The U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013), decided that "isolated" genomic DNA is a product of nature and not patent eligible merely because it has been "isolated."1 The Court also held that claims to synthetic DNA (e.g., complementary DNA or cDNA) were valid.2 Although given broad coverage by the general media,3 Myriad may turn out to be of limited consequence to the biotechnology industry.
Myriad Genetics, Inc., a Utah-based biotechnology company, markets a genetic test that identifies when a patient carries certain mutation(s) in the BRCA1 and/or BRCA2 genes. BRCA1 and BRCA2 mutations significantly increase the risk, relative to the general population, of a patient developing cancers of the breast and ovary. Myriad's tests are protected by a variety of patent claims, including claims at issue that cover the isolated BRCA genes. The patent subject matter eligibility of only nine claims, taken from only three of Myriad's patents, was at issue before the Court.
The Court held that claims to isolated genomic DNA were not patent eligible merely because genomic DNA was isolated, but that claims to synthetic DNA were valid.4 The Court emphasized that the Myriad holding was limited in scope. For example, the Court stated that it is "important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes . . . it could possibly have sought a method patent."5 "Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes."6 Indeed, the Court noted that "Many of [Myriad's] unchallenged claims are limited to such applications."7
The limited holding of Myriad is unlikely to affect many routine biotechnology patent claims. In addition to method claims,8 claims drawn to unnatural (e.g., modified) proteins and the polynucleotides that code for these, vectors (e.g., plasmids) containing isolated genes, genetically modified organisms, and methods of making and using these, all staples of the biotechnology industry, remain patent eligible post Myriad.
Proponents of the importance of Myriad's holding point to the fact that, post Myriad, other biotechnology companies are coming out with, or plan to come out with, competing BRCA testing methods.
Whether these companies will infringe Myriad's remaining, valid claims remains an open question. It is possible that since many of Myriad's original BRCA patents will expire in the next few years, and getting an injunction in this short time period may be problematic, competitors may feel emboldened. More broadly, because of the timelines associated with gene patenting, many (or most) patents that contain claims to isolated genomic DNA, had these claims remained valid, would nevertheless be expiring over the next few years, since the genome was completed almost 20 years ago. Thus, the narrow holding of Myriad, coupled with ageing patents, means that the impact of Myriad on the biotechnology industry will likely be limited.
Of some interest, it remains to be determined whether Myriad may affect other isolated natural products (e.g., statins, or antibiotics that may otherwise occur in nature). Myriad may raise issues regarding the validity of claims to these isolated natural products, and it is reasonable to predict a Myriad-based challenge at some future point. However, isolated natural products, unlike isolated genomic DNA, often contain structural features or formulations that convey biological functionality. Also, isolated natural products can have significantly different properties than the natural product in its in vivo milieu. Finally, isolated natural products are typically administered as compositions. To this end, the Court noted that "Myriad's claims are simply not expressed in terms of a chemical composition, nor do they rely in any way on chemical changes that result from the isolation of a particular section of DNA."9 Thus, it is far from clear that any Myriad-based challenge to claims drawn to isolated natural products, and compositions containing these, would be successful.
While the impact of Myriad may be limited, the case certainly increases the need for careful claim preparation.
1 Myriad at page 18.