In respect to the human body, Article 5(2) of Directive 98/44/EC is inadequate and outdated given the current state of biomedical research. There are three reasons why Article 5 is no longer relevant. First, the isolation and purification technique has become a standard research tool. Unless there is a new and better isolation technique that is developed, products which are isolated and purified should not be perceived as new and inventive. Moreover, the concept of isolation and purification is inadequate. It is a legal
675 Article 5(2) of Directive 98/44/EC
676 Article 5(3) of Directive 98/44/EC
174 term, artificially constructed to draw a line between what is/not patentable pertaining to human genetic information. However, the concept of isolation has been adopted by the EPO and USPTO with a legal value. In the US, this has taken place through case law. In the EU, this development was through the enactment of Directive 98/44/EC. It is
submitted that principles such as ‘isolation,’ ‘purification’ and ‘modification’ of naturally occurring substances are emphasized in determining whether the claimed product or process constitutes an ‘invention,’ ridding decision makers the task of making decisions based on policy.
4.5. Patenting isolated genes in the EPO and US 4.5.1. AMP v. Myriad (2013)
In the United States, isolated genes are no longer considered inventions after Myriad because they are ‘products of nature.’677 The Supreme Court decided whether Myriad’s claimed isolated DNA sequences were products of nature using Chakrabarty’s
“markedly different” test. The ‘markedly different’ test is now being utilized in
assessing whether there is a difference in the information between the claimed sequence and the naturally occurring one. The Supreme Court maintained that Myriad’s BRCA sequences were not ‘markedly different’ from the naturally occurring sequences.
Unfortunately, the Supreme Court failed to provide further clarification of what the
677 Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. 569 U.S. 12-398 (2013) Ten amicus briefs were filed from groups with an economic stake in biotechnology patents. These groups included Genentech, the Pharmaceutical Manufacturers Association, the New York Patent Law
Association, and the American Society for Microbiology, the American Patent Law Association, the American Bar Association, James Watson, Eric Lander and James Watson. James Watson, co-discoverer of the double helix structure of deoxyribonucleic acid, maintains that human genes should not be
patented, emphasizing the informational nature of a gene and that it is a product of nature. See: Brief of James D. Watson, as Amicus Curiae in Support of Neither Party. The Association of Molecular
Pathology, et al., v. Myriad Genetics, Inc., et al., No. 12-398. 2013 at 4. The American Bar Association submitted that isolated DNA compounds should be held eligible for patenting. Otherwise, it would disrupt decades of reliance on the Court’s precedent and the USPTO’s practice in allowing such claims. See:
Brief of the American Bar Association as Amicus Curiae in Support of Respondents. The Association of Molecular Pathology, et al., v. Myriad Genetics, Inc., et al., No. 12-398. 2013 at 4. Eric Lander, a geneticist and molecular biologist, maintained that in the scientific community, it is a well-accepted fact that isolated DNA fragments of the human genome (including isolated DNA fragments of the BRCA1 and BRCA2 genes) are routinely discovered in the human body and are thus, products of nature and not eligible patent subject matter. See Brief for Amicus Curiae Eric S. Lander in Support of Neither Party.
The Association of Molecular Pathology, et al., v. Myriad Genetics, Inc., et al., No. 12-398. 2013 at 29.
175 notion of ‘markedly different characteristics’ encompasses, and how these differ from characteristics that are not markedly different. It is uncertain whether the markedly different test is based on a different chemical structure or a greater concentration, or whether the utility of the claimed function needs to be entirely different from the natural function.
The reason why the case is confusing is because prior to this case, the product of nature doctrine had been circumvented by novelty and utility of the invention through isolation and purification (Parke-Davis). In the Federal Circuit, the court applied the Parke-Davis line of argument to the tools for isolation and purification of genes in determining whether they were new and useful.678 Novelty was determined by considering the chemical differences between the naturally occurring gene and the claimed isolated gene, rather than the informational content. For the utility requirement, the court considered the isolated sequences useful in developing a diagnostic test for BRCA1 and BRCA2 genes. However, this argument was not adopted by the Supreme Court, which instead has returned to an ‘old school’ product of nature interpretation as found in Latimer and Funk Bros by holding that the claimed isolated genes are not markedly different enough to qualify as an invention, which is the first of its kind since the industry expected the acts of isolation and purification to overcome the product of nature doctrine.
It is submitted that the observance of isolated genomic sequences as products of nature is a result of the emphasis on their informational qualities. As a result, there seems to be a shift in perception of DNA, as it is no longer considered to be a mere chemical molecule no different from other chemicals. It can be argued that information inherent in DNA represents a law of nature, although there are still disagreements over
678 Association for Molecular Pathology v United States Patent and Trademark Office et al (2011)
176 how DNA should be understood.679 But for now, it seems in the US that the function of a claimed DNA sequence (and not merely its chemical structure) needs to be markedly different, or possess a completely new genetic identity from any that naturally exists in the human body.
The day before the US Supreme Court issued its judgement, Senator Leahy wrote to Francis Collins, Director of the NIH to enforce its march-in rights found in section 203 of the Bayh-Dole Act of 1980.680 Leahy emphasized that a part of Myriad’s research was federally funded and, therefore, was required to offer licenses to a
“responsible applicant or applicants.”681 If Myriad remains unwilling to license its cDNA patents, then the NIH can grant the license. Myriad’s sole recourse would be to litigate in the Court of Claims. Leahy wrote that the “health needs of the public are not reasonably satisfied by the patentee…because many women are not able to afford the testing provided by Myriad.”682 Myriad’s continued refusal to license its patents and pursuance of law suits against its competitors may have been the motivation for Leahy’s letter to Collins. Interestingly, the day after the Supreme Court invalidated Myriad’s
679 Interview with Trevor Cook, April 20, 2012. Trevor Cook states:
“Everything holds information in a way. It may mean that perhaps the basis for the inventive step analysis is different. It may mean that you need to claim things functionally. But I don’t see that just because something has an information-rich quality that you should have some sort of miraculous effect in and of itself. The early days of DNA patenting, like EPO, or the HGS type of patenting, people are not actually concerned with protecting the DNA itself even though they claim the DNA. They claim the DNA because of the information inherent to those claims as a way of seeking to monopolize the proteins to which those sequences code it. Thus, you have DNA claims in the EPO patent, DNA claims in the HGS patent. But the interest was not in the DNA, the interest was that it was a good way of claiming the protein itself, or claiming the protein when produced by recombinant DNA technologies. Because the protein itself was already isolated and thus lacked novelty.” With the quotes I think you need to go over them and add missing words in square brackets so the meaning is clearer
680 35 USC § 203 (a)(3)“With respect to any subject invention in which a small business firm or nonprofit organization has acquired title under this chapter, the Federal agency under whose funding agreement the subject invention was made shall have the right, in accordance with such procedures as are provided in regulations promulgated hereunder to require the contractor, an assignee or exclusive licensee of a subject invention to grant a nonexclusive, partially exclusive, or exclusive license in any field of use to a
responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if the contractor, assignee, or exclusive licensee refuses such request, to grant such a license itself, if the Federal agency determines that such—action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees.”
681 35 USC § 203(a)
682 Leahy, P. Letter to Dr. Francis Collins. July 12, 2013. http://www.patents4life.com/wp-content/uploads/2013/07/LeahyGeneTesting.pdf. Accessed October 2, 2013.
177 BRCA1 and BRCA2 gene patents, the NIH offered BRCA1 and BRCA2 testing on its website.683