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Biotechnology

Student’s Name

University

Research and Development Marketing

This paper will discuss the research and development of the new product. Over the number of years our organization has been producing drugs, and in this particular case the team used to generate insulin for diabetic patients, but it has decided to launch a new type of insulin that will be administered through a transdermal patch instead of the traditional method of injections. Therefore the research and development department has been mandated with the responsibility of trying to test, develop manufacture and market this particular project (Sender, 2002). 

Legal Patents

To succeed in this particular venture, this organization will have to ensure that it has been granted patent rights with a view to developing this venture. The patent rights will ensure that this organization has exclusive rights over this new medication. However, in order to gain these rights, the organization will have to carry out extensive research on this venture. To begin with, this cannot be described overall as a new product since insulin has been in existence for some years; this particular development mainly focuses on developing a new method of administering insulin to the body of the patient. Therefore the organization will have to test this new method before launching it officially.

However, the team should put into consideration the fact that the cost of production may be a lot because each stage of development has its requirements that may be different from the other stages. In addition to this, the cost of developing this particular product may come at a surprising cost commonly referred to as opportunity cost. The opportunity cost in this particular case will be the reflection of the expected returns that the organization will have generated if it could have stuck with the injection method. The rise in the cost of production in this particular case is expected to be high due to the current developments in the field of technology being experienced in the pharmaceutical industry. Secondly, the time taken to develop this particular venture may be lengthy and thus increasing the cost of coming up with this particular product.

Also for this organization to be granted the patent rights, it must ascertain that this particular method will be safe for patients to avoid damages and injuries. This will be through the conducting some tests to affirm its safety. Therefore this development should be in a position to bring out some results. To begin with, it should be in a position to ensure that the insulin is absorbed into the bloodstream as expected. Secondly, this development should not alter the normal function of the body that is it should not interfere with the normal metabolic reactions to a significant level; the interferences should be within the accepted levels. Also, this method should ensure that the insulin will be metabolized in the correct manner. Lastly, this development should proof to be toxic free. These tests can be conducted on computational models or live specimens.

Secondly, the organization should try the effectiveness of this product by the use of healthy volunteers. This test can be carried out on a small number of people with the aim of assessing the risk associated with the use of the transdermal patch. The use of volunteers will help in testing as to whether this new method has any side effects on the body of the patient. If at this stage the transdermal patch will be successful, then the organization will try and use a minute faction of the patients. The use of patients’ will help in determining if the development of the transdermal patch should proceed. If active, the organization will try and use it one a much large scale. This stage will be one of the costliest states. Also to being costly, this stage will also be the longest. The amount of time taken will be used to guarantee that the transdermal patch will be of high quality.

After these various tests and confirming that this new method is safe for use, the organization will be required to submit an application to the NDA and the FDA to seek approval. However, this will not be a guarantee that the process has been successful because the FDA will still request for extra research to approve its use. The above measures will ensure that this organization is given patent rights over the transdermal patch.

The acquisition of patent rights will ensure that this organization will acquire a system of the intellectual property thus making the chances of efficiencies and transaction to escalate. Secondly, the patent rights will provide motivation for more innovations that are highly needed to fight diabetics. Also, patent rights will allow this organization to come up with the much-needed capital for innovation and also for inventions. Patent rights will also enable this pharmaceutical organization to determine the procedure to be followed in the development of this particular design. Patents will also help to in the elaboration of a patent portfolio. This will greatly help this organization to meet its production requirements.

Patent Infringement

To avoid a patent infringement, the group should try and formulate a licensing deal that will give this particular organization the right to use, produce and sell the transdermal patches. This will be achieved by this company having an exclusive license since it will permit this organization only to provide the transdermal patch.

To come up with a patent, this organization will be required to document this innovation. That is the organization should keep records showing the modification and also all the aspects of this particular invention. This means that the organization should be able to describe how it was able to formulate this particular idea. Documentation of these individual efforts can be used as evidence to this particular invention. Secondly, the organization should be in a position to affirm that this particular device is qualified to be termed as an invention. This can be secured by the demonstrating the functionality of the transdermal patch. Lastly, this organization should conduct a thorough patent search to ensure that no any other pharmaceutical organization has a product that resembles this one or is the same as this one.

Coverage

The transdermal patch aims at being supplied to people who have diabetes. This innovation aims at ensuring that people with diabetes get contact to medication, provisions and other medical supplies required in improving their health conditions. Therefore one can easily say that this innovation will be an important tool in ensuring that people living with diabetes can lead a healthy life and also it aims at reducing the cost of medication for such individuals. This will in return help these patients to live a longer productive life. The use of transdermal patch will be of significant benefits in case a patient is in an emergency situation that could have otherwise been impossible to handle with the injection method (Fishman, 2014). 

Additionally, the use of this innovation will help reduce the pain that comes along with the use of needles when treating diabetes. In conclusion, the use of this innovation will contribute to cover a large percentage of people living with diabetes; this will be because it will be a great innovation in the field of medicine due to its attractiveness when compared to the other methods of treating diabetes. Additionally this change aims at covering people suffering from liver diseases, and still, they have diabetes. The use of the transdermal patch will help reduce the first pass effect. The use of injection frequently leads to an early metabolism of the insulin and thus weakening it by making it less useful (Jakkrit, 2010). 

The concept behind this particular innovation is mainly to help people suffering from diabetes live better lives and healthy lives because the previously used methods of treatment have been known to be ineffective in most of the cases due to the fact that people living with diabetes tend to resist insulin administration through the use of injections because of the side effects associated with the use of needles (German, 2000). 

Marketing

Having developed this product this organization will have to make contracts that will enable it to sell this product and get the expected profits. This particular organization can get into a contract with other marketing agencies that will be able to market this particular product to the target market. However, before getting into a contract, the organization will have to define its target market to the marketing company to develop a better understanding of this particular product. Contracting will enable this team to develop a good sales plan that will include the sales goals, the sales activities, the target accounts and also the timeline that will be required to market this product entirely. Also contracting will help this organization build its market, and through this, the organization will be able to gain the much-needed confidence when it comes to the marketing of medical products (Fishman, 2014). 

However, caution should be taken, and the group should try dwelling more on non-disclosure agreements. This is because such arrangements are the best when it comes to the protection of crucial information regarding the development of this particular product. Secondly, this type of understanding will help this organization keep the rights of this particular group thus upholding this organization’s patent rights. Therefore a non-disclosure agreement is one of the best ways of ensuring that any confidential information regarding the transdermal patch is protected. Lastly this organization should consider seeking help from the legal system in order to ensure that this particular invention is not used in any other setting. Therefore the involvement of the right legal team will ensure that the ideas of this particular organization are protected. In addition to this the organization can decide to set up contractual measures in order protect their secrets and also in order to ensure that they are not exploited by other interested shareholders.

References

Fishman, S. (2014). Consultant & independent contractor agreements. Berkeley: Nolo.

German, M. (2000). Everyday legal forms and agreements made e-z. Deerfield Beach, FL: Made E-Z Products.

Jakkrit. (2010). Patent rights in pharmaceuticals in developing countries : major challenges for the future. Cheltenham, UK Northampton, MA: Edward Elgar.

Ladas, S. (1975). Patents, trademarks, and related rights : national and international protection. Cambridge, Mass: Harvard University Press.

NoAuthorFound. (2009). Securing intellectual property : protecting trade secrets and other information assets. Burlington, MA: Butterworth-Heinemann/Elsevier Syngress/Elsevier.

Sender, M. (2002). Cross-border enforcement of patent rights : an analysis of the interface between intellectual property and private international law. Oxford u.a: Oxford University Press.