Will I lose my dignity?
Will someone care?
Will I wake tomorrow
From this nightmare?
"Will I," Rent
By Kevin E. Noonan --
The Supreme Court's grant of certiorari over the question "Are human genes patentable" had raised for many the specter of an uninformed generalist court rendering a decision containing dicta that would negatively affect biotechnology. This possibility is real, in view of the voices raised against patenting human genes based on moral, policy, or ideological grounds. While strongly felt, these sentiments are based, in large part, on a misunderstanding or mischaracterization of either the facts or the law, specifically patent law. These misstatements include arguments based on patent claims somehow exerting an ownership interest in individual's DNA, or that isolated human nucleic acid claims preempt future research (in the face of thousands of published scientific journal articles published since the BRCA gene patents were granted), or that isolated DNA patents inhibit future technologies like personalized medicine.
This is an argument that might have been relevant 30 years ago, but at least two facts mitigate against resolving this issue now. The first is that the day of the DNA patent claim is rapidly coming to a close. These types of patents were first filed directed to specific genes encoding biologically relevant proteins having therapeutic benefits. These include erythropoietin, tissue plasminogen activator, interferon, blood clotting Factors VIII and IX, and others. (Indeed, one of the most compelling types of evidence not considered by any court in the Myriad case is the testimony of the tens or hundreds of thousands of patients whose lives have been saved or bettered by biotechnology drugs protected, in part, by so-called "gene patents.") Myriad's BRCA gene patent claims are in this form, one of the reasons why these claims are not infringed by genetic diagnostic methods used today.
The vast majority of gene patent applications, however, were filled as the result of the Human Genome Project. These patents are limited in at least three ways. First, the U.S. Patent and Trademark Office has established a policy that patents will be granted only if an applicant provided on the filing date specific, substantial, and credible utility for the protein encoded by the claimed DNA. This provision prevents an applicant from obtaining patent exclusivity unless the applicant shows that she establishes utility, a requirement of the patent statute, of the encoded protein. (This requirement is related to the policy enunciated in Brenner v. Manson, where claims to methods for making steroid molecules were invalidated based on failure to disclose a utility for the steroid molecules made using the methods.) Second, certain researchers (notably, Sir John Shulston in England) made certain that the sequence results of the HGP were published in public databases as soon as possible; doing so placed the sequences in the prior art and precluded patentability for any application filed after the sequences were made public. Finally, because almost all of these patents were filed at the turn of the century, and the term of these patents will expire no later than 20 years after application filing, the "problem" of gene patents will disappear no later than 2020 (and in many instances much earlier even if a patent can be obtained under the enhanced utility requirements).
Another reason why the ACLU's challenge is anachronistic (except for those meaning to make an ideological point) is that present and future technology, such as genetic diagnostic testing or personalized medicine, is not prevented or inhibited by claims to isolated DNA molecules encoding a specific human protein. This is a consequence of the history of these type of claims for providing means for producing biologically relevant proteins like EPO and TPA. The claims require that the DNA is isolated and that it encodes the full-length protein, as defined by specific amino acid sequence. (For these reasons these claims are exceedingly narrow, and do not broadly preempt: for example, such claims are not literally infringed if the encoded protein differs by a single amino acid, meaning that a difference of a single methylene group (the difference between a valine and an isoleucine residue) is enough to take a species outside the scope of the claim.) Modern gene sequencing methods used for diagnostics neither isolate DNA nor produce a full-length DNA molecule encoding the protein. Rather, sequencing is performed in such a way that fragments of the DNA are produced in a reaction mixture and sequenced without isolation; what is produced is the sequence, a characteristic of the DNA molecule that is not protected by the patent. (This is why infringement of isolated DNA claims does not lie by using the sequence information to, inter alia, interrogate a DNA database.) And the Myriad case has established that method claims directed to merely comparing an individual's gene sequence with a reference sequence and disclosing mutations identified as indicating a risk of disease, without more, are not patent eligible (under either Bilski v Kappos or Mayo v. Prometheus).
So there appears to be no sound policy reason for having the Supreme Court render a decision on the patent eligibility of human genes. Sadly, there is seemingly no sound business reason for Myriad Genetics to have the Court decide this question either. Myriad's counsel, Greg Castanias, argued in the first Federal Circuit oral argument that the plaintiffs did not have standing because there was no redressability to their claim. Specifically, Mr. Castanias argued that even if the Court ruled in plaintiffs' favor, Myriad had other patent claims that would prevent Dr. Harry Ostrer and other plaintiffs from providing BRCA gene diagnostic tests. In addition, while these patents were undoubtedly important when Myriad was establishing its diagnostics business they are less important now. Fifteen years and thousands of genetic tests (apparently without any failures) later, the company's reputation, experience and extensive database is far more valuable than the claims at issue.
Under these circumstances, the question must be asked whether the prudent thing for Myriad to do is grant Dr. Ostrer a covenant not to sue on all the patents and claims involved in this litigation. The result would be to render the issues before the Court moot; regardless of the perceived importance of the Question Presented, even the Supreme Court is limited by Article III of the Constitution and cannot render an advisory opinion on this issue. Such an action by Myriad would not only prevent this case from being decided, it would preclude the Court from including in its opinion dicta on the patent eligibility of isolated DNA from other species (which may have importance in fields like agriculture or biofuels) or other "products of nature" that may provide the basis for biologic and other types of drugs. In view of the seemingly complete lack of any practical reason for having the Supreme Court decide this issue, and the risks to the progress provided for a generation by the biotechnology industry, nothing other than a desire to be vindicated remains to support seeing this case through to its conclusion. Frankly, in view of what is at stake, such vindication is simply not enough.