Patent Term Extension: Everything You Need to Know
Patent term extension was created by the Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act. 3 min read
2. What Does It Mean
3. How to Obtain an Extension
4. Interim Extensions
Patent Term Extension
Patent term extension was created by the Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act. As patents do expire, this act allows for an extension of a patent on a product that would have to undergo regulatory approval. The United States Patent and Trademark Office (USPTO) is responsible for determining whether or not a patent extension will be granted; this is done in consort with the regulatory agency that is responsible for the oversight and approval of the product (for example, the Food and Drug Administration, in the case of pharmaceuticals).
What Does It Mean
There are various details and specifics that go into why a patent holder may look to obtain a patent term extension. Among them include:
- If a patent holder is waiting on regulatory approval regarding the safety of the product, a patent term extension may be sought to restore any portion that was lost during the regulatory approval process.
- The above is generally basedupon the length of time the idea or product was undergoing any clinical testing and regulatory review.
- A way by which a patent term extension is calculated is by dividing the time of the testing phase in half then adding the time of the review phase.
- However, this time may be reduced if it is determined that the patent holder did not do his or her due diligence during the periods of clinical testing and regulatory review.
- If you are a patent holder requesting a patent term extension and it is due to a delay in the regulatory review process, you will need to file three copies of your request with the USPTO and pay a fee of $1,120.
How to Obtain an Extension
Certainly, if you are an inventor and feel that you qualify for a patent term extension, you may wonder about how to obtain an extension. Fortunately, it is a pretty straightforward process:
- Within 60 days of the regulatory approval of your idea or product, you will need to file a patent term extension with the USPTO.
- This application must include the length of time you feel the patent needs to be extended, and how you came up with that calculation.
- Additionally, the application for a patent term extension must include information regarding how your idea or product was subjected to the regulatory review process, and any details or activities, thereof.
- Up to four extensions may be requested; however, they cannot extend past one year beyond the original term of the patent.
- You will have from six months prior to the end of the patent term until 15 days after its expiration to file for an extension.
- If the extension is being requested by someone other than the patent holder, such as a marketing agent, the person requesting the patent term extension will be required to provide written documentation, verifying that they have permission to request the extension on behalf of the patent holder.
Can interim patent term extensions be granted for reasons, such as, while you wait for approval for your initial application for an extension? Circumstances under which an interim patent term extension may be granted include:
- If the regulatory review process is going to cause the initial patent term to expire. In this case, the goal of the interim patent term extension is to keep the patent in effect until the conclusion of the regulatory review process.
Much as with any type of patent term extension, interim extensions are also based upon the date of expiration of the initial patent term.
Many people have questions regarding interim patent term extensions as it pertains to newly approved pharmaceuticals from the FDA. Are they eligible for interim extensions? In some cases, the exclusive rights to a new drug, via patent term extensions, can be extended by up to fourteen years. The result of this is much larger profits for the drug company, as they will not have any competition during that time, allowing them to essentially charge whatever they see fit, for their drug. Additionally, it means that there are not going to be any generic (read, less expensive) options for individuals needing that particular pharmaceutical.
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