By Kevin E. Noonan --
Some of our commenters have asked (with greater or lesser degrees of stridency) that we "take a position" on claims like the Myriad method claims at issue in the lawsuits brought against Ambry Genetics, Gene-by-Gene, and Quest (and purportedly threatened against others). We have declined the opportunity to do so in deference to a determination by the Utah District Court (or the California District Courts where Quest and Counsyl Genetics have filed declaratory judgment actions). This decision is not because we don't have an opinion (to think otherwise would evince that the commenter has not been paying attention to our posts), but because it is ultimately a futile exercise. And the reason for that conclusion rests solely on the Supreme Court's Mayo v. Prometheus decision. As we've said before, this is the Potter Stewart/pornography view of patent eligibility, where the Court thinks it knows it when it sees it. The very subjectivity of the standard condemns it.
A discussion of whether a particular claim satisfies the Court's patent eligibility "test" quickly devolves into whether a party (or judge) believes that there is "enough" inventive in the claim to recite more than a law of nature and the instruction to "apply it," in the words of the Mayo opinion. And this analysis is particularly difficult when the Court says elsewhere that "applications" of natural laws can recite patent-eligible subject matter. The question becomes where to draw that metaphysical or semantic line distinguishing what is an application and what is an instruction to apply the natural law. The Court's preemption "standard" is also unavailing, for the same reason: all claims preempt (the ability of a third party to practice the claims) but when do we decide how much preemption is too much? The Court doesn't say.
Among the many doctrinal errors in the Mayo opinion, ignoring the rubric that claims must be assessed as a whole causes a particular kind of mischief. Taken to its extreme, the principles espoused in Mayo would render a bicycle patent-ineligible, on the following analysis. A bicycle is merely a collection of previously known "simple" machines (wheels, levers, gears, pulleys) that are put together in a routine and conventional way to preempt the use of human muscle motion to take advantage of natural laws of motion. A similar analysis can be applied to almost anything.
This analysis is not limited to mechanical devices, of course; what of a previously known compound that is formulated by routine and conventional methods to produce a pharmaceutical composition that treats a disease (where the use to treat the disease was unknown in the prior art)? After all, the therapeutic effectiveness of the pharmaceutical composition is dependent merely on the natural law that this particular drug treats this specific disease, and claims to methods for treating the disease thus merely embody the recognition of the natural law and an instruction (and means) to apply it. An example is U.S. Patent No. 4,724,232:
1. A method of treating a human having acquired immunodeficiency syndrome comprising the oral administration of an effective acquired immunodeficiency syndrome treatment amount of 3'-azido-3'-deoxythymidine to said human.
Of course, if Justice Breyer's view of patent-eligibility was the law in the 1980's there would have been little chance for azidothyidine (AZT), for many years the only treatment for Acquired Immunodeficiency Syndrome, to have been commercially available. After all, it is patently unlikely that Burroughs Wellcome would have incurred the costs of developing and obtaining regulatory approval of the drug without the very patent exclusivity the Court would deny Myriad.
The objection may be made that even the Court recognizes therapeutic methods are different. However anyone taking that position needs to recall that the claimed Prometheus test was not a diagnostic test but rather a test to determine the dosage of 6-thioguanine that would have an optimal therapeutic effect. So not only diagnostic methods like Myriad's, but methods like companion diagnostics methods having the potential to reduce the risk of adverse side effects from drug administration, can be readily categorized as "merely" reciting a law of nature and thus being patent ineligible.
These are just two of the many illustrations of the mischief the Mayo decision can and has occasioned. (It is the rare applicant that has not encountered a rejection under § 101 based on the Mayo opinion, and district courts in addition to those in the Myriad cases are grappling with these issues, often on summary judgment.) One of the many consequences of the Mayo decision, trivial for the discussion of our "position" but important for continued innovation in America, is that the Court has dismantled one of the outstanding achievements of thirty years of Federal Circuit jurisprudence (although the Federal Circuit has been doing some dismantling of its own lately): providing sufficient stability and clarity to U.S. patent law that a businessperson could sit down with her patent lawyer and assess the metes and bounds of her patent claims and those of her competitors, to make rationale, legally sound business decisions. That task has become much more daunting in an era where the only honest answer to a client's question of whether a claim is valid or an invention eligible for patenting will be "that depends on what court reviews the claims." This is, paradoxically, precisely the situation that existed prior to the institution of the Federal Circuit, where the judicial differences were geographic rather than philosophical (and thus easier to reliably identify).
So the answer to the question of where do we stand on Myriad's (or any other) diagnostic method claims is simple: there is no way to know whether such claims are valid or not until sanity (meaning legal analysis that depends on patent law rather than subjective prejudice) returns to U.S. patent law.