Early Reaction to Supreme Court Decision in Mayo v. Prometheus

By Donald Zuhn --

Following the Supreme Court's unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., issued earlier today, in which the Court reversed the Federal Circuit and found Prometheus' claims to be invalid for "effectively claim[ing] underlying laws of nature," few organizations have thus far decided to issue public statements regarding the decision.  In fact, Patent Docs has received only two statements from organizations, each representing a different side of the issue.

In a statement by Dr. Robert Wah, Board Chair for the American Medical Association (AMA), the group welcomed the Supreme Court's decision invalidating Prometheus' patents.  Asserting that the Court had "prevented irreparable harm to patient care with today's unanimous decision to invalidate two patents that gave Prometheus Laboratories exclusive rights over the body's natural responses to illness and medical treatment," the AMA declared that the decision was "a clear legal victory that ensures critical scientific data remain widely available for sound patient care and innovative medical research."

Had the Court found the patents to be valid, the AMA argued that "physicians would have encountered a vast thicket of exclusive rights that would prevent them from considering all relevant scientific information when reviewing diagnostic test results."  The group also suggested that a finding of validity would have "inhibit[ed] future discoveries."

The AMA, together with the American College of Medical Genetics, the American Hospital Association, the American Society of Human Genetics, the Association of American Medical Colleges, the Association for Molecular Pathology, the Association of Professors of Human and medical Genetics, the College of American Pathologists, the Florida Hospital Association, the Minnesota Hospital Association, and the Minnesota Medical Association, submitted an amici curiae brief in support of Petitioners Mayo Collaborative Services and May Clinic Rochester.

The Biotechnology Industry Organization (BIO) viewed the Court's decision in a decidedly different light.  In a statement that the group distributed this afternoon, but had not yet posted to its website, Dr. Hans Sauer, BIO Deputy General Counsel for Intellectual Property, noted that BIO was "surprised and disappointed in the Court's decision, which disregarded the considered judgment of the Executive Branch experts and numerous amici such as BIO, who warned about the unintended consequences of attempting to use patent eligibility as a basis to strike down these patents for biomarker-based diagnostic methods."

While the group indicated that it was still analyzing the Court's opinion, BIO expressed "concern[] that it introduces new and confusing concepts into the traditional body of patent law, which patent examiners and lower courts will struggle to consistently and rationally implement."  In addition, BIO noted that "[w]hile the opinion's lack of guidance may limit its practical impact, we are troubled that the Court's opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases."  The group ended its response to the decision by offering to "work with the Administration and the U.S. Patent and Trademark Office to ensure that the future application of this opinion does not irrationally restrict the ability of innovators to protect inventions that lead to cures, medical breakthroughs, and other technologies that make our lives and our environment cleaner, safer and healthier."

BIO submitted an amicus curiae brief in support of Respondent Prometheus Laboratories.

Comments

[Geoff Karny]

Prevented irreparable harm to patient care? What a crock! It prevented irreparable harm to the wallets of infringers who want to get a free ride on the time, money, and effort of innovators who bring new products and processes to the market.

[Gary Johnston]

Geoff Karny, do you even know what you are talking about? Would you have felt better if the justices killed the patent under 103? I dare you to answer that question honestly. How is it possible that every singe justices is wrong? At the time the applications were filed everything in the claims was already well known except for the correlation between the specific amounts of metabolites and "optimum" dosage. The drugs were known, the fact that the drugs were effective to treat immune-mediated GI disorders was known, the fact that the drugs had toxic side effects was known, and the fact that people metabolize drugs differently was known. It was also well known how to detect the metabolites of the drugs. Everything was old except for the specific correlation. But that correlation exists regardless of any hand of man. It's just a fact of the world we live in. The patentee was trying to prevent others from EVER determining metabolite levels of thiopurines following their administration, regardless of how they were being determined. The claim didn't even require that you DID anything with the information you generated. Anyone, and I mean ANYONE, who thinks SCOTUS got this wrong should not be permitted to represent clients.

[Dan Feigelson]

Gary:

"The patentee was trying to prevent others from EVER determining metabolite levels of thiopurines following their administration..."

Seems to me the people who "should not be allowed to represent clients" are those who think that patents are of unlimited duration.

My concern, like that of BIO, is that this decision may result in the stifling of research in the medical field, as in a worst-case scenario patent eligibility would be denied for the fruits of worthwhile types of research, resulting in less or no investment in such research. I'd rather have new drugs and treatment techniques that are someone's exclusive property for 20 years and then become public domain than never have those drugs or treatments see the light of day. For that reason, like many other people, I wonder if it wouldn't have been more prudent to kill the patent on obviousness grounds than patent eligibility grounds.

[Gary Johnston]

Touché Dan. "Ever" during the life of the patent, that is. You knew what I meant.

[Brian Stanton]

Re would it be better to have the patent invalidated under 103? The answer is decidedly YES. Moving prior art questions into 101 begs indiscriminate use of a blunt sledge hammer to deny IP. 101 should be used carefully since it tends to be asserted rather than debated and applicants will always lose before the PTO since per se eligibility determinations carry little administrative risk.

[Baltazar]

How does this affect the patentability of DNA claims? I fear courts could now find that DNA represents a law of nature. Of course, Prometheus claimed a process while Myriad is about a composition of matter.

[Geoff Karny]

Gary Johnston, yes it would have been better for the court to have invalidated the patent under 103. And yes, the justices can be wrong. Ever hear of the Dred Scott decision? And yes, the application of a biological correlation should be patentable. The universe operates according to scientific principles. Every invention involves the application of one or more scientific principles. Applying the reductionist analysis of the court, every invention can be restated as a "law of nature" and, therefore, unpatentable. As to your personal attack, I'll refrain from stooping to your level.

[EG]

How Prometheus claimed this drug dosage calibration method was problematical in getting over patent-eligiblity hurdle. After Bilski, I was very concerned that these data-gathering “determining steps” might not make it into the “patent-eligible zone.” Justice Breyer's opinion confirms that fear

But Breyer’s opinion is also ghastly, based on nonsenscial reasoning, Supreme Court precedent (especially Parker v. Flook) that is logically flawed, and frankly being very unhelpful in how you can turn a patent-ineligible “law of nature” into a patent-eligible application of that “law.” I’m particularly irked by Breyer’s snide remark about using the “draftsman’s art” to make what is claimed patent-eligible. After all, doesn’t 35 USC 112, second paragraph, say the invention is defined by “one or more claims”? So if you can’t use the “draftsman’s art,” then what, pray tell, Justice Breyer can you use since your opinon also tells us we can’t rely upon steps that are “routine, conventional activity”?

For those who think there is now a "free lunch" to copy the drug testing methods of others, guess again. There are two potential reactions by those researching, developing (and funding) such drug dosage calibration or other drug testing methods if the patent-eligibility bar is perceived as being raised too high by Mayo Collaborative Services, both of which would be a far greater impediment to innovation, as well as increasing the storehouse of scientific and technical knowledge for such drug testing methods. One is that research, development (and funding) of drug testing methods will simply dry up if the investment in such testing cannot be protected (or is perceived to unprotectable) by patents. (And without patents, there is no “disclosure to the public” of the drug testing methods being claimed.) The other is that such research, development (and funding) of drug testing methods will continue to the extent that such methods can be viably protected as “trade secrets.” Again, there's no "free lunch."

[Skeptical]

Baltazar,

You comment that Prometheus claimed a process while Myriad is about a composition of matter.

I would point out to you that the Court has classified as mere "drafting artiface" the choice of class. I would suspect that compositions will NOT offer any solace from this decision.

[MR]

There are many tests of blood drug levels that are used in medicine to adjust drug doses. Some of the tests are performed using automated instruments (e.g. marketed by Roche, Integra system) and others are performed using "home brew" instruments. The clinical lab then interprets the drug levels, and the lab or another clinician, such as a clinical pharmacist, provides drug dosing recommendations based on the levels and other clinical characteristics of the patient. What is it that Prometheus claimed was protected: the lab method of making the measures in blood? Or the few words of dosing recommendations for thiopurines based on the measures (which, by the way, are flawed)? Or both?

[Gary Johnston]

EG, this was not a "drug testing method." The researchers at the Sainte-Justine Hospital in Montreal (Prometheus in-licensed the patents from Sainte-Justine) did not invent a new way to determine thiopurine metabolite levels in blood. All they discovered was the significance (for lack of a better word) of those levels. Asserting that this decision stifles innovation in the esoteric testing industry is weird. These types of correlations will be discovered with or without patent protection. Once discovered, it takes little to bring to market a test that "incorporates" the correlation. Obviously it requires some money and elbow grease, but every single business requires these things to succeed. The decision should be cheered by anyone that truly cares about innovation.

[EG]

Gary,

To be exact, the claimed method is about drug dosage calibration, but I decided to refer to it under the generic category of "drug testing method." Take your pick.

As noted upthread, Prometheus' claims are problematical as to whether they reach the "patent-eligible zone" for reasons I've stated on this thread or others. But to say we should "cheering this decision" tells me your drinking far too much of the "Kool Aid" proffered by the amici supporting Mayo's position. I also stand by what I said upthread and others have said it as well: Breyer's opinion is ghastly for it's nonsensical and conflicting logic. Again, it does nothing to help us determine when a patent-ineligible "law of nature" becomes a patent-eligible application of that "law."

And those who fund research aren't going to do so if that investment is unprotectable by patent or "trade secret." Just ask any VC if they're willing to invest in a technology which is unprotectable by patents.

[Eckhard Kuesters]

In addition to the concerns noted previously, consider the fact that the supremes have reverted to the analysis of stripping the claim of everything "old" and determining if what is left is statutory. Not only does this undermine the review of the claim "as a whole" but will undoubtedly result in mischief in the PTO.