Gene patents may hamper innovations in patient care
known or inventive methods or technologies. Furthermore, isolating and cloning a natural gene in avector 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 hasused inventive methods to isolate or clone a naturally occurring gene, the patent privileges should belimited to the process or the recombinant product, not extended to naturally occurring gene that is notpatentable. 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 isolatedcompound for treating human or animal diseases can be an invention since it is not a naturally knownphenomenon. 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 ortherapeutic associations or roles of these genes have been discovered. The association of genes, genemutations 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 inventorwho has discovered a disease specific mutation in a gene for all possible known and undiscoveredmutations in that gene cannot be scientifically justified. Such practices may result in hampering futurediscoveries since incentives from these discoveries are automatically transferred to a third partythroughtheir broad patent claims. Gene patents should not be granted for claims with broaderapplications without scientifically validated experimental evidences, which are very critical for anyscientific inventions. Besides, patents do not follow basic scientific principles and this offer ampleopportunity for inventors to claim any hypothetical or impracticable applications of patented genes,without even considering the scientific merits of their discoveries or inventions. Consequently, thismay lead to unrealistic patent claims on clinical and commercial potentials of scientific discoveriesthat 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 scientificdiscoveries 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 beused as therapeutic drug targets for the prevention or treatment of diseases. Likewise, over expressionor 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 discoveryrather than an invention. The real use of disease specific genes will be the discovery of new drugstargeting genes or gene products that may lead to the development of novel drugs or new treatmentmethods. If a disease specific gene patent has a claim like “diseases can be treated by inhibiting thegene 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 toa 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