Patent Protection for Three- Dimensional Structure of Protein

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1 Patent Protection for Three- Dimensional Structure of Protein Genomic Science Center, RIKEN Itsuki Shimbo

2 Protein structure analysis and Industrial utilization A data array comprising the atomic coordinates of protein "inventions based on information contents" Patent eligibility matter, statutory invention in silico screening methods "information utilization methods" Treatment of information contents in Programs invention Compounds and pharmacophores inferred from in silico screening methods "products obtained from the use of information" Specification Description Requirements, Enablement matter Trilateral Project WM4, Comparative studies in new technologies, "Report on comparative study on protein 3-dimensional (3-D) structure related claims", Nov. 4-8, 2002

3 Problems with Patent Protection of Protein Three-Dimensional Structures A data array comprising the atomic coordinates of protein "inventions based on information contents" Patent eligibility matter, statutory invention in silico screening methods "information utilization methods" Treatment of information contents in Programs invention Compounds and pharmacophores inferred from in silico screening methods "products obtained from the use of information" Specification Description Requirements, Enablement matter Trilateral Project WM4, Comparative studies in new technologies, "Report on comparative study on protein 3-dimensional (3-D) structure related claims", Nov. 4-8, 2002

4 Patentability of Protein Three-Dimensional Structural Coordinate Data Computer model or data sequence pertaining to protein three-dimensional structural coordinates "simple presentations of information or abstract ideas" JPO a highly advanced creation of technical ideas utilizing a law of nature(article 2(1)). USPTO the inventions regarded as natural laws, physical phenomena or abstract ideas not being eligible for patent EPO "presentations of information" are defined as not being eligible for patent (EPC Article 52(2)(d))

5 Information contents and Computer-program invention A claim of an information storage medium encoded with "information contents is regarded as simply the presentation of information or an abstract idea. In Japan, the current computer software examination standards were announced in January In order for a program to be granted patent, data processing by the program is required to be realized concretely as a result of being used in an integrated manner with hardware resources (CPU, hard disc and so forth). In the IBM decision rendered by EPO in 1998, it was ruled to the effect that, in the case the processing steps by a program demonstrate a technical effect greater than ordinary physical interaction between software and hardware, they are not excluded from patent eligibility The software functionally interactive with the hardware. Computer-program information contents for works of music or literature

6 Patentability of in silico screening methods (In silico screening claim) searching for a compound that interact with an active site from a large-volume compound library using protein three-dimensional structural data A CoMSIA analysis of thrombin inhibitors.

7 Patentability of in silico screening methods EPO If protein three-dimensional structure data has novelty, an in silico screening method satisfies the requirements for novelty and an inventive step. The inventive step of an in silico screening method using protein three-dimensional structure data is judged based on the entire invention, including the three-dimensional structure data itself (= technical data). JPO USPTO In the case the algorithm of a screening method is commonly known, if only the protein three-dimensional structure data has novelty, the screening method does not satisfy the requirements for novelty and inventive step. patent requirements are attempted to be judged by separating the de facto data contents from the invention, and extracting only the technical idea of the screening method.

8 Pharmacophore Claims and Requirements of Requirements A pharmacophore is that which defines a compound considered to yield desirable biological activity using spatial data between atoms instead of a chemical formula. Enablement requirement Clarity Written description Chemical formulas are described as a general rule, when a chemical substance is unable to be adequately represented with a chemical formula, the identification of compounds by parameters is allowed EPO Guidelines Part CIII 4.7a, B 1.59+/-0.50 n A 1.33+/-0.25 n C 0.95+/-0.25 n

9 Pharmaceutical Claims and Requirements of Requirements Enablement requirement Case of a muscarine-like receptor antagonist, Tokyo High Court, 2001 H Case of an antiemetic, Tokyo High Court, 1996 H Pharmacological test methods and pharmacological data are required for the product to be used as a pharmaceutical. Incomplete invention Case of a herbicidal imidazole derivative, 1990 H Case of a sodium excretion accelerating peptide, Tokyo High Court, 1999 H Compounds that did not demonstrate the prescribed effect were included. Written description Regents of University of California vs. Eli Lilly Co. (1997)

10 Patent Strategy of Protein Three- Dimensional Structural Analysis Markush Claims A Markush claim refers to a form of expression in which two or more items are alternatively described. [compound A selected from the group consisting of a, b, and w] [substitution group R represents A, B or C] Markush claims clearly describe a concrete compound, its product is able to be created (how to make), requirement of invention clarity. Pharmaceutical Claims increase in the economic value of the patent Pharmacological test methods and pharmacological data are required for the product to be used as a pharmaceutical. Certificate of experiment results, Affidavit (37CFR1.132)