In this case, decided on on 29 March 2010, the plaintiffs took action in the United States District Court for a declaration of the invalidity of patents held on the human BRCA1 and BRCA2 genes. Variant alleles of these genes have been connected to heightened susceptibility to breast and ovarian cancer. All of the relevant patents were invalidated.
The patents had been issued by the United States Patent and Trademark Office ("the USPTO") to Myriad Genetics and the University of Utah Research Foundation (collectively "Myriad"), giving Myriad a lucrative monopoly right to conduct or license medical tests relating to the genes. Myriad's patents covered the genes themselves (composition patents) as well as processes making use of them (method, or process, patents).
This case provided the opportunity to test the legal validity of gene patents, which have long been controversial but have been issued freely by the USPTO in recent decades. Leaving aside issues of public policy relating to whether such patents assist or impede innovation, it is often thought that these patents are contrived. While there has long been no doubt that the genome of a genetically-engineered organism is patentable, that is because this organism is something new: in effect, it is an invention. Other patents have related to processes or methods for isolating segments of DNA, supposedly purified genes that (it is alleged) are not found in such a form in nature, and methods or processes that make use of DNA segments.
The lengthy opinion handed down by Justice Sweet deals with various issues; however, these are mainly procedural or otherwise formal. The central issue in the case has always been the validity of gene patents. To give something of the flavour of the claims in the disputed patents, a representative claim in the composition patents reads as follows:
An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
A representative method claim reads as follows:
A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from a group consisting of the alterations set forth in Tables 12A, 14, 18, or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA of the said human sample with the proviso that said germline alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.
The key statutory provision applied in the case was section 101 of Title 35 of the US Code, which provides as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Accordingly, the court had to determine whether the relevant segments of DNA and the processes used to test for them could be brought under the rubric: "new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." In the past, it has been authoritatively held that scientific principles, laws of nature, things occurring in nature, and abstract ideas do not fall within the section and cannot be patented.
This reflects the commonsense reality that none of these are the sorts of things that can be invented, though of course the language is more complex as it also refers to somebody who "discovers" a "new and useful process", etc. The US Supreme Court has held that the discovery of natural phenomena is not the kind of discovery that patents were intended to protect and that these phenomena should not be the subject of property claims as they are basic tools for scientific and technological work.
Thus, for a process, etc., to be patentable, it must be novel, useful, and fall within the subject matter of the statute (in particular, it must not be something occurring in nature). In this case, there was no dispute that the subject matter of the patents was "useful".
The court held that the composition patents were invalid, essentially because they are products of nature. To overcome this, Myriad would have had to establish that the "isolated" and "purified" DNA segments in question had markedly different characteristics, or were fundamentally distinct, from what was found in nature. Thus, mere extraction and purification of a naturally-occurring chemical element or compound would not be patentable (the process for doing this might be, but not the extracted and purified substance itself). Myriad argued that a purified substance not found in nature in pure form was patentable, but this was rejected.
Thus the question was whether Myriad had patented something with markedly different characteristics from naturally-occurring DNA. On this, it failed: in particular, the isolated DNA patented by Myriad resembled the equivalent naturally-occurring DNA in encoding the same genetic information. Whether this is the correct test will likely be a key issue in any appeal. Note that Myriad argued unsuccessfully that its isolated and purified DNA segments were markedly different from naturally-occurring DNA because of their better amenability for use in, for example, medical tests.
The method patents were rejected essentially on the basis that section 101 did not apply to a mere comparison of a DNA sample from a patient with Myriad's isolated DNA. As written, the patents did not relate to any process of transforming or manufacturing something, but simply covered an abstract mental process of comparing or analyzing. The patents did not cover any transformative acts such as actual steps to extract or sequence DNA, and they could not be read expansively to include these by implication. To do so would mean that any patent could be granted on something as abstract as a mental process to be carried out by some unspecified and perhaps unpatented means. In any event, something more than a mere step of data gathering would need to be included in the patent to make it valid.
One patent related to the use of cells into which an altered BRCA1 gene known to cause cancer had been inserted. Growth rates of the cells could be compared in the presence or absence of a potential cancer drug as a test of its efficacy. This was rejected because it amounted to a patent on the scientific method itself: what Myriad proposed to patent was the broad principle that slower cell growth in the presence of a substance was a possible indicator that the substance could be therapeutic for cancer.
In summary, the patents were invalidated mainly because the composition patents were considered to relate to something too much like a product of nature, without the required marked difference, while the method patents covered highly abstract descriptions of mental operations, such as making comparisons.
While I agree that all of these patents seem like contrivances to cover essentially unpatentable subject matter, the outcome will doubtless be appealed, and it remains to be seen whether higher courts will agree with me.
The impact one way or another on biotechnological innovation is somewhat imponderable. There are numerous complexities involved, including how Justice Sweet's reasoning would apply by analogy to a drug that is essentially a chemical extracted and purified from naturally-occurring plants. Such a drug might not be markedly different from something found in nature in less pure form, but trialing it might nonetheless be enormously expensive (as is inevitably the case with new drugs). Some kind of intellectual property protection might therefore be in the public interest. While Justice Sweet plays down the likelihood of this kind of situation - he distinguishes the unique information-coding characteristics of DNA - it is difficult to rule out.
At the same time, there could well be inefficiencies, hindrances to innovation, and harsh outcomes for members of the public such as cancer patients if the USPTO and the courts continue to allow a regime of massively fragmented intellectual property rights in short segments of DNA.
It may be that legislatures will eventually have to develop a separate scheme of intellectual property for the biotech industry to handle the unique and competing public interests involved. At the moment, however, any such resolution seems far off.