Not Magic but Ingenious: Federal Circuit Issues Myriad Decision

Isolated DNA encoding disease-causing proteins and drug-screening methods built upon it can meet the threshold test for patent-eligible subject matter under 35 U.S.C. § 101 in light of various Supreme Court holdings, “particularly including Mayo.”

Myriad Genetics, Inc. and the Directors of the University of Utah Research Foundation (collectively, “Myriad”) appeal from two decisions of the United States District Court of the Southern District of New York: one holding that an assortment of medical organizations, researchers, genetic counselors, and patients (collectively, “Plaintiffs”) have standing under the Declaratory Judgment Act to challenge Myriad’s patents and the other granting summary judgment that all of the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101. This appeal returned to the Court after a petition for certiorari was filed on this Court’s decision of July 29, 2011. At stake are “composition claims covering two ‘isolated’ human genes, BRCA1 and BRCA2 (collectively, ‘BRCA1/2’ or ‘BRCA’), and certain alterations, or mutations, in these genes associated with a predisposition to breast and ovarian cancers,” as well as claims to certain methods of comparing” or analyzing sequences and a method of screening potential cancer therapeutics.

Having found one plaintiff with standing to maintain action, the Court walked through a lesson in “Molecular Biology 101,” set the record straight upfront as to what this appeal was NOT about (e.g., not about §§102, 103, nor 112), and ultimately set the stage for the decision: “The issue is [and always was] patent eligibility, not patentability.” In its earlier (vacated) decision, as now, the Court ruled two sets of issued claims eligible and one ineligible subject matter. And to the question as to whether the Court’s decision necessitated a different result now that we have Mayo, the Court twice answered in the negative. These were the issues the Court set out to decide, “not whether is it desirable for one company to hold a patent or license covering a test that may save people’s lives, or for other companies to be excluded from the market encompassed by such a patent—that is the basic right provided by a patent, i.e., to exclude others from practicing the patented subject matter.” As to plaintiffs’ positions “disapproving of patents on medical methods and novel biological molecules," these, according to the majority, “are policy questions best left to Congress.”

Accordingly, and starting with the claims drawn to “isolated DNA,” the court noted that “Mayo does not control the question of patent-eligibility of such claims. They are claims to compositions of matter, expressly authorized as suitable patent-eligible subject matter in § 101.” Therefore, as in the previous appeal, the issue was “whether they claim patent-ineligible products of nature. We hold that they do not.” The framework set forth by the Supreme Court’s decisions in Chakrabarty and Funk Brothers so dictates because “[u]nder the statutory rubric of § 101, isolated DNA is a tangible, man-made composition of matter defined and distinguished by its objectively discernible chemical structure.” The claimed “isolated DNA” compositions are distinguished because they “are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity.” They are not something a “magic microscope” can focus on, as alleged by the government, at least because “isolated DNA results from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA.” And neither is the dissent’s analogy to “snapping a leaf from a tree” appropriate, because “[w]ith respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect.”

Second, the Court turned to “claim 20 of the ’282 patent, directed to a method for screening potential cancer therapeutics via changes in cell growth rates of transformed cells.” Under Mayo, “to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it’.” 132 S. Ct. at 1294. The majority found that “claim 20 does do more,” because “the claim is based on a man-made, non-naturally occurring transformed cell-patent eligible subject matter.” In this regard, the Court’s rationale supplements its initial decision, whereby claim 20 was held eligible for patent “on the ground, inter alia, that, in addition to the step of comparing the cells’ growth rates, the claim also recites the steps of growing transformed cells and determining those growth rates.” Even in light of Mayo’s holding that “certain transformative steps are not necessarily sufficient under § 101 if the recited steps only rely on natural laws,” here the Court “arrive[s] at the same conclusion of patent-eligibility because at the heart of claim 20 is a transformed cell, which is made by man, in contrast to a natural material.”

Not so for Myriad’s challenged “comparing” and “analyzing” method claims, which were found “indistinguishable from the claims the Supreme Court found invalid under § 101 in Mayo.” In this regard, Mayo “held that the steps of administering and determining, combined with a correlative ‘wherein’ clause, were not sufficiently transformative of what was otherwise a claim to a natural law” thereby reversing this Court’s decision. Now, “[t]hat holding governs Myriad’s claims to methods of ‘comparing’ and ‘analyzing’ DNA sequences.” And because these methods “are only directed to the abstract mental process of comparing two nucleotide sequences,” and “do not even include” a Mayo-like “determining” step, the Court held them “invalid under § 101 for claiming patent-ineligible processes.”

The Supreme Court challenged this court with reviewing its earlier decision in view of Mayo. This court addressed this task under the overarching Supreme Court principle that “courts must be cautious before adopting changes that disrupt the settled expectations of the inventing community.” In a concurring opinion, Judge Moore pointed out a discrepancy between the U.S. Patent and Trademark Office (USPTO) and the government’s position with regard to “isolated DNA.” On one hand, the Court’s decision is consistent with the USPTO’s long-standing position that “[a]n isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because . . . that DNA molecule does not occur in that isolated form in nature . . . .” On the other, and as the dissent alleged, “the Patent Office’s past views are “substantially undermined by the position the government has taken in this case.” Ultimately, the settled expectations largely remain settled where they were pre-Mayo, at least with regard to issued patents drawn to isolated DNA. The decision offers only slight insight into what it takes to “do more” and “transform an unpatentable law of nature into a patent-eligible application of such a law.” We now know that creating and using a novel cell based on a law of nature meets more “than simply stat[ing] the law of nature while adding the words ‘apply it.’” But didn’t we know that before? After all, as the Court pointed out, “at the heart” of those methods “are the products of man, albeit following, as all materials do, laws of nature.”

Please click here to read The Association for Molecular Pathology v. U.S. Patent and Trademark Office decision.