Utility Patent Law Prof Merges Newsflash Senate to vote on cloture and possible amendments re Patent Reform tonight Could even pass the House bill may get patent reform this week, or maybe not Utility Section 101 Whoever invents and new AND USEFUL machine, manufacture,... Main Trouble Areas No known utility (perpetual motion machines) Newman v. Quigg, 877 F.2d 1575 [ 11 USPQ2d 1340] (Fed. Cir. 1989) (claims to a perpetual motion machine ruled inoperable) Malicious utility a "useful" invention is one "which may be applied to a beneficial use in society, in contradistinction to an invention injurious to the morals, health, or good order of society, or frivolous and insignificant" Third major trouble area Chemical, pharmaceutical, and biotech- related inventions Why? The nature of chemistry-related research Structures (molecules) and their uses... Justice Story View Appendix, Note on the Patent Laws, 3 Wheat. 13, 24. See also Justice Story's decisions on circuit in Lowell v. Lewis, 15 Fed. Cas (No. 8568) (C. C. D. Mass.), and Bedford v. Hunt, 3 Fed Cas. 37 (No. 1217) (C. C. D. Mass.).3 Wheat. 13, 24Lowell v. Lewis, 15 Fed. Cas (No. 8568)Bedford v. Hunt, 3 Fed Cas. 37 (No. 1217) Brenner v Manson This is not to say that we mean to disparage the importance of contributions to the fund of scientific information short of the invention of something "useful," or that we are blind to the prospect that what now seems without "use" may tomorrow command the grateful attention of the public. Brenner, contd But a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. "[A] patent system must be related to the world of commerce rather than to the realm of philosophy. * * *" In re Brana 34 U.S.P.Q.2d 1436 C.A.Fed. 1995 Brana, contd N: Markush group R1-R4: Markush groups Brana contd FDA approval, however, is not a prerequisite for finding a compound useful within the meaning of the patent laws. Usefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development.. Were we to require Phase II testing in order to prove utility, the associated costs would prevent many companies from obtaining patent protection on promising new inventions, thereby eliminating an incentive to pursue, through research and development, potential cures in many crucial areas such as the treatment of cancer U.S.P.Q.2d 1436, 1443 Project Initiation: Pure Concept Stage Promising Experimental Results: Brenner v. Manson Promising Clinical Results, e.g., in vitro In re Brana Working Model or Prototype; in vivo effectiveness The Oklahoma Land Rush A Good Use of Resources? Mining Claim Systems: Require- ments and Timing Issues Some quick economics Terry L. Anderson & Peter J. Hill, The Race for Property Rights, 33 J.L. & Econ. 177 (1990) David D. Haddock, First Possession Versus Optimal Timing: Limiting the Dissipation of Economic Value, 64 Wash. U. L.Q. 775 (1986). Dean Lueck, The Rule of First Possession and the Design of the Law, 38 J.L. & Econ. 393 (1995) Terry L. Anderson Montana State; Hoover Institution David Haddock, Northwestern Law School Ex Parte Fischer Major case involving expressed sequence tags Utility the key issue: did inventors demonstrate patentable utility as of the filing date of the patent? Fischer claim 1: p. 241 A substantially purified nucleic acid molecule that encodes a maize protein or fragment thereof comprising a nucleic acid sequence selected from the group consisting of SEQ ID NO: 1 through SEQ ID NO: 5. Ex Parte Fischer Claim 1, Casebook p. 241 Substantially purified echoes of Parke- Davis Selected from the group consisting of... What is this claim form? Markush Group An article of clothing, selected from the group consisting of Shirts Shoes Pants A chemical entity selected from the group consisting of Carbon COOH CH(6) Expressed Sequence Tags Most DNA: Unknown Function The good stuff: DNA that codes for a protein EST: Short Tag Multiple Biotechnology Patents: SNP/EST Example C Owns SNP_3/EST_3 A Owns SNP_1 (Or EST_1) B Owns SNP_2/EST_ 2 Fischer What utilities are claimed? P. 3 determining a relationship between a polymorphism and a plant trait isolating a genetic region... Or mapping determining [protein] levels... Fischer - holding P 22 Immediate utility is to conduct further experiments Too attenuated under Brenner and Brana Expressed Sequence Tag Patents: policy issues Bad Idea! Eisenberg & Merges opinion letter, 1995 Patent laws utility requirement bars these patents Why? Capturing someone elses investment dominates incentive motive; Transaction Costs a Major Issue Transaction Costs End Product Firm E A B C Transaction Costs II A B C End Product Capturing Someone Elses Investment Disproportionate reward The Proportionality Principle in IP Law