Supreme Court Rules Human Genes Unpatentable
In a highly anticipated ruling, the Supreme Court has unanimously held that human genes are not patentable, but DNA constructs that “are not a product of nature” may be patentable. While expressly limited to the particulars of this case, the long-term impact of this decision will reverberate throughout both the pharmaceutical and biotechnology industries.
The Myriad case, discussed in our earlier posts, [ here], is the latest in a line of cases, including Prometheus, discussed [ here], in which the Supreme Court has further spelled out what subject matter is eligible to be patented under §101 of the patent laws. In Myriad, the Court holds that “genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.” In a statement limited to these facts, cDNA, which is not naturally occurring, is patent eligible. The Myriad case could have significant ramifications for the biotechnology and pharmaceutical industries in the coming years, including the extent to which research done by companies and universities is skewed by this decision toward synthetic targets and away from gene identification. Of course, the decision’s direct effect on the validity of patents claiming naturally occurring genetic sequences will be profound. However, in its relatively short opinion, the Court was careful to explain the narrow scope of the ruling, which arguably still leaves a great deal of latitude for gene-related patenting and patenting related to naturally occurring substances generally .
What Is Decided
The facts of Myriad are a complex fusion of biotechnological science and patent law considerations. But centrally, the Supreme Court's ruling focused on only two types of claimed subject matter, namely: (i) a claimed DNA segment - a gene - isolated from the surrounding genetic material of its environment by breaking the covalent bonds from the segment to the rest of the molecule, but in all other respects the same as it existed in nature ("isolated DNA"), and (ii) a claimed gene which subsequent to isolation had been manipulated so that inactive (non-protein producing) portions (introns) were removed to leave only constituent active portions - i.e., an "exons-only molecule" ("cDNA"). (As described in the opinion, during protein synthesis, DNA is transcribed to messenger RNA, which in turn is translated by the cellular machinery into the amino acids that comprise proteins. The messenger RNA contains only exons. cDNA is a strand of DNA made in the laboratory that is complementary to such messenger RNA.)
In brief, the history of the case is that the Federal Circuit Court of Appeals had reversed a District Court decision to the effect that neither of these two claimed embodiments, a naturally occurring gene sequence or a sequence cDNA, was eligible for patenting under §101. Rather, the appellate court held that both of those claimed embodiments could in theory be patented under §101. The Federal Circuit's views are typified by the rationale that "[i]n each chromosome [in nature], the DNA molecule is packaged around histone proteins into a structure called chromatin, which in turn is packaged into the chromosomal structure ... [such that] a distinctive chemical identity and nature" of the isolated DNA would be "markedly different" from its counterpart in nature, thereby conferring patent eligibility.
Declining to follow the path of either the district court (neither the naturally occurring gene nor the cDNA sequence is patentable) or the Federal Circuit (finding both patentable), the Supreme Court split the difference between the two categories, holding that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.” At the threshold, the Supreme Court observed:
As we have recognized before, patent protection strikes 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.' We must apply this well-established standard to determine whether Myriad's patents claim any 'new and useful ... composition of matter,' §101, or instead claim naturally occurring phenomena.
The Court noted that §101 provides "[w]hoever invents or discovers any new and useful ... composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title," but also recognized that the provision "contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable ... [which the Court called] 'basic tools of scientific and technological work." The Court further noted its prior reservation that "without this exception, there would be considerable danger that the grant of patents would 'tie up' the use of such tools and thereby 'inhibit future innovation premised upon them.'" The Court confirmed its long-held rule that: "Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry."
As to isolated DNA, the Court determined that although "Myriad's patent descriptions" indicated "that the location of the gene was unknown until Myriad found it among the approximately eight million nucleotide pairs contained in a subpart [of a particular] chromosome," this was simply the result of an "'iterative process' of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought." The Court was unconvinced, stating that "extensive effort alone is insufficient to satisfy the demand of § 101." Further, the Court said, "Nor are Myriad's claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule." Here, the claiming strategy utilized by Myriad was indicted:
Myriad's claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the ... genes. If the patents depended on the creation of a unique molecule, then a would-be infringer could arguably avoid ... [them by using] a molecule ... [not] chemically identical to the molecule 'invented' by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.
For good measure, the Court additionally disposed of Myriad's argument that "the PTO's past practice of awarding gene patents is entitled to deference" with the insights that "Congress has not endorsed the PTO's position in subsequent legislation," and that the United States had actually argued before the Court that "isolated DNA was not patent eligible under §101," which weighed "against deferring to the PTO's determination."
By way of contrast, the Supreme Court concluded that "cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments." The Court had no apparent difficulty with the notion that "creation of a cDNA sequence ... [involves forming] an exons-only molecule that is not naturally occurring.” An argument that cDNA's exon sequence is the same as in naturally occurring DNA such that the sequence is dictated by nature, thereby making the cDNA a naturally occurring phenomenon, was unpersuasive to the Court because while "cDNA retains the naturally occurring exons of DNA ... it is distinct from the DNA from which it was derived" since the inactive portions have been removed. Although the Court explained that cDNA is the inverse image of mRNA, which is naturally occurring and which also is an exons-only sequence, the Court did not address in any way how this fact was taken into consideration in determining that the cDNA is, from the Court’s point of view, not naturally occurring for purposes of determining patent eligibility under §101.
What Is not Decided
The Court made very clear that it was withholding any pronouncement on the patent eligibility of other concepts that could have been built upon Myriad's discovery of the genes at issue. Thus, the Court emphasized that certain things are "not implicated by this decision," namely: "First, there are no method claims before this Court" (the Court stated that the "processes used by Myriad to isolate DNA were well understood by geneticists at the time"); "Similarly, this case does not involve patents on new applications of knowledge about the ... [discovered] genes"; and lastly, "[n]or do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered." It is evident from the Court's closing language that such developments present independent issues and are not to be understood as necessarily deemed patent ineligible under the Court’s decision in Myriad. Accordingly, while the Court has found that a naturally occurring gene sequence is unpatentable, knowledge gained as a result of identifying that sequence or a method invented to identify and isolate such a sequence is not foreclosed from giving rise to patentable subject matter. For this reason, it may well be the case that the perceived incentive structure that frames research efforts in the area may not be significantly altered by this decision.
Take-away Points
Several inferences follow from the Court's careful handling of the issues before it:
- The law is not intrinsically hostile to the patenting of biotechnological inventions based on naturally occurring material, but to be patent eligible, an invention must be distinct in some manner from a phenomenon that occurs in nature; mere isolation of a unit of matter that is already fully present in nature will not suffice.
- Inventions keyed in some manner to natural phenomena, if patent eligible, will typically be "second order" developments, i.e., a derivative or application of a naturally occurring phenomenon rather than the phenomenon itself; defining a patentable invention would prudently include this consideration.
- Precise identification of the invention is an indispensable part of achieving patent eligibility; if there is a distinction between a naturally occurring material or other phenomenon and the invention, a language prescription reflecting the difference must be present in a patent claim.
- Critical scrutiny of patents in the biotechnological area is warranted before attempts to enforce them, as their issuance by the U.S. Patent and Trademark Office has specifically been called into question by the Myriad Court insofar as patent eligibility is concerned.
Following closely on the heels of the Court’s decision in Prometheus (discussed here) and the Federal Circuit’s recent decision in CLS Bank v. Alice Corp., it is plain that §101 patent eligibility issues have taken on much greater prominence than in past years and will likely play a larger role in the legal and economic evaluation of patent applications, patents, and patent litigation.
© TROUTMAN SANDERS LLP. ADVERTISING MATERIAL. These materials are to inform you of developments that may affect your business and are not to be considered legal advice, nor do they create a lawyer-client relationship. Information on previous case results does not guarantee a similar future result.