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Patenting your medical device in the USA

Medical devices patent

Many a genius took their idea to their graves. All for the wanton fear of a wolf lurking to steal their ideas and take them for themselves. Perhaps the fear is nowhere close to being wanton – given the life-saving immediacy that surrounds medical device invention, first time medical device patent applicants stand the risk of losing their unpatented idea.

It would do the world no good that you go to your graves with such patentable idea as a device that could rescue us all from the novel coronavirus. So, you need to master these steps to patenting your medical device in the USA.

A patent is a legal document, normally drawn up by a patent attorney, which provides claims that define a new device, process, etc. and grants the owner of the patent exclusive rights to use it (Ogrodnik, 2012). Apologies if this definition gives you the feeling of being back in the four walls of a classroom – laws are best stated verbatim.

It is a form of intellectual property that ensures that all your efforts put into designing a new device does not go to waste by granting you a monopoly for the tenure of the patent.

It is public knowledge that medical treatment is barred from patent – for its approval would mean your physician’s education and practice would be largely impaired. However, the instruments at your physician’s disposal are patentable.

A patent should be filed in your country of residence. However, you may choose to file in another country if that is your location of interest – the USA is the world’s largest market for medical devices. Priority date is the date upon which you file a patent and such patent is defined by this date.

A patent may be extended beyond its 20 year validity if it has lain dormant for tangible reasons, notable among which is years spent in obtaining regulatory approval to market.

patent

Steps to processing your device patent

Adding to the woes of a first time medical device patent applicant, the cost of drawing up a patent document do not come by any cheap. Running into thousands of dollars, this cost is meager compared with the cost of patent upkeep.

Processing involves:

  • Filing
  • Examination

Filing

To file a medical device patent, you’ll need a patent attorney. However prior, you’ll need to carry out a prior art search. Prior art is any information that  is in the public domain that relates to your patent – and it can be very broad, ranging from orthopaedics to cardiology. You are best qualified to carry out this search yourself since it requires you to investigate anything that isn’t novel about your device.

Prior art search may not be limited to patents, look into published works, copyright materials, etc. Failure to keep your work confidential and a poor prior art will definitely mark the downfall of your patent – do your homework.

Your attorney’s primary assignment is to develop and write claims for the patent. The claims must be written by someone who knows their onions – to do otherwise is akin to carrying out a Cesarean section on one’s wife just because one has watched the whole series of Grey’s Anatomy.

Thereafter, the attorney will file your patent with the U.S. patent office, following which you will receive notification of filing and from then on enjoy the freedom of public disclosure without the fear of theft – there would be no invention to steal if it doesn’t scale through examination stage anyways.

The patent application is pending for about a year, during which time you may modify the patent application within reasonable limits.

Examination

You are required to defend your claims as the examiner’s job is to contest your claims thereby ensuring that they are all new. This is where your stated prior art comes in; if you have done your homework, then the patent examiner will find in it all the prior art required, including justification for the novelty of your device.

A poorly documented application will be rejected at the first examination. This will necessitate modifying your application to produce arguments as to why your claims are valid. The patent attorney would then return the modified application to the examiner. Further rejections present the risk of your application categorized unsuccessful, upon which re-submission is impossible.

However, success implies that your invention is novel and patent-worthy. You will be presented with your letters patent stating that you, and not anyone else are the owner of a patent. Your patent is thereafter published and uploaded in the United States patent office online search engine for public perusal.

Do not be overjoyed with your success at the Patents Office as to forget that you are dealing with a medical device – patent gives you a monopoly to your product, but it doesn’t reserve the right to market as a medical device. Such approval is granted by obtaining an FDA clearance to market.

This entails a more detailed application process of similar duration, comprising your company and device registrations, device classification, pre-market notification, prove of substantial equivalence, standard, safety etc.

Wish you the best in your very first patent application. 
WATCH OUT FOR; Obtaining Regulatory Approval to Market your Medical Device

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