International Laws And Its Effects On Public Health

Critics have pointed a finger at the unethical use of intellectual property in the pharmaceutical industry claiming it is being used to set prices far above what those in third world countries can afford. Given that a good number of the raw material came from these regions, it is unethical to use intellectual property

Some how They are above copy write and patent law; that states that an individual/company can hold exclusive rights for only three years to regain research and development costs and make some profit. This was established so companies/individuals could not establish a monopoly on a product/service letting them completely control the market price. This is some thing that in the rest of the civilized democratic countries is not allowed and drug are part of the free market system. An example of this would be in Canada the same U.S. Company sells its drugs cheaper to compete with prices in the open market and in the U.S. they charge more money because of their monopoly on the drug.

Economic: Globalization of the pharmaceutical industry is an exciting opportunity to have research and development done at cheaper prices in other countries. However, this could be a double edged sword for companies because it is easy for other countries, such as India, to produce generic versions of the drug in bulk.

“The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. What is granted is not the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention. Once a patent is issued, the patentee must enforce the patent without aid of the USPTO” (ALEXANDRIA 1).

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.

After watching the video, I have realized that intellectual rights protection is based on the foundation of R&D investment, which are also the building blocks of the pharmaceutical industry. There is adequate evidence to proof that intellectual rights in the form of trademarks and patents are very significant in the pharmaceutical industry as is compared to any other industry. This may be caused by the fact that copyrights on prescription drugs are a better effective measure for increasing the limitation costs than copyrights on other commodities. The value of copyright protection relies on the duration of exclusivity. Although the lifespan of copyrights is predetermined by international treaty at 20 years from the filing of the copyright application, the actual period between gaining market approval and patenting, the significance of the copyright is much less than 20 years.

If competitor could immediately copy a new drug the long and high cost development process would be less attractive. In order to encourage drug manufactures to have active R&D, prescription drugs are protected by patents (lasting anywhere from 10-14 years based on the contract). These patents create a monopoly for that drug and ultimately the one for the company that produces it.

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

The United States Patent and Trademark Office is overloaded with thousands of applications a year, given an applicant can even get their patent filed. In the pharmaceutical industry, the patent process is in dire need of being reformed. A typical patent last twenty years and the process is a little different when it comes to manufacturing drugs compared to other industries. Partly because in the medical field research is more or less openly shared. However, on the pharmaceutical side the more concealed the better the chances are to get good profitable returns. During the beginning stages of getting a drug to market the drug must be tested and adhere to the Food and Drug Administration’s (FDA) guidelines. An FDA approved drug means that the

The pharmaceutical industry has shown remarkable structural stability as majority of its key players have been in existence for almost a century now. However, it has not been an exception to unpredictable times of the 21st century as it is grappling with quite a number of challenges. The most urgent issues include termination of manufacturers’ rights, importation risks, pricing problems and the infiltration of counterfeit drugs, the cost of R&D and political and administrative constraints notwithstanding. Most of these challenges have existed over a long period and the rate at which they are escalating presents a big threat to the industry.

Technological change moves much faster than bureaucracy, and it is the patent office that must bear the collision of novelty and government – for anyone who wishes to profit from their genius must go there to have their constitutional right to the proceeds from it verified. Exactly what technology can be patented in this day and age, as our bodies and proteins become subject to technology themselves, is indeed in need of some clarification.

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

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.

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.