USPTO Provides Update on Status of Revised Myriad-Mayo Guidance

By Donald Zuhn --

During a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsels Committee (IPCC) fall conference, which took place this week in Nashville, TN, the U.S. Patent and Trademark Office provided a status update regarding forthcoming revisions to the Myriad-Mayo Guidance.  Once again representing the Office was June Cohan, Legal Advisor with the USPTO's Office of Patent Legal Administration.  Ms. Cohan's latest presentation marked the fourth time in the past eight months that she has addressed the Guidance at a BIO event (she previously presented on the Guidance in April at the BIO IPCC spring conference in Palm Springs, CA, in June at the BIO International Convention in San Diego, CA, and in September at the BIO IP & Diagnostics symposium in Alexandria, VA).  Also participating in the session on "Protecting Products of Nature," were Dr. Fangli Chen of Choate Hall & Stewart LLP (who moderated the session); Henry Gu, Director, Intellectual Counsel for Cubist Pharmaceuticals; Dr. Steve Bossone, Vice-President of Intellectual Property for Alnylam Pharmaceuticals; and Hugh Goodfellow of Carpmaels & Ransford LLP.

Dr. Chen began the session by providing an overview of patent eligibility for biotechnological subject matter, including the origins of the gene patenting debate, the procedural history of the AMP v. Myriad Genetics suit, and the Supreme Court's decision in that case.  With respect to the origins of the gene patenting debate, Dr. Chen pointed to a Parade magazine article from November of 2006 (which was first addressed in this space in December of 2006).

Dr. Chen then turned the session over to Ms. Cohan, who began her presentation by indicating that while the revised Myriad-Mayo Guidance had to comport with four Supreme Court decisions on patent eligibility (Bilski v. Kappos (2010), Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Alice Corp. v. CLS Bank International (2014)), the Office had "a lot of room to maneuver."  She pointed out that the Office currently has two sets of eligibility guidance in place:  the Preliminary Examination Instructions that were issued in June of 2014 in response to the Alice Corp. decision (see "USPTO Issues Preliminary Examination Instructions Regarding Alice Corp. v. CLS Bank International"), and the Myriad-Mayo Guidance that the Office issued in March (see "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products").  While Ms. Cohan noted that the Alice guidance had been favorably received by the patent community, she acknowledged that response to the Myriad-Mayo Guidance had been "unfavorable."

Regarding the public feedback on the Myriad-Mayo Guidance, Ms. Cohan addressed four issues:  the breadth of the Guidance, the patent eligibility of discoveries, the impact of examining claims that are directed to a judicial exception rather than those that merely recite or involve a judicial exception, and the Guidance's "significantly different" standard.  With respect to breadth of the Guidance, Ms. Cohan noted that the Myriad-Mayo Guidance addresses Myriad in the context of other Supreme Court decisions.  To those who have asked why the Office, in issuing the Guidance, went beyond Myriad, Ms. Cohan replied that "Myriad is not a case that stands alone," but rather "relies on earlier Supreme Court precedent including Chakrabarty, Funk Brothers, and Mayo."

As for criticism that the Guidance relegates discoveries to second-class status despite the express language of 35 U.S.C. § 101 that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter . . . may obtain a patent therefor. . ." (emphasis added), Ms. Cohan countered that the Supreme Court had explained in a number of decisions over the past 65 years that "a mere discovery of nature's handiwork" is not patent eligible.  Although the Court has also indicated that a discovery may be patent eligible when practically applied, she conceded that the distinction between patent eligible and patent ineligible discoveries can be somewhat confusing.

Turning to the difference between claims that are directed to a judicial exception and those that merely recite or involve a judicial exception, Ms. Cohan noted that the original Guidance required examiners to analyze claims that recite or involve a judicial exception rather than claims that are directed to a judicial exception.  She explained that critics of this approach complained that way too many claims had to go through the three-step examination process implemented by the Guidance.  Ms. Cohan indicated that consistent with the Alice Corp. decision, which was issued by the Court almost four months after the Office issued the Myriad-Mayo Guidance, the revised Guidance would focus on the (allegedly) narrower category of claims that are directed to a judicial exception.

The final issue addressed by Ms. Cohan was the Guidance's creation of the "significantly different" standard, which "brings together the outcomes of both Myriad and Mayo" by merging the "marked difference" standard of Chakrabarty, which was applied in Myriad, with the "significantly more" standard of Mayo, which was applied in Alice Corp.  Ms. Cohan argued that the Office did not intend to merge the two tests, and that the Guidance's standard was only intended to be a teaching tool for examiners.  Nevertheless, she reiterated that the phrase "significantly different" would not appear in the revised Guidance, and that the Office would be "sticking closer to the cases."  This suggests that the revised Guidance may focus on one or both of the tests from Chakrabarty/Myriad and Mayo/Alice Corp.

In addition to the above issues, Ms. Cohan indicated that the revised Guidance would allow applicants to demonstrate that the claimed subject matter is markedly different from a natural product by showing differences in function or utility.  Referring to the controversy surrounding the Guidance's fireworks example and the Office's observation that simple gunpowder, which is a combination of three naturally occurring products, would not be patent eligible due to a lack of structural differences (despite the obvious functional difference between the individual components and the combination), Ms. Cohan explained that the Office had "found a way for gunpowder to be eligible."  She also noted that the complex, twelve-factor test of the original Guidance would not appear in the revised Guidance.

Given that Ms. Cohan's presentation did not appear to till any new ground, the question on everyone's mind was when the revised Guidance would be issued.  Ms. Cohan indicated that the new Guidance would be issued "very soon," adding that she "was hoping to have it by now," but that it was "not quite ready."  Towards the end of the session, Ms. Cohan did sound one (possibly) worrisome note when she indicated, without elaboration, that the revised Guidance "had to pass a few more checkpoints" before it could be issued.  For those who recall Ms. Cohan's prediction at the BIO IP & Diagnostics symposium that the revised Guidance would be issued in October (see "USPTO Expected to Issue Revised Myriad-Mayo Guidance in October"), her remark about "checkpoints" likely gave skeptics in the audience pause.

Patent Docs will discuss the session's other presentations in a subsequent post.

Comments

[Paul Cole]

It is unclear why the Office is unable to publish the proposed new guidance as a working draft open to public comments. That would be democratic, whereas doing everything in-house and presenting the public with a fait accompli would be autocratic and more befitting George III and Lord North than Thomas Jefferson.

Given what was said in the Myriad oral arguments, refusal to withdraw the Amazonic Acid example with immediate effect is inexplicable.

The extraordinarily low level of technical competence underlying the present guidance is amply illustrated by the gunpowder example which incorporates errors of technical fact unbefitting a graduate in the chemical sciences, and arguably also unbefitting a schoolchild with elementary knowledge of human history. If it has taken many months for the Office to find a way for gunpowder to be patent-eligible, that raises significant doubts about the technical and legal competence of the team working on the guidance.

[Paul Cole]

On reflection, the real issue is not that the Office got the guidance wrong. People often make mistakes or ill-judgments, and people who do not make mistakes rarely make anything.

It is different, however, when something is wrong, the error is very clear once pointed out, but is allowed to persist on the record for a long time. Damage accumulates daily, and the longer the error is allowed to persist the less pardonable it becomes.

[GrzeszDeL]

"Given what was said in the Myriad oral arguments, refusal to withdraw the Amazonic Acid example with immediate effect is inexplicable."

Exactly right. I remember when I first read the Guidance, I had to page through my transcript of the Myriad argument to make sure that I was not misremembering Justice Alito's hypothetical. The funny part about that exchange was that even the ACLU's lawyer agreed that making the Amazonic acid "substantially more concentrated than it was in nature" would be enough to confer patentability, but the Guidance took that example and ran in exactly the opposite direction with it.

One almost has to admire the nerve of whoever wrote that example in the Guidance. To take an example that Justice Alito intended as a clear example of something 101 eligible and use it as a didactic example of something INeligible--that takes guts.

[Simon Elliott]

The PTO could have avoided these problems by starting with public notice and comment before formulating the guidelines.

Now I have to respond to final rejections under the old guidelines, knowing that the new guidelines will be very different.

We have spent the better part of a year and lot of money going around in a circle.

I think that the Office should consider a guideline making non-final all rejections under the old guidelines, and giving applicants a new, non-final rejection under the new guidelines to address any remaining issues. The PTO can do this before they issue the new 101 guidelines.

[The Big Lebowski]

"To those who have asked why the Office, in issuing the Guidance, went beyond Myriad, Ms. Cohan replied that "Myriad is not a case that stands alone," but rather "relies on earlier Supreme Court precedent including Chakrabarty, Funk Brothers, and Mayo.""

Funk Brothers was pre-1952. Anything the court said in it is irrelevant. Ms. Cohan's and her cohorts' persistence in feeling beholden to a court interpretation that was statutorily overruled is as puzzling as it is astonishing. And it is detrimental to investment and commercialization in the life sciences.

[Paul Cole]

Unfortunately we cannot ignore Funk Brothers because the Supreme Court has cited it recently and with approval. What we can do, though, is to try to understand it and identify any relevant rules of law applied by the Court.

Unfortunately the opinion of William O Douglas is confused and legal interpretation is blisteringly difficult. The opinion cites Cuno and hence appears to be related to obviousness, but recent decisions have reinterpreted it in the context of eligibility. However, the fact that a Supreme Court justice thinks that the opinion was an eligibility opinion does not make it so: it is impossible to re-write the past. What is needed is to study the facts of the case and figure out the true rule of law. That means looking at the patent in issue, the particular claim in issue, the earlier Appeals Court opinion and the opinions in the Supreme Court. And much as we might prefer the opinion of Justice Frankfurter, the majority opinion was that of Douglas and the rule of law must be derived from what he wrote.

It was known to mix strains of Rhizobium bacteria, and the claim was limited by the result that the bacteria were non-interfering without the inclusion of any feature in the claim that made this happen ("selected" in context was meaningless). Justice Douglas was not prepared to give any weight to the result because the existence of non-interfering strains was the discovery of a law of nature. The application of this principle in the empirical state of the art was the discovery of particular non-interfering strains identifiable e.g. by deposit in a culture collection, but that was not in issue. What Justice Douglas did was notionally to cross out the non-interference wording as mere expression of a law of nature and to hold that there was nothing else that amounted to invention. Something similar is done in Europe for business method and computer patents where non-technical features are ignored. Interestingly though, this approach was expressly disapproved in Mayo.

Beyond concluding that judicial exclusions within statutory rights should be interpreted narrowly, there is not much more that can be added. We can all try to psycho-analyse William O Douglas, but there are likely to be as many outcomes as there are people undertaking the analysis. Perhaps the best way forward would be to say that beyond some unexceptionable statements of general principle no clear rule of law is derivable and that the decision should merely stand on its own facts. Pre-1952 many more patent cases reached the Supreme Court than nowadays, and it should not be expected that every decision would have wide-ranging and fundamental implications. But certainly it is not a case that provides any clear precedent that provides straightforward guidance for the USPTO.

[Skeptical]

Mr. Cole,

Your past admonitions of careful, thoughtful and limited application of our Supreme Court jurisprudence were completely ignored in today's release of Ultramerical III.

Sometimes it is painful to say "I told you so," but - I told you so.

[Skeptical]

To quote Brody: you're going to need a bigger boat

https://www.youtube.com/watch?v=8gciFoEbOA8