PTO Seeking Comment on AI as Patent Owner, Inventor

The U.S. Patent and Trademark Office still has its hands full over the question of the Supreme Court’s views on life science patents, but the agency must now begin to grapple with an entirely new set of dilemmas. PTO recently announced it is seeking feedback on the status of artificial intelligence (AI) as an inventor and as a patent owner, two questions that may defy answer in the near term.

U.K. Researchers Argue for Change

Researchers at the University of Surrey in Surrey, U.K., announced at the beginning of August that they had filed for patent protection for two inventions autonomously created by an algorithm known as DABUS. The inventions are for relatively simple products – one is a beverage container with a design based on fractal geometry, while the other is a device for attracting the attention of would-be rescuers – but the team at Surrey has applied for patents for these items in the patent offices for the U.K., the U.S., and the European Union.

According to the statement, the U.K. Intellectual Property Office has already concluded that the inventions pass the preliminary test for inventiveness, although the agency has not yet taken up the question of whether non-human entities can be cited as an inventor. So far, this is as much as the researchers at Surrey are asking the agency to consider.

Ryan Abbott of the University of Surrey School of Law said in the statement, “there would be no question the AI was the only inventor if it was a natural person,” and argued that DABUS should be listed as an inventor. Abbott said developers of an algorithm should be designated the assignee or owner of any patents produced by that algorithm, arguing that such an outcome would reward innovation and “keep the patent system focused on promoting invention by encouraging the development of inventive AI, rather than on creating obstacles.”

The question is not an entirely novel one as indicated by a discussion of the question in a law journal last year, but the difficulty for patent offices is that the statutes under which these agencies work seem to leave them with little leeway. The statute in the U.S. states that a patent can be awarded to “whoever” invents something useful, while the law in the U.K. make reference to “persons” as inventors. Thus much of the debate is likely to center on a need for legislation.

PTO Broaches Ownership Question

The American patent office announced Aug. 27 that it seeks feedback on whether further guidance from the agency is needed to “promote the reliability and predictability” of patent applications filed on behalf of AI. PTO also poses the question of whether new forms of patent protection are needed, adding that some of the issues surrounding software inventions are relevant for the discussion of AI patents.

There is a need for clarity regarding terminology as the PTO noted that the term “AI inventions” is used to denote both inventions that utilize AI and those that are developed by AI. PTO also is inquiring into the circumstances in which humans might be designated co-inventor with the algorithm, as well as whether the laws and regulations are in need of revision to address the question of inventorship.

However, PTO went further, asking whether an algorithm can and should be allowed to be designated the owner of the invention. As intractable as such a problem may be, some of the more prosaic questions are likely to prove challenging as well, such as whether a change is needed in the written description requirement regarding the level of detail provided about the algorithm. PTO noted that this question could prove difficult to answer, given that some deep learning systems may have layers of functions that are obscured, and that some functions may evolve without human assistance or intervention. PTO is taking comment through Oct. 11, but it seems likely that the debate over AI inventorship and ownership has only just begun.

Senators Inquire into FDA Digital Precert

The FDA precertification program for digital health has raised eyebrows across the industrial spectrum on several points, but the program has now caught the attention of three members of the U.S. Senate. An Oct. 10 letter from the trio, a document spanning a dozen pages, pokes at the agency on a number of issues, including the question of whether the agency has the statutory authority to conduct a premarket review process that bears no apparent resemblance to anything found in the Food, Drug and Cosmetic Act.

The FDA precert program was the target of criticism from early on regarding whether the organizational certification process was equivalent to a premarket review of each application, but the agency has a compelling argument that its traditional review mechanisms are too clunky for the fast-moving digital space. Nonetheless, Senators Patty Murray, Elizabeth Warren and Tina Smith posed the question of whether the FDA believes the law provides the agency with the authorities to conduct the precert pilot, let alone stand up a full-blown precert program.

The letter also raises the question of whether high-risk devices would be allowed to make use of the precert model, and whether the National Evaluation System for Health Technology will be serviceable as a medical device registry in time to sustain the precert program’s momentum.

On the compliance side, the senators state that there is no evidence the FDA has issued an inspectional form 483 to any companies regarding software products, but they also raise the prospect that the precert program’s mechanism for bypassing premarket reviews for individual products could diminish the volume of user fees collected over the course of the existing user fee agreement.

One of the interesting things to consider is the matter of the senators’ home states. Murray is from Washington, not exactly known as a hotbed of med-tech innovation, but Warren’s and Smith’s home states – Massachusetts and Minnesota, respectively – are indeed medical device hubs for traditional hardware medical devices. That does not necessarily mean that the old guard among device makers is pushing back against what they might see as either favoritism to digital or a high-risk enterprise by the FDA that could damage the reputations of all device makers, but that possibility cannot be ruled out, either.

The Unfinished Business of Myriad

The patent law case of AMP v. Myriad handily brought an end to patent subject matter eligibility for DNA, but the Supreme Court’s June 2013 decision in the case left a few moving parts in play for the life sciences. A case recently emerging from the Court of Appeals for the Federal Circuit suggests that while the outcome in Myriad left complementary DNA in a good place where Section 101 tests are concerned, the use of oligonucleotide primers may now be an appropriate topic for another look if the remarks by one of the judges at the Federal Circuit are any indication.

The Federal Circuit decreed in Roche v. Cepheid that the contested Roche patents, which Cepheid was alleged to have infringed, were not patent eligible, principally because of the test’s reliance on amplified DNA. However, the test also makes use of a number of oligonucleotide primers, which is where the three-judge panel was split.

Judge Kathleen O’Malley made the point that there was nothing in the Supreme Court record for Myriad that spoke directly to the question of subject matter eligibility for these primers, and she said there was some confusion at the Federal Circuit on that point as well. Strictly speaking, O’Malley’s opinion is a concurrence, but she clearly believes the Federal Circuit botched a chance to clarify an issue that is pertinent to a number of diagnostics that make use of primers during the amplification process.

O’Malley said the mere fact that the primers replicate the DNA in question does not necessarily mean the primers are entirely identical to the DNA of interest, but it is not clear yet how Roche intends to respond. The case drew the attention of several patent blogs, but by no means all of them, so this is as yet a niche legal issue. That could change quickly, however, if the question arises again, which seems nearly certain given the widespread use of polymerase chain reaction technologies for in vitro diagnostics.