On August 16, 2012, the Federal Circuit again issued an opinion in the well-publicized case of Association for Molecular Pathology v. U.S. Patent and Trademark Office. The case centered on patents owned or controlled by Myriad Genetics, one of the defendants in the case, and whether the types of isolated DNA molecules and methods claimed in those patents are eligible for patent protection under U.S. law.
The isolated DNA molecules are related to the BRCA1 or BRCA2 genes. Some mutations in these genes are associated with an increased risk of certain cancers, such as breast and ovarian cancer. Myriad Genetics offers genetic testing to determine whether an individual has a mutation in one of these genes. Some of the isolated DNA claims cover “cDNA” molecules, which are DNA molecules synthesized to be complementary to a naturally occurring messenger RNA molecule, a molecule which directs protein production in a cell. Other isolated DNA claims are broad enough to cover isolated genomic DNA encoding BRCA1 or BRCA2, or smaller fragments of that DNA.
In 2009, a collection of physicians, patients and associations filed suit in U.S. District Court for the Southern District of New York, seeking a declaration from the court that several claims of several Myriad patents were invalid as encompassing categories of subject matter ineligible for patent protection under 35 U.S.C. § 101. To the surprise of many, the district court agreed, holding that all of the challenged claims were indeed invalid. That decision was appealed to the Federal Circuit, which agreed that some of the method claims were unpatentable but held that the claims to isolated DNA molecules (and to one of the patented methods) were patent-eligible under 35 U.S.C. § 101. The Supreme Court accepted review of the case and sent it back to the Federal Circuit for further review in view of the Supreme Court’s recent pronouncements on patent eligibility in Mayo v. Prometheus.
Armed with this new guidance from the Supreme Court, the same panel of three Federal Circuit judges revisited the issues in this case afresh — and reached the same conclusions they had reached before. Although each judge wrote a separate opinion, they agreed that claims to isolated cDNA molecules are patent-eligible, because cDNA molecules do not exist in nature, but are man-made.
In contrast, only two of the three judges concluded that the other isolated DNA claims were patent-eligible. Judge Lourie, writing for the court, held that because isolated DNA molecules are chemically different from natural DNA and have additional uses, they are “markedly different” and patent-eligible. Judge Moore disagreed with Judge Lourie’s reasoning, but not with the conclusion, dismissing the idea that the chemical differences between isolated DNA and naturally occurring DNA (for example, the covalent bonds broken when isolating DNA) are sufficient to confer patent-eligibility, but nevertheless holding the claims to isolated DNA to be patent-eligible. Judge Moore emphasized the importance of such patents to the biotechnology industry and concluded that if isolated DNA was no longer to be deemed patent-eligible, that change should come from Congress and not the courts. Judge Bryson dissented, holding that the claims to isolated DNA should not be eligible for patent protection because they hold the same information content as the genes in the human body and are therefore not “markedly different.” Judge Bryson analogized the isolation of a gene to snapping a leaf from a tree, and an isolated gene to a human kidney after it has been removed from the body. The other judges disagreed with Judge Bryson’s analogies.
On the method claims, all three judges were able to agree. Most of the challenged method claims involved analyzing a DNA sequence or comparing two DNA sequences. The judges held these claims unpatentable abstract mental processes, as the claims did not involve any concrete, physical steps such as extracting or sequencing DNA or processing a sample. The court noted that the comparison of two sequences, without more, could be accomplished by mere inspection alone. One method claim related instead to the screening of potential cancer therapeutics using a cell with an altered BRCA1 gene. The judges acknowledged this claim to be patent-eligible, by virtue of its reliance on a cell altered by human intervention.
Given the differing views of the appellate judges deciding the case, the entire Federal Circuit may be inclined to review the case en banc, if petitioned to do so. Furthermore, the Supreme Court previously signaled an interest in the case and may choose to review the Federal Circuit’s decision if (when) one of the parties asks them to do so. So although the decision, as it applies to isolated DNA molecules, has been warmly welcomed by many in the biotechnology industry, their final victory is by no means assured.
For now, however, Judge Moore warns that the “scope of the law of nature/manifestation of nature exception was certainly enlarged in Prometheus.” Companies and inventors should take this opportunity to reevaluate their U.S. patent strategies, particularly when claims could be characterized as natural products or mental processes.