Researchers who have acclimated to a publish-or-perish environment are in for a climate change when the first-to-file provision of the America Invents Act (AIA) settles over the land next March.
At the front of that change is the Patent and Trademark Office's (PTO) proposed rule to expand the reach of prior art. If the rule is finalized, researchers who publish too soon before a patent application is filed could see the claims perish.
"There's a real danger to publishing before you file" under the proposed rule, Banner & Witcoff shareholder Paul Rivard told BioWorld Insight, explaining that publication, in most instances, would be considered prior art.
The rule expands the definition of prior art to include disclosures made by anyone, even the applicant, prior to the filing of a patent application. However, there are a few exceptions. Disclosures made by the patent applicant within a year of the filing date would not be considered prior art, Rivard said.
But if a third party publishes something on the invention in that year, it would be prior art – unless the applicant can show that the publication stems from its own disclosure or prior publication within that year.
This is a narrow exception, said Courtenay Brinckerhoff, a partner at Foley & Lardner, as the PTO expects strict correlation between the third-party publication and that of the applicant. In other words, the third-party publication can't reveal more than the applicant did; otherwise, it's prior art. And applicants will need to keep records of disclosures they've made so they can prove a subsequent third-party disclosure originated with them.
Clouded Collaborations
The PTO's expansion of prior art could increase the tension that often exists between academic researchers who feel the pressure to publish and patent attorneys trying to ensure clear skies for a university's or biotech's intellectual property, Rivard said.
That tension has clouded a number of industry-university collaborations, as industry research tends to be more secretive and patent-focused. Because of that tendency, the biopharma industry should be able to adjust to the new prior art climate, Brinckerhoff said.
The technology transfer offices at major universities also are well aware of the changes that need to be made to protect the patentability of research. But smaller universities where patents tend to be secondary to publication will have to change their environment if they hope to profit from their research, Brinckerhoff added.
The publish-or-perish environment pre-dates the 1980 Bayh-Dole Act, which allowed universities, for the first time, to patent the results of their federally funded research. In opening that revenue stream, Bayh-Dole unleashed an economic current that helped form the biotech industry by turning early stage academic research into approvable drugs.
In its first 30 years, Bayh-Dole spawned more than 130 new drugs, vaccines and devices, adding at least $187 billion to the U.S. gross national product and creating nearly 300,000 jobs. (See BioWorld Today, Dec. 2, 2010.)
Despite the success of Bayh-Dole, some academic researchers are still locked into early publication. Given the PTO's proposed disclosure restrictions, which are stricter than those in the AIA itself, researchers must be advised that their publications could affect the ability to patent an invention, Rivard said.
"It's going to be at your peril if you publish before you file," he reiterated.
There doesn't need to be a conflict between patents and publications, as they can be written simultaneously, Mao Mao, a research fellow at Pfizer Oncology Research, said during a session at the Society for Laboratory Automation and Screening's annual meeting earlier this year. (See BioWorld Today, Feb. 7, 2012.)
By writing them at the same time, the paper can be submitted almost as soon as a patent application is filed, he added.
Also in the Forecast
Prior publication isn't the only threat to patentability under the proposed rule. The PTO's expansion of prior art includes other activities, such as selling a product in another country before filing for a U.S. patent, Rivard said.
The prior art rule is one example of how the new first-to-file system, modeled on what other countries do, will change patent strategies in the U.S. The biggest danger once first-to-file is implemented March 16 is that a researcher, company or university could lose the right to patent its work, Brinckerhoff said.
Prior art is just one way an inventor could lose out under the AIA. While filers must be the inventors, or their assignees, they could be denied a patent if someone who was working independently on similar research files for a patent first. Under current law, the first inventor could protect its claims by showing its earlier work. The loss of that protection will make the filing date more important, Brinckerhoff said.
Because of the upcoming changes in the rules, both Rivard and Brinckerhoff encourage applicants to file claims under the old patent system before the new one kicks in with its expanded definition of prior art. At the same time, biopharma needs to prepare for the switch to first-to-file, they said. (See BioWorld Today, Aug. 24, 2012.)
Comments on the proposed disclosure rule are due Oct. 5. After reviewing stakeholder comments, the PTO could ease up on its definition of prior art in its final rule. The office listened to stakeholders in shaping the final rules to implement AIA provisions that take effect Sept. 16, Brinckerhoff said.
Those rules, which are largely procedural, cover such provisions as:
• an assignee's right to file and prosecute patent applications;
• new supplemental examination proceedings;
• new trial proceedings to be conducted by the Patent Trial and Appeal Board, including inter partes review, post-grant review and the transitional program for covered business method patents.
Regardless of how the PTO shapes the final rules for the first-to-file provisions, the full impact of the AIA won't be known for several years, Brinckerhoff said. A lot will depend on how people use the challenge provisions included in the law, she added.
And it will depend on how the courts rule on future lawsuits testing some of those provisions, Rivard said, adding that the law presents real questions that will likely lead to litigation.