Competition within the U.S. pharmaceutical industry is very high. With less elastic demand than for other industries, profit potential is enormous. Demand is more inelastic as prescription drugs are necessary for many individuals with illnesses such as diabetes and high blood pressure. Within the industry, there are two types of manufacturers: brand name and generic. These groups compete not only among one another, but with each other as well. Brand name pharmaceutical companies often try to, and succeed in preventing or delaying approval and circulation of generic equivalents. The most common tactic used is a reverse payment settlement agreement, otherwise known as “pay-for-delay”. Generic firms promise to delay the circulation of their …show more content…
On the other hand, generic companies’ primary activities include developing, producing, marketing, distributing, and gaining regulatory approval for generic drugs (Philips, 2014). While generic companies do engage in research and development (R&D), it’s goal is to create similar drugs that the brand name manufacturer just patented. If successful, the generic company files an Abbreviated New Drug Application (ANDA) for approval and must make a certification against each patent by the brand name manufacturer. To do this, the generic company must make a Paragraph IV certification which states that the patent is invalid or will not be infringed by the generic product (Fitzpatrick, Cella, Harper & Scinto, 2012). In a reverse payment settlement agreement, brand name pharmaceutical manufacturers provide compensation to generic pharmaceutical manufacturers in order to settle the challenge to their patent. In order to receive the compensation, the generic company must agree to drop its patent challenge and is restricted from marketing and distributing its product for some stated period of time. These settlements act as patent extensions, providing the brand name firm with more monopoly time on a drug. Reverse payment settlement agreements appeared as an unexpected result of the Hatch-Waxman Act of 1984, which
Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and
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.”
In the video Escape Fire, I was so flabbergasted by the numbers and health outcomes we as a society have let our nation become. One of the most heart-wrenching evidence is, even though our health care industry is so expensive our health outcomes are the worse. 75% of disabilities and dead’s are preventable, according to the film.
So companies that are about to face that competition have big incentives to delay the entry of new generics to the market -- and to erect obstacles to switching to the cheaper upstarts. Even a few months' delay in a generic's entry can salvage billions in revenue for the makers of a blockbuster pioneer
Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.
Recently, there had been a controversy over the rise in pharmaceutical costs involving the EpiPen in the United States. The EpiPen, also known as adrenaline/epinephrine, is a widely used injection that is used to treat allergic reactions. This generic drug has been available for many years. The EpiPen controversy is a prime example of how monopoly
While this case is literally full of negative aspects, we will only focus on the main points for both arguments. Pharmaceutical companies want to be sure that the products they spend years and millions of dollars to create are not easily reproduced and sold at discount prices. The profits pharmaceuticals make of their patented products are supposed to refinance new research. So taking away their exclusive distribution rights and allowing other manufacturers to just copy the product and sell it at
If congress would focus on making generic drugs available the cost of prescriptions would not be as high, and Americans could save approximately $35 billion during the next decade. Compared to $72 a month for brand name drugs, generic versions average $17 a month or 25 to 89 percent lower. Under current legislation original manufacturers of a drug may file multiple lawsuits to prevent other companies from producing a generic version of their drug after the patent runs out. Each lawsuit that is filed delays the production of the generic version by 30 months. If the new bill is passed only one lawsuit will be allowed which would speed the production of generic drugs. The proposed law would also decrease the time it
Federal antitrust enforcers are investigating whether a multinational pharmaceutical company has attempted to minimize the impact of generic competition to one of its most profitable prescription drugs. This antidepressant drug is the company 's best seller, with sales last year of $2.11 billion, representing a 22% increase from the year before. The Federal Trade Commission (FTC) is conducting an investigation to determine whether the company engaged in activities to prevent generic alternatives to the prescription drug from entering the market. Specifically, the FTC is challenging a practice among brand-name and generic drug manufacturers to agree to
When it comes to market access mechanisms, there are many legal entry barriers into the healthcare industry relating not only to the preparation of a portfolio of prototype and innovative medicines but also to the control and determination of the respective prices by the applicable health policies (patents, drug approval process, health facilities, clinical procedures etc.). In contrast, healthcare organizations focusing on treatment for rare diseases face a low threat of potential substitute products (medicines) regarding treatment for rare diseases, whilst they have a strong bargaining power against various industry players that focus mainly in the production and/or distribution of highly marketable drugs and substances. In addition, traditional market access mechanisms relate to a great extent to payer cost control mechanisms and strategic pricing, factors that are mainly affected by market demand and the supply capacity of the healthcare
The main purpose of creating the drug patent is to achieve market exclusivity for the product created. With only select brands of the same drug available it is much easier to market and sell the product. Companies are able to determine their price which allows them to achieve maximum profit. The importance of making a large profit in the pharmaceutical industry is that drug-testing and clinical trials are extremely expensive. In many cases the profit gained by selling expensive products will be allocated for future endeavors such as the creation of a future drug, or of the improvement of the drug already on the market. New research is done every day to find the new miracle drug that will fix whatever illness is at hand (FDA). If the selling price exceeds the production cost, the pharmaceutical companies will continue to receive a large profit. Often the company will choose to continue their research, making advancements to the existing drug, that way it can
Pharmaceutical products are the key element of health systems that helps the community. Despite pharmaceutical being a huge multi-billion dollar industry. This element of governance describes the negative and positive sides of the pharmaceutical industrial parameters.
In recent years there has been much discussion both within Australia and internationally on the extent to which countries benefit from international trade agreements. In this case study we aim to focus on the global context of the pharmaceutical industry, in particular the effect of governmental intervention through the use of international trade agreements, highlighting the problematic patent system and how it affects the market place both internationally and domestically.
High drug prices are the result of the approach the United States has taken in granting government protected monopolies to drug manufacturers. A few short-term strategies to address high prices include enhancing competition by ensuring the availability of generic drugs; and effectively educating patients, physicians, insurers, and policy makers about these choices.
Patent indirect infringement,as the name implies,is opposite to patent direct infringement. Generally, the conception of patent indirect infringement is to meet the need of pantent protection. It expands the protection domain of the patent right to the no-patented products, improves patent protection’s horizontal and provides sufficient legal protection for patentees.