How to patent a medical device?

How To Patent a Medical Device?

Many physicians have engaged in R&D to remodeling devices, neurostimulation devices, and cardiac rhythm management devices. But few only have surpassed the eye of a needle. The problem with most medical inventions stems from the standard of care and marketable demand in the healthcare space. 

Nowadays, there has been increasing demands for obesity management & bariatrics, ophthalmology & eye care, nephrology & dialysis equipment for urology and incontinence, and glucose monitoring & insulin infusion, and wound care.

That’s why with combined experiences and a solid background in Freedom to Operate Process and Intellectual Property Management, the Medical Device Patent Attorneys in Bold Patents lead your desire for the marketability and patentability of your medical invention – aiming to provide the best IP strategies in the medical field. 

What Are Some Examples of Medical Device Patents?

medical device

Check out our full length guide on how to patent an idea here!

The biggest challenge for a physician-inventor is to surpass the Criticisms of Intellectual Property in patenting medical devices. More often, societal views on intellectual property defeat the marketability of a physician’s medical device invention.

Due to rising of novel diseases, some physicians who work in Oncology and Orthopedics have remodeled Surgical Equipments like Prosthetics, Orthotics, Robotics, and Spine for Minimally Invasive and Endoscopic Procedures;

Some physicians have innovated Drug-Eluting Devices and Stents, Valves, & Loading Devices, and Embolic Protection to cure Blood Vessels and support Peripheral Vascular in treating Sleep Apnea; Some physicians have redesigned Sterile Field Devices, and Pacemakers & Electrical Devices, and Biocompatible Polymers and Coating for treating Cardiovascular disease and improving Aesthetic and Implants. 

How to patent a Medical Device

Invention Disclosure or Intellectual Property Disclosure

Medical devices are your intellectual properties. Thus, the first step in patenting a medical device is disclosing your invention, including:

– The technical and specific details of your medical device;

– The sketch or the prototype of your developed invention; and 

– The potential manufacturers or licensees involved in the selling or making of your invention or design. 

Hire a Medical Device Patent Attorney 

Hiring a medical device patent attorney will help you provide an IP strategy to advance your application in a speedy disposition and to protect your IP rights. Since the USPTO strictly enforces a “first-to-file” patent rule, make sure that you can file immediately after your invention disclosure.

Helpful Links:

Blog Article: Questions to Ask a Patent Attorney

Ask for a Legal Opinion 

Your Medical Patent attorney will conduct a patent search in helping you avoid patent infringement. Also, your medical patent attorney will perform an FTO process to identify IP problems and formulate suggestions to advance your application. 

Need an opinion? Book a free consultation today to learn more!

File a Provisional or Nonprovisional Application for your Medical Device

If you plan to market your medical device and technology instantly, then apply for a non provisional application. Here, the patent examiner directly examines and gives the result of your patent application. 

If you’re willing to wait in the queue of applications and claim only an early priority date, otherwise, file for a provisional application.

You can read our article on provisional and non provisional patent difference here.

File the Medical Device Patent Application with the USPTO

As you file your medical device patent application with the USPTO, be reminded to submit the following requirements:

  • Oath/Declaration
  • Information Disclosure Statement
  • Cover Sheet
  • Specification
  • Claims
  • Drawings
  • (optional) Application to Make Special
  • (optional) Patent Cooperation Treaty (for International Filings)
  • Fee Sheet
  • Entity Status Form
  • Application Data Sheet (ADS)

Blog: How to Write and Submit a Patent Application

How long does a Medical Device patent last? 

The IP law provides that the patent duration of a Medical Device lasts for 20 years from the date the application was filed.

How do I license a Medical Device for a patent?

Identify potential licensees.

First, you need to list all the third-party entities which are involved in the commercialization of your medical device invention.

Blog Article: Can Multiple People Own a Patent?

Sign a Patent Non-Disclosure Agreement

A Patent Non-Disclosure Agreement will serve as a legal contract, binding you and your potential licensee, to preserve the disclosure of confidential information in your pending patent application and to protect your Ip rights. 

Deal a Patent License

Under the Intellectual Property Law, there are three kinds of patent license agreements: exclusive patent license agreement, nonexclusive patent license agreement, or solo license. 

If you want to give a single licensee all of the rights to produce, sell, and use the invention, then deal with an exclusive patent license agreement. 

If you desire to transfer Intellectual Property Rights but allow licensors in negotiating and signing agreements with others, then deal with a nonexclusive patent license agreement. 

If you opt to choose privileges between exclusive patent and nonexclusive patent, then deal with a sole patent license agreement. 

Complete a Patent License Agreement

Your Patent License Agreement will help regulate the Intellectual property right of each party – the terms and conditions which covers the following: 

  • Royalties. The patent license agreement will determine the patent royalty rate (percentage of sales), royalty base (gross/net revenue), minimum patent royalty payments (licensor’s compensation in royalty payments each year), royalty payment schedule (system of compensation), and other royalty payments.
  • License Term. The license term in a patent license agreement will estimate the period as to when the licensee is going to work with your patent. Also, it helps determine the triggering events that would lead to the termination or renewal of your license.
  • Annual License Fee. This fee will be the payment of the licensee to the patent owner yearly.
  • Dispute resolution. If for any reason both parties would cause a dispute on patent ownership, the patent license agreement will determine what cause of legal action should be taken.

Blog Article: Marketplace to Buy/Sell Patents

Can a doctor license a patent? 

Patent License Agreement

Yes, but it depends on a given circumstance.

If a physician has solely practiced in the medical service, then he can own all intellectual property rights and Intellectual property protection as provided by the licensed medical device patent. 

But, if the physician works in a hospital, wherein he is bound by an employment contract that stipulates the hospital IPR policy and Opposition practices in the acquisition of patented inventions, then the hospital has a share or partakes of the rights of the licensed patent invention. In common scenarios, some hospitals give financial rewards to the doctor who licensed a patent. 

Hence, before you plan licensing your patented medical device, always check the contract and hospital IP policies. 

For more information check out our article on patent ownership vs inventorship.

Conclusion

To recap our medical device patent article we covered the following:

Table of Contents

While intellectual property criticisms demand for a complex and tough process, our Medical Device Patent Team will help you simplify and overcome the challenge by crafting the best intellectual property portfolio for your medical device. 

Patenting your medical device while you’re employed can be too demanding. It needs your time to thoroughly understand the Criticism of intellectual property and Intellectual property laws.

Regardless of your profession, we care about your invention – especially that Medical Informatics & Software Systems, Hypertension Management Devices, Dental Service, Drug-Eluting Devices, Dermatology Service, OB/GYN service, and Neurology Devices are in-demand in the market of medical technology. Also, physician-inventors are improving the Imaging, Catheters and Probes, and Ventilators to treat Ear, Nose, and Throat in Gastrointestinal complications.

That’s why Bold Patent aims to ease your burden by offering a Free Medical Device Patent Consultation. Through a virtual consultation, we want you to inform your existing IP rights and the Intellectual Property law that regulates patenting.

Are you ready to patent your medical device? Book a free consultation today!

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