Drug Developers Protecting Their Intellectual Property

¶ … ability of drug developers to protect their intellectual property. The Me-too drugs According to Angell, a Harvard Medical School lecturer, the 'me-too' drugs are being put out in the industry in large amounts. They are similar to the present treatments which mean that they are no better than the drugs that are already present in the market treating a similar condition.

Even seventy-five percent of the drugs that are being approved by the FDA are me-too drugs so there is always a possibility that it can be more effective than the present drugs in the market but as long as they are effective as compared to a placebo, they would always get the approval of the FDA making it difficult for the drug developers to protect the actual drugs (Jones, 2004).

Inflated prices The American industry spends a lot of money on marketing as compared to research and at least every 3rd drug that was marketed by the leaders of the industry were invented by small biotech firms or universities, however they are sold at inflated prices to the public. For example, Taxol which is a cancer drug, was discovered by NIH (National Institute of Health), but it was sold by Bristol-Myers Squibb for twenty thousand dollars a year, which is twenty times more than the manufacturing cost (Jones, 2004).

Market-based pharmaceutical industry The market-based pharmaceutical industry is a bigger factor for the drug developers to protect their intellectual property. Almost forty million people are without insurance while there is a lot of spending on healthcare in the U.S. as compared to other countries. The infant mortality rate and the life expectancy rate are also on the bottom but the system distributes the healthcare as a commodity and not as a social service that the country is doing.

It gets worse when the investing companies compete with each other to insure the people on the lowest costs (Jones, 2004). Describe two strategies now available to drug and device developers in the U.S. to extend their intellectual property exclusivity. The U.S. has the largest pharmaceuticals market in the world and so it provides a large amount of exclusivities related to drugs in the industry which are available to both the generic companies as well as the innovators (Mistry & Maheshwari, 2015). 1.

New Chemical Entity Exclusivity NCE or New Chemical Entity is provided to a new drug that contains a new chemical entity. It offers 5 years of data exclusivity and marketing for the date of the approval of the drug. This prevents the FDA to approve the drug that contains the same NCE for the approved five years. The FDA can approve it after the five years so the results are in the favor of the patentee (Mistry & Maheshwari, 2015). 2.

180-Day Generic Product Exclusivity America provides 180-day exclusivity to the generic applicant because it is against public interest to pay extra money for the drugs that are weakly protected. During that 180 period, no drug with the same generic version can be marketed. Being the first one to get the drug approved is advantageous as it helps the patent to compete for a high priced brand in the market. This.