Myriad Case Sent back to the Federal Circuit after Mayo v. Prometheus

The Myriad case has been sent back to the Federal Circuit to review that court’s previous decision in view of last weeks Supreme Court decision in Mayo v. Prometheus.  I discussed the Mayo decision, which dealt with medical diagnostic claims.  The myriad claims are also diagnostic in nature in that they relate to testing patients for particular genetic mutations that can be contributing factors for ovarian cancer.

Here is the entirety of the order:

The petition for a writ of certiorari is granted. The
judgment is vacated, and the case is remanded to the United States Court of Appeals for the Federal Circuit for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012).

Myriad’s stock took a beating after the Mayo decision as many suspect that a majority of the court would invalidate the claims in the Myriad case.  However, with the remand order today, Myriad’s stock is, oddly enough, benefiting from the uncertainty.  The new procedural posture means it will likely be at least a year, and more likely two, before the case is taken up by the Supreme Court again.  That gives Myriad another year or two where prospective competitors may not be willing to enter the market for these gene diagnostic tests.

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, 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.

Pinterest’s Future

There have been a lot of blog posts and articles about Pinterest and how copyright claims may affect its future. I agree with the sentiment that Pinterest’s opt-out system is a clumsy response to the situation, but their phenomenal growth to this point may be their saving grace. I wrote a bit about the dust-up last week between Pinterest and content providers

If Pinterest had a fraction of the users that it has now, some copyright holders may have already tried to shut it down. By utilizing the DMCA safe harbor, Pinterest has been able to operate and expand to the point that many copyright holders are seeing the advantage of such a wide reaching platform.

To take advantage of this situation, Pinterest may need to make some changes. After they talked with Kristen Kowaiski, it sounds like Pinterest may be making some changes after all. Here are a couple of things I see:

  1. By its terms of service, Pinterest asserts the right to copy and even sell whatever a person pins on a board.   Even if it’s a right never exercised by Pintererest, the specter of such a term will have a chilling effect on participation by those who want to pin their own work.
  2. The opt-out plan is not workable.  An opt-in system would be much better for the web ecosystem in general and show greater respect for the copyrights of creative publishers. Granted, if Pinterest was just starting, it would never get the traction for people to opt-in. Now, though, with the number or users and all the buzz, the incentives are there for the people Pinterest would likely want to opt-in to do so (potential advertisers and content providers).

There is speculation about how Pinterest will make money, and I have some guesses as well. Pinterest’s appearance could be adversely affected by the inclusion of ads unless they are very subtle. That would be particularly problematic since so much of the buzz has been about how Pinterest is revolutionizing page design.

The real potential is in data mining the interests of its users based on their pins and predicting other interest based on them.  This can allow for targeted advertising, not just on Pinterest’s site, but on third party sales sites.  Imagine going to and seeing ads for things related to what you have pinned on your board, or that people similar to you have pinned.

Facebook does things like this, but I think “pinning” could provide an even better indication of what a user might spend their money on than “liking.” To reach this potential, Pinterest has to avoid scaring off content providers and users. Time will tell if they can.