Commercialization of a Medical Product It is important to note, from the onset, that patents present the most effective approach to 'locking' the desired market after realizing the fruits of research. This is particularly the case given that the commercialization of medical research in itself brings about a high level of risk to the key stakeholders...
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Commercialization of a Medical Product It is important to note, from the onset, that patents present the most effective approach to 'locking' the desired market after realizing the fruits of research. This is particularly the case given that the commercialization of medical research in itself brings about a high level of risk to the key stakeholders involved in the entire research process, particularly investors.
In the case under consideration, we assume that investors will have a two-year period of market exclusivity, after which the medical research team will lose its patent protection. This effectively means that other companies will be free to manufacture and sell the drug. The relevance of formulating the right strategies to guarantee the profitability of the company after the two-year period cannot, therefore, be overstated. The removal of patent holder's monopoly not only promotes, but also encourages competition (Joly and Knoppers, 2014).
There are several approaches that the company could adopt to protect its market share and, hence, guarantee its profitability going forward. To begin with, the company could develop a new version of the drug in question by essentially making changes to the original compound. The new formulation would, in this case, be presented as being superior (from a clinical perspective) to the older formulation (Gupta, Kumar, Roy, and Gaud, 2010).
The company would then apply for a new patent and either re-launch the product as a better version of the original or continue with the same dispensation. In the words of Gupta, Kumar, Roy, and Gaud (2010), "developing and patenting new formulations that promote patent compliance ..., is particularly advantageous for defending against generics and protecting market share.
" While this approach could be very effective in seeking to protect the existing market share, it could also be a costly approach, particularly given that in addition to the application of the new patent, the company would have to conduct new clinical trials. Further, there is still a possibility that the new compound could still encounter some significant competition from the original generic product (Joly and Knoppers, 2014).
Another approach towards the further enhancement of the commercial life of the product is the acquisition of new treatment indications as well as uses (Gupta, Kumar, Roy, and Gaud, 2010). In the words of the authors, "developing new methods of use for identified compounds can be a successful strategy for maximizing research dollars and for increasing the commercial life" (Gupta, Kumar, Roy, and Gaud, 2010). As a matter of fact, quite a number of companies have, in the past, successfully applied this approach.
These include, but they are not limited to Merck's Finasteride - whose patent protection and marketing were founded on its ability to treat and inhibit the enlargement of the prostate (Gupta, Kumar, Roy, and Gaud, 2010). According to the authors, Merck sought additional FDA approval as well as patent protection after the product, at the time marketed as Proscar, was found to be able to treat male baldness. In our case, additional research could reveal new uses for the blockbuster cardiovascular drug.
This, in addition to protecting the drug's original market share, would create yet another new market for the same -- further enhancing the company's profitability. It should, however, be noted that this approach would call.
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