Ethics And Intellectual Property (Patents) By Prof. Mojisola Christianah Adeyeye The Director General National Agency For Food And Drug Administration And Control (NAFDAC) At The Annual Research Fair University Of Lagos

 

August 28, 2018,

Protocol

The Vice Chancellor, the Deputy Vice Chancellor (Development Studies), the other Deputy Vice Chancellors who are unavoidably absent, the Registrar, the Bursar, the University Librarian, other principal officers of the University, members of the Senate, all invited guests, gentlemen of the press, distinguished ladies and gentlemen.

It is my delight to be back at the University of Lagos to deliberate on the topic that is very dear to my professional life, i. e, research and the joy of finding out new ways of doing things, specifically pharmaceutical development of conventional drugs or bio-actives. As academicians, we daily labour to invent new ideas that could be disseminated in form of a manuscript, design and work of art to which one can claim  right or copyright. Sometimes, one may be able to file for an intellectual property (IP) right or patent from such research output.

Since the occasion is Research Fair, I will also address the students, without which academic research cannot progress. I remember long ago as a student, I had a very limited understanding of IP as a set data or findings for which one can claim a right, the ethics behind it and the overall process of patenting. This was partly due to the fact that my research advisor was not versatile in patenting himself despite his being a great mentor, and possibly due to the cost that he envisaged but for which I had no knowledge.  As a consequence, I lost the opportunity to patent a unique controlled drug release technology.  It was not until my early years as an Assistant Professor that I got exposed to patenting. Even at that stage, I had lost a second opportunity to claim an IP on an invention from my lab. This time, it was due to lack of proper coordination from the University Research/Technology Transfer Office.  After this, I became more proactive with heightened awareness of the value of invention.

An Intellectual Property is a body of works that was done with creativity and good design and that resulted in an output that has not been documented in previous times. If it was done before, the creativity may be in the complexity of new variables that were used, or a new purpose for which the research findings can be applied. The discovery must show novelty and “non-obviousness”. An IP can also be a concept that has not been put into practice or translated into verifiable experiment.

Whose work is it? In some academic circles, the originator of the research idea is the inventor. In this case, the student is seen as a helping hand that doesn’t fit the profile of an inventor.  However, in other environments, the faculty member or Professor includes the student, post-doctoral fellows or other significant contributors that might have given an intellectual advise or data that changed the design and the course of the research positively toward a patentable body of work.

It is important to emphasize the importance of ethics at this early stage and how to handle the subsequent development of the IP.  A patent attorney that is retained by the university or organization usually should be invited earlier. It is at this point that the invention disclosure form is filled. Information such as the date the idea was conceived, date of turning idea into practice or when experiment was initiated and date of publication (presentation at meetings, publication in a local journal or even on a social media), are expected to be provided in the form.

This is also where the contributions of each inventor (true inventor, student or other significant contributor) in percentage or ratio, with description of such contributions are documented. The University Sponsored Research/Technology Transfer Office usually handles the invention disclosure processing and other processes in the patenting process. Other information such as the funding source for the research, any confidential agreement with outside organization, collection of the data from another facility other than the inventor’s lab and university are also provided in the disclosure form.

It is important to be forthright and truthful to give full disclosure to avoid academic misconduct, future litigation by any contributor whose idea was not included. Full disclosure is also very important in cases where there could be similarity, no matter how slight, to a previous invention. Otherwise, that could become problematic during the examination of the validity of the invention.

Who Owns a Patent: According to Patents and Designs Act Chap 344, Laws of the Federation of Nigeria, 1990, the employer of the inventor (statutory inventor) and organization that pays for the patent owns the patent (US Patent Law).  The statutory inventor is the entity that has the validity of  “first to file” or that is valid to claim priority over the invention.  The true inventor is the professor/students/post-doctoral fellows, etc., who made the discovery. The true inventor is named on the final patent as the inventor or inventors. The University patent attorney will take the process further once the invention disclosure (ID) is completed and properly signed.  If the work is done in more than one institution and the patentable findings were collected from such institution, the contributor from the institution should be included in the invention disclosure.

In some cases, a university may not want other outside institution to be included but the best approach is to understand that “winner take it all” in many cases does not work.  Many research-oriented institutions usually would have their formula for apportioning the future commercial revenues from patents. For example, an institution could have a ratio for sharing revenues from future commercialization of the IP, e.g., 4:4:1:1 for the Provost (Vice-Chancellor) Office, Inventor, Department, and College respectively.  The ratio varies from institution to institution.

The money for future sharing is the net amount after the university has been paid the cost of the patent or any other cost such as money spent on patent infringement litigation. This final formula must be disclosed to the inventors or should be known by all parties from the beginning, i.e., the process must be transparent even though there may be disagreements. It is through such agreement that re-negotiation could be sought.  If the inventor is more than one as stated in the invention disclosure form, the ratio of contribution shall be used to determine the sharing formula as shown in the example earlier mentioned.  Prior to commercialization and realization of any revenue, a long process of full patent filing, licensing or sub-licensing agreement must have taken place. This will be discussed later.

Confidentiality Agreement: If the information will need to be shared with a third party, including students, post-doctoral fellows or significant contributors, a confidentiality agreement should be signed.  Within the context of our culture and the Nigerian law, the inventor may not be the owner of the patent.  Taking an example of an herbal medicine developed by an herbalist outside the university, the herbalist is the inventor.

However, if the bio-actives of the herbal medicine were elucidated by a scientist in an institution, the scientist becomes a co-inventor because without the research findings, there will not be an advancement in the health benefits of the medicine. It is extremely important that the herbalist be presented with the facts before initiating any discussion with the scientist in the university. A confidentiality agreement (CDA) should be signed where it is stated that any information shared with the scientist will not be shared with others and that all shared information belongs to the inventor up to the time of signing the CDA. This is because any shared information prior to signing the CDA could be claimed by the scientist if he/she is unscrupulous.

Timing of Public Disclosure:  The timing of the first public disclosure, presentation or marketing of an herbal medicine is crucial in the patent process. If the medicine has been advertised or registered or listed by a regulatory body, i.e., it has been made public, then a patent can only be filed within a year of the first publication.

Keeping Records of Patentable Data: The collection of any data from the laboratory experiment, a work of art or design should be kept in a notebook dedicated solely for the work. The recording must be dated; any cancellation of information in the notebook must be signed and dated. The data could be transcribed into a file on the computer but the original must be kept in the notebook.

After the invention disclosure, the work or research usually continues.  The patent attorney is given a charge to investigate the patentability of the findings. If the data are patentable, a provisional patent can be filed. This will give the inventor one year within which to gather more data that could be used for filing the full IP. If the one-year is passed, the full patent could no longer be filed.

Filing of the Patent: Once the full patent has been submitted to the attorney’s office, there will be iterations of adjustment or re-writing of clauses between the inventor and the attorney.  The patent is thereafter submitted to the Patent Office. Prior to submission, a decision is made regarding the scope, i.e., if the patent will be worldwide, limited to a country or it will cover multiple countries.  The cost of filing can increase astronomically if filing will be in multiple countries. During the evaluation of the patent, a patent application number is given. If the evaluation is successful or the invention is deemed novel with non-obviousness, an assigned number is given.

 It should be noted that having a patent does not translate into earning money or royalty; it will depend on how successful is the technology transfer or commercialization potential. This will be discussed later on.

Life of a Patent:  A new patent’s life is 20 years from the date the application for the patent was filed in the United States or Nigeria or, in special cases, from the date an earlier related application was filed, subject to the payment of maintenance fees. The U.S. patent grants are effective only within the United States. This is also the case in  the Nigerian Patent law.

Technology Transfer and Licensing:  After the assignment of the patent number, the level of interest in the body of works or invention may increase due to visibility and wider readership. If an interest is shown, the owner will ask that a CDA be signed. Thereafter, a licensing agreement is usually drawn between the statutory inventor or the true inventor (licensor) and the potential licensee.  The licensor dictates the terms of the potential license.  There are two basic types of license – exclusive or non-exclusive license.   In either case, a royalty agreement is included in the licensing document.  The terms of the licensing may also include options such as option to sub-license by the licensee and term limit. In the latter case, the license may cease after a certain period if there are no possibilities of commercialization.  Sometimes the patent may be bought from the owner, in which case the owner forfeits all rights in lieu of the payment or money settlement.

Exclusive license: The statutory or true owner transfers all rights (including the right to sue for infringement and the right to license) to the licensee only retaining the title of the patent.  The license at this point has acquired the right to sub-license the patent and sue for patent infringement. However, the licensor can limit the use of the license to certain areas, i.e., the licensee gets a promise from the patent owner that the patent will not be licensed to anyone else in a stipulated field of use.

Non-exclusive license:  The patent owner essentially promises not to sue the licensee for patent infringement.  But if the licensee’s products infringe other patents, the licensee may be sued.

Successful commercialization would lead to revenues that should then be shared based on the terms of the license agreement.

In conclusion, claiming an IP right over an invention should be encouraged but the university or organization must be willing to commit or source fund for the patent filing.  There is no guarantee that a patent will lead to viable commercial product or revenues. But there are many successful examples of university-based patents that ended up as successful commercial products.

Thank you