By Matthew Bultman
Law360 (January 11, 2019, 6:14 PM EST) -- The Patent Trial and Appeal Board dipped its toe into the pool of marijuana-related inventions with a recent decision involving an epilepsy treatment patent, providing the cannabis industry a glimpse at what to expect in America Invents Act reviews.
The PTAB's decision, issued Jan. 3, came in an inter-partes review Insys Development Co. Inc. brought against a patent belonging to a unit of GW Pharmaceuticals PLC, a U.K. company known for its marijuana-derived medicines. The board invalidated two patent claims but upheld several others.
Insys' challenge was believed to be the first to a cannabis-related patent in AIA review by PTAB watchers, who said the board's decision provides insights on how the PTAB will handle cannabis patents, something expected to become more common as the burgeoning industry expands. Here is a look at a few big takeaways.
PTAB Appears OK Reviewing Cannabis Patents
The U.S. Patent and Trademark Office has issued hundreds of cannabis-related patents, covering inventions that range from cannabis lozenges, to methods for cultivating cannabis, to a process for extracting hash oil.
But marijuana is still considered a Schedule 1 drug by the federal government, which raises questions about the viability of enforcing these types of patents in federal court. These sorts of questions, however, do not appear to extend to the PTAB.
The board, which is part of the USPTO, did not delve into the legality of marijuana in its decision. It focused instead on whether the patent's claims were valid under U.S. patent law — just like it would in other IPRs, Duane Morris LLP attorney Gretchen Temeles said.
McDonnell Boehnen Hulbert & Berghoff LLP partner Nicole Grimm said this isn't unexpected, "given that the USPTO is both reviewing and granting cannabis patents.
"But there's always uncertainty until you have that first decision," Grimm said.
There is nothing to suggest the board wouldn't remain consistent in this approach moving forward, which could alleviate any concerns that companies may have about the legality of marijuana when considering whether to challenge a cannabis-related patent at the PTAB.
"Parties who were thinking about whether to file an IPR but were hesitant because of the Schedule 1 status, it could embolden them a bit," Temeles said.
Cannabis Fits Into Familiar Legal Framework
GW Pharma's patent is directed to the use of marijuana components such as cannabidiol, a cannabinoid also known as CBD, in the treatment of epilepsy. GW Pharma makes Epidiolex, which was approved by the U.S. Food and Drug Administration in 2018 to treat Lennox-Gastaut syndrome and Dravet syndrome, two rare forms of epilepsy.
While patents for cannabis-related medicines may be new territory for the PTAB, the board's analysis was quite ordinary.
The prior art in the case, for example, came from clinical literature, including articles that described medical studies. And many of the legal arguments were focused on the dosage range described in the patent and whether that would have been obvious.
Pauline Pelletier, a director at Sterne Kessler Goldstein & Fox PLLC, said both of those themes will be very familiar to those who litigate biopharmaceutical patent disputes.
So too will be the PTAB's choice for a "person of ordinary skill in the art," a hypothetical person presumed to have known the relevant art at the time of the invention. The board decided it was a person with "an M.D. or a Ph.D. in pharmacology, chemistry, biochemistry, neurology, or in a related field" and is "up-to-date on the developments in the field of treatment of seizures."
Nowhere did the board say that person needs to be familiar with cannabis.
"A cannabis drug fits pretty comfortably into a familiar legal framework," Pelletier said. "This patent wasn't treated noticeably differently from any other biopharmaceutical invention."
This could bring a degree of certainty to those who own or are applying for patents related to cannabis medications. Pelletier said attorneys know how to claim biopharma inventions and understand how those patents fare, both at the USPTO and in litigation.
"This case in some sense removes a few unknowns from the patenting perspective and helps situate this subject matter, namely cannabis therapeutics, in a more settled and predictable patent territory," she said.
Certain Patents May Be More Susceptible to Challenge
The amount of published information in the cannabis field is still relatively small, which attorneys attribute, in large part, to the federal government's view of marijuana.
What this means in the patent context is USPTO examiners have a smaller pool of prior art to refer to when reviewing an application for a patent. This has led to some concern that the USPTO has granted cannabis patents that are overly broad.
But the lack of available art can also make it difficult for companies to find grounds to petition for review of cannabis patents in IPR, where challenges are limited to anticipation or obviousness based on earlier patents and printed publications.
"If you don't have prior art, if that doesn't exist, as a petitioner you are sort of hamstrung in how you might seek to challenge the patent in an IPR," said Tryn Stimart, a director at Gibbons PC.
Grimm highlighted, in particular, patents that are directed to the cannabis plant.
"There is a lot of unpublished industry know-how surrounding breeding plants and the chemical makeup that might not be in a domain that's accessible to third parties to uncover and then use in a challenge," she said, noting this could change as the industry matures.
Perhaps easier to find is medical and scientific research involving marijuana-related treatments. This can make patents that specifically cover methods of treatment using cannabinoids — as GW Pharma's patent did — potentially more susceptible to a challenge.
"That certainly lends itself more opportunity to find prior art for challenging those patents," Grimm said.
In its ruling on GW Pharma's patent, the PTAB found the broadest patent claim was invalid but let most of the more narrow claims stand. Temeles said this reinforces the idea that companies applying for patents need to think strategically about their claims.
"It's fine to have broad claims, but you also want medium and narrow claims that cover your product, particularly in an emerging field like this," she said.
--Editing by Brian Baresch and Aaron Pelc.