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Post by longliner on Dec 1, 2023 19:34:24 GMT -5
The LQDA response: www.streetinsider.com/SEC+Filings/Form+8-K+Liquidia+Corp+For%3A+Nov+30/22479032.htmlThis is the relevant bit: Because neither the ’793 Patent nor the ’327 Patent was issued prior to the filing of the original NDA for YUTREPIA, we believe United Therapeutics is not entitled to a statutory 30-month stay with respect to either of these patents.UTHR have the same problem as with their standalone lawsuit for '327, it wasn't in the Orange book when LQDA made their filing for PH-ILD. That means it isn't covered by the Hatch Waxman Act since that requires the patent to be in the Orange book when the filing is made (the Act set up the Orange book specifically to clarify what was and wasn't covered.) On the face of it I don't think UTHR has a case, but then I am not a lawyer and I long ago gave up being surprised by what the courts will do. I think the grey area here is, LQDA had been notified that the patent claims for '327 had been approved for the patent grant, and they stated they were evaluating the claims before they filed for PH-ILD. In reading the orange book guidelines, LQDA will have to amend its application to include a patent certification statement addressing the '327 patent, though I do not know what that means as far as a 30 month stay goes. I agree that the rules state UTHR is not entitled to a mandatory 30 month stay at that point. However, I believe UTHR could make a good argument based on the intent of the law, versus the technicality of the wording. LQDA knew about the patent approval and claims well before they filed for PH-ILD, and the law is intended to protect patent holders from infringement on known, valid, patents.What's that old saying Aged? No honor among ?  |
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Post by agedhippie on Dec 1, 2023 19:49:03 GMT -5
I think the grey area here is, LQDA had been notified that the patent claims for '327 had been approved for the patent grant, and they stated they were evaluating the claims before they filed for PH-ILD. In reading the orange book guidelines, LQDA will have to amend its application to include a patent certification statement addressing the '327 patent, though I do not know what that means as far as a 30 month stay goes. I agree that the rules state UTHR is not entitled to a mandatory 30 month stay at that point. However, I believe UTHR could make a good argument based on the intent of the law, versus the technicality of the wording. LQDA knew about the patent approval and claims well before they filed for PH-ILD, and the law is intended to protect patent holders from infringement on known, valid, patents. I agree about the grey area. The key thing LQDA seem to believe is that since they filed the NDA prior to the patent issue and being posted into the Orange book they are in the clear from the standpoint of a stay. I think both sides are quite capable of dragging this out for the foreseeable future, but without a stay it's a bit pointless for UTHR from a practical point of view. |
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Post by agedhippie on Dec 1, 2023 19:51:09 GMT -5
What's that old saying Aged? No honor among ? Pharmas?  |
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Post by longliner on Dec 1, 2023 19:57:34 GMT -5
What's that old saying Aged? No honor among ? Pharmas? Well, that little pharma (LQDA) is stacking up a boatload of karma........  |
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Post by longliner on Dec 1, 2023 20:01:06 GMT -5
I think the grey area here is, LQDA had been notified that the patent claims for '327 had been approved for the patent grant, and they stated they were evaluating the claims before they filed for PH-ILD. In reading the orange book guidelines, LQDA will have to amend its application to include a patent certification statement addressing the '327 patent, though I do not know what that means as far as a 30 month stay goes. I agree that the rules state UTHR is not entitled to a mandatory 30 month stay at that point. However, I believe UTHR could make a good argument based on the intent of the law, versus the technicality of the wording. LQDA knew about the patent approval and claims well before they filed for PH-ILD, and the law is intended to protect patent holders from infringement on known, valid, patents.I agree about the grey area. The key thing LQDA seem to believe is that since they filed the NDA prior to the patent issue and being posted into the Orange book they are in the clear from the standpoint of a stay. I think both sides are quite capable of dragging this out for the foreseeable future, but without a stay it's a bit pointless for UTHR from a practical point of view.I don't think it's pointless to protect your company from theft. Time is $, tic toc.... |
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Post by prcgorman2 on Dec 1, 2023 22:15:30 GMT -5
I agree about the grey area. The key thing LQDA seem to believe is that since they filed the NDA prior to the patent issue and being posted into the Orange book they are in the clear from the standpoint of a stay. I think both sides are quite capable of dragging this out for the foreseeable future, but without a stay it's a bit pointless for UTHR from a practical point of view.I don't think it's pointless to protect your company from theft. Time is $, tic toc.... UTHR also can't expect a stay if they don't ask for one. Nothing ventured, nothing gained. |
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Post by prcgorman2 on Dec 2, 2023 9:29:44 GMT -5
I want to add people should remember that Martine made the money she used to create UTHR as a brilliant telecom lawyer who lobbied the FCC to license (Sirus?) satellite radio service in the US. That was before acquring a doctorate in pharma development and creating UTHR specifically to develop a treatment for Pulmonary Arterial Hypertension to save the life of one of her daughters. Dr. Rothblatt is both a legal and pharma and executive genius not to be underestimated.
I also don’t assume, as many have opined here, that Martine is emotionally invested in helping MannKind out of respect for Dr. Al Mann. Treprostinil went off patent and UTHR stock took a hit. 3 companies were developing competing Treprostinil products; Liquidia, MannKind, and I forget the name of the third because Martine bought them to remove them as a threat.
It’s been said here she also tried to buy LQDA but failed to negotiate terms acceptable to LQDA so then it turned into an offensive legal battle to keep LQDA at bay while Martine negotiated a grossly favorable (to UTHR) development deal with MNKD who had successfully and independently taken Treprostinil on Technosphere (Tre-T) through Phase 1 trial. It was brilliant. MKND was not in a good financial position to fully develop Tre-T and market it on their own. I assume the development deal cost significantly less than acquiring LQDA (thank you LQDA for being a hold-out) and the legal footing was good enough to prevent LQDA from bringing Yutrepia to market before UTHR and MNKD could complete the development and FDA approval of Tre-T as Tyvaso DPI. I assume the royalties would have been nearly double (because of comments I’ve read here about common development and royalty arrangements) had MNKD been in better financial position to negotiate. We’ve barely ever heard a peep about the “2nd molecule” that was in the agreement even though Tyvaso DPI has been a spectacularly successful accomplishment for both companies, so I continue to be skeptical that Dr. Rothblatt did anything other than brilliant legal and business maneuvering to maintain the value of the Treprostinil franchise.
I think this most recent development is just another example of Dr. Rothblatt having undeniable executive prowess and a brilliant legal mind. The cost of the filing and processing is peanuts regardless of how likely it is to succeed. Nothing ventured, nothing gained.
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Post by agedhippie on Dec 2, 2023 10:36:22 GMT -5
^ That is pretty much one of the best summaries I have seen on this.
I expect the legal challenges to keep coming because Martine is essentially buying first mover advantage. Compared to the revenue at stake the legal bills are peanuts. Even if UTHR loses the appeal (which is by no means certain, as a 80% probability of a loss still has a 20% probability of a win) I would expect more law suits.
Speculating on motive; I think UTHR expect to lose the appeal (there are comments on the call about competitors for DPI), and Martine has moved on to focusing on protecting the PH-ILD market. That makes sense because the PAH market is relatively crowded compared to the PH-ILD, plus there is the impact Merck looks like it will have on the PAH market with Sotatercept given results that seem to reverse PAH rather than the current palliative approach. It is worth noting though that in the Stellar trial Sotatercept was used with a background PAH drug. Although there is talk of Sotatercept being launched in 2024 my expectation would be 2025.
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Post by agedhippie on Dec 2, 2023 18:25:28 GMT -5
This is a review of the pending appeal from someone who actually is a lawyer (and yes, he is long LQDA) www.valoremresearch.com/p/the-lionel-hutz-substack-is-now-valoremI have read his work for a while and find it well written and easy to understand. I also like that he talks about both the strong and weak points in a case. He also brings up an outcome that I hadn't considered; the court could send it back to the PTAB for review. This is definitely worth a read. |
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Post by wyattdog on Dec 2, 2023 18:59:20 GMT -5
Is Lionel Hutz a good lawyer?
Lionel Hutz is a character in the popular American television show “The Simpsons.” He is a shady and unethical lawyer who often takes on cases for the Simpson family and other characters in the show. He is known for his fast-talking and unprofessional behavior, and is a frequent source of humor in the series.
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Post by cppoly on Dec 4, 2023 12:19:08 GMT -5
Did anyone listen to UTHR vs LQDA just now?
I couldn't keep up with 95% of the lawyer jargon but UTHR made some good points and seemed to have the edge. I could be wrong.
Something interesting I heard when one of the judges interacting with LQDA's attorney about not having a declarant and pushed back by saying:
"You don't need one (declarant) but it is a big stretch. You have 20,000 people that get these and you can't produce a single person that says I went, I received, I'm satisfied at all."
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Post by cretin11 on Dec 4, 2023 12:48:27 GMT -5
LQDA share price bouncing around a bit today too.
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Post by jkendra on Dec 4, 2023 13:22:07 GMT -5
Did anyone listen to UTHR vs LQDA just now? I couldn't keep up with 95% of the lawyer jargon but UTHR made some good points and seemed to have the edge. I could be wrong. Something interesting I heard when one of the judges interacting with LQDA's attorney about not having a declarant and pushed back by saying: "You don't need one (declarant) but it is a big stretch. You have 20,000 people that get these and you can't produce a single person that says I went, I received, I'm satisfied at all." I too had trouble with lawyerspeak but from listening to this it definitely does not seem like a 'slam dunk' for Liquidia as many have asserted. It also seems from the rebuttal at the 2 hour 10 minute mark that this issue is far from over.
Link to live stream. UTHR v LQDA begins around 1 hour 42 minutes.
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Post by agedhippie on Dec 4, 2023 16:56:11 GMT -5
It's the legal system, it's seldom a slam dunk! Even if there is an 80% chance that LQDA wins that still means that there is a 20% chance that UTHR wins and 20% isn't nothing!
I haven't listened to it as I am not a lawyer and wouldn't understand what and how they were arguing.
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Post by sayhey24 on Dec 4, 2023 17:40:13 GMT -5
Did anyone listen to UTHR vs LQDA just now? I couldn't keep up with 95% of the lawyer jargon but UTHR made some good points and seemed to have the edge. I could be wrong. Something interesting I heard when one of the judges interacting with LQDA's attorney about not having a declarant and pushed back by saying: "You don't need one (declarant) but it is a big stretch. You have 20,000 people that get these and you can't produce a single person that says I went, I received, I'm satisfied at all." I too had trouble with lawyerspeak but from listening to this it definitely does not seem like a 'slam dunk' for Liquidia as many have asserted. It also seems from the rebuttal at the 2 hour 10 minute mark that this issue is far from over.
Link to live stream. UTHR v LQDA begins around 1 hour 42 minutes.
If you listen starting at the 2:10 mark as you suggest it sounds like LQDA is doomed but with any trial you just never know until the decision is filed. Right now I would be concerned if I were LQDA. |
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