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Obtaining a patent (or patents) for your medical device is the best way to protect your intellectual property from being used by competitors.
If you obtain a patent for your device in the United States, you’re protecting your product in the world’s largest market for medical devices, which is great. However, the US isn’t the only market for medical devices. Furthermore, a patent obtained in the US isn’t valid anywhere else—meaning it doesn’t protect your device in, say, France.
So, if you’re considering moving into another market—like the EU, for instance—you’ll likely want to protect your intellectual property there, as well. And that’s where things get tricky.
Before we get into it, let me just say that this article is just a primer on your options for international patents and should not in any way be taken as constituting legal advice. If and when you’re ready to get a patent, you should speak to a patent attorney with experience in the country you’re seeking to file in.
The first thing you need to know about international patents is that there is no type of patent you can apply for that will cover you everywhere. Each country has its own system for obtaining patents and enforcing them.
So, one option is to simply file a patent application in every country you expect to do business in. If you plan on applying to one or two other countries, this might be the best option for you. Just remember that these patent applications have to be done within one year of your filing date for a utility patent in the US. For a design patent, you’ll need to file within six months of your US application date.
Want to learn more about the difference between design and utility patents? We’ve got you covered in this blog post where we explain how to choose the right one for your medical device.
If you want to file for patent protection in several foreign countries, there are organizations and programs available to help you navigate the intricate system of international patents.
The Office of International Patent Cooperation (OIPC) was founded in 2014, with the stated goal of supporting and improving the international patent system while helping US businesses and inventors protect their patent rights around the world.
The OIPC has a number of programs and services for patent seekers, which include:
Global Dossier - Provides access to the related applications across the five largest patent offices in the world, known as the IP5.
Cooperative Patent Classification (CPC) - The CPC is a joint partnership between the US Patent and Trademark Office and the European Patent Office with the goal of harmonizing their existing classifications and moving toward a common classification scheme.
Patent Cooperation Treaty (PCT) - The PCT is an international treaty that allows businesses to seek patent protection on a device in a large number of countries simultaneously by filing a single international patent application.
Now, the PCT may sound like the elusive “worldwide” patent, but it’s important to note that this is an international patent application. The PCT streamlines the application process, but approval is still given by the individual countries you have applied to through the PCT. Still, it’s a useful tool if you plan to expand into several different foreign markets and know your medical device will need protection in each of them.
In addition to the PCT, there is a European-specific option for obtaining patents in many countries via one application: The European Patent Convention (EPC).
When you file a patent application under the EPC, your application may then be reviewed by the 38 member states of the European Patent Organisation (EPO). Keep in mind, like the PCT application, this does not mean you are automatically granted a patent in each country. It’s simply a streamlined application process. Each member state must still validate your patent individually before you obtain a patent in that country.
The benefit of filing under the EPC is that you only have to submit one application in one language, rather than submitting many applications in the official language of each country. This can greatly reduce the time and expense of obtaining patents in several European countries.
Whether we’re talking about the metric system or medical device regulations, you may have noticed that the US often does things a little differently than the rest of the world. And patents are no exception.
There are a number of differences between the US and other countries when it comes to patenting medical devices that you should be aware of.
In 2013, the US joined the rest of the world in using a “first to file” method for awarding patents. This simply means that if two or more businesses or individuals apply for a patent, the first to file their application for a patent will get it. Before 2013, the US used a “first to invent” method of awarding patents.
To smooth the transition from “first to invent” to “first to file,” the US has a one-year grace period in their patent application system. This means an inventor can file a patent application up to one year after publishing their invention. This grace period does not exist outside of the US. In the EU, if you publicly disclose the invention before filing your application, you will not be able to patent your invention.
To be patentable, a device in the US must be both novel and non-obvious. In the EU, however, the device must be novel and use an inventive step, meaning it solves a technical problem in a non-obvious way. The difference may seem minor, but the EU’s focus on the problem-solution relationship may create a difference between what is and isn’t patentable in some cases.
While medical devices are patentable around the world, there are significant differences between what you can patent in different countries that may apply to your situation as a medical device manufacturer. For example, you can patent methods of surgery and medical treatments in the US, but not in Europe or Japan. And in many countries, a treatment method that includes a surgical step is not patentable.
The takeaway here is that you need to understand the requirements and details of not only the patent application process but patent law itself in the country you’re attempting to patent a device in. That’s why we recommend getting a good patent lawyer and talking to folks who have been through the process before.
If you’re looking for help making decisions around international medical device patents, I’d recommend talking to the Torrey Pines Law Group. The patent attorneys at Torrey Pines are regarded as some of the foremost experts in securing and defending international IP rights for medical devices, and we’re proud to have them in our Greenlight Guru partner ecosystem.
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Laura Court is a Medical Device Guru and Mechanical Engineer who loves learning about new technology and sharing her experiences with others. She has experience in New Product Development and Manufacturing with both small and large companies. Having managed products through their full product lifecycle into post...