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.
Patent Docs 
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