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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 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 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 through their 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 opportunities 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.

genepatents

Fig.1: Possible impact of patentable and non-patentable discoveries in patient care innovations

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 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).

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 patient’s 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 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 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).

Link to the original blog: Sciclips Blog .

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

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Innovation Fostering innovation through scientific intelligence

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Scientific and technical areas covered: Drug discovery, Stem cells, Genomics, Proteomics, Biomarkers, Clinical diagnostics, Companion diagnostics, Molecular diagnostics, Personalized medicine (theranostics), Plant and agricultural biotechnology

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InnovationIt is very interesting to note that “stealing others idea’ is a widely accepted common practice in research, both in academic and industrial laboratories. In a society where stealing, even petty things, is considered as a punishable crime, people steal ideas openly, without any hesitation, in academic and industrial organizations. Stealing expressions or ideas from other’s speech or articles (plagiarism) is considered wrong and can be punishable too. So many people have lost their reputation and career as a result of our harsh approach on preventing plagiarism. Conversely, people get away with stealing others ideas in a research set-up for making money or for attaining power or position. We all agree that this is wrong and unethical; however, most of the researchers may feel helpless and do not how to address this issue without jeopardizing their current and future job security. In this blog, we will discuss the direct scientific and socio-economic impact of “idea stealing” in a scientific research environment, particularly in industrial R&D laboratories.

“Idea Thieves”: Who are they?

You have an idea and relate it to your boss; he appreciates it but at the same time thinks it is not a very practical idea for the current project or for initiating a new project. Three months later he comes up with the same idea and completely forgets to mention your name. Sound familiar? Many have gone through this scenario at times in their career path. These “idea thieves” are the very people who kill the scientific innovation/creativity in an organization and these people negatively affect the long term-growth of a company. Now the question is: why do some people steal ideas and who they are? People, who steal ideas in an industrial set up have specific career goal such as peer recognition as an innovative scientist, as well as corporate advancement and monetary reward. Often times they are in middle and top management positions and lack creative/innovative ideas of their own. Working at the management level, they often have the power to decide the job security of the people who are working for them and have the support from the higher authorities in the company. This places them in a position to misuse their power and steal ideas from their subordinates. One of the main quality management criteria of an innovative/creative company is to find out these so called “idea thieves” and take necessary actions. Most of the organizations won’t consider taking any immediate actions since it is not affecting their growth or revenues in the short term. In fact there are more long-term scientific, business and social impact of “idea stealing”. Often, share holders and consumers pay the price for the above mismanagement.

“Idea Stealing” & Consequences

Dealing with supervisors who are stealing ideas, often has a significant negative consequence on the scientific creativity of the researchers who come up with original ideas. In any given organization, one will find a handful of researchers who are intelligent, innovative, creative they are the “true innovators”: the building blocks of a company. They have a broad understanding of scientific knowledge, beyond their working area of research, and these researchers generate ideas based on basic fundamental principles. Once they have a concept, these researchers will teat and expand their ideas by thinking, reading and critically evaluating all the aspects of their ideas. Since they have the in-depth scientific understanding and knowledge, they can predict any negative outcome and find possible ways to overcome hurdles that a certain project may face. On the contrary, managers who steal ideas lack scientific/technical understanding and are likely unable to predict the future obstacles of a specific project, this may result not only in creating a poor product with many loopholes but also misuse of years of R&D investments and time. Above all, the practice of “idea stealing” destroys innovative minds, decapitates innovation in scientific research and promotes mediocrity in R&D laboratories where “pseudo innovators” can sustain.

Favoritism within an organization often plays a significant role and encourages “idea stealing”, which is often adopted to help to create a fast track career path for a person of choice. The executives/managers who champion favoritism and the beneficiaries of the favoritism tend to be more parasitic on others ideas; probably they see “stealing ideas” are the only path to attain their career success. A deadly combination of power, favoritism and “idea stealing” can completely wipe out innovation from R&D laboratories.

Often time in an organizational set-up where “idea stealing” is prevalent, patents are filed without the real inventor’s name though the patent law bars this behavior. Most of the time, the true inventors will not jeopardize their career by filing a complaint against their own employer. Thus, “idea stealing” challenges the fundamental principles of invention, innovation and creativity.

Negative impact of “Idea Stealing” felt at different level of product lifecycle-research products sector as an example

The immediate negative impact of “idea stealing” affects R&D cost and time which results in the development of a poor product, but its adverse consequences are far reaching. It affects product development, marketing, sales, even the consumers. This is very prominent in companies who are involved in making drug discovery assays or reagent kits. The research reagents made by these companies are used for research or screening procedures. These products can be launched within a short period of time, without the approval from any regulatory agencies. Since many of these “idea thieves’ are the middle and upper management in these organizations, they can dictate the marketing and sale personnel to aggressively market inferior products, irrespective of the functional quality, often through hijacking the job security of marketing or sales persons. Sales and marketing will then adopt various strategies/tactics to market and sell these products to the consumers/researchers. Ultimately, researchers lose time and money, which is often paid by tax payers, a major factor that differentiates consumer products from specialized research products. It is true that if a product is bad researchers will not buy the product again and this bad reputation can be spread by word of mouth in course of time. However, worldwide net work of sales force enables to market these products and get the investment back, even before the product reviews are out, which may take years. Sloppy products resulted from “idea stealing” can slow down scientific discoveries and destroy innovation.

What are the solutions?

Solutions are not possible unless significant changes are made within an organization Personal ethics and a “Golden Rule” mindset should be established and strictly enforced. Workers who feel appreciated and secure in their positions and can trust the chain of command in an organization are more likely to be productive. While monetary gain is an incentive for some; professional growth and respect of peers and management often times goes farther in securing a qualified worker to remain with an organization. People want their work to mean something for themselves and for their employers.

Since many of the culprits of this undesirable behavior are in management change must be made from a system wide perspective. Concrete documentation of innovation prior to revealing insights to management can provide a fallback position should you need proof of discovery. Having an open atmosphere at team meetings where new ideas can be discussed without fear of losing discovery rights and peer insight may lead to new directions of exploration.

Another way to reduce “idea stealing” in an organization is by exposing negative practices through web based platforms, including social networking sites. If companies can be ranked through an open platform, perhaps we could expect organizational policy changes. The hard part is to get the people, present and past employees of an organization, to participate in these types of discussion forums because of the “corporate policing” on web based forums and social networking sites. Organizations need to develop and implement strategies that foster creative thinking from multiple layers of employees for maintaining sustainable innovation, which can help the organization to attain excellence in this competitive globalized market. Again honesty is key for any of this to work, it is up to the individual to state the transgression clearly and without embellishment. Finally, it is the social and moral responsibility of all researchers to take courage and fight against this “innovation crime” or “innovation corruption” encouraged by an organization.

“We need to stress that personal integrity is as important as executive skill in business dealings….Setting an example from the top has a ripple effect throughout a business school or a corporation. After nearly three decades in business, 10 years as chief executive of a Big Eight accounting firm, I have learned that the standards set at the top filter throughout a company….[Quoting Professor Thomas Dunfee of the Wharton School of the University of Pennsylvania] .
“A company that fails to take steps to produce a climate conducive to positive work-related ethical attitudes may create a vacuum in which employees so predisposed may foster a frontier-style, everyone for themselves mentality.’ “— Russell E. Palmer

Notes added

It looks like there is some confusion around the concept of “idea stealing” described in our blog, which needs to be explained in detail. Let’s think about a hypothetical scenario to demonstrate our view of “idea stealing” and how it affects innovation and creativity. A scientist in an organization came up with an idea for a novel drug target for a high value disease like cancer. The scientist spent considerable amount of time to study and made a hypothesis based on solid scientific data. Once the scientist had the confidence on the theoretical feasibility of his/her idea, the scientist approached the manager with the idea. The manger realized the importance of this idea and the value it can add to the organization. The manager was excited and gave green signal to the scientist to do the experiments to show proof-of concept. The scientist was waiting for this “approval moment” from the manager and did all the needed experiments to prove the concept. The manager presented the data to the upper management and told the scientist that the management liked the idea and would like to see more data to make it a fully supported project. The scientist went back to the laboratory started working on experiments the manger wants him/her to do. The poor scientist did not realize the fact the manager had presented the data to the upper management as his/her own idea, not as the scientist’s idea or mentioned the scientist contribution, and the manager has already got the green signal from the upper management to proceed with the idea as a high priority project for the company. The scientist also did not know that the manager has already discussed with marketing/sales department for market value/share assessment and the legal department for patent processing. Within few weeks manger called the scientist and told that he got the approval to expand the group to work on the project. The manager did not stop there, the manager convinced the scientist to work on a different project where they need his/her innovative and creative approach; with the assurance that the scientist still be the point person in the project that was started with the scientist’s idea. The scientist was transferred into a new project and after few weeks/months the scientist was surprised to see a companywide news flash about a breakthrough idea for a multimillion dollar product from the manger and the manager got promoted for his contribution. This moment only the scientist has realized that the manager had deceived him and at the same time the manager is in such position that the scientist cannot question the “idea ownership” without risking the job. Ultimately, the scientist was laid-off later sometime because the company was downsizing Though this is a hypothetical example, believe or not things like this truly happen in various organizations. Can we say that the manager did this for the interest of the organization? May be the manager may argue that the scientist is not capable in executing the idea; the manager has to do this. We can agree to this argument because only the manger has the power to get the approval and resources to execute the idea. Does this justify the “idea stealing” by the manager? On the other hand, the fact is that if the scientist would have given an opportunity and support to execute the idea, as a team, the project would not have been a failure. This approach would have created an innovative research atmosphere, which would have benefited the organization in the long-term. It may be also true that the manger would have found another scientist in his/her group to find his next successful breakthrough idea, which may benefit the organization through serial innovations from the manager.


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