Since the courts have long held that products of nature are patentable once isolated or manipulated by man, the District Court decision of Judge Sweet in the “Myriad” case1 that isolated or manipulated genes are not patentable and the subsequent appeal of that decision to the Court of Appeals for the Federal Circuit (CAFC) 2 has prompted considerable legal debate. While the CAFC should issue its decision shortly, there is every expectation that the Myriad case will be appealed to the Supreme Court, further prolonging current uncertainties as to the patentability of isolated and manipulated genes. Given this uncertainty, those who seek or hold patents directed to isolated or recombinant nucleic acids should adopt strategies to protect their intellectual property irrespective of what the courts ultimately decide.
In developing strategies for patenting genes post-Myriad, potential Court holdings ranging from the most to least restrictive can be anticipated and addressed. Patent applicants have a wide array of options for meeting post-Myriad patentability criteria that might be imposed by the courts while preserving their rights to pre-Myriad claims if patentability of isolated or manipulated genes is ultimately maintained. At one extreme of the spectrum of potential outcomes is a scenario where the District Court decision is upheld in full, rendering claims to both genes in general and “isolated” genes in particular unpatentable. If the District Court decision is upheld and composition claims to genes are held to be unpatentable, methods of using genes should still be patentable if they meet the Bilski4 requirements (i.e. the methods do not comprise “abstract ideas” or “mental steps”). Applicants should thus be certain to claim any methods of using genes or portions of genes to make therapeutic proteins, to diagnose conditions or select traits, to confer useful properties on non-human transgenic organisms, and the like using concrete language that provides for “transformations of matter” or otherwise meets Bilski4 requirements. Nonhuman transgenic organisms should also be claimed since their patentability was upheld in the Supreme Court’s Chakrabarty5 decision. Another potential outcome is that the Courts will hold that claims to genes that have been engineered or otherwise manipulated by man are patentable while genes that are simply “isolated” are unpatentable as advocated by the US Department of Justice in its Amicus Brief3. If this occurs, properly crafted claims to recombinant DNA molecules or cDNAs can distinguish the claimed gene from its naturally occurring form. An additional advantage of claims to recombinant DNA molecules is that they are not subject to the limitation of being “isolated.” However, applicants must distinguish the claimed recombinant DNA molecules from potential prior art recombinant molecules such as clones used in whole genome sequencing projects. At the other extreme of this spectrum of outcomes is the possibility that the lower court decisions are overturned in full, rendering claims to isolated and manipulated genes patentable as per pre-Myriad case law. Claims to isolated DNA may be useful and should thus be maintained in pending applications in the event that Myriad is overturned in full and for any foreign patent application filings.
Holders of issued U.S. patents with claims directed to isolated or recombinant genes will also need to carefully monitor Myriad and consider seeking reissue of those patents if a ruling adverse to the patentability of such genes is ultimately handed down by the CAFC or the Supreme Court. Reissue provides for correction of patents that are wholly or partly inoperative or invalid when the patentee claims more or less than he or she had a right to claim in the patent under 35 USC §251. Since reissue entails the surrender of the original patent and subsequent examination of the reissue application in the same manner as a non-provisional application, the pros and cons of seeking reissue must be carefully weighed for each case. Furthermore, reissue applicants are only entitled to seek amendments that would broaden claim scope within two years of the grant of the original patent. After two years from grant, reissue applicants can only seek amendments that would maintain or limit claim scope. Turning to a scenario where a patent has claimed “an isolated nucleic acid sequence” and an adverse ruling is ultimately handed down by the appellate courts in Myriad, any amendment that strikes the term “isolated” would likely be viewed as a broadening amendment and thus prohibited after two years from grant of the original patent. Nonetheless, amendments where the term “isolated” is retained but other limitations that further distinguish the claimed nucleic acid from its form as found in nature are added would not likely be viewed as “broadening” the claims and should be permitted.
Although the ultimate outcome of Myriad may not be decided for some time, those seeking or holding patents directed to isolated or manipulated genes do have a number of viable options for protecting their intellectual property. To paraphrase Samuel L. Clemens’ retort to those who prematurely reported his demise, blanket statements that “gene patents are dead” are an exaggeration. Nonetheless, the potential impact of any decision adverse to the patenting of such genes merits close observation and prudent precautionary actions.