The American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole host of others have filed a lawsuit challenging patents on two human genes associated with breast and ovarian cancer claiming such patents stifle research that could lead to cures and limit women’s options regarding their medical care.
The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. The plaintiffs in the lawsuit include several patients and more than a dozen universities, genetic specialists and medical associations, such as the Association for Molecular Pathology and the American College of Medical Genetics.
The challenged patents cover diagnostic tests for mutations along the genes, known as BRCA1 and BRCA2, which are responsible for most cases of hereditary breast and ovarian cancers. The suit claims that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid because “human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”
Since the U.S. Patent and Trademark Office (PTO) granted patents on the BRCA genes to Myriad Genetics, Myriad’s lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad’s monopoly on the BRCA genes makes it impossible for women to use other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford.
The ACLU says that patenting the genes limits research and the free flow of information, and as a result violates the First Amendment. The ACLU’s lawsuit is, in effect, challenging the entire practice of gene patenting so the case could have wide-reaching effects for the research and genetic diagnostics fields. A draft report by the NIH shows that around 20 percent of human genes currently are patented, including genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, and asthma, and corresponding to 4,382 of the 23,688 genes as of 2007. The genes found in the claims of over 4,270 patents.
As these things usually go, the issue is not that Myriad has a patent and is keeping withheld from patients. The issue is that Myriad is charging high prices, which could possibly keep some women from seeking preventative genetic testing. There is a natural cycle where medical breakthroughs receive patent protection, which allows the patent-holder to charge higher prices. High prices yield high profits, which creates an incentive to develop the next generation of therapeutics and diagnostics.
The question might be better framed as “Who should pay for health care costs as expensive diagnostics become available?” It would seem to be more productive to focus on what we can do to address health care costs that are spiraling out of control. There is nothing particularly extraordinary about gene patents that should require that they be held to a higher standard than, say, pharmaceutical patents or non-gene based diagnostics, both of which can be subject to high cost and limited availability based on the patent holder’s rights.
As the courts have opined:
A gene is a chemical compound, albeit a complex one, and it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it. Amgen Inc. v. Chugai Pharmaceutical Co. and Genetics Institute, Inc., 927 F.2d 1200.
For various reasons — rational or irrational — groups that oppose gene patents have made the BRCA1 and BRCA2 patents the poster children of an anti-gene patent movement. For one thing, the Myriad patents cover tests related to breast cancer, a disease with unusually high media attention lately. For another, Myriad has been particularly aggressive in its tight control over licensing. Among the thousands of patents on human and animal genes, the Myriad patents have attracted by far the most notoriety.
The ACLU now wants to go beyond claiming a defect in the particular patents and instead claim that all gene patents should be disallowed. Claiming that such patents are unconstitutional, however, is unlikely to go very far. The U.S. Constitution itself is quite broad in its grant, stating:
The Congress shall have Power … To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries; Art. 1, Sect. 8.
The U.S. Supreme Court has given this grant broad interpretation, citing the Committee Reports accompanying the 1952 Act showing that Congress intended statutory subject matter to “include anything under the sun that is made by man.” Diamond v. Chakrabarty, 447 U.S. 303 (1980). Under this interpretation, live, human-made micro-organisms (as well as isolated nucleotide sequences) were deemed patentable subject matter under § 101. An appeal that gene are unpatentable as somehow different seems to be an attempt to use fear of vitalism in genes to get such patents disallowed.
While human genes are products of nature, the Myriad patents claim isolated forms of the genes not the genes in there natural state. That is, imagine pulling out a gene in its unrecognizable natural state hidden among a million other base pairs in the genetic code. One patent for example, U.S. Pat. No. 5,747,282, claims “[a]n isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.”
In the end, a fight over the patentability of isolated genes is misplaced and is not likely to change the overall landscape of diagnostic and therapeutic costs. Very often, patents are obtained not just on the isolated gene but also on methods of use and as part of more complex assays or kits. Preventing just one kind of claim might provide some additional competition in the marketplace but any impact would likely be muted.
Earlier, the Board of Appeal of the European Patent Office (EPO) upheld a rejection of some of the BRCA1 claims in Europe based on failure to meet the disclosure requirements in a 1994 US patent, changing the priority date to a 1995 patent deemed too late to claim the gene itself. After seven years of legal tussling, the patents were allowed in amended form where the original scope was reduced to cover only frameshift mutations and not the gene itself. Even then, it is the frameshift mutations that account for most of the relevant mutations in BRCA1 so the practical effect may be quite limited.
Gene patents have been around now for decades and are unlikely to go away now just because a lawsuit was filed. An argument that gene patents should not be allowed so that patients could have access to cheaper versions could just as easily be applied to every patentable item that finds a use in health care from pharmaceuticals to medial devices to hospital instrumentation. Really, almost anything right down to the paper used for writing prescriptions.
In the end, patents work more or less as expected. They reward innovation for a limited time. When the patents expire, the discoveries are available to everyone. Forever.
Plaintiff and supporter statements and a copy of the complaint can be found here. More information, including a video of why they’re fighting to knock out the breast cancer test patents, plaintiff and supporter statements and a copy of the complaint, is here.
A copy of the complaint is also available here: myriad-brca1-complaint (pdf)