gene patents may hamper innovations in patient care

7/30/2019 Gene patents may hamper innovations in patient care

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1 | P a g e Gene patents may hamper innovations in patient care

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Published online on December 11, 21012Link to the original blog:http://www.sciclips.com/sciclips/blogArticle.do?id=1025&blog=Gene%20patents%20may%20hamper%20innovations%20in%20patient

%20care

Gene Patents may Hamper Innovations in

Patient Care

The impact of gene patents on fostering innovation is a highly debated topic. Several compellingarguments 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 offuture 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 anynaturally occurring biomolecules, such as genes, proteins or metabolites or nucleic acids (like

miRNA), that are relevant to biomedical applications may hamper future innovations in developingcost-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 naturallyoccurring genes or recombinant genes isolated from natural environment can be considered as apatentable 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 isisolation 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 willhamper 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 carecosts. 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 corethriving 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 asan 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 isthe 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


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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 ofa 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 belimited 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 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 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 inventorwho 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 futurediscoveries 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 broaderapplications without scientifically validated experimental evidences, which are very critical for any

scientific 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 discoveries

that may not have any direct impact on improving patient care. If we continue with the practice ofpatenting 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 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 drugs

targeting 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 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


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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 scientificallydisputable aspects of gene patents, which may contain dubious and impracticable claims on the utility ofgenes. 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 innovationsin 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 fromdiseases, reducing health care costs and creating high growth entrepreneurial startups (Fig.1).


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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 thedevelopment 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 orbiomolecules 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 efficientclinical 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 toidentify 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 above-mentioned patentable high-value innovations can attract investments that can create sustainable

entrepreneurial establishments and scientific jobs, which may be significantly higher that gene patentsalone 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 fordeveloping 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 geneand 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 clonedgene 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 basedinnovations 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 specializedtherapeutic/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 incloned 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 betrue, 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 drugsand clinical diagnostic tools that will reduce patient care costs. Granting patent rights to naturally


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occurring biomolecules such as genes, proteins or metabolites may hold back these innovations. It isunfortunate that if gene patents are treated as an easy source of return of investment (ROI) with lesseffort, 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 tous 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 methodsor technologies. Evidently, scientific and technological innovations in molecular cloning, sequencing,

PCR, bioinformatics, biochemical methods etc., have created innovative ways to identify genes andassign 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 andscientific inventions. Most importantly, unprecedentedinnovations are warranted to establish the

usefulness of genes for the invention of novel therapeutic drugs and clinical diagnostic assays that mayprovide 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 futureinnovations in patient care, specifically the development of cost-effective novel diagnostic and

therapeutic products that enable physiciansto 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 tothe citation details

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