I HAVE SEEN IN THE UNITED STATES A HEARING AID APPARATUS THAT WOULD FIT A FEW OF MY PATIENTS, BUT THAT IT´S NOT FOR SALE IN MY COUNTRY, MAY I SUPPLY IT TO THEM?

24 May 2017

 

In theory, you may, for instance, import and sell the hearing aid in your country. But, first, you shall answer two questions: one about prohibition and another about permission. 

 

The first question is about industrial property and is: May anyone prohibit me of using, producing, selling or offering for sale this apparatus? The second question is referred to the sanitary agency that regulates the access to drugs and medical appliances: do I need any authorization before using, producing, selling or offering for sale this apparatus?

 

In order to answer the first question, one needs to know if there is any patent right protecting the technology in the hearing aid apparatus. It´s possible that a single apparatus contains various patents. For example, one for the microprocessor,  another for the plastic it is made of, another for the special chemical composition for cleaning it. Even the physical appearance may be protected by a design patent or by an analogous right. In some countries, such as Brazil, there is no Design Patent, although design itself may be protected by registration. So, before anything else, one has to rule out the existence of a patent owner that may prohibit the use, production, sale or importation of the apparatus. It´s convenient to hire a industrial property professional to help you out with that, see this post

 

It´s important to highlight that expired rights do not count. An expired patent can no longer be used to prohibit anyone and this was explained in this post.

 

Those with a mere application do not have yet the right of excluding anyone. An application is just an expectation and it may be denied or granted.  It´s interesting, though, that if the right is granted in the future, the reparation will be have to be paid, generally speaking, since the application or publication date, depending on the country. So, it´s wise to wait until the application is at least examined before taking any decision. By the way, this is the biggest evil of the patent backlog: it avoids the entrance in the market of competitors for products that are not innovative - the waiting can, sometimes overpasses 10 years. 

 

If you find a patent, don´t get discouraged! rs You may negotiate with the patent owner to get a licence. By paying him a certain amount of money (called royalties), the patent owner compromises not to prohibit you of using, producing, selling or offering for sale the licensed product.

 

Some countries have included in their legislation, a legal tool that prohibits the maintenance of a patent without local exploration of the technology; others, accept importation as a form of local exploration. That´s because keeping a patent without exploring it is excluding the access of the members of society to an innovative technology, something with very bad consequences. Imagine that someone invents, I don´t know!, the cure for diabetes, and decides not to sell, produce, import and also decides to prohibit anyone of selling, producing and importing. It would be, at least, morally questionable, isn´t it? On the issue of abusive price, some countries, including Brazil, has another tool called compulsory licence, used just once in Brazil, for the anti-AIDS drug Evafirenz. Contrary to what the Press likes to say, there wasn´t a patent breaking, the patent was still valid, it was just that the patent owner was obliged to licence (compulsorily) the technology for a lab chosen by the Government for a price considered fair. Normally, this extreme measure is not needed and just declaring the drug as being of public interest and, therefore, appropriate for compulsory licencing, already facilitates the negotiation with the patent owner for a reasonable price. 

 

Therefore, it´s highly likely that the patent owner, not using, producing, selling or importing himself the technology for the country where you want to explore, negotiates with you a license. You may arrive to a reasonable price for both of you. In this case, it is also highly advisable to count on the help of a industrial property professional. 

 

To answer the second question, you shall check if it is needed any governmental authorization for production/importation. As it has been explained earlier, a patent is just a right to exclude others; it does not mean a right to explore the technology. Technologies that may affect human life, such as drugs, foods, cosmetics, telecommunications, transports, etc are generally subject to regulations that varies from country to country. It may be required proof of safety and efficacy. There are professionals specialized in regulatory issues that may be of great help in this stage and avoid future annoyances. 

 

Industrial property and authorization issues solved, it´s up to you to decide on how to explore the technology. You may, for example, open your own factory and produce yourself the appliance. You may start from scratch, producing all the components, or choose to buy the parts and just assemble the final product. Instead of producing, you may opt to outsource the production or import the product. You may even import it from a country where there is no patent and various companies compete for the market. The competition naturally reduces the prices. Ultimately, this decision is strategic for your business.

 

Of course that is only for those interested in establishing a business, the information for individual importation may vary depending on the country - I mean, you may ask your patients to import the hearing aid apparatus for their own use - still, the same logic applies: by one side, the patent to prohibit; by the other side, the sanitary agency to authorize it. 

 

In summary, in order to know if you can supply this apparatus to your patients, you need to check both the issues on industrial property and on governmental authorizations and regulations for the specific apparatus.

 

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