ChIPs Global Summit, September 15, 2016 From Tech to Biotech, Does a Single Test Make Sense? Diverse Perspectives On Patent Eligibility Hon. Georgianna Braden Isabella Fu Laurie Hill Jennifer Johnson Moderator: Tracey Davies ChIPs Global Summit, September 15, 2016

Patent Eligibility under Section 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.” 35 U.S.C. § 101. The Supreme Court has long recognized “three specific exceptions to Section 101’s patent-eligibility principles: laws of nature, physical phenomena, and abstract ideas.” Bilski v. Kappos, 561 U.S. 593, 609 (2010). Whether a claim is directed to patent-eligible subject matter under 35 U.S.C. § 101 is a question of law. Accenture Global Servs., GmbH v. Guidewire Software, Inc., 728 F.3d 1336, 1340-41 (Fed. Cir. 2013).

The Alice/Mayo Test Is A Two Step Analysis Step 1: Determine whether the claim is directed to a law of nature, natural phenomenon, or abstract idea. Alice Corp. v. CLS Bank, 134 S. Ct. 2347, 2355 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289, 1296-97 (2012)). Step 2: If the first step is met, determine whether there is an “inventive concept” in the claims. To do so, “consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether” there are additional claimed elements that “‘transform the nature of the claim’ into a patent-eligible application.”  Id. at 1357 (quoting Mayo, 132 S. Ct. at 1298).

Eligibility Goalposts: Computer Science/Technology Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016): Claims directed to software are not inherently abstract. “[S]ome improvements in computer-related technology when appropriately claimed are undoubtedly not abstract, such as a chip architecture, an LED display, and the like.” - The claims were directed to an improvement to computer functionality (self- referential database structure) rather than “fundamental economic [or] conventional business practices.” See, e.g., OIP Technologies, Inc. v. Amazon.com, Inc. 788.F.3d 1359, 1362-1363 (Fed. Cir. 2015). DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1257 (Fed. Cir. 2014): “The claimed solution is necessarily rooted in computer technology to overcome a problem specifically arising in the realm of computer networks.” The claims  “specify how interactions with the Internet are manipulated to yield a desired result.” Id. at 1258.

Eligibility Goalposts: Biotech/Life Science Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., No. 2015-1570, 2016 WL 3606624, at *6 (Fed. Cir. July 5, 2016): Method of “producing a desired preparation of multi-cryopreserved hepatocytes” was a “new and improved technique, for producing a tangible and useful result.” Claims “recite an improved process for preserving hepatocytes for later use. The benefits of the improved process over the prior art methods are significant.” Id. Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116-17 (2013): “[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.” “Creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring.” Id. at 2119.

Source: Bilski Blog - Two Years After Alice Survey (June 2016 stats) at 2.

Source: Bilski Blog - Two Years After Alice Survey (June 2016 stats) at 2.

Source: Bilski Blog - Two Years After Alice Survey (June 2016 stats) at 3.

Total number of patent lawsuits filed Source: https://www.patexia.com/ip-research/lawsuits.

Total Number of Patents In Force Source: WIPO statistics database; last updated 12/2015.