This article was originally published on June 16.
A former Stanford University graduate student who last year sued the school and his faculty advisor for allegedly excluding him from patents related to a gene-modification technique he helped invent, this week filed an amended suit claiming that the advisor also plagiarized his PhD dissertation and lab notebooks to support additional patent applications, among other alleged misdeeds.
The former student, Christopher Sclimenti, also alleges that Stanford and the faculty member, genetics professor Michelle Calos, have financially benefitted from licensing the patents to at least one outside entity while denying Sclimenti his share of the profits, according to Sclimenti's lawyer.
The amended lawsuit, filed in the US District Court for the Southern District of California, alleges some 15 charges against Stanford and Calos, including intentional misrepresentation, breach of contract, copyright infringement, defamation, negligence, and unjust enrichment.
At the heart of the litigation is a pair of US patents, Nos. 6,808,925 and 7,141,426, entitled "Altered recombinases for genome modification." Both name Calos as the sole inventor.
As reported last year in BTW, Sclimenti sued his alma mater and former advisor on Sept. 22, 2008, for breach of contract and correction of inventorship on the patents (see BTW, 9-24-08).
That complaint, filed in the same court, alleged that Sclimenti, who obtained his PhD from Stanford in 2002 in cancer biology and molecular genetics, was originally named as a co-inventor on the application for the '925 patent, which Stanford's Office of Technology Licensing filed on behalf of Calos and Sclimenti in February 2001.
Sometime around July 2002, while the US Patent and Trademark Office was prosecuting the filing, Sclimenti claims the university removed his name from the '925 application. Meantime, in April 2004 Stanford and Calos filed an application for the second patent naming Calos as the lone inventor.
In October 2004, the '925 patent issued; and in November 2006, the '323 patent issued. Both patents name Calos as sole inventor and Stanford as sole assignee.
According to various documents supporting the claim, Stanford removed Sclimenti's name from the '925 patent application after it amended certain of the application's claims to satisfy USPTO requirements for awarding the patent.
But according to Manuel de la Cerra, a Carlsbad, Calif.-based intellectual property lawyer representing Sclimenti, Stanford and Calos modified the patent application at or around the same time the Stanford OTL was negotiating a licensing agreement for the IP with Poetic Genetics, a company co-founded by Calos in 2002 to commercialize gene therapies based on the technology.
"Right about the time they changed the inventorship, we believe Stanford was negotiating a license agreement with [Poetic Genetics] that had as an officer Calos," de la Cerra told BTW this week.
He said Calos wanted Sclimenti off the patent "for the sole reason of getting the entire kickback. The timing is very suspicious. They had no basis whatsoever to kick Chris off this patent, and they certainly had no basis to copy his work product and not give him credit."
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De la Cerra and Sclimenti also believe that Stanford has licensed the patents to other entities, and that Sclimenti "has not to this day received one penny … and Stanford has received a significant amount of money from licensing these patents," de la Cerra said, without elaborating. These complaints formed the basis of the original suit against Stanford and Calos.
It is unclear whether Stanford has licensed the patents to others besides Poetic or how much licensing revenue or equity the school and/or Calos has received from the Poetic deal.
Stanford's OTL directed all questions about the litigation and licensing of the patents to Stanford's Office of General Counsel. Neither Calos nor representatives from the Stanford OGC returned calls seeking comment. In September 2008, a spokesperson from Stanford's OTL told BTW that it is university policy not to comment on litigation in which it is a party.
However, under the Stanford OTL revenue-sharing policy, licensing revenues are to be split equally among the inventor or inventors, their academic department, and the university. According to the lawsuit, the inventors would be entitled to about 28.3 percent of any licensing fee, which would be divided among the inventors.
Amended Complaint
The charges in Sclimenti's amended suit stem from new allegations that since filing and being awarded the '925 and '426 patents, Stanford and Calos have filed an additional family of patent applications on which Calos is named sole inventor but which also essentially cite Sclimenti's research work.
According to de la Cerra, he and Sclimenti worked with an undisclosed "neutral party" to review the allegations in their first lawsuit, and during their research stumbled upon this second family of patent applications, excerpts of which Sclimenti recognized as his own PhD dissertation.
"We pulled out his thesis, and sure enough, [Calos] plagiarized word for word about 35 pages of my client's thesis and provided it as her own in the patent application," de la Cerra said. "So we amended the complaint to add a copyright violation because she is infringing my client's copyright."
According to the amended complaint, some two dozen paragraphs of US patent application 20060128020 and 20050208021, entitled "Methods of unidirectional, site-specific integration into a genome, compositions, and kits for practicing the same;" as well as one international patent application, "include word-for-word verbatim the work solely conceived, performed, and authored by [Sclimenti]" in his dissertation.
The suit also alleges that US patent application 20050208021 required a written declaration from Calos that she solely conceived of the method, and that Calos attached as evidence to support this declaration excerpts from laboratory notebooks that belonged to Sclimenti.
"At this point, what we're finding with this second patent family is that [Calos] is still doing what she did at first: stealing my client's work," de la Cerra told BTW. "And what's most disturbing is that she was the thesis advisor, so she has intimate knowledge of what he's doing; she's in a position of trusted authority, and she's stealing this stuff."
The second suit does not call for correction of inventorship on the more recently filed patent applications because such decisions are beyond the jurisdiction of a district court, de la Cerra said. However, in a separate action, de la Cerra and Sclimenti have filed a formal request with the USPTO to add Sclimenti as an inventor to the applications.
De la Cerra also told BTW that Stanford and the OTL filed the patent applications on Calos' behalf and thus should be held equally responsible.
"Every step of the way I've been on [Stanford] trying to get this thing moving, and they've waited to the last minute every time," de la Cerra said. "And this last time, the allegations I'm making are not a surprise to Stanford.
"Is it their responsibility to watch over their employee? Absolutely," he added. "Is it their responsibility to make sure that these lab notebooks were actually hers? I think it is."