“The list of possibilities is so long and intertwined that it is simply not known how many compounds the described genera and subgenera actually contain.” – CAFC
In a precedent decision published Monday, the US Court of Appeals for the Federal Circuit (CAFC) upheld a decision by the Patent Trial and Appeal Board (PTAB) to invalidate a pharmaceutical patent owned by the University of Minnesota.
Gilead Sciences is between the parties A 2017 review (IPR) challenged the university’s assertion of U.S. Patent 8,815,830 as unpatentable. The ‘830 patent covers compounds that prevent the reproduction of viruses and the growth of cancerous tumors.
The PTAB found that the University of Minnesota failed to provide a sufficient written explanation to support its patent priority claim. Therefore, the Board concluded that the patent does not direct the person skilled in the art to the claims of the patent.
The CAFC concurred with the PTAB’s decision and holding that the 2010 patent application publication filed by Gilead was “prior art” with respect to the University’s patent. The CAFC also ruled that it was incidentally estoppel for the university to claim that it was a sovereign state institution after the Supreme Court refused to hear that claim in a previous lawsuit.
problem at hand
Because the patent claims a genus of chemical compounds, according to the Circuit Court judge, the requirement for a written description “raises particular problems” in this case. Yes, because the patent owner must state “not only the outer limits of the genus, but also the outer limits of either the representative number of members of the genus or the structural features common to the members of the genus.” .
Gilead has a Food and Drug Administration (FDA)-approved drug, sofosbuvir, that falls under the genus claimed in the ‘830 patent. The pharmaceutical company markets the drug as a treatment for chronic hepatitis C infection. Gilead argued that one of its patent applications from 2010 anticipated the ‘830 patent.
Rather than arguing that the patent adequately describes the claimed subgenus, the University of Minnesota, when it determined that the two preceding patent applications did not contain sufficient written descriptions, the Board claimed to have made a mistake. Both the PTAB and CAFC disagreed with this allegation.
“Maze-like Road”
According to the Circuit Court Judge, the University’s argument is not “a description of what would have been described if each optional step were set as the only method,” but “each step represents multiple alternative paths.” It forms a maze-like road that provides option. “
The traveling judges quoted famous baseball player Yogi Berra, who is known for his proverbs.
“The list of possibilities is so long and intertwined that it is quite unclear how many compounds the described genera and subgenera actually contain,” the judges wrote.
Similarly, the PTAB ruled that the university failed to provide a sufficient blaze mark to support its patent priority claim. Again, the CAFC concurred with the Board’s decision.CAFC quoted here Fujikawa v. Wattanasin “Priority Application”[] Don’t direct directly to the specifically proposed tree.[] Don’t tell me where to go out of my way to find it. “
The CAFC also agreed with the Board’s opinion that the University of Minnesota mischaracterized its standards. ARIAD Pharmaceutical Co., Ltd. v.Eli Lilly & Company By arguing that disclosure of structural features is sufficient to show ownership of the claimed genus. Ariad The case establishes two additional requirements, the first of which the University of Minnesota agreed was not met.
The second requirement is the disclosure of “structural features common to members of the genus.” However, the PTAB ruled that the blazemark evidence was insufficient, and the CAFC ruled that it was “not erroneous.”
According to the court, these common structural features must constitute nearly the entirety of the compared structures. But “because the structure here is so extensive and diverse, [the first patent’s] Claim 47, by virtue of its multiple dependencies, encompasses a much larger genus than that claimed in the ‘830 patent, and has sufficient commonality with the claims of claim 1 of the ‘830 patent to provide written explanations. does not support,” the circuit court judge wrote. .
Ultimately, Gilead’s 2010 patent application is considered prior art to the patent because the Commission and the CAFC did not find a proper blazemark in the priority patent application, the court said.
Alleged APA Violation and Collateral Estoppel
The University of Minnesota also alleged that the PTAB “violated” several requirements of the Administrative Procedure Act (APA).
First, the university argued that the board failed to address the aspect of expert witness testimony. However, the CAFC cited precedent stating that “the board is not required to address every argument brought by a party or explain every possible reason that supports its conclusion.”
Second, the patent owner sought to cite an unprecedented written decision from the PTAB that the university argued contradicted the PTAB’s ruling in this case. However, the board and his CAFC ruled that the case was significantly different from the University of Minnesota case. The CAFC did not find any other APA violations outlined by the university in her.
Finally, the university claimed to be a sovereign state immune to the IPR. However, the CAFC previously dismissed this claim from the University of Minnesota, and the Supreme Court declined to hear it.
“Because this matter was ultimately litigated and decided on the merits, the State of Minnesota is estopped by estoppel from making any argument of immunity here,” the CAFC ruled.
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Author: Alexis84
