Presenting a live 90-minute webinar with interactive Q&A Patent Subject Matter Eligibility: Navigating the New "Myriad" Guidelines Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework WEDNESDAY, APRIL 16, 2014 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Donna M. Meuth, Associate General Counsel, Eisai , Andover, MA Leslie McDonnell, Finnegan Henderson Farabow Garrett & Dunner , Boston, MA Amelia Baur, Finnegan Henderson Farabow Garrett & Dunner , Boston, MA The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .
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Patent Subject Matter Eligibility: Navigating the New Myriad Guidelines Analyzing Subject Matter and Avoiding Rejection Under the USPTO’s Detailed Framework April 16, 2014 Donna Meuth Leslie McDonell Amelia Baur
Disclaimer • These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. These materials should not be taken as individualized legal advice and do not reflect the views of FINNEGAN or EISAI, It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, FINNEGAN, EISAI, and the panelists cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with FINNEGAN, EISAI, or the panelists. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 5 5
The § 101 Roller Coaster • New guidelines are the USPTO’s sixth attempt in five years to define patentable subject matter: 1. August 2009 (machine-or-transformation) 2. January 2010 (computer-readable media) 3. July 2010 ( Bilski ) 4. July 2012 (Process Claims Involving Laws of Nature; Mayo ) 5. June 2013 (Memorandum re Myriad ) 6. March 2014 Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products 6 6
Interim Guidelines Released • 2012 Mayo Guidance; MPEP 2106.01: Process claims involving Laws of Nature. • June 13, 2013 Memo – Noted Supreme Court decision in Myriad : claims to isolated DNA not patent-eligible. • “As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated.” • March 4, 2014 Memo: New Guidance Replaces Both – “all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products should be examined using the Guidance.” – “examination procedure set forth in the Guidance is effective today and supersedes the June 13,2013 memo[.]” 7 7
USPTO Guidance to Examiners • Not a statute • Important USPTO policy document – Used to train patent examiners. 8 8
USPTO: The New Subject Matter Eligibility Guidance • “For use in subject matter eligibility determinations of all claims (i.e., machine, composition, manufacture, and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products. ” 9 9
USPTO: Three-Step Analysis “walk through the three questions in the flowchart … to determine whether the claim is drawn to patent- eligible subject matter. If not, then the claim is prima facie ineligible, and the claim should be rejected[.]” 10 10
USPTO: Three-Step Analysis 1. Does a claim reciting one of the four statutory categories of patent eligible subject matter? (process, machine, manufacture, composition) 2. Does the claim recite or involve one or more judicial exceptions? (abstract ideas, laws of nature/natural principles, natural phenomena, natural products) 3. Does the claim as a whole recite something significantly different from the judicial exceptions? 11 11
USPTO: Three-Step Analysis • “Recite or involve” appears to mean -- looks like, sounds like, smells like, or is somehow derived from or related to, a natural product, law, phenomenon -- even if it is but a single component in a multi-component composition. • It is not enough that the claim is directed to a product or composition that is non-naturally occurring – it must also be significantly different in structure from naturally occurring products. 12 12
USPTO: Three-Step Analysis • What does “significantly different” mean? – Markedly different – More than nominally, insignificantly, or tangentially related – More than well understood, purely conventional, or routine in the relevant field – Not insignificant extra-solution activity • Words such as “synthetic”, “isolated”, “recombinant”+ “cDNA”, “composition”, “primer”, “purified”, “vector” recited in a claim do not influence the determination of significant difference (Guidelines) (added in Training Slides) 13 13
USPTO: How to Analyze “Significantly Different” • Factor-based analysis of whether claim as a whole is “significantly different” from the judicial exception • Not a single, simple determination, but a conclusion reached by weighing the relevant factors, varying the weight accorded each factor based on the facts of the application – “[S] imilar to the Wands factor- based analysis” • On balance, does the totality of the relevant factors weigh toward eligibility? 14 14
Prometheus : “Significantly Different” • “A process that focuses on the use of a natural law also [must] contain other elements...an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself .” ‒ Prometheus , citing Flook , Bilski , Diehr • “Too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” ‒ Prometheus 15 15
USPTO Factors – Natural Product Weigh Against Eligibility Weigh Towards Eligibility g) claim recites a product that is not a) claim recites something that is markedly different in structure non-naturally occurring and from naturally occurring products markedly different in structure from naturally occurring products • Grounded in Chakrabarty ? • “Here...the patentee has produced a new bacterium with markedly different characteristics from any found in nature and having the potential for significant utility. His discovery is not nature’s handiwork, but his own.” • The combination of bacteria in Funk Brothers was merely “the handiwork of nature.” • Grounded in Myriad ? • “Separating [a BRCA] gene from its surrounding genetic material is not an act of invention.” • “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived...except insofar as very short series of DNA may have no intervening introns” 16 16
USPTO Factors – Preclusion Weigh Against Eligibility Weigh Towards Eligibility h) claim recites elements at a high b) claim recites elements that level of generality such that impose meaningful limits on substantially all practical scope , such that others are not applications of the judicial substantially foreclosed from exception are covered using the judicial exception • Grounded? • Precedent “warn[s] us against upholding patents to processes that too broadly preempt the use of a natural law.” – Prometheus , Benson , Flook • A process must contain other elements “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself” – Prometheus • Diehr sought only to foreclose the use of an equation in conjunction with all of the other steps of the claimed proces s – Prometheus 17 17
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