Merging Technology Transfer with Knowledge Translation

Academic to industrial research

Vivek Dave, Department of Pharmacy Banasthali University

Sachdev Yadav, Department of Pharmacy Banasthali University

Isha Mehta, Department of Pharmacy Banasthali University

Harshavardhan ML Yadav, Department of Pharmacy Banasthali University

Technology transfer is not just limited to industries and R&D. A research scientist working in R&D may also work with universities. There are several examples of patent or product commercialisation happening in universities. This article focuses on how technology transfer can be coupled with knowledge translation.

The government and research academics are increasingly aware of the relevance of their result to the industrial sector. The term knowledge translation was coined to represent proactive strategies to communicate research findings to those in a position to put the findings into practice. As it happens in most cases, the first consideration is given to market size. Simply put, it means that the market where we are supposed to market the product should be large enough to trade it in a very big volume. Moreover, it is very important to see weather the intended result can be patentable or not, especially in the pharmaceutical industries. Technology transfer does not always involve a patentable invention, but also the transfer of the intact technology including copyrights, proficiency, and others. A good patent is that which cannot be overcome by any other universities; a weak patent will allow other universities or researchers to come up with good amendments on our idea leading to the problems of licensing. Some universities require employees and graduate students to report all inventions to the universities and, upon request, execute a formal assignment document. The Bayh Dole Act, a nonprofit organisational research and its documentation work that is closely concerned to the field, permits funding agencies to grant inventors requests to retain title, provided the universities have waived election of the title. However, if universities believe an invention is valuable, they will usually elect title, apply for patents, and then license the rights exclusively back to the inventors. This is the procedure usually followed in the case of inventors who obtain venture capital to form companies to develop their discoveries. However, a number of universities support their employees who wish to preserve the title to their inventions, and have sensible plans to ensure growth. Most universities also assert ownership over non patentable materials created by their employees and recorded information generated by their employees. The quality of industry technology transfers is based on the student and industry relationships. The interaction with industry can also educate faculty and students with regard to salaries and working conditions in industry. Students learn that scientists in industry also publish. They learn that scientists in industry can spend less time raising funds for their labs than those in academia. It also has the potential for educating them with regard to the rewards of working in industry. This interaction can go a long way towards ridding industry of the stigma that has caused it recruitment problems in the past. Technology transfer can also provide funds for students and resources for enhancing programmes. They set some goals for preparing and distributing technology transfer guidelines which are shown in figure 1.

The Bayh Dole Act Providing the Platform for Universities Technology Transfer

The Bayh Dole Act enacted on December 12, 1980 (The Patent & Trademark Act Amendments) (Public Law 96-517) created a uniform patent policy among federal agencies that fund research. Bayh-Dole enables small businesses and non-profit organisations, including universities, to retain title to materials and products they invent under federal funding. Subsequent amendments created uniform licensing guidelines and expanded the law to include all federally funded contractors (Public Law 98-620). The implementing regulations for Bayh-Dole are published at 37 CFR Part 401.

Regulations Implementing Federal Patent and Licensing Policy Regarding ‘Rights to Inventions Made by Nonprofit Organisations, Universities and Small Business Firms’ are Codified at 37 Cfr Part 401. The Following Summarises the Significant Aspects of these Regulations

• The provisions apply to all inventions conceived or first actually reduced to practice in the performance of a federal grant, contract, or cooperative agreement. This is true even if the federal government is not the sole source of funding for either the conception or the reduction to practice. The provisions do not, however, apply to federal grants that are primarily for the training of students and postdoctoral scientists

• The university has an obligation to disclose each new invention to the federal funding agency within two months after the inventor discloses it in writing to the universities

• The decision whether or not to retain title to the invention must be made within two years after disclosing the invention to the agency. This time may be shortened, if, due to publication of research results or public use, the one-year US statutory patent bar has been set in motion. Under such circumstances, the universities must make an election at least sixty days before the end of the statutory period. If the university does not elect to retain title, the agency may take title to the invention

• Upon election of title, the universities must file a patent application within one year, or prior to the end of any statutory period in which valid patent protection can be obtained in the US. The universities must, within ten months of the US filing, notify the agency whether it will file foreign patent applications. If the university does not intend to file foreign applications, the agency may then file on its own behalf in the name of the United States

• Universities must include within the specification of the patent a notification of government support of the invention and government rights in the invention

• If the universities elect to retain title, the universities must provide the government, through a confirmatory license, a non-exclusive, non-transferable, irrevocable, paid-up right to practice or have practiced the invention on behalf of the US throughout the world

• The universities is obligated to have written agreement with its faculty and technical staff required disclosure and assignment of invention.

Documentations for Universities Technology transfer includes

Inventor information:

Full college name that is mentioned on the certificates of inventor, name of college and institute, phone number of person and the institution, address for correspondence, age, sex etc. is to be mentioned in this column.

Title of invention:

Selection out of column of the field your work belongs to. Like if it belongs to physical science, engineering, pharmaceuticals, or any other branch.

Funding sources:

Name of department that is providing funding, like CDRI, CSIR, DBT, DST or any other funding agency that is providing funding to the said invention. Along with this account number grant number is to be mentioned. Did this invention utilise data or materials any biological products or population data if was in use.

Dates of conception and public disclosure:

The date and mode of public disclosure is to be mentioned like on such date an oral disclosure or disclosure in research paper was made. Has the invention been reduced to practice YES or NO is to be mentioned. If yes, then it is to be provided with the information regarding the first successful operation of the invention that has been proved its advantages that distinguish it from prior technology. Describe the particular problem the invention seeks to solve. Describe how others have attempted to solve the problem and the limitations or deficiencies your invention

Background research and prior art:

The researcher should describe all background research and prior art of related invention (novelty and non-obviousness of patent claims are judged against everything publicly known before the invention, as shown in earlier patents and other published material. This body of public knowledge is called prior art) for this researcher should disclose all the information like to give complete description of the invention. To describe the invention diagrams, graphs may be used. Attachments can also be made in order to check disclosure and information made on such. Describe in detail the novel features of your invention In support of the invention it must be describe that why invention is must and how novel the work is and what are its benefits to society. What are other forms of this invention or alternative uses or aspects of it? What has been done to demonstrate that your concept actually works, what is the current state of development? The stage of development is a critical question that both investors and companies asked in their evaluation of new technology. Indicate one of the following stages and include any supporting information (e.g. concept, early stage, bench prototype, industrial prototype, product, market.) What research plans do you have for further development of your invention. This column will indicate Future plan with that same invention if they are scheduled, or are in progress. And finally declaration is made signature that indicates all entries made by person was correct and he is responsible for all information. Sometime declaration is also made by both parties and every party is given a copy of same.

Supporting or Assisting Students in Commercialising their Products

The guidelines help students to take care of each and every step while trying for technology transfer. Technology transfer is a complex subject, but its complexity may be reduced by following these guidelines and moving step-by-step for transfer purpose. Since students don’t have their own earnings to invest in such project, many government organisations provide funding to them. These include CSIR, DST, DBT, ICMR, DSIR etc. Students need send their filled up forms and a synopsis of their work and estimated results so that funding agencies can calculate the worthiness of the project. Making inventions available to all consumers is the next step. This is done through suitable advertising of the inventions. Defining rights and responsibilities are the major part of goals of technology transfer many collaborations are there, sometime like with faculty, or institute itself, so who will take care of which part is mandatory to clear.

Research Collaborations an Intangible Vagueness

Simple Collaborations

Research partnerships sometimes have totally different meanings and there tends to be some degree of conceptual vagueness one must be concerned about, especially in case of a review. For this purpose, a major type of intangible vagueness in research collaboration is easily seen with differences in level of analysis. The term research collaboration describes relationships between individuals as well as organisations. Many university researchers even go for co-authorship. For this reason, much of the published work focuses on co-authorship. By this definition, collaboration not just about on publishing articles, but articles that are more often concerned with technology development, software or patents and sometimes publication is not an objective. Collaboration does not require person-to-person interaction. Very large associations of specialists interact to produce research and publications and there are some cases where collaborators never meet or interact with each another.

Knowledge and property focused collaborations

There are two different types of R&D output here, and they are very critical and relevant to this research collaboration. Knowledge is generally measured in terms of scientific and technical articles produced, cited and used. Increments to wealth are typically measured in terms of patents, new technology, new business start ups, and profits. In particular, most property-focused collaborations at some point have a knowledge focused phase or aspect. Most R&D collaboration are seen in private industry because most researchers are there working in these firms. The objectives and content of research in industry are very different from the universities, government or Nongovernmental Organisations (NGOs). In universities research, we examine two different research outputs: first, work focused on collaborations for expansion of knowledge and enhancing academic researchers, and second, work focused on collaborations dedicated, in order to producing economic value and wealth for the researchers.

Faculty collaboration

A student and faculty working together goes beyond the standard for an undergraduate or graduate student at a university. The term must be defined in comparison to the usual level of support provided to all students within a department or discipline, and the definition may vary from one discipline to another. The determination must be made by the department or division head, subject to the affirmation of the dean. Collaboration may take to the form of a student assisting faculty with research or creative activities. It may take the form of students and faculty working together to develop an exhibit or production of works of art, outside of for credit courses. It does not include independent study courses taken for credit. It does not include work for pay or other compensation under the guidance of a faculty or staff person.

The scientist discloses the invention to the university. Once the invention is disclosed, the technology transfer office evaluates the invention and decides whether or not to pursue acquiring a patent. The technology transfer office must consider the commercial potential of the invention, as well as prospective interest from the public or private sector. If the technology transfer office decides to invest in the invention, the next step is the patent application process. If the patent is awarded, the technology transfer office markets the technology to organisations and entrepreneurs. The goal of this marketing effort is to match the technology with an organisation or entrepreneur that who can best utilise the technology and provide opportunity for revenues to the universities. When a suitable partner is found, the university works with the organisation or entrepreneur to negotiate a licensing agreement. The licensing agreement typically includes a royalty to the university, an equity stake in the startup, or other such compensation. When an agreement is reached, the technology is officially licensed. In the final stage of the process, the organisation or entrepreneur adapts and uses the technology. The original invention typically undergoes extensive adaptation during the process to commercialisation. The university, and sometimes the inventing scientist, might continue to be involved with the organisation or entrepreneur to help develop the technology or to maintain the licensing agreement.

Different Phases of Knowledge Transfer from Universities / Academics Institute to Market

Knowledge transfer flows throw research, development and commercialisation phase in universities as described infigure 3. The transfer process of knowledge is done in three steps: research phase, development phase, and commercialisation. Research phase further includes researcher knowledge, methodology, research findings, and global knowledge.

Here, the developer first collects knowledge about the product or technology they want to work on. Then they develop proper and validated methods for the establishment of technology transfer, and to mention all validated tests and their references and then at the end it is subjected to known people by the mode of papers. Next comes the development phase where first step is to introduce the product by defining all its benefits, side effects etc. In this phase all assessments are to be done and consumer’s needs are to be checked. A proper plan should be in place to work with for which implementations are necessary. At last the specifications of the products are to be given and various test models were prepared. From there it directly enters the commercialisation phase where testing is done by consumers, and finally when good feedback is seen from users, the production is planned along with all billings of productions and materials. Intellectual property is reviewed once again and final impact is seen if everything is fine with it, it is finally filed for a patent.

Ownership Claim of Student and Universities

The advent of heightened interest around the issue of ownership of the intellectual property rights of what is created, invented or discovered by students has created a much more complex situation on the part of students, faculty and providers of sponsorship and case studies. Universities respect the long standing tradition that students own their academic work. The university does not claim ownership of such intellectual property. There are some common point focus ownership claim as showed in figure 4. When the university provides material support beyond the standard for student research, including academic credit and non-credit work, intellectual property will be owned by the universities. If work is done by faculty collaboration, when there is collaboration between a student and universities faculty or staff to create works as part of research or development activities, intellectual property will be owned by the universities.

In special situations the certain courses or special projects where students are presented with the opportunity to participate in projects or activities, the ownership of any resulting intellectual property must be assigned either to the universities or to a sponsoring entity as a condition of the student's participation.

Conclusion

Technology plays a crucial role for creating market growth. Academic institutions or universities act as a cradle for innovations, new ideas and knowledge creation. In India, academic institutions and universities suffer from a low rate of technology /IP commercialisation. To improve this rate universities and industry need to establish a close and intensive relationship and formulate strategies for achieving better technology transfer for mutual benefits. For this, enhancing technology transfers by giving a chance to universities is an appreciable step. Universities may follow government guidelines or have their own, but they are supposed to follow the Bayh Dole Act. These guidelines are of great significance in order to make technology transfer convenient and help to eliminate dark sides of the practice.

--Issue 29--

Author Bio

Vivek Dave

Vivek Dave received his Ph.D in Pharmaceutics from Banasthali University, India. Since 2008 in academics he has accumulated substantial knowledge on technology transfer and novel drug delivery system which is shared in publication and seminars all over the world.

Sachdev Yadav

Sachdev Yadav has earned his Ph.D in Pharmacology from Banasthali University, India. Since 2003 he has been instrumental in both industry and academics.

Isha Mehta

Isha Mehta has completed M.Pharm, in Pharmaceutics from Banasthali University, India My area of interest is technology transfer. Basically my main aim to put my knowledge to the advancement of drug technology and make it affordable and reachable to each one of us.

Harshavardhan ML Yadav

Harshavardhan ML Yadav, B.A.LL.B (RMLNLU), LL.M in IPR (NUSRL), NET-JRF. Since 2015 working as Assistant Professor (Law) at Jamnalal Bajaj School of Legal studies, Banasthali University.

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