In Israeli slang there’s the person who is a “rosh gadol” versus the person who is a “rosh katan”, literally “big head” versus “small head”. A “rosh gadol” is someone who volunteers to take on responsibility. A “rosh katan” is someone who avoids taking on responsibility and who tries hard not to stand out, someone who in English we would describe as a person who keeps his head down.
The “rosh gadol”/”rosh katan” dichotomy came to mind as I was listening to Drew Hirshfeld and June Cohan of the USPTO talk yesterday at BIO 2014 about the USPTO’s patent eligibility guidelines, which were published earlier this year in response to the Mayo and Myriad decisions. (I leave it to the wonderful guys and gals at PatentDocs to report on the substance of those talks.) From the moment of their issuance, those guidelines have been roundly attacked by people in nearly all corners of the patent world, both on procedural grounds (for first publishing the guidelines and only afterward soliciting outside input) and substantive grounds, and Mr. Hirshfeld addressed many of the criticisms that have been raised against the guidelines. Specifically with respect to the complaint that the guidelines are overly broad and go well beyond what the Supreme Court said in the Myriad and Mayo decisions, Mr. Hirshfeld explained that in issuing the guidelines, the PTO attempted to synthesize all the Supreme Court caselaw on patent eligibility – Funk Brothers, Benson, Flook, Chakrabarty, Mayo, Myriad, etc.
The problem, of course, is that those cases are not reconcilable, and collectively the later cases in the group represent the conflation of the novelty and obviousness tests of 25 U.S.C. 102 and 103 with the patent-eligibility requirement of 101 – in other words, a complete ignoring by the Court of the enactment of the 1952 statute and a return to the pre-1952 law. In the face of such an impossibility, the “rosh katan” approach would have been to simply take Myriad and Mayo at face value, and limit their applicability to the exact facts at issue in those cases. The PTO’s choice to instead attempt to synthesize those cases into a set of coherent rules for patent eligibility is a very “rosh gadol” thing to do, because it’s unnecessary to try do the impossible.
Unfortunately, this particular attempt to do the impossible is also harmful. As anyone who has read the guidelines knows, at best they will cause examiners to waste time assessing the patent-eligibility of claimed inventions the patent-eligibility of which is a no-brainer. See example “C” of the guidelines, which takes a whole page to explain why – duh! – a claim on a firework cartridge is patent-eligible. At worst, the guidelines make it impossible to have patent claims of meaningful scope deemed patent-eligible when those claims include a recitation of materials that are (sort of) found in nature.
For instance, instead of judging whether an antibiotic isolated from nature is new or non-obvious, a claim drawn to such an isolated antibiotic will be deemed patent-ineligible, even though the antibiotic is not found in isolation in nature, because the antibiotic compound itself exists in nature. And the guidelines indicate (see example “B” therein) that a claim drawn broadly to a method of treating an infection using that antibiotic will be deemed patent-ineligible as well; only if a particular dosing regimen is recited will they be considered patent-eligible. Such preclusion from patent protection will in turn preclude the development of new antibiotics isolated from nature – who’s going to invest over a billion dollars running the FDA gauntlet for a compound that anyone else can then use or sell?
Instead of taking a Quixotic, “rosh gadol” approach, the PTO would have done better to be a “rosh katan” and to simply limit its guidelines to the facts of each case, thereby limiting the potential damage to patentability. The Supreme Court has said (incorrectly) that DNA clipped from a gene is the same as naturally occurring DNA, and therefore patent-ineligible? Ok. Make that your guideline, and leave it at that. No need to extrapolate from a decision that’s founded on (un)scientific nonsense. Likewise for the administering-measuring-correlating steps at issue in Mayo that the Court said are patent-ineligible – limit the guidelines to that particular case. If the PTO later issues a patent with claims that the nine robed wizards who have shown themselves to constitute one the dumbest groups of smart people in the world think are directed to patent-ineligible subject matter, they’ll say so. In the meantime, the PTO won’t be pulling the rug out from under an entire field of endeavor, namely the development of new medicines and diagnostic tests.
Unquestionably the highlight of the session was the rebuke given to the PTO by one of their own, Nancy Linck. Dr. Linck, now of counsel at Rothwell Figg, served as the Solicitor at the PTO (the top legal advisor) in the mid-1990’s, and also served as an administrative patent judge before returning to private practice. She put it simply (and if this isn’t an exact quote, it’s close): “You’re going about this all wrong”. When she was at the PTO and new examination guidelines needed to be put in place, she said, the PTO tried to limit the damage, and issue minimally invasive guidelines. If there’s a question of patent-eligibility, she said, then the PTO should err on the side of eligibility, not the other way around.
In other words, on the patent-eligibility issue, the PTO should be a “rosh katan”.
Comments on the guidelines may be submitted until July 31 to [email protected]. If you think new medical treatments are a good thing, you should weigh in on why the guidelines are bad.