On June 13th, the US Supreme Court took a historic decision on intellectual property. DNA is a product of nature and is not legally eligible for patenting. This order puts an end to an intense trial against the biotechnology company Myriad Genetics. Several of their patents on genes involved in breast cancer were contested. Maurice Cassier, a sociologist at the CNRS (French National Center for Scientific Research) and specialist of the relationship between intellectual property and innovation in health fields, helps us grasp the true scope of this decision.
This article is a translation of “Brevetage de l’ADN interdit aux Etats-Unis : « La fin d’un cycle »” by Timothée Froelich.
What does the US Supreme Court’s decision on DNA patenting imply?
This order resets the criteria of patentability. It states clearly that genes remain in the public domain as long as they have not been modified. Only synthesized genes are eligible for patenting. The Supreme Court’s decision has thoroughly investigated Myriad Genetics’ patents and demonstrated that the company uses the language of discovery and not of invention.
The biotechnological landscape has experienced an outbreak of patent filing since the 1990’s, particularly in the field of genetics. It is used as a bargaining chip to raise capital. It is a very specific economy to which universities and startups contribute by encouraging researchers to patent their results. This decision marks the end of an era.
What are the stakes of this order?
The issues concern especially research and the medical field. One of the biggest difficulties in genetics is to give a medical meaning to a genetic variation or to a mutation. To make progress in research and verify their conclusions, scientists need to work in a consortium. This system is seriously hindered by the process of patent filing. In this regard, the decision of the Supreme Court encourages exchange and open access to the data concerning Nature. Furthermore, the pressure to patent results, exerted by universities and startups, generates great distrust among some researchers in biotechnology. This can sometimes lead to withholding information.
The Genae Girard case against Myriad Genetics _ Sources: MyScienceWork
In addition, industry forbids the medical field to carry out certain kinds of genetic testing. The isolation and the interpretation of genes for therapeutic purposes would be like counterfeiting the industry’s patents. This situation pushed the medical community to pursue the trial against Myriad Genetics.
What about Europe?
The European Patent Office (EPO) stands in contradiction to the decision of the US Supreme Court. In 1988, a first version of the Directive of the European Parliament on the patentability of biotechnological inventions had authorized the patenting of genes. It was then postponed and reconsidered under the pressure of industry and patient associations. Today, two of its articles seem to be in total contradiction. One forbids gene patenting, whereas the other authorizes it. The US Supreme Court’s decision is likely to accelerate the revision of this directive.
Will this decision extend to living things in general?
Obviously, saying that an isolated gene cannot be eligible for patenting does not only apply to human genes. The important issue here is to revisit the whole American doctrine concerning the patenting of living things. For now, it cannot be said how influential this decision will be for intellectual property as a whole. The evolution will happen gradually. In any case, this decision will certainly bring greater attention to filing patents related to life.
To find out more:
The opposition against Myraiad Genetics patenting and their total or partial revocation in Europe: first lessons, Maurice Cassier and Dominique Stoppa-Lyonnet, M/S : médecine sciences, Volume 21, issue 6-7, June-July 2005, p. 658-662 [Available on MyScienceWork in French]
Patent Law: How Patents Grew Over Time to Include Living Organisms, Joe Miller, Cooking up a story
Placard “end patents of life forms”: http://www.flickr.com/photos/kgnixer/7227341916/