In the case briefs of Myriad Genetics vs Associated Molecular Pathology, amongst the several moving stories of victims of gene patents, contained the story of Abigail, a 10-year-old with a long QT syndrome, a serious heart condition that, if left untreated, could result in sudden death. A company in this case had obtained patent on two genes associated with this condition and developed a test to diagnose the syndrome. But then they went bankrupt and never offered such tests. Another lab tried to offer the test to Abigail, but the previous company which held the patent to such diagnosis threatened to sue the lab for patent infringement. So as a result, for 2 years, no test was available. During that time, Abigail died of undiagnosed long QT.

In 1790, the US Government started issuing patents under Patents Act 1790, with the motive of “Encouraging Arts and Sciences”. These intellectual property rights slowly became the biggest statutory safeguards of research and investment in a democracy. Edible business cards, nicotine infused coffee, a rock-paper-scissors card game for people too lazy to use their hands and finally thong diapers which make up the list of some rather amusing patents the USPTO has issued to protect intellectual property.

In initial days, this IPR regime was under huge criticism from ethical and moral firewalls which questioned how the right of commercial exploitation of resources can be rested at the hands of a selected few [link found here]. But the intensification of competition in industries (especially the biotechnological industry in this case) called for some sort of incentive creation for investment in research which came in the form of patents.

SCIENTIFIC DIFFERENTIATION OF FORMS OF DNA IN QUESTION 

Genes as we have pointed out before are units of heredity. A gene is a segment of DNA that codes for a specific protein or set of proteins. In this article, we will talk about legal framework of gene patenting with respect to the following three forms DNA in its natural cellular environment, isolated genomic DNA, modified synthetic cDNA. Scientists have discovered methods of extracting DNA from its natural cellular environment which is later used for purpose of diagnosis through gene sequencing. This isolated genomic DNA is sometimes modified by splicing and removing the non-coding introns to make a DNA made of only exons. This kind of modified DNA is called cDNA and the same is used to express particular proteins by scientists in human body. The difference between isolated genomic DNA and cDNA is that there is human modification involved in the later while there is none in the earlier [link here].

HISTORY – CASE LAWS SURROUNDING GENE PATENTING IN USA

The landmark decision of Diamond vs Chakrabarty in 1980- opened the floodgates for patenting of microorganisms where the judge ruled that human-made living matter is
. Anything under the sun made by man was considered to be patent worthy as long as they were not discoveries or manifestations of nature. The court clarified the threshold required for obtaining a patent as: “relevant distinction was not between living and inanimate things but between products of nature, whether living or not, and human-made inventions.”

“Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity. Such discoveries are “manifestations of . . . nature, free to all men and reserved exclusively to none.”

 

The United States Patents and Trademarks Office though seemed to have paid little attention to the limitations under the patent regime which in no way allowed patents to products of nature. The Patents Office undertook an expansive interpretation of law and went on to grant patents to a number of “engineered DNA molecules”. It handed patents for isolated DNA on the ground that since these molecules had been secluded from their natural cellular environment they were no longer “products of nature”.

This standing USPTO practice was challenged for the first time in a 2009 case against the grant of patents to Myriad Genetics. Myriad Genetics had after extensive investment and research discovered locations of BRCA 1 and BRCA 2 genes on the human chromosome which was landmark in the medical science. Mutation of BRCA 1 and BRCA 2 genes could lead to breast and ovarian cancer in women (it increases the chances of contracting breast cancer by 50-80% and ovarian cancer by 20-50% approximately according to case reports of Myriad Genetics vs. AMU). Though the scientific community was aware of threat of cancer from heredity, they were clueless as to the exact location of the BRCA 1 and BRCA 2 genes on the human chromosome. USPTO gave Myriad Genetics the exclusive rights to isolate these genes and carry diagnostic tests. The problem started when Myriad tried to enforce these patent rights against organisations which tried to test such gene mutation since they had an exclusive right over the isolation process which is an essential step in any diagnostic testing.

The case of Association of Molecular Pathologies vs. Myriad Genetics can be contextualised as a case of civil rights versus intellectual property rights. The company’s patents on BRCA 1 and BRCA 2 genes were ruled invalid on March 29, 2010 by Judge Robert W. Sweet in a U.S. District Court. On an appeal, the Court of Appeals for the Federal Circuit reversed the trial court judgment on July 29, 2011 and held that the genes were eligible for patents.

On December 7, 2011, the ACLU (fighting the case on behalf of petitioners) filed a petition for a writ of certiorari to the Supreme Court. On March 26, 2012, the Supreme Court vacated the Federal Circuit’s judgment and remanded the case for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc. in which the Supreme Court had ruled, just six days earlier, that more restrictive rules were required to patent observations about natural phenomena.

Myriad Genetics vs. AMP

“Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but ground-breaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”