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Post by jkendra on Mar 15, 2024 10:10:46 GMT -5
news.bloomberglaw.com/ip-law/united-therapeutics-to-take-lung-drug-patent-fight-to-high-courtUnited Therapeutics Corp. plans to petition the US Supreme Court by June 10 to review its failed bid to revive a patent for its blockbuster lung-disease drug, Tyvaso, canceled by an administrative tribunal , according to a filing in Delaware federal court. UTC urged Judge Richard G. Andrews to deny Liquidia Corp.'s request to remove part of his 2022 judgment blocking final approval of its rival drug, Yutrepia, according to a letter filed Wednesday in the US District Court for the District of Delaware. The filing argues Liquidia’s request is premature a day after the company touted a favorable Federal ...
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Post by agedhippie on Mar 15, 2024 12:27:54 GMT -5
news.bloomberglaw.com/ip-law/united-therapeutics-to-take-lung-drug-patent-fight-to-high-courtUnited Therapeutics Corp. plans to petition the US Supreme Court by June 10 to review its failed bid to revive a patent for its blockbuster lung-disease drug, Tyvaso, canceled by an administrative tribunal , according to a filing in Delaware federal court. UTC urged Judge Richard G. Andrews to deny Liquidia Corp.'s request to remove part of his 2022 judgment blocking final approval of its rival drug, Yutrepia, according to a letter filed Wednesday in the US District Court for the District of Delaware. The filing argues Liquidia’s request is premature a day after the company touted a favorable Federal ... The full article suggests that UTHR are unlikely to get a friendly hearing from Judge Andrews. It quotes his "The sense I get is that the Plaintiff is simply trying to run down the clock" comment when he granted Liquidia's request to use material from the '793 case in the '327 hearing. I cannot see him letting the injunction remain in place for a Supreme Court appeal that everyone know will be rejected. |
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Post by longliner on Mar 15, 2024 13:05:30 GMT -5
news.bloomberglaw.com/ip-law/united-therapeutics-to-take-lung-drug-patent-fight-to-high-courtUnited Therapeutics Corp. plans to petition the US Supreme Court by June 10 to review its failed bid to revive a patent for its blockbuster lung-disease drug, Tyvaso, canceled by an administrative tribunal , according to a filing in Delaware federal court. UTC urged Judge Richard G. Andrews to deny Liquidia Corp.'s request to remove part of his 2022 judgment blocking final approval of its rival drug, Yutrepia, according to a letter filed Wednesday in the US District Court for the District of Delaware. The filing argues Liquidia’s request is premature a day after the company touted a favorable Federal ... The full article suggests that UTHR are unlikely to get a friendly hearing from Judge Andrews. It quotes his "The sense I get is that the Plaintiff is simply trying to run down the clock" comment when he granted Liquidia's request to use material from the '793 case in the '327 hearing. I cannot see him letting the injunction remain in place for a Supreme Court appeal that everyone know will be rejected. Your words, not his. The courts may do the right thing here. Everyone knows LQDA infringed on UTHR patents...  |
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Post by agedhippie on Mar 15, 2024 13:32:27 GMT -5
The full article suggests that UTHR are unlikely to get a friendly hearing from Judge Andrews. It quotes his "The sense I get is that the Plaintiff is simply trying to run down the clock" comment when he granted Liquidia's request to use material from the '793 case in the '327 hearing. I cannot see him letting the injunction remain in place for a Supreme Court appeal that everyone know will be rejected. Your words, not his. The courts may do the right thing here. Everyone knows LQDA infringed on UTHR patents... The Supreme Court picking up a unanimous non-precedent ruling from the CAFC upholding a PTAB finding and with a rejected en-banc appeal? Yeah, right.  Although I suppose it's all billable hours  |
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Post by neil36 on Mar 26, 2024 16:15:50 GMT -5
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Post by ktim on Mar 26, 2024 19:15:35 GMT -5
All the patients in their trial were on "background therapy", and remained on it. 60% were on "triple therapy" which I believe always has prostacyclin as one of the three drugs. The trials seem clearly to not be designed as replacements, but rather adjuncts, to existing therapies. It seems extending people's quality of life with PAH is tough enough it often involves throwing the kitchen sink at the problem. |
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Post by agedhippie on Mar 26, 2024 21:37:00 GMT -5
This is going to fall into two parts; existing patients and new patients. They will add this to existing patients treatment if the patient is stable so the base treatment remains. The new patients are more interesting and the couple of reports I read said they will use this as early as possible, ideally at diagnosis, and then they can use simpler drugs (sildenafil or tadalafil) with the aim of stopping the need to move to things like treprostinil. It is not going to work for everyone though. |
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Post by otherottawaguy on Apr 1, 2024 12:02:02 GMT -5
LQDA
snip :
09:58 AM EDT, 04/01/2024 (MT Newswires) -- Liquidia (LQDA) said Monday that a US court has set aside an injunction that had prohibited the US Food and Drug Administration from issuing final approval of Liquidia's amended new drug application for Yutrepia inhalation powder.
Liquidia said Yutrepia was tentatively approved by the FDA in November 2021 to treat pulmonary arterial hypertension. Liquidia amended its NDA in July 2023 so that it could also be used to treat pulmonary hypertension associated with interstitial lung disease.
United Therapeutics (UTHR) sued the FDA to prevent it from approving the amended NDA as its Tyvaso had exclusive rights to treat pulmonary hypertension associated with interstitial lung disease. However, those exclusive rights expired on Sunday, according to Liquidia.
Liquidia said United Therapeutics has appealed the decision to set aside the injunction, and has filed two separate lawsuits seeking new injunctions against Yutrepia.
Representatives for United Therapeutics did not immediately respond to a request for comment from MT Newswires.
(Started this as a "New" topic)
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Post by cppoly on Apr 17, 2024 8:07:31 GMT -5
Aged, any thoughts on what's going on with Yutrepia? I think you mentioned a while back there would be a 2 month delay. We're closer to 3 and I can't help wonder what's going on. Thanks
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Post by agedhippie on Apr 17, 2024 16:32:02 GMT -5
Aged, any thoughts on what's going on with Yutrepia? I think you mentioned a while back there would be a 2 month delay. We're closer to 3 and I can't help wonder what's going on. Thanks I think the next hearing is the 29th April unless the FDA decides to approve it sooner (I don't think they will) in which case there will be a 3 day warning before approval. I vaguely feel like there was meant to be something on the 19th as well, but I am unsure of that. |
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Post by agedhippie on Apr 17, 2024 19:30:59 GMT -5
It looks like there was something out there I was forgetting, but not on the 19th! There was a court status review today for UTHR's request for an injunction to prevent Yutrepia being used for PH-ILD. As I had expected it went badly for UTHR and they won't be getting the injunction. This is what happens when the judge thinks you are trying to game the system. For me the tell was his earlier comment about plaintiffs using the courts to run down the clock. The ruling will be next week.
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Post by bones1026 on Apr 17, 2024 21:55:58 GMT -5
It looks like there was something out there I was forgetting, but not on the 19th! There was a court status review today for UTHR's request for an injunction to prevent Yutrepia being used for PH-ILD. As I had expected it went badly for UTHR and they won't be getting the injunction. This is what happens when the judge thinks you are trying to game the system. For me the tell was his earlier comment about plaintiffs using the courts to run down the clock. The ruling will be next week. One again, I tip my hat to you, not even an investor in MNKD, but come here and do this level of research on our behalf, is welcomes and appreciated…🫡🫡 |
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Post by agedhippie on Apr 17, 2024 22:07:44 GMT -5
One again, I tip my hat to you, not even an investor in MNKD, but come here and do this level of research on our behalf, is welcomes and appreciated…🫡🫡 No need for thanks, just happy to help. 🫡 |
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Post by agedhippie on Apr 18, 2024 20:22:49 GMT -5
The rejected motion is on the Bloomberg Terminal courtesy of Bloomberg Law. The headline is " UTC's losses mount in bids to delay Liquidia's rival lung drug". Denying the UTHR motion the judge said that an invalid patent cannot give rise to an injunction. My personal favorite is the footnote the judge wrote  "I also doubt that the public interest is served by keeping a drug off the market because of an competitor's expired patent." |
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Post by cppoly on May 6, 2024 11:24:22 GMT -5
Anyone else wondering why there's such a delay from the FDA with Yutrepia?
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