If you have an invention that would benefit the health of people, medical device founders need to secure both patent and FDA approvals. However, the FDA process may be quite lengthy and eat into the terms of your patent life. Fortunately, there is a process where you can keep your medical device invention protected as long as possible. As a patent attorney with over 20 years of helping medical device companies, we show you the process for seeking a term extension for your medical device patent. Read on to get more life!
Table of contents
- What is patent term extension?
- Process for seeking a patent term extension
- Process for Patenting your medical device
- Utility Patents for Medical Devices
- Provisional Patents for Medical Devices
- Design Patents for Medical Devices
What is patent term extension?
A term extension for a medical device invention is a way to extend the length of time that a patent is in effect. In the United States, term extensions for medical device inventions are typically granted by the Food and Drug Administration (FDA) under the Hatch-Waxman Act.
To obtain a term extension for a medical device invention, the following steps must be taken:
- File a New Drug Application (NDA) or a Biologics License Application (BLA) with the FDA for the medical device invention.
- Obtain FDA approval for the NDA or BLA.
- File a request for a term extension with the FDA. The request must be filed within 60 days of FDA approval of the NDA or BLA and it must include the patent number and the date of expiration of the patent.
- The FDA will review the request and determine whether to grant the term extension. The FDA will consider factors such as the length of time it took to obtain FDA approval and the commercial impact of the medical device invention.
- If the term extension is granted, the patent term will be extended by a certain number of days, usually up to five years.
The amount of time added to the life of a patent when requesting a term extension for a medical device invention can vary depending on the specific circumstances. Under the Hatch-Waxman Act, the FDA can grant term extensions of up to five years for medical device patents. However, the actual amount of time added to the patent term will depend on the specific circumstances of the case.
The FDA considers a number of factors when determining the length of the term extension, such as the length of time it took to obtain FDA approval for the medical device, the commercial impact of the medical device, and any other relevant factors.
It’s worth noting that term extensions are not granted for all medical devices and the FDA has the discretion to grant or deny the term extension request. Additionally, it’s also worth noting that the term extension is added to the remaining term of the patent, not the total term of the patent. For example, if a patent has five years remaining before expiration, and the FDA grants a five-year term extension, the patent would be in effect for an additional five years.
It’s worth noting that term extensions are not automatic and they are not granted for all medical device inventions. The FDA has the discretion to grant or deny the term extension request, and the decision is based on a number of factors. Additionally, it’s also important to note that term extension does not change the expiration date of the patent, but it only extends the term.
Process for seeking a patent term extension
If you have a patent for a medical device, you may be eligible to have it extended. You will need to meet a number of requirements before you can apply. For example, you will need to demonstrate that your product has never been patented before.
Before applying for a patent term extension, you will need to prepare and submit an application to the USPTO, as detailed in the next section. The patent examiner will review the application and decide whether or not to allow the claims. Occasionally, the examiner will reject one or more of the claims. In most cases, the rejection is based on a failure to describe the invention in a sufficient manner. However, in other cases, the rejection may be based on similarity to prior art.
During the patent prosecution process, your examiner will conduct a short search to identify prior art. He or she will also review the application for compliance with the applicable statute. Once the Patent Trademark Office grants your patent, the patent will officially be published.
You can extend the term of a medical device patent if you can show that the patent has not expired. To do so, you will need to submit an application to a USPTO office within sixty days of the FDA’s approval of your commercial marketing application. The patent can be extended up to five years.
Generally, a pharmaceutical patent will not qualify for an extension unless the active ingredient of the drug product is in the final dosage form before administration. This means that you are able to extend the patent on a different component of the product, but only if that component has not been approved before.
When submitting your application, make sure you have all of the information that the Patent Trademark Office requires. You must include details about the FDA’s approval of your product. Also, you should make sure that you have the correct expiration date for your patent.
When calculating your patent term, you will need to calculate the length of time between your filing date and your earliest priority date. Then, you will need to use this to determine the date of your patent’s expiration. If you want to increase the length of your patent, you can either choose to apply for a patent term extension or a continuation patent.
When applying for a patent term extension, you must remember to include any relevant information about the FDA’s approval of your product. For example, you can extend your patent if you can show that you have been granted permission to use the product in food-producing animals or that you have been given approval for a new salt or ester of an acid that was previously approved.
Process for Patenting your medical device
Utility Patents for Medical Devices
Utility patents cover an invention. Anyone who discovers a useful invention is eligible to receive a utility patent. Utility patents are often granted for new methods and mechanical inventions. They also cover new compositions of matter or processes.
Each year, the USPTO receives more than 500,000 patent applications. These applications are mostly nonprovisional utility patent applications. These applications are reviewed by a patent examiner before being issued if they satisfy certain patentability requirements.
There are many types of patents for medical devices. A utility patent is the most common. It focuses on how the device functions.
Patents may be granted for medical device software. The software must be unique and not easily copied. Functionality is also a requirement. It must also meet FDA requirements for medical devices. It must, for example, be able to track data and perform more functions than just calculate. It will not be eligible to receive a patent if it doesn’t meet the FDA’s requirements.
When drafting a patent request for a software device, it is important to take into account the eligibility criteria for patentability. These criteria were set by the United States Patent and Trademark Office. Patent eligibility is only possible if the invention is novel, useful, and unobvious.
The USPTO published guidelines for mobile apps. To be eligible for a patent, an app must have some type of “inventive idea”. Apps must include a novel, non-obvious technology.
To draft a mobile patent application that has a high likelihood of being granted, it is important to clearly and precisely describe your invention. To help explain the invention’s operation, you should include technical details and drawings.
It is important to make sure that the claims in the application are clear and specific enough to distinguish the invention from prior art.
The inventor must swear or make a declaration when filing a nonprovisional utility application. This declaration can be made using either PTO/AIA/01 or PTO/AIA/08.
Before you start to draft your application, it is important to thoroughly search the prior art. This will help ensure that your invention is original and not already known.
A patent attorney can help you with the drafting of a mobile patent application that meets all patent eligibility criteria. It can be difficult to obtain a patent for a medical device. It can also be costly. It is recommended that you seek legal advice before considering patent protection.
Provisional Patents for Medical Devices
A provisional patent is a type that lasts one year for medical device software. This allows the inventor to evaluate the invention and decide if it is worth filing a full patent application.
If an invention is patentable, the inventor can sell the patent to a third party. The process can be complex. Before you begin the process, contacting a patent attorney is a good idea.
A provisional patent covering medical device software can also be called “patent pending” (or a “design patent”). Patents that protect the design of a device can also be used to protect its exterior design.
These medical devices include instruments and equipment for surgery, drug delivery systems, and patient monitoring devices. Software solutions are often used to develop these types of products. The software can be used for tracking health information as well as hospital management, staff allocation, and staff allocation.
A provisional patent is a good option for anyone who wants to patent medical device software. The first is that it’s cheaper. Because the United States Patent and Trademark Office, USPTO (USPTO), does not examine provisional applications, you will pay less for a Patent than for a complete non-provisional one.
A provisional patent also preserves rights while you decide whether to file a full patent request. This allows you to test your invention and determine its worth without having to pay for a patent.
Provisional patents can have negative side effects. They may not offer complete protection. You won’t get full patent protection if you aren’t clear on the scope of your invention. You won’t get a priority date if your invention is only partially disclosed.
Design Patents for Medical Devices
Understanding the patent landscape is essential for medical device manufacturers. This can assist them in improving their designs. It can also give insight into the competition in the space.
Design patents are sought by most medical device companies. These patents cover both the design and graphical interfaces of the device. This protects a company against a competitor copying a design.
For medical devices, utility patents can also be granted. These patents are granted to inventors who have created a useful product or process. The invention must be original and not already known by the applicant.
A patent examination can be complicated and time-consuming. Hire an expert to speed up the process. You might be able to get a provisional patent if you don’t have the funds to hire an outside patent attorney. This will allow you to file your patent application within one year. After one year, the patent can be converted to a non-provisional.
To protect the visual elements of a medical device, a design patent can also be obtained. It is less frequently used than a utility patent.
Mobile medical devices have seen a surge in popularity due to the COVID pandemic. These devices can be designed in a way that is attractive and makes them easy to use. These customizations can be used by companies to distinguish their products from others.
Medical device manufacturers have the ability to create innovative products. They must also protect their intellectual property. They must protect their intellectual property, whether it’s a utility or design patent.