USPTO Provides Update on Status of Revised Myriad-Mayo Guidance

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Biotechnology Industry Organization (BIO)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).

USPTO SealDr. 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.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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