Genes contain the blueprint of the human body. Since the genetic code
contains all the information necessary for organized physiological activity of
the body, patent over a gene can be determined by traditional methods. In light
of the genes considered a valid patentable subject matter under the Patents Act,
1970, modified by significant human intervention. This article explores the
conflicts between right to health and the gene patents. The possibility of a
violation of right to health should be approached with great caution.
Introduction
A patent grants to its owner the right to exclude others from making, using or
selling a patented machine or composition of matter, or using a patented method,
typically for a period of 20 years from the date of filing a patent application.
Patents require disclosure that teaches the world how to make and use an
invention, rewarding the inventor with a period of exclusivity during which time
profits may be earned from its commercialization.
In developed countries, patents are granted (such as the European Patent Office
and the United States Patent and Trademark Office) after the patent office
examines the application. Inventions meet patent criteria and ensure that only
patentable inventions are protected. A patent claim defines the meaning of
patent protection.
A genetic substance that can be reproduced by using artificial means, similarly
as with the isolation and cloning of a gene, is viewed as an artefact, a
man-made innovation, and is, subsequently, qualified for patenting on the
condition that the substance, its function, or a strategy to produce it is an
invention, is novel, has a specific disclosed function, isn't clear concerning
current information, and can be applied industrially.
Objectives of the Study:
The objective of the study is to understand about whether gene patenting is
valid or not, and on what conditions patent can be given and what are the
implications of gene patenting.
Research Problem:
There is no clarity about gene patenting and how it affects the development of
medicines and where and how can the patent be used.
Research Question:
- What is gene patenting? Is it valid?
- Where and how can the patent be used?
- What are the implications of gene patenting?
Research Methodology
My study is based on "Doctrinal Method." The resource materials are secondary. I
have used secondary assets like books, articles, and journals, and
Internet-based research.
Analysis
Human genetic patents are the result of genetic cloning and recognition of
sequences whose role or function is known. With the rapid development of cloning
and screening techniques in the 1980s, many patent applications for human genes
have been filed.
But in 2001, the concerns over the scope of gene patents led the US Patent and
Trademark Office to clarify its patentability standard for genes, requiring that
a patent applicant make a credible assertion of specific and substantial utility
of the genetic invention[1],[2].
Gene patents cover three types of inventions:
- diagnostics,
- compositions of matter and
- functional uses.
Diagnostic Uses
The first type of genetic 'invention' covers testing of genetic differences. We
have referred to these types of patents as 'disease gene patents', because they
claim the characterization of an individual's genetic makeup at a
disease-associated locus when performed for the purpose of diagnosis or
prognosis[3].
These patents typically cover all known methods of testing, including the use of
hybridization, Southern analysis, PCR and even DNA chips. Since the fundamental
discovery patented is the statistical observation of a genetic difference and a
phenotypic difference (such as the occurrence of disease), then any method for
testing for that genetic difference can be covered by the patent[4].
Compositions of Matter
The second broad kind of genetic invention connects with compositions of matter
(i.e., materials and chemicals), including the purified and isolated gene (cDNA)
and every derivative product (e.g., recombinant proteins or drugs, viral vectors
and gene transfer 'therapies', transfected cells, cell lines and higher-order
animal models in which the patented gene has been added or removed).
Functional Use
At last, a third and arising class of gene patents is what claims the functional
use of a gene. These patents depend on the discovery of the role genes play in
disease or other bodily and cellular functions or pathways, and claim methods
and compositions of matter (regularly called 'small molecule' drugs) used to up
or downregulate the gene. Note that these drugs are not likely gene products,
yet rather different sorts of chemicals found to influence gene functioning, and
the drugs are possible patentable themselves as novel chemical entities useful
as therapy.
Gene patents in current medicine
Fear of gene patents originated from genetic sequencing's nascency in medical
practice. During the 1990s and mid-2000s, diagnostic sequencing was generally
ordered only for single-gene, Mendelian traits, and performed using DNA
amplification and Sanger sequencing, technologies that expected the production
of various, isolated copies of individual genes or genes fragments.[5] This made
diagnostic sequencing all the more likely to infringe on patents covering
individual, isolated genes.[6][7]
Today, medical practice has adopted new types of genetic sequencing for a number
of uses, including next-generation sequencing, therapeutic companion
diagnostics, and prenatal genetic diagnosis. Like their predecessor
technologies, the effect of conventional gene patents on these applications is
probably going to be quiet.
Concerns relating to the genetic patents
The latest worries about genetic patents connect with their results (upstream
patents v. downstream ones), a few patent-holders' abusive use of their monopoly
position, patent thickets (i.e., overlapping sets of patent rights with
different ownership, requiring several licenses), excessively broad patent
claims; and blocking patents because of protective IPR policies of the
companies. Many organizations file patent applications for defensive purposes (ie
to ensure freedom to operate), but seldom pursue them.
There is an assumption that all applications filed will be granted, or that they
are even 'patents' before this. These issues are seen as hindering further
innovative work, increasing the expenses or potentially preventing access to new
diagnostic tools in clinical practice.
Most factors, other than genes, influencing the function of the human DNA are as
yet not known. Information suggests that non-coding DNA ('junk DNA') is
substantially more critical than expected. Patents over non-coding biological
materials further complicate essentially in light of the fact that patent claims
wrongly expect that information on their existence is same as information to
apply this information in medical and scientific research.
Accordingly, it is fundamental for future research to guarantee that existing
gene patents don't impede the possibility of studying on factors that underlie
or are related with the working of a certain gene or its interaction with
different variables, like the environment.
Additionally, concerning outcomes of additional improvement of protected
developments, there is a distinction among upstream and downstream patents:
licensing difficulties of the first might hindrance to the exploitation of the
second, despite the fact that both are patentable accordingly. Some fear that
the increasing of upstream patents gives patent holders a control on the
downstream development and delivery of all genetic tests related with a gene for
a limited period of time.
Problems relating to patents
Reach-through claims, royalty-stacking
By reach-through claims a patent holder might attempt to acquire royalty rights
or other advantage from prospective inventions made by another person with the
use of the patent-holder's innovation. The issue is the breadth of the claim.
The more extensive the extent of the claim, the more the patent holder can
exclude others from taking advantage of innovations that come within the scope
of the claim and therefore the greater the patent-holder's negotiating position.
The patent holder regularly has an upstream patent to a research tool, that is,
biological materials or methods.
Product patents
The issue with product patents is that under the current patent frameworks the
assurance might extend to all subsequently invented new uses, regardless of
whether they were not expected in the patent application. Many recognize that it
is sensible that a test itself might give security, yet not every potential
purpose of the gene it is related to. Genes have unknown functions, they can
produce several proteins; introns can have independent functions, supposed
junk-DNA can be associated with regulating the genes and how and when genes are
expressed. Many functions are still to be found. Along these lines, product
patents in biotechnology are not commonly held fair and reasonably, and
extremely tough use of the basis for inventiveness should be applied.
Defensive use
Defensive patent policies, as on account of medication targets represent an
overall issue, as just a little piece of such targets will ultimately prompt a
commercially exploitable invention. As referenced, there are few such patents,
although many patent applications. However, the fact that there are such
applications pending could disallow further research and development of
therapies in view of this objective. These are viewed as harmful.
Research tools
Scientists need resources or research tools that have no quick therapeutic or
diagnostic value except for fairly used in conducting scientific work. Research
tools can be arranged into three general classes: research techniques,
consumables, and targets.[8] Genetic research tools include partial DNA
sequences or ESTs, SNPs, and different sequences that may be complete however
where the function may not be clearly known, so they don't meet with the utility
basis. The Nuffield Council sees these as merely routine discoveries that are
qualified for patenting.
There are a few justifications for why somebody probably won't gain access to
the new patented technology he wants:
- the patent holder would rather not want it;
- the license fee is excessively high;
- different terms of the license are unacceptable;
- the innovation is covered with so many (dependent and/or crossed)
patents that it is troublesome or costly to get hold of them. This list is
not exhaustive.
Future research needs
Existing studies are not viewed as adequate to establish regardless of whether
patents in the biotech represent an issue to the research or the accessibility
of the novel technologies;[9][10] what is the frequency of harmful licensing
practices; what is the frequency of accumulated license fees? Or is simply
dislike against paying charges to use genetic knowledge? The effect of patenting
and licensing practices on industry and public research ought to be studied.[11]
Future research needs to include the assessment of whether current practices for
patent assessment have permitted various conflicting patents on the same gene;
the scope and significance of the anti-commons problem;[12] and the effect of
research tool patents on biomedical research.[13] An external assessment of gene
patents is, however, reported to be incredibly difficult.[14][15]
Conclusion
'Gene patents' cover an expansive scope of inventions. Each type has its
own potential uses and marketable products, and each raises potential problems
depending on how the patents are used in the relevant marketplace. Much remains
unknown, and to be sure, the market is as yet adjusting to these patents. In
this manner, it is critical to proceed to study and monitor how gene patents are
being used, licensed and enforced in order to develop policy interventions if
deemed necessary.[16]
The flow of patients on human genes has raised practical and moral worries. A
huge piece of public opinion is contrary to the rule of the patentability of
life and, by incorporation, against the patentability of human genes. The
research community is worried about the foreseeable limitations of their
research projects in the field.
The health care professionals and payers are worried about the expected effect
of the patents on the expense of tests. The industry, particularly the small and
medium-sized organizations, and the patent attorneys are worried about the
troubles they might need to confront as a result of various licenses important
to develop another new drug or diagnostic kit.
One crucial concern has been the broadness of the genetic patents. A
considerable workshop participants and contributors felt that the foundation
between a disease and a genetic sequence or a defect ought not be patentable
because of the absence of innovative step and the absence of novelty.
Besides, individual mutations in known disease genes ought not be patentable.
For sure, limiting the granting of a patent to a particular reason may be vital
on the grounds that many queries connecting with genetic functioning and
interactions are still unknown.
Absolutely new issues might be created alongside every one of the new strategies
and 'omics': there is a progressive shift from gene-based tests to genome-based
tests, and, for example, a mix of metabolic and molecular biology. Genome-based
diagnostics and multiple gene tests might make new difficulties in the field.
The patent claims for RNA interference are arising and could bring along genuine
patent thickets.[17]
Thus, main issues include how to get to existing information, regardless of
whether patented, and how to have the option to do research in the area of
biotechnology, while simultaneously not losing the patent framework as a
incentive for product development.
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- 66 Federal Register 1092–1099, January 5, 2001.
- Berkowitz A, Kevles DJ: Patenting human genes; in Magnus D, Caplan A,
McGee G (eds): Who Owns Life? Amherst, Prometheus, 2002, pp 75–98.
- Merz JF, Cho MK, Robertson MA, Leonard DGB: Disease gene patenting is a
bad innovation. J Mol Diagn 1997;2:299–304.
- Merz JF, Cho MK: Disease genes are not patentable: a rebuttal of McGee.
Camb Q Healthc Ethics 1998;7:425–428.
- Godard B, Kääriäinen H, Kristoffersson U, Tranebjaerg L, Coviello D,
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- International Bioethics Committee. Report of the IBC on Ethics,
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