Will the USPTO Respond to Public Feedback of Its Eligibility Guidance?

25 August 2014 Personalized Medicine Bulletin Blog

Periodically, the USPTO holds open meetings with the public to discuss its thinking on current topics relating to the patent procurement process. Late last week, the Biotechnology, Chemical and Pharmaceutical Customer Partnership of the USPTO announced the first bi-coastal meeting to be held via webcast in Washington, D.C. and San Jose, California on September 17th, 2014. Included on the September 17th agenda is a panel discussion of the U.S. Supreme Court patent-eligibility decision, Assn. for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (“Myriad”). Myriad, along with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (“Mayo”), are the subject of the USPTO’s controversial “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” (“2014 Guidance”). Under the 2014 Guidance, any patent claim that may be directed to a “judicial exception” to patent-eligibility – such as a law of nature, a natural principle, a natural phenomenon, or a natural product – must be evaluated to determine if the claim recites something significantly different than the judicial exception. If the claim does not recite something significantly different according to the 2014 Guidance, it must be rejected as ineligible for patent protection.

Consistent with the publication of the 2014 Guidance, U.S patent examiners have been rejecting any patent claim that relates in any manner to a law of nature or product of nature. Prior to issuance of the 2014 Guidance, Section 101 rejections were rare and could easily be remedied by a minor amendment to the rejected claim. In contrast, one recent survey reported that after adoption of the 2014 Guidance, out of 1,500 applications that were reviewed, approximately 40% received Section 101 rejections for failing to recite patent-eligible subject matter. (See, “Stopped at the Threshold: The Practical Impact of the Supreme Court’s Mayo and Myriad Decisions on Biotechnology Patent Practices” Bloomberg BNA Life Sciences Law & Industry Report, S-5 (June 25, 2014)).

The life science industry, patent attorneys and academic research institutions have criticized the USPTO for the 2014 Guidance. In response to public criticism, the USPTO held an open forum on May 9th, 2014 and accepted written comments from the public as to whether and/or how the 2014 Guidance should be revised. Over 20 U.S. and international associations, 4 research and academic institutions, 6 law firms and over 40 individuals have posted written comments. Many of the commenters argued that the USPTO improperly expanded the holdings of Mayo and Myriad and that the 2014 Guidance is inconsistent with prior related Supreme Court decisions.

The locations and times of the September 17th meetings are:

East Coast Location, From 12:00PM to 5:00 PM, at the  USPTO Headquarters, Madison Auditorium, 600 Dulany Street, Alexandria, VA; and

 West Coast Location, From 9:00AM to 2:00PM, San Jose State University, College of Engineering, Conference Room E285/287, San Jose, CA.

Participants must register by September 12th, 2014 by email at USPTOBCP1600@USPTO.GOV and include in the email body the following information: Name, title and organization; contact information (email, phone, etc.); and attending location: Washington, D.C., San Jose, C.A, or on line.

The September 17th forum will provide the USPTO an opportunity to respond to the publics’ criticism and signal whether the 2014 Guidance will be revised.

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