Aralez Pharmaceuticals will press charges against Teva in the USA for infringing four patents.
Aralez and its subsidiaries Aralez Pharmaceuticals Trading DAC (APTD), Aralez Pharmaceuticals US Inc. (APUS), and Pozen Inc. (Pozen), said on Friday it has filed a lawsuit in the United States District Court for the Eastern District of Texas against Teva Pharmaceuticals USA, Inc. for infringement of four patents covering Yosprala (aspirin and omeprazole)
According to Aralez’s press release, the patents are currently listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) of the FDA, and another patent Pozen plans to list in the Orange Book.
As the company said, the lawsuit is about an Abbreviated New Drug Application (ANDA) filed by Teva with the FDA seeking FDA approval to market generic versions of Yosprala 325mg/40 mg and 81mg/40mg before the expiration of the identified patents.
Aralez’s press release further reads: “November 4, 2016, the FDA website indicated that an ANDA for a generic version of Yosprala 81mg/40mg was submitted on October 14, 2016, as described in more detail in the “Legal Proceedings” section of the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission on November 8, 2016 (the “September 2016 Quarterly Report”). The Company ultimately received the related Teva Paragraph IV certification notice on December 12, 2016, which included Yosprala 325mg/40mg in addition to Yosprala 81mg/40mg.”
Eli lilly v. Teva
Earlier in January, in a case of Eli Lilly versus Teva Parenteral Medicines, the court affirmed the earlier district court’s rulings that the vitamin regimen patent is valid and would be infringed by the generic challengers’ proposed products. If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force. The Alimta compound patent remains in force through January 24, 2017.
Teva paid $519 to U.S. for foreign bribery charges
Israeil’s largest drugmaker Teva Pharmaceuticals Industries in December 2016, settled with the United States government over international bribery of government officials in Russia, Ukraine and Mexico in violation of the Foreign Corrupt Practices Act (FCPA).