A Landmark Case Comes Down

Editor: Please describe your background as a life science patent attorney at Phillips Lytle.

Clower: I hold a PhD in molecular biology from the University at Buffalo School of Medicine and Biomedical Sciences, where my research focused on elucidating the bimolecular mechanisms of mammalian DNA replication. Having dealt with isolated DNA on a daily basis, I am quite familiar with the technical aspects of this case, Association for Molecular Pathology v. Myriad Genetics, Inc. I have counseled clients on similar matters – anywhere from Fortune® 500 clients to universities to independent research centers. My work as a patent attorney typically involves drafting and prosecuting patent applications, and negotiating the scope and breadth of the claims with the patent office. I have drafted upwards of a hundred or more applications involving DNA-based inventions. As an aside, before I joined Phillips Lytle, while at a previous firm, I worked on a few applications for the University of Utah, the institution from which Myriad Genetics, Inc. was spun out.

Editor: The patent bar and scientists have been awaiting the outcome of Association for Molecular Pathology v. Myriad Genetics, Inc. for some time. Why was it considered such a landmark case?

Clower: To start, it’s important to note that this case garnered quite a bit of media attention, which led to, or framed in part, a variety of different perspectives. Media attitudes, politics, and emotion played a role in driving the opinion of the general public to one side or the other. But, we have to keep in mind that patent attorneys and scientists are part of the general public as well. Those influences, however, are really outside the purview of patent law generally and, in particular, this case. In any event, when we just look at the decision from the viewpoint of scientists and the patent bar community, it can be said that the Myriad decision was highly anticipated because of the known and the unknown.

The known consisted of two cases that preceded Myriad – Bilski and Mayo – which concerned the same type of broad question relating to what is patentable and what’s not. These cases involved certain “exclusions to patentability” that the Supreme Court has noted throughout the years, but only recently has decided to redefine and consequently narrow the scope of patent eligible subject matter. The Bilski case involved business methods, which were too obtuse or abstract to satisfy the Supreme Court’s measure of patent eligibility. Mayo v Prometheus was all about natural principles or phenomena, which were decidedly outside the scope of patent protection according to the Court. And, because the scientific and patent communities knew about these two decisions when certiorari was granted for Myriad, many feared that a similar ruling would occur with respect to the scope of patent eligibility for DNA-based technologies. Of course, there were also those in the scientific community who welcomed narrower protection of inventions involving DNA, insofar as they feel that this would stimulate more research in the biomedical sciences.

The unknown relates to the extent or breadth of the Supreme Court’s ruling, such as how would a broad exclusion (of DNA) to patentability affect the biotech industry, given that many patents are already granted in the DNA arena?

Editor: What was the Supreme Court’s ruling and what was the rationale for the decision?

Clower: The decision was more or less straightforward: DNA in isolation – isolated genes, or for that matter, anything that is an isolated product of nature – is not eligible for patent protection. The reasoning involves products of nature and how they are generated, that is, by nature and not from a human being. This has always been the rule of patent law, but here, in Myriad, the Supreme Court reiterated this principle and explained it in the context of an isolated gene. In contrast, cDNA (or complementary DNA), which is synthesized in a laboratory, is patent eligible since its manifestation occurs through a synthetic means, i.e., by human manipulation.

What’s interesting is that there is more than one way of looking at this rationale. One is that you can view a gene as a physical structure removed from its environment via breaking chemical bonds, which was how the lower court viewed the case (and decided in favor of Myriad). The Supreme Court, however, appeared to view DNA, not as a physical structure, but as something more akin to a conduit for information, which can be later translated. Viewed in this way, it becomes clearer that an isolated strand of information (the gene) is the same regardless of whether it is within the chromosome or removed from it. In either case it is a product of nature encoding certain information, which is outside the scope of patent protection. In contrast, cDNA is a human manipulation of this genetic information making it more readily usable by somebody in a lab and therefore patent eligible.

Editor: Please give the factual background on this case. What patents did Myriad Genetics Inc have that involved synthesizing and developing tests for BRCA 1 and BRCA 2?

Clower: Myriad has over 24 different patents with more than 500 claims, many of which relate to the BRACAnalysis® tests – the tests that employ the claimed isolated DNA sequences at issue in the case. Many of their patents, however, are directed towards methods and applications of the claimed DNA, which were not at issue. The three patents at issue in Myriad, which served as the basis for developing these assays, involved DNA sequences pertaining to the BRCA1/2 genes. Mutations within these genes impart an increased susceptibility to various cancers, including breast cancer. Myriad wanted to protect these sequences so that they could exclude others from using applications of the sequences, such as developing a diagnostic test for breast or ovarian cancer.

Editor: Please review the history of the District and Federal Circuit Courts’ decisions.

Clower: There is a long procedural history dating back to 2010 with the case being heard in the Southern District of New York with Judge Robert Sweet as the presiding judge. His ruling held that method claims, composition claims, and applications of the compositions relating to the claimed DNA were invalid. They were all products of nature or principles of nature according to Judge Sweet, and thus not patentable. An appeal was then taken to the Court of Appeals for the Federal Circuit, which overruled the District Court holding that isolated DNA is patentable along with various related methods. AMP (Association for Molecular Pathology et al.), who lost that case, then appealed to the Supreme Court. During the interim, the Supreme Court decided Mayo v. Prometheus, a case related to the patent eligibility of natural principles, and accordingly remanded the case back to the Federal Circuit in view of Mayo. That case held that naturally occurring pharmacological correlations, between a drug and a human’s metabolism, were natural principles and therefore not eligible for patent protection. The Federal Circuit nevertheless again ruled that the isolated gene products were patentable since Mayo concerned method claims, which were inapplicable to the isolated DNA product claims. The case then went back on appeal to the Supreme Court, which we are discussing now.

Editor: Does the decision in the Myriad case sufficiently differentiate it from the decision in Mayo Collaborative Services v. Prometheus Laboratories? Was the Supreme Court’s decision in this case consistent with its earlier rulings?

Clower: For the most part, yes. While Myriad involves products of nature and Mayo concerned natural principles, both cases concerned the bigger issue of just what actions need to be done to impart patentability. In short, they both involved the exclusions to patentability. And, in essence, both cases follow along the same lines: that you need to have something a little bit more than simple recitation of a scientific principle followed by ‘apply it,’ as in Mayo. Or you need to have something more than a natural product that has merely been isolated without further manipulation, as in Myriad.

Editor: Why was the biotech industry fearful that a more expansive ruling might have caused severe repercussions for billions of dollars of investment in other biologic products?

Clower: The biotech industry is not big pharma, which commands huge financial resources and can recover when adverse judgments are handed down. Biotech innovation stems from start-up companies, universities and spin-offs from universities, such as Myriad. Those companies need money at the outset. The only way they are going to secure funding is to protect their intellectual property by way of patent protection. Patents induce investors to invest. If for some reason they are not able to safeguard their intellectual property going forward, it could have a huge impact on what type of monies would become available to startups.

Editor: Explain the Court’s reasoning in allowing cDNA to be patent eligible while the genes themselves were not.

Clower: There are a number of ways to look at this. Digging deeper into the minutia of molecular biology, there really is not a lot of distinction – cDNA is de facto mRNA, which is transcribed from DNA and provides the cell information that can be used to make proteins. However, genes themselves also include introns, which are not part of cDNA. But there’s really no difference in the end product. The Court’s reasoning basically permits complementary DNA (cDNA) to be treated as a non-natural product because it has to be synthesized in a lab (there are certain circumstances where it is also found in nature with viruses, but the Court noted that this variance would not proscribe patent eligibility). But for the most part, cDNA has to be made in a lab, it’s not a natural product, and thus it is patent-eligible according to the Court.

Editor: What important breakthrough does the ability to synthesize genes have for medical science?

Clower: Recombinant DNA technology has been around since the 1970s, and the first patent was issued on synthetic or recombinant DNA back in the 1980s. Many genes have been synthesized and many more can be. They have served as a very important foundation for medical discoveries, therapeutics and diagnostics, such as in the manufacture of insulin, diagnostic tests for HIV, the development of factor VIII for blood clotting. All of these processes use recombinant DNA technology, i.e., synthetic DNA, to make their products. Therefore, it is very important, now and going forward, that this research on DNA and its recombinant processes be continued. As a result of the Myriad decision, it is important that there not be a natural product among a patent’s claims, which preempt use of that natural product. Going forward, patent claim language will be ever so important for ensuring patent protection. And while past Supreme Court cases have inveighed against manipulation of words to impart patentability, that is in fact what it all boils down to in the end – claim language.

Editor: Do you think this is going to revolutionize or change the way biotechnology advances in terms of seeking to synthesis other products or genes?