Dr David Pearce, patent attorney at Barker Brettell lists some of the common pitfalls for up-and-coming medtech innovators and the strategies to avoid them.
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1. Do your research
A common problem for innovators, and not just in the medical technology area, is not knowing enough about what has already been developed. If your invention is not new it won't be patentable. It's important to do your research first to reduce the risk of being disappointed later on. Think about how much you know about the field you are working in. Do you know what others in the same field are doing at the moment, and what they have patented or published? Remember that anything made available to the public will count as prior art, not just what is currently on the market. This includes published patent applications, journal articles, newspapers and any other disclosure that is not bound by confidentiality. A good place to start with your research is by searching patent databases, starting with keywords describing the invention and working up to using the international patent classification system. The EPO's patent database Espacenet is a very useful resource of practically everything that has ever been published as a patent application.
2. Is your invention excluded?
If your invention is about medical technology, think about what the real advance is. If it relates to a surgical, therapeutic or diagnostic method, have you developed a new tool or is it perhaps a new way of using existing tools? If the latter, there is a strong chance it could be excluded (at least in Europe), but not if your invention is something physical that might be used for such methods. If your invention is implemented in software, think about what the result of running the software is. Is there an effect on something in the real world? If, for example, the software controls an instrument by taking inputs and providing outputs after doing some new type of analysis, the software itself might be patentable. This area can be fraught with difficulties, and there can be a fine line between what inventions are excluded and what are not. Before you go any further, speak to a patent attorney to get some initial advice on what to do and how to go about protecting what you have.
3. Can you afford to protect it? Can you afford not to?
An important part of protecting your innovation is cost. Can you afford to spend the money needed to get patent protection? Getting an application prepared and filed, and dealing with the application for the first year after filing, can cost several thousand pounds, and costs will typically rise further after this. Make sure you have the budget to do this, and have a clear plan of what you intend to do with your application, bearing in mind that it might not be granted as a patent for two or more years. Are you going to be able to start making money in that time? Once you have filed a patent application you will be faced with strict deadlines that have to be met, with fees that have to be paid, otherwise your application will fail.
Think also about what the consequences would be of not applying for a patent. How easy would it be for someone else to copy your invention? Would it be possible to reproduce the invention by seeing what you have put on the market? Are there any hurdles that others would have to overcome to get a competing product on the market? In the medtech area, regulatory hurdles can be substantial, so the first to get an approved product can often have a useful lead over the competition. A patent, however, can give you protection for up to 20 years.
4. Don't over-reach
A common mistake is to assume that protection in as many countries as possible is the thing to do. This is not necessarily a sensible move, as it can result in spending huge amounts of money for little added benefit. If you are a big pharmaceutical company with a blockbuster drug, patenting everywhere there is a market for the drug might make sense. If, however, you are a small startup with a new type of medical device, be practical about what countries you go for and budget accordingly. Remember that the costs of patenting increase with every country you add to your list, and to justify the costs of a patent in any country there has to be a plan for making money from the invention in that country.
