On May 05, 2021, Delaware court granted-in-part request of Granules pharma regarding inclusion of prosecution bar in protective order.

Plaintiffs (Avion pharma / Rx Omeg therapeutics / Romeg) sued Defendant (Granules pharmaceuticals) for infringement of US 9,907,751, US 10,226,423 and US 10,383,820 and US 10,383,821 patents. These patents are listed in OB for Gloperba (colchicine) oral solution and Granules pharma filed ANDA containing P-IV certification. Granules sought to impose restrictions on the individuals from Plaintiff side, who access its confidential information during litigation because both companies are competitors. Specifically, Granules proposed division of duties among Romeg executives between who manages litigation & who engages in competitive decision making (prosecution & regulatory activities). Romeg is a small company in which Dr. Muni & Dr. Vishnupad handles many functions including litigation, prosecution, regulatory etc. Romeg argued that proposed prosecution & regulatory bar would force Romeg to choose between the day-to-day activities & the litigation.

With respect to “Prosecution bar”, court said that for inclusion in protective order, it must first consider whether there is an “unacceptable” risk of an inadvertent disclosure or competitive use of confidential information. Defendant has met its burden of showing “good cause” requirement. The risk of inadvertent disclosure is high in this case because Romeg’s executives are competitive decision makers & the company is small. The risk of harm is heightened because both the parties are competitor in the market. On the other hand, to the Romeg, the harm is also significant if prosecution bar is included because it would impair Romeg’s ability to continue prosecuting pending applications. But, on balance, the risk of inadvertent disclosure outweighs the potential harm to Romeg. However, this bar should be limited to reissue proceedings & no other post grant proceedings. Therefore, Defendant’s request is granted-in-part with respect to “prosecution bar”.

With respect to “Regulatory bar”, court said that it has evaluated requests for regulatory bars by considering the Pansy factors. Requests for regulatory bars are generally denied because there is “little” risk of inadvertent disclosure of confidential materials to the FDA. Defendant’s proposed regulatory bar would prevent next party from receiving Defendant’s  confidential information from engaging in regulatory agencies. Defendant suggested that Romeg could ask the FDA to withhold the approval of Granules generic product based on non-public information. But, the language of protective order expressly prohibit Romeg from using confidential information for any other purpose mentioned in the order. Therefore, Defendant’s request is denied with respect to the “regulatory bar”.

Thanks to Chaitra Gowda for this tip!