Patents for Human Genes Face Legal Challenge

Fenwick & West partner Dr. Michael Shuster was quoted in a MedPage Today article titled "Patents for Human Genes Face Legal Challenge."

Along with more traditional inventions, products and ideas, the U.S. Office of Patent and Trademark Office allows for parts of the human genome to be patented. This in turn enables patenting organizations to have the ultimate say in how tests and procedures on specific genes can be carried out. Approximately 20% of the human genome has been covered under such patents.

But now, an ACLU-led group of plaintiffs (comprised of scientists, civil libertarians and cancer patients) is challenging the merits of that patent system.

Their lawsuit was spurred after a patient in Texas was denied additional "second opinion" tests for ovarian cancer because no other tests could be performed on the gene in question without prior permission of the company that had it patented. The plaintiffs point to this as an example of how patents on the human genome constrict not just patients' rights, but also the progress of medical practice and research.

"[The lawsuit] is an attempt to define where you draw the line," said Shuster, Ph.D., J.D., an intellectual property lawyer at the San Francisco firm of Fenwick & West. "There is concern that patents are not serving their constitutional objective of promoting science and technology, but instead are hindering it."

Still, Shuster insisted that gene patents should not be disallowed entirely. He suggested that organizations filing for such patents should be required to demonstrate an understanding of the specific gene they wish to lock up, which would prevent a "land grab" of patents being filed broadly across parts of the human genome.

"You had to have some idea about how you could specifically use it," said Shuster.


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