Isolated Genes Are None Of Your Business! – SCOTUS Decides Myriad

Isolated Genes Are None Of Your Business! – SCOTUS Decides Myriad

On June 13, 2013, the U.S. Supreme Court rendered a decision which ruled against the patenting of isolated DNA sequences in their natural form in the now infamous case involving Myriad Genetics, Inc. and the BRCA1 and BRCA2 genes.  The decision represents a major milestone in the legal treatment of biotechnological inventions, and presents a number of relevant social and economic consequences.

Myriad Genetics, Inc., after discovering the exact location and sequence of the genes BRCA1 and BRCA2 – mutations of which may increase the risk of breast and ovarian cancer – was able to isolate these genes, enabling, inter alia, the identification of genetic predisposition to these cancers. Only a subset of nucleotides can code for amino acids and consequently generate a protein ("exons"), while other nucleotides ("introns")are not able to perform this function.  Myriad created synthetic DNA sequences (so-called "complementary DNA" or "cDNA"), in which the natural introns are removed and only the exons remain, providing significant advantages for genetic examinations and other scientific purposes. On this basis, Myriad obtained patents on isolated genes BRCA1 and BRCA2, as well as patents relating to their synthetic DNA sequences. After obtaining these rights, various stakeholders filed actions against Myriad and the USPTO, claiming the invalidity of patents based primarily on patent ineligibility of products of nature.  The case made its way through the District and Federal Courts, and all the way to the U.S. Supreme Court. (For some of the IPilogue's past coverage on this story, click here and here.)

In its decision, the U.S. Supreme Court  stated that:

a) Laws of nature, natural phenomena and abstract ideas are not patentable under § 101 of Title 35 U.S.C.;

b) Isolation of genes without any creation or alteration of genetic information is not an act of invention. Despite the great scientific relevance of Myriad's discovery, the isolated BRCA1 and BRCA2 genes and their genetic information are merely a product of nature, and therefore are not patentable under § 101; and

c) Unlike the genes BRCA1 and BRCA2, cDNA molecules, consisting only of exons, are not naturally occurring, but a result of human inventiveness. Even if the nucleotide sequence of cDNA is dictated by nature, it is unquestionable that the lab technician creates something new when cDNA is made. Therefore, cDNA is distinct from the DNA from which it was derived, so that it is patentable under § 101.

The U.S. Supreme Court also distinctly pointed out that this case did not involve method patents, new applications of knowledge about BRCA1 and BRCA2, and alteration of order of naturally occurring nucleotides, thereby preventing any implication of this case to these endeavors.

As a consequence of the decision, Myriad no longer has exclusive rights to the BRCA1 and BRCA2 genes, thereby allowing competitors in the biotechnological sector to recreate and use them. This will have important implications both socially and economically.  Firstly, the free use of the genes by various companies increases the opportunity for development and innovation for identification and treatment of cancer and for the discovery of new functions for the genes. In this way, public health can potentially obtain a number of additional long-term benefits.  Secondly, due to the competition exerted by other companies, the price of tests for identifying susceptability to cancer is expected to be reduced. Currently, the price of a complete test is around $3,000 to $4,000 USD, making the test an unfeasible option for many people. The real economic benefits of the decision, however, are still questionable because (1) Myriad's patent on the cDNA was upheld and (2) Myriad likely has a number of trade secrets related to mutations of the BRCA1 and BRCA2, guaranteeing it significant exclusivity in this sector.  It will be necessary to observe the development of the market in the coming months to draw more concrete conclusions.

Despite its advantageous practical effects, the decision deserves criticism for some inconsistencies. In order to support the non-patentability of the genes BRCA1 and BRCA2, the U.S. Supreme Court emphasized that since the genetic information of these genes was not created or changed by Myriad, it should be considered as a product of nature and, consequently, ineligible for patentability. In order to support their conclusions on the patentability of the cDNA, however, the Court did not apply the same logic. Although the elimination of introns does not occur naturally, the genetic information contained in exons is pre-existing and results from purely natural processes, and by the Supreme Court's logic applied to BRCA1 and BRCA2, should be considered non-patentable. Furthermore, even while recognizing the possibility that a molecule similar to cDNA may possibly occur naturally by an unusual and rare phenomena caused by viruses, the Court confirmed its patentability as a composition of matter (§ 101) without providing a reasoned analysis of their opinion. Finally, the Court suggested that if the patent claims were focused merely on the chemical composition of the molecules of BRCA1 and BRCA2 instead of the actual genetic information of these genes, patentability may be possible; a statement which does not seem to be well-supported by the judiciary in light of § 101 and of the law of nature exception. In short, the U.S. Supreme Court did not exactly establish a boundary between the concepts of "product of nature" and "the result of human inventiveness", and as a result there is still legal uncertainty with respect to biotechnological patents.

Apart from the criticisms, it is important to note that the decision in Myriad under U.S. law is opposite to the current law in the European Union. Directive 98/44/EC states that isolated DNA sequences are patentable. Many scholars dispute whether the scope of protection provided by these patents is absolute (comprising all applications of the chemical compound) or purpose-bound (comprising only the applications indicated by the patent applicant). On this, the European Court of Justice decided prima facie that the scope of protection of biotechnological patents is purpose-bound (see Monsanto v Cefetra). This difference in legal treatment in the EU is favorable to holders of patents related to DNA sequences, who can still enjoy legal protection in several European countries.

In my opinion, the decision by the U.S. Supreme Court is, to some degree, appropriate. The acknowledgment that the isolated genes occur naturally is correct; if the product itself is not a result of the human inventiveness, but only found in the nature, it is not an invention. This view excludes the patentability of DNA sequences and promotes development and innovation by competitors. If the isolation of genes constitutes an inventive step, the methods of isolation may be considered patentable, but not the chemical compound itself. The novelty of the isolated genes, however, is questionable since its existence is known before isolation. In spite of this, there remains some well-founded criticisms of the decision, which the Court will need to address them in future cases.

The decision of the U.S. Supreme Court in Myriad creates an important precedent for cases related to the patentability of biotechnological inventions in the USA and, considering its subject-matter, can serve as a model for improvement for legislatures and judiciaries in other countries.

Pedro Henrique Dias Batista is an IPilogue Editor and a PhD student at Ludwig Maximilian University of Munich.