When issuing a compulsory license, the effect is to exempt the user who produces the patented substance or uses technology from liability of infringement. If a patentee applies for a patent for a newly discovered or an alienated substance, or a synergy of entities, she is not required to disclose the “know-how” to the public. Therefore, she can retain the information undisclosed as trade secrets. Ordinarily, companies use patent and trade secret protection together in a synergistic manner to enhance exclusivity as a common strategy. As a result, if the user of a compulsory license does not comprehend the know-how, then the production of the final product would eventually come to naught. Under the situation of a …show more content…
Nonetheless, arbitrariness is inevitable due to analytical difficulties faced by examiners and courts. Without setting up a utility model, examiners and courts are plagued by hindsight bias in the U.S., let alone to say having a sub-requirement as such. Section 3(d) of the IPA is also designed to narrow the scope of patent protection, notwithstanding it has a definite goal — preventing evergreening. Section 3(d) also utilizes an explanatory note to delimitate special conditions of nowadays pharmaceutical practices. This thesis considers an explanatory note is a workable solution to comply with the non-discrimination obligation under article 27.1 of the TRIPS.
2. The Capability of the Patent Office The Indian Patent Office (IPO) has full authority under law to determine what is patentable and what should be excluded from patentability if the condition set in section 3(d) is met. Owing to no patents granted to pharmaceutical substances before the amendments coming into effect, the Indian Patent Office received 8,926 mailbox applications prior to January 1, 2005. For the blank period of no protection for nearly 35 years, the capability of the IPO examiners to review and evaluate efficacy data was in
They have also attacked patent listings in the Food and Drug Administration “Orange Book” and have alleged monopolization through fraud on the Patent and Trademark Office and sham litigation. Yet other cases have condemned distribution agreements as unlawful exclusive dealing. These government actions have led to substantial private class action litigation against the pharmaceutical industry. The FTC has also challenged numerous mergers and acquisitions in the industry over the last decade. One common feature in all of these cases is the need to define a relevant market. In nonmerger cases, the FTC and private plaintiffsgenerally allege narrow markets, limited to a single drug and its generic equivalent in some cases and to generic drugs excluding the bioequivalent “brand-name” drug in other cases. In its merger challenges, on the other hand, the FTC has alleged markets ranging from those based upon a particular chemical compound, to broader markets based upon various drugs’ manner of interaction or dosage form, to still broader markets of all drugs used to treat a disease or condition. In numerous pharmaceutical merger challenges, the government has included in the market not only currently marketed drugs but also other drugs under development, alleging “innovation markets.”
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.
Protection of intellectual property are investments based on acquired knowledge, thought and effort by one or multiple individuals on behalf of themselves, the business they work for when the property is created, and a financial investment. Each of these – acquired knowledge, thought, physical effort, financial investment – have a value that can be attached as it relates the usefulness or importance of the resulting product. That value will have a level of importance to the individual(s) creating the product and if applicable, the investor providing the funds in support of the creation.
Under TRIPS, a nation may decide to exclude pharmaceutical patents if it determines they are immoral.
Proponents of patent reform largely focus on the cost of patent infringement litigation to the U.S. economy and companies. While some argue that the type of patents issued should be limited in order to uphold the intent of Article I, Section 8, others claim that standards for issuing patents should be strengthened in order to reduce the number of costly patent infringement lawsuits. The cost of litigation and standards for issuing a patent is the focus of the proceeding text and justification for patent reform in the United States.
In 2004 Mayo Collaborative Services and Mayo Clinic Rochester (Mayo) announced that they would be releasing a diagnostic test that utilizes thiopurine drugs to treat autoimmune diseases. Mayo’s announcement came after they had purchased and utilized similar diagnostic tests based on Prometheus Laboratories, Inc. (Prometheus) patents. After Mayo’s Prometheus sued Mayo claiming patent infringement. This paper will examine the Mayo Collaborative Services v Prometheus Laboratories, Inc. case that refers to the patent infringement law. We will examine both sides of the case by exploring Diamond v. Diehr, Mackay Radio & Telegraph Co. v. Radio Corp. of America, Bilski v. Kappos, and Parker v. Flook’s relationship with the case. This paper will ultimately conclude in favor of Mayo because Prometheus’ patents effectively claim natural laws and are therefore not patent eligible.
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.
It is intended both to provide thumbnail descriptions of the various intellectual property regimes to economists working in this area and to indicate where additional economic research might be useful. The other papers in this symposium provide important examples of ongoing research on the economics of intellectual property. Suzanne Scotchmer analyzes the complex effects of patent protection when innovation is cumulative. Rather than analyzing situations in which several firms vie to develop the same innovation-the approach of the "patent race" literature-her analysis examines circumstances in which only one firm can develop an initial innovation but others can also build upon it. She focuses on how the incentive to develop both the initial and subsequent inventions may be affected by the scope of patent protection. Janusz Ordover considers ways of adjusting the patent system that may help to both provide returns to the inventor, and encourage the diffusion of the innovation in the economy. His paper is part of a line of work that explores the place of the intellectual property system among the large number of institutions that affect the amount and nature of research and development that takes place. In the final paper, David
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.
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
In 1970 the government passed two new regulations that has effect on the pharmaceutical industry. “The India Patent Act prohibited
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.