If you are interested in learning more about prior patent term extension filings, the USPTO and FDA provide some helpful links, which are provided in this post. Two ways that the term of a patent can be extended* are PTA and PTE: 1) Patent Term Adjustment (PTA) is based on delays during patent examination by the USPTO, and 2) Patent Term Extension (PTE) is based on the time it takes a drug from getting the OK from the FDA to start clinical trials to the date of approval as long, minus any time a drug sponsor did not act with due diligence during the clinical trial/FDA review process. With respect to PTE, patents can be extended for up to 5 years. See Table 1 below for the basic requirements for eligibility for PTE.
We were doing some research recently related to the status of a PTE filing. We found it helpful that the FDA and USPTO each provides a web site with links to apparently identical spreadsheets that list pending and granted PTEs. You can find the FDA web site containing the PTE spreadsheets HERE. The USPTO web site containing the PTE spreadsheets is HERE. As of the writing of this article (7/4/23), the FDA web site provided all PTEs filed and approved as of May 2023. There were 982 PTE certificates granted as of May 2023.
The actual status of any application that are not approved as well as any of the relevant filing documents, can be found in the USPTO's Patent Center by searching based on the patent number.
TABLE 1 Requirements for eligibility:
The patent claims a product, a method of using the product, or a method of manufacturing
The patent has not expired
The term of the patent has never been extended
The application is submitted by the owner of record or its agent
The product has been subject to a regulatory review period before its commercial marketing or use
No other patent has been extended for the same regulatory review period (i.e., only one patent can be extended per approved product)
* Technically PTE is a misnomer, as the extension is only for exclusivity rights that relate to the approved product whose approval is the basis for the PTE, not for the legal right to block other methods and compositions that fall within the claims of the "extended" patent (See MPEP 2750).
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This post is not legal, tax or investment advice. Please seek professional guidance from a licensed US patent attorney before relying on any information in this post.
Post published on 7/4/23 by EJV