Patent Laws And Its Legal Justifications

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

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.

Some pharmaceutical companies are feeling grief from a decline in research slump but the issues are more serious in reference to the United States intellectual property laws on which these same companies need to inflate their profits. Maybe the focus should be on an idea that came about several years ago. Give drug patents a shorter term of 15 years but don’t start the clock until the FDA approves the drug.

U.S. based companies hold rights to most of the world’s rights on new medicines and holds thousands of new products currently being developed. As of 2012, the industry helps support almost 3.4 million jobs in the U.S. economy. It is also one of the most heavily R&D based industries in the world. In the United States, the environment for pharmaceuticals is much friendlier than other countries around the world in terms of pricing ability and regulations. Both the Pharmaceutical and Biotechnology industries have experienced significant growth in the past year with year-over-year increases of 13.02% and 34.69% respectively. It is an even more striking when looking at the past five years considering both have beat out the S&P 500 with pharmaceuticals increasing an additional 31.44% and the biotechnology sector besting an astonishing 269.3% more return than the

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.

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

This casebook concentrates on the negative effects that the pharmaceutical industry’s trade and production policies have on third world nations suffering from disease epidemics. My position is that pharmaceutical companies are not concerned with the health benefits of their drugs, but rather with the market that their drugs generate. I illustrate this notion by describing the trade policies that pharmaceutical companies influence and the pharmaceutical companies’ production policies which concentrate on producing life-style drugs rather than drugs that cure life-threatening diseases.

I selected the oral argument in the United States Supreme Court case Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., No. 13-854 (argued, October 2014). This argument was presented on October 15, 2014. First I will provide a summary of the prosecution history behind this case. Teva Pharmaceuticals USA created a multiple sclerosis drug called Copaxone and subsequently obtained a patent for the drug. Sandoz Inc. desired to create a generic version of Copaxone and submitted their request to the Food and Drug Administration. In 2012, Teva sued Sandoz in the U.S. District Court for the Southern District of New York on the grounds of patent infringement. The District Court then considered the patent through claims construction by examining the patent’s plain language and its prosecution history. Then, the court examined expert testimony and the public record to the patent in order to see if the terms were definite. The

Acquiring patents for inventions in the chemical and pharmaceutical industry is a major part of my work here at Technology Law, PLLC. Chemical patents differ from other types of patent because of the high research costs involved and the risk in bringing new drugs on to the market. It is specialized work and I have years of experience in doing it. Patent protection lasts for 20 years from the date of its first filing, and in the US patent rights are enforced by litigation in federal district courts.

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

Pharmaceutical companies had been reluctant to provide drugs to developing countries at reduced prices because of concerns around distributing drugs in unregulated and unreliable environments. They argued that this could create new drug-resistant

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.