Position statement on Gene Patenting

The ICSU position on Gene Patenting has been up-dated in the light of scientific and legal developments.

ICSU Statement on Gene Patenting (September 2011)

This statement was updated and approved by the ICSU Executive Board in September 2011. It replaces the version of June 2002.

In light of significant recent developments in science and law (see below), ICSU specifies its position on gene patenting as follows:

  1. Efforts to patent genetic information should not jeopardise either progress in the basic science or access to the information which is necessary for such progress to continue (ICSU Statement, 1992);
  2. ICSU opposes attempts to patent complementary DNA (cDNA) sequences corresponding to portions of unknown messenger RNAs (mRNA) by stimulating important investments and developments;
  3. ICSU urges the relevant authorities to take due account of the possible implications (for science and society) when considering (gene patenting) applications and to ensure a strict application of long-established patenting principles (ICSU, 2002).

In 2000, relevant agencies in Europe and the USA revised their positions on gene patenting:

Over the past decade, the principle laid out in the EC directive has been broadly interpreted and applied, and a fifth of human genes now have patents granted or pending. While beneficial in securing investment for product development, the ruling has been criticised on the grounds of being anticompetitive (since a gene cannot be re-invented) and of being illogical (since the information content of a gene is identical whether it is inside or outside the human body). Practical concerns are that monopolistic pricing can disproportionately restrict access to benefits, and that the proliferation of human gene patents will create a ‘thicket’ that inhibits development of multi-factorial genetic testing.[ii]

Recent events in US law-courts and developments in science are now raising serious questions about this principle and its interpretation by patent granting agencies:

As the science of genetics continues to develop, opening up new and exciting opportunities for commercial development and medicine, it is important that the lessons of the last decade are taken on board. An optimal balance needs to be maintained between the use of patents to protect and encourage genuine invention and the value of genetic information being openly available such that it can be widely exploited in research and innovation for the benefit of humanity as a whole.[vi]


OJ L213/13, 30 July 1998; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:213:0013:0021:EN:PDF


Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests: Report of the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS, NIH, Bethesda, MD, April 2010); http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS_patents_report_2010.pdf.


Association for Molecular Pathology v. U.S. Patent and Trademark Office, Southern District of New York (29 March 2010); http://www.aclu.org/files/assets/2010-3-29-AMPvUSPTO-Opinion.pdf


This followed a variety of court challenges around the world to gene patents, particularly those of Myriad.


Brief for the United States as Amicus Curiae in Support of Neither Party submitted to the U.S. Court of Appeals for the Federal Circuit, re (1) (29 October 2010); http://patentdocs.typepad.com/files/croplife-international-amicus-brief.pdf.


Venice Statement on the Right to Enjoy the Benefits of Scientific Progress and its Applications, Venice, Italy, 17 July 2009, http://unesdoc.unesco.org/images/0018/001855/185558e.pdf.

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