Presenting a 90-Minute Encore Presentation of the Webinar with Live, Interactive Q&A Overcoming Sect. 101 Rejections Post-Alice Corp. Leveraging USPTO Guidance and Recent Decisions to Meet Sect.101 Patent Eligibility Requirements TUESDAY, MARCH 31, 2015 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Katherine M. Kowalchyk, Ph.D., Partner, Merchant & Gould, Minneapolis Denise M. Kettelberger, Ph.D., Counsel, Sunstein Kann Murphy & Timbers, Boston Charles Bieneman, Member, Bejin Bieneman, Detroit 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. FOR LIVE EVENT ONLY Sound Quality If you are listening via your computer speakers, please note that the quality of your sound will vary depending on the speed and quality of your internet connection. If the sound quality is not satisfactory, you may listen via the phone: dial 1-866-819-0113 and enter your PIN when prompted. Otherwise, please send us a chat or e-mail [email protected] immediately so we can address the problem. If you dialed in and have any difficulties during the call, press *0 for assistance. Viewing Quality To maximize your screen, press the F11 key on your keyboard. To exit full screen, press the F11 key again. FOR LIVE EVENT ONLY For CLE purposes, please let us know how many people are listening at your location by completing each of the following steps: • In the chat box, type (1) your company name and (2) the number of attendees at your location • Click the word balloon button to send Guidance Through the Maze of Patentable Subject Matter for Life Sciences Katherine M. Kowalchyk Merchant and Gould March 31, 2015 The Statute and its Exceptions 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 EXCEPT (according to the courts) Natural law Natural product Abstract idea 5 Supreme Court 101Trifecta • Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012). • Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). • Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014). 6 Mayo: Where’s the Inventive Concept • Inventive concept was only natural law natural law was the correlation of the metabolite level and the toxicity • Nothing new to add anything significant to the Inventive Concept determining step was not specified, standard diagnostic method steps • An application of a law of nature is patentable: e.g. Diehr process transformed or reduced to a different state or thing: new steps or new result 7 Myriad: Patent System as Gatekeeper • DNA is a product of nature claimed product did not differ in sequence: basic tools • Separation of or locating a gene from surrounding genetic material is not sufficient for patentability Identify markedly different characteristics: cDNA (Chakrabarty vs. Funk Bros.) 8 Alice: Basic Tools of Business • Two step process: 1) is the claim directed to an exception; 2) does it add enough additional content (inventive concept) to render the exception patentable • Additional content-(102/103) technology/new steps or features 9 Post Alice Cases In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig. v. Ambry Genetics Corp., 774 F.3d 755 (Fed. Cir. 2014). Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 14- 1139 (Fed. Cir. argued Nov. 7, 2014). Genetic Techs. Ltd. v. Bristol-Myers Squibb Co., Nos. 12-394, -396, 2014 U.S. Dist. LEXIS 154443 (D. Del. Oct. 30, 2014), appeal docketed, No. 15- 1203 (Fed. Cir. Dec. 18, 2014). 10