Bioinformatics Patents - The Challenges
DOI:
https://doi.org/10.5912/jcb744Keywords:
ioinformatics Patents, Information Technology, research tools, biotechnology and software patents, Intellectual Property Rights.Abstract
This paper examines the problems and complexities created by the patent regime as well as challenges posed by accommodating new technologies like bioinformatics in its traditional patent framework. It examines and analyses the standards of biotechnology and software patents followed in the US, EU and India based on judicial precedents and its implications on bioinformatics patents, analyses bioinformatics patents granted in the United States and European Union and examines the Indian Patent Manual and the patentability standards followed in India.
Keywords: Bioinformatics, Patents, Information Technology, research tools, biotechnology and software patents, Intellectual Property Rights.Â
References
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Sufficient relevant identifying characteristics such as The claimed invention Reduction to Practice Actual reduction to practice not always required. Deposit of biological materials not a substitute for written description.Clear depiction of the claimed invention in detailed drawings Weigh factual considerations in view of level of skill and knowledge in the art. The less mature the technology, the more evidence is required to show possession. Level of skill and knowledge in the art increases over time.
Specific means that utility must not be general that would be applicable to the broad class of the invention. It must be specific to the subject matter claimed.
.“Substantial utility†means current “real world†use. To illustrate substantial utility of a protein that would be coded by any gene found by the probe. This makes it clear that in the absence of such knowledge patent cannot be granted.
If the only utility of a compound is for scientific research, then there is no substantial utility.
Credibility refers to the reliability of the statement based on the logic and facts that are offered by the applicant to support the assertion of utility. To illustrate this consider a claim for a DNA fragment whose use is disclosed simply as a “gene probe†(pieces of DNA that can be used to find new genes by hybridizing to them), would not be considered specific in the absence of a disclosure of a specific DNA target (means particular site of DNA were these fragments hybridize). This specific DNA target will be different for other “gene probe.†For example a particular gene probe is used for cancer gene mutation, the specific ,real world use of probe is to be given than its general use.
[2004] UKHL
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Research tool patents found in several different areas of biotechnology include expressed sequence tags (ESTs), single nucleotide polymorphisms (SNPs), identified receptor and screening methods. They can be a sequence used in research with no immediate therapeutic or diagnostic value. They are a means to develop a commercial product such as a medicine or a vaccine, but not an end product sold directly to consumers.
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See, Association for Molecular Pathology v. USPTO, 569 U.S. June 13, 2013 .
The claim 14 reads as follows - A method of using a computer system to present information pertaining to a plurality of biomolecular sequence records stored in a database, the method comprising: displaying a list of said records or a field for entering information identifying one or more of said records; identifying one or more of said records that a user has selected from said list or field; Then matching said one or more selected records with one or more protein function categories from a first hierarchy of protein function categories into which at least some of said biomolecular sequence records are grouped; and displaying the one or more categories matching said one or more selected records, wherein said protein function categories specify biological functions of proteins corresponding to said biomolecular sequences and said first hierarchy includes (i) a first set of protein function categories specifying biological functions at a cellular level, and (ii) a second set of protein function categories specifying biological functions at a tissue level.
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561 U.S 2010.
Ibid
.Association for Molecular Pathology v. USPTO (569 U.S. June 13, 2013),
Association for Molecular Pathology v. USPTO (569 U.S. June 13, 2013),
The European Patent Convention (EPC), Article 52, paragraph 2, excludes from patentability, "in particular discoveries, scientific theories and mathematical methods;aesthetic creations; schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; [emphasis added] presentations of information. Paragraph 3 then says:"(3) The provisions of paragraph 2 shall exclude patentability of the subject-matter or activities referred to in that provision only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such."
The EPO has granted at least over 30,000 patents for computer program-related inventions. Many of these patents were in the core areas of information technology, i.e. digital data processing, data recognition, representation and storage. Others were granted in different technical areas such as automotive and mechanical engineering, e.g. for program-controlled processors.
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[1987] 1 OJEPO 14 (T208/84)
Yogesh Anand Pai, Patent Protection for Computer Programs in India: Need for a Coherent Approach computer Programs, The Journal of World Intellectual Property (2007) p. 34
Ibid.
Id.
IBM/Data Processor Network, T83/67, EPO Journal [1990]. Where the invention was related to coordination and control of the internal communication between programs and data fields.
See, infra n.67
.IBM/Computer-Related Invention (text processing), T85/115, EPO Journal [1990]. the claims related to a method of decoding stored phrases and of providing a display of events in a text- processing system.
Koch & Sterzel/X-ray Apparatus, T26/86, EPO Journal [1998]. Where the claim was for computer control of a known X-ray apparatus.
Yogesh Anand Pai,(2007)Patent Protection for Computer Programs in India: Need for a Coherent Approach computer Programs, The Journal of World Intellectual Property p. 34
. 75. (T356/93)
2010 EWCA Civ 33,.Kitchin J set out the following guidelines which essentially summarise EPO jurisprudence: a.the capability of industrial exploitation must be deliverable by the skilled person from the description read with the benefit of the common general knowledge; b.the description, so read, must disclose a practical way of exploiting the invention in at least one field of industrial activity. That is to say, it must disclose in definite technical terms the purpose of the invention and how it can be used to solve a given technical problem;c.the requirement will not be satisfied if what is described is merely an interesting research result without any specified application. A speculative indication of possible objectives is not sufficient. The patent should not leave the skilled person with a research programme to carry out in order to exploit the invention;e,if a substance is disclosed and its function is essential for human health, the identification of the substance having that function will immediately suggest a practical application. If the function of that substance is not known or is incompletely understood and no disease has been identified which the substance is implicated in, and no other practical use is suggested for it, then the requirement of industrial applicability is not satisfied (even if there is a scientific achievement of considerable merit in the disclosure); and it is no bar to patentability that the invention has been found by homology studies using bioinformatics techniques but this may have a bearing on how the skilled person would understand the disclosure.
Charlotte Harrison Nature Reviews Drug Discovery (7), 722-723 (September 2008) http://www.nature.com/nrd/journal/v7/n9/full/nrd2679.html, | doi:10.1038/nrd2679 (5 January 2010)
2010 EWCA Civ 33
Genome-wide screening for SNP and mutations related to disease conditions, Hoheisel, Joerg, EP2052087 (A2)(29 March 2009)
A method for identifying a genome-wide mutation, comprising:
(a) providing DNA from two sample pools of a subject, wherein a first sample pool is obtained from an diseased cell and a second sample pool is obtained from a normal cell;
(b) digesting each DNA sample pool to generate at least two DNA fragments;
(c) ligating a short oligonucleotide adapter to each fragment at a site of mismatch cleavage; and
(d) selectively amplifying and identifying the sequence differences between the two sample pools to identify a mutation.
The method of claim 1, wherein the diseased cell is a cancer cell.
Eli Lilly v. Human genome science,( emphasis by the Author)
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