Patent Strategies Like Evergreening Differently Impact The Developing World

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.

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.”

Lionel Bentley and Brad Sherman have, in their book; "Intellectual Property Law” acknowledged that indeed there is tension between competition law and intellectual property law. While discussing the effect of competition law on the exploitation of copyright , they state that a copyright entitles an owner to use the property in a manner which he or she so wishes and that the copyright owner cannot be compelled to apply their rights in a particular manner. This is the exclusivity of a right. They, however, acknowledge that there are circumstances in which competition law may require a property owner to make available the right for use by the public. They state that operators in dominant positions have a special responsibility not to allow their conduct to impair

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

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

Pharmaceutical companies are often able to achieve temporary monopolies from patents granting them the exclusive right to produce and market drug formulations they have developed. These patents are:

Evidently, both the EU and the U.S. enacted special provisions legislative, which extended the pharmaceuticals patents' life. As is the case with America, the Waxman-Hatch Act increased the copyright protection based on name-brand drugs with up to five years, but still it also puts

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

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

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

Another one of Porter’s five forces is the threat of new substitutes, which is the main problem in the generics market. A new firm must be cognisant of the fact that every company in the industry will be able to produce the same

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

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.

This enabled numerous “me too” drugs to achieve satisfactory returns on investment. Imitating a known drug reduced R&D risk considerably, while the marketplace was open to products offering minor advantages such as a more convenient dosage with fewer side effects, but with much the same therapeutic outcome. Generics legislation had a major impact on the industry, providing incentives for innovation and a race to market. The time during which R&D costs could be recouped was drastically curtailed, putting upward pressure on prices. By the end of the 1970s generic entrants and more stringent controls on clinical trials had led to substantial increases in R&D spending.