Posts Tagged: "market exclusivity"

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and “exclusivity” separately. “Exclusivity” refers to exclusive marketing rights granted by the FDA upon approval and was designed to promote a balance between new drug innovation and generic drug competition. Some differences are that patents can be issued or expire at any time – before, during or after FDA approval– while exclusivity attaches upon approval of a drug product. Further, some drugs have both patent and exclusivity protection while others have just one or neither… Make no mistake, it would be tremendously unwise to proceed sans patents. No patent means the generic can enter the market as soon as the FDA exclusivity period expires, and having a patent can extend the exclusivity period to the end of the patent term, often years later.

Globally there are approximately 7,000 medicines in development to treat and cure a wide variety of diseases. Of these, more than 5,000 are in development in the United States. It’s difficult to argue that the strength and success of the U.S. biopharmaceutical industry is uncorrelated with the IP protection available here. It is, therefore, disappointing that the recently negotiated Trans-Pacific Partnership (TPP) Trade Agreement fails to deliver sufficient IP protection for biologics. Much of the continuing controversy plaguing the TPP Agreement surrounds data exclusivity protection for biologic medicines and the future of the agreement may hinge on precisely this issue.