Pharmaceutical Patents Essay

Patents refer to exclusive property rights to the intellectual creation of the humans. Patents are forms of intellectual property. The property rights under patent exist only as provided under the laws of a given sovereign state. Thus, these rights can always be enforced to the extent to which they apply under the provided laws which they were made. However, patents often have a validity period of about 20 years from the date of issue. Thus, any new product, process description or an article of manufacture in the patent application must be something that has never been disclosed previously anywhere across the world (McCarthy et al., 2006, p. 446). The patented ideas must not also be obvious to be solved by any ordinarily skilled individual of the given skill set. Determination of the authenticity of any given patent application is always done through comparison with the existing public literature in the field as well as the previously issued patents. The process of determining the authenticity of the patent application is known as examination and is often done to ensure that no one can claim the patent rights after that. Despite all these, in the pharmaceutical industries, the off-patent drugs often find their way into the market.

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The patent application must often include more claims, with each claim defining a given right. Each of these claims must also meet the relevant patentability requirements which provide for usefulness, novelty, and non-obviousness (Schneider et al., 2016, p. 4392). The exclusive rights enclosed in a patent often cuts across every country in which the protection is made to prevent other individuals from using, manufacturing, importing, selling or distributing the ideas for commercial gains without the permissions of the owner. Patents across the globe are administered by specific organizations such as the National Patents Offices found within every country, The World Intellectual Property Organization (WIPO), and the World Trade Organization (WTO). Inventions across the world are often patented before being released to the market regardless of the technology used. However, the patents often vary from technology to technology. In fields such as consumer electronics, patents are often shared among competitors. Chemical compounds such as pharmaceuticals, on the other hand, are exclusively patented and not licensed to others (Alfonso-Cristancho et al., 2015, p. 9). For this reason, the patents in the pharmaceutical industry often equal the product.

The innovation span and spectrum of the engineered plants used in the pharmaceutical industries varies. The industry varies extensively from that of computers and electronics. Computers and electronic industries are characterized by patent pooling and sharing of trade secrecy with the competitors to accommodate the government as well as the industrial standards. In pharmaceutical industries unlike other product producing industries, the patented products can be easily as well as cheaply replicated by the generic copiers with minimal investment regarding capital (Schneider et al., 2016, p. 4397). Most capital investments in the chemical compounds industries such as pharmaceutical industries are often directed towards the laboratory research as well as clinical trials. Thus, skipping this step often adversely reduce the capital investments to any copier of the patented product. For this reason, according to WIPO (2018), patent exclusivity becomes the only effective way of protecting and ensuring maximum return on the pharmaceutical investments. However, on the expiration of the patents, another pharmaceutical often produce a generic of the original drug, which is cheaper and easily available in the market.

The operations of pharmaceutical companies follow that any new development of a drug to counter a condition will be sold under a brand name that will help the clinician prescribed it to the patients. However, these drugs are often protected under the patents. Meaning, only the manufacturing pharmaceutical company has the exclusive rights for manufacturing, production, and marketing of the drug. Nonetheless, like other patents, the pharmaceutical patents are also awarded for 20 years in most countries across the globe such as the United States. However, according to Correa (2016), in some countries, the period varies depending on the laws of the land and the nature of the drug. Often, these pharmaceutical companies apply for patents before the clinical trial aimed at accessing the drug's safety as well as efficacy. Thus, after approval, the patent period is often reduced to a period of seven to twelve years making it easier for the production of the cheaper off-patent drugs.

On the patent expiry, any pharmaceutical industry is often at liberty to manufacture, produce, and sell these drugs. The freedom of production of these drugs by other companies often reduce the selling cost since their production process is not inclusive of the laboratory tests. The drugs produced by these other companies are often referred to as the generic drugs. Most countries across the world including those from the US FDA, similarly apply the generic drug to the branded drugs regarding their safety, efficacy, route of administration, usage, pharmacodynamics, and pharmacokinetics (Dunne and Dunne, 2015, p. 173). The production of the generic off-patent drugs is always permissible on various conditions. Some of these conditions include the expiry of patents, certification by the patents rights owners that the patent is unenforceable or invalid and would not be infringed upon, lack of any existing patent on the given drug in the market, and jurisdictions in which the drug has not been patented (Millum, 2008, p. 25).

If the generic drug has been introduced in the market, the monopoly of the patents right holder on the given drug is often removed. The removal of such monopolies results into competition followed by significant drops in cost. The generic drugs have been essential across the globe as they have been instrumental in ensuring the lifesaving as well as other vital drugs reach every individual mostly composed of the poor population across the world at competitive prices (Dunne and Dunne, 2015, p. 173). However, companies holding such patents always have the power to renew the patents to form a new version of the drug which is often composed of different formulas as compared to the original compounds. Nonetheless, other companies often counter the production of such drugs through producing them in the countries which the patents have not been effected maintaining the percentage of the generic and off-patent drugs in the market to be at ninety-five percent.

According to Dr. Ananya Mandal, (2010), the renewal of patents by the patent holders is always seen as an expensive process in the long run as it always includes the re-application process involving extensive examination and the new clinical trials for the certification of the efficacy and the safety of the drug. Also, the process is not always cost effective as the newly patented, and compounded drug may always have to compete with the original as well as the existing generic drugs in the market. Thus, the validity of the patents and the challenges facing the renewal of the patent as well as the reproduction of a new form of the drug have contributed significantly to the increase of the generic drugs in the marketing asserting the sustainability of the thesis statement and the given scenario.

References

Alfonso-Cristancho, R., Andia, T., Barbosa, T. and Watanabe, J.H., 2015. Definition and classification of generic drugs across the world. Applied health economics and health policy, 13(1), pp.5-11.

Correa, C.M., 2016. Guidelines for pharmaceutical patent examination: examining pharmaceutical patents from a public health perspective. UNDP, New York, DOI, 10.

Dr. Ananya Mandal, M. (2010). Drug Patents and Generic Pharmaceutical Drugs. [online] News-Medical.net. Available at: https://www.news-medical.net/health/Drug-Patents-and-Generics.aspx [Accessed 16 Apr. 2018].

Dunne, S.S. and Dunne, C.P., 2015. What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs. BMC medicine, 13(1), p.173.

Millum, J., 2008. Are pharmaceutical patents protected by human rights?. Journal of medical ethics, 34(11), pp.e25-e25.

Schneider, N., Lowe, D.M., Sayle, R.A., Tarselli, M.A. and Landrum, G.A., 2016. Big data from pharmaceutical patents: a computational analysis of medicinal chemists' bread and butter. Journal of medicinal chemistry, 59(9), pp.4385-4402.

McCarthy, I.P., Tsinopoulos, C., Allen, P. and RoseAnderssen, C., 2006. New product development as a complex adaptive system of decisions. Journal of product innovation management, 23(5), pp.437-456.

Wipo (2018). [online] Available at: http://www.wipo.int/wipo_magazine/en/2005/05/article_0006.html [Accessed 17 Apr. 2018].