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Pig Model Law


From Judge Wendy Beetlestone (E.D. Pa.)'s opinion in Houser v. Feldman & Temple Univ., decided Thursday, here are the plaintiff's allegations (note, as usual, that they are just the allegations, since this is an opinion on defendant's motion to dismiss):

Houser and his laboratory staff ("lab") developed a pig model ("Pig Model") by inducing heart attacks in pigs and opening their arteries after ninety minutes. He and his lab then took tissue samples from these models ("Pig Samples"), conducted tests of therapies for the treatment of heart failure, and collected data pertaining to heart function ("Pig Data"). Houser alleges that, together, the Pig Model, Pig Samples and Pig Data ("Pig Materials") constitute his trade secrets. He further alleges that the Pig Materials are valuable because they have "broad clinical significance" as tests on such models are necessary precursors to the development of potential treatments and therapies for humans.

Defendant Feldman, like Houser, was studying heart failure. Specifically, he was studying the relationship between heart failure and levels of a molecule known as "BAG3" on a mouse model. Feldman did not have a large animal model like Houser's Pig Model, and his mouse model did not hold the same degree of relevancy or significance to the development of human therapies and treatments.

For whatever reason, sometime in 2014 or 2015, Feldman told one of the graduate students working in Houser's lab, Thomas Sharp, that Houser had authorized Feldman to use the Pig Data and Pig Samples for his BAG3 research and that Houser would be a collaborator on forthcoming papers. In reality, Houser had not provided any such authorization, and Feldman had managed to lure Sharp into providing him with Houser's trade secrets ("Stolen Pig Materials"). In 2015, Feldman and Sharp co-authored and published a paper that included the Stolen Pig Data and additional data derived from the Pig Samples. In 2017, Houser learned of this and reported Feldman to the Senior Associate Dean of Faculty Affairs at Temple's School of Medicine, who in turn, forwarded Houser's report to Temple's Integrity Officer and Vice President of Research, Michele Masucci.

Houser's report was made pursuant to Temple's "Policy on Misconduct in Research and Creative Work" ("Policy on Misconduct"), which protects "traditional principles of academic freedom" and requires that individuals "engag[ing] in or supervis[ing] research or creative work conduct[ ] their activities in an ethical manner." Houser contends that the Policy on Misconduct is incorporated into Houser's employment agreements with Temple….

The Policy on Misconduct provides that it "typically will be followed" upon a report of misconduct. Under its terms, an individual may complain of a violation or act of misconduct by reporting it to an Integrity Officer, like Masucci, who "preliminarily will assess" the complaint and determine whether sufficient information exists to refer the matter to an "Inquiry Committee." The Inquiry Committee then evaluates whether there is sufficient evidence of actionable misconduct to warrant an investigation or a formal proceeding to impose discipline or dismissal. The Committee provides a recommendation to the President of the University on the propriety of a formal proceeding, who ultimately decides whether to pursue further action or impose discipline.

About a week after Houser's report regarding Feldman's theft of his Pig Materials, Houser was told that Masucci would like him to accept an apology from Feldman. Houser accepted the apology and assumed that was all that could be done; Feldman did not return the Stolen IP or correct the 2015 Paper to note Houser's contribution. As far as Houser is aware, no inquiry or investigation into Feldman was launched pursuant to the Policy as a result of his complaint.

Things were quiet for a while, but then in October of 2018, Houser learnt, through a public posting by Harvard University, that a peer-reviewed paper he had authored with other academics was under scrutiny by Harvard and the American Heart Association for including a potentially fabricated figure. The concern arose due to the paper's affiliation with a disgraced former professor at Harvard University. Houser corrected the figure, the paper was unflagged and "remains accepted and competent scientific research." But that was not the end of the matter.

Around this time, Feldman—according to the Amended Complaint—began to falsely tell other people, including Houser's colleagues, that Houser was under investigation by Harvard as well as the National Institute of Health. Also, sometime between October 2018 through September 2019, Temple began a preliminary assessment into Houser related to the peer-reviewed paper as well as Houser's ties with the Harvard professor.

{The scope and purpose of this investigation is not clear from the Amended Complaint, likely because Houser himself avers that he was never informed about the scope of the inquiry or "the real reasons for the Inquiry." He alleges that Temple launched an "inquiry" into this paper, and asked Houser's staff and co-workers to gather information regarding "the collaboration between" Houser and the Harvard Professor."}

As part of Temple's assessment, on October 10, 2019, Houser was interviewed by attorneys from the law firm of Wilmer Hale LLP. At that interview, Houser complained about false statements Feldman made to two faculty members, Dr. John Daly and Patrick O'Connor, about Houser being under investigation. Somewhere in the midst of all this, Temple interviewed Houser's laboratory staff and collected his scientific notebooks and other documents.

While this investigation was pending, Houser contacted Masucci to ask whether Feldman had used the Stolen Pig Materials in connection with any patent filings as he had learned that Feldman's company, Renovcar, had obtained significant private investment for its BAG3 treatments. Masucci noted it was a fair question but declined to provide an answer until the close of Temple's investigation.

Houser's troubles only continued to mount. In 2020, Temple launched a second investigation into Houser following a complaint from the Office of Research Integrity of Department of Health and Human Services ("Office of Research Integrity"). This complaint pertained to anonymous allegations of plagiarism or fabrication made on the publishing website "PubPeer." This investigation is governed by regulations promulgated by the United States Secretary of Health and Human Services.

Over time, due to the investigations and Temple's failure to respond to his own complaints about Feldman, Houser lost faith in Temple. He again complained to counsel for Temple (in January 2020) and to Masucci that he believed Feldman had defamed him, but the University took no action. Because he no longer believed that Temple would respond in good faith to his question as to whether Feldman used the Stolen Pig Materials in patent filings, he enlisted a colleague to help him independently research the issue.

This search led him to the discovery, on November 17, 2020, that Feldman and Temple had jointly filed two U.S. patent applications and three foreign patent applications between 2015 and 2020, all of which include the Stolen Pig Materials. As of the date of the Amended Complaint, none of the five patents had issued. Houser alleges that the Defendants are relying on the Stolen Pig Materials to prosecute the patents. He further alleges that Renovacor is using the Stolen Pig materials to develop treatments for heart failure using BAG3, and that the Stolen Pig Materials were integral to both Renovacor's obtaining private equity financing and also merging with another entity—Chardan Healthcare Acquisition Corporation.

Houser alleges that based on the contribution of his Pig Materials to these inventions, he is, pursuant to the terms of Temple's Policy on Inventions and Patents ("Inventions Policy"), entitled to a portion of the net income from the use of his Pig Materials, but that he will be deprived of his profits because he is not named as an inventor or contributor on the patents….

For more on the legal dispute (related to breach of contract, unjust enrichment, trade secrets, defamation, and more), see the opinion. The defamation issue is basically this:

Houser claims that Feldman defamed him by telling their colleagues that "Dr. Houser was under investigation by Harvard and the National Institutes of Health ('NIH')" some time "[a]fter Harvard's listing of retraction requests in October 2018…." …

But this particular opinion focuses just on the statute of limitations question:

Applied here, all the Amended Complaint reveals about the timing of the alleged defamation is that there were several statements which were made to more than one colleague, and that they were made "[a]fter Harvard's listing of retraction requests in October 2018 were made public." The Amended Complaint does not specify the date on which Harvard's listing was made public, nor does it specify how many statements were made, or the dates on which they were made. All one can tell from the Amended Complaint is that at least some defamatory statements were made prior to October 10, 2019, the date of Houser's meeting with attorneys from Wilmer Hale LLP, because Houser professes to have informed the attorneys about "rumors [Dr. Daly and O'Connor] heard which were the same as those being disseminated by Dr. Feldman." It is evident from the face of the complaint that the one-year statute of limitations for the specific statements about which Houser complained in October 2019 had run by the time he filed this suit in February 2021.

But it is far from clear that the statute of limitations puts an end to Feldman defamation claim—as written the Amended Complaint can plausibly be read to suggest that there were more such statements made within the limitations period. Because it is not clear from "the face" of the Amended Complaint that all the statements which form Houser's defamation claim are time-barred, Feldman's motion to dismiss is granted with respect to those statements made to Dr. Daly and O'Connor which Houser disclosed to the Wilmer Hale attorneys and they shall be dismissed with prejudice. Feldman's motion shall be denied with respect to all other statements in that any such statements are not barred by the statute of limitations….