The July 20 hearing at the Court of Appeals for the Federal Circuit addressing the Myriad case did not last a terribly long time, but there were a few object lessons to take away. We last visited this situation shortly after the Supreme Court decision in Prometheus v Mayo, when I opined that there might not be much reason to hit the panic button, and I have to say I didn’t hear much on July 20 to change my mind.
But who can say for certain? After all, who’d have guessed at the 9-0 outcome at the Supreme Court (a.k.a., SCOTUS) for Prometheus? At any rate, here are the three take-aways courtesy of yours truly.
1. The same three judges = the same three views
I didn’t see much reason to think any of the three justices had changed their minds. Judge Alan Lourie did not make much noise over the machine-or-transformation test in the second go-round, but he didn’t evince much sympathy for the claims of the Department of Justice and the American Civil Liberties Union, both of which argued strenuously that the prime principal should be whether a patent pre-empts other uses of the DNA in question.
Judge Kimberly Moore wasn’t particularly inclined to give DoJ and ACLU much room on the pre-emption argument either, describing such discussions as “a waste of time.” However, Judge William Bryson also didn’t seem inclined to change his views, and hence can be counted on to vote against the Myriad patent.
2. PTO can indeed frustrate the Supreme Court’s intent
As we’d discussed previously, the U.S. Patent and Trademark Office is not exactly powerless to frustrate what might appear to the Supreme Court’s intent in Prometheus.
Take for example the March 21 rule published by PTO in response to the Prometheus decision. The guidance states that claims “that recite a law of nature or natural correlation, with additional steps that involve well-understood, routine, conventional activity” are not eligible for patents, but patents that recite a law of nature coupled with “several unconventional steps … that confine the claims to a particular, useful application of the principal” are eligible for patent protection.
Now it’s true that I’m not a patent attorney and this could be read several different ways. But I do write quite a bit and know something about the English language, and I have to tell you … this could be read several different ways. One thing it says is that the patent in Prometheus is too simplistic, but it’s not just me who believes this passage is not all that prescriptive otherwise. An individual with some expertise in this area spoke to me off the record at CAFC and said PTO has a lot of leeway in interpreting the Prometheus decision.
One little point of interest in this context is that Bryson asked the DoJ attorney whether PTO was on board with the government’s argument. DoJ’s Melissa Patterson struggled mightily to avoid admitting that PTO disagrees, but it was strikingly obvious that PTO director David Kappos thinks DoJ is nuts on this score.
3. CAFC is in no way hamstrung by Prometheus
This obviously is similar to the discussion of PTO, but let’s face it, if CAFC doubles down on its first decision in Myriad, it’d be more of an in-your-face response to the Supreme Court than anything PTO is liable to engage in. Still, what can the Supreme Court do? Send over a nasty letter? The Supreme Court, like all courts, can’t do anything unless someone files a case in its jurisdiction.
Furthermore, there is one huge problem in the arguments leveled by ACLU and DoJ. I won’t argue that a patent should be allowed to tie up an entire area of scientific inquiry, but if you’re going to grant patents on genes – or patents for anything for that matter – there has to be at least some pre-emption of activity. Otherwise a patent is worthless.
Beyond that, I’d point out that biotech exclusivity lasts only a dozen years. Whatever the scope of pre-emption, it won’t last very long at all regardless of what happens next at CAFC, which is another reason for Moore and Lourie to hold their ground.
An experienced patent attorney might argue that if my prediction turns out to be correct but for the wrong reasons, I might as well have got it wrong, period. Whatever the case, I don’t see Lourie and Moore as having shed their previous positions on this, and Myriad will show that the outcome in Prometheus is far less earth-shaking than some might have believed.
P.S.: To the guy who showed up at CAFC in sneakers, jeans and a polo shirt: Seriously? Sneakers, jeans and a polo shirt? Did you just get out of high school?