Court says doctor's report can't be included in dispute over synthetic opioid patents

By Takesha Thomas | Dec 4, 2018

NEW ORLEANS – The U.S. District Court for the Eastern District of Louisiana recently ruled that a report from a doctor cannot be presented regarding a dispute over patents involving a synthetic opioid compound. 

In a Nov. 26 filing, U.S. District Judge Susie Morgan ruled that the motion in limine presented by the United States and the Administrators of the Tulane Education Fund against Cytogel Pharma LLC would be granted. Cytogel had requested that the expert report of Dr. Gregory K. Bell be used in the lawsuit involving the parties. 

According to court documents, Bell's report for Cytogel assessed the impact of the alleged actions of Tulane University, Dr. James E. Zadin, and the Department of Veterans Affairs on the “commercial value and opportunities of Cytogel.” The report stems from a lawsuit involving several patents regarding an opioid compound.

 Zadina and his colleagues at Tulane researched and developed opioid compounds related to endomorphins in the 1990s. Tulane obtained two patents claiming these compounds. In December 2003, Tulane entered into a licensing agreement with Cytogel where the patents were handed over, court papers state. 

Zadina, an employee of Tulane and the VA, began performing consulting work for Cytogel, eventually executing a consulting agreement. According to court documents, while advising Cytogel, Zadina developed a synthetic opioid peptide that was covered under two of the patents for commercial use as an analgesic.

In court filings, Cytogel alleges that" Zadina accessed confidential data and information relating to Cyt-1010 and used this information to further his own secret work on the development of compounds that would compete directly with Cyt-1010." Cytogel filed a U.S. provisional patent application in July 2010.

In September 2010, Tulane informed Cytogel via email that Zadina had designed a “new family of peptides." In August 2012, Zadina and a Tulane colleague "formally assigned to Tulane and the VA their ownership rights to a patent application that incorporated and claimed the benefit of the provisional application." In May 2014, Tulane and the VA were issued patents for the new family of peptides.

Cytogel argued to have Bell's report submitted as evidence. According to court filings, Bell's report includes the "estimated value of the commercial opportunities available to Cytogel in a counterfactual situation in which Cytogel had ownership of the 436 Patent compounds in July 2010. Dr. Bell then estimates the value of the opportunities available to Cytogel in two hypothetical scenarios in which Cytogel is awarded damages at the resolution of the instant case."

Attorneys for Tulane and Zadina argued that Bell's opinions are "irrelevant, unreliable and based on speculative and unsupported assumptions."

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