Stakeholders Testify on Patent Subject Matter Eligibility

15 May 2014 PharmaPatents Blog

On May 9, 2014, the USPTO held a public forum on the USPTO’s new patent subject matter eligibility guidance (the “Guidance”), previously discussed here. In promoting the forum, the USPTO stated that it wished to “to receive public feedback from organizations and individuals on the Guidance.” The USPTO may be regretting it did not request public input prior to the Guidance’s release, because the feedback it received at the forum was overwhelmingly critical of both the substantive principles and scope of the Guidance and the procedures by which it was promulgated.

USPTO Opening Remarks

Perhaps anticipating criticism, USPTO officials opened the forum by explaining why the USPTO issued the Guidance without first soliciting public input and the principles behind the Guidance.

Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy, emphasized that the USPTO never intended to exclude the public from providing input, but implemented the Guidance as a “stop-gap” measure to direct examination of currently pending cases while it determines what additional guidance is needed. He indicated that further iterations of the Guidance may be issued based on concurrent feedback from the public and patent examiners, including feedback provided at the forum.

Mr. Hirshfeld also explained that the Guidance is necessarily comprehensive and goes beyond nucleic acids, because the Guidance is not based solely on Myriad. Instead, the Guidance is based on Myriad in the context of prior Supreme Court decisions, including American Fruit Growers, Flook, Benson, Funk Brothers, Bilski, J.E.M. Ag Supply, Chakrabarty, Mayo, Diehr, and Morse.

Raul Tamayo, Senior Legal Advisor in the Office of Patent Legal Administration, explained that the “significantly different” standard in the Guidance captures the “marked difference” standard in Chakrabarty and the “significantly more” standard in Mayo. Mr. Tamayo explained that the Guidance requires a “marked difference” to be a structural difference because the “Supreme Court has never held a claim reciting a natural product eligible unless it was structurally different than what exists in nature.” Mr. Tamayo also stated that Myriad changed the USPTO’s understanding of the law on subject matter eligibility.

Stakeholders Speak Out

Following the USPTO remarks, 10 speakers representing public stakeholders presented their views on the Guidance, relevant Supreme Court precedent, and the likely impact the Guidance will have on investment and innovation. The speakers’ presentations can be accessed on the USPTO website here. Members of the audience also spoke during question-and-answer sessions.

Many of the speakers and audience members shared disappointment with the scope of the Guidance and the manner in which it was implemented. The following list highlights top themes raised by the speakers .

  • The USPTO inappropriately issued the Guidance without first providing the public with an opportunity to comment on the Guidance.

The USPTO in the past has published significant guidances for public comment before finalizing them. –Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization.

The USPTO obtained public input before issuing the 2001 Utility Guidelines. –Member of the audience.

In response, USPTO officials confessed to not knowing the facts behind the 2001 Utility Guidelines, but believed that the “stop-gap” implementation of the Guidance followed standard protocol.

  • The Guidance unjustifiably extends beyond nucleic acid molecules and covers subject matter not addressed by the Supreme Court in Mayo or Myriad.

The Supreme Court in Myriad and Mayo cautioned against overly-broad applications of subject matter eligibility exceptions. In Mayo, the Court stated that “The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law.” –Courtenay Brinckerhoff, Partner, Foley & Lardner LLP; Duane Marks, Patent Counsel, Roche Diagnostics Operations, Inc.

Pharmaceutical and method of treatment claims should not be included within the scope of the Guidance. The Supreme Court in Mayo and Myriad explicitly stated that it was not addressing “a typical patent on a new drug” or “new applications of knowledge” about genes. –Courtenay Brinckerhoff, Partner, Foley & Lardner LLP.

The USPTO’s interpretation of Myriad would render claims directed to formulations comprising purified or isolated Paclitaxel or Baccatin III in therapeutically effective amounts for treating cancer to be patent ineligible in view of the Pacific yew tree (from which these compounds are purified/isolated), even though the tree is not a “formulation” or “composition” comprising therapeutically effective amounts of the compounds. –Suzannah Sundby, Partner, Smith, Gambrell & Russell, LLP.

There is no policy justification for expanding the scope of the Guidance to encompass subject matter not at issue in Myriad. The USPTO’s interpretation of Supreme Court cases is not the only permissible one. –Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization.

The Court’s decision in Mayo needs to be analyzed in view of the specific claims at issue, and not in the abstract. The Court provided a roadmap of “useful clues” for applying the case to diagnostic claims. –Duane Marks, Patent Counsel, Roche Diagnostics Operations, Inc.

Purified product claims offer the best patent protection and do not run afoul of Myriad, which is limited to “genes and the information they encode.” –Kenneth Sonnenfeld, Partner, King & Spalding LLP.

Counsel for Petitioner during oral arguments in Myriad acknowledged that a purified product may be eligible for a patent, stating that “by both changing its nature and by giving it a new function, you may well have patent.” –Kenneth Sonnenfeld, Partner, King & Spalding LLP; Warren Woessner, Founding Shareholder, Schwegman Lundberg & Woessner, P.A.

Practical effects are being felt, as Office Actions are now being issued against claims not directed to genetics, including pharmaceutical compositions, industrial enzymes, and methods of treatment. –Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization.

  • The Guidance misinterprets the Supreme Court in Myriad by ignoring function and requiring a “markedly different” structure for product claims.

Chakrabarty discussed the markedly different standard in terms of “markedly different characteristics,” which is not limited to structure. –Suzannah Sundby, Partner, Smith, Gambrell & Russell, LLP; Warren Woessner, Founding Shareholder, Schwegman Lundberg & Woessner, P.A.; Barbara Fiacco, Partner, Foley Hoag on behalf of American Intellectual Property Law Association.

The Guidance takes an overly narrow interpretation of Funk Brothers by focusing only on Myriad’s statement that the Funk Brothers composition was not patent eligible because “the patent holder did not alter the bacteria in any way.” However, Myriad also discussed Chakrabarty’s patent eligible bacterium as having “markedly different characteristics.” –Courtenay Brinckerhoff, Partner, Foley & Lardner LLP.

The Supreme Court in Myriad focused on genetic information presented by the claim language, not on the chemical structure of DNA. The Court conflates structure with function, as evident by the decision’s numerous recitations of “information” and “sequence,” but no mention of “function” and only a single mention of “structure.” Because the Court considered DNA sequence to be “information,” basing a claim’s eligibility by considering only structure applies only when structure and function completely collapses. –Leslie Fischer, Senior Patent Attorney, Novartis Pharmaceuticals Corporation.

  • The Guidance’s requirement that examiners weigh a number of positive and negative factors to determine subject matter eligibility is inappropriate.

The factor-based approach is similar to the Wands factor-based analysis for enablement under § 112, but is inappropriate for a § 101 analysis. Supreme Court decisions on subject matter eligibility never weighed positive factors against negative factors. –Suzannah Sundby, Partner, Smith, Gambrell & Russell, LLP.

Claims should be considered as a whole and not parsed apart into claim elements such that only those elements that are not a judicial exception can support patent eligibility. –Courtenay Brinckerhoff, Partner, Foley & Lardner LLP.

The claims must be read as a whole. –Barbara Fiacco, Partner, Foley Hoag, speaking on behalf of American Intellectual Property Law Association; Gregory Cox, Assistant General Patent Counsel, Eli Lilly and Company, speaking on behalf of American Bar Association Section of Intellectual Property Law.

The Guidance factors should be simplified. There is a concern that more factors are likely to be generated by the USPTO or caselaw. –Anthony D. Sabatelli, Partner, Dilworth IP LLC.

  • The Guidance examples do not provide a good roadmap for examiners or patent practitioners.

The USPTO should provide real examples to guide § 101 analysis. –Suzannah Sundby, Partner, Smith, Gambrell & Russell, LLP; Kenneth Sonnenfeld, Partner, King & Spalding LLP.

The Guidance’s amazonic acid method claim example is limited to a single indication and contains multiple limiting elements (e.g., 10 to 20 days and 0.75 to 1.25 teaspoons) that a potential infringer could avoid by making “immaterial changes.” –Kenneth Sonnenfeld, Partner, King & Spalding LLP.

The Guidance examples are not useful due to oversimplification or a scope that is too narrow. –Member of the audience.

Practical effects are being felt through Office Actions rejecting method claims that do not contain as much detail as the examples in the Guidance. —Member of the audience.

What’s Next?

USPTO officials acknowledged suggestions that the Guidance be withdrawn, but were skeptical that a wholesale suspension of the Guidance would occur. Instead, the USPTO officials renewed their request for comments offering different interpretations of the case law and additional examples of eligible and ineligible subject matter that could be used to supplement the Guidance. In the meantime, applicants were advised to respond to new § 101 rejections as they would to any other rejections.

You can find the USPTO patent eligibility guidelines, related information, and instructions for submitting comments on the USPTO’s Myriad-Mayo Guidance webpage.

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