In a decision of landmark importance for the biotechnology industry, the Federal Circuit recently held that isolated genes remain patentable subject matter.1
The lawsuit, brought against the USPTO and patent owners Myriad Genetics and the University of Utah Research Foundation by the American Civil Liberties Union, the Public Patent Foundation and others,2 challenged patents on two human genes associated with breast and ovarian cancer.
The relevant patents are based on identifying mutations in two human genes, BRCA1 and BRCA2, which strongly increase the risk of breast and ovarian cancers. Plaintiffs contended the patents stifle research that may lead to important cures and treatments. They argued the patents are unconstitutional and invalid because “human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”3 The Southern District of New York agreed.
In July 2011, the Federal Circuit affirmed in part and reversed in part. The decision reflects three key claim sets: genes; methods of diagnosis; and methods of screening for therapeutics.
Genes are patentable subject matter
According to the decision, genes can be considered patentable subject matter. Patents will continue to be granted to applicants who isolate nucleic acid sequences from their natural environment, sequence them and identify functions and uses for those sequences.
In its ruling, the court concluded, “It is undisputed that Myriad’s claimed isolated DNAs exist in a distinctive chemical form – as distinctive chemical molecules – from DNAs in the human body, i.e., native DNA . . . [i]t is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect.”
Interestingly, the court said if the law is to change, then Congress must change the law, not the courts. The court also noted that the issue may not be significant because many gene patents are expiring.
Methods of diagnosis claims – patentable or unpatentable?
Regarding the second issue, the court ruled that patents covering methods of analyzing or comparing genes (diagnostics), per se, are not patentable because they claim “only abstract mental processes.” The court distinguished Myriad’s claims from the recently upheld Prometheus claims.
The Prometheus patents claimed methods for optimizing drug dosages to treat gastrointestinal disorders.4 In finding these claims satisfied Section 101, the Prometheus court concluded that in addition to the “administering” step being transformative, the “determining” step was both transformative and central to the claims’ purpose. Indeed, the court found the determining step required a transformation and the step was essential to the Prometheus claim.
The Myriad court explained that Myriad’s claims, in contrast, did not include the step of “determining” the BRCA genes’ sequence by, for example, obtaining a biological sample and isolating nucleic acid from it, then sequencing the nucleic acid. The claim only provided for comparing sequences by observation or inspection. Thus, the court said, Myriad’s methods failed to satisfy the machine-or-transformation test and were merely directed to an abstract mental process of comparison.
The court noted that even if the Myriad claims included transformations associated with isolating and sequencing DNA, these transformations would constitute no more than “preparatory data-gathering.” The method claim of “comparing” cellular growth rate, the court found, simply restated a basic scientific principle. Such method claims are therefore patent-ineligible under Section 101.
Will patent diagnostic methods become unpatentable?
A close reading of Myriad suggests it may be possible to patent diagnostic methods by adding steps that include a transformative process. A further step indicating a therapeutic regimen would likely also be required to clarify the claim’s purpose. Because Myriad’s claims did not include any “transformative” language before the “comparing” steps and the court concluded that Myriad’s claims were merely observations, it does not appear the court dismissed the notion of diagnostic method claims. However, such claims must include a transformative process.
Drafting claims to include additional steps seems counter-intuitive to the idea that method claims should include as few steps as possible to capture infringers more easily. Adding steps to a diagnostic claim, while preserving the claim’s validity, could result in fewer infringement challenges.
Methods of screening for therapeutics
Finally, the court held that methods of screening for cancer compounds based on the facts in this case and the claim language are patentable because the steps of growing cells containing these genes, and manipulating the cells in the presence or absence of a therapeutic, requires transformation of the cell culture rather than mere observation without intervention.
Whether isolated genes remain patentable will ultimately be a decision for the United States Supreme Court. Prometheus has been submitted to the Court. Myriad has not yet been submitted, but likely will be.
For more information, please contact Dr. Lisa Haile.
1. Ass’n for Molecular Pathology v. US Patent & Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011).
2. Ass’n for Molecular Pathology v. US Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010).
3. 35 U.S.C. § 101 (1952).
4. Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347, 1349-50 (Fed. Cir. 2010), cert. granted, 131 S. Ct. 3027 (2011).