Monday, June 12 2023   \  Published by JD Supra.

What is a Patent Term Extension and How Do I Get One?

What is a Patent Term Extension and How Do I Get One?

For some types of inventions, such as new and nonobvious pharmaceutical compositions, securing a patent from the federal government is only half the battle. In addition to obtaining patent rights, pharmaceuticals and other compositions that might be consumed by humans are required to undergo a review process conducted by the Federal Food and Drug Administration (FDA).


Patent rights prevent others from making, using, selling or importing the patented invention. But patent rights are only enforceable for a set amount of time (twenty years from their filing date), and the prosecution of the patent application can take a number of years on its own. But even if a patent is issued for a novel pharmaceutical composition, that does not mean that the pharmaceutical company can immediately go sell the product. New pharmaceuticals cannot go to market without FDA approval.

The FDA approval process for new pharmaceuticals can be complicated and can take many years to complete. All the while, the lifespan of the patent on the new drug is getting shorter and shorter. If the FDA takes too long to provide approval of the new drug, the pharmaceutical company effectively loses out on the commercial exclusivity that its patent rights afforded to it concerning the sale and licensing of the new drug. Read more

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