Turning Patent Swords into Shares
Science, Vol. 330, No. 6011, pp. 1630-1631, December 17, 2010
9 Pages Posted: 20 Dec 2010 Last revised: 25 Dec 2015
Date Written: December 20, 2010
The present paper discusses the decision earlier this year of Judge Robert W. Sweet of the District Court for the Southern District of New York to deny patent protection for isolated human genes and associated diagnostic methods. The case related to genetic tests for familial breast and ovarian cancer developed by the company Myriad Genetics. The product claims (used to describe the compound in question) were directed to isolated DNA containing human BRCA1 and BRCA2 gene sequences. The method claims (used to describe the activity exercised upon the compound) covered the process of identifying certain mutations in the BRCA genes. The court held that the claimed isolated DNA "is not markedly different from native DNA as it exists in nature" and constitutes unpatentable subject matter. The court also ruled that the claimed method is "directed only to the abstract mental process of comparing or analyzing gene sequences," fails the so-called "machine or transformation test" and is unpatentable as well.
The case hit the biotech community as a shock-wave as it is a U-turn in the 30 year old US patent practice to grant patents for human genes as a matter of routine. Although the Myriad decision has been appealed and may be reversed in light of the heavily criticized transformation test in the Bilski case or arguments set forth by the U.S. Department of Justice, many public-policy issues relating to diagnostic gene patenting will persist. In light of the controversies surrounding gene patents and the growing discontent with some undesirable effects of the current patent system, the paper analyses a series of measures to meet the alleged problematic impact of patents in the area of human genomic science.
The paper discusses compulsory licenses, diagnostic-use exemptions, "march in" rights, and carefully examines the exclusion of patents for diagnostic methods, the exclusion of gene patents altogether and purpose-bound protection regimes. The paper also explores specially tailored genetic patent pools and clearinghouses to navigate through the genetic patent landscape.
The paper concludes that in order to assist modern patent law in achieving its major objectives and in coping with the various public-policy concerns, patent rights need to be reconceptualized. Especially in the field of healthcare, a patent can no longer be viewed as a title giving (almost) complete freedom to exclude others from use, but rather as a temporary permit to exploit monopoly rights under fair and reasonable conditions, investing technology owners with the authority to invent and share, in other words, as a "dutybearing privilege".
Keywords: Gene patents, Myriad, Breast cancer, US District Court, Judge Sweet, restrictive licensing, patent thickets, compulsory license, diagnostic use exemption, march in rights, exclusion diagnostic method patents, exclusion gene patents, patent pools, clearinghouses
JEL Classification: D23, D45, H 41, H51, I18, K11, L14, L4, L 65, O31, O32, O34
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