What Is The Difference Between Drug Patents And Drug Exclusivity?

When a new treatment modality is developed, the originator of the new treatment has the right to file a patent for the treatment. The role of the patent is to protect the intellectual property of the treatment originator, since the process of developing treatments and testing them through trials is time consuming and expensive.

For the drug to be patented, technical information regarding how it is manufactured as well as its chemical nature has to be provided. If it is truly a novel product and no other patented drug is similar to it, then the originator ends up getting the patent for it. Patents usually last 20 years in the United States, but this can vary depending on the country and drug involved.

On the other hand, exclusivity refers to the system whereby a drug originator retains exclusive rights to manufacture and distribute the drugs for a specified duration. For instance, if you are a researcher and come up with a new drug for a specific condition, you will apply for a patent and also have the rights to market it without any other company producing similar or generic drugs. Exclusivity is one way of ensuring that the drug originator recoups most of the cost of development and research of the drug. Exclusivity periods typically last five years, though this might vary depending on one’s locality.

Once the exclusivity period ends, other pharmaceutical companies can obtain technical information to manufacture variants of the drug. In some cases, the companies doing this have to pay a fee to the originator of the drug before doing so. In this way, the drug originator may get some revenue from the manufacturers of generic versions of their drugs.