The Pros And Cons Of Drug Patents

There is a long standing debate on whether generic drugs are as effective and safe as the branded drug. A brand name drug is a medicine that is discovered, developed, and marketed by a pharmaceutical company and is protected by a patent. A generic drug is said to be a bioequivalent of the branded drug and does not have a patent by it self and is manufactured and marketed only after the expiration of the branded drugs patent. Brand name drugs are well known and trusted but are expensive. Generic drugs are less expensive than the brand name drugs but drugs are not always trusted by the people. How ever, the final decision to choose a brand name drug or a generic drug involves both the patient and the health care team.

According to Howland(2010),

The average cost of this entire process is estimated to be $800 million to $1 billion. This includes the cost of thousands of failures. For every 5,000 to 10,000 compounds, that enter the research and development, only one receives approval. Once the drug is approved by the FDA, the pharmaceutical company can apply for a patent. A patent provides the company, the right to exclude others from making, using, selling, or importing the patented invention. In the US, patent provides a protection of 20 years, but it is applied from before the beginning of clinical trials. So the effective life of a drug patent could be between 7-12 years. Once a patent is obtained, the pharmaceutical company enjoys a period of market exclusivity or monopoly, during which the company is able to set the price of the drug so as to maximize profitability. This high price can help the drug company to make a significant profit on their investment in research and development. Generic drugs cannot be produced legally until the patent has expired or the generic company certifies that the brand companies patent is invalid or in countries where the patent is not in force. Once the patent of the branded drug has expired, any pharmaceutical company can manufacture and sell that drug and hence generic drugs come in to play, which prevent the branded drug company from dictating the overall

Food and Drug Administration (FDA), "generic drugs are identical or with in an acceptable bioequivalent range to the branded drug with respect to pharmacokinetic and pharmacodynamic properties." Two drugs are said to be bioequivalent, if their rate and extent of availability after administration are similar to the extent that their safety and efficacy can be expected to be same. This implies that the generic drugs are identical by dose, strength, route of administration, safety, efficacy, intended use and they have the same active ingredient. Law requires the generic drug manufacturers to prove the bioequivalence of their drug with the branded drug and the range of bioequivalence should be between 80%-125% of that of the branded drug. Bioequivalence does not necessarily mean that the generic drug should be pharmaceutically equivalent to the branded drug and some chemical differences may exist. According to the Hatch-Waxman Act, an applicant should file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration and demonstrate the bioequivalence of his generic drug with the branded drug in order to get an approval. FDA , approves the drug, if it feels that the generic drug is bioequivalent with the innovator drug. Hence all the marketed generic drugs are bioequivalent with the branded drug and are therefore safe and effective as the branded drug. But in some cases, generic drugs may show some undesirable effects which are not seen