The U.S. Patent and Trademark Office (PTO) has opened a priority track for patents related to the COVID-19 pandemic, another signal of federal government intent on overcoming this new plague. However, Scott Marty, a partner with the Atlanta office of Ballard Spahr LLP, told BioWorld that while the program offers some distinct advantages for pandemic-driven patents, inventors should have their filings in good form before entry because any delays incurred by a less-than-airtight application could lead the PTO to boot the application out of this program.
The PTO unveiled the COVID-19 priority program with the advisory that eligibility is limited to small and micro entities, although the fees associated with other prioritized examinations would be waived. The program also offers disposition of the application within 12 months, a much more rapid turn-around than is ordinarily seen. That 12-month examination time could fall to six months if the applicant responds more promptly to communications from the agency’s examiners than is required in other priority programs, however.
The applicant patent must describe a product that is regulated by the FDA, and PTO said in the associated Federal Register notice that this includes investigational drugs and devices, along with biologics license applications. Also, within the scope of this program is any other item that would fall under one of the FDA’s emergency use authorization (EUA) programs, a category that includes specimen collection swabs and personal protective equipment.
Program resembles Track One program
While PTO promises to engage helpfully with filers, a large number of claims can make the process complicated, and if the applicant fails to respond to a query sufficiently quickly, that patent may be rejected from the COVID-19 priority program. The COVID-19 priority program resembles the PTO’s existing Track One program, and Marty said, “what I advise my clients when it comes to Track One is let’s do a little homework,” and examine the application the way an examiner at PTO would. This kind of up-front work could save the applicant a substantial sum after entry into the program because there are fees despite the waiver of some priority-related fees. Still, would-be applicants can’t afford to tarry in this regard either, because “you don’t know how fast that 500-request bucket is filling up,” Marty said.
PTO has listed several specific eligibility requirements, including that the application must be a non-provisional application. Marty noted that the limitation of four independent claims and 30 total claims should not exclude a significant number of would-be applicants. However, he pointed out that PTO has in the past instructed an applicant that multiple independent claims are suggestive of more than one invention, which might trigger a restriction requirement. This outcome adds time to the process, and in that scenario, PTO might say “you need to choose which one of those inventions you want to pursue,” Marty said. He noted that this is one area of patent development that can be difficult to navigate, even for experienced hands.
Marty said the claims found in patents will be more important than specifications when determining whether an application is pandemic-related, suggesting a need to carefully draft the claims. He said the PTO “is taking the first 500 [applications] and then is going to hit pause,” at which point the agency will reevaluate the program in terms of the response. It is not yet possible to determine whether the agency will receive at least 500 applications, but Marty noted that patent pendency at PTO often runs to three years or longer, depending on the technological area, and thus even the 12-month turn-round “is a third to a fourth faster” than is typical.
Most life science products, such as vaccines, therapies and diagnostics, will be relatively easily tied to COVID-19, and Marty said the program might encompass software as well. The inventor of any software may have to tie that software’s function to a specific non-software product – such as a vaccine, a test or a therapy – to qualify. “My suggestion is that if you can say its specific to a COVID product, you can try” to gain entry for software, but the software has to be applicable to new products “and technologies” used in the prevention, treatment or diagnosis of COVID-19.
Marty observed that the term “and technologies” might seem a little squishy, but PTO hasn’t provided any further guidance on this question other than is seen in the FR notice and the press release. “If they don’t hit 500 [applications], my guess is they might be more lenient on what’s COVID-related,” he said, although a large volume of applications will allow the agency to be selective. The PTO might have limited the program to 500 applicants by virtue of resource limitations, and Marty said that while examiners will have to move quickly on these filings, the agency may be of the view that it must take care to avoid creating unrealistic expectations among inventors.
P4P database hints at vigorous industrial response
The Patents 4 Partnership (P4) database is perhaps suggestive of the industrial response, Marty said, which if true suggests the volume of applications for the COVID-19 program will be considerable. The database was already past 190 patent applications and patents granted as of May 14, although this database is designed to make the public aware of technologies that are available for licensing. It is not clear which, if any, of these patents were filed for or could be included in the COVID-19 priority program.
Marty noted that 12 to 18 months may pass before a patent application becomes known to the public, so it is difficult to predict how many pandemic-related patents are in queue at the PTO beyond the 195 that appeared in the P4P database as of May 14. Some of the P4P items might not be sufficiently well developed to qualify for the COVID-19 program, but Marty advised that once a patent examination commences, the applicant party is liable for the same cost as are associated with other patent prosecutions. The accelerated timeline means, however, that those costs are incurred in a compressed timeline, a fact of which the applicant – particularly the less well-heeled applicant – should be aware.