The Supreme Court recently granted a writ of certiorari in the highly controversial case Association for Molecular Pathology v. Myriad. In the coming months, the Court will determine whether the genetic material claimed by Myriad’s composition patents is patentable subject matter under Section 101 of the Patent Act. The high profile case has generated a widespread debate often framed as whether genes should be patentable. To the extent that the patentability of genetic material is not the specific question at issue in Myriad, such publicity may be misleading or overstate the impact of the Supreme Court’s decision. This post seeks to serve as a reminder that a holding in favor of Myriad would only establish that the claims at issue meet one of the many requirements of our patent system.
The nonobviousness and written description requirements set forth in sections 103 and 112 of the Patent Act provide additional and, some argue, more effective filters for claims directed towards genetic material. According to some academics, these requirements have been much further developed in the case law, are more finely tuned to address patents on genetic material, and provide more appropriate filters for separating truly inventive additions to human knowledge from unpatentable matter. Two landmark cases illustrate how these requirements have been used to invalidate claims directed towards genetic material.
First, the Federal Circuit invalidated patent claims for failing to meet the written description requirement in Regents of the University of California v. Eli Lilly & Co. The patent specification described cDNA encoding rat insulin, which the court held did not give the patentee a right to also claim the cDNA encoding human insulin. The court emphasized that even if the disclosure was sufficient to enable a person of skill in the art to make and use that cDNA, it still failed to meet the written description requirement. On the other hand, the court noted, a recitation of the actual nucleotide sequence would suffice. As some scholars argue, the requirement so applied compels applicants “to spell out the exact sequence of all the DNA they hope to claim, rather than just the function of the genes.” Denise DeFranco argues that the primary goal of applying the requirement in this way to biotechnology patents “is to limit inventors to their actual inventions.” Indeed, at the time the Plaintiffs in Eli Lilly applied for the patent claiming human insulin, they had only cloned the rat insulin gene, and did not clone the human insulin gene until two years later.
In another significant biotechnology case in 2009, In re Kubin, the Federal Circuit invalidated patent claims on obviousness grounds. The case involved a claim to the isolation and sequencing of a gene encoding a protein domain known as NAIL. In light of the prior art references, which taught a prophetic method for isolating the gene that codes for the NAIL protein as well as a probe specific to the protein, the court held that the claims were invalid. Prior to this holding, similar patents had been upheld even when the prior art included as much or more information as that considered in Kubin, such as the actual polypeptide sequence of the protein at issue and not just a probe for the protein. This decision has thus been characterized as “a major change in the law that will lower the bar for finding biotechnology patents obvious.” Joanne Kwan postulates that following Kubin, biotech inventions such as claims to isolated genes that encode particular proteins may now be routinely invalidated as obvious under Section 103.
This post does not comment on the social desirability of allowing patents on genetic material, nor on the legal merits of the arguments in Myriad. Rather, it seeks to highlight that the question raised by the patentable subject matter challenge in Myriad is a narrow one, a “coarse eligibility filter” in the words of the Federal Circuit. The Patent Act provides a number of other requirements to ensure that patents on genetic material aren’t improvidently granted when, for example, the inventors have not actually cloned the gene they are claiming, or when the protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions for cloning the gene already exist in the prior art. Regardless of the precedent ultimately set by Myriad, these and other additional statutory requirements will continue to have a significant impact on the validity of patent claims directed to genetic material.