As research, development and growth continues in medical device and new healthcare technologies, the need to patent ideas quickly is essential. More than 20,000 new medical device patents alone were filed with the United States Patent and Trademark Office in 2014, a number that grows annually.
Medical device and healthcare companies are driven by R&D costs and rely on patents to monetize these investments. But often, even the most experienced doctors, PhDs, and engineers find the patent process daunting and procrastinate to their detriment.
Filing early and often is the best approach. File a provisional patent application to create a legal “book mark” with the PTO to claim important “first to file” rights. This is better than failing to file at all and having another inventor end up as owner of the patent rights.
A provisional patent also preserves your rights for 12 months which is usually enough time to determine preliminary efficacy, financial viability, and required level of investment. Additionally, the application is kept secret from the world in most cases, and the filing holds your place in line. But, the utility patent must be filed within 12 months of filing the provisional patent application to avoid losing all rights in the invention.
Below are the three items required to conduct a serious patent process:
Understand why you need a patent search. Making sure no one else got there first is vital so don’t wait. Start with a patentability search or, at the lower end of the cost spectrum a patent landscape search, that gives a good idea of what exists in the invention space (sometimes called “white space”). This will turn up inventions and products that may compete with or preclude your own application which is important as you consider the next steps. Use an experienced patent lawyer to identify prior art will save you time while having their expertise to help you frame the invention in the white space.
Understand the value of the patent. Whether a medical diagnostic product, patient device, or another healthcare solution that is a brand-new invention – having an issued patent will give you the exclusive right to prevent others from making, selling or using the patented claimed aspects of the invention. This allows the inventor to monetize the invention, become the market leader, and prevents others from making or selling a product that infringes. The potential for financial gain is generally what drives the decision to file for a patent including:
— Manufacturing and selling the product or device. This is the traditional route where an inventor or the inventing company invents, makes and sells its own invention.
—Selling or licensing the rights to another company: Your growth may benefit more by licensing the product versus development and self-implementation.
— Cross-licensing: Patent owners can engage in cross-licensing after a patent is issued. It’s an exchange of rights to use patented material between two or more parties to allow incorporation into a complex device that requires both inventions, or functions more effectively with both inventions. Note that since a patent can be “an improvement on… “ an existing device, patent or not, you would have the underlying patent rights in the patented invention you have improved. In this case, the owner of the underlying patented device would need your permission and licensed patent right to use your improvement with their invention.
There are two types of patents that would be relevant in the medical and healthcare industries. These are design patents and ultility patents. Design patents cover the appearance of a product, such as ornamental shape and styling. Design patents are less expensive, providing less protection. Yet, a design patent can fill a gap in protection where you might not otherwise be able to obtain a utility patent. In contrast, a utility patent covers the functionality of an invention and will cost more money to file as it provides ownership of the invention’s functionality which is critical in the medical device and healthcare fields to generate ROI.
The patent process is often an adversarial one where patent applications are sent back to the applicant with initial rejections by the PTO for adjustment or argument before being granted.
Know the process and be prepared every step of the way!
Thomas Dunlap is Managing Partner of Dunlap Bennett & Ludwig, PLLC, a leading corporate and intellectual property law firm based in the Washington, DC metro area. He specializes in patent, trademark, trade secret, commercial, entertainment law, business and government contracts disputes, litigation and transactions. For more info visit: www.DBLLawyers.com and on Twitter @DBLLawyers.