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Post by wyattdog on Aug 21, 2023 11:14:11 GMT -5
7:48 AM ET, 08/21/2023 - Briefing.com LQDA -8.2% (United Therapeutics (UTHR) was issued patent number 11,723,887, the claims of which generally cover the manufacture of treprostinil salts on Aug 15)
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Post by wyattdog on Aug 21, 2023 11:16:57 GMT -5
Liquidia to Defend Product Access 'Aggressively' After United Therapeutics Secures New Treprostinil-Related Patent 11:52 AM ET, 08/21/2023 - MT Newswires 11:52 AM EDT, 08/21/2023 (MT Newswires) -- Liquidia (LQDA) said in a regulatory filing Monday it is evaluating claims covered in the patent recently awarded to United Therapeutics (UTHR) related to the manufacture of treprostinil salts, indicated for the treatment of pulmonary arterial hypertension.
The new patent "belongs to the same patent family" of three patents that were subject to a previous lawsuit and covers the same basic method of manufacturing treprostinil, Liquidia said.
Liquidia plans "to aggressively defend the ability of patients to access the company's products," according to the filing.
United Therapeutics didn't immediately respond to a request for comment by MT Newswires.
Liquidia shares fell 1.7% in recent Monday trading, while United Therapeutics shares dropped.0.4%.
Price: 6.84, Change: -0.12, Percent Change: -1.72
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Post by hellodolly on Aug 22, 2023 5:31:37 GMT -5
The court result was highly predictable. Realistically there was no way the court would grant LQDA's appeal while UTHR's appeal against the rejection pf the '793 patent was outstanding. While UTHR is almost certain to lose the appeal the court couldn't put the genie back in the bottle if somehow UTHR won - they have to let UTHR's appeal run it's course before they allow LQDA to start selling. On LQDA's part this appeal was never going to succeed for the reasons above, but they had to try because it would have taken 6 months off the launch time line as it currently stands (they could launch late 2023 rather than mid 2024). The drop in the LQDA price is people pulling out money for a few months and investing it elsewhere before coming back nearer the launch date (there's little point in leaving money tied up going nowhere for 6 months.) The bottom line is that the launch remains on target for mid-2024. So, what is left of these patent suits? Launch still remains for mid-2024?
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Post by agedhippie on Aug 22, 2023 8:52:38 GMT -5
The court result was highly predictable. Realistically there was no way the court would grant LQDA's appeal while UTHR's appeal against the rejection pf the '793 patent was outstanding. While UTHR is almost certain to lose the appeal the court couldn't put the genie back in the bottle if somehow UTHR won - they have to let UTHR's appeal run it's course before they allow LQDA to start selling. On LQDA's part this appeal was never going to succeed for the reasons above, but they had to try because it would have taken 6 months off the launch time line as it currently stands (they could launch late 2023 rather than mid 2024). The drop in the LQDA price is people pulling out money for a few months and investing it elsewhere before coming back nearer the launch date (there's little point in leaving money tied up going nowhere for 6 months.) The bottom line is that the launch remains on target for mid-2024. So, what is left of these patent suits? Launch still remains for mid-2024? The only remaining legal action is UTHR appealing against the US Patent Office decision to revoke their patent. Once they lose that (95+% probability) the FDA will approve Yutrepia and it can be launched. The timelines for that are late this year or early next year depending on whether the court issues and oral or written judgement. There are claims they will launched early next year, but I think around June 2024 is far more likely. There is another complication for LQDA which is that UTHR has exclusivity for PH-ILD until March 2024 from the FDA so launching before that. even if they could, would be confusing.
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Post by wyattdog on Aug 22, 2023 9:37:40 GMT -5
from page 54 and 55 of liquida's form 10-q ● Tyvaso DPI, licensed from MannKind by United Therapeutics, is a dry-powder formulation of treprostinil that was approved for the treatment of PAH and PH-ILD in the United States in May 2022. There is a 54
Table of Contents
possibility that the FDA could grant three years of market exclusivity to Tyvaso DPI as an inhaled dry-powder formulation of treprostinil that could delay the final approval of YUTREPIA until said exclusivity expires.
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Post by agedhippie on Aug 22, 2023 10:09:16 GMT -5
Liquidia to Defend Product Access 'Aggressively' After United Therapeutics Secures New Treprostinil-Related Patent 11:52 AM ET, 08/21/2023 - MT Newswires 11:52 AM EDT, 08/21/2023 (MT Newswires) -- Liquidia (LQDA) said in a regulatory filing Monday it is evaluating claims covered in the patent recently awarded to United Therapeutics (UTHR) related to the manufacture of treprostinil salts, indicated for the treatment of pulmonary arterial hypertension. The new patent "belongs to the same patent family" of three patents that were subject to a previous lawsuit and covers the same basic method of manufacturing treprostinil, Liquidia said. Liquidia plans "to aggressively defend the ability of patients to access the company's products," according to the filing. United Therapeutics didn't immediately respond to a request for comment by MT Newswires. Liquidia shares fell 1.7% in recent Monday trading, while United Therapeutics shares dropped.0.4%. Price: 6.84, Change: -0.12, Percent Change: -1.72 The patent is really about UTHR trying to narrow the '393 patent to the point where it was defensible. Their issue was that the '393 patent was overbroad and there was a different production method (Phares) that produced the same result which was partly why UTHR lost the IPR. This patent narrows the scope in exchange for protecting their explicit process. I feel the LQDA response was them trying to get ahead of a perception that this would impact their timelines (which I don't believe it will.) There are already a lot of companies producing generic treprostnil including some of the very large generics pharmas.
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Post by agedhippie on Aug 22, 2023 10:21:37 GMT -5
from page 54 and 55 of liquida's form 10-q ● Tyvaso DPI, licensed from MannKind by United Therapeutics, is a dry-powder formulation of treprostinil that was approved for the treatment of PAH and PH-ILD in the United States in May 2022. There is a 54 Table of Contents possibility that the FDA could grant three years of market exclusivity to Tyvaso DPI as an inhaled dry-powder formulation of treprostinil that could delay the final approval of YUTREPIA until said exclusivity expires. That is from the Risks section of the 10Q which is a "kitchen sink" list of all risks, no matter how improbable, as disclosure provides a defense. This particular risk is only realized if UTHR wins the pending patent lawsuit which seems unlikely (he says tempting fate). Also from the 10Q: The FDA also confirmed that the clinical data in the NDA would support our pursuit of an amendment to our NDA to treat patients with pulmonary hypertension and interstitial lung disease (PH-ILD) upon the expiration of regulatory exclusivity in March 2024. We filed an amendment to our NDA to include PH-ILD as a labelled indication on July 24, 2023.
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Post by Clement on Sept 2, 2023 7:36:51 GMT -5
United Therapeutics Corporation to Present at the Morgan Stanley 21st Annual Global Healthcare Conference finance.yahoo.com/news/united-therapeutics-corporation-present-morgan-100000163.htmlUnited Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that James Edgemond, Chief Financial Officer and Treasurer, will provide an overview and update on the company’s business during a fireside chat session at the Morgan Stanley 21st Annual Global Healthcare Conference in New York City. The session will take place on Monday, September 11, 2023, from 12:55 p.m. to 1:25 p.m., Eastern Daylight Time, and can be accessed via a live webcast on the United Therapeutics website at ir.unither.com/events-and-presentations.
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Post by Clement on Sept 4, 2023 7:08:27 GMT -5
Re: TETON study -- inhaled treprostinil for IPF On Aug. 8, 2023 there were changes in Study Description as follows. Old: "Study RIN-PF-301 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) over a 52-week period." New: "Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52." Also the anticipated enrollment changed from 396 to 576. I wonder if those changes mean anything. Is the placebo (nebulized solution without treprostinil) providing health benefits compared to nothing?? And UTHR needs to show superiority with a strong p-value? Can UTHR see results for patients who by now have completed the specified 52 weeks of treatment? Anyone? classic.clinicaltrials.gov/ct2/history/NCT04708782?A=42&B=43&C=merged#StudyPageTop
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Post by agedhippie on Sept 4, 2023 10:39:02 GMT -5
Re: TETON study -- inhaled treprostinil for IPF On Aug. 8, 2023 there were changes in Study Description as follows. Old: "Study RIN-PF-301 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) over a 52-week period." New: "Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52." Also the anticipated enrollment changed from 396 to 576. I wonder if those changes mean anything. Is the placebo (nebulized solution without treprostinil) providing health benefits compared to nothing?? And UTHR needs to show superiority with a strong p-value? Can UTHR see results for patients who by now have completed the specified 52 weeks of treatment? Anyone? classic.clinicaltrials.gov/ct2/history/NCT04708782?A=42&B=43&C=merged#StudyPageTopThe question they are asking is if this works. TBH they already strongly suspect they know the answer from work in the INCREASE trial, but they need to prove it (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9402520). There are only four approved treatments for IPF, one of which is nintedanib. I am curious to see where MNKD-201 (inhaled nintedanib) goes in light of this. Was that work being done for a customer? The placebo will be an inert substance delivered by the same mechanism as the real drug.
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Post by tingtongtung on Sept 4, 2023 13:06:29 GMT -5
Re: TETON study -- inhaled treprostinil for IPF On Aug. 8, 2023 there were changes in Study Description as follows. Old: "Study RIN-PF-301 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) over a 52-week period." New: "Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52." Also the anticipated enrollment changed from 396 to 576. I wonder if those changes mean anything. Is the placebo (nebulized solution without treprostinil) providing health benefits compared to nothing?? And UTHR needs to show superiority with a strong p-value? Can UTHR see results for patients who by now have completed the specified 52 weeks of treatment? Anyone? classic.clinicaltrials.gov/ct2/history/NCT04708782?A=42&B=43&C=merged#StudyPageTopJust looking from plain English perspective (being naive!), changing from "evaluate the safety and efficacy" to "evaluate the superiority" means, they are good with both safety and efficacy and looking to check if it is superior? Wouldnt that be a good thing?
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Post by uvula on Sept 4, 2023 15:15:16 GMT -5
How do you ethically give someone a placebo for a horrible disease for 52 weeks?
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Post by wyattdog on Sept 6, 2023 17:19:08 GMT -5
Liquidia Technologies: United Therapeutics Corporation files lawsuit alleging infringement of Tyvaso patent already found to be invalid by U.S. Patent Office 4:40 PM ET, 09/06/2023 - Briefing.com MORRISVILLE, N.C., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company), announced today that United Therapeutics Corporation (UTHR) filed a patent infringement action under the Hatch-Waxman Act in the U.S. District Court for the District of Delaware (District Court) asserting infringement of U.S. patent No. 10,716,793 ('793 patent) in response to Liquidia's amendment to add the PH-ILD indication to the tentatively approved New Drug Application (NDA) for YUTREPIA (treprostinil) inhalation powder. The '793 patent was previously found to be unpatentable by the PTAB in an inter partes review (IPR) in July 2022, a decision that was reaffirmed by the PTAB in February 2023.Click here for full release.
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Post by agedhippie on Sept 7, 2023 16:59:36 GMT -5
Liquidia Technologies: United Therapeutics Corporation files lawsuit alleging infringement of Tyvaso patent already found to be invalid by U.S. Patent Office 4:40 PM ET, 09/06/2023 - Briefing.com MORRISVILLE, N.C., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company), announced today that United Therapeutics Corporation (UTHR) filed a patent infringement action under the Hatch-Waxman Act in the U.S. District Court for the District of Delaware (District Court) asserting infringement of U.S. patent No. 10,716,793 ('793 patent) in response to Liquidia's amendment to add the PH-ILD indication to the tentatively approved New Drug Application (NDA) for YUTREPIA (treprostinil) inhalation powder. The '793 patent was previously found to be unpatentable by the PTAB in an inter partes review (IPR) in July 2022, a decision that was reaffirmed by the PTAB in February 2023.Click here for full release. This filing is because LQDA filed to have Yutrepia cover PH-ILD as well as PAH. What UTHR is doing is making sure that if UTHR wins the appeal LQDA cannot get Yutrepia approved for PH-ILD. Really this is paperwork though which is why the share price is where it is as nobody expects LQDA to lose that case. If UTHR loses the appeal then the '793 patent is dead and the Hatch-Waxman filing, which this is now part of, is void since you cannot infringe a nonexistent patent.
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Post by harryx1 on Sept 8, 2023 12:02:05 GMT -5
Liquidia Technologies: United Therapeutics Corporation files lawsuit alleging infringement of Tyvaso patent already found to be invalid by U.S. Patent Office 4:40 PM ET, 09/06/2023 - Briefing.com MORRISVILLE, N.C., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company), announced today that United Therapeutics Corporation (UTHR) filed a patent infringement action under the Hatch-Waxman Act in the U.S. District Court for the District of Delaware (District Court) asserting infringement of U.S. patent No. 10,716,793 ('793 patent) in response to Liquidia's amendment to add the PH-ILD indication to the tentatively approved New Drug Application (NDA) for YUTREPIA (treprostinil) inhalation powder. The '793 patent was previously found to be unpatentable by the PTAB in an inter partes review (IPR) in July 2022, a decision that was reaffirmed by the PTAB in February 2023.Click here for full release. This filing is because LQDA filed to have Yutrepia cover PH-ILD as well as PAH. What UTHR is doing is making sure that if UTHR wins the appeal LQDA cannot get Yutrepia approved for PH-ILD. Really this is paperwork though which is why the share price is where it is as nobody expects LQDA to lose that case. If UTHR loses the appeal then the '793 patent is dead and the Hatch-Waxman filing, which this is now part of, is void since you cannot infringe a nonexistent patent. Once again you seemed to ignore that it's not a black & white case... mnkd.proboards.com/post/254256As you and Gregonius (on Stocktwits) speak in definitive terms regarding LQDA 100% winning all the appeals and launching in 2024, I hope people take caution. Not only is it not a certainty that LQDA will prevail, but if they do, it could still take years to go through the appeal process. The other item that I have brought up to Gregonius that he seems to ignore (and you probably will as well) is that the District Courts are not bound by PTAB decisions. The DC ruled that the patent was not invalid. The case is not black & white as you and Gregonius want people to believe, a lot can happen in courts that aren't expected. I've followed other companies that have been in patent disputes where it looked like one side had an iron clad case and end up losing. Again the District Court can supersede the Patent Death Squad aka PTAB and cases can be extended many, many years beyond the averages. Itzafugazi and I have both provided evidence of what I have stated above, so I hope people do their own DD. IMO, UTHR will at the very least do everything they can to drag the cases out to beyond the 2027 patent expiration. What happens when a district court and the PTAB disagree over the validity of a patent?
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