Revised Myriad Guidance from the USPTO Now What is Patentable?

Transcription

1 Revised Myriad Guidance from the USPTO Now What is Patentable? Pacific Rim Summit On Industrial Biotechnology and Bioenergy December 9,

2 Workshop Panelists Mark Benedict, Ph.D., J.D. Moderator Partner in Orange County and San Diego offices of Knobbe Martens patent protection, portfolio strategy, due diligence and opinions biotech, chemical, pharma, life sciences Hans Sauer, Ph.D., J.D. Deputy General Counsel for IP, BIO Adjunct Professor Georgetown University Law Ctr Formerly MGI Pharma, Guilford Pharma 2

3 Workshop Panelists Jason Jardine, J.D. Partner in San Diego office of Knobbe Martens patents protection and enforcement chemistry, biotech, pharma, semiconductors, metalworks/mining, action sports Teresa Spehar, Ph.D., J.D. Synthetic Genomics, Inc. Vice President, Intellectual Property formerly Pharmexa-Epimmune, Foley Lardner 3

4 Firm Profile Five Decades. One Focus: IP Eight offices nationwide California (Six Offices) Washington, D.C. Seattle, WA Broad Technical Expertise Over 280 lawyers and scientists Practice across a broad array of industries Over 95% of attorneys hold technical degrees 4

5 Firm Philosophy A Culture of Collaboration Compensation structure cultivates a collegial atmosphere focused on high quality of service Attorneys motivated to match clients with an attorney/scientist team custom built to deliver success The Importance of Team Continuity Continuous team throughout lifecycle of a patent from development to litigation Increased efficiency 5

6 Firm Recognition National Reputation Ranked among 2015 Best Law Firms U.S. News & World Report - Best Lawyers Edition Biotechnology Law Firm of the Year in the U.S., 2014 Acquisition International Top IP Boutique Firm, 2014 Daily Journal Top IP Firm in the U.S., 2014 Lawyer Monthly 6

7 Intro to Patentable Subject Matter Constitution Article I, Section 8, Clause 8, of the Constitution mandates that Congress shall pass laws that promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." Congress (Patent Law) 35 USC 101 Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 7

8 Intro to Patentable Subject Matter Judicial Interpretation of 101 (Case Law) Chakrabarty (1980) Supreme Court held that a live, human-made microorganism is patentable subject matter under 35 USC 101. The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to "include anything under the sun that is made by man." 8

9 Intro to Patentable Subject Matter Judicial Exceptions to 101 s broad scope of patent-eligibility The laws of nature, physical phenomena, and abstract ideas have been held not patentable. A new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity. Such discoveries are "manifestations of... nature, free to all men and reserved exclusively to none." 9

10 Intro to Patentable Subject Matter Myriad (2013) Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated However, synthetic cdna is patent eligible because it is not naturally occurring (introns are omitted). PTO Guidance On March 4, 2014, the PTO issued "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance"), to implement a new procedure for determining subject matter eligibility of claims under 35 U.S.C. 101 in view of the Supreme Court's decisions 10

11 Mark Benedict (949) & (858)