With 50 years experience in ocular research and more than 30 patents under his belt, John Marshall MBE, Professor of Ophthalmology at the Institute of Ophthalmology, and member of MedTech Engine’s advisory board, is well placed to give us his thoughts on securing medical patents.
My general advice is to keep an old-fashioned paper lab book and, once a month, take it to a notary who will sign and stamp each page, giving you legal proof that you had that idea on a particular day and have listed any experimental work done. This isn’t a patent but it does provide extremely good legal protection for any subsequent intellectual property (IP) negotiations.
If you’re working in a university department, it depends on whether your contract says all IP generated from your work belongs to the university, or if it allows you to do work in your own time that can be independently protected. If the university owns all the rights, then you can talk to its IP transfer department. But I’ve found that generally this doesn’t lead anywhere.
If you can handle your own IP, the next thing to do is to write the patent. If you have no experience, download a couple of patents (preferably from the US Patent Office) to use as a model. The most important aspect is the claim. In contrast with scientific papers, which need to be specific, patent claims need to be as general as possible to exclude others from making, selling or using your idea. A classic example of being too specific was the scanning laser ophthalmoscope. The company that built the first one specified a 5mm aperture; other companies then came in with 4mm, 3mm versions etc, making the patent largely ineffectual.
There is a lot of discussion about this. The more countries you patent in, the more it costs. But it’s been my experience that if you patent in the US, it covers pretty much the rest of the world.
It varies. A provisional US patent will cost you $1,000 to $3,000 if you do it yourself, and this will protect your device for up to a year – giving you time to think about what’s next. The downside of filing a provisional patent is that the world knows what you are doing!
Having got your year’s grace, if you have a really brilliant innovation that’s going to make you a fortune, you need to progress the patent, which will be a significant investment in both time and money. If it’s a good idea but not a brilliant one, you could look for a commercial partner and offer to license the patent to them and then it’s their responsibility to keep the patent going. Generally patents last for 20 years from the initial filing date.
The belief that ‘Now I’ve got it, I’m protected’. Some countries ignore patents, and in the past, China was a prime culprit. Or a wealthy company might decide to infringe your patent and you could end up in litigation. Even if you do finally win, it can be at great financial cost. So you need to know the potential value of your innovation and how fierce your potential competitors are.
Different countries have different criteria. So in the UK and Europe, you have to show innovation (it has to be new) and to demonstrate ‘reduction to practice’ (that the claimed invention works for its intended purpose). In the US, until relatively recently, you had to show innovation, but not reduction to practice. So a lot of American patents are patents of ideas, not necessarily working principles. The US patent office has recently upset the apple cart by allowing ‘discovery’ to be patented, in particular, that of new genes. With the European patent office, you can patent a novel gene conscript – where you have a gene and then alter it (the innovation) but you can’t patent being the first person to discover a particular gene.
Again, that varies. In Europe, you can’t patent procedures, but you can patent devices in medicine, whereas in the US, you can patent a procedure. In Europe, it’s your device and anyone using it is free to do so, unless you come up with a clever idea like a disposable version (which could be seen as having a procedural fee). In America, however, you can patent a procedure and charge a procedural fee – as happened in the early days of refractive surgery with Photo Refractive Keratectomy.
The application process is relatively quick if the innovation is novel but commercialisation takes longer. If companies think they have a potentially strong IP portfolio, most get on with systems development before the patents are issued. As an example, from idea to approval for our first refractive surgery device through the FDA took just over 10 years, although during that period we were selling it in the rest of the world.
In many areas, providing you design something that is radiation, electrically or mechanically safe, you’re on your way to the marketplace. Whereas in medtech, you have to go through all the ‘joys’ of regulatory affairs. Bodies such as the FDA or the European Medicines Agency can make or break products.
The regulatory situation is more costly and time-consuming in the States and unfortunately Europe is moving towards the American model; if that happens it could add another three to four years onto development release and $20 million to $70 million to costs.
While we need regulations, it seems to me that many of the agencies are obsessed with process rather than the end point – patient safety and efficacy.
Another issue is that every regulator wants their own trials, which costs startups a huge amount of money. While it might be difficult to achieve, it would cut costs if we could have ‘standardised’ trials and data that was acceptable throughout Europe – and hopefully, after some time, in the US.
The patent of the Excimer laser for the correction of refractive disorders – a prime example of attention to detail and ensuring that the patent wording was correct. We have now seen more than 50 million patients undergo one form or another of laser refractive surgery.
Don’t rule out serendipity – ideas can come from anywhere at any time. See what nobody else has seen, think what nobody else has thought and do what nobody else has done. Never try to innovate just from within your field – look beyond it for potential uses in other areas.
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