... the parties over. Next patent ruling from the court is scheduled for mid December. With the last 3 rulings and markman decisions going completely against us the court is letting the generic manufacturer's know we are not going to win this case and that the basis of our contentions are unfounded. Have you closely read the details of the last markman decision the court handed down on 10/8. I'm hearing the December ruling is to be even more damaging than the last 4 and will open the door for a generic launch at risk right after the first of the year. It was a fun party while it lasted. The past year and a half have been great. No new Latuda studies and no worth while data to share. Quick reminder detail, log calls and I'm off to the gof course by noon if not sooner every day. I will miss that. The pediatric exclusivity associated with Sunovion’s composition-of-matter patent for Latuda (lurasidone hydrochloride) is set to expire on January 2, 2019. In an effort to protect Latuda from generic competition beyond January 2019, Sunovion has sued several ANDA filers for infringement of a 2024 method-of-use patent and a 2027 formulation patent. During the litigation, Sunovion and the ANDA filers disputed the meaning of certain terms in those patents. In September 2018, Judge Stanley Chesler of the U.S. District Court for the District of New Jersey (Newark) held a “Markman” hearing to interpret the disputed terms. This afternoon (Thursday, October 9, 2018), Judge Chesler issued a “Markman” decision setting forth his interpretation of the disputed terms in Sunovion’s 2024 method-of-use patent and 2027 formulation patent. Judge Chesler’s Markman decision generally favored the ANDA filers. Judge Chesler’s Markman decision appears to make it more difficult for Sunovion to prove that the 2024 method-of-use patent covers the proposed generic tablets. Judge Chesler’s Markman decision also make it more difficult for Sunovion to prove that the 2027 formulation patent covers some of the proposed generic tablets. Because Sunovion has asserted the 2027 formulation patent against only some of the ANDA filers (but not others), that patent only affects the number of ANDA filers that may enter the market on “Day 1” of generic competition. The trial in the lawsuit will begin on November 26, 2018. We expect Judge Chesler to issue his post-trial decision sometime in late December, shortly before the pediatric exclusivity associated with Sunovion’s composition-of-matter patent expires on January 2, 2019. If Judge Chesler issues a post-trial decision in favor of the ANDA filers (for example, by declaring that the 2024 method-of-use patent does not cover the proposed generic tablets or is invalid), then it is possible that the ANDA filers could launch “at risk” as early as January 2019. In our prior updates, we had stated our view that the 2024 method-of-use patent provided Sunovion with leverage to negotiate settlement agreements that would permit generic competition to begin sometime in 2021-2022. Today’s Markman decision appears to reduce Sunovion’s leverage This afternoon (Tuesday, October 9, 2018), Judge Chesler issued a “Markman” decision setting forth his interpretation of the disputed claim terms. The Markman decision generally favored the ANDA filers
1 November 27, 2018 Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma Announces Resolution of Disputes under Consolidated Patent Infringement Lawsuit Regarding ANDAs for L AT U D A ® in the U.S. Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura) announced today that, as a result of settlements (the “Settlements ”) with remaining defendants of the consolidated patent infringement lawsuit (the “Lawsuit ”), jointly filed with its U.S. subsidiary, Sunovion Pharmaceuticals Inc. (“Sunovion”), before the U.S. District Court for the District of New Jersey (the “Court ”) in February 2018 against a total of 16 generic companies seeking to market a generic version of their proprietary atypical antipsychotic agent, LATUDA ® (lurasidone HCI), based on U.S. Patent No. 9,815,827 (the “827 Patent ”) and U.S. Patent No. 9,907,794 (the “794 Patent ”), all disputes underly ing the Lawsuit have been resolved. After filing the Lawsuit, Sumitomo Dainippon Pharma and Sunovion had, while pursuing the Lawsuit, engaged in negotiation with defendants for settlements, following the Court ’s order, and the number of defendants of the Lawsuit had reduced through withdrawal and settlement agreements. As a result of the Settlements, all disputes underlying the Lawsuit have been resolved and the Lawsuit will conclude with respect to all the defendants thereof, following confirmatory procedure of the Court. Pursuant to the Settlements and other settlement agreements entered with some of the defendants of this Lawsuit, certain number of generic companies that were parties to the Lawsuit will be permitted to distribute their generic versions of lurasidone HCL starting on February 21, 2023. Other terms and conditions of the settlement agreements will not be disclosed.
This is great other than the fact there are still 3 unresolved lawsuits plus, top talent leaving and a hiring freeze. I guess when you cancel any field activity like lunches and dinner programs our home office should expect a lot of turn over which is on going. Turn out the lights, the party is over.
Nah, it looks like all 16 settled, according to post 5. Terms undisclosed, meaning we paid some of them a shit pot load of money to delay their entry into the market. Gives us four more years to in-license more winning products like the trio of castoffs from Nofartus.
Of course we paid a lot of $. What else do we have? Our respiratory products literally are DOA. Little to no managed care coverage and me too products. Sunovion is on life support. Paying theses generic houses big $ to keep Latuda going is our ventilator. Once the decision to pull that plug is made, Sunovion will go into the abyss.
We have some more time? The same bad management that caused this problem is still in place. Until there is a complete change with senior management, this ship is taking on water and sinking fast. There are not any successful companies that have a hiring freeze plus not allow for lunches or dinner programs. The gig is up, turn out the lights the party is over. Our leadership had failed and continues to fail.
Brand new year with same bad management leading the company. This brand new year will bring more of the same with people continuing to leave while we are being told everything is just fine. Turn out the lights the party is over on day one of a brand new year.
