Understanding Medical Device Patents

What is a Medical Device Patent?

Medical device patents legally protect inventions and innovations related to the medical field. Having a medical device patent allows the inventor to protect against another person or company from unauthorized use of the invention. Medical devices generally qualify for utility patents protection, given that they are novel, which means the invention is new and different from all prior inventions and cannot have been previously disclosed. The invention must also be non- obvious meaning that someone of ordinary skill in a relevant field could not have easily made that invention. In addition, medical devices can qualify for a design patent, which protects the device’s ornamental design, such as its configuration and shape. Many applicants apply for a provisional patent, which is a low- cost way to gain protection for up to 12 months before the filing date of a full patent. This also gives the inventor time to test and perfect the invention before filing for a full patent, also called a non- provisional patent. Those granted a provisional patent have the term “Patent Pending” associated with their invention. Provisional patents can be issued on utility patents, but not design patents.

How to Patent a Medical Device

Generally, the process to receive a medical device patent in the United States can be broken down into 6 steps.

1. Decide if the Invention Meets the Requirements to Receive a Patent
For a US utility patent, the medical device must fall within one of the statutory classes, must be novel, and must not have been used in prior art. The invention must also be non- obvious and works the way in which its inventor claims it does and be clearly useful for a specific purpose.
For a US design patent, the medical device design must be for “an article of manufacture,” which means that it is a tangible object made by man. The design must be original and not obviously derived from other designs, the design must have unique ornamentation, and be different from prior art.

2. Prepare to Apply
If the invention meets all the specified criteria, gather the documents and drawings associated with the invention. It is crucial to do a preliminary search of US patents and published applications to ensure that the invention is not already patented. The Patent and Trademark Resource Centers (PTRCs) provide online access to the PatFT (Patents Full-Text and Image) and AppFT (Applications Full-Text and Image) databases. Search through the database using keywords that describe the invention based on its purpose, composition, and use.

3. Submit Application to the United States Patent and Trademark Office (USPTO)
Complete all the necessary forms and follow instructions to submit the application to the USPTO for further review. Necessary application fees will have to be paid at the time of filing.

4. Work with an Examiner
Once the patent application is submitted, an examiner will be assigned to the case and will work with you to determine if your application meets all the criteria for US patent approval consideration.

5. Gain Approval
Once a patent application gets approved, the inventor will be issued a Notice of Allowance, which will list the issue and publication fees to be paid. After that is complete, the patent will be issued to the inventor or inventors and assigned a unique patent number.

6. Maintain Patent Protection
Once patent approval has been granted, make sure to continuously maintain the patent protection and pay all necessary fees. Utility patents generally last for 20 years and design patents generally last for 15 years.

Understanding the Intellectual Property (IP) Landscape

Knowledge of the intellectual property (IP) landscape is an important consideration for understanding medical device patents. An IP landscape is a thorough overview of the current patents and practices in a technical space. Through references, documentation, etc., an IP landscape can show potential legal validity and provide a competitive analysis of the chosen space, as well as uncover “white space,” which are opportunities and gaps in the market. An IP landscape investigates a wide variety of data, such as documents and other useful information that is taken from computer programs, software and machine learning. Patent landscape analysis and research are beneficial to the field of medical device because innovators can look at previous patents and creations and customize and improve existing designs and devices. The customizations can lead to more avenues for new medical devices and companies can use these devices to differentiate themselves from the competition.

Posted in: Medical Device, Quality & Regulatory