Published online on December 11, 21012

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Gene Patents may Hamper Innovations in Patient Care

The impact of gene patents on fostering innovation is a highly debated topic. Several compelling arguments have been put forward to support the notion that gene patents will promote innovation and banning gene patents will hamper current and future investments that may affect the development of future patient care products (1). Further, the long-term effects of gene patents in innovation and research have been considered as myths (2). On the contrary, we believe granting patent rights to any naturally occurring biomolecules, such as genes, proteins or metabolites or nucleic acids (like miRNA), that are relevant to biomedical applications may hamper future innovations in developing cost-effective patient care products and services. Gene patents are discoveries, not inventions patenting discoveries may hamper scientific innovations It is a well known fact that genes, proteins and other biomolecules present in humans or any other living organisms are naturally occurring and cannot be patented. The question is, whether naturally occurring genes or recombinant genes isolated from natural environment can be considered as a patentable invention? Several scientific aspects, excluding legal interpretations that will not be discussed in this blog, need to be considered to answer this question. The foremost argument is isolation and functional characterization of a gene is a discovery, it is not an invention. If discoveries are considered as patentable inventions, not only scientific discoveries are at stake but also it will hamper sustainable scientific knowledge based innovations that may lead to the development of innovative and low-cost patient care products, which are certainly required for reducing health care costs. Moreover, discovery based patents are vulnerable to costly legal battles that will slow down R&D innovations and deeply destroy entrepreneurial initiatives by start-ups, which are the core thriving force behind transforming scientific discoveries into patient care innovations. Genes can be isolated and cloned using well-known technologies and such genes cannot be considered as inventions. However, a new method developed for isolating or cloning a gene may be considered as an invention. Likewise, identification of the function of a gene or a gene mutation associated with the incidence of a disease is a discovery, it cannot be considered as an invention. The obvious reason is the function of an isolated gene or the association of gene mutation/s with a particular disease is a natural occurring phenomenon that was not invented by researchers, rather it was discovered using 1|Page
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known or inventive methods or technologies. Furthermore, isolating and cloning a natural gene in a vector or other formats do not mean that the inventor will automatically get all the rights on the use of a gene that is naturally present in humans or other living organisms. In other words, if a scientist has used inventive methods to isolate or clone a naturally occurring gene, the patent privileges should be limited to the process or the recombinant product, not extended to naturally occurring gene that is not patentable. Likewise, discovery of a compound present in a plant species is not an invention, however, development of a novel process for isolating this compound or a method of using this isolated compound for treating human or animal diseases can be an invention since it is not a naturally known phenomenon. Often, such examples have been cited to justify the validity of gene patents. It is also important to note that isolated genes are of no use unless the clinical or diagnostic or therapeutic associations or roles of these genes have been discovered. The association of genes, gene mutations and biomarkers with diseases can be dependent on several factors such as ethnicity, geographical location, environmental factors, food habits etc. Granting patent rights to an inventor who has discovered a disease specific mutation in a gene for all possible known and undiscovered mutations in that gene cannot be scientifically justified. Such practices may result in hampering future discoveries since incentives from these discoveries are automatically transferred to a third party throughtheir broad patent claims. Gene patents should not be granted for claims with broader applications without scientifically validated experimental evidences, which are very critical for any scientific inventions. Besides, patents do not follow basic scientific principles and this offer ample opportunity for inventors to claim any hypothetical or impracticable applications of patented genes, without even considering the scientific merits of their discoveries or inventions. Consequently, this may lead to unrealistic patent claims on clinical and commercial potentials of scientific discoveries that may not have any direct impact on improving patient care. If we continue with the practice of patenting discoveries, it will not only delay or prevent genuine applications of basic scientific discoveries but also challenge the fundamental ethical principles and values of scientific research. Gene patents may hamper innovations in drug discovery and clinical diagnostics Over expression or down regulation of genes can be associated with diseases and these genes can be used as therapeutic drug targets for the prevention or treatment of diseases. Likewise, over expression or down regulation of genes can be used as biomarkers for the diagnosis of diseases. Association of genes with a disease is a natural phenomenon and identification of such association is a discovery rather than an invention. The real use of disease specific genes will be the discovery of new drugs targeting genes or gene products that may lead to the development of novel drugs or new treatment methods. If a disease specific gene patent has a claim like diseases can be treated by inhibiting the gene or gene products using drugs molecules such as, but not limited to, small molecules, proteins, oligonucleotides, antisense nucleic acids, miRNAs, antibodies, aptamers, peptides, that could lead to a real problem. Such claims may block or decelerate promising research and development (R&D) activities related to a patented gene and destroy creativity in entrepreneurial scientist cum innovators, who could transform current limitations in clinical patient care into high potential enterprises that 2|Page
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Fig.1: Possible impact of patentable and non-patentable discoveries in patient care innovations

deliver innovative patient care products through creating large number of innovation driven jobs. In gene patents, genes and gene sequences as well as further downstream applications of genes can be patented without providing any supporting scientific experimental evidences. This is one of the most scientifically disputable aspects of gene patents, which may contain dubious and impracticable claims on the utility of genes. Gene patents can also slow-down or cripple innovations in promising next generation patient care strategies such as personalized medicine. Therefore, gene patents can be a real road block to innovations in drug discovery research, which may have long-term positive impact on inventing new therapeutic drugs or treatment methods, faster bench to clinics timeline, reducing mortality and morbidity from diseases, reducing health care costs and creating high growth entrepreneurial startups (Fig.1). 3|Page
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In clinical diagnostics arena, gene or similar biomarker patents may have different consequences. Identification of genes or biomolecules associated with diseases is only a primary step towards the development of clinical diagnostics assays. The most critical aspect is to develop and optimize highly sensitive, robust, reliable and cost-effective assays or methods for the detection of specific genes or biomolecules in patients for the accurate diagnosis of diseases. Undoubtedly, innovations are essential for the development of reliable and robust diagnostics assays, which are very critical for developing efficient clinical diagnostics products. Disease specific genes or biomarkers offer incredible opportunities for innovations through the development of 1) new diagnostic or companion diagnostic tools and methods, 2) methods for the prevention of diseases though early detection methods (diagnostic imaging, nanoparticle based diagnosis etc.), 3) new biomedical and analytical devices and instruments, 4) diagnostic assays to identify patients response to a particular drug, 5) methods for optimizing personalized drug treatment regimen (drug dose, drug treatment schedule etc), 6) methods for monitoring the efficacy of treatment (disease stage, tumor progression, tumor recurrence etc), 7) methods for predicting life-threatening side effects of therapeutic drugs and 8) novel theranostics (diagnostics therapy) approaches. The abovementioned patentable high-value innovations can attract investments that can create sustainable entrepreneurial establishments and scientific jobs, which may be significantly higher that gene patents alone can offer. Conversely, granting patent rights to naturally occurring genes or biomarkers may obstruct health care related technological, scientific and clinical innovations that are very critical for developing life-saving patient care products.

Recombinant genes may not have any direct clinical or commercial value in patient care Genes can be isolated and cloned using standard recombinant DNA methods, and these recombinant gene and gene products (proteins) can be used for studying structure-function analysis, which can be utilized for identifying drugs and developing diagnostic assays using known or inventive methods. The cloned gene may be considered as non-natural and may be patentable. However, recombinant genes may not have any direct clinical or commercial value whatsoever in patient care (exceptions are gene based innovations such as use of recombinant gene in gene therapy or recombinant gene based vaccines and biopharmaceuticals or cell therapy using cells expressing recombinant gene or similar specialized therapeutic/diagnostics technologies). The reasons are 1) any drugs that are invented will be targeted towards the natural gene present in humans, not the cloned gene, and 2) disease specific mutation/s in cloned gene has no value in diagnosing a disease, instead diagnosis must be performed through the detection of specific mutation/s in patients or patient derived samples using known or inventive methods. Granting patent rights to all possible use and applications of natural genes or gene variants based on the fact that recombinant gene is non-natural is not scientifically and ethically justifiable. The general conception that banning gene patents will prevent innovations or investments may not be true, rather it will encourage innovations in critical areas where clinical health care inventions are required. These inventions may lead to the development of innovative cost-effective therapeutic drugs and clinical diagnostic tools that will reduce patient care costs. Granting patent rights to naturally 4|Page
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occurring biomolecules such as genes, proteins or metabolites may hold back these innovations. It is unfortunate that if gene patents are treated as an easy source of return of investment (ROI) with less effort, without even taking into consideration the scientific, social and moral responsibilities of discoveries, which are more often publicly funded. It may be true that isolated genes may be unknown to us earlier; therefore, can it be considered as an invention? The answer will be no, because genes were already been present in humans and we could not isolate these genes due to the lack of suitable methods or technologies. Evidently, scientific and technological innovations in molecular cloning, sequencing, PCR, bioinformatics, biochemical methods etc., have created innovative ways to identify genes and assign functions, without these inventions genes would have been a still unknown factor. Thus, gene patents are not true inventions; rather these are discoveries made possible through other technological and scientific inventions. Most importantly, unprecedented innovations are warranted to establish the usefulness of genes for the invention of novel therapeutic drugs and clinical diagnostic assays that may provide clinical and economical benefits to patients. Unfortunately, gene patents and the complex legal interpretations of simple scientific principles surrounding gene patents may slow down or hamper future innovations in patient care, specifically the development of cost-effective novel diagnostic and therapeutic products that enable physicians to provide best possible care for their patients. Moreover, gene patents may lead to innovation bottlenecks that favor fewer inventions, restricted entrepreneurial initiatives, limited job growth, and non-competitive monopoly (Fig. 1). Note: This scientific blog is a contribution from Sciclips Consultancy team. References References are hyperlinked to respective abstracts or full articles. Please click the reference numbers to the citation details Related blogs on biomarkers:
Strategies for Rational and Personalized Cancer Biomarker Discovery

Cancer Biomarker Strategy to Develop Companion Diagnostics for Predicting Prescription Drug Induced Tumors Analysis using pioglitazone (Actos) and bladder cancer
Cancer Theranostics Potential Applications of Cancer Biomarker Database How to Identify Clinically Successful Biomarkers? Potential Use of Drug Response-Efficacy Biomarkers for Predicting Life-Threatening Disease Causing Side Effects of Therapeutic Drugs Metabolon vs. Stemina Are Biomarkers Patents can be Considered as True Inventions?

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Gene patents may hamper innovations in patient care
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