Background

Thousands of patent applications have been filed with the United States Patent and Trademark Office for human genetic material.¹ A human gene consists of hundreds or thousands of combinations of the chemical building blocks adenine (A), cytosine (C), guanine (G), and thymine (T). A gene is represented by a series of these letters. For example, one segment of the hemoglobin gene is made up of CCTGAGG. A mutation in a gene can be likened to typos in the spelling of that gene. Mutations in a gene can be harmless but many lead to disease. For example, a single switch of the letter A to T in the hemoglobin gene causes sickle cell anemia.

Learning the chemical makeup of a gene is important because research can then be undertaken to determine which mutations in the gene cause disease. Subsequent research can then lead to gene therapy to correct the mutation or to the development of a technique to produce the protein created by the gene in a laboratory to provide a pharmacological cure for the genetic disease.

Patents covering human genetic material are controversial due to a variety of issues, including their relatively recent arrival into the patent realm, their grant of exclusivity over naturally-occurring sequences of human genes, and their effect on research and diagnosis. Ultimately, these issues reflect both legal factors, dealing directly with the application of patent laws, and policy factors, implicating problems of access, cost, and quality in both the patient realm and the research setting. Because many gene patents either directly claim or include genes and/or the corresponding proteins that are essential to genetic diagnosis, a grant of exclusivity may hinder both health care and the advancement of scientific technology.²

Gene patents are under siege worldwide because they grant to their holders certain exclusive rights over specific sequences of human genes for twenty years from the date of filing the application. ³Gene patents are being challenged in courtrooms,⁴ legislatures, ⁵ and in the arena of public opinion. Numerous international organizations, such as the Council of Europe's Committee on Legal Affairs and Human Rights and UNESCO, view genes as belonging to the common heritage of mankind.⁶ Intense opposition to gene patents is also coming from researchers,⁷ politicians,⁸ organized religions,⁹ indigenous groups,¹⁰ patient groups,¹¹ and medical professional organizations.¹² Patents covering human genetic material raise a variety of issues related to legal appropriateness, scientific and medical research, and access to health care, as well as issues regarding privacy, autonomy, religious freedom, and reproductive liberty.

In May 2004, the European Patent Office dealt a serious blow to gene patents by revoking Myriad Genetics' controversial patent for genetic mutations that predispose certain women to breast cancer.¹³ This patent, entitled Method for diagnosing a predisposition for breast and ovarian cancer , was issued January 10, 2001 and covered any methods of diagnosing a predisposition for breast and/or ovarian cancer utilizing the BRCA1 gene sequence.¹⁴ The revocation was made by the Opposition Division, a panel of three patent examiners and one legal expert, applying current law as set forth in the European Patent Convention.¹⁵

¹ Human International Genome Sequencing Consortium, Initial Sequencing and Analysis of the Human Genome, 409 Nature 860-921 (2001); J. Craig Venter et al., The Sequence of the Human Genome, 291 Sci 1304-1351 (2001).
² For a discussion on the negative impact of gene patents on biotechnology and research, see Michael A. Heller & Rebecca S. Eisenberg , Can Patents Deter Innovation?: The Anticommons In Biomedical Research, 280 Sci 698-701 (1998).
³ 35 U.S.C. § 154 (2002)
⁴ See Greenberg v. Miami Children's Hospital, 264 F.Supp.2d 1064 (S.D. Fla. 2003).
⁵ See "Genome Research and Diagnostic Accessibility Act of 2002," 107 th Cong. (2002).
⁶ "Council of Europe Says No to Patenting Genes," 401 Nature 420, 420 (1999); UNESCO General Conference, "Universal Declaration on the Human Genome and Human Rights," November 11, 1997.
⁷ Declan Butler & Sally Goodman, "French Researchers Take a Stand against the Cancer Gene Patent," 413 Nature 95, 95 (2001).
⁸ Paul Willcocks, "Canadian Premiers Wade Into Gene Patenting Debate," Reuters, Aug. 3, 2001.
⁹ Fred B. Charatan, "U.S. Religious Groups Oppose Gene Patents," 310 B.M.J. 1351, 1351 (1995); See also Southern Baptist Convention, "Resolution on the Patenting of Animal and Human Genes," June 1995, available at www.sbc.net.resolutions/amResolution.asp?ID=570, last visited July 23, 2004.
¹⁰ Debra Harry, "Letter to Commissioner of Patents and Trademarks, Indigenous Peoples Council on Biocolonialism," Comment 39 ( Mar. 21, 2000 ).
¹¹ Greenberg v. Miami Children's Hospital, 264 F. Supp. 2d 1064 (S.D. Fla. 2003).
¹² Association for Molecular Pathology, Clinical Practice Committee, "AMP Position on Patenting of Genetic Tests," November 22, 1999, available at http://www.ampweb.org/PRC/prc-tests.htm, last visited July 16, 2004.
¹³ European Patent Office Press Release, "'Myriad/Breast Cancer' Patent Revoked after Public Hearing," May 18, 2004, at http://www.european-patent-office.org/news/pressrel/2004_05_18_e.htm, last visited July 16, 2004. This type of legal challenge is called an "opposition" to a granted patent under European patent law and allows third parties to challenge the validity within nine months from the grant of the patent. See European Patent Convention, Article 99 (1998), available at http://www.european-patent-office.org/legal/epc/, last visited June 22, 2004.
¹⁴ European Patent Office Press Release, "Public Opposition Hearing on 'Myriad/Breast Cancer' Patent at the European Patent Office (17-19 May)," May 12, 2004 , available at http://www.european-patent-office.org/news/pressrel/2004_05_13_e.htm, last visited July 16, 2004.
¹⁵ Id. The European Patent Office has yet to publish an official statement on the Opposition Division decision. Myriad will have the right to challenge the decision in front of the European Patent Office's Technical Board of Appeals within two months of the decision's publication.