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Gene Patenting And Right To Health

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:
  1. diagnostics,
  2. compositions of matter and
  3. 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:
  1. the patent holder would rather not want it;
  2. the license fee is excessively high;
  3. different terms of the license are unacceptable;
  4. 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.

Bibliography:
  1. 66 Federal Register 1092–1099, January 5, 2001.
  2. Berkowitz A, Kevles DJ: Patenting human genes; in Magnus D, Caplan A, McGee G (eds): Who Owns Life? Amherst, Prometheus, 2002, pp 75–98.
  3. Merz JF, Cho MK, Robertson MA, Leonard DGB: Disease gene patenting is a bad innovation. J Mol Diagn 1997;2:299–304.
  4. Merz JF, Cho MK: Disease genes are not patentable: a rebuttal of McGee. Camb Q Healthc Ethics 1998;7:425–428.
  5. Godard B, Kääriäinen H, Kristoffersson U, Tranebjaerg L, Coviello D, Aymé S: Provision of genetic services in Europe: current practices and issues. Eur J Hum Genet 2003; 11 (Suppl 2): S13–S48.
  6. International Bioethics Committee. Report of the IBC on Ethics, Intellectual Property and Genomics (Justice Michael Kurby, rapporteur), Paris 2002, (http://portal.unesco.org/shs/en/files/2139/10541304201FinalReportIP_en.pdf/FinalReportIP_en.pdf).
  7. Cho M, Illangasekare S, Weaver M, Leonard D, Merz J: Effects of patents and licenses on the provision of clinical genetic testing services. J Mol Diagn 2003; 5: 3–8
  8. Gold ER, Joly Y, Caulfield T: Genetic Research Tools, the Research Exception and Open Science. GenEdit 2005, Vol. III, No. 2
     
  9. Caulfield T, Cook-Deegan RM, Kieff FS, Walsh JP: Evidence and anecdotes: an analysis of human gene patenting controversies. Nature Biotech 2006; 24: 1091–1094.
  10. Gold ER, Bubela T, Miller AF, Nicol D, Piper T: Gene patents – more evidence needed, but policymakers must act. Nature Biotech 2007; 25: 388–389.
  11. OECD: Genetic inventions, intellectual property rights and licensing practices: evidence and policies. OECD 2002.
  12. Gold ER, Bubela T, Miller AF, Nicol D, Piper T: Gene patents – more evidence needed, but policymakers must act. Nature Biotech 2007; 25: 388–389.
  13. Gold ER, Joly Y, Caulfield T: Genetic Research Tools, the Research Exception and Open Science. GenEdit 2005, Vol. III, No. 2.
  14. Verbeure B, Matthijs G, Van Overwalle G: Analysing DNA patents in relation with diagnostic genetic testing. Eur J Hum Genet 2006; 14 (1): 26–33.
  15. Lopez-Beverage CD: Should congress do something about upstream clogging caused by the deficient utility of expressed sequence tag patents? J Tech Law & Policy 2005; 10: 35–92.
  16. What Are Gene Patents and Why Are People Worried about Them? - FullText - Community Genetics 2005, Vol. 8, No. 4 - Karger Publishers
  17. Schmidt C: Negotiating the RNAi patent thicket. Nature Biotech 2007; 25: 273–275.

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