Patenting proteomics : patentability and scope of protection of three-dimensional protein structure claims under German, European, and US Law /
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| Author / Creator: | Schuster, Martina. |
|---|---|
| Imprint: | Baden-Baden : Nomos ; Augsburg : MIPLC, Munich Intellectual Property Law Center, 2010. |
| Description: | 273 p. : ill. ; 23 cm. |
| Language: | English |
| Series: | MIPLC studies ; v. 6 MIPLC studies ; v. 6. |
| Subject: | |
| Format: | Print Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/7991912 |
Table of Contents:
- List of Abbrehensions
- Chapter 1. Introduction
- Chapter 2. Scientific background
- A. Definition of the Term
- B. Proteins and the biological organism
- I. Amino acid sequences
- 1. Primary structure
- 2. Secondary structure
- 3. Tertiary structure
- II. Protein folding
- 1. Folding funnel theory of protein folding
- 2. Protein misfolding and diseases arising from 'folding' defects
- III. Structurally similar, sequence dissimilar proteins
- IV. Posttranslational modifications (PTM)
- V. Role of Enzymes and their chemical activity
- C. Genetic coding of proteins
- D. Recombinant Protein Synthesis
- E. Proteomic research
- I. Proteome initiatives
- II. Proteomics Technologies
- 1. Protein expression, purification and characterization
- a. Gel electrophoresis
- b. Mass spectrometry
- 2. Physical methods of determining the three-dimensional structure of proteins
- a. Protein Crystallization
- b. X-ray crystallography
- c. NMR structure determination
- d. Protein modeling (homologous-comparison)
- III. Data and Bioinformatics for proteomics
- 1. Databases
- 2. Cross-linking of database information
- 3. Database screening and drug design
- 4. In-silico screening of binding pockets
- Chapter 3. Patentability Requirements
- A. Statutory Background and Fundamental Case Law in Europe and the U.S.
- II. ntroduction
- II. Applicable law in the U.S. and Europe
- 1. Patentable Subject Matter
- a. U.S.
- b. Europe
- aa. Patentability of biological material
- bb. Exclusions from patentability
- 2. Utility and Industrial Applicability
- a. U.S. (Utility)
- b. Europe (Industrial Applicability)
- 3. Novelty
- a. U.S.
- b. Europe
- aa. The principle of unambiguous parameters
- bb. The principles of second and further medical indications
- 4. Nonobviousness and Inventive Step
- a. U.S. (Nonobviousness)
- b. Europe (Inventive Step)
- 5. Written description/patent description and sufficient disclosure
- a. U.S.
- aa. Basic statuatory background
- bb. Deposit requirements
- cc. The debate on a separate written description requirement
- i. Background to the debate
- ii. Development of a 'separate written description' doctrine
- iii. The' dissenting line'
- b. Europe (Sufficient disclosure)
- III. Conclusion
- B. Case study related to protein 3-D-structure related inventions
- I. Introductory Remarks
- 1. Aim of the study
- 2. Major fields of 3-D protein structure inventions
- II. Proteomics and protein structural properties per se
- 1. Structure defined by structural coordinates and protein crystals
- a. Claims
- b. Background
- c. Solutions proposed by the EPO and the USPTO
- d. Discussion
- 2. Protein Domains
- a. Claims
- b. Background
- c. Solutions proposed by the EPO and the USPTO
- d. Discussion
- III. Proteomics and Bioinformatics
- 1. In-silico screening methods
- a. Claim 1
- aa. Background
- bb. Patent Offices Analysis
- cc. Discussion
- i. The discussion on the patentability of computer-implemented inventions in Europe
- ii. Classification of In-Silico Screening Methods in Europe
- iii. Classification of In-Silico Screening Methods in the U.S
- b. Claim 2
- aa. Background
- bb. Patent Offices' Analysis
- cc. Discussion
- 2. Structural Data of proteins per se
- a. Claims and Claim Background
- b. Patent Offices' Analysis
- c. Discussion
- 3. Compounds identified by in-silico screening methods
- a. Claims
- b. Patent Offices' Analysis
- c. Discussion
- aa. Reach-through-Claims
- bb. Reach-through licensing
- i. Statutory background in Germany
- ii. Legal situation under U.S. law
- IV. Conclusion
- Chapter 4. Scope of Protection
- A. Introductory Remarks1
- B. Claim construction in the U.S. and in Europe
- I. Claim construction and doctrine of equivalents in the U.S
- 1. Claim Construction
- 2. Doctrine of equivalents
- II. Claim construction and Doctrine of equivalents under German law
- 1. Claim Construction
- 2. Doctrine of equivalents
- a. Moulded Curbstone
- b. Further Decisions
- III. Research/Experimental Use Exemption
- 1. Germany
- 2. U.S
- C. Use of 3-D protein structure (concrete claim analysis)
- I. Use of 3-D structure from naturally obtained proteins
- II. Use of 3-D structure from recombinant proteins
- III. Use of 3-D structure from crystallized proteins
- IV. Use of new proteomics technologies: An example using sequence-dissimilar proteins sharing common 3-D fold
- 1. Protein engineering and legal standards for the use of protein variants
- 2. Literal infringement
- a. Treatment of protein variants in the U.S.
- aa. Claims defining proteins in terms of function
- bb. The USPTO Guidelines for Examination of the 'Written Description Requirement'
- b. Treatment of protein variants in Germany
- c. Application of the principles reliable for protein variants on the use of sequence-dissimilar proteins
- d. Analysis of the approach to define a protein by folding type and function
- 3. Infringement under the doctrine of equivalents
- a. U.S.
- aa. Methods for determining equivalents
- i. The ôHypothetical Claimö Analysis
- ii. The interchangeability test
- iii. The 'function-way-result' test
- bb. The ruling of Genentech v. Wellcome and the doctrine of equivalents
- cc. Application of the 'function-way-result' test to the issue of sequence-dissimilar proteins
- dd. Expansion of the patent coverage to as yet unidentified species
- b. Germany
- aa. Infringement under the doctrine of equivalents
- bb. Transfer of the case law related to figures and measurements to the field of 3-D protein structures inventions
- c. Conclusions
- V. U.S. Patent No. 5,835,382 ôSmall Molecule Mimetics of Erythropoietinö: A characteristic proteomic patent
- VI. Use of selective 3-D protein structure parts (Selection inventions)
- 1. Relationship to patents covering the entire protein
- 2. The Amgen case
- 3. Applicable law
- VII. Use of compounds identified through 3-D protein structure screening methods
- 1. Protection as product of patentable process
- 2. The Bayer v. Housey Case
- VIII. Concluding Remarks
- Chapter 5. Summary and Findings
- A. Patentability of Proteomic Patent Claims
- B. Scope of Protection
- C. General Findings
- Bibliography
