INVENTIVE STEP

This morning, the PTO has released another decision on patentable subject matter, this time concerning a biomedical invention, Mayo Collaborative Services v. Prometheus Labs., Inc.  In the opinion for the unanimous Court, Justice Breyer writes that the claims at issue are not directed to patentable subject matter.

I have previously covered the details of the claims at issue in this case.  As a reminder, claim 1 of U.S. Patent No. 6,355,623 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 8×10⁸ 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 8×10⁸

red blood cells red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

In its opinion, the Supreme Court continues to make the all too common mistake of conflating patent eligibility with novelty and obviousness (inventive step) or claim breadth (§ 112):

the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field.

If the Court’s statement is true, the claims should be unpatentable because they lack novelty or are obvious.  There is simply no need to add another step of complexity to the analysis.

The Federal Circuit had determined that the claims were not directed merely to a law of nature, but to a particular application of the law.  The claims recite specific treatment steps and not merely the correlation between metabolite levels and drug efficacy or toxicity.  The Supreme Court disagreed.

Referring to the specific steps of the claims, the Court characterized the “administering” step as simply referring to the relevant audience, doctors.  This step simply picks out the group of individuals that are interested in applying the law of nature.  The Court’s statement about this step again seems to indicate that the step was part of the prior art:

doctors used thiopurine drugs totreat patients suffering from autoimmune disorders long before anyone asserted these claims.

The “wherein” clauses are simply telling the doctors to take laws of nature into account when treating patients.  Finally, the “determining” step tells the doctor to determine the level of metabolite in the blood.  Again, referring to this step as existing in the prior art:

doctors used thiopurine drugs totreat patients suffering from autoimmune disorders long before anyone asserted these claims.

The Court then summarized its conclusion of the claims:

To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of wellunderstood, routine, conventional activity already engaged in by the scientific community; and those steps, whenviewed as a whole, add nothing significant beyond the sum of their parts taken separately.

Finally, the Court went through its precedents regarding patent-eligibility (hardly a study in clarity) and determined that the claims in this case present a weaker case for patent eligibility than those in Diehr, and no stronger than those in Flook.

The Court did attempt to address the issue that I raise in this post.  In an amicus brief, the government argued that other sections of the Patent Act (§§ 102, 103, 112, etc.) can be used to screen claims.  For example, the government argued that the claims at issue in this case are likely not novel.  In addressing this issue, the Court recognized that there may be some overlap between § 101 and § 102, but this won’t always be the case.

And to shift the patent-eligibility inquiry entirely to these later sections riskscreating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do.

The government’s position (quite a reasonable one) is that laws of nature are by definition part of the prior art.  The Court addressed this issue by suggesting that if that is so, no invention can be patentable because all inventions are applications of laws of nature.  The Court seems to ignore the all-important word application.

Gene Patents

It has been speculated that the Supreme Court was holding the petition for review in the Myriad gene patent case until it released this opinion in Prometheus.  Perhaps the Court will GVR (grant-vacate-remand) that case back to the Federal Circuit for reconsideration in light of this opinion.  The Court scheduled consideration of the Myriad petition over a month ago, so that very well could be what will happen.  Given that the Federal Circuit had already held the method claims in Myriad to be unpatentable, while upholding the claims to isolated genes, this opinion would not seem to have much bearing on Myriad.

This entry was posted on March 20, 2012 at 11:28 am and is filed under Court Decisions, Supreme Court. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.