Evaluating Indian Professionals Knowledge for Innovation and Need for Patent Education

The Patent system encourages invention, disclosure, and investment. Several patents are granted in medical sciences, but a misconception remains with health care professionals regarding criteria for patentability of their valuable invention. Though the Indian Patent system has promoted the progress of science and technology, its scope has not been extended to treatment procedures in medical and dental sciences. This research was conducted to assess the knowledge and awareness of health care professionals about the Indian patent system. The study was conducted to assess the awareness and knowledge of the Indian patent system and the need for patent education among professionals of different streams. This cross-sectional study was carried out among private practitioners of different streams (medical and dental, ayurvedic, and homeopathic). Results made a poor show of patent education and knowledge. Only 6% of participants had more than 50% knowledge regarding this topic. Since educational institutions are opting for accreditations. Research and innovation is an important criterion for that. This study highlighted that there is a great need for patent education for professional and institutional growth.


Introduction
Intellectual property (IP) has a remarkable role in the current economy. Intellectual labor along with innovation may benefit at the public level if given due significance. IP is a novel concept generated in the human mind or intellect, artistic, technical, scientific, or literary. Intellectual property right (IPR) is a legal right or exclusive right granted to the creator or inventor so that he/she can protect his/her invention for a definite period of time. IPR protects funds, investments, time spent in the invention, and cost utilized in addition to efforts. Similar to other properties, IPR can also be transferred or sold. (Saha & Bhattacharya, 2011) The patent is an intellectual property right. Its protection ensures a fair return for companies on their investment or the cost of making a product from an invention. Patent rights are obtained by filing a patent application in the patent office. (Heus et al., 2017) Graduates, students in educational institutes, and universities are indulged in innovation. Hence projects and innovative work needs support which in turn adds to reputation (Kassiri, Corejova, 2015). The Patent system encourages progression in science & technology. It provides incentives for an invention, disclosure, and investment, which encourages innovation and efficient use of that invention. Developing countries are taking remarkable inspiration from developed countries to efficiently use the patent system to improve the economy which is the most important aspect. In the era of evidence based medicine health care professionals are incorporating rigorous efforts for research and development. Medical methods are excluded from the scope of patentable subject matter in most of the countries on the grounds of ethical issues in medicine. (WMA Statement on Patenting Medical Procedures, 2019) Medical devices range from simple products i.e. disposable gloves to highly technical and complex products i.e. surgical implants. Diagnostic kits and drug delivery systems are also included in this category.
Devices are required to yield results equivalent to clinical trials of medicinal products to prove their safety and efficacy. Section 4A of the Patents Act 1977 (as amended by the Patents Act 2004) states that methods for treatment of the human body or animals by surgery or therapy and diagnostic methods are not patentable whereas patents for medical devices are possible (Intellectual property and access to medicines, 2012). Patent protection can be granted for surgical, diagnostic or therapeutic instruments or apparatus if they demonstrate novelty with regard to the way to be used in surgery or therapy. Patent protection for a known medical device (e.g. an injector pen for injecting insulin) cannot be provided for supplementary use (same injector pen to deliver another drug for the treatment of a different illness). A few products fall on the margin between medical devices and medicinal products.
(Fact SheetIntellectual property considerations for medical devices, 2018). IPR management of medical devices, treatment, and diagnostics is very important (Dixit et al., 2011). According to Section 4A, If medical methods are patented, they should have an industrial application, but they do not have any such effect (WMA Statement On Patenting Medical Procedures, 2019., Indian patent act 1970, 2015. If the Indian patent system permits patent of these methods, then it can serve several advantages, as shown in fig.1 (Gupta et al., 2018;Method of Treatment A Patent Perspective, 2017, Kassiri, Corejova, 2015.

Figure 1. Advantages of Patenting Medical Methods
As per Section 3(i), any process carried out for the prophylactic, curative, surgical, medicinal, or any other therapy for humans/animals/ plants to cure a disease or money-making is non-patentable. (Indian patent act 1970(Indian patent act , 2015. Examples of some methods are shown in table 1 and table 2. Method for Treatment Example Surgery surgical treatment including incision, excision, injection and implant insertion, maintenance, operation, and extraction of a medical device like a catheter, endoscope inside the human body preparatory treatment for surgery-anesthesia for surgery and disinfection of skin before injection/incision cosmetic methods Therapy providing medicine or physical treatment to a patientfor disease cure or control implanting of a medical device or transplant of an organpreventing a disease -e.g., tooth decay or influenza maintenance of physical health -.e.g. massage or Yoga or Pranayama Curative and prophylactic treatment of a disease in general curative treatment and alleviation of the symptoms of pain and suffering Medicine administration of different drug forms -i.e., capsule, tablet, syrup, injection for the treatment dosing drugs at definite time interval treatment mixing two or more forms of the medicine for the treatment drug dose form Diagnostic Determination of diseases and physical health, the mental condition of a human body, or prescription or treatment/ surgery plans based on these conditions. (excluding determination by a device) determination any complication inpatient by observing the test result or imaging On the other hand, blanket prohibition has been laid by developing countries on medical procedures via statutory provisions. This dissimilarity between the developing and developed nations is raised due to social circumstances and national patent processes. (WMA Statement on Patenting Medical Procedures (MAY, 2019) In dentistry, various patents have been granted in foreign countries, which may be because of a better understanding of IPR. Patent grants and applications are very few in India. (Bijle, 2011) some of the patent applications are shown in table 2.
Intellectual property is the creation of the human mind (intellect) (Bijle, 2011), and the right granted is termed an 'Intellectual Property Right' (IPR). (What is Intellectual property? 2020) A patent is granted for 20 years to an inventor, excluding others from using or making a particular invention. (Gupta et al., 2018) For that period, patent holders enjoy the benefits, and the public can not enjoy them freely (Gupta et al., 2018., Bronwyn, 2007. Once the term of the granted patent is over, it can't be patented again, and the patent goes into the public domain, i.e., it becomes public property (Gupta et al., 2018), as shown in Figure 2.

Figure 2. Term of Patent
Indian Patent Act, 1970 allows patentability of pharmaceuticals or medical devices such as scalpels, surgical sutures, staplers, stents, diagnostic kits, and reagents. (Indian patent act 1970, 2015) There has been so much research and development in medical science. However, medical methods are still nonpatentable in the Indian patent system with issues and reasons (Table no.3) ( WMA Statement on Patenting Medical Procedures, 2019). Table 3. Reasons on the grounds of which medical methods are not subject to patentability ( WMA Statement on Patenting Medical Procedures, 2019) Reasons Ethics intrinsic in the medicine practice Unbalancing of health care by economic benefit, raised financial load as well as damage to privacy and confidentiality of patient Access to that medical method will be decreased for the patient due to provisions of the license Physicians might prefer an inferior method instead of licensing the patented method, thus compromising safety The threat of infringement will prevent advanced medical methods be adopted Decreased peer review of the method with a resultant decline in safety and quality of novel methods In some countries use of a patented invention is not allowed for academic and research purposes The exploitation of privacy of the patient after examining the patient record for evaluating if a physician has performed patented method Today research and innovation is an observed phenomenon but not every research is patentable. In recent years there has been a remarkable increase in Patents in dentistry. Dental professionals are concerned with practical problems of patent processing to manufacture equipment used to diagnose, prevent, and treat disease. Inventions are there in dentistry, but knowledge about IPR and its substantial value in society are questionable. (Bijle, 2011).
The present study was conducted among

Gaps of the study
Research studies from the past evaluated IPR among other professionals except for medical professionals. In literature, no study has been found related to this topic. There is a wide gap in the survey of the need for patent education. Only a few studies in India have focused on other IPRs, not on the patents like in our research.

Rationale of the study
Mere evaluation of knowledge does not provide information. There is a stringent need to assess the barriers among Indian professionals and pitfalls in the education system.

Significant contribution and the novelty from this present study
Present study will contribute to new gaps in patent education since this type of study was not conducted among medical professionals before.
It will encourage other authors to conduct more research on this topic and strengthen patent education.

Method
This cross-sectional study was conducted from a period of May 2017 to January 2018. A convenience sampling method was used. A well-designed study questionnaire (offline) was used, which was divided in 7 parts. The first part consisted of 3 questions (1-3) ; demographic information, Part two consisted of 3 questions containing basic knowledge about Patent, part 3 consisted of 2 questions (4-5) regarding attitude towards patent, part 4 consisted of 2 questions (6-8); regarding knowledge about the patent procedure and grant, part 5 consisted of question (9)about knowledge of patentability of treatment methods part 6 consisted of 2 questions (10-11); for barriers in the patent knowledge, part 7 consisted of 2 questions (12-13); for participant's enthusiasm towards the patent. Participation in the research was voluntary. Only those participants who were interested and willing to participants enrolled in the study. The confidentiality of research participants was kept throughout the study. 175 private practitioners and academicians were approached from different streams i.e. (dental, medical, ayurvedic, and homeopathic). Out of these, 22 participants refused to participate in the study, and 15 questionnaires were found incomplete, so we excluded them from the final analysis, so we had 138 questionnaires for final analysis. Data was fed in an excel sheet and analyzed for percentage, correct responses, mean, p-values, and ANOVA followed by a post hoc test using SPSS version 20, IBM SPSS Statistics for Windows, Version 20.0. IBM Corp., Armonk, NY, USA.

Findings
The present study was conducted to gather knowledge for innovation and patent education among professionals from different streams. The response rate in the present study was good i.e. 138/175 (78.8%).  In our study, 15 participants were in the age group of 22-30 yrs, 34 participants were in the age group of 30-40 yrs, 26 participants were in the age group of 40-50 yrs, 42 participants were in the age group of 50-60 yrs, 21 participants were in the age group of 60 and above. Professions distribution include 56, 25, 29, and 28 professionals from medical, dental, ayurvedic, and homeopathic.

Basic knowledge of Indian professionals about the patent system
Our study indicated a poor basic knowledge about the Indian patent system, and there was no statistically significant difference in the understanding among various groups. The patent is an intellectual property right, and it is a technical document that requires inputs from technical and legal experts for protection. (Gupta et al., 2018) In our study, 94% of participants had less than 50% knowledge, and 6% had more than 50% knowledge about this statement.

The attitude of Indian professionals towards patent
In our study, none of the participants had any previous experience with the patent application. On further exploration, it was found that they did not file a patent for an invention before because 99/138 (72%) did not have time, 10/138 (7%) were not interested in a patent application, and 29/138 (21%) possessed a lack of awareness regarding this topic but were interested in applying.

Knowledge of Indian professionals about patent protection and grant procedure
Patent protection can be applied for products as well as processes. (Gupta et al., 2018) In our study, only 3% of participants correctly responded to this statement. The patent is a right granted by the government to an inventor excluding others from making, using, or selling a particular invention. (Gupta et al., 2018) Our 93% of participants responded correctly, and 7% did not know. A patent is a territorial right i.e. patent granted once in a country is valid only in the country where the application has been applied, and it is not a worldwide grant. (Gupta et al., 2018) In our study, 74% of participants did not know about this statement, and 26% responded incorrectly.

Knowledge of Indian professionals about the term of the patent for an invention
Once granted a patent for an invention it is term is 20 years after applying to the patent office (Gupta et al., 2018), so an investor can enjoy their right for 20 years. A patent allows an inventor to disclose an invention publically rather than secrecy. (Gupta et al.,2018) None of the participants were aware of the statement. Once the term of the granted patent is over, it cannot be patented again, and the patent goes in the public domain i.e. it becomes public property. (Gupta et al., 2018) A large majority i.e. 96% participants, did not respond, and a very few i.e. only 4%, responded incorrectly that it can be patented again.

Knowledge of Indian professionals about patentability of medical and dental treatment methods
Medical and dental treatment or surgical procedures are not patentable in India. (WMA Statement On Patenting Medical Procedures, 2019; Gupta et al.,2018) In our study 2% participants responded that these methods are not patentable while 34% participants were having misconception that these methods are patentable and 64% did not give any response i.e. did not attempt question.

Barriers in the knowledge of patent among Indian professionals
Participants accepted that they were not acquainted with patent knowledge. Since they were never taught patent in their educational curriculum. Lack of topic in educational curriculum was found a barrier in patent knowledge. All participants responded that this topic was never discussed in continuing education programs, seminars, conferences attended by them.

Enthusiasm towards patent among Indian professionals
In our study, 99% of the study population did not explore the patent search engine, a structure-based search in the patent database. (Gupta et al., 2018) Due to lack of time, inadequate knowledge, and lack of interest. Only 1% of study participants showed interest in exploring and increase their knowledge.
As the knowledge was found very poor concerning the Indian patent system among participants, analysis of our study data was not presentable through mean, p-values, and ANOVA followed by a post hoc test, so results were presented only in percentage form.

Discussion
Our study was conducted to evaluate Indian professionals' knowledge for innovation and the need for patent education. Education of patent is an important aspect of faculty development programs. The findings from our study indicated a poor show of patent education. Traditional medicine serves as an important element of human health care with added commercial value. Researchers or companies may also claim IPR over biological resources and traditional knowledge after making slight modifications in the existing invention. The patent applications in the case of traditional medicine, natural products, and herbal medicinal products possess their IPR policies showing a rapid growth in herbal medicine. (Saha, 2011) In our study, only 3% of participants responded about the need for patent protection, in contrast to Ahmed et al., where 57% of respondents were aware of the need to protect IPR. (Ahmed & Kumar, 2017) )This indicates a lack of knowledge. In our study, 94% of participants had less than 50% knowledge, and 6% had more than 50% knowledge.
Further, in one study carried in Lucknow, 50% of research scholars were aware of patent. (Ahmed & Kumar, 2017) In our study, results showed a lack of experience in patent application. Large numbers of respondents were not aware of the laws relating to patent protection in contrast to the findings of a study carried by ahmed et al. where 50% of respondents were aware of IPR protection laws. (Ahmed & Kumar, 2017) Researchers in the academic field are deficient in awareness of IP-related issues to proceed with patent application procedures for their invention and publication. Once the public disclosure of research findings happens, the invention is not considered to novel anymore. (Intellectual property and access to medicines, 2012).
Universities and academic hospitals generate revenue from clinical care and teaching costs to capture business operations and cost of employees, leaving minimum residual finances for further development of product and clinical trials. On patent expiry, generic pharmaceutical companies replicate drugs spending only a part of the original costs of drug development, reducing the original cost of the drug (Taylor D, 2015). They have to verify only bioequivalence and the quality of the drug in terms of pharmaceuticals. Literature review suggests that barriers among health care inventors are limited knowledge of complicated international patent laws with inadequate access to qualified IP lawyers. In addition, increased price (price of filing, legal counseling, and maintenance of patent) increases the product price, time, and logistics resisting them from patent procedure. (Chao & Mody, 2015). In our study, all participants accepted that they were not acquainted with patent law. They have never been taught about patent in their curriculum, and the topic was never discussed in workshops, continuing education programs, seminars, conferences. This lack of topic in the curriculum was found a major barrier, Whereas in one study among library professionals in domains of medical sciences, the source of awareness were found books, the internet, friends, formal courses. (Gnanasekaran D, 2014) In our study, 93% of participants responded that patent is a right in contrast to the findings (60%) of the study carried by Ahmed et al. (Ahmed & Kumar, 2017). Curricular adequacy among professionals is also found to be deficient . motivation level was also found inadequate. (Bansal & Meenakshi, 2016). Our study found no significant difference in knowledge among participants, but it does not mean there is no difference clinically. (Prasad, 2019).
A large majority (99%) did not explore patent databases due to a lack of time and knowledge. In one study, 23.6% of participants visited sites to be informed about technological innovations. (Metallidou, 2020) Research advances in science and medicine provide the latest interpretations of already existing facts. Research is the activity of human origin that utilizes intellect to investigate and interpret. There arises a need for greater participation in research by the physicians as well as clinicians and patients. (Gup ta et a l., 2 0 1 9 ) Since intellectual property (IP) is an original creation of the human mind. In our study, only 1% of the participant showed interest in exploring and increasing their knowledge as a part of the research. In a study carried out by Ahmed et al in Lucknow, only 40% of the respondents were aware of the contribution of IPR in research and innovation. (Ahmed & Kumar, 2017) None of the participants had any previous patent application experience indicating weak research activity among participants, lack of interest. They did not file a patent for an invention. This is again because of lack of time, awareness, and absence of interest in the research area. In a study carried in Greece, only 18.3% of participants had consideration for an innovation. (Metallidou, 2020) This study will contribute to filling existing gaps in the field of IPR among Indian professionals. Findings from this study will reveal new gaps in the literature that had not been previously exposed or adequately described by others. Our study necessitates strengthening patent education with a weak backbone.

Conclusions
The findings of the study revealed poor knowledge of patents due to the flawed system in our country. Developing countries like India are in extreme demand for improvement or amendments in existing patent law. In addition to improvements in the Indian patent system, there is a stringent need to promote progress and development of medical sciences in India. Research and innovation is an important criterion for application and approval of such activities.
The major implication of our study was the weakened backbone of Indian patent education among medical professionals. Patent education is not given due importance among them. In past, no such research has been carried out among medical professionals, but some studies among engineering and pharmacy professionals have been conducted. Medical sciences pay consideration to this topic only for smoothening of accreditation procedure, not for educational and professional upliftment. Medical education emphasizes only research but not on IPR, which is the next step to research. We conclude that there is a great need for patent education for professional and institutional growth. Dental, Medical, and other associations should include IPR in their workshops, conferences as a significant part of the continued education program. Accreditation bodies necessitate educational institutions to have completed research projects and filed patent applications. There arises a stringent need for medical bodies to encourage affiliated institutions, universities to teach IPR.