The Office was put in a tough spot by the Supreme Court’s rulings in Association for Molecular Pathology v Myriad Genetics in June last year, in which the Court ruled that isolated genomic DNA is a product of nature and not patent eligible, and Mayo v Prometheus in 2012, in which the Court ruled that a method of determining the proper dosage of the thiopurine drug did not sufficiently transform the naturally occurring correlations on which they were based to be patent eligible.
In response, the USPTO last month issued guidance to patent examiners to help them examine all claims involving laws of nature, natural phenomena or natural products.
The guidance did not go down well. This was starkly illustrated on a panel (right) at our US Patent Forum last month when speakers expressed their concern about the ramifications of what they see as a shifting of the goalposts. For example, Sherry Knowles, principal at Knowles Intellectual Property Strategies, said the guidelines were “horrifying to the pharmaceutical and biotech industry”.
“According to the utility guidelines that came out in March this year, not only is no natural product patentable in the US, arguably derivatives of natural products may also not be patentable. That is a clear change in the law,” Knowles said.
The USPTO responded to the criticism by giving Managing IP a detailed explanation of its position and revealing that it is seeking public feedback on the issue (including holding a roundtable) that may lead to updated guidance. Andrew Hirshfeld, deputy commissioner for patent examination policy at the USPTO, told us that the guidance brings together the outcomes of Myriad and Mayo in its expression of the “significantly different” standard for eligibility. He said the Office’s interpretation of Section 101, which determines patent eligibility, is based on the Supreme Court, which has refused to consider all discoveries eligible.
In many ways, the USPTO has been forced into making an unpopular move by circumstances outside its control at the Supreme Court. While it is easy to criticise the USPTO’s conclusions as expressed in the guidance, it is commendable it has at least tried to take a stand. This will not do much to assuage the criticism of the deeply unpopular guidance.
However, the USPTO’s willingness to take the public’s ideas on board and potentially refine the guidance further down the road – whether it was planned from the outset or instigated as a result of the backlash to the guidelines – is to be applauded.
I spoke to David Kappos (left), former director of the USPTO and now partner at Cravath Swaine & Moore, to get a sense of the office’s workings in situations like this.
“While I know there has been significant public push back on them and there may be aspects of them that need to be modified or refined, I will say I applaud the agency for doing something and for going out quickly with some guidance and then agreeing to iterate on it,” he said.
Kappos said the USPTO has three options in situations where a new law has been put in place by the courts.
“Choice one is you can tell the 7,000 to 8,000 people coming into work every morning that have got to examine patent applications to sit on their hands and do nothing until we can take the six months to a year needed to go through formal notice and comment process to get an enormous amount of public input and try to come up with consensus guidelines on a controversial and very difficult set of court decisions. I don’t think that is a very fine way to move forward because it is tremendously ineffective.
“Choice two would be we are not going to come out with any guidelines at all because we are going to spend a year working on this so you guys just go and use your best judgement, you can read the case too. I don’t really like that choice either because it is totally punting and not giving people any guidance.
“Or there is choice three, which is we are going to come out with something that is the best we can do in a very short period of time so that we can at least get going in some sort of generally sensible direction and then we are going to take input and iterate on it and quickly. It is that third view that the agency is taking and I have to say I applaud them, in a world in which there is no perfect solution, for finding the best one overall and moving forward by it.”
The USPTO’s approach here of issuing guidance first and refining it later is not unusual, said Kappos. He said historically the USPTO did not move as fast on issues such as this but during his time at the office there was a mandate of getting guidance out quickly after a decision and committing to take full comments from the public and then putting out more robust guidance.
The biotech community now has the chance to influence whether guidance it hates will be changed to something more palatable. The USPTO should be braced to receive a barrage of criticism during the feedback process until it is.