The Pharmaceutical Patent System Is Good For Patients - Article Example

Student’s Name: Instructor’s Name: Course Code: Date Assignment is due: The Pharmaceutical Patent System Is Good for Patients Pharmaceutical Patent A pharmaceutical patent is a typical patent for any novel invention localized to the pharmaceuticals industry. As is the norm in most jurisdictions around the world, the pharmaceutical patent is the same as the chemical patent in terms of legal requirements while seeking a patent for a novel invention. A pharmaceutical patent cannot be classified as a sui generis (special patent type) (Bently and Sherman 213-215). Most experts concur that patents gain a particularly important when it comes to the pharmaceuticals industry. Unlike in other areas of invention, pharmaceutical patents usually protect large investments by organizations as opposed to individual inventions. Generally, patent protection bears a great significance on the commercial survival of any company (Pressman 174-188). Pharmaceutical patents are especially necessary in the industry because they make development of new drugs possible. Pharmaceutical patents act as the core instrument protecting originator/inventing companies against their competition/generic companies. The maxim behind the patents is basically simple. The originator companies, also called inventor companies, invest millions of dollars in researching a disease, developing its medicine, marketing the drug and supplying it to the sick. This has been the path taken by most innovative drugs in contemporary use (Schechter 34). It therefore becomes essential to protect these investors when they finally develop a valid drug so as to provide a justifiable reward for their innovation, a return on their heavy investment and incentives for their future research in innovative medicine (Cook 84-87). Most countries however have a limit to which a patent allows the monopoly of the patented discovery to be accessible to the originator or inventor. Once the patent protection expires, an originator company usually loses its exclusive rights to the manufacturing and marketing of the patented medicine. Without the exclusive rights to the invention of the drug, many generic manufacturers enter the pharmaceutical market with numerous medicines more or less equivalent to the novel medicines once under pharmaceutical patent. The minimal investment that generic manufacturers have to it drug versions helps in lowering the counter prices of these drugs significantly. Allowing a patent to expire after some considerable time is meant help contain the public health budgets affordable. It also helps to increase the consumer welfare besides creating incentives for the companies to commit to further innovation. Today, patents in both the pharmaceutical and the chemical industry feature a valuable source of bibliographic and technical information (Durham 143-161). Pharmaceutical Patent System Of all users of the patent system in a country, the pharmaceutical sector is among the most patent reliant. Records in the US patents registry as well as in other parts of the world indicate that very few new chemical products are approved for patent annually. In fact, the number has been declining over the years (Grubb 261-273). Nonetheless, we have thousands of patent applications meant to protect variant products derived from an existing product, a patented manufacturing process or even second indications of an already patented pharmaceutical product. A patent system is the collection of national laws that grant patents to players of a particular industry. The patent system usually confers the exclusive rights of production, marketing, sale and even use of any patented subject matter to the inventor/originator. The system is used to legally restrain market competition for the originator for a determined amount of time, to allow them recoup and gather returns for their investment to research and development of the product (Wegner 234). This is more applicable in the pharmaceutical patent system where emergence of competitive drugs would totally ruin the inventing companies. The amounts required to research and develop a new drug are irrecoverable in the face of competing products, which can easily be derived from the original drug and produced at a fraction of the cost. The pharmaceutical patent system thus gains its core purpose in the justifiable need to encourage huge investments towards developing new drugs (Thomas 131-177). The pharmaceutical patent system has substantial effects on the competitiveness of the industry. These effects trickle down into determining prices of essential medicines, availability and distribution. The pharmaceutical patent system is thus a relatively controversial criterion in many nations, especially the US. Great considerations must be made when examining the applications for pharmaceutical patents since, each patent granted gains an extremely important effect on public health policies. Unlike other types of patent systems whose only effect only concerns the industrial policy, patents in the pharmaceutical industry have far reaching effects to the health and quality of life the populace enjoys. A Critic of the Pharmaceutical Patent System Recent debates on the pharmaceutical patent system have been very heated. There is an increasing need for policy makers, especially those in the health area and even patent examiners as well to be consciously aware of the effects that each of their decisions in granting of a pharmaceutical patent has to a nation’s public health sector. Whenever the pharmaceutical patent system helps grant and enforce patents on innovative drugs, there is a direct consequence suffered by the health of the people in that nation. As such the ranging debates concerning pharmaceutical patent systems, mainly focuses on drugs pricing effects of the patents, fair and affordable access of the masses to quality health care. The debate has actually come into the fore and given a lot of media attention consequent to the worldwide attention focused on the threatening growth of the HIV/AIDS pandemic. The United Nation’s lead specialized agency mandated with the management of intellectual property standards and issues in the international realm, World Intellectual Property Organization (WIPO), has patroned if nor stirred this debate in recent years (World Health Organization). The most vocal opponents of the American pharmaceutical patent system for instance, believe that the system has lead to the exploitation of the American people. According to this school of thought, patents in the pharmaceutical sector create a monopoly of vital drugs by some individual market players (Harmon 819-932). This in turn limits the treatment options the patients have since there is lack of alternative prescription drugs in the market. It also leads to high prices for medications even among terminal patients of such conditions as cancer. The monopolistic response of patents in the sector helps manufacturers to keep their drug's price very high and uncompetitive (Malempati 2010). This is especially so in America because the pharmaceutical patent system gives a monopoly in a free market setting where the companies themselves determine the pricing for their products without a form of pricing regulation. While their concerns are understandable though, the arguments projected by the school of thoughts are not tenable. In Africa today, some drugs such as those treating HIV/AIDS are not protected by patents and yet they are still exorbitantly high in prices. In numerous jurisdictions around the world, such as the UK, the prices of patented drugs are regulated. The UK Pharmaceutical Price Regulation Scheme ensures that in all cases, the National Health Service can purchase innovative drugs at justifiable reasonable prices (European Commission). In the Canada context, the Patented Medicine Prices Review Board regulates drug pricing by comparing the prices proposed by a manufacturer to those of seven developed nations so as to avoid excessive pricing. Yet even when drug manufacturers are required by law to submit their proposed pricing to regulatory agencies, the prices always compare to those within the American market. Conversely, therefore, the American pharmaceutical patent system cannot be entirely blamed for high prices of drugs. An objective review of the system will reveal that the patent protection is the singular reason that we have some of the most essential drugs in the market today. Pharmaceutical products are especially important than those of other industries mainly because their manufacturing process can easy be replicated and copied with minimal investment that does not in any way compare with the amount invested in researching and clinically testing a new drug (Schwartz 79-86). The offer of exclusive rights to a new drug has helped safeguard and motivate companies to boot the extensive long-term cost necessary in the production of new pharmaceutical product. The only reason why the private sector is willing to invest in pharmaceutical innovation is not that they want to alleviate sickness among the masses, but that they want to make a profit on their investment. The public sector is unable to sponsor such extensive research and production required in the innovation of new drugs. Patients living in and out of a country with a pharmaceutical patent system owe their innovative drugs to that system. The US pharmaceutical industry has been vibrant and very instrumental in the entire world, mainly because of the strong patent system combined with market free conditions without price controls (Scholer 514-574). Without even trying to defend the pharmaceutical patent system against such charges as unfair effects on pricing and accessibility to medications, it is evident that without the system, very few medications would be available for the public to access. To an extent, national and international governments realize that their only guarantee in keeping medical research and pharmaceutical innovation at its edge is if the patent system is put in place and enforced to the maximum. For patients, it is deductively better for medication to be available, albeit at a high price, than if the drugs are unavailable. Conclusion Rather than exploit the poor, a national pharmaceutical system actually benefits the disadvantaged members of the society (Correa 34-35). The system provides incentives for investors, inventors, entrepreneurs and top cream researchers to study the diseases plaguing the masses and come up with a curative drug. The fact that pharmaceutical industry spends billions and billions of dollars in research and drug development expenditures should indicate the impossible situation that countries would be put under if the patent system were removed. There are some nations of the world that cannot spare a dollar for research and they rely on patented drugs acquired from elsewhere to treat their population (World Health Organization). A robust pharmaceutical patent system is good for patients. From every angle you look at it, the adequate protection given to innovative drugs originators has been the crucial and indispensable incentive to inventive and ground braking treatments of the recent past (Bale and Harvey 95). By creating an attractive commercially viable environment, the patent system stimulates new innovative drug research, facilitates better healthcare for the masses, creates jobs, sustains economic development in the nation (foreign exchange earnings from exported drugs), breaks the poverty cycle, improves education standards and leads to higher living standards. Works cited Bale Jr. and Harvey E. “Patent Protection and Pharmaceutical Innovation”. 29 New York University Journal of International Law and Politics (1996-97), 95. Bently L. and Sherman B. Intellectual property law. Oxford: Oxford University Press, 2001, 213-215 Cook, Trevor. A User's Guide to Patents. London: Butterworths, 2002, 84-87. Correa, Carlos. Trends in drug patenting. Buenos Aires: Corregidor. 2001. 34-35. Durham, Alan. Patent Law Essentials: A Concise Guide. New York: Quorum Books, 1999. 143-161. European Commission. ‘Pharmaceutical Sector Inquiry, Preliminary Report.’ DG Competition Staff Working Paper, 28 November 2008. 5 Grubb, Philip. Patents for chemicals, pharmaceuticals and biotechnology. Fundamentals of Global law, practice and strategy. Oxford: Clarendon Press, 1999. 261-273. Harmon, Robert. Patents and the Federal Circuit. New York: Bureau of National Affairs, 2006. 819-932. “IMS Health”. Market Report. 09 March 2010. . Malempati, Siddhartha. “Patent System - Who benefits?” Free Software Foundation, Tamil Nadu. 09 March 2010. . Pressman, David and Stim Richard. Nolo's Patents for Beginners. Richard Stim, Berkeley: Nolo, 2006. 174-188. “Public Health, Innovation and Intellectual Property Rights.” Commission on Intellectual Property Rights: World Health Organization. 09 March 2010. From Schechter, Roger. Principles of Patent Law. New York: West Group Publishing, 2004. 34. Scholer, Kaye. Pharmaceutical and Biotech Patent Law. New York: University of Minnesota, 2008. 514-574. Schwartz, Herbert. Patent Law and Practice. New York: Bureau of National Affairs, 2005. 79-86. “The Impact of Essential Drugs”. World Health Organization. 09 March 2010. Thomas, John. Pharmaceutical Patent Law. New York: Bureau of National Affairs, 2005. 131-177. Wegner, Harold. Patent law in biotechnology, chemicals & pharmaceuticals. Chippenham: Stockton, 1994. 234. Read More