Key Takeaways

  • Medical device patents are essential for protecting innovations and securing competitive advantages.
  • Devices must be novel, non-obvious, and useful to qualify for patent protection.
  • There are three primary types of medical device patents: utility, design, and plant patents—with utility patents being the most common.
  • Timing is critical—delays in filing can result in loss of patent rights due to public disclosures or foreign filings.
  • International protection requires separate filings or use of the Patent Cooperation Treaty (PCT).
  • Medical device patents can be part of a broader intellectual property (IP) strategy, including trade secrets and trademarks.
  • Freedom-to-operate (FTO) analysis is crucial to avoid infringing on existing patents.
  • UpCounsel can connect you with experienced patent attorneys for help throughout the application process.

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 a 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.

Types of Medical Device Patents

Medical devices can be protected by three primary types of patents, each serving a different purpose:

  1. Utility Patents: The most common form, these protect the way a device functions or is used. For example, a new type of catheter or implantable sensor would likely qualify for a utility patent.
  2. Design Patents: These protect the ornamental design or appearance of a medical device rather than its function. This can be critical for devices where form impacts usability or market appeal.
  3. Plant Patents: Rare in the medical field, but applicable in cases involving genetically modified plants used for pharmaceutical purposes.

Choosing the correct type depends on the nature of your invention, and in some cases, multiple patent types can be used for different aspects of a single product.

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 protection in other countries. You will need to file for a medical device patent in every country where you want to protect your invention.

Patent Application Timeline and Strategy

Timing and strategy play a critical role in the success of medical device patents. Delaying your application can risk losing exclusive rights due to prior public disclosures or competing filings. Here’s a general timeline for U.S. patent filings:

  • Provisional Application: Often the first step, offering 12 months of “patent pending” status without the formal requirements of a utility patent.
  • Non-Provisional (Utility) Application: Must be filed within 12 months of the provisional to claim priority. This starts the official USPTO review process.
  • Patent Cooperation Treaty (PCT) Filing: If international protection is needed, a PCT application can extend the filing window in multiple countries.

Companies should file as soon as the invention is fully conceived and before any public disclosures occur to preserve rights globally.

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.

Freedom to Operate and Patent Searches

Before launching a product, companies must ensure they have the “freedom to operate” (FTO). This means their device does not infringe on existing, enforceable patents held by others.

A comprehensive FTO analysis involves:

  • Searching existing patents in the U.S. and relevant international markets.
  • Assessing claims of related patents to identify overlap.
  • Consulting legal professionals to interpret ambiguous or broad claims.

Failing to conduct an FTO analysis can result in expensive litigation or the need to redesign products post-launch.

International Patent Protection and the PCT

Medical device companies often operate in global markets, making international patent protection essential. U.S. patents offer no protection outside the U.S., so companies must either file directly in each country or use the Patent Cooperation Treaty (PCT).

Benefits of the PCT include:

  • A single international application process.
  • Up to 30 months to enter national phases in over 150 participating countries.
  • Delayed costs and strategic market entry decisions.

However, enforcement still depends on national laws, and each country’s patent office must ultimately approve the patent.

Patentability Criteria for Medical Devices

To qualify for a patent, a medical device must meet three fundamental criteria:

  1. Novelty: The device must be new and not disclosed in prior art.
  2. Non-Obviousness: It must represent a significant technical advancement that wouldn’t be obvious to someone skilled in the field.
  3. Utility: The device must have a specific, substantial, and credible use.

The application must clearly describe the invention and include drawings if necessary. Ambiguous claims or insufficient detail can lead to rejection.

Integrating Patents into Broader IP Strategies

Medical device patents often form part of a more comprehensive intellectual property (IP) strategy. Other protections to consider include:

  • Trade Secrets: Useful for proprietary manufacturing methods not easily reverse-engineered.
  • Trademarks: Protect your brand name and logo associated with the device.
  • Copyrights: May apply to software or user interfaces integrated into a device.

A layered IP approach enhances market protection and can increase company valuation, especially during investment rounds or acquisitions.

Frequently Asked Questions

  1. What qualifies as a medical device for patenting purposes?
    A medical device includes any instrument or apparatus intended for medical use in diagnosing, preventing, or treating conditions. It must be novel, useful, and non-obvious.
  2. Can you patent an improvement to an existing medical device?
    Yes, improvements that offer a new and non-obvious function or design can be patented independently of the original invention.
  3. Do medical device patents automatically allow you to sell your product?
    No, a patent gives you the right to exclude others from using or selling your invention, but you must also comply with FDA regulations and other legal requirements to market it.
  4. How long does it take to get a medical device patent?
    On average, it takes about 2–3 years to secure a utility patent from the USPTO, depending on the complexity of the application and the USPTO's backlog.
  5. Is international patent protection automatic with a U.S. patent?
    No. You must apply separately in other countries or use the Patent Cooperation Treaty (PCT) to seek broader protection.

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, Menlo Ventures, and Airbnb.