Bringing an innovative medical device from conception to widespread delivery involves overcoming immense scientific, engineering, business, and legal obstacles. Of these challenges, one of the obstacles that is least understood by aspiring medtech entrepreneurs is intellectual property protection. Patents can serve as either a barrier to progress or shields protecting development investments from laboratory prototypes to commercial products. This blog discusses considerations, risks, processes, and best practices inventors encounter navigating the medical device patent landscape.
Why Medical Device Patents Matter
Healthcare technology progress depends on innovators taking risks testing unproven concepts that may ultimately flop after years of painstaking research. Development may span computer simulations, 3D anatomical models, animal labs, custom components, and eventually cautious human trials. These efforts require massive persistence, both emotionally and financially, before concepts can be commercialized.
Patent protection limits competition and helps innovators recoup the steep R&D costs. When the basic functionality looks promising, it can spur further improvement investments. Patent protection also deters those copying novel features without paying the cost of development. For these reasons, medical device patents are crucial in achieving commercial success.
Overlapping Patent Application Claims Raise Risk
However, realizing watertight protection rarely proves simple when seeking patents within crowded technology domains. Examiners reject claims that lack a sufficient inventive step above known prior art.
With decades of medical device patents spanning imaging, dialysis, lasers, telemetry, diagnostics software, implantable objects, and beyond, novel innovations become increasingly rare. Far more common are iterative improvements that build upon previous inventions.
Teasing out patentability therefore necessitates identifying the problem(s) that the invention addresses and claiming the unique or surprising solution to each problem. The vast majority of patents are on improvements.
Navigating the Long Road from Application to Allowance
Successfully prosecuting patents to Allowances commonly requires several years including learning how the cited prior art functions, how the current invention differs in structure, function and advantages from the cited prior art, how we can amend the claims (within the scope of the Detailed Description) to further differentiate the structures, functions, and advantages of the application claims from the cited prior art.
One way to argue difference is to show how a device having elements (structures) of the various cited prior art documents results in a combination which does not meet all the functions of the current invention or lack one or more advantages provided by the current invention.
Medical device patents stop or slow others from making, using, selling, or importing products into a country covered by an active patent for up to 20 years from filing dates. But the marathon journey securing them evades even seasoned veterans. We collaborate with our clients, before filing, to ‘brainstorm’. We also expand inventions to include several novel embodiments before filing their patent applications. This has resulted in our firm acquiring a high patent issuance success rate.
Medical device patents present a significant advantage to the patent owner in commercial sales. It is difficult to invent – but it is easy to copy.
Contact Zale Patent Law, Inc. at 570-878-5000 (text, voice), or ip@zalelaw.com to schedule a confidential consultation about protecting your medical device invention.
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