Examining Intellectual Property Concerns In Medical Device Development
From patent applications to FDA approvals, the process of protecting intellectual property has become more crucial than ever for designers and manufacturers.
When it comes to designing and developing new medical device technologies, identifying and protecting intellectual property is often an overlooked step that can have serious consequences. Unlike traditional forms of technology, medical devices often require clinical studies, peer reviews, FDA approvals, and other requirements that can result in years of research and development, and a significant development cost before a product can actually hit the market.
Patenting the design and functionality of a device is paramount to designers and manufacturers to ensure others do not copy or infringe on their intellectual property over the course of its development. Recently we’ve seen industry giants like Google continue to add to their collection of medical-related intellectual property, as they prepare various medical devices and wearables for launch.
In the following Q&A, Qmed chats with Joel Harris, the senior director of intellectual property at InCube Labs, a life science research and development lab led by Mir Imran that is working on a number of different innovative medical technologies. Harris will be speaking next month at the BIOMEDevice San Jose event on the topic of intellectual property concerns in medical device development. Today he discusses the importance of securing intellectual property rights, and the challenges companies might face along the way.
Qmed: What would you say is the biggest challenge that medical device designers face when it comes to addressing intellectual property concerns?
Harris: There are several. First, there is the market necessity of getting patents. Unlike high tech, where a new product may cost five to ten million to develop, in med tech a high margin product such as an arterial stent, which has relatively low manufacturing costs, may cost upwards of $50 million to develop due to clinical studies and other FDA requirements. So patents are absolutely essential to prevent copying and to create barriers to entry for competitive products. Second, the patent claims have to be sufficiently broad enough to prevent design-arounds for the same reasons, since claims that are too narrow allow the competition to sell similar products that do not infringe your patent. Third is the challenge of defining and then articulating in the patent what makes your product better than existing products or technologies. This is particularly important in areas where there is a lot of prior art (e.g. patents), or so-called crowded art areas.
Finally, there is the human factor, that is drafting claims not only on the design of your device, but how it interacts with the human body as well. For example, opening up a blocked artery with a catheter, stimulating a nerve with an electrode to block pain, or reshaping the cornea with a laser to improve vision. These claims are accomplished through the use of methods claims, which do not claim the device per se, but rather how the device interacts with the body and/or the result achieved. Such claims are important because they serve as a barrier for preventing a competitor from producing a different device that can achieve the same result.
Qmed: What is the best way for designers and manufacturers to secure these IP rights and avoid some of these pitfalls?
Harris: Find and work with a good patent attorney or patent agent who specializes in medical device intellectual property. Also, make intellectual property a priority from the start of the product development cycle, so that you can devote sufficient time and attention to capturing new product ideas and filing early on in the process — especially since we are now on a first to file system in the US — then you can easily file follow up applications with successive product iterations. You should also pay particular attention to your initial applications to make sure that they define and articulate what sets your product apart. These early applications should also be rich in disclosure to allow for broad claims, which can get around the prior art and also describe design-arounds and other alternative versions of the product so that these can later be claimed if need be. Also, be sure to spend some time reading the patent claims in your own product area to get an idea of how others go about describing and claiming products in the field.
Qmed: Can you walk us through the process of obtaining and protecting intellectual property rights, and maybe some tips for success when filing for a patent?
Harris: In the U.S., one works with a patent attorney or patent agent to prepare a patent application on the device, which is then submitted to the United States Patent Office (USPTO). Starting about two years later (sometimes longer), the application is then examined by a patent examiner at the USPTO to ascertain whether the patent meets the requirements of U.S. law for getting a patent (there are similar, albeit sometimes different, requirements in foreign jurisdictions). In particular, this involves the examiner comparing the patent claims against any description of the product in prior art patents or publications, and making one of two types of prior art rejections: anticipation, where the examiner finds a single reference (patent or publication) describing your claimed invention; or obviousness, where the examiner identifies two or more inventions which, when combined, describe your claimed invention. Unless the invention is very revolutionary in nature, one can usually expect to get an obvious rejection and sometimes an anticipation rejection as well — the examiner does this by sending out a formal correspondence known as an office action to your patent attorney.
Amendments then have to be made to the claims, typically narrowing them, to get around what is described in the prior art reference. This is where it is important to have richly described variations to your invention in your patent application, so that you have the support in the application for making changes in the claims to get around the art, but don’t unnecessarily narrow the claim to allow a competitor to make a design around.
Qmed: How difficult can it be when it comes to defining intellectual property, and how difficult can it be to protect intellectual property rights that are particularly challenging to define?
Harris: This depends on how many prior art patents or publications there are in the field. If there are quite a few (i.e. a crowded art field), it can be very difficult. Again, this is where a rich patent disclosure and a skilled patent attorney or agent can become particularly important, in order to be able to draft and/or amend the claims to get around the art while still retaining meaningful claims. If there is less art, then it may not be as difficult, but rarely is it ever a slam dunk as you can almost always expect to get some form of rejection (usually under obviousness) in your first office action.
Qmed: Do you think intellectual property rights can sometimes get in the way of the progress of emerging innovation? If so, how can designers and developers avoid or prevent intellectual property concerns from stalling innovation?
Harris: This depends on your perspective. If you are a first mover in the field, you want your intellectual property to impede others from iteration on your new product ideas and reaping the benefits of your research and design efforts. In fact, for startup companies it can be strongly argued that intellectual property actually drives innovation because it allows them to obtain the necessary investment to bring their innovations to market. Further, countries with strong intellectual property rights tend to bring a far greater number of innovative products to market.
On the other hand, if you are a second mover you may feel that a competitor’s patents are unnecessarily impeding your progress due to the risk of patent litigation. To overcome this hurdle and work toward being able to secure your own intellectual property, you will probably want to carefully review the prior art before even embarking on your own research and design and eventual intellectual property efforts.
Qmed: Finally, do you have any other thoughts or words of advice that you would give to potential medical device engineers and designers when it comes to avoiding their own issues with securing intellectual property rights?
Harris: Read the prior art to make sure you understand what has already been described and claimed in your field. Next, put a priority on intellectual property early on in the development process and work with your patent attorney or agent during patent prosecution. This can include reviewing the prior art rejections, as well as making suggestions for claim amendments, as you can bring a perspective your patent attorney hasn’t thought of. When I get stuck on a difficult case, I will often talk to the engineers and get some ideas for how to get around the rejection.
Finally, make friends with your patent examiner via phone or in person interviews at the patent office. While their job is to make sure that they only allow claims which are distinguished over the art, they can often times help you by providing insights as to what they think may be allowable subject matter.