BulletProofBlog the blog on crisis communications

In this regular feature, Bulletproof interviews top plaintiffs' attorneys for their perspective on the crises likely to affect businesses in the near future. Today we talk to Chris Hansen, staff attorney with the ACLU First Amendment Working Group, which scored a major victory on November 2 when the United States District Court for the Southern District of New York ruled that its lawsuit challenging patents on human genes can go forward.

Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., originally filed on May 12, charges that two patents on genes associated with hereditary breast and ovarian cancer are illegal. The patents, owned by the University of Utah Research Center, are licensed to Salt Lake City-based Myriad Genetics. Along with claims that the patents restrict scientific research and patient access to medical care, the suit contends that patents on human genes violate First Amendment and patent law because genes are "products of nature."

The American Civil Liberties Union was joined in the suit by the Public Patent Foundation, a not-for-profit affiliated with the Benjamin N. Cardozo School of Law.

What will be the impact of this case?

Chris Hansen: That depends on whether we win it or lose it. The next step is to try it in the U.S. District Court for the Southern District of New York. After that I would expect appeals all the way to the Supreme Court, which might well agree to hear a case of this magnitude.

The issue of whether human genes can be patented has been around a long time and it seemed the Patent Office had concluded the debate was resolved in favor of patent-holders. At the very least, Judge [Robert] Sweet’s decision not to dismiss should disabuse them of that notion.

If we succeed, the potential impact can best be measured by the fact that 20% of the genes in the human body are now patented. Among them are genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma, and many other illnesses

Success in this case will encourage new lawsuits regarding any or all of those patents. Theoretically, the facts in each instance are sufficiently different so that there would be no across-the-board invalidation of the patents. Each case would be separate.

Practically, however, the impact would be even more decisive. A favorable decision upheld throughout the appeals process would effectively establish a guiding principle that no one should be able to patent a part of the human body.

What if you lose?

Chris Hansen:  One of the purposes of filing cases like this is to gain visibility for an idea. The idea behind this lawsuit won’t go away.

Meanwhile, the Patent Office under Obama could conceivably change its mind on this issue. Or, Congress could simply pass laws prohibiting patents on genes. There are influential voices on our side of this debate, including the American Medical Association, the March of Dimes, and the American Society for Human Genetics.

What would be the impact on the biotech industry if Congress were to change the law, or if you eventually prevail in your lawsuit? Might it devastate the industry?

Chris Hansen: Quite to the contrary. The industry itself, and the public, needs to realize that, by invalidating patents on human genes, we actually create significant competitive advantages for biotech companies.  

On the one hand, Myriad now has the exclusive right to perform diagnostic tests on the patented genes. It’s a monopoly that makes it impossible for women to have access to alternate tests or to even get a second opinion about their results. Myriad can also charge a high rate for its tests.

For the broader biotech industry, invalidating the patents would provide opportunity to do a much greater volume of testing and treatment because they would obviously not be prevented by existing patents. Of course, they could still patent specific tests and drugs. It would be a free market.

Yet based on a few initial reactions I’ve seen to Judge Sweet’s ruling, the industry does not seem aware that it is very much in their interests for us to finally succeed.

Larry Smith is Senior Vice President of Levick Strategic Communications, the nation's top crisis communications firm, and a contributing author to Bulletproof Blog. Connect with Levick on Twitter: @Levick.