A 2:1 decision reaffirming Myriad Genetics’ patent rights was made by the U.S. Court of Appeals for the Federal Circuit on August 16 2012, following re-examination of the decision in Association for Molecular Pathology v Myriad in light of the U.S. Supreme Court’s decision in Mayo Collaborative Services v Prometheus Laboratories, Inc. (Mayo).
In Mayo the Supreme Court found that methods were not patent-eligible if they simply applied laws of nature.
The patents in question, owned by Myriad Genetics, cover three inventions: isolated DNA, a diagnostic method, and a method of screening for new therapeutics. All are related to Myriad’s test for the BRCA genes associated with some breast and ovarian cancers. The court considered only the question of what subject matter is patent-eligible, finding that man-made compositions of matter including isolated DNA molecules are patent-eligible. However they found that the eligibility of methods incorporating such matter depends on whether the method claims go beyond ‘abstract mental steps’.
Isolated DNA: a product of man following laws of nature
Isolated DNA was found to be patent-eligible as it is sufficiently distinct from natural DNA molecules, being not just purified but ‘chemically cleaved’ from its natural state. Judge Lourie observed that all matter is ultimately derived from products of nature and it does not equate to equivalence with natural products, “Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.”
The United States Patent and Trademark Office’s practice of granting patents for isolated DNA for almost thirty years was cited with reference to the potential adverse impact of changing eligibility on the biotechnology innovation system. Judge Moore stated that the court “must be particularly wary of expanding the judicial exception to patentable subject matter where both settled expectation and extensive property rights are involved.”
Many commentators predicted that the court’s decision would not change because Mayo concerned method patents and the first decision in Myriad had already invalidated their comparison method patents on similar grounds. However Judge Bryson dissented on isolated DNA being patent-eligible based on Mayo. Bryson’s opinion is that Mayo should alter the court’s previous decision based on its criteria that, in order to be patent-eligible, subject matter should contribute or add ‘enough’ inventiveness for it to no longer be well-understood, routine or conventional activity and that isolation of DNA does not satisfy these criteria.
Methods must be more than abstract mental steps
In line with the decision in Mayo the court found that diagnostic methods always include natural laws and are patent-ineligible unless they go beyond an ‘abstract mental step’ to apply a natural law. The diagnostic method examined consists of comparing of a patient’s gene sequence to Myriad’s proprietary sequence that is associated with a predisposition to certain types of breast cancer. The court found this method to be simply an abstract mental step.
The court noted that an abstract mental step could be one element of an eligible method, but not the sole process involved. They also stated that a method claim would have been better supported by specific reference to physical embodiments of the method, for example extraction of DNA and sequencing.
In illustration of the above points, it was found that a method for screening for cancer therapeutics was eligible on the grounds that the screening took place in cells transformed by isolated DNA molecules into transgenic cells by the hand of man. This decision found that at the heart of the claims is a manmade, transformed cell thus conferring eligibility to the screening process which taken alone could be considered an abstract ‘comparison’ step.
What next for Myriad?
While this reconsideration in light of the decision in Mayo reaffirms this court’s 2011 decision, in November 2012 the Supreme Court agreed to hear the Association for Molecular Pathology’s appeal against the decision with respect to the single question, “Are human genes patentable?” This hearing is yet to take place.
Commentators believe that it is likely the Association for Molecular Pathology will argue that the outcome could be consistent with Judge Bryson’s opinion that isolation of DNA does not ‘add enough inventiveness’ to conventional activity. Regardless of on-going litigation the first of Myriad’s patents are set to expire in 2015, allowing competitors to offer the test without requiring a license, although improvement patents will not expire until 2018.
No doubt the biotechnology community will continue to watch this case with interest, however for the meantime isolated DNA, and in particular cDNA sequences, are patent-eligible. Regarding diagnostic and prognostic methods, while both the Mayo and Myriad courts agreed that methods which simply involve abstract mental steps are not patent-eligible, provided certain criteria are met, diagnostic and prognostic methods may still be protected. We recommend obtaining legal advice before making any decisions about patent eligibility and/or filing a patent application in the United States.
If you require advice on patenting of biological materials please contact Shelley Rowland.