Conexión de cámara independiente

The U.S. Supreme Court, finally, took on the task of settling whether isolated native DNA sequences should be deemed patent eligible under 35 U.S.C. § 101.

The Court did not align with any of the views expressed by the District Court’s and Federal Court’s judges, which focused on devising DNA sequences as “chemical molecules” or “information”. It rather focused on the delicate balance that patent protection strikes.

Justice Thomas, who delivered the opinion of the court, first clarified that Myriad “did not create or alter any of the genetic information encoded in the BRCA1 and 2 genes”,936

but it contributed to locating the genes and identifying the sequences.

He, then recalled Chakrabarty, but it highlighted that the Myriad’s patent claims directed to isolated DNA sequences “fell squarely within the law of nature” exceptions.937

Justice Thomas did not dwell on the “nature” of genes and DNA sequences, but on the form of the claims. In particular, he pinpointed that they were not “expressed in terms of chemical composition”938

and did not “rely in any way on the chemical changes that result from the isolation of a particular section of DNA”.939

Conversely, the claims were focused on “the genetic information encoded in the BRCA1 and 2 genes”.940

However, as cDNA sequences differed from natural DNA ones, since the intron regions had been removed, they were found patent eligible as synthetic products created in laboratories. The Court, therefore, concluded that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”.941 Nevertheless, the Court deemed cDNA patent eligible, as it results in an exons-only molecule that is not naturally occurring.

The judges did not linger over the nature of genes and DNA sequences, but looked at Myriad’s claims, concluding that they were not expressed in terms of chemical composition nor do they rely on chemical changes that result from the isolation of a specific section of DNA. Conversely, they were focused on genetic information encoded in the BRCA1 and BRCA2 genes. As Parthasarathy illustrated, the Supreme Court did not tackle policy and “distributional concerns” related to gene patents.942

The Court, rather, embraced a technical approach and claimed to apply the product of nature doctrine, as set forth in Chakrabarty. Its

936 ibid. 937 _{ibid 2117.} 938 _{ibid 2118.} 939 _ibid. 940 _ibid. 941 ibid 2109. 942 _{Parthasarathy (n 888) 170-171.}

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decision, however, substantially reshaped the boundaries of the natural, which have been stabilized for decades by the practices of the USPTO and courts decisions following

Chakrabarty.

On March 4, 2014 the USPTO issued a new guidance memorandum943 titled “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws Of Nature, Natural Phenomena & Natural Products”,944

superseding the June 13, 2013, memorandum and implementing a new procedure “to address changes in the law relating to subject matter eligibility under 35 U.S.C. § 101 in view of recent court decisions”.945

In the guidance, the overall process to assess subject matter eligibility under 35 U.S.C. § 101 is set out and the examiners should consider whether a patent claim is “significantly different” from a judicial exception, such as a natural product or phenomenon, or not. Some factors weigh for and against patent eligibility. As far as nucleic acids are concerned, the memorandum clarifies that their patent eligibility assessment would be based only on whether “a product claim reciting something that initially appears to be a natural product” is markedly

different in structure from naturally occurring products or not.946 As AMP suggests, this evaluation relies considerably on how the structure of nucleic acids, such as DNA, is interpreted and defined: whether they are considered chemical molecules or carriers of information.

The influential historian of the life sciences947 Hans-Jörg Rheinberger, together with other biologists,948 noticed that “the spectacular rise of molecular biology has come about without a comprehensive, exact, and rigid definition of what a gene is”.949 In particular, Rheinberger illustrated that:

“This claim can be substantiated for both aspects distinguishing the gene concept of molecular biology from that of classical genetics: the aspect of representing a material

943 _{This comment and the following has been published in Emanuela Gambini, ‘In the Aftermath of the ‘Myriad}

Case’ – Myriad is Denied Preliminary Injunction Against Ambry Genetics’ (2014) 3 EJRR 407, 411-412.

944 _{USPTO, Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws Of}

Nature, Natural Phenomena & Natural Products, 4 March 2014, available on the Internet at <http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf>.

945

ibid.

946 _{ibid 4.}

947 _{This long remark, together with the following citations, has been published in Emanuela Gambini, ‘In the}

Aftermath of D’Arcy v. Myriad Genetics Inc: Patenting Isolated Nucleic Acids in Australia’ (2016) 7(2) European Journal of Risk Regulation 451, 458.

948

Fogle (n 458) 3.

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entity, and that of being a carrier of information.950 The meaning of both these notions has remained fuzzy and tied to the experimental spaces that the new biology was going to explore, from the identification of DNA as the hereditary material in bacteria in 1944 to the genome sequencing projects of the late 1980s”.951

He pointed out that the gene is a “boundary object”,952

namely “an analytic concept of those scientific objects which both inhabit several intersecting social worlds (…) and satisfy the informational requirements of each of them”.953

Boundary objects, such as the atom in physics and the molecule in chemistry, he observed, are provided with “organizing power” in research fields and “are embedded in experimental operations”.954

Within molecular biology the “gene” underwent several shifts of meaning:

“At the beginning, molecular genetics, with its set of biochemical practices and genetic manipulations, was characterized by switching from higher plants and animals to bacteria and phages as model organisms. First, it transformed its boundary object, the gene, into a material physicochemical entity. Second, it has made a unit endowed

with informational qualities from the object. The first transformation provided a

solution to the problem that classical genetics had with the stability of its units. The answer was: Genes consist of metastable macromolecules of such as nucleic acids. The second transformation provided a solution to the problem that classical genetics had with its units’ mode of reproduction, and the connection between genotype and phenotype. The answer was: Nucleotide sequences and DNA in particular, can be replicated specifically and faithfully by virtue of the stereochemical properties of their building blocks”.955

Understanding the gene as a “boundary object” accounts for the different views of the gene which molecular genetics endorsed and has become legally pivotal in order to argue about the very nature of DNA sequences and their patent eligibility in isolated/purified form.

However, the analysis of AMP further shows that the “genetic code” and “chemical molecule” have been used as conceptual ontological metaphors in the judicial discourse to

950 _{Sahotra Sarkar, ‘Biological Information: A Skeptical Look at Some Central Dogmas of Molecular Biology’}

in Sahotra Sarkar (ed), The Philosophy and History of Molecular Biology: New Perspectives (Kluwer Academic Publishers 1996), 187.

951

Rheinberger (n 433) 221.

952 _{Susan Leigh Star and James R Griesmer, ‘Institutional Ecology, Translations and Boundary Objects:}

Amateurs and Professionals in Berkeley’s Museum of Vertebrate Zoology 1907-1939’ 19 Social Studies of Science 387.

953 _{ibid 393.} 954

Rheinberger (n 433) 220.

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support and foster a particular definition and view of the gene and its patent eligibility. These two conceptual metaphors have also largely shaped and oriented the work of molecular biologists and geneticists throughout decades and are still influential in their fields, as chapter two has illustrated. The legal discourse has relied on these very influential scientific metaphors on the genome and DNA sequences to validate a view and a definition of the gene in order to solve the issues related to its patent eligibility in the U.S. patent law. The counter- narrative maintained by the plaintiffs, based on the metaphor of the genetic code, undermined the well-established view of the genes as chemical molecules embraced by the USPTO in the Utility Examination Guidelines.

Furthermore, it questioned the well-established sociotechnical imaginary life and nature linked to biotechnology. It pointed out in particular that, if the promotion of biotechnology in terms of products available to the public hinged on their patent eligibility, IPRs over DNA sequences did not contribute to fulfill the needs of patients and bring about a suitable future environment for American scientific research.