Tulane University is suing French pharmaceutical firm Ipsen for, among other things, alleged breach of contract, breach of fiduciary duty, and correction of inventorship in relation to patents surrounding a diabetes drug undergoing clinical trials in the US, according to court documents filed last week.
The drug, taspoglutide, is currently being shepherded through Phase III clinical trials by pharmaceutical giant Roche, which in 2006 acquired the rights from Ipsen to develop and market the drug in most of the world.
If the court finds in Tulane’s favor, the school could be in line to receive a portion of at least $76 million that Roche paid Ipsen as part of their licensing agreement, as well as royalties of 3.5 percent of net sales if the drug is commercialized, according to documents.
Tulane and David Coy, a professor of medicine and adjunct professor of biochemistry at the university, filed the suit last week in the US District Court for the Eastern District of Louisiana. The suit names as co-defendants Paris-based Ipsen, its US subsidiary Biomeasure, and its French subsidiary Societe de Conseils de Recherche et d’Applications Scientifiques, or SCRAS.
According to the suit, taspoglutide, also known as BIM-5077, was developed as part of a joint research program between Tulane and Biomeasure that lasted nearly two decades. Specifically, the suit claims that between 1984 and 2005, Biomeasure, which is based in Milford, Mass., funded scientific research at Tulane led by Coy related to designing and producing stable hormone peptide analogs.
During the course of this collaboration, Tulane said, Coy conceived of and shared with Biomeasure a group of analogs of the human hormone glucagon-like peptide, or GLP-1, which plays a key role in controlling blood sugar levels and is expected to be effective in treating diabetes and obesity.
The suit alleges that Coy shared these analogs, including BIM-51077, “at least as early” as the first of two joint research collaboration meetings held between Tulane and Biomeasure researchers in 1997 and 1998.
Following these meetings and early testing of the GLP-1 analogs between June and October 2008, Tulane alleges that Biomeasure filed two different sets of US patent applications relating to the analogs on Dec. 7, 2008.
The first set of patent applications names as co-inventors Coy and Biomeasure researcher Zheng Xin Dong, but “does not specifically recite BIM-51077 or the complete genus of compounds” that Coy developed and disclosed to Biomeasure, Tulane claims.
According to the suit, unbeknownst to Tulane or Coy, Biomeasure on the same day filed a second set of patent applications entitled “Analogues of GLP-1” on which Dong is named sole inventor.
The first set of “joint” patent applications issued as a US patent, and were included as part of a licensing agreement signed in 1999 between Tulane and Biomeasure, and referred to as the GLP-1 license, the school claims.
However, the second set of “Biomeasure-only” patent applications eventually turned into separate US and European patents, served as the basis for several continuation patents, and are claimed as priority in several pending US patent applications, the suit alleges.
These Biomeasure-only applications and related patent family were ultimately assigned to co-defendant SCRAS, and are the patents on which Ipsen claims taspoglutide is based.
In 2003, Roche signed an option agreement with Ipsen related to the Biomeasure-only patents, and in 2006 Roche exercised that option, acquiring exclusive worldwide rights to develop and market the drug, except in Japan where rights are shared with pharmaceutical company Teijin, and France, where Ipsen may elect to retain co-marketing rights.
“Biomeasure’s conscious decision to secretly develop a compound taspoglutide … which it now maintains is not covered by the GLP-1 license, constitutes a breach of Biomeasure’s duty of good faith and fair dealing.”
According to Ipsen’s 2006 annual report, the company received a €57.7 million (about $76.2 million at the time) option payment from Roche as a result of the licensing agreement. Future Ipsen annual reports allude to milestone payments received by Ipsen from Roche related to taspoglutide, but do not specify the amounts. Ipsen was unable to be reached for comment.
It appears that Tulane and Coy only became aware that a licensing deal had been struck between Ipsen and Roche in June when Roche announced plans to conduct Phase III clinical trials of taspoglutide as a treatment for type 2 diabetes, and alluded to the deal with Ipsen in that statement.
Also in June, following the announcement by Roche, a news story in NewWave, an official university publication, touted Coy’s role in the development of taspoglutide, and said that the drug that Roche licensed from Ipsen is the same that Ipsen licensed from Tulane. It also discussed the potential payoff to Tulane in terms of royalties should taspglutide be marketed.
It is unclear why Tulane published a news story claiming it had a stake in taspoglutide several months before the university filed its suit. Calls to Tulane were not returned in time for this publication.
The following month, Ipsen informed Tulane and Coy that neither was due a stake in taspoglutide, and that the compound was not covered by a Tulane patent, Tulane said in its suit.
As part of the suit, Tulane is claiming that, among other things, Biomeasure “has breached its obligations under its agreement with Tulane” by failing to assign to Tulane the Biomeasure-only patents, failing to name Coy an inventor on the patents, and failing to provide notice that it had licensed related patents to Roche or submitted related products to regulatory authorities for evaluation.
Further, Tulane is asserting “breach of duty of good faith and fair dealing” under its research agreement due to Biomeasure’s “willful and deliberate refusal to file a patent application directed to all subject matter identified by Coy during the joint collaboration … and conscious concealment of the identity of the clinical compound taspoglutide.”
In addition, the lawsuit alleges Ipsen with breach of the licensing agreement with Tulane; breach of fiduciary duty; and correction of inventorship related to the taspoglutide patents.
Among Tulane’s specific claims are that Biomeasure “failed to use its best reasonable efforts to develop a product covered by” the joint patent; “failed to provide written annual reports to Tulane;” and failed to provide notice of the Biomeasure-only patent applications. It also claims that Coy should be named as a co-inventor on the “Biomeasure-only” patents that became the basis for Ipsen’s deal with Roche.
“Biomeasure’s conscious decision to secretly develop … taspoglutide … which it now maintains is not covered by the GLP-1 license, constitutes a breach of Biomeasure’s duty of good faith and fair dealing,” the suit alleges.
“Tulane put Biomeasure in the GLP-1 business with the expectation of full and fair compensation, including royalties and fees as prescribed in the” research agreement, the suit continues. “Full and fair compensation for Tulane’s integral part in the development of the GLP-1 peptides … including taspoglutide …has not been forthcoming and now Biomeasure maintains that such will not be forthcoming.”
Lastly, Tulane claims that “despite being aware of [Tulane’s] reliance” on Biomeasure to protect the school’s fiduciary interests in IP stemming from their collaboration, Biomeasure “secretly tried to divide up the IP and deprive Tulane of its fair compensation. To that end, Biomeasure induced Tulane to sign the … 1999 GLP-1 license without knowledge of Biomeasure’s attempts to divide up the IP.”
It is unclear whether the research agreement between Tulane and Biomeasure stipulates that Tulane would receive a portion of any money received by Ipsen in a licensing deal, such as the €57.7 million it received from Roche.
However, in its lawsuit, Tulane asks the court to award it damages in an amount including, but not limited to, its fair share of “any payments received by Biomeasure and/or Ipsen in connection with the Biomeasure-only patent family or any other exercise of rights under” the research agreement or GLP-1 license between Tulane and Biomeasure.
The suit also claims that the GLP-1 license provides for royalties payable to Tulane, including an initial license fee and an annual license fee payable until the first commercial sale of a product, at which time Biomeasure was to pay Tulane a royalty of 3.5 percent net sales of any product sold by Biomeasure or any sublicenses in the US and any other foreign country where a patent has issued.
The market potential for taspoglutide is unclear. However, the June NewWave story said that similar drugs have worldwide annual sales exceeding $200 million.
“From what we can see — and from what the analysts are saying — we have a good chance of being the market leader on this because of ease of administration,” Coy said in the story. “If this becomes an important diabetes drug, royalties would be quite substantial.”