CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
cDNA
Just as plaintiffs cheered the holding that naturally occurring DNA is not patentable, Myriad Genetics and its allies found cause to rejoice in the ruling that cDNA is not naturally occurring and is, therefore, patent eligible—or, more accurately, is patent eligible unless it is a “very short series of DNA … [with] no intervening introns to remove.” (Op. at 17). The biotech industry may see synthetic DNA as the hook to recapture the huge investment that has been made in mapping various genes and in other forms of genetic research. Once again, however, that result is by no means a foregone conclusion.
Notably, the conclusion that cDNA is not a product of nature and is therefore eligible for patent protection does not necessarily mean that patents on cDNA will be granted or enforced. Rather, to be enforceable, a patent must be the invention or discovery of the patent holder, 35 U.S.C. § 101, and must, inter alia, be both novel (id. at § 102) and non-obvious (id. at § 103). The battle will now shift, therefore, from patent eligibility to whether those who assert a patent have met the other tests for patentability.
Here, another footnote in the Supreme Court’s recent decision may have ominous portent for the biotech industry. Specifically, in footnote 9 (Op. at 17), the Court stated as follows:
The Court may not have expressed an opinion on whether cDNA will satisfy the other statutory requirements of patentability, but those who oppose genetic patents certainly will: They will undoubtedly argue that no patent on synthetic DNA can meet the other relevant requirements.
With respect to the BRCA1 and BRCA2 genes, the opponents of patentability will point out that there is considerable doubt as to whether Myriad Genetics was the sole entity that isolated and mapped those genes. (See Assn. for Molecular Pathology v. US PTO, 702 F. Supp. 2d, 181, 200-203 [S.D.N.Y. 2010] [describing the development of the Myriad patents].) More generally, opponents of patents on cDNA will argue that, once the nucleotide sequence of a gene is known, there is nothing novel or non-obvious in synthesizing the gene. Rather, they can be expected to assert that the gene can be synthesized by any knowledgeable researcher using well-understood laboratory techniques. Thus, while acknowledging the tremendous work and creativity involved in isolating and mapping any gene in the first instance, they will deny that there is anything patentable about synthesizing a gene once its sequence is identified. This sort of argument will simply have to work its way through the courts.
Moreover, the courts may not be the only battleground. This article has already pointed out that the biotech industry might well take the patentability issue to Congress. Similarly, the research and medical communities can equally make their case in Congress. And once the Pandora’s box of patent protection for genetic discoveries and implementation of those discoveries is opened in the legislature, there is simply no telling what is ultimately going to come out.
Method patents and genetic alterations
Thus far, this article has dealt with the likely sequelae of the two issues that were explicitly addressed by the Supreme Court in Myriad Genetics. However, a number of issues that the Court did not confront are also relevant.
The first of these relates to method patents that cover diagnostic testing using isolated or synthesized genetic material. As Justice Thomas observed (Op. at 17), “there are no method claims before this Court.” However, the Federal Circuit had previously invalidated several Myriad patents on methods for analyzing and comparing DNA sequences. (See Assn. for Molecular Pathology v. U.S. P.T.O, supra, 689 F.3d at 1333.) On the other hand, that Court upheld a Myriad patent on a method for screening potential cancer therapeutics via changes in growth rates of transformed cells where that method involved growing host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic. Id. at 1335–1336.
On the patentability of diagnostic methods using products of the human genome, the decision of the Supreme Court a year earlier in Mayo Collaborative Services v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), is relevant. There the Court announced that, to be patentable, a method based on a law of nature has to “provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Id. at 1297. I anticipate considerable litigation in which courts will be called upon to draw the line between: 1) a method that involves nothing of substance beyond instructions to use an isolated gene in a diagnostic procedure (not patentable) and 2) a method that qualifies as a patent-eligible process for using the gene for diagnostic purposes (patentable).
In this connection, a memo to the Patent Examining Corps from Andrew H. Hirshfeld, deputy commissioner for patent examination policy, provides insight into the thinking of the PTO. Written on June 13, 2013—the same day as the Court issued its decision in Myriad Genetics, the memo instructs patent examiners at the PTO to “reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not.” But, the memo goes on to state that “(o)ther claims, including method claims that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2016, Patent Subject Matter Eligibility.” In other words, method claims will have to be evaluated on a case-by-case basis. Until there have been judicial decisions on the patentability of methods using extracted or synthesized DNA, it is too early to know whose claims of victory will turn out to be correct.
Two related questions are whether isolated DNA that has been radiolabeled for use as primers or probes—or isolated DNA that has had its nucleotide sequences altered—will be held to be patentable. The June 13 memo to the Patent Examining Corps suggests that at least the PTO considers such DNA to be patent eligible:
However, as the decision in Myriad Genetics confirms, the PTO is hardly the last word on these issues. Moreover, even if coded DNA or altered DNA sequences are deemed to be the work of human beings and therefore patent eligible, patents on these items may, or may not, survive scrutiny under tests for novelty and non-obviousness. Finally, as noted earlier, Congress may well intervene and craft a legislative resolution of these perplexing issues.
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In the final analysis, the words of Winston Churchill on Nov. 9, 1942 at the conclusion of the Battle of Egypt are equally fitting to describe the decision in Association for Molecular Pathology v. Myriad Genetics: “This is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.” The decision of the Supreme Court on June 13, 2013 is neither the end, nor even the beginning of the end, of the controversy over the patentability of discoveries and methods relating to the human genome. However, it is the end of the beginning. On the question of who will emerge victorious in that ongoing controversy, “the jury” is, as lawyers like to say, “still out.” And it will, I suspect, be a long time before the verdict is in.
[hr]Jack Bierig is a partner in the law firm of Sidley Austin, LLP, lecturer in law at the University of Chicago, and former general counsel of the CAP.