The ACLU and the Public Patent Association (PUBPAT) filed the lawsuit against Myriad and the U.S. Patent Office nearly a year ago over the BRCA1 and BRCA2 gene patents. On March 29, 2010, a Federal court in New York ruled that Myriad's patents linked to breast and ovarian cancer are invalid. In the 153 page decision, U.S. District Court Judge Robert Sweet invalidated seven Myriad patents covering mutations related to these cancers on the basis that they were "improperly granted" because they involve a "law of nature".
Myriad sells, for over $3,000, a test that looks for mutations in the BRCA1 and BRCA2 genes to help ascertain whether a woman is at risk for the associated breast or ovarian cancers. The plaintiffs stated in their suit that the high cost coupled with Myriad's monopoly on the test prevented women from having reasonable access to the test. Further complicating the issue is that based on the patent, no other company can develop a test for the genes and if you are unsatisfied with the results from your first test, you will likely be unable to get a second opinion from another company."
The ACLU released a statement after the verdict that it "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." One of the ACLU's staff attorneys Bryan Roberts said "the human genome, like the structure of blood, air or water, was discovered not created… gene patents put up unacceptable barriers to the free exchange of ideas."
Roughly 20% of all human genes are currently subject to thousands of patents issued by the U.S. Patent office. Once a gene has been patented, the patent holder can prevent others from researching, studying or testing that gene. The plaintiffs in the case against Myriad believe that patents on the BRCA1 and BRCA2 genes has limited research and testing in search of a cure for certain types of cancers.
The ruling in this case asserts that although Congress intended for patent law to be given wide scope and that the Supreme Court has supported broad interpretation that "this broad reading of § 101 and statutory patent eligibility is not without limits." It goes on to quote a landmark case from 1852 which is perhaps even more relevant today: "The Supreme Court has recognized that scientific principles and laws of nature, even when for the first time discovered, have existed throughout time, define the relationship of man to his environment, and, as a consequence, ought not to be the subject of exclusive rights to any one person."
Specifically, the Supreme Court has defined three categories that lie outside the scope of patent law:
- The laws of nature, physical phenomena, and abstract ideas have been held not patentable.
- The rule that the discovery of a law of nature cannot be patented rests, not on the notion that natural phenomena are not processes, but rather on the more fundamental understanding that they are not the kind of 'discovery' that the statute was enacted to protect.
- Phenomena of nature, thought just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.
In a dissenting opinion in a 2006 case, Supreme Court Justice Breyer stated of these exclusions "that sometimes too much patent protection can impede rather than 'promote the Progress of Science and useful Arts', the constitutional objective of patent and copyright protection."
In considering the case, the first threshold was to determine whether or not the subject matter of the patent was patentable prior to any considerations of whether it was non-obvious, novel or beneficial. The court said, "The distinction between the § 101 inquiry into patentable subject matter and the other requirements for patentability set forth in Title 35 is of particular importance in evaluating the authorities cited by the parties and the arguments presented."
The decision then referenced a 1979 statement from Judge Rich on what considerations are "salient" in a USC 35 § 101 analysis. "Section 101 states three requirements: novelty, utility, and statutory subject matter. The understanding that these three requirements are separate and distinct is long-standing and has been universally accepted…. Thus, the questions of whether a particular invention is novel or useful are questions wholly apart from whether the invention falls into a category of statutory subject matter. Of the three requirements stated in § 101, only two, utility and statutory subject matter, are applied under § 101."
Because the plaintiffs were not disputing that the subject matter of the BRCA1 and BRCA2 patents had utility, the ruling stated that the "sole task of this Court is to resolve whether the claimed compositions and methods constitute statutory subject matter or fall within the judicially created products of nature exception to patentable subject matter."
The plaintiffs had made motions requesting that the court consider that composition claims that isolated DNA containing naturally-occurring sequences falls within the products of nature exception. The court supported this motion and found that the exception applied to the BRCA 1 and BRCA 2 patents.
For its part, Myriad asserted the plaintiff's claims should be dismissed because of a presumption of validity of the issued patents and the "carefully considered policy of the USPTO" that is "entitled to great respect from the courts."
In its ruling, the Federal circuit stated "that it owes no deference to USPTO legal determinations" and that while Congress has created a presumption of validity for issued patents, that "approximately 40% of patents challenged in the courts have been found invalid, demonstrating that this presumption is far from absolute."
The court went on to say that in order for the patents to not be invalidated by the products of nature exception, "the patentable subject matter must be 'markedly different' from a product of nature" and that the "Supreme Court has established that products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product."
Plaintiffs in the case include the Association for Molecular Pathology, American College of Medical Genetics, American Society for Clinical Pathology, College of American Pathologists, a handful of MDs, PhDs, professors and ethicists and non-profits and collectives such as Breast Cancer Action and Our Bodies Ourselves. Perhaps the most important plaintiffs to the suit are breast and ovarian cancer survivors whose medical care has been impacted by Myriad's patents.
The patents are held by Myriad Genetics along with the University of Utah Research Foundation. In their request that the judge dismiss the plaintiff's suit, they assert that the process of isolating the DNA from the body transforms it and makes it patentable. However, critics of gene patents believe that this claim is simply a 'lawyer's trick' to skirt the ban on direct patenting of human DNA.
Ethics of the decision aside, there are other concerns to weigh. Edward Reines, a patent attorney who represents biotechnology firms believes that loss of the right to patent could impair incentives to conduct genetic research. Reines said after the judgment, "The genetic tools to solve the major health problems of our time has not been found yet. There are discoveries we want to motive by providing incentives to all the researchers out there."
Of wider concern is the notion that patenting human genes is a violation of the First Amendment and of U.S. patent law. The suit asserts that genes are "products of nature" and are therefore unpatentable. However, the Judge ruled that because the case could be decided within the boundaries of patent law, the constitutional question did not need to be addressed.
Genae Girard, a breast and ovarian cancer sufferer who is one of the individual patients in the suit, applauded the decision, saying it is "big turning point for all women in the country that may have breast cancer that runs in their family."
Myriad's CEO Peter Meldrum told investors, "regardless of the outcome of this particular lawsuit, it will not have a material adverse effect on the company or on the future revenues of our products." Myriad plans to appeal the invalidation of seven of its 23 patents related to BRCAAnalysis ® to the Court of Appeals for the Federal Circuit. An official statement from the company said, "While we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that that 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."