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.

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MAIN REPORT

I. Situational Analysis:

a) 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.

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b) 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.

c) 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.

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d) Criteria and decision rule:

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

2. 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.

3. 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.

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

5. 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.

6. 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

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II. Decision process

a) Alternatives
1. Not to apply for patent – Go for further clinical trial
2. Apply for patent using anyone method of licensing:
a. Outright transfer to a third party for a one-time license fee
b. Use a registered pharmaceutical unit to manufacture the formulation, but
do the marketing though IMC
c. Enter into an agreement with an entrepreneur, under which the latter would
pay annual royalties on sale of formulation

b) Evaluation of alternatives
Table 1: Criteria v/s Alternatives
Alternatives
Patent Further clinical trial
Reliability ✓
Promotion and
acceptance of Siddha
✓
Motivation for research
✓ ✓
Criteria Academic benefit ✓
Financial returns
Probable ✓
Influence on the
Treatment cost

1. Reliability:

 Although "new" may imply "better," it is not known whether the potential
medical treatment offers benefit to patients until clinical research on that
treatment is complete. Clinical trials are an integral part of new product
discovery and development. Dr. Ramkumar’s formulation has only been tried
on 45 patients so far with encouraging results. This means it is still in Phase I
which includes 20-80 patients. According to WHO, medical products could
only be marketed after 3 phases of clinical trials. It still needs to go through 2
more phases before acceptance.

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  Patient sample size is not large enough to include people with various
conditions. E.g. The formulation may not be suitable for person with diabetes
 Long-term consequences of the formulation are not yet known, as the research
is still in its nascent stage
 Dr Ramkumar has been secretive with his formulations till now, and this is the
first time he has approached Dr Narendran to commercialize his product.
Thus, his intentions about the medicine are not clear, and the formulation
raises the question of reliability.
 Further research of the formulation over the years may help prove its
reliability.

2. Promotion and acceptance of Siddha:

If the new formulation works as intended, it will help propagate the discipline of
Siddha, but if it has negative impact on public health it will disgrace the discipline
and the loss will be irreversible.

3. Motivation for research:

Since other faculty members are observing the decision about IP rights, it will
motivate them for conducting further research in future if patent is applied.
Also, if patent is not applied, but further clinical trial of the formulation is
encouraged by IMC, it will motivate other faculty members to disclose their
studies and conduct a complete research which may lead to commercialization if
clinical trial is successful.

4. Academic benefit:
The research if patented will not be available to others for further studies in the
discipline of Siddha or other medical systems.
By encouraging further trial of the formulation, IMC hospital and college will also
get a chance to work on exploring newer technologies.

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 5. Financial returns:
The financial returns are an important factor, but not the sole factor. The
probability of getting the patent is 0.9. Considering the expected returns from the
exhibit are further calculated as follows:

Table 2: Monetary gain

Options Option 1: One-time Option 2: Job work by Option 3: Annual
License fee (INR) registered royalties on sale of
pharmaceutical unit formulation (INR)
(INR)

Accumulated p-0.7 p-0.3 14,054 14,565

Interest over 20,127 30,191
5 years
Year 1 50,000 75,000 4,000 15,000
Year 2 NA NA 20,000 13,200
Year 3 NA NA 20,000 12,000
Year 4 NA NA 10,000 9,000
Year 5 NA NA 4,000 6,000
Total 70127 1,05,191 72054 69765
*Assuming risk free interest to be 7% annually on revenues generated
*excluding the patenting cost of 25,000.

There is a 0.1 chance that the patent is not accepted, which will result in the
financial loss of 25,000. Also, the gains generated are not much significant
compared to the research costs by the institute, which runs into millions.

6. Influence on the Treatment cost:

The formulation, if patented and commercialized, will result in making the

treatment for coronary atherosclerosis affordable and non-invasive.

c) Chosen decision:

Not applying for patent immediately and further “encouraging clinical trial” of the
formulation seems to be the best alternative as per the evaluation criteria.

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III. Implementation
 Dr. Ramkumar should be advised to further conduct clinical trials on human beings:
o to observe the long-term impact on patient health
o expansion of sample base will help to include diverse patients
 Government funding should try to be obtained for Ramkumar’s study, so that he can
carry on his trial. This will also motivate other faculties who are looking at the
decision closely.
 Once a research seems to have been tested adequately on human beings with all 3
stages of trials completed, IMC should look forward to IP protection and
commercialization of the product, as it will result in monetary gain and propagation of
Siddha.