Genes, Law, and the Race to Patent

DNA sequence mutations in BRCA1 and BRCA2 (Breast Cancer, early onset 1 and 2) genes impose a lifetime risk of cancer in women, with rates for breast cancer ranging between 60-85% and ovarian cancer between 15-40%.1 Known for their role as tumor suppressors, BRCA1 and BRCA2 promote cellular death and protect cells from uncontrolled growth.2 In many ovarian and breast cancers, functional loss of BRCA1 or BRCA2 enables unrestricted cancer cell growth. 

In an unprecedented ruling on March 29, 2010, seven U.S. patents claiming gene sequence and methodology of BRCA1 and BRCA2 were invalidated. The ruling in Association for Molecular Pathology, et al. vs. United States Patent and Trademark Office, et al.3 provides that products of nature are not patentable (35 U.S.C. 101).

The first gene patent (US 4,447,538) did not appear until 1982. It claimed a recombinant DNA transfer vector containing the Chorionic Somatomammotropin gene.4 The 1980 ruling Diamond vs. Chakrabarty paved the way for the patenting of genes by declaring genetically engineered bacteria to be patentable material.5 A patent document search for gene in SciFinder reveals that at the time of Diamond vs. Chakrabarty, only 38 gene-related patents were issued. The 1980s saw a rise in gene patents to 4,459. By 1999, the numbers had increased to 26,401.

Once underway, competition to isolate and sequence genes for patenting grew rapidly. The story of BRCA patenting begins with the announcement linking BRCA1 to chromosome 17q21 in 1990. By the time BRCA1 was sequenced in 1994, a second gene for hereditary breast and ovarian cancer, BRCA2, was localized to chromosome 13q12.3. Seizing the opportunity to commercialize gene discovery and diagnostics, Myriad Genetics, Inc. filed BRCA1 related patents in 1995. An international race ensued for the sequencing and patenting of BRCA2. Myriad was granted U.S. patents covering the BRCA2 sequence in 1998. International patents soon followed, with Canada granting BRCA1 patents in late 2000 and BRCA2 in 2001. The EPO granted patents for both genes in 2001.6

It is still too soon to speculate on the outcome of the BRCA genes and their impact on gene patents. The heart of the issue is that patent law struggles to keep up with the pace of technological advances in cloning and sequencing. The Supreme Court may need to rule on the patentability of BRCA1 and BRCA2 (and genetic material in general) before their legacy can be determined.

Use SciFinder® and STN® to explore more information about genes and patents to be found in the CAS databases.

Contributed by
Kathryn J. Kitzmiller, Ph.D.
CAS Public Relations


References
  1. National Cancer Institute. http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA (accessed March 30, 2010).
  2. American Cancer Society. http://www.cancer.org/docroot/ETO/content/ETO_1_4x_oncogenes_and_tumor_suppressor_genes.asp (accessed April 5, 2010).
  3. Association for Molecular Pathology vs. United States Patent and Trademark Office, No. 09 Civ. 4515 (S.D.N.Y., Mar. 29, 2010).
  4. Goodman, Howard M., Shine, John, Seeburg, Peter H. Microorganism containing gene for human chorionic somatomammotropin. U.S. Patent  4,447,538, 1984.
  5. Diamond, Commissioner of Patents and Trademarks vs. Chakrabarty, No. 447 U.S. 303 (U.S.S.C., June 16, 1980).
  6. Williams-Jones, Bryn. History of a gene patent: Tracing the development and application of commercial BRCA testing. Health L. J. 2002, 10,123-146.

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