Patents for Medical Devices and Avoiding Infringement

Medical device patents are a method for legally protecting inventions and innovations related to the medical field.

To create a medical device or a diagnostic technique, a person must have an understanding of the natural laws of biology. While most medical inventions are based on these laws, the laws themselves are not eligible for patent. Protecting medical inventions using patents can be extremely difficult, but it is vital for companies to apply for these patents if they want to successfully compete in this field.

Receiving a medical device patent only allows the inventor to protect another person or company from unauthorized use of the device. It does not provide the right to sell the invention, which is only granted after following several other steps. Novelty is one of the primary requirements for applying for a patent. This means that the invention must be brand-new and cannot have been previously disclosed.

For your invention to be novel, it cannot have appeared in prior art. This means your invention cannot have appeared in an advertisement, a patent, or a trade brochure. If the medical device that you have invented has appeared in prior art, then it is not novel and is not eligible for a patent.

Depending on where you are applying for a patent, you may not be able to tell anyone outside of your company about your invention until your patent application has been filed. It is possible to lose the novelty of your invention if you or your company acts improperly, even if you couldn't control these actions. For example, if someone other than you discloses your invention in a prior-art publication, this would be considered outside of your control.

If you want to search for United States prior-art patents, you can reference the U.S. Patent and Trademark Office website.

Inventors are allowed to control the public display of their invention. If your invention is displayed before your patent application is filed, you may lose novelty. Your patent rights can also be lost if you abandon your invention. Your invention is considered abandoned if you fail to file a U.S. patent application within twelve months of applying for a foreign application.

As soon as you have fully developed your invention, you should file your patent application. Before you invest in developing an invention, you should search for patents owned by competitors in your field. The benefit for medical device and diagnostic inventors is that these inventions are not usually challenged, as most challenges are in the business and software fields.

Why Are Patents Necessary for Medical Device Companies?

Companies that invent medical devices must invest a great deal of money in research and development. Medical device patents are useful because they protect smaller manufacturers from larger medical device companies.

The USPTO reported that nearly 20,000 patents were granted in 2014, which represented a tremendous increase from the number of patents granted in 2009.

Securing a patent allows an inventor to prevent others from:

  • Making their invention.
  • Using their invention.
  • Importing their invention.

In most countries, a patent will last for 20 years.

According to the USPTO, it takes 36 months for a patent to be granted after an application has been filed. Unfortunately, patents that are granted in the United States do not provide protections in other countries. You will need to file for a medical device patent in every country where you want to protect your invention.

The Value of Medical Device Patents

The cost of securing your patent can be a tremendous investment, and your costs may increase depending on where you are applying for a patent and the technology involved in your invention. In cases involving a large number of claims or complex litigation, your patent costs can be much higher than normal.

The judgments in patent cases related to medical devices can be significant, with some patent owners being awarded millions of dollars after their device was used improperly. If a judge finds that a person or company has infringed on your medical device, you, the patent owner, are entitled to damages. At the very least, the person who infringed on your patent must pay you a “reasonable royalty” for using your device. Reasonable royalties are payments that the person would have provided if you had licensed them to use your medical device.

If you need help applying for medical device patents, you can post your legal needs on UpCounsel's marketplace. UpCounsel accepts only the top 5 percent of lawyers to its site. Lawyers on UpCounsel come from law schools such as Harvard Law and Yale Law and average 14 years of legal experience, including work with or on behalf of companies like Google, Stripe, and Twilio.