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.
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.
Patent Term Extension
Pharmaceutical companies may have the right to seek patent term extension in situations where delays in the FDA approval process cost the company its ability to exercise its patent rights in the drug. The purpose is to compensate patent holders for the delays that occurred during regulatory review.
An application for patent term extension can be submitted to the Director of the Patent Office, by the patent owner or its agent. There are a few requirements when applying such as:
- The patent must not be expired at the time the patent term extension is submitted.
- The patent term must never have been previously extended.
- The patented invention must have been subject to a period of regulatory review prior to being being marketed or used.
- The patented invention must specifically be recited in the patent claims.
- Patent term extension application must be made within 60 days of obtaining regulatory approval.
When patent term extension is granted, the extension is tacked on to the expiration date of the issued patent. For example, if a patent was filed on January 1, 2000, it would normally expire on January 1, 2020. However, if an extension of two years is granted for the patent, the patent would not expire until January 1, 2022. Patent term extension is capped at an additional five years of patent term.
A Patent Lawyer Can Help With Patent Term Extension
There are a number of nuances when it comes to being eligible for patent term extension and when it comes to applying, a patent lawyer can help with the process. Patent holders should be warned that there are a number of ways that a pharmaceutical patent could be rendered ineligible for patent term extension. Work with an experienced attorney.
 35 USC Section 156.
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