What is a Patent Term Extension?

If you’ve applied for a patent, you should know that patents don’t last forever. Utility patents, for example, have a patent term of 20 years from the date an applicant applies for a utility patent. The patent office currently has a backlog of 550,000 pending patent applications.

So, in some circumstances, it takes the patent office longer than usual to either grant or deny a patent application. If the patent office takes unusually long to grant a patent application, an applicant may be able to extend how long his patent lasts with a patent term extension. So, what exactly is a patent term extension? We will cover this below.

What is a Patent Term Extension?

According to the USPTO, a patent term extension allows patent applicants to restore (extend) the patent term that was lost due to delays caused by obtaining approval from a regulatory agency. The patent office typically grants patent term extensions for pharmaceutical patents that lose much of their patent term while an applicant is waiting for regulatory approval from a governmental agency.

Said differently, if it takes the patent office too long to grant a patent application, the patent office may extend the life of a patent if the delay was caused by the applicant having to obtain regulatory approval from a government agency, such as the Food and Drug Administration (FDA). Patent term extensions are granted to make up for the lost time that it took to obtain regulatory approval to obtain a patent.

Patent term extensions are usually granted for applicants seeking to patent pharmaceutical drugs. Patenting pharmaceuticals often takes between 7 to 12 years, depending on how long it takes for the FDA to approve a new drug or pharmaceutical. That said, patent term extensions are also granted in situations where the patent office takes too long to grant a patent on things like medical devices for humans and pharmaceuticals for pets.

When Must an Applicant Submit a Patent Term Extension Application?

According to the USPTO, to obtain a patent term extension, the patent applicant must submit a patent extension application to the patent office within 60 days of the regulatory approval agency completed its review of the product (invention) to be patented.

For example, if the regulatory approval of a new glucose monitor or glucose pill was completed on January 1, 2020, an applicant must submit an application to extend the term of the patent within 60 days, meaning no later than March 1, 2020, for this example.

Note: An applicant cannot submit a patent term extension application until the regulatory body has completed its review of the product you’re in the process of patenting.

So, what do applicants do in the situation where regulatory approval can extend beyond the life of a patent. For example, if an applicant has submitted a patent application for a new drug and he expects that the FDA will take longer than the patent term (20 years), he can file what is known as an interim extension. Filing an interim extension allows applicants to extend the patent term until the regulatory body completes its review of your product.

Requirements to File a Patent Term Extensions Application

For a patent holder to extend the term of a patent, the patent must have not have expired before a patent holder submits a patent term extension application. Also, to submit a patent term extension, a patent holder must have never extended the term of a patent under 35 U.S.C 156.

That said, not anyone can submit a patent term extension application, either the patent holder or the patent holder’s authorized agent must submit the patent term extension application.

Additionally, if you know or anticipate that you’ll have to file a patent term extension application, do not commercially market or pitch your product to others before filing a patent term extension. We say this because qualifying for a patent term extension requires that an applicant not have commercially marketed the product before regulatory approval. There are a few exceptions to this rule that this article does not cover.

What Information Must a Patent Term Extension Application Contain?

For an inventor to extend the term of his patent, the term extension application must include the following:

• An application must identify the product (medication or medical device) that was waiting for regulatory approval from a governmental agency, such as the FDA,
  
  
• An application must include the federal statute that requires regulatory approval,
  
  
• An application must identify the patent that the patent holder wants to extend,
  
  
• An application must identify all of the claims for the approved product,
  
  
• An application must include a brief description of the applicant’s activities while the product was pending regulatory approval

How Long Can the Patent Term be Extended For?

We know that the patent office can extend the patent term to compensate the patent holder for delays that occurred while the patent holder is waiting for regulatory approval of his product, but for how long can the patent term be extended? According to U.S Patent Law, a patent term cannot be extended for more than 5 years, regardless of how long it took the regulatory body to review the invention.

For a patent holder to obtain an extension, the delays in obtaining regulatory approval must not have been caused by the patent holder. The patent holder must have acted with due diligence during this period to obtain an extension.

How Much Does a Patent Term Extension Cost?

According to the USPTO, a patent term extension costs $1,120. The fee is the same for micro-entities, small entities, and large entities. The fee must be paid to the USPTO upon filing a request for a patent term extension. Unlike almost all other requests and filings, a patent term extension request cannot be filed online, an applicant must prepare a paper application and file it with the patent office.

Remember that the person filing the patent term extension should be authorized to do so by the patent holder. To satisfy this requirement, it’s advisable that the application include a letter that details the source of the filer’s authority to file the application.

How Long is the Life of a Patent?

In the United States, utility patents last for 20 years from the date an applicant files his patent application with the patent office. It’s important to note that some of the patent term is eaten up by the amount of time it takes the patent office to grant a patent.

On average, it takes the U.S Patent Office 24 months to approve a patent application. That said, don’t panic if it takes the patent office longer than 24 months to approve your patent applications because some applications take longer and some take less, depending on the complexity of the invention. The point is that, for most utility patent applicants, 2 years of the 20-year patent term is lost due to the amount of time it takes the patent office to examine and approve a patent application.

Should the Patent Office Allows Inventors to Extend the Life of Their Patents?

The answer to this question depends on who you ask. We agree with the patent office in that patent extensions should be granted to inventors who often wait 7 to 10 years waiting for approval of their invention by a regulatory body such as the FDA.

It would be unfair to inventors who invent products and processes that require regulatory approval to lose much of their patent term because the government took too long to review their invention.

Having a mechanism in place to extend the patent term in situations where an applicant is not responsible for the delay helps place the inventor on equal footing with other applicants who invent things that don’t require regulatory approval.

Without having patent term extensions, inventors would not have the incentive to research and develop products that require regulatory approval. Some of the most important categories affected by regulatory approval are those involving medications and medical devices for both humans and animals.

So, allowing inventors to extend the term of their patent, incentivizes them to spend the time and money researching and developing new inventions. This is so because inventors will be able to recoup their investment and profit from their invention in the same manner that other inventors are able to do so.

Patent Term Extension

As you may know by now, a patent term extension allows inventors who develop products and processes that require regulatory approval to extend the term of their patent. Some products, such as medicine, pharmaceuticals, and medical devices require regulatory approval by bodies such as the FDA. This approval takes time and often reduces the patent term (patent life) of a product.

Therefore, to make an applicant whole, the patent office allows inventors to file a patent term extension request to extend the life of the patent. There are some rules that must be followed to qualify for a patent term extension and we covered the most important rules. That said, if you have any general questions or comments, please feel free to leave them in the comments section below.