Note – Invalidating Gene Patents: Association for Molecular Pathology v. U.S. Patent & Trademark Office

Ashley McHugh

Volume 62, Issue 1, 185-220

Biotechnology companies and research institutions have patented thousands of genes based on the idea that a gene in an isolated and purified form is a patentable invention. The biotechnology industry has since grown to a multibillion dollar industry using gene patents as a basis for targeting new drugs, researching genetic disease, and developing diagnostics. One company, Myriad Genetics, faces the threat of having their patents invalidated because of their monopolistic use of their patents on human breast cancer genes. In Association for Molecular Pathology v. U.S. Patent & Trademark Office, the district court found Myriad’s gene patents invalid and unenforceable. If upheld, the decision will invalidate all patents on human genes and potentially many
other patents on isolated and purified natural products, having far-reaching implications for health, science, and biotechnology.

This Note questions the district court decision in Association for Molecular Pathology to grant the plaintiffs standing to sue Myriad and the United States Patent & Trademark Office and to invalidate gene patents under existing case law. Opponents of gene patents argue that genes are products of nature and are therefore not patentable subject matter under § 101 of the Patent Act. However, circuit courts have consistently endorsed the principle that isolated and purified products of nature are still inventions and patentable subject matter in certain circumstances. Although the patentability of human genes under § 101 had not been addressed by courts until now, human genes have been upheld as patentable under other requirements of the Patent Act. Because
invalidating gene patents will not likely remedy the monopolistic effects of gene patents, this Note reviews several legislative approaches that could serve as a more appropriate vehicle to address the harms that gene patents cause.

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