S. Court of Appeals for the Federal Circuit. The appeal court reversed the district court decision and held Myriad's patents valid on the grounds that isolated genes are chemically and structurally distinct from genes in the body. The Association for Molecular Pathology appealed this decision to the U.S. Supreme Court where in a unanimous 9-0 decision, SCOTUS decided that naturally occurring gene sequences are not patent eligible, however gene sequences that are not occurring in nature are indeed patent eligible. This decision reverses in part and affirms in part the decision of the appeals court.

To understand the two-fold implications of this Supreme Court decision, some molecular biology background is required. Genes are sequences of DNA. This case sets the precedent that naturally occurring sequences of DNA cannot be patented because they are products of nature, and merely isolation does not, on its own, make these sequences of DNA patent eligible. However, there are sequences of DNA that are not occurring naturally in nature. The prime example of these sequences include cDNA. cDNA is DNA that is made in laboratory settings, excluding introns - noncoding regions of DNA.


Therefore, this decision sets precedent for gene patents in that naturally occurring sequences cannot be patented, however cDNA can be patented.

Sources:
(1) https://www.ocf.berkeley.edu/~edy/genomics/cdna.jpg
(2) https://www.oyez.org/cases/2012/12-398 
(3) http://i2.cdn.turner.com/cnnnext/dam/assets/130523190137-sulik-myriad-genetics-protest-horizontal-large-gallery.jpg