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Post by prcgorman2 on Dec 29, 2021 15:08:03 GMT -5
Generally speaking, patents don’t preclude others from doing what is in a patent, only that they would need to first acquire a license on Fair, Reasonable, and Non-Discrimantory (FRAND) terms.
An interesting thing to note here is the strategy UTHR has employed with regard to protecting the value in their Treprostinil PAH medication. They bought one small company to eliminate their competition. They sued LQDA (and I totally believe it was because LQDA wanted too much and it was cheaper to sue them). And with respect to MNKD’s development of TreT, UTHR paid out over $200M between the development milestone payments to Mannkind and the PDUFA.
It doesn’t sound like LQDA is worth paying too much for if their competition is “at least” 10% market share. Caveat emptor.
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Post by sportsrancho on Dec 29, 2021 16:35:31 GMT -5
cretin11 I'm not sure if there are/were any restrictions for going over 100 mcg The analyst said LQDA’s patent precludes UTHR/MNKD from doing that, but I don’t have any independent verification of that. mnholdom just mentioned to me that more than one dose could be taken, as in a follow-up dose. |
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Post by cretin11 on Dec 29, 2021 17:49:05 GMT -5
The analyst said LQDA’s patent precludes UTHR/MNKD from doing that, but I don’t have any independent verification of that. mnholdom just mentioned to me that more than one dose could be taken, as in a follow-up dose. Thanks. So it sounds like there may be validity to the issue of us dosing over 100. But there’s a workaround at least. |
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Post by sayhey24 on Dec 29, 2021 20:30:29 GMT -5
Interesting comments but I’m not convinced that I should buy LQDA. He talked about the patent infringement and said he thought LQDA would prevail but didn’t mention the other lawsuit about theft of trade secrets. I was confused about this patent for maximum dosing, saying that LQDA owned the 100mg dose and the higher the dose the more effective the product would be??? He said UTHR tried to license the print technology but offered too little (10% royalty) and was rebuffed. (There was no public disclosure of this.) He said UTHR could cancel the MNKD deal with 30 day notice and return to LQDA before or after March (court hearings) and market their product since we have a CRL. He insinuated that the MNKD product was a failure and didn’t say that the CRL was due to a 3rd party test house. Or UTHR could buy them out to eliminate the competition for PAH. He also gave the “go it alone” scenario with the product or other buyers for the company now that they have an FDA approved product which should capture at least 10% of the PAH market. He did not mention other indications. He gave a down side risk of $3 and an up side of 2-3x this coming year or a buyout of $15-20. I am not really convinced this guy knows what he is fully talking about. I am not sure how LQDA holds a patent on TreT dosing. I doubt they own a patent on the MNKD cartridge which would hold 100mg+ of TreT. Moreover, if a patient needed more than 64mg I would think they could take a 64 and 48. How many patients need 100+. Is it even worth manufacturing a 100+ cartridge? He also talked about a severe cough when taking more than 100. I have not heard of that in the TreT studies as I thought it was well tolerated but assuming you are increasing the volume of powder in the cartridge, coughing a little could be expected depending on how much is hitting the back of the throat. We see that with afrezza and I would think LQDA would see the same with their powder. I would be surprised if they didn't. I assume he is not aware that afrezza is highly stable even when not refrigerated. I would assume TreT would inherit the same Technosphere stability. It sounded like he thought LQDA had something unique here. I highly doubt UTHR is backing out of the MNKD deal after spending a ton of $$$ building the production facility in Danbury and is currently paying MNKD to make product. Does LQDA even have a production worthy facility? I know the FDA approved something but what? Maybe its good. I have not seen it. Will it scale? I kind of think they have something similar to what MNKD had during their trial days which was not production scalable but maybe they do. It cost about $200M to build the original afrezza plant. Does LQDA have that kind of money? At the time of the interview I got the impression he was not expecting UTHR to refile as fast as they did. Well, to bad so sad. MNKD is already making product and UTHR will be ready to go Day 1 of approval with sales of TreT. By the time LQDA is really ready to scale up sales UTHR could have 1-3 years of TreT sales. IMO, LQDA should have taken the 10% deal with UTHR. One thing Al always said was you needed 10 things to launch a new business and the first three things where money, money and more money. |
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Post by prcgorman2 on Dec 29, 2021 23:18:06 GMT -5
I agree with whoever it was that posted that the LQDA announcements and pro-posts look desparate and sketchy. Martine is one shrewd cookie. I’m unconcerned LQDA represents a significant wildcard.
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Post by cretin11 on Dec 30, 2021 3:25:56 GMT -5
I agree with whoever it was that posted that the LQDA announcements and pro-posts look desparate and sketchy. Martine is one shrewd cookie. I’m unconcerned LQDA represents a significant wildcard. Martine is definitely shrewd. She wanted to make a deal with LQDA before, what are the odds she doesn’t try again? The litigation is impossible for any of us to accurately handicap without being on the inside in the trenches. Check out that guy Finn’s resume, he’s apparently pretty shrewd as well. |
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Post by sportsrancho on Dec 30, 2021 6:56:10 GMT -5
It’s concerning to me, I haven’t kept up on it like I should because I’m focused on Afrezza every day. I’m hoping Mannkind is also.
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Post by prcgorman2 on Dec 30, 2021 7:15:18 GMT -5
I agree with whoever it was that posted that the LQDA announcements and pro-posts look desparate and sketchy. Martine is one shrewd cookie. I’m unconcerned LQDA represents a significant wildcard. Martine is definitely shrewd. She wanted to make a deal with LQDA before, what are the odds she doesn’t try again? The litigation is impossible for any of us to accurately handicap without being on the inside in the trenches. Check out that guy Finn’s resume, he’s apparently pretty shrewd as well. Oh yes, I agree a deal is possible, and the lawsuit might have been partially as a stall tactic and to ensure it was based on separating value from blue sky. Do I think UTHR will abandon everything they’ve put into TreT? Hmm, let see, they told the street their estimate of it’s value, and they’ve sunk somewhere upwards of a quarter billion dollars into it so far. How much are they paying attorneys to sue LQDA? “Follow the money.” |
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Post by slapshot on Dec 30, 2021 7:47:23 GMT -5
For what it's worth, i took a quick look at a/the liquidia patent (10898494) and found the following:
Claim 1: A method for treating a patient, comprising: administration of a dry powder composition comprising from about 100 micrograms to about 300 micrograms treprostinil or a pharmaceutically acceptable salt thereof to a patient by inhalation using a dry powder inhaler over one to four breaths to treat pulmonary hypertension.
Thus, looks like LQDA's patent excludes all others from administering over 100 mcg Trep. (assuming it's one breath per cartridge, this would also prevent using up to 4 cartridges to total 100-300) However a few things to note:
1) if UTHR tested dosing to 150 mcg, it could serve as prior art to invalidate the LQDA patent.
2) it's possible that the claim is unduly broad as it doesnt seem to have a time frame of reference - is "administration" or the "one to four breaths" for a single sitting /dosage or throughout a day or life?
3) the patent is based on 3 provisionals filed earlier in which they only seem to have support for up to 100 mcg dosing (which uses a combination of lower dose capsules) and it isn't until the PCT filed 5/5/2017 that they have support for using greater than 100 mcg dosage.
4) for reference, UTHR patent 9604901 is based on a provisional filed in 2007...Also note that they (LQDA) have three child applications pending from this patent as well. disclaimer: just observations (not a professional opinion). Here's what I wrote on ST pertaining to several posters on the LQDA stream... It's fairly obvious to me that many of those LQDA peeps are connected to Caligan Partners and have brought in Findell hedge fund to short and to spread as much FUD as possible from different angels so they can scare MNKD investors and prop up LQDA as much as possible. www.globenewswire.com/news-release/2021/04/13/2208936/0/en/Liquidia-Corporation-Announces-21-7-Million-Private-Placement.htmlAs Boca said above, he leaves out a lot of important information and spins a lot of other info in LQDA's favor. UTHR decided on 3 treatment doses (32, 48, 64 mcg) and obviously had a reason to do so. (They could've gone higher if they wanted to) Previous evaluation of Tyvaso DPI in healthy volunteers demonstrated it was safe and well-tolerated at doses of 30, 60, 90, 120, and 150 μg. |
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Post by sayhey24 on Dec 30, 2021 7:53:05 GMT -5
This guy also said several times LQDA had a better mouse trap. I did not follow the LIQ861 trials. Did LIQ861 have significantly better results than TreT in their trials? One thing we know from our afrezza experience is it takes a lot more than better patient results or even life changing results to have a significant impact on the market when the market is dominated by a few major players. In this case UTHR owns the market and TreT should be a significant improvement over their current product. It seems UTHR is going to try and tie LDQA for another year or more in court. finance.yahoo.com/news/stipulation-partial-judgment-favor-liquidia-114500360.htmlAs of today UTC has agreed to the entry of judgment of Liquidia’s non-infringement of the ’901 patent based on the Court’s construction of certain terms in the patent. UTC has preserved its appellate rights with respect to the ‘901 patent in the event the Court’s construction of those terms is reversed. With this stipulation of partial judgment, only U.S. Patent No. 9,593,066 (‘066 patent) will now serve as a basis for the on-going regulatory stay for final approval of YUTREPIA™ (treprostinil) inhalation powder by the U.S. Food and Drug Administration (FDA). |
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Post by boca1girl on Dec 30, 2021 8:27:16 GMT -5
For what it's worth, i took a quick look at a/the liquidia patent (10898494) and found the following:
Claim 1: A method for treating a patient, comprising: administration of a dry powder composition comprising from about 100 micrograms to about 300 micrograms treprostinil or a pharmaceutically acceptable salt thereof to a patient by inhalation using a dry powder inhaler over one to four breaths to treat pulmonary hypertension.
Thus, looks like LQDA's patent excludes all others from administering over 100 mcg Trep. (assuming it's one breath per cartridge, this would also prevent using up to 4 cartridges to total 100-300) However a few things to note:
1) if UTHR tested dosing to 150 mcg, it could serve as prior art to invalidate the LQDA patent.
2) it's possible that the claim is unduly broad as it doesnt seem to have a time frame of reference - is "administration" or the "one to four breaths" for a single sitting /dosage or throughout a day or life?
3) the patent is based on 3 provisionals filed earlier in which they only seem to have support for up to 100 mcg dosing (which uses a combination of lower dose capsules) and it isn't until the PCT filed 5/5/2017 that they have support for using greater than 100 mcg dosage.
4) for reference, UTHR patent 9604901 is based on a provisional filed in 2007...Also note that they (LQDA) have three child applications pending from this patent as well. disclaimer: just observations (not a professional opinion). I’m not an attorney either but for Finn to say that LQDA “owns” 100mg dose is stretch. All good points above plus they use a “salt” and we use a “sugar”. Does the lower dose of TreT work as effective or more effective than 100mg or more of LQDA’s drug due to our inhaler vs their’s? Finn said the higher the dose, the better, … I don’t believe that is necessarily true. Finn may be well educated, shrewd, and a good salesman but may also be ignorant of the science or dishonest in his explanation of LQDA’s superiority. |
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Post by tarheelblue004 on Dec 30, 2021 9:27:23 GMT -5
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Post by cretin11 on Dec 30, 2021 10:41:46 GMT -5
Several good points being made on this thread. Hopium is something we know well here, it stands to reason the LQDA crowd partakes in it too. It seems the uncertainty of the situation is helping to keep both MNKD’s and LQDA’s share prices depressed. That hopefully means opportunity for one or both to realize gains, once this dispute gets resolved.
Martine has clearly hitched her wagon to MNKD’s formulation. Presumably she’d rather not unhitch it and switch wagons. However, it’s also safe to assume she’s at least having those conversations with her team, in conjunction with the convos she has with legal when they give her the real scoop on how they view their chances in court (probably a different story than what gets communicated publicly - and that goes for LQDA too of course).
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Post by harryx1 on Dec 30, 2021 10:43:49 GMT -5
sayhey24LQDA - www.liquidia.com/static-files/45372c97-4e9f-4871-bfb6-c73e63c9a239vs. UTHR - pipeline.unither.com/wp-content/uploads/2021/09/2021-ERS-BREEZE-Poster.Final_-1.pdfKeep in mind that LQDA uses a generic inhaler that was designed by an Italian company circa late 1980's and MNKD spent millions on design and engineering using "flow balance"* to have a consistent delivery of powder. * A concept called “flow balance” was employed in the design to provide effective dispersion and de-agglomeration of the powder. The contributors to the flow balance including inlet/outlet areas, feature geometries, and proximities define the principle characteristic of the system called flow resistance. Based on the inhalation pressure supplied by the patient, the resistance determines the available air flow that drives powder delivery/performance. Importantly, pressure differentials across the inhalation system produce flow rates that are consistent with the Bernoulli principle, shown by the equation: ∆P½ = ΦR where ∆P is pressure drop, Φ is flow rate, and R is resistance.
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Post by tarheelblue004 on Dec 30, 2021 11:08:52 GMT -5
Do we know who owns the Tyvaso DPI IP?
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