Note: This is the final segment in a six-part series that explores the legality, methodology, and application of reverse engineering as it pertains to the IP life cycle to help companies moving into the market for consumer-grade medical devices understand how and why they must protect their intellectual property rights.

Other articles in this series:

Part I: Look Before You Leap
Part II: Defining the IP Life Cycle
Part III: The Right to Reverse Engineer
Part IV: Using Constructive Destruction to Look Under the Hood
Part V: Seeing Inside Very Small Components

There was once a company that attempted to patent a process for the precise measurement of the knee joint prior to surgery without resorting to expensive CT scans. The process was ingenious in its simplicity, combining low-tech hardware with a custom software solution to build a 3-D image from a few standard 2-D x-rays.

Clever? Yes. Innovative? Yes. Original? No.

It turned out that a method for converting 2-D images into 3-D images had been developed and patented decades earlier for a completely different application. What’s notable about this example is that this company didn’t set out to rip off another’s invention—it had unknowingly recreated a previous invention in another field.

This example illustrates the thin ice upon which many companies can inadvertently find themselves as the partition between hardware and software continues to shift in favor of the latter. A software algorithm that can perform a desired function in place of a hardware component can yield significant cost savings and dramatically shorten time to market. For companies eager to compete in a market as cost-sensitive as consumer electronics, achieving desired functionality and device efficacy with a software solution in lieu of hardware can be a Holy Grail.

Software, of course, can have a relatively high upfront development expense. But once it’s in production, the on-going maintenance is far less costly than continuing to churn out in high volume an expensive hardware component which it can replace.

Take, for example, a sophisticated sensor that’s costly to produce, fragile, and required in large volumes. This could be anything from a sensor in a weigh scale to one in a steam iron that reads heat and pressure to adjust the temperature setting. That same sensor can be replaced with one that’s far more economical, robust, and easier to manufacture, if combined with a software algorithm.

Patenting the device alone is far from enough
Today’s consumer electronics market, and the growing medical device subset of this market, is no exception. Processes within a device once executed solely by hardware are increasingly being driven by a software algorithm. The software and firmware embedded within a device has become a key point of differentiation from a competing product. Simply put, hardware components are what you outsource or buy off the shelf; software is the proprietary secret sauce that one keeps in house.

But as many companies fail to appreciate, one can not simply develop a functional device, such as a blood glucose monitor or a body fat monitor, and think that its primary function, as well as all of its inner workings, can be subject to a single patent.

Take, for example, the disposable strip used with consumer-grade blood glucose monitors:

How is the data from the chemical reaction on the test strip amplified, converted, or stored? How does the device measure time and determine when the data is not reliable? A real-time operating system certified for medical applications, packaged together with an off-the-shelf microcontroller that is able to communicate with certain sensors and perform certain computations, drives these functions using any number of proprietary software algorithms. But any of these algorithms could have already been independently developed and patented years before in an industry as far removed from consumer-grade medical devices as automotive.

Software snooping with cause
Ultimately, a rigorous and effective IP strategy demands a deep understanding and review of competing technologies on the market through a process of reverse engineering to avoid, or assert, a claim of infringement. But as explored in our third article in this series, software/firmware, unlike hardware, is subject to copyright law.

This application of copyright law limits the circumstances under which it is legal to engage in a process of software reverse engineering—there must be a clear and credible allegation of infringement to proceed. Even then, it’s often better to engage the services of a third-party reverse-engineering firm, which has the specialized expertise, processes, and equipment to perform a thorough and impartial analysis of the software in question to produce evidence that’s admissible in court.

Perhaps most importantly, you as the client of the reverse-engineering firm are granted an extra level of legal protection—the reverse engineering firm should disclose to you only the information required to substantiate or invalidate the claim, rather than provide you with an inside look at all of the third-party’s software code.

Software reverse engineering: A variety of flavors
When the legality of software reverse engineering is being discussed, one often hears mention of disassembly and decompilation—the two most drastic and revealing methods that can be employed to probe the secrets of a program or algorithm.

However, it bears noting that, depending on the nature of a claim—whether it pertains to high-level functionality, how components and systems are communicating with each other, or specific processes deep within the code—full reverse engineering may not be necessary. It may be possible to acquire the necessary information with a less intrusive process such as oscilloscopy, IP traffic sniffing, in-circuit emulation, protocol analysis, or signal measurement.

In conclusion, reverse engineering, as we have explored throughout this series, is a fundamental offensive and defensive tool for a company looking to develop and introduce new products to the market. It lies at the heart of the IP life cycle that sees a product through concept, introduction, growth, maturity, and decline.

However, reverse engineering can take a number of different forms, from device tear down to structural analysis, circuit extraction, and software decompilation, all of which require sophisticated and expensive equipment, custom-designed processes, and expertise that takes years to develop. An experienced reverse-engineering firm can be an OEM’s best strategic ally to navigate the legalities of reverse engineering and achieve technological and commercial success.

Mike McLean is the vice-president of intellectual property rights and professional services at UBM TechInsights. He holds a Bachelor of Science, Engineering with First Class Honours from Queens University and is a licensed member of the Association of Professional Engineers of Ontario.

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