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A Myriad of Issues in Gene Patents

This June the Supreme Court issued it’s opinion in Myriad. In a Solomonish move, the Court split the baby of biotech. Here, all nine members of the Court chose to cleave at a point between isolated DNA being ineligible subject matter on the one hand, and complimentary DNA (cDNA) being eligible on the other.

Without belaboring the point too much, isolated DNA is just that: a portion of a DNA molecule isolated from its natural environment in a cell. Generally, this is a very specific portion of the genome encoding a particular gene or genes. DNA, however, includes long portions that don’t code for proteins. These segments may be removed to yield a modified DNA strand that only has the active, coding portions of molecule. This “refined” version is cDNA and exists nowhere in nature.

In effect, the Court put levels of human manipulation on a spectrum and drew a line, albeit a bit fuzzy, that separates patent eligible DNA based inventions from those that are not. According to the Court, isolating DNA is not enough of a transformation to be patentable, but removal of introns to yield cDNA is. The problem is that “isolated” DNA doesn’t exist in nature either. Further, the requirement of a specific utility for the DNA sequence claimed already limits the scope of inventions to those isolated sequences with a known usefulness.

An Alternative Approach

The line drawn between isolated DNA and cDNA is an arbitrary one that, while allowing more uses of the genes for basic research, arguably still protects the most valuable components of genetic tests. I believe Section 101 is a very broad declaration of patent eligibility and limiting it in an arbitrary way is not helpful. Stronger application of obviousness to prevent the patenting of known elements would improve things without creating an unpredictable regime with little basis in the statute.

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SCOTUS Grants Cert in Myriad Gene Patenting Case

Last week, the Supreme Court granted a writ of certiorari in the Myriad case. I previously wrote about the status of this case and, to be honest, the case has gone back to the Supreme Court a bit faster than I had expected.

All we know is that four Justices voted to grant Certiorari, but there are some tea leaves that we can try to read. For example, the decision about which questions to grant Certiorari on is telling. Three questions had been posed to the Court:

  • Are human genes patentable?
  • Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court’s ruling in Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
  • Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad’s “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally and directly threatened with an infringement action?

Often, the Court rephrases the question when the writ is granted. However, question one was granted verbatim. The wording of the question may be troublesome for Myriad as the Court isn’t even asking if isolated and purified DNA is patentable, but only if human gene generally are.

Another interesting fact is that the Court did not grant cert on the second question. The Mayo decision had invalidated a DNA diagnostic test as not being statutory subject matter. However, in this case, the Federal Circuit has upheld Myriad’s own diagnostic claims, and now, the Supreme Court will leave that decision in place and not address it head on in the Myriad case. The Court could still invalidate the diagnostic claims with a broad holding related to question one, but I think that is unlikely.

This means the Court may be willing to let diagnostic tests to stand despite a potentially hostile position on patenting gene sequences and isolated genes. This would allow for exploitation of gene based diagnostics and other inventions, even if claims to the genes themselves are not patentable.

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Mayo v. Prometheus: Potentially Far Reaching Effects

Yesterday the Supreme Court, by a unanimous decision, invalidated the claims of a patent exclusively licensed to Prometheus.  Claim 1 is representative of the claims as a whole and reads as follows:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointesti­nal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointesti­nal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×10^8 red blood cells indicates a need to increase the amount of said drug subsequently admin­istered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Some sites, like ipwatchdog.com, have already written that the sky is falling.  The criticisms I have read thus far focus on the supposedly terrible impact this case will have on investment in medical diagnostics and biotech companies.  However, in this case, an obviousness analysis may well have invalidated the claims as well.

Steps (a) and (b) were known in the prior art, and, according to the Court, it was already known that the metabolite concentration in the blood correlated to the drugs activity and toxicity.  Under KSR, it likely would not have been too difficult to combine the prior art and invalidate the claims.  Claims like those of the Prometheus patent would still not be valid, but at least there wouldn’t be a new and ambiguous standard for patent eligible subject matter.

My personal feeling is that invalidating the claims under §103 would have been more appropriate.  There is a principle in law that cases should be decided narrowly if possible.  Had an obviousness analysis been used, the precedent would have applied to similar claims having only known steps and the recitation of a “natural law.” Invalidating the claims under §101 provides a very wide reaching precedent that will need to be applied in a variety of other contexts.  For example, Dennis Crouch at PatentlyO has written on the Mayo decision and potential implications on the Myriad case relating to isolated DNA.  He speculates that the Court will vacate and remand the Myriad cast to the Federal Circuit and that the claims, drawn to isolated and purified DNA, may very well be declared ineligible subject matter.

Methods of Treatment

Another possible implication of the decision could be the invalidation of claims to method of treating a disease.  After all, administering a medication in a particular way is likely known in the art.  The beneficial results of the drug in the human body could be considered a natural outcome, even if it was not previously known.  We don’t know if It will make a difference if the drug is naturally occurring or synthetic.

Chemical Formulations

What about the combination of known chemical species into a novel combination?  Would the Court hold that the synergistic effects or unexpected results of the combination are merely the natural consequence of the combination?  Again, what if one or more of the components is a synthetic compound?  While “unexpected results” are typically discussed in the context of an obviousness analysis, this is an illustration of how the decision may conflate obviousness and subject matter eligibility and the confusion that may result.

Unfortunately, the decision creates uncertainty that Congress will have to fix. Otherwise, it may take years for the courts to determine the reach of §101.