In re Fisher (Fed. Cir. 2005)(04–1465) (Oral Arguments Scheduled for May 3, 2005).
Fisher could have an even greater impact to the field biotechnology than the upcoming Supreme Court case of Merck KGaA v. Integra. After being denied a patent by the USPTO’s Board of Patent Appeals & Interferences (BPAI), Monsanto has appealed to the Court of Appeals for the Federal Circuit (CAFC).
Monsanto’s argument is that the USPTO, without any statutory authority, is applying a heightened standard of utility to biotechnology inventions — specifically their argument is directed to the standard of usefulness under 35 U.S.C. Section 101 applied to nucleotide sequences known as expressed sequence tags (EST’s). [EST definition]. On appeal, Monsanto has asked the CAFC to consider whether the BPAI’s ruling that EST’s corresponding to genes of unknown function are incapable of satisfying the utility requirement, even though the EST’s are quite useful as research tools.
Monsanto’s appeal is a blunt attack against USPTO patent prosecution procedures and will impact a large number of biotech applications, past, present and future. Hal Wegner has noted Monsanto may even be hoping to lose the appeal and thereby firmly establish a standard of utility that would keep others from obtaining patents in the area.
The briefs have all been filed, and oral arguments are scheduled for May 3, 2005.
I have uploaded the briefs filed in the case.
- Monsanto’s In re Fisher CAFC brief.pdf
- USPTO brief.pdf
- Monsanto’s reply brief.pdf
- Amicus brief by Eli Lilly et al.pdf
- Amicus brief by Affymetrix.pdf
- Amicus brief by Genentech.pdf
The BPAI Decision is Available here: File Attachment: Ex Parte Fisher.pdf (209 KB)
Thanks to Paula Davis at Eli Lilly and Stephan Walsh at the USPTO for providing the PDF versions.