USPTO Expected to Issue Revised Myriad-Mayo Guidance in October

By Donald Zuhn --

During a session at today's biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting, the U.S. Patent and Trademark Office provided an update on the status of the Myriad-Mayo Guidance.  The BCP session on the Guidance, coming at the end of the Office's first Bicoastal BCP (BCBCP) event, included presentations and comments from June Cohan, Legal Advisor with the USPTO's Office of Patent Legal Administration; and Suzannah K. Sundby of Canady & Lortz LLP at the USPTO's Alexandria, VA campus; and from Jeffery Tung, Patent Counsel, Isis Pharmaceuticals; Paul Naik, Vice President, Intellectual Property, Genentech, Inc.; and Dan Sullivan, Director, TC1600, USPTO at San Jose State University.  Although the BCP session encompassed both the Myriad-Mayo Guidance and the Alice Corp. Guidance, the bulk of the session focused on the former.

Ms. Cohan spoke first, reminding attendees that at the last BCP meeting in April she had given a presentation on the Guidance following its March release (unlike her earlier presentation, this one was not accompanied by slides).  Since the April BCP meeting, she noted that the Office had conducted a forum on the Guidance in May, had collected comments on the Guidance over the summer, and had taken the opportunity to discuss the Guidance at other events (including during a BIO IPCC workshop in April and at the BIO International Convention in June).  Before discussing the impact of the eighty comments the Office had received in response to the Myriad-Mayo Guidance, Ms. Cohan posed the question that has been on many practitioners' and applicants' minds the past few months:  are there things in the Guidance that the Office can change?  To that question, her answer was a simple "yes".  As a result, she indicated that the Office intended to release "revised" Guidance in about a month.

Following this welcome announcement, Ms. Cohan discussed what the Office had learned from the comments and public feedback as well as what aspects of the Guidance it intended to change.  She noted that the Office did not explain things as clearly as it could have in the Guidance, and that it was not the Office's intent to give the impression that the Supreme Court has set a high bar for patent eligibility.  Rather, it is the Office's belief that the Court has set a low bar for eligibility.  She also indicated that the Office did not intend to create a per se rule on purified products, and could have provided a better explanation on this aspect as well.

With respect to questions about the eligibility of hybrid plants, hybrid animals, and antibodies expressed in mouse cells (which otherwise would not have been expressed in such cells), Ms. Cohan noted that all of these constituted patent eligible subject matter.  As for comments questioning the Office's interpretation of certain cases, she pointed out that the Office has gone back a reconsidered those decisions.

In crafting the Guidance that was issued in March, Ms. Cohan suggested that the Office had "cast too broad a net," and that the Guidance's "significantly different" test, which focuses only on structural differences, might be too narrow.  She indicated that the revised Guidance would permit applicants to establish that a claimed product was significantly different from a natural product by pointing to functional differences (or differences in biological activity).

As for the factor-based analysis of the Guidance, Ms. Cohan acknowledged that the scheme presented in the Guidance was "too complicated," and that the analytical framework in the revised Guidance would be "simplified".  Practitioners and applicants can also expect to see more examples in the revised Guidance.  Once the revised Guidance is released, Ms. Cohan noted that the Office wants "to keep the dialog going," explaining that several cases are working their way through the courts that could impact the manner in which the Office examines claims for subject matter eligibility.

Following Ms. Cohan's presentation, Mr. Tung provided a few comments regarding the impact of the Guidance.  He argued, as have other commentators, that in contrast with the Guidance, the Myriad holding is narrow -- even in the context of nucleic acids.  Ms. Cohan, however, responded that the Guidance applied to more than just nucleic acids because cases like Funk Bros., Chakrabarty, and Roslin concern more than just nucleic acids (i.e., bacteria and sheep), and therefore, "I don't see how we can limit this to DNA."

Dr. Naik provided two observations regarding the Guidance.  First, he agreed that more examples were needed, pointing out that examples are extremely powerful tools, especially given something as nebulous and vague as subject matter eligibility.  He also suggested that more examples that were closer to the eligibility line were needed, rather than examples that encompassed subject matter that was too clearly eligible or too clearly ineligible.  Second, he argued that the Guidance's filter was too low, explaining that an analysis in which the recitation of a protein in a claim forced the examiner to quickly move to the third prong of the subject matter eligibility analysis was "unnecessarily broad," and not a good use of either the examiner's or applicant's time.

Ms. Sundby suggested, as have other commentators, that it would be useful for the Office to create a subject matter eligibility webpage on which it would compile relevant decisions and new examples of patent eligible or ineligible subject matter.

Note:  Ms. Cohan will be participating in a session that will highlight the Myriad-Mayo Guidance at next week's Biotechnology Industry Organization (BIO) IP & Diagnostics symposium in Washington, DC.  The session, entitled "Squaring the Circle: Obtaining Patents That Are Valid, Commercially Meaningful, and Enforceable," which is sponsored by McDonnell Boehnen Hulbert & Berghoff LLP, will also feature Sherry Knowles of Knowles IP Strategies (former Senior Vice President and Chief Patent Counsel at GlaxoSmithKline) and Patent Docs authors Kevin Noonan and Donald Zuhn.

Comments

[Paul Cole]

Well done in getting a speedy report of this important discussion.

What would be good would be for USPTO to put the present draft informally on its website and enable further comments to be made before revised Guidance is published in October. That way we might have a revised draft which is (nearly) right first time.

[Suzannah]

I'm optimistic that things are moving in a positive direction. However, I'm a little skeptical that the so-called smaller net cast as a result of the difference between "directed to" and "reciting" or "involving" a judicial exception will be better for applicants. In particular, without sound guidance and examples as to when a claim is "directed to" a judicial exception, there is a risk of conclusory assertions by the PTO that will be difficult to rebut. In any event, it is clear that the PTO wants and needs our continued input so keep it up!

[Bob Cook-Deegan]

Extremely helpful. Thanks.

I would not want the job of giving examples close to the border, however. How could you be confident the Courts would agree? CAFC and SCOTUS clearly don't.

[Paul Cole]

What the USPTO wanted, above all, was EXAMPLES.

My comments contained a number of new examples worked through on the scheme proposed by the USPTO.

However, the outstanding effort along those lines was submitted by Coalition for 21st Century Medicine (see documents received after 1 August). Their efforts exceed mine by a factor of 2 or 3.

The best way forward is to take up the challenge refused by Bob Cook-Deegan and create further instructive examples that USPTO can use. It is probably still not too late to do some work in that regard, and everyone, both USPTO staff and the profession, will benefit from your efforts.

[Suzannah]

Re: Examples in view of the Courts and SCOTUS.

There are two completely different considerations. The first one is clear that the courts do not always agree with what the USPTO does. That's not going to change. The second, which is more important at this point considering everything that has happened, the USPTO has to devise a process that is clear and consistent for all applicants now. It may be that later the courts come back and tell the USPTO that they still have it wrong. The USPTO must not cower and do nothing or be overly and hence improperly restrictive out of fear of SCOTUS telling them that they are wrong. Such will drive a wrench into the engine of innovation (and also how our government is supposed to work... recall checks and balances -- the Executive Branch, the Legislative Branch, and the Judicial Branch each have a particular role to play).

[Mark Freeman]

As was discussed at the meeting, the Examples provided in the Guidance were intended to be clearly eligible or ineligible. Examiners sometimes incorrectly view the Examples as establishing the bright line between eligibility and ineligibility. Perhaps, the new Guidelines not only can provide Examples closer to the eligibility line, as Dr. Naik mentioned, but also provide instructions for interpreting the Examples, such as disclosing limitations in the Examples that are not critical to eligibility determination.

[Bunion]

Good point, Mark Freeman, especially since Ms. Cohan noted that Alice took the approach of separating elements from the claims for analysis (thus negating the 'old' approach/rule of considering the claim as a whole).

[Skeptical]

Not intending to be contrary to Paul Cole, I just do not agree with his post in reply to Bob Cook-Deegan.

Paul - I do not think that Bob is "refusing any challenge" whatsoever. I think instead that he is pointing out that the examples that are far from the "grey zone" are examples that we need the least. It is explicitly the close calls wherein guidance is most beneficial. Examples that are clearly one way or the other are completely unhelpful in precisely the situations wherein we need the most help.

Decreasing the alarm we should feel is not a help to rectifying the situation. Rather, I would posit that sounding more alarm is in fact more helpful to resolving something that should have been resolved if the Court had chosen to act in a more decisive (and more helpful) manner.

In fact, I would posit that the Court has settled for a "peace for out times" AVOIDANCE of the critical challenge. Instead of accusing Bob Cook-Deegan of the avoidance, I would place the "blame" somewhere more appropriate.