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Cardozo Journal of International and Comparative Law

Abstract

Now that the Supreme Court of the United States has held that isolated DNA fragments are not patentable subject matter under 35 U.S.C. §101 in Association for Molecular Pathology v. Myriad Genetics, Inc., thousands of existing isolated gene patents can be invalidated. In the European Union, by contrast, patent protection for human genetic sequences has always been strong and the BRCA gene patents at issue in Myriad are still valid in the European Union. It remains to be seen how the differential gene patent protection regimes in these developed nations will affect the biotechnology industry.

This Note poses that question through the lens of pharmacogenomics, asking whether the multifaceted emerging field will benefit or be stifled without intellectual property protection over isolated DNA sequences. This Note argues that precluding isolated DNA patentability will have positive results for patients and the industry because the public no longer must rely on a single entity to pursue the potential of any one gene when performing fullgenome scans, diagnostic tests, and drug research and development. These and other changes to patent law and the way we think about gene patents stand to increase accessibility of personalized medicine to doctors and patients in the near future.

Disciplines

Food and Drug Law | Intellectual Property Law | Law | Medical Jurisprudence | Science and Technology Law

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