- Drugs
- Thursday, 05 Mar 2020
The ITC Complaint Against Estar Medical in the U.S. Is Withdrawn by Regenlab
Regenlab USA LLC, a subsidiary of Regen Lab SA ("Regenlab") has withdrawn its U.S. International Trade Commission ("ITC") complaint against Estar Technologies Ltd. ("Estar Medical") and Eclipse Medcorp LLC (Inv. No. 337-TA-1147). In its pre-trial brief submitted to the administrative law judge, the ITC's official Investigative Staff Attorney ("Staff Attorney"), agreed with Estar Medical that the asserted claims of Regenlab's US Patent No. 10,064,894 ("'894 Patent") were invalid and not infringed by Estar Medical and Eclipse Medcorp. The Staff Attorney also agreed that RegenLab failed to show that it either has or is in the process of establishing a U.S. domestic industry.
Notably, the Staff Attorney also pointed to certain misrepresentations made by Regenlab and its CEO, Antoine Turzi, during the course of the ITC investigation and questioned their credibility: "Any one of these misrepresentations might be chalked up to a mistake or a typo. Taken together, however, the Staff views RegenLab's and Mr. Turzi's misrepresentations to the Commission and the other parties as reflecting poorly on RegenLab's and Mr. Turzi's credibility. And as noted above, much of RegenLab's evidence relies on Mr. Turzi's unsupported testimony. Whether or not Mr. Turzi appears credible is thus an important issue in the investigation."
Mr. Turzi's credibility issue was also raised during the UK trial in 2019, during which the UK Patents Court stated that he was "not being a reliable witness." In its ruling, the UK Patents Court stated that Regenlab's patent No.2073862 "is invalid for lack of novelty and inventive step."
Since then, Regenlab SA has been in breach of two UK High Court orders after failing to pay Estar Medical's extensive legal expenses, amounting to hundreds of thousands of pounds. In fact, while trying to delay these court-ordered payments, Regenlab admitted to the UK Court that such payments "could have a 'domino effect' on the viability of the business" and "would impact on Regen's business in a way that would be difficult to quantify financially" and that "the amount of cash Regen can access is limited."
It should also be noted that the Opposition Division of the European Patent Office (EPO) has also revoked Regenlab PRP patent in its entirety in Europe due to (i) lack of novelty; and (ii) added subject matter. Estar Medical filed an opposition against Regenlab's European PRP Patent in 2017, and the patent was revoked following a hearing in April 2019.
Estar Medical also defeated Regenlab in Germany and in the U.S. federal district court, winning a non-infringement judgment in the former and obtaining a dismissal in the latter. Regenlab's U.S. subsidiary and its CEO Antoine Turzi are also still facing antitrust claims in the U.S. federal district court in Manhattan, New York.
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