On April 15, 2013, the Supreme Court heard oral arguments in one of the most controversial and publicized biotech patent cases–the “ACLU/Myriad” gene patent case (e.g., The Association For Molecular Pathology v. USPTO). While it is always risky to predict the outcome of a Supreme Court case from the oral arguments, the Justices seemed to have accepted the U.S. Solicitor General’s arguments that cDNA molecules satisfy § 101, but seem unlikely to find that human genes can be patented.

Are Human Genes Patentable?

The Supreme Court granted certiorari to address the fundamental, threshold question of the patent-eligibility of human genes. The specific Myriad patent claims at issue are directed to “isolated DNA” molecules that embody the BRCA1 and BRCA2 mutations associated with an aggressive form of breast cancer and ovarian cancer. The Federal Circuit has upheld the patent-eligibility of these claims twice (before and after the Supreme Court decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services). The Supreme Court’s decision to take up this case for review has been seen by many as a sign that the Court disagrees.

The Court will evaluate Myriad’s patent claims under the “product of nature” exception to 35 USC § 101, which holds that a patent cannot be granted on a naturally-occurring product. The Court has been presented with three ways to resolve this issue:

  • The ACLU would have the Court decide that human DNA sequences cannot be patented because they encompass naturally-occurring human genes, or embody the same genetic information as human genes.
  • Myriad would have the Court decide that any “isolated” DNA molecules can be patented, because they are distinct from products of nature on that basis.
  • The U.S. Solicitor General has urged the Court to decide that claims the might encompass human genes should not be patent-eligible, but claims that are directed to DNA sequences that are not found in nature (such as Myriad’s cDNA claims) could be patented, even if they contain the same “genetic information” as a human gene.

The Federal Circuit Decisions

The Federal Circuit twice upheld Myriad’s “isolated DNA” claims in fractured decisions. Each time, Judge Lourie wrote an opinion in support of the majority decision, which was joined by Judge Moore, Judge Moore wrote a concurring opinion, and Judge Bryson dissented.

Judge Lourie’s opinion emphasized the “isolated” nature of the claimed DNA, and the fact that covalent bonds in the naturally-occurring genomic DNA sequence must be broken in order to obtain “isolated” DNA.

Judge Moore was less certain that isolated DNA is sufficiently distinguished from naturally-occurring DNA to satisfy 35 USC § 101, but was persuaded by the USPTO’s long-standing practice of granting patents on isolated DNA, and the significant investment-backed expectations of the biotechnology industry.

Judge Bryson disagreed with respect to claims that might encompass human genes, but agreed that claims that are directed to DNA sequences that are not found in nature (e.g., the cDNA claims) can be patented.

Supreme Court Oral Arguments

The Justices actively questioned the parties, with all but Justice Thomas engaging in at least one round of questioning. Mr. Christopher A. Hansen, Esq., argued on behalf of Petitioners (the ACLU),; Solicitor General Donald B. Verrilli, Jr., argued for the U.S. as amicus curiae supporting neither party, and Mr. Gregory A. Castanias, Esq., argued on behalf of Respondents (Myriad).

The Justices seem to have accepted the Solicitor General’s view that cDNA molecules satisfy § 101 because cDNA sequences do not occur in nature. Thus, their questions focused on the patent-eligibility of “isolated” naturally-occurring DNA sequences, such as isolated human genes. The Justices grappled with the issue of just how far removed from nature a product has to be in order to be patent-eligible. The Justices approached the issue from many angles, using analogies to drugs isolated from plants, baseball bats carved from trees, gold made into jewelry, and eggs, salt and flour used to make a cake. (Many scientists may bristle at Chief Justice Robert’s suggestion that making a baseball bat from a tree requires more invention than identifying a gene.)

How would we draw the line?

The Justices seemed unable to draw a line that would permit patents on isolated genes, but not permit patents on other products that could be obtained from a human, such as whole chromosomes or whole organs. When Mr. Castanias discussed the additional uses for isolated DNA, the Justices offered method of “use” patents as an alternative. When Mr. Castanias tried to explain that the separate utility requirement of § 101 might prevent some of the hypothetical human products from being patented, the Justices did not seem to follow his arguments. For example, when Mr. Castanias noted that a whole chromosome would have to have a “specific, substantial, and credible utility,” in order to satisfy the utility requirement, Justice Kagan responded quickly with, “Yes, of course it does.”

Are there incentives to innovate?

At least Justices Scalia, Kennedy, Alito and Kagan appeared to be concerned with whether companies would have sufficient incentives to innovate if they could not obtain patent protection on products isolated from nature. Justice Scalia was not impressed with Mr. Hansen’s comment that “enormous recognition” would be sufficient, and Justice Kennedy would not put the burden of innovation on taxpayers. Nevertheless, the Justices seem to believe that “process” patents (relating to novel methods of extracting products of nature) and “use” patents (relating to novel uses for products of nature) could provide adequate protection. Indeed, Justice Breyer provided this interesting statement of what he referred to as “hornbook patent law:”

It’s important to keep products of nature free of the restrictions that patents there are, so when Captain Ferno goes to the Amazon and discovers 50 new types of plants, saps and medicines, discovers them, although that expedition was expensive, although nobody had found it before, he can’t get a patent on the thing itself. He gets a patent on the process, on the use of the thing, but not the thing itself.

Is cDNA a good compromise?

The Justices asked the parties whether permitting claims to cDNA would strike the right balance. Solicitor General Verrilli took the position that permitting claims to cDNA would provide some patent protection to the innovator, while permitting others to conduct research on the naturally-occurring gene. Mr. Hansen disagreed, arguing that it would be “harder” to conduct research on the gene without using cDNA. Mr. Castanias stated that the potential impact of such a decision is too uncertain to know, but argued that drawing such a line would “hurt” the product of nature doctrine, because courts will have to “draw fine distinctions under Section 101” on a case-by-case basis.

Looking Ahead

As noted above, the Court appears likely to render a decision that will uphold the patent-eligibility of cDNA molecules, but seems unlikely to find that “isolated” forms of naturally-occurring sequences can be patented. Thus, the Court may add to the number of “uneasy compromises” that Justice Breyer said “the patent law is filled with.”

The Court’s decision is expected by the end of June 2013. While it will of course be of great interest to the biotech community, it is likely to impact fields beyond the genetic screening market. For example, the Court’s decision could impact the ability to patent a synthetic version of any substance found in nature, such as antibiotics, antigens useful in vaccines, peptide drugs, oil-eating bacteria, enzymes, etc. A decision that restricts the patent-eligibility of DNA sequences also could further undermine the ability to obtain patent protection for diagnostic methods and personalized medicine, which has become more difficult in the wake of the Supreme Court decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services.