Did you know that genes are civil liberties? At least that’s what the American Civil Liberties Union (“ACLU”) thinks.
That was the message emblazoned across the ACLU’s website following the June 13, 2013, United States Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013) (“Myriad”). In Myriad, the Supreme Court invalidated patents on two human genes associated with hereditary breast and ovarian cancer in response to a lawsuit filed by the ACLU and the Public Patent Foundation, ostensibly on behalf of researchers, breast cancer patients, women’s health groups, and medical professionals everywhere.
The ACLU’s version of the story is that those patents allowed a Utah company, Myriad Genetics, to exclusively control access to genes known as BRCA1 and BRCA2. This exclusive control gave Myriad Genetics the right to prevent others from doing research or offering competing diagnostic tests for the genes. Since access to such diagnostic tests is vitally important for making important medical decisions about diagnosis and treatment for breast cancer, Myriad Genetics’ ability to set the terms and cost of testing posed an unconscionable barrier for women to access alternate tests or get a second opinion regarding test results.
But the ACLU came to the rescue, proudly portraying itself as a white knight fighting against corporate greed in an age when the ability to read and understand the very blueprints for life has been corrupted into a land grab for market share.
Following the Supreme Court’s decision in Myriad, the ACLU touted that the Court had struck down a major barrier to patient care and medical innovation. Because of this ruling, patients would have greater access to genetic testing and scientists would be able to engage in research on these genes without the fear of being sued for patent infringement. On the day the Myriad decision was released, a company called Ambry Genetics was the first to announce that it would provide alternative genetic diagnostic testing for the BRCA1 and BRCA2 genes. A second company, Gene by Gene, Ltd., soon followed.
What a triumph for the public good! David defeats Goliath! Don’t tread on me and my genes!
So why then, less than a month after the Myriad decision (on July 9 and 10, 2013, to be exact), did Myriad Genetics sue Ambry and Gene by Gene for infringement of claims in multiple patents relating to genetic diagnostic testing?
Surely these were frivolous lawsuits. Through Myriad, the ACLU had paved the way for free and open access to the use of genes in diagnostic tests, right?
Well, as is often the case, the truth is more complicated than what the general public was led to believe. The thumbnail version is that Myriad Genetics’ position is that the Supreme Court merely invalidated five total claims out of the patents reviewed by the Court, but it still has over 500 remaining claims across 24 patents that were not impacted by the Court’s decision. To that end, Myriad Genetics contends that the Supreme Court decision in Myriad regarding claims covering the naturally-occurring isolated DNA itself does not have much of an effect on its ability to exclude others from offering a competing test since Myriad Genetics still holds patents with valid claims to, among other things, methods covering processes for diagnosing breast cancer.
You see, in the Myriad decision, the Supreme Court also was careful to qualify its opinion by noting that its holding regarding the patent ineligibility of isolated naturally-occurring DNA does not apply to methods of using DNA, new applications of knowledge about naturally-occurring genes, or the patentability of DNA in which the order of the naturally-occurring nucleotides has been altered. While some of those methods, particularly in the diagnostics area, may be limited by another recent Supreme Court holding (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)), enough of a gray area exists that when it comes to genetic diagnostic testing for the BRCA1 and BRCA2 genes, the Myriad decision is not as much of a loss to the biotechnology industry as the ACLU and pundits would have you believe.
The impact of the Myriad decision on the biotechnology industry is a mixed bag. If you have a company with a business model based solely on the sale or use of naturally-occurring genes, then, of course, Myriad is going to be a big problem for you. However, most biotechnology companies these days, including those in the genetic diagnostic testing arena, are not based on a single patent around an isolated naturally-occurring DNA sequence. As recently stated by Richard Marsh, General Counsel for Myriad Genetics, “The types of patents that we’re now seeing in the molecular diagnostic space are no longer with respect to specific genes…What you’re seeing today is a shift from molecular diagnostic testing focused on a single gene or a small set of genes rather to what we call panels of genes.” Marsh also stated, “Candidly, the future of molecular diagnostic testing…will probably be more contingent on the Mayo type of case…Your claims to the patents are now going to recite to the method of determining disease identification based upon this panel as opposed to claiming a specific isolated gene.”
Even companies that have relied on patent claims to isolated naturally-occurring DNA for therapeutic products (like Amgen’s blockbuster anemia treatment based on the human protein erythropoietin) also generally have patents containing claims covering either the types of synthetic DNA that the Supreme Court said are patent eligible, or covering the types of technology the Court explicitly carved out of its decision, such as methods of using DNA and new applications of knowledge about naturally-occurring genes. In fact, most genetic patents acquired during the last decade have been for synthetic sequences, so some in the industry view synthetic DNA as the most commercially important form of DNA. For example, agricultural biotechnology companies work with plant DNA, but most of the time they are modifying or combining naturally-occurring genes in new ways, such as to make better seeds. It’s not that you can’t patent DNA sequences, it’s how you go about doing it. Potential losers within the biotechnology industry following Myriad actually have nothing to do with genetic diagnostic testing. That’s because while Myriad was limited to isolated naturally-occurring DNA, the test applied by the Court could potentially render patents to other isolated naturally-occurring biomolecules, such as proteins and peptides, invalid as well. This could impact companies with patents claiming isolated naturally-occurring industrially-useful or therapeutic proteins. For example, many naturally-occurring enzymes have been identified and isolated for uses ranging from the production of ethanol to the processing of paper.
On the therapeutic side, the most powerful antibodies against HIV are antibodies that have been isolated from untreated subjects who have failed to control their HIV infection for many years. Such subjects have developed so-called broadly neutralizing antibodies (“bNAbs”). These bNabs do little to help the people who produce them, but they may be isolated to target different parts of the virus. Myriad places such isolated naturally-occurring biomolecules in a gray area for patent eligibility in the United States. While it is true it should still be possible to patent combinations of such isolated proteins that do not occur naturally, or recombinant versions of such isolated naturally-occurring proteins, it is clear that Myriad has implications beyond just isolated naturally-occurring DNA.
On the research front, researchers may now have more freedom to engage in gene sequencing because they won’t have to worry about a slew of isolated DNA patents covering individual sequences. Some have speculated, however, that because early‑stage research on newly-discovered DNA sequences cannot be patented, it may encourage companies to be more secretive about those early-stage discoveries, or to pursue trade secret protection for potentially valuable discoveries.
And there’s the rub. At least with patents, once the patent term is up, the discovery is free to use by the public. That’s part of the balancing act that is built into the patent system (which is derived directly from the United States Constitution in Article I, Section 8, Clause 8). As a society, we want to promote innovation, but we also want to encourage the dissemination of knowledge for the public good. So in exchange for a limited period of time in which you can keep others from practicing your invention, you agree to disclose your invention in enough detail so that at the end of that period of time, the invention is freely available to the public. In contrast, with trade secrets, as long as a company adequately protects the secrecy of the information, it is proprietary and not available to the public.
Ultimately, any move toward trade secret protection would not impact DNA and proteins themselves since it is easy to “reverse engineer” or sequence those biomolecules. But methods and correlations and other useful applications of knowledge using those biomolecules may not be as easily reverse engineered. In fact, Myriad Genetics has already developed a proprietary database of DNA sequence variants and related clinical information pertaining to the breast cancer genes BRCA1 and BRCA2 from the vast populations of patients subject to their tests. Some fear that, in light of Myriad (and its intersection with Mayo) there will be pressure on other companies working on diagnostics and therapies relating to personalized medicine to increasingly rely on trade secret protection.
So, the real losers after Myriad may be members of the general public, who will be denied access to useful information that might otherwise have been part of the public domain once the patent term expired. Is that what the ACLU intended?
Please don’t get me wrong; the ACLU does a lot of good defending and preserving the individual rights and liberties guaranteed by the Constitution and laws of the United States. I’m just afraid that their foray into the patent arena has resulted in a myriad (pun intended) of misunderstood implications and unintended consequences and has done more harm than good.
This article was published originally in WRALTechWire, Raleigh NC - http://wraltechwire.com/winning-a-battle-losing-a-war-why-aclu-s-strategy-in-myriad-genetics-patent-case-may-have-backfired/12945433/