ACLU mob attacks breast cancer test patent

The fight over the patentability of isolated genes is misplaced since patents are usually obtained not just for the isolated gene, but also for methods of use and as part of more complex assays or kits.

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An isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because the isolated version does not occur in that form in nature. In this light, the United States Patent and Trademark Office (PTO) granted patents on the BRCA1 and BRCA2 genes to Myriad Genetics. The patents cover diagnostic tests for mutations along the genes responsible for most cases of hereditary breast and ovarian cancers.

Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad's monopoly on the BRCA genes allows it to charge a high rate for their tests—as much as $3,000.

For various reasons—rational and irrational—groups that oppose gene patents have made the patents held by Myriad Genetics the poster children of an anti-gene patent movement. For one thing, the Myriad patents cover tests related to breast cancer, a disease with unusually high media attention. For another, Myriad has been particularly aggressive in its licensing practices.

The American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole host of others have now filed a lawsuit challenging the patents on the genes associated with breast and ovarian cancer, claiming such patents stifle research that could lead to cures and limit women's options regarding their medical care.

The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed against the PTO, Myriad Genetics and the University of Utah Research Foundation. The plaintiffs include several patients and more than a dozen universities, genetic specialists and medical associations, such as the Association for Molecular Pathology and the American College of Medical Genetics.

The suit claims the patents are unconstitutional and invalid because "human genes are products of nature, laws of nature and/or natural phenomena and abstract ideas or basic human knowledge or thought." The ACLU's lawsuit is, in effect, challenging the entire practice of gene patenting, so the case could have wide-reaching effects for the research and genetic diagnostics fields.

As these things usually go, the issue is not that Myriad has a patent and is keeping withheld from patients. The issue is that Myriad is charging high prices, which could possibly keep some women from seeking preventative genetic testing. There is a natural cycle where medical breakthroughs receive patent protection, which allows the patent-holder to charge higher prices. High prices yield high profits, which creates an incentive to develop the next generation of therapeutics and diagnostics.

The question might be better framed as, "Who should pay for health care costs?" There is nothing particularly extraordinary about gene patents which should require that they be held to a higher standard than, say, pharmaceutical patents or non-gene based diagnostics, both of which can be subject to high cost and limited availability based on the patent holder's rights. As the courts have opined, a gene is a chemical compound, albeit a complex one.

Claiming that such patents are unconstitutional is unlikely to go very far. The U.S. Constitution itself provides no limitations, and the U.S. Supreme Court has given this grant broad interpretation, citing that Congress intended statutory subject matter to "include anything under the sun that is made by man." Under this interpretation, live, human-made micro-organisms (as well as isolated nucleotide sequences) were deemed patentable subject matter. 

While human genes are products of nature, the Myriad patents claim isolated forms of the genes, not the genes in their natural state. That is, imagine pulling out a gene in its unrecognizable natural state hidden among a million other base pairs in the genetic code. Therefore, an appeal that genes should be unpatentable and somehow different seems to be an attempt to use fear of vitalism in genes to get such patents disallowed.
An argument that gene patents should not be allowed so that patients could have access to cheaper alternatives could just as easily be applied to every patentable item that finds a use in healthcare from pharmaceuticals to medial devices to hospital instrumentation. Really, almost anything right down to the paper used for writing prescriptions.

In the end, the fight over the patentability of isolated genes is misplaced since patents are usually obtained not just for the isolated gene, but also for methods of use and as part of more complex assays or kits. Thus, any impact would likely be muted.
For the most part, patents work more or less as expected. They reward innovation for a limited time and when they expire, the discoveries are available to everyone. Forever.
Stephen Albainy-Jenei is a patent attorney at Frost Brown Todd LLC, serving up chat at Write him with comments or questions at Albainy-Jenei doesn't own shares of companies mentioned in this article.

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