USPTO Releases 2019 Eligibility Update

On January 4, 2019, the US Patent and Trademark Office (USPTO) announced revised guidance for determining subject matter eligibility under 35 U.S.C. § 101 for computer-implemented inventions (Guidance). The Guidance takes effect Monday, January 7, 2019. The Guidance is important for medical patents that use algorithms for diagnosis and treatment decisions in personalized medicine.

Two Primary Changes to Improve Clarity

Two primary changes on how patent examiners should apply the first part of the two part U.S. Supreme Court’s Alice/Mayo test, are made to improve “clarity, consistency, and predictability of actions across the USPTO” (quoting Under Secretary of Commerce of Intellectual Property and Director of the USPTO Andrei Iancu Guidance Press Release):

  1. The revised Guidance “extracts and synthesizes key concepts identified by the courts as abstract ideas to explain that the abstract idea exception includes certain groupings of subject matter: mathematical concepts, certain methods of organizing human activity, and mental processes”;
  2. The revised Guidance “includes a two-prong inquiry for whether a claim is ‘directed to’ a judicial exception. In the first prong, examiners will evaluate whether the claim recites a judicial exception and if so, proceed to the second prong. In the second prong, examiners evaluate whether the claim recites additional elements that integrate the identified judicial exception into a practical application.”

Guidance Press Release

Public Comments Requested

The USPTO is seeking public comment on the Guidance documents. The public is invited to submit comments and suggestions for future guidance documents to Eligibility2019@USPTO.gov on or before March 8, 2019.

 

The Business of Personalized Medicine

This year marks the 15th anniversary of the completion of the Human Genome Project. In the decade and a half that has passed since, the genomic revolution has spurred an immeasurable level of excitement and support surrounding the promise of personalized medicine, setting high expectations for a new era of health care and rapidly transforming the field into a multi-billion dollar industry. While realizing that promise has turned out to be neither quick nor easy, recent scientific and technological progress has been impressive, pointing to a possible tipping point for mainstream clinical adoption as well as tremendous commercial growth potential for innovators, entrepreneurs, and investors.

For a deep-dive into this current issues to impacting the industry, please join me in South San Francisco on Thursday, December 6, 2018, for the 5th Business of Personalized Medicine Summit. This one day summit explores sustainable business model solutions for entities that are already engaged in the personalized medicine marketplace as well as those seeking to enter the competitive space. Through a series of thought-provoking discussions with key executives from across multiple stakeholder perspectives, the program examines in depth the latest financial, regulatory, policy, R&D, and technology-related complexities, trends, and opportunities impacting the business of personalized medicine, and introduces strategies for successfully navigating the challenging and ever-evolving market.

The day begins with Dr. Helmy Eltoukhy, co-founder and CEO of Guardant Health, a pioneer in the liquid biopsy space that is hot on the heels of an impressive $238M IPO debut – one of the largest in life sciences so far this year.  Dr. Eltoukhy will discuss lifecycle strategy and his company’s potentially game-changing technology for early cancer detection, Guardant’s growth trajectory in a promising yet complex and increasingly competitive field, and what the future holds in terms of innovation and market interest.

Mr. Harry Glorikian will close out this year’s program. Mr. Glorikian is an influential leader with more than 20 years of experience in life sciences, healthcare, and health IT who has been a driving force behind major business transformations that accelerated growth, efficiency gains, cost reductions, and competitive advantage for market leaders as well as up-and-coming innovators with next-generation ideas. Drawing from his most recent book, Mr. Harry Glorikian will offer his insights and advice for thriving in the new data-driven market.

 

DIAGNOSTIC METHOD CLAIMS AND PRIMER TOOLS LACK PATENT-ELIGIBILITY

In Roche Molecular Systems, Inc. v Cepheid, (Slip Op. 2017-1690, October 9, 2018), the Federal Circuit held that patent claims directed to primers and methods of detecting pathogenic bacteria using the primers are invalid for failing to claim patent-eligible subject matter. The decision summarizes this panel’s current thinking on the patent-eligibility of unmodified polynucleotides and methods to detect “natural phenomena” using “conventional” tools. Also, the panel deferred opining on the patent-eligibility of modified polynucleotides and the use of polynucleotides as therapeutics. Continue reading this entry

Medical Treatment Patent Claims Held Patentable Subject Matter Under the Alice/Mayo Section 101 Test

In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd, Slip Op. (Nos. 2016-2707, 2016-2708, April 13, 2018) the U.S. Court of Appeals for the Federal Circuit provided useful guidance for patentees seeking to survive a patent-eligibility challenge under Section 101.

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All of Us Research Program Opens May 6th

The National Institutes of Health (NIH) opened national enrollment today, May 6th, for the All of Us research program. Initially branded as the “Precision Medicine Initiative Cohort Program,” All of Us is the largest health and medical research program on precision medicine, aiming to enroll 1 million or more diverse volunteers. Any adult age 18 or older may enroll. Continue reading this entry