The new guidelines, entitled Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (Guidelines), are effective immediately and supersede the guidance issued on June 13, 2013, when Myriad was decided. The Guidelines are 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.” However, the Guidelines do not apply to claims reciting an abstract idea, “which should continue to be analyzed for subject matter eligibility using the existing guidance in MPEP § 2106(II).” Stakeholders and patent practitioners will need to pay close attention to the multiple factors to be considered and the examples recited in the Guidelines as they potentially impact patent eligibility determinations across a broad range of technologies.
Expansion of Myriad to All Natural Products, Not Just Nucleic Acids
Importantly, the Guidelines expand the holding in Myriad to all natural products, not merely nucleic acids, that are not “significantly different” than the product found in nature. According to the USPTO, “while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.” The USPTO also interprets Myriad as “clarify[ying that] not every change to a natural product will result in a marked difference, and that the mere recitation of particular words (e.g., "isolated") in the claims does not automatically confer eligibility.” Thus, while the holding in Myriad was fairly focused, these Guidelines are relevant to all claims reciting or involving all natural products.
USPTO Examples Underscore Breadth Of The Guidelines
The Guidelines include eight sets of exemplary claims (Examples A-H) directed to different subject matter, and analyze their subject matter eligibility under the new guidelines. The examples underscore the breadth of the Guidelines and their potential impact on patent eligibility determinations across a broad range of technologies:
Case-By-Case Consideration Of Multiple Factors
The Guidelines provide that patent eligibility is to be determined on a case-by-case basis, upon consideration of multiple factors that may weigh towards or against patent eligibility. Because the Guidelines represent a significant change in the patent eligibility examination process, stakeholders with pending patent applications should consider seeking advice of counsel as to the potential impact of the Guidelines on their patent portfolios.
For a more detailed review of the specific questions and factors of the new Guidelines, visit Foley’s PharmaPatentsBlog and Personalized Medicine Bulletin.
Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and our colleagues. If you have any questions about this update or would like to discuss this topic further, please contact your Foley attorney or the following:
Benjamin A. Berkowitz
Jeanne M. Gills
Antoinette F. Konski
Palo Alto, California
Courtenay C. Brinckerhoff
Stephen B. Maebius