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IP/Technology Update Series IP/Technology Year in Review and Forecast for 2013: Protecting Your Company’s IP Position PATENT LAW Wednesday, January 30, 2013 arnoldporter.com IP/Technology Update Series IP/Technology Year in Review and Forecast for 2013: Protecting Your Company’s IP Position PATENT LAW Wednesday, January 30, 2013 8:00 − 10:00 a.m. (PST) Table of Contents Agenda ........................................................................................................................Tab 1 Presentation Slides ....................................................................................................Tab 2 Speaker Biographies ..................................................................................................Tab 3 Jennifer Sklenar, Monty Agarwal, Mike Berta, Tom Magnani Practice Overview ......................................................................................................Tab 4 Intellectual Property Supporting Materials..................................................................................................Tab 5 Monsanto Co. and Monsanto Technology LLC v. Bowman Myriad Genetics, Inc. Mayo Collaborative Services v. Prometheus Laboratories, Inc. 692 F.3d 1301 Selected Cases on Implied Patent Licensing Tab 1: Agenda arnoldporter.com IP/Technology Update Series IP/Technology Year in Review and Forecast for 2013: Protecting Your Company’s IP Position PATENT LAW Wednesday, January 30, 2013 8:00 − 10:00 a.m. (PST) Agenda 8:00–8:05 a.m. Introduction 8:05–9:50 a.m. Presentation and Discussion Speakers: Jennifer Sklenar, Partner, Arnold & Porter LLP, Los Angeles Monty Agarwal, Senior Counsel, Arnold & Porter LLP, San Francisco Mike Berta, Partner, Arnold & Porter LLP, San Francisco Tom Magnani, Partner, Arnold & Porter LLP, San Francisco 9:50–10:00 a.m. Question-and-Answer Session 1.5 hours of CA CLE credit, other states pending. Tab 2: Presentation arnoldporter.com IIPP//TTeecchhnnoollooggyy YYeeaarr iinn RReevviieeww aanndd Forecast for 2013: Protecting Your Company's IP Position – Patent Law JJeennifeer SSkleenaar Monty Agarwal Mike Berta Tom Magnani 1 Patent Eligible Subject Matter  AApppplliiccaattiioonn ooff llaawwss ooff nnaattuurree ((MMaayyoo)) E=mc2  Aspects of human genes (Myriad) 2 Patent Eligible Subject Matter “TThheerree iiss nnoo ppaatteenntt. CCoouulldd yyoouu ppaatteenntt the sun?” -- Dr. Jonas Salk 3 Mayo v. Prometheus, 132 S. Ct. 1289 (2012)  PPrroommeetthheeuuss’ ppaatteenntt ccllaaiimmss:: mmeetthhooddss ttoo aassssiisstt doctors determine appropriate dosage of thiopurine drugs to treat patients with autoimmune diseases,  Mayo entities began using/selling its own test  RReelleevvaanntt llaaww ooff nnaattuurree:: rreellaattiioonnsshhiipp bbeettwweeeenn concentration in the blood of certain thiopurate metabolites and likelihood dosage will be effective or result in side-effects 4 Mayo v. Prometheus, 132 S. Ct. 1289 (2012) CCoommppeettiinngg lleeggaall pprriinncciipplleess  “‘[L]awsof nature, natural phenomena, and abstract ideas’ are not patentable.” Diamond v. Diehr, 450 U.S. 175, 185 (1981).  “ [A]n application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Id. at 187. Competing public policy  Grant of a patent should not tie up laws of nature and inhibit future innovation.  Those who make discoveries and innovate should be rewarded with a patent. 5 Mayo v. Prometheus, 132 S. Ct. 1289 (2012) 1. A method of optimizing therapeutic efficacy for treatment of an iimmmmuunnee-mmeeddiiaatteedd ggaassttrrooiinntteessttiinnaall ddiissoorrddeerr, ccoommpprriissiinngg:: (a) administeringa drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determiningthe level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, whereinthe level of 6-thioguanine less than about 230 pmolper 88x1008reedd bbloooodd cceellss inddiccaatteess aa neeeedd ttoo inccreeaassee tthee aamoouuntt oof said drug subsequently administered to said subject and whereinthe level of 6-thioguanine greater than about 400 pmolper 8x108red blood cells indicates a need to decrease the amount of said drugsubsequently administered to said subject. 6 Mayo v. Prometheus, 132 S. Ct. 1289 (2012) “The qquestion before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe the answer iiss nnoo. . . [[AA]]nnyy aaddddiittiioonnaall sstteeppss ccoonnssiisstt ooff wweellll understood, routine, conventional activity already engaged in by the scientific community . . . .” 7 ASM v. Myriad Genetics – Supreme Court 2013  CCllaaiimmss iinnvvoollvvee aassppeeccttss ooff BBRRCCAA 11 aanndd BBRRCCAA 22 breast cancer genes  Myriad had history of aggressive enforcement of rights against other suppliers of diagnostic test  Petition filed by group of doctors represented by tthhee AAmmeerriiccaann CCiivviill LLiibbeerrttiieess UUnniioonn aanndd PPuubblliicc Patent Foundation  Question 1: “Are human genes patentable” 8 ASM v. Myriad Genetics, 689 F.3d 1303 (Fed. Cir. 2012)  AAfftteerr rreemmaanndd ffrroomm SSuupprreemmee CCoouurrtt iinn vviieeww ooff Mayo  2-1 decision authored by Judge Lourie  Reversed in part and affirmed in part on patent- eligible subject matter issues in view of Mayo 9 ASM v. Myriad Genetics, 689 F.3d 1303 (Fed. Cir. 2012)  CCoommppoossiittiioonn ooff mmaatttteerr ccllaaiimmss rreellaattiinngg ttoo BBRRCCAA 11 and BRCA2 genes are patent eligible  Method claim directed to screening potential cancer therapeutics by assessing changes in cell growth rates of transformed cells is patent- eliggible  Method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible 10