I am not a huge fan of case write-ups, at least in the style of memo I wrote in law school. For me, for practical utility, it gets too into the legal weeds and strays away from what I think most of us want – the take-home message. Namely, get to the point- what should I do differently or what should I watch out for?
Two recent federal circuit cases caught my eye over the last few months. They are both non-precedential, meaning that they are in the realm of circumstance-specific facts, so the court doesn’t want the conclusions to be seen as a broader take on the issue. despite this designation, these cases are interesting to me because they give a view on the court’s reasoning and how it grapples with the science-related factual issues. It’s take on the technical facts and what exists as the state of the art often determines whether a patent stands or falls.
The question: Is a patent claim indefinite if it specifies mathematical measurements but doesn’t specify which method of measuring to use?
In this case the answer was yes, but spoiler alert – other cases have gone the other way.
The claims required that an extended release formulation of the drug memantine provide a change in the concentration of the drug as a function of time less than 50% that of an immediate release form with of the drug.
So what type of study was to be used for this comparison? Did it need to be a study comparing both forms, or could you test the extended form and compare it to the results provided for the immediate release formulation in the patent?
The court decided that while the patent and its prosecution history indicated that human studies of both forms were required, there was not a sufficient description of the study design to be used for the comparison. Why did this matter? Apparently, different types of studies yielded different measurements.
And where did that leave it? The claims were invalid because they were indefinite.
Now you might take from this that specifying which method of measurement to use is important. It could be. But here’s an example that went in the opposite direction – Ethicon Endosurgery v. Covidien. The patent claimed a surgical device that required a range of clamping forces and pressures but did not specify a particular method for measuring force and pressure. The Federal Circuit concluded in this case that specifying a particular method wasn’t required.
Crystal clear? Not really.
Looking at these 2 cases, the cynical view is that the Forest case dealt with clinical trials and pharmacokinetic measurements, likely a topic that doesn’t seem straight-forward to non-scientists. With Ethicon, however, we all remember force and pressure measurements from high school physics class, and it may therefore seem antithetical that specific methods of measurement need to be described (even if different tests give different results).
To me, this suggests that where you can spell out some exemplary methods in the patent, with general principles of what is measured and how, it is worthwhile.
The question: Can claims to a medical device and method of using it be deemed not patentable subject matter because they analyze a natural phenomena?
Here, the answer was no. But in a number of previous cases, the answer was a definitive yes. So, what is the difference here? The court decided that the technique applied for measuring was not routine and conventional.
At the heart of this case is body temperature measurement – ok, we can all agree that body temperature is a natural phenomenon. The inquiry therefore centered around whether the patent described measuring it using routine and conventional techniques (and thus not patentable material) or whether it brought something new. The latter won out. Interestingly, the technique it used, scanning skin surface for arterial temperature was known, but had been used for identifying tissue injuries, not for calculating human body temperature.
Why does this case stick out for me? You could look at it and conclude that as long as the steps applied to a natural product or phenomenon are a new use of the technology, no worries. But this doesn’t compute with the Ariosa v. Sequenom case. In this case, using circulating fetal DNA in maternal blood for diagnosis was new, but the PCR method of identifying the DNA was a routine technique. In Ariosa, the court concluded the application of a known technique in a new way was not patentable subject matter.
Again, cynically, it might come down to perspective as to what is new and how that novelty is explained. Is it more of a leap to take known temperature scanning methods to calculate a familiar measurement, body temperature, as compared to taking a novel observation of circulating fetal DNA in a mother’s blood and bringing in known DNA diagnostic techniques to make a new type of diagnostic assay?
Bottom line is that this issue of what is patentable subject matter is constantly shifting sands and very fact-specific. The more that an argument can be made (in the patent specification or later in litigation) that some step is new, rather than the observation or identification of a new thing, the more likely the claim will stand.