Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., a suit by the American Civil Liberties Union and joined by the Public Patent Foundation, challenges the patentability of gene patents on two human genes associated with breast and ovarian cancer.  Along with claims that the patents are illegal, the group charges that they 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.”

BulletproofBlog has now interviewed 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 the suit can go forward after denying a motion filed by the US Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation to dismiss a lawsuit for lack standing to sue the USPTO, lack of subject matter jurisdiction, and because the action is barred by the sovereign immunity.

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.

This was originally posted at Bulletproof Blog.  You can see the entire article here.

What is left unsaid?

The impact of the case on future patent challenges is not addressed.  More significant than one crazy suit regarding gene patents is the fact that the suit names the US  Patent & Trademark Office as a defendant, and then asks the court to issue an affirmative injunction requiring the USPTO to revoke the patents in suit.

While the Patent Office moved to dismiss because there is no “case or controversy” involving the USPTO — because the USPTO hasn’t threatened anyone with an infringement suit — the judge felt the court had jurisdiction.  Presumably, the court felt that gene patents sound really scary and this case should be heard.

If this case stands, then anyone could sue the USPTO — and not the actual patent owner — in any Federal District Court, in any jurisdiction, to challenge any patent. It would seem that such a suit could now go forward without participation of the patent holder. his would leave the USPTO to uphold the validity of all patents.

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