Biotechnology in Malysia : Medicinal Patent Essay

In “Patenting Life,” Michael Crichton argues that the government is mishandling the patenting office with the awarding of patents for human genes. Gene patenting is blocking the advancement of modern medicine and could be costing many patients their lives. The hold on research results in the discovery of fewer cures for modern diseases.

Chapter 25 – 1976-1988 – This chapter details the history of patenting living organisms — 1980 Supreme Court ruling which declared that Ananda Mohan Chakrabarty could patent a bacterium genetically engineered to consume oil and to help clean up oil spills.

Under TRIPS, until a pharmaceutical patent is actually granted, a country has no obligation to protect potential prospective rights (during the pendency of the

Secondly, it reduces the time for patient’s evaluation. Due to DTC, drug companies are rarely encouraged to research and evaluate the effect of drugs on patients. The companies do not research enough to evaluate the side effects of drugs before the drug administration. This will cause crucial damages to patient’s health. Same is the case facing by PharmaCARE who had to face negative consequences of drugs because the company was having lack of research before administrating the drug. Due to direct marketing, patents do not feel the need for taking doctor opinion and take self-treatment which sometime cause risk to patients life.

Pharmaceutical companies also defend the costs because of the patent laws. When a patent expires, a generic drug can be made and sold for lower cost. "Although

This industry has monopolized drug distribution to sustain and control high cost of the brand name prescription drugs. These brand name drugs were covered under patent protections, which stipulate that only that pharmaceutical company awarded coverage can manufacture, market and eventually profit from that specific drug. As long as the patent protections exist, these drugs cannot be sold as generic brands by other companies. The regulations outlined in the PPACA, however, challenged these patents to allow a more competitive field, thus dropping the cost of drugs and sales of brand named prescriptions. This lowered the revenue of high cost drugs and opened accessibility for lower cost options. The PPACA continued to further impose regulations, even on biologic pharmaceutical products. These products, which are versions of the original biologic products “that have the same mechanism of action in the body and are used for the same clinical indication but are not identical to the original product (variously referred to as the reference, pioneer, or innovator product)” (Health Policy Brief, 2013, para 5).  The reform also included the Biologics Price Competition and Innovation Act (BPCIA), which encourages to allow competition, as the regulation of the patent protections, in the market for biologic

The owner of a patent covering a manufacturing method for a multiple sclerosis drug brought an action against marketers of a generic version of the drug, alleging infringement. The marketers filed counterclaims seeking declaratory judgment of non-infringement, unenforceability, and invalidity.

In 1970 the government passed two new regulations that has effect on the pharmaceutical industry. “The India Patent Act prohibited

Ideally a patent is not supposed to give monopoly over an idea to an inventor unless the idea is useful to the public. Thus, a gene should be shown to be capable of being useful to the public in the form of new products or treatment, before anyone should be able to patent it.

Patents give intellectual rights to a person or a group of people that invent something. Patents fuel innovation because they give a temporary monopoly to the inventor that received the patent. Otherwise, the originator of a product may not receive the credit, more specifically, the financial reward for creating something useful and sharing it with the world. This applies to medicine just as much as anything else. Pharmaceutical companies spend enormous amounts of time and treasure to research and develop new, effective and safe medications to

A patent is an exclusive right granted for an invention, product or process that provides a new way of doing something, or that offers a new technical solution to a problem. An invention in general must fulfill certain criteria in order to be protected by a patent. For example, the Patents Act, 1970 in S. 2(1) (j) defines invention as a new product or process involving an inventive step and capable of industrial application. In other words, an invention in order to be patentable must show an element of novelty, must show “an inventive step”, and must be of practical use. Particularly, the Patents Act, 1970 defines “inventive step” as a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art. In other words, patent rights are not available for new advances that are merely obvious extensions or modifications of prior designs. Besides, the requirement of difference over prior art, there is a requirement to establish the extent of common general knowledge that exists while

Techniques, like “[plant] cell culture, recombinant DNA [deoxyribonucleic acid] technology and cellular cloning, [would] now provide us with new ways to tap into natural diversity”(Seidler para. 3). To put it another way, biotechnology could provide new medicines. New medicines could eliminate side effect and eradicate repeated visit for injection in treatment for diseases or cancer(Christopher para. 4). Therefore, limiting biotechnology would hinder the process of creating new medicine. Medine would not be the only one affected in the medical field, but in addition, diseases could be

Therefore, protection of patents is one of the key conditions necessary for further development of the pharmaceutical industry. At the same time, non-efficient legislation that does not provide the necessary level of patent protection is one of the factors that hamper expansion of “Big Pharmaceutical” companies to the developing countries8.

A compulsory license is an authorization given by a national authority granted without the permission of the patent/IPR holder. Historically speaking, a compulsory license can be invoked on one of the various grounds, and should be issued on a case-by-case basis. Using compulsory license is one of the flexibilities retained under TRIPS, and hence permitting Member States to determine the appropriate circumstances within certain limits. Particularly, compulsory licensing provisions in India have been under criticism regarding compliance with international treaties. The Indian Patent Act does not confine the grounds to public health needs only. The grounds and types of compulsory license under the Indian Patent Act are listed in Table 3 succinctly. This part would discuss the failure of working (non-working), the especially contested grounds in the following passages.

The concept of product patent for pharmaceutical products is likely to make life saving medicine beyond the reach of the poor and deprived section of the society around the world.