First Inventor to File
Ron D. Katznelson, Ph.D., president of Bi-Level Technologies, contends that by adopting first-inventor-to-file, the U.S. walked away from a successful system that equitably determined the first to conceive inventions as long as conception was followed up by reduction of the invention to practice during a “grace” period.
America Invents Act retains a one-year grace period but narrows it to prefiling “disclosures” by the inventor, derived from the inventor, or after the inventor had already publicly disclosed as well as disclosures appearing in applications and patents. Since “disclosure” is undefined, it remains to be interpreted whether the grace applies to all prior art including “on-sale” activity.
“The problem is, when I have an inventive and valuable concept, I don’t necessarily want to publish it until I actually obtain a patent. It may not be complete,” Dr. Katznelson told GEN. “Even if I publish it early to gain priority, it wouldn’t have the details that I’d need to enable some of the claims, and others’ intervening disclosures based on what they learned from my early publication would act against me. I may have no effective patent protection for the concept.”
By emphasizing reduction to practice, Dr. Katznelson said, America Invents compels biopharma startups to rush to file patent applications, at risk of not completing the experimentation and vetting needed so others can practice the claimed invention. Risks for smaller biopharmas include:
- filing earlier and more often, at significant cost, or risking losing patent rights.
- filing before “on-sale” events such as pilot production of drugs requiring a paid subcontractor and other commercial transactions allowed under the old grace period.
- increasing vulnerability to disclosure because they are likelier than big biopharmas to employ outside collaborators, strategic partners, or consultants.
Biopharma manufacturers will have to decide how much of their manufacturing processes to patent and how much to shield from disclosure by keeping them in-house as trade secrets, said John D. Garretson, a partner with the law firm Shook Hardy & Bacon L.L.P. That decision will vary from drug to drug as well as how widely the process is applicable to producing other drugs or to improving the product lines of other companies: “In many situations if you have a process that really confers an advantage on a particular drug from a trade secret standpoint, the question is whether or not in the particular circumstances you might be better off getting a patent and deriving licensing revenue from that.”