Case Analysis of Dr Narendran's Dilemma

EXECUTIVE SUMMARY

The three basic objectives of Indian Medical College (IMC) are imparting, promoting and developing of the siddha medical system.

Dr. Ramkumar puts forward the proposal for protection of IP rights for herbo-mineral Siddha medicine for coronary atherosclerosis to Dr. Narendran, Director of IMC. This formulation reduces uses of commercial stents considerably and is also cost-effective.

IMC has been conducting researches in various fields but has never faced a situation where in they have thought about protecting their intellectual property. But with Dr. Ramkumar approaching IMC about his invention, it creates a dilemma whether IMC should learn from other parallel medical systems which believe in protecting their intellectual property and patenting them. It also gives an opportunity to generate revenues so that those revenues can be channelled to improve infrastructure facilities at IMC. At the same time it is to be seen that Dr. Ramkumar is a loner and very secretive about his formulations, so it becomes dubious why has he approached IMC with his formulation.

But by patenting the formulation, IMC’s mandate of sharing and imparting knowledge of Siddha seems to be violated. And also the study has been tested on few patients only; its long time effects and side effects, if any cannot be known. So it is not advisable to spend such amount of money in filing for patent as IMC is already short on money until study is fully validated. Dr Ramkumar should be encouraged for further clinical trial of the formulation.

MAIN REPORT

1. Situational Analysis:

1. Introduction:

Dr Ramkumar, head of Pharmacology Department of Indian Medical College (IMC) had put forward a proposal to Dr Narendran, Director of IMC in October 2010 to protect the IP rights and commercialize the herbo-mineral Siddha medicine for coronary atherosclerosis developed by him which reduces the need for commercial stents.

Dr Ramkumar has a good record as practitioner-cum-researcher but is also secretive about his formulations. Ramkumar’s intentions regarding herbo-mineral Siddha medicine for coronary atherosclerosis are not clear, as this is the first time he had approached someone with his formulation.

IMC was setup in 2008 with an objective to impart postgraduate education in Siddha, research various aspects of Siddha and to develop, promote and propagate the science and art of Siddha. In May 2010, IMC had approved 4 research projects and got a funding of 3 million rupees, but till date had never encountered a dilemma to protect the Intellectual Property (IP) rights and so does not have any funds put aside for this purpose.

During a recent discussion with the head of all departments, a unanimous decision to supplement textual authority with research was reached to promote the acceptance and credibility of Siddha among other medicines and countries.

Dr. Narendran consulted one of his friend from a management education institute to understand commercialization of the formulation and was suggested three options for licensing it – Transfer to third-party for a one-time license fee; to use a registered pharmaceutical unit to manufacture and to market through IMC; agreement with an entrepreneur for annual royalties on sales of formulation – along with the estimates.

It is already 3 months since Dr. Ramkumar had come to Dr. Narendran with this request so Dr. Narendran owed him a response. If Dr. Narendran approves the request, it will benefit the institute financially and academically but his response should be guided by IMC mandate and will be watched closely by other faculty members who are pursuing similar research studies.

1. Statement of Objective:

In August 2010, in a meeting with the Head of Department, the group had come to an agreement that Siddha still had some way to go in developing a globally-acceptable research designs and defining appropriate outcomes of treatment which will make it acceptable in other systems of medicines, become visible and available to patients in other countries.

Although IMC had been conducting research in Siddha since 2008 to develop, promote and propagate the art of Siddha and Dr. Narendran himself has done some research in his career spanning 32 years, he has never encountered the question of IP protection. This was an unfamiliar territory for IMC and no funds had been put aside for this purpose.

1. Problem statement:

With Dr. Ramkumar approaching Dr Narendran for IP protection of his research and commercialization of the same, the latter has been put into a dilemma of how to respond to the request.

1. Criteria and decision rule:

1. Reliability

The credibility and reliability of the formulation should be taken into consideration.

1. Promotion and acceptance of Siddha

It is to be seen that the solution to the problem does not hamper IMC’s objective of developing propagating and promoting art of Siddha.

1. Motivation for research

Various researches are being conducted at IMC by faculty members and hence it needs to be seen that the decision to this problem doesn’t deter them from sharing their research and their trust in institute remains intact.

1. Academic benefit

The decision taken should not negatively impact IMC’s objective of imparting Siddha education.

1. Financial returns

IMC is already facing financial crunch as it is already short on manpower and consulting rooms. So its financial situation should not worsen.

1. Influence on the Treatment cost

It is to be seen that the cost of treatment for patients of coronary atherosclerosis becomes optimum.

Decision Rule: Fulfilment of criteria 1, 2, 3, 4 and 5 are required

 Fulfilment of criteria 6 can be negotiated

1. Decision process

1. Alternatives

1. Not to apply for patent – Go for further clinical trial
2. Apply for patent using anyone method of licensing:

1. Outright transfer to a third party for a one-time license fee
2. Use a registered pharmaceutical unit to manufacture the formulation, but do the marketing though IMC
3. Enter into an agreement with an entrepreneur, under which the latter would pay annual royalties on sale of formulation

1. Evaluation of alternatives