The battle over “gene patents”: ACLU v. Myriad Genetics

Will complacency allow patent protections to come apart?

The merits of “gene patents” – patents directed to DNA sequences including disease-associated mutations — have been debated for years: Do they stifle genetic research, or promote it? Are gene patents essential for the commercialization of genetic testing? Do they raise the cost of medical care?  As a patent attorney with a focus in the life sciences, I find that these questions are being raised more frequently now. Why? What’s happened? In a word, ACLU v. Myriad Genetics.

What does the American Civil Liberties Union, the defender of free speech in the United States, have to do with genes and patents, and why would they sue a company that’s successfully commercialized a genetic test for breast and ovarian cancer?  I’m not really sure. The connection between patents and free speech is tenuous at best. Is this really a women’s free speech issue or is it part of a larger debate on healthcare?

Whatever the case, the ACLU ran a well-executed public relations attack on Myriad Genetics and the U.S. patent system, garnering high-profile media coverage and ultimately convincing a lower court that the subject matter of the patents was not proper under U.S. law. While I have little doubt that the federal appeals court will reverse the decision, the case illustrates the poor job the life-sciences industry has done in defending the patent system.

On May 12, 2009, the ACLU, the nonprofit Public Patent Foundation, and a group of patients, physicians, academic researchers and medical societies filed a lawsuit against the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation. The lawsuit challenged patents on two human genes associated with breast and ovarian cancer, BRCA1 and BRCA2, claiming such patents stifle research that could lead to cures, and limit women’s options regarding their medical care.

The patents cover isolated DNA encoding the BRCA1 and BRCA2 proteins and specific mutations that are responsible for many cases of hereditary breast and ovarian cancers, as well as their application in diagnostic tests. While this complaint focused on patents licensed to Myriad Genetics, in my opinion the ACLU had its sights on a broader target: all patents that cover human genes and their application in genetic testing.

Judge Robert Sweet’s decision, on March 29, 2010, took some in the patent and medical community by surprise. He ruled that human genetic sequences and the scientific enquiry of looking at a gene or comparing two genes constitute natural phenomena, laws of nature and abstract ideas, and are not patentable.

Some people, including many in the science and business communities, heralded the decision as landmark, contending that gene patents are to blame for many of the ills of the health care system, inhibiting academic research and blocking access to treatment. They argue that the patents give a monopoly to one company, making the cost of the test prohibitively expensive for those without insurance.

I find myself in the opposite camp. I fear that invalidating legal protections for genetic testing would reduce incentives for development and commercialization of new tests and treatments, thus diminishing the chances that genetics research will benefit patients. Why should a company spend tens of millions of dollars or more validating a test if a competitor could jump in and sell the same test after the hard work is done?

The judge’s decision is only a first step. It doesn’t affect how the U.S. Patent and Trademark Office evaluates patent applications relating to DNA-based inventions, and is not binding, as a district court decision, on any other courts. Myriad Genetics recently filed an appeal to the Court of Appeals for the Federal Circuit. Given that the decision was based on emotion and not the law, the appeals court will likely reverse it, potentially landing it in the Supreme Court.

The patent system has its flaws, but weakening patent protection won’t encourage investment in the early-stage academic research needed to move diagnostic tests to the clinic. In the past—recent years especially—a strong patent system has promoted the successful transfer of technology from world class hospitals and research centers like Children’s to industry, leading to the treatment of diseases and benefiting millions of patients. As my colleague Ron Eisenstein recently told the Los Angeles Times, “Critics have yet to present a feasible alternative system, such as government subsidies for diagnostic test validation. Given the current government budget deficits, looking to the government to pay for the additional work is not going to happen.”

Those who support medical innovation can’t continue to be complacent. The ACLU and other opponents of the patent system are not stopping their attack; the ACLU is now advocating for legislation proposed by Representative Xavier Becerra (D-CA) to bar the issuance of gene patents (H.R. 977, the “Genomic Research and Accessibility Act”).

Let industry trade groups like the Massachusetts Biotechnology Council, Biotechnology Industry Organization (BIO), and the Association of University Technology Managers (AUTM) know how you feel. Failure to act will prevent the benefits of scientific research from reaching patients in need of treatment.