AMP v. USPTO: What the Parties Are Saying About the Decision

    By Donald Zuhn --

On Monday, the District Court for the Southern District of New York ruled in favor of the plaintiffs in Association of Molecular Pathology v. U.S. Patent and Trademark Office, finding the claims of several patents directed to the BRCA1 and BRCA2 genes invalid as encompassing non-statutory subject matter (see "Round One Goes to the ACLU").  So what are the parties saying about Monday's decision?

The originally named defendants in the case included the U.S. Patent and Trademark Office, Myriad Genetics, and the Directors of the University of Utah Research Foundation.  The District Court's dismissal of claims against the USPTO left Myriad Genetics and the University of Utah Research Foundation as the remaining defendants.

While the University of Utah Research Foundation has not issued a statement regarding the decision, Myriad Genetics released a statement on Tuesday in which the molecular diagnostic company announced that it will appeal the decision to the Federal Circuit and "will continue to vigorously defend this litigation."  Myriad President and CEO Peter Meldrum said that "[w]hile we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation."  Mr. Meldrum added that "[m]ore importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad's operations due to the patent protection afforded Myriad by its remaining patents."  Myriad noted that while the District Court invalidated 15 claims in seven BRCA patents that the company owns or exclusively licenses, there are 164 remaining claims in those seven patents and an additional 16 patents covering Myriad's BRCA tests that were not challenged in the case.

Among the organizational plaintiffs and their counsel, the Association for Molecular Pathology, American College of Medical Genetics, American Society for Clinical Pathology, American Civil Liberties Union (ACLU), and Public Patent Foundation (PUBPAT) all issued statements regarding the decision (the College of American Pathologists, Breast Cancer Action, and Boston Women's Health Book Collective did not issue any statements on their respective websites).

In its press release, the ACLU noted that "[t]he precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes." ACLU First Amendment Working Group staff attorney Chris Hansen said the decision was "a victory for the free flow of ideas in scientific research," adding that "[t]he human genome, like the structure of blood, air or water, was discovered, not created.  There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."  With respect to the USPTO's dismissal, the ACLU asserted that "[t]he court found that it was unnecessary to reach the First Amendment claims against the USPTO because it had already ruled in favor of the plaintiffs."  The ACLU release also suggested that "[b]ecause the ACLU's lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes."  ACLU Women's Rights Project staff attorney Sandra Park predicted that the decision was "the beginning of the end to patents that restrict women's access to their own genetic information and interfere with their medical care."

In a statement issued by PUBPAT, Executive Director Daniel Ravicher said that "[t]he court correctly saw that companies should not be able to own the rights to a piece of the human genome."  Mr. Ravicher added that "[n]o one invented genes.  Inventions are specific tests or drugs, which can be patented, but genes are not inventions."

The Association for Molecular Pathology (AMP) applauded the decision in its release.  AMP President Dr. Karen Mann called the outcome "a landmark decision that has the potential to dramatically improve patient access to genetic testing."  Dr. Mann suggested that the decision would also be "a boon to personalized medicine in the purest sense as nothing is more personal than one's genetic makeup."  The AMP noted that it had adopted a Policy Statement on gene patenting in 2008 that "urged an end to the practice of granting patents on single genes, sequences of the genome or correlations between genetic variations and biological states," and "encouraged groups that currently hold gene patents, including higher educational and research institutions, not to grant exclusive licenses to access those patents."  The AMP release contends that the decision is a "significant step forward to eliminating future DNA patents and calls into question the appropriateness of those already in existence."

In its statement, the American College of Medical Genetics (ACMG) "celebrated the US District Court ruling [on Monday] that genes are 'unpatentable.'"  The group's release states that "[t]he outcome of this case is likely to have far-reaching positive implications for physicians, researchers and patients."  ACMG executive director Dr. Michael Watson contended that "[t]he invalidation of gene patents will allow patients to get second opinions on test results, encourage quality improvement of current testing, allow researchers to develop new and better methods of testing and decrease costs of laboratory testing."  ACMG President Dr. Bruce Korn added that "[t]he successful outcome will pave the way towards genome-wide testing, avoiding an obstacle course of patent protection of individual genes that will prevent reporting of a complete set of results."  The group's release notes that the ACMG was the first professional medical association to establish a position against gene patenting (which it did in 1999).

The American Society for Clinical Pathology's (ASCP) release "hailed" the District Court's decision.  ASCP President Dr. Mark Stoler said the ruling "gives patients the right to choose who will perform the test that determines whether they are at greater risk for breast cancer -- a right they never should have been denied."  He added that as a result of the court's decision, "[w]e have won back our natural right to own our own genes."

Comments

[Bob Cook-Deegan]

Kevin,

Thanks for collecting these comments.

[Geoff Karny]

The plaintiffs and their ACLU attorneys have wrapped themselves in the mantle of scientific freedom and women’s health, but the suit is ultimately about money. Myriad hasn’t gone after people doing pure research. Why should they waste the time, money, and effort? Why should any company?

The molecular pathologists want to be able to offer the tests themselves for a fee. The opinion is replete with references to people charging much less than Myriad charges. Of course they can. Myriad invested substantial amounts of time, money, and effort to commercialize the technology. Once the tests have been developed and proven, it’s easy for someone else to take a free ride. That’s why the friendly street corner vendor is able to offer Avatar for a dollar.

I guess I don’t blame the anti-patent cabal for gloating over this. It’s the culmination of years of effort of spewing out misinformation and propaganda. Check out the ACLU web site. It’s propaganda machine would have made Stalin jealous.

[EG]

Don,

As they've done in the past, the ACLU statement's has (again) grossly distorted in the media what Myriad's patents cover, as well as the controlling legal precedent. This win by the ACLU and its clients will be short-lived. Sweet's ruling has a "snow ball's chance in hell" of being upheld by the Federal Circuit, if nothing else for misrepresenting the holding in In re Bergy. Also, Sweet's reliance on the Bilski test to invalidate the method claims was extremely ill-advised, as that test will likely be overturned by SCOTUS long before this appeal is reviewed by the Federal Circuit. Get ready for the judicial version of a "verbal blood bath" as Sweet's opinion is torn to pieces.

[Keep It Real]

The molecular pathologists want to be able to offer the tests themselves for a fee. The opinion is replete with references to people charging much less than Myriad charges. Of course they can. Myriad invested substantial amounts of time, money, and effort to commercialize the technology.

How much is Myriad's CEO paid?

[Kevin E. Noonan]

Dear Keep:

I don't think Myriad is among the top earning diagnostic companies. Or that Myriad's CEO is the top-earning CEO.

Thanks for the comment.

[Ryan]

Geoff, sure, companies deserve to patent their inventions, but they didn't invent genes - they just discovered them. I could spend a lot of time and money isolating a channel from a song, but I shouldn't then be able to copyright that channel.

[Kevin]

Amazing that Newton blew his chance to patent gravity. What was he thinking!

He must have been thinking that the idea of patenting products of nature is patently absurd.

This trial should have taken no more than 5 minutes.

[Brett]

Ryan,

Sure Myriad did not invent the gene, but they did invent a novel use for the gene, in a way that had never been used before.

[Tim R]

'Products of Nature' aren't patentable? So only supernatural inventions can be patented?

'Discoveries' *are* patentable - S101 says so. What is not patentable is what is not new. If (like Newton) your discovery is how an existing thing works, you have nothing to patent. You need to produce a useful new process or thing.

[7]

You can read my published law review article on why gene patents should inspire legislative reform at : http://omnilegalgroup.com/publications.html

[Jeremy Segal]

I am a molecular pathologist. We perform tests for any and all types of genetic changes. Many test procedures, including gene sequencing, are industry standards, and the genetic sequences are all part of the public domain, performed by the NIH funded human genome project. Myriad doesn't just hold a patent on a test method. That would be ok with me. Myriad claims a patent on the gene sequence itself (even though it's publicly available at genome.ucsc.edu) and any conceivable test, present or future, that could test for any sequence in that gene. However, even they believe a claim to block people from sequencing their whole genome (including the BRCA genes) wouldn't hold up and is untenable. So they only block people who just want to sequence that gene alone. How does that double standard hold up?

You're not allowed to patent what you find in nature. That's one of the basic rules of patents. Our own DNA sequences are a product of nature. If you want to patent a method to look at gene sequences, that's fine with me. But all they did is patent some letter sequences that they read out of someone's cells, and they want to block anyone else from doing it by any method imaginable. It's ridiculous.