The United States Court of Appeals for the Federal Circuit, in the case Association for Molecular Pathology (AMP) and ACLU v. USPTO and Myriad Genetics (Myriad), held in August that isolated genes are a patent-eligible subject matter. The Court of Appeals reaffirmed its prior ruling on the matter, which was recently covered by IP Osgoode.

The case concerned whether Myriad’s patents, describing the composition of isolated DNA molecules and methods of isolating and analyzing genes used to detect certain types of breast and ovarian cancers, are patent eligible in light of the recent ruling of Mayo v Prometheus (Mayo). Patent eligibility in the United States is defined by 35 U.S.C. § 101. The United States Court of Appeals for the Federal Circuit had originally reviewed the patents in July 2011, before the United State Supreme Court’s holding in Mayo. During their original review, the Court found that Myriad’s composition based claims, the claims covering the actual isolated genes themselves, were patent-eligible. In contrast, Myriad’s patent claims covering comparison and analysis were almost all patent-ineligible. The original ruling was a 2-1 split decision with Justice Bryson stating in dissent that genes and their fragments were also patent-ineligible. The decision was appealed to the United States Supreme Court.

The Mayo decision was handed down nine months later, in March of this year. In this decision, covered in a guest blog on IP Osgoode here, the Supreme Court ruled that the method claims found within Prometheus Laboratories’ patents were not eligible for patent protection because the claims were based on laws of nature, a patent-ineligible subject matter. In light of the Mayo decision, the Supreme Court remanded the Myriad case back to the Court of Appeals for reconsideration.  Some expected the Supreme Court decision to remove the legal foundation that the original Myriad ruling was built on, as human genes could be considered products of nature. Instead, the U.S. Court of Appeals for the Federal Circuit respectfully held that the Mayo decision would not alter their judgement against Myriad’s patents.

In the decision by the Court of Appeals, the majority relied on precedent established in Diamond v Chakrabarty (Chakrabarty) and Funk Bros. Seed v Kalo Inoculant (Funk Bros.) to help determine how patent-eligibility laws, specifically 35 U.S.C. § 101, should be interpreted in regards to Myriad’s composition patents. In Chakrabarty, the U.S. Supreme Court recognized bacteria engineered to break down different components of crude oil as patent-eligible. The Court found that because the claim was to a non-naturally occurring manufacture or composition of matter that was the product of human ingenuity, the claim was patent-eligible. In Funk Bros., the U.S. Supreme Court held that a grouping of unmodified bacteria was not patent-eligible as the aggregation of species did not make any of the species acquire a different property or use. Applying both of these precedents to the case at hand, the Court found that the composition patent claims, covering isolated human genes, were valid under 35 U.S.C. § 101 as they “are markedly different—have a distinctive chemical structure and identity—from those found in nature”. Although stating that the Mayo decision did not modify their holding, it should be noted that the Court of Appeals’ decision to hold the majority of Myriad’s method claims as patent-ineligible falls in line with the Mayo ruling. In Myriad, the Court of Appeals found that method claims that simply ‘analyze’ or ‘compare’ patent-eligible subject matter are not themselves patent-eligible as they only claim abstract mental processes. The only claim that escaped this judgement, claim 20 in U.S. Patent 5,747,282, included “transforming” the inputs of the method before analyzing, which in the Court’s eyes was more than simply applying a law of nature.

Also of interest in the instant case was the conflict between the government’s role and the role of the United States Patent and Trademark Office (USPTO). The USPTO was a defendant, while the government, as amicus curiae, argued that that human-engineered DNA molecules are eligible for patent protection, but isolated and unmodified genomic DNAs, like those targeted by Myriad’s patents, are not. In their ruling, the majority stated a desire to defer the issue to Congress and to allow the USPTO to continue to issue patents relating to DNA molecules as they have been for 30 years. In dissent, Justice Bryson raised an argument that the government’s position undermines that of the USPTO and therefore the issue should not be deferred.

This is a very contentious decision as it involves the patent-eligibility of naturally-occurring human genes. There are strong opinions that this subject matter should not be patentable, while others claim that the subject matter’s “fundamental nature as a chemical compound” make it patent-worthy. The ACLU, who was represented in this case, has stated that the ruling “prevents doctors and scientists from exchanging their ideas and research freely.” Myriad, however, defends the ruling and believes that their gene patents have not hindered research on the DNA sequences that they cover. It is expected that this case will be appealed to the United States Supreme Court.

Mark Bowman is a JD Candidate at Osgoode Hall Law School.