By Donald Zuhn --
In an amicus brief filed last week in support of respondents Myriad Genetics, Inc. et al., the Intellectual Property Owners Association (IPO) asked the Supreme Court to affirm the Federal Circuit's decision in Association for Molecular Pathology v. Myriad Genetics, Inc. that claims to isolated human DNA are patent-eligible. The IPO brief opens by noting that "[w]hile Petitioners and their amici provocatively refer to the subject matter at issue in this case as 'human gene patenting,' this term inaccurately characterizes the claims in Myriad's patent," and that "what is claimed is a specific sequence of isolated human DNA."
The IPO argues first that isolated human DNA constitutes patent-eligible subject matter. Citing Diamond v. Chakrabarty, the brief reminds the Court that it "fashioned a straightforward test of whether a manufacture or composition of matter was patent-eligible: it must demonstrate the 'hand of man,' something that is 'a product of human ingenuity 'having a distinctive name, character [and] use.''" The IPO argues that "[t]he Court's Chakrabarty test is the proper standard for patent-eligibility, not the imposition of bright line, categorical rules applying broad, categorical prohibitions such as that advanced by Plaintiffs and their amici," and thus, "[a]nything that evinces the 'hand of man' is patent-eligible" (emphasis in brief).
According to the IPO, isolated human DNA satisfies the requirement in Chakrabarty that claimed subject matter show "the hand of man," and therefore is patent-eligible. With respect to the characteristic of being "isolated," the brief notes that "the entire genetic complement (or genome) in the cell comprises about six billion nucleotides of DNA," and that "[a]n individual gene typically comprises about 1,000 of these nucleotides." The brief points out that "to isolate a gene requires these specific 1,000 nucleotides to be separated from the remaining (approximately) 5,999,999,000 nucleotides in the cellular genome."
The IPO next addresses the impact of other Supreme Court decisions on the Myriad case, arguing that no other precedent controverts Chakrabarty. Noting that the Court recently addressed the issue of patent eligibility in Mayo Collaborative Services v. Prometheus Labs., Inc., the brief states that the Court's concerns about the scope of patent eligibility "arise when the claims produce no more than information (inform a relevant audience about certain laws of nature)." Citing the Court's decisions in O'Reilly v. Morse, Gottschalk v. Benson, Parker v. Flook, and Bilski v. Kappos, the brief contends that "[i]n each of these decisions, the Court found a lack of patentable subject matter because the claimed method provided little (or nothing) more than abstract information as opposed to concrete inventions that 'promote the Progress of . . . the useful Arts.'" Contrasting these cases with Myriad, the brief states that:
Unlike the method claims in Mayo, Benson, Flook and Bilski, Myriad's composition of matter claims at issue here are not broadly preemptive. They are both specific and concrete and as such do not implicate the policy concerns enunciated by this Court in those cases where preemption rendered claims patient-ineligible. Rather than being directed to mere information, the claims at issue are drawn to a useful and concrete composition of matter that falls within the statutory classes of patentable subject matter defined by Congress in Section 101 of the patent statute. Since Myriad's claimed inventions "evince the hand of man," they are directed to patentable subject matter per Chakrabarty.
Turning to Petitioners' argument that isolated human DNA is patent ineligible because it constitutes a product of nature, the IPO counters that "[t]his contention is incorrect as a matter of law and as a matter of fact." The brief explains that:
The claimed isolated human BCRA1 and BCRA2 DNA are not "products of nature" because, as claimed, they are not found in nature. These isolated human DNAs are never found "isolated" in nature. First, they are not merely associated with contaminants (like the "intracellular material" contaminating cellulose in the Wood Paper Patent Cases); they are intrinsically (and covalently) attached to and are a part of the physical and chemical structure of the chromosomal DNA, and their isolation requires them to be separated from this DNA, i.e., to be present in an entirely new chemical structure. . . . [I]n other (cDNA) embodiments the claimed isolated human DNA is also not merely "isolated" but chemically changed in the process, first by the cell in making mRNA, and again by the inventor in converting the mRNA into cDNA. Thus, the claimed subject matter is different, physically and chemically, from the DNA present in nature.
The brief continues by arguing that:
[Another] line of reasoning, enunciated by the Court in Funk Brothers and recited with approval in Chakrabarty and more recently in Mayo, is that claims cannot encompass a "natural law" or "phenomenon of nature." Myriad's claims to isolated human DNA do neither. These claims recite man-made manufactures or compositions of matter, not phenomena. They are tangible, physical compounds, having particular and specific structures capable of being elucidated and described. They do not foreclose anything other than making, using, selling, offering to sell, or importing these specific and particular chemical compounds.
The IPO also takes the Petitioners to task for "wrongly equat[ing]" the patenting of isolated human DNA with the patenting genetic information. While acknowledging that "[t]here is no dispute that genetic information, standing alone, is not patentable subject matter and does not belong to one of the statutory categories required for patent-eligibility," the IPO argues that "[p]atent claims to isolated DNA only cover the isolated DNA itself, and not the genetic information per se." The brief also argues that:
The dichotomy between patent-eligible isolated human DNA and patent-ineligible genetic information is consistent with precedent. For example, in O'Reilly v. Morse, 56 U.S. 62, 63 (1853), the ability to use electricity for communication was found to be patent-ineligible, but the specific telegraph invented by Morse was determined to be patent-eligible. Algorithms per se have also been held to be patent-ineligible, Parker v. Flook, 437 U.S. 584, 585 (1978); Gottschalk v. Benson, 409 U.S. 63, 64 (1972), while the use of an algorithm (an equation) in a patented process has been found to be patent-eligible, Diamond v. Diehr, 450 U.S. 175, 177 (1981).
The brief next discusses the adverse impact that a ban on isolated human DNA patenting would have on the development of biologic drugs and personalized medicine. The brief also suggests that "[a]bsent patent protection, and under the circumstances of multigenic causation (or at least association) of common diseases, the impetus will be to develop and protect this nascent technology using, inter alia, trade secret protection." The brief predicts that "[u]nder these circumstances, innovation in genetic-based diagnostics would be severely limited, since there would be no incentive (indeed, there would be strong disincentives) to disclose the genetic basis of the diagnostic assay," and that as a result, genetic information "as a trade secret, could be kept out of the public domain indefinitely."
The brief concludes by arguing that isolated human DNA patenting does not impede research. In support of this conclusion, the brief cites a study performed by the American Association for the Advancement of Science on the effects of isolated human DNA patenting on basic research in the U.S., Germany, the U.K, and Japan, the study finding that "intellectual property rights had little negative impact on the practice of science." Suggesting that "[p]erhaps the best measure of [research] activity is the number of research reports in public databases that reflect ongoing basic scientific research in peer-reviewed scientific journals," the brief notes that "[w]hile reported estimates differ depending on the search term used, a simple search of 'brca1 or brca2' resulted in 10,652 publications [in the scientific literature]." The brief then adds that:
If [Myriad's] patents had a chilling effect on basic research, the expectation would be that the number of scientific research reports would have declined in the face of these patents. On the contrary, the number of such publications has steadily increased each year, which is precisely what would be expected if these patents had no significant effect on basic scientific research.
What these patents do, of course, is prevent commercial activity -- using the patented isolated human DNA or performing the patented methods for profit. This is a legitimate exercise of the patent grant.
Note: the IPO brief was co-authored by Patent Docs author Dr. Kevin Noonan.