Myriad: Positive Implications for Genetic Research, but Some Questions Remain Unanswered
|Written by Jim Lennon and
Gregory J. Brodzik
Young Conaway Stargatt & Taylor, LLP
Posted: June 20, 2013 @ 1:29 pm
Widely divergent views have formed in the wake of the Supreme Court’s decision in Association of Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, slip. op. (U.S. Jun. 13, 2013). Some commentators have reacted with dire predictions for the biotech industry, suggesting that the Court’s holding has unduly narrowed patent protection traditionally granted to DNA technology and has disincentivized researchers in the field, particularly those from small start-ups. Other commentators suggest that the Supreme Court’s decision in Myriad will actually benefit genetic research, particularly researchers at the start-up level. The authors of this post tend to agree with this latter view.
The Court’s holding with respect to what constitutes unpatentable DNA subject matter was quite limited. Justice Thomas, writing for the Court, explained that “[w]e merely hold that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material.” Id. at 18. In other words, a naturally occurring DNA segment does not qualify as patentable subject matter merely by virtue of its “isolation from the remainder of the human genome.” Id. at 1. Despite this limitation, the Court identified and implicated several related areas of technology that would not, as a matter of law, qualify as unpatentable subject matter. Indeed, if read carefully, the opinion actually provides instructions on how to successfully procure patent rights for technologies related to genes that have been identified and isolated.
First, the Court held that cDNA, synthetic DNA, is not a naturally occurring product of nature and therefore passes § 101 muster as patentable subject matter. Id. at 16-17. Second, it explained that Myriad’s invalidated claims had been drafted in a manner that were code-centric—i.e., they were drafted with a focus on the genetic code as represented by the particular nucleotide sequence rather than a focus on some other physical or chemical property of the isolated code sequence that is not naturally occurring. Id. at 14-15. Thus, while it is not entirely clear how the PTO would react to such claims, a focus on the non-naturally occurring physical or chemical aspects of the isolated sequence may allow similar claims to satisfy § 101. Third, and most importantly, the Court suggested that “applications” of knowledge gleaned from the genes identified and sequenced, in addition to DNA that has its natural nucleotide order altered, may qualify as patentable subject matter. Id. at 17-19.
Carving these areas out as potentially fertile ground for patent eligibility, the Court has left intact sufficient space for researchers to procure protection for innovations related to genes that have been identified and sequenced, so long as the patent claims are drafted appropriately with Myriad’s guidelines in mind. Thus, rather than unduly limiting patent rights, the holding from Myriad simply invites savvy patent drafting and curtails overly broad claiming practices. For example, rather than draft a claim in terms of an isolated DNA sequence, patent attorneys will try harder to draft claims directed to what is new about the sequence discovery, either in terms of the chemistry or how the sequence can be beneficially applied. Rather than create disincentives for research and innovation in the biotechnology industry, the Court’s holding will likely open the door to more applied generic research, research that was, prior to the Myriad decision, barred by the first party to isolate and claim in patent a previously undisclosed gene sequence, regardless of that party’s knowledge of its full range of usefulness. No longer can a generic researcher claim to have “invented” an isolated DNA segment without any knowledge or disclosure as to the new and beneficial uses for the isolation segment. Not only will inventors be incentivized to discover and disclose the range of utility of the isolated DNA sequence, Myriad will also increase the demand for more sophisticated patent prosecution.
Some may still argue that the manner in which the Supreme Court split the baby—or, in other words, drew the line of patentable subject matter between DNA and cDNA—was arbitrary. It is difficult to argue against this perception. The Court did not provide much explanation for why the removal of introns from a nucleotide chain makes cDNA patent eligible, yet severing covalent bonds to isolate a DNA segment was insufficient to render the claim patent eligible. In both instances, the precise substance is acknowledged by the Court to be non-naturally occurring. Indeed, prior to the Supreme Court’s decision, Judge Lourie from the Federal Circuit had found isolated DNA segments to be non-natural, and therefore patentable subject matter, because the chemical alteration to the covalent bonds created a nonnaturally occurring molecule.
Myriad presented the Court with a profoundly fundamental question to resolve, where to draw the line between natural and man-made, in the face of very complex science. Myriad represents a critical step in the Court’s quest to delineate the boundaries of patent eligibility, particularly in the world of complex biotechnology. And as the science of biotechnology continues to advance, conventional distinctions between natural and non-natural may only become more obscured. Regenerative medicine, for example, may present many interesting questions regarding the boundaries of natural versus patent eligible. If nothing else, the Myriad decision demonstrates that the complexity of the underlying science will not impede the Court from resolving fundamental legal questions, including the law regarding patent eligibility. The fact that technology presents difficult questions does not mean that our judiciary will avoid answering difficult questions. And to the extent the Court was required to draw a line in this instance, these authors believe the line was drawn in the correct place.
Specifically, in reaching its decision, the Court echoed the well-established principle that a fundamental purpose of the patent laws is to “strike a delicate balance between creating ‘incentives that lead to creation, invention, and discovery” and ‘imped[ing] the flow of information that might permit, indeed spur, invention.’” Id. at 11. The Court’s reliance on this basic tenant guided it in maintaining the vital balance. The Court’s apparent position, consistent with the reality in the biotechnology sector, is that particular genes that are identified and sequenced are “the basic tools of scientific and technological work.” Id. (emphasis added). They are not ends in themselves, but rather comprise the basic foundation to spur new and useful applications. Innovators will now have these genetic compositions, the basic building blocks of their research, at their disposal without fear of a patent on an isolated gene sequence. With these genetic “tools” no longer “tie[d] up,” researchers have a new freedom to innovate. Id.
Others will maintain that the Court did not strike the correct balance here, as the discovery and sequencing of genes requires a substantial amount of time, energy, and up-front capital, and should therefore be rewarded with broader, and therefore more valuable, patent protection. It is often advocated, in support of this view, that it is impossible for researchers, especially small start-ups, to be cognizant of every application of a newly discovered gene, and it is therefore only the extensive monopoly over all uses of the isolated sequence that justifies the researchers’ investments in countless failed endeavors before discovering the proverbial needle in the haystack.
However, while the amount of labor and capital required to identify, sequence, and isolate a gene are appreciable, those investments never have and never will set the standard for what constitutes patentable subject matter. Indeed, the discovery of laws of nature and natural phenomena—for example, Einstein’s discovery of the famous E= mc^2 equation—almost always require significant discovery efforts. As the Court correctly explained, these discovery efforts cannot set the bar for § 101: “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Id. at 12. If such efforts did set the standard, an undesired imbalance would arise, as patent protection could be implemented to improperly restrain the basic tools and flow of information that innovation demands. While one might quarrel with the Court’s suggestion that a “discovery” is an act that is separate and distinct from an “invention,” at its root the Myriad decision reflects the proper view that patent subject matter eligibility—unlike the consideration, for example, of non-obviousness—should not turn on the degree of “effort” made by the inventor.
Moreover, granting a patentee a monopoly over an isolated gene sequence tends to disincentivize innovators, as it creates an unjustified barrier to entry for any future application involving that sequence. Why would researchers invest and work to discover and patent an application that they will be unable to practice as the result of a related isolated gene patent? By narrowing the scope of the legal patent monopoly to the man-made substance or new uses for a natural substance, inventors will have incentives to discover new applications of a particular gene even after it has been identified and sequenced.
Despite these positive implications, the Myriad decision still leaves some questions unanswered. For instance, while the decision precludes the patenting of isolated genes, it does not address whether purified natural materials will be patent eligible. Further, the decision calls into the question, but does not provide a concrete answer, to the patent eligibility of proteins and other naturally occurring substances.
Moreover, it is uncertain how Myriad’s § 101 analysis will be reconciled with the Supreme Court’s decision Mayo Collaborative Services v. Prometheus Laboratories, Inc., No 10-1150, slip. op. (U.S. Mar. 20, 2012). In Prometheus, the patent eligibility of method claims related to “optimizing [the] therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder” was at issue. The Court held that the claims did not satisfy § 101, reasoning that the “claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Id. at 11 (emphasis added). In light of this language and similar statements throughout the opinion, it appears the Prometheus Court allowed a § 103 obviousness analysis to creep into its § 101 analysis, and such an approach under § 101 is problematic. Courts and scholars have recognized that when addressing the § 103 obviousness inquiry, a certain amount of hindsight bias may be inherent. To protect against this hindsight bias, courts have allowed patentees and those procuring patent rights to assert secondary considerations of nonobviousness to rebut an obviousness presumption. However, when an obviousness inquiry appears in the context in the § 101 analysis, such protections are not available.
On the other hand, Myriad appears to have taken a step in the right direction with respect to § 101’s analysis. The Court found cDNA, a composition of matter, patent eligible pursuant to § 101, but explicitly asserted that it “[e]xpressed no opinion whether cDNA satisfies[ed] the other statutory requirements of patentability.” Myriad, No. 12-389, slip. op. at 17 n.9 (emphasis added). Further, the Court may have suggested that cDNA would be obvious pursuant to § 103 if such an issue were before a court, as it appeared to concede that “the nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” Id. at 17. Thus, in Myriad, it seems the Court appropriately separated the §§ 101 and 103 statutory inquiries. It may be that Myriad’s apparent inconsistency with Prometheus is a result of the fact that Prometheus addressed method claims, whereas Myriad addressed a composition of matter. Regardless, the Court will eventually reconcile this apparent inconsistency, and will hopefully apply an analysis more in line with Myriad, irrespective of the claim type addressed.
To conclude, these authors anticipate Myriad’s impact on biotechnological innovation as more likely positive than negative. On the other hand, several questions remain unanswered, including whether Myriad foreshadows the Supreme Court’s retreat from what many believe was overreach in Prometheus.
About the Authors
Jim Lennon is a registered patent attorney and a partner in the Intellectual Property Litigation Practice Group at Young Conaway Stargatt & Taylor, LLP in Wilmington, Delaware. Jim has successfully represented clients in patent litigations in various forums in a wide array of technological fields.
Greg Brodzik holds a degree in bioengineering and is an associate in the Intellectual Property Litigation Practice Group at Young Conaway Stargatt & Taylor, LLP in Wilmington, Delaware