Case Analysis of Dr Narendran's Dilemma
Autor: Adnan • August 24, 2018 • 1,581 Words (7 Pages) • 919 Views
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- 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.
- 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.
- 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.
- 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.
- 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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- 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 License fee (INR)
Option 2: Job work by registered pharmaceutical unit (INR)
Option 3: Annual royalties on sale of formulation (INR)
Accumulated Interest over 5 years
p-0.7
p-0.3
14,054
14,565
20,127
30,191
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.
- Influence on the Treatment cost:
The formulation, if patented and commercialized, will result in making the treatment for coronary atherosclerosis affordable and non-invasive.
- 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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- Implementation
- Dr. Ramkumar should be advised to further conduct clinical trials on human beings:
- to observe the long-term impact on patient health
- 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
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