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Post by figglebird on Oct 8, 2021 14:46:13 GMT -5
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Post by cjm18 on Oct 8, 2021 15:07:42 GMT -5
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Post by boca1girl on Oct 8, 2021 15:42:20 GMT -5
I can’t understand what decision was made by looking at either link. Could someone please interpret the decision for me? Was it in favor of UT?
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Post by cedafuntennis on Oct 8, 2021 16:12:10 GMT -5
I second that. Reading through the many pages, seems like UTHR lost on most claims but won on 3 or so. Looks like at least one of the claims (claim 6) seems to be rather important but I am no expert in legaleeze or implications to UTHR, hence on MNKD. I would pray that a lawyer on this board would cast some light on this issue.
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Post by porkini on Oct 8, 2021 16:13:47 GMT -5
I can’t understand what decision was made by looking at either link. Could someone please interpret the decision for me? Was it in favor of UT? Half answer for you (i.e., IDK)... Need to go to the link, near the top is a Document Title, "Final Written Decision: original", which will download a 64 page document for the legal eagles to interpret. I don't have time to read through it right now and I don't play a lawyer on TV or in real life anyway.  |
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Post by ktim on Oct 8, 2021 16:28:20 GMT -5
Seems to be a split decision. Without being a domain expert hard to know the importance of the claims dismissed vs the ones upheld. Though as is always the case with patents, UTHR has a distinct advantage in having deeper pockets to fight the battle as long as they have some claims to stand on.
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Post by cedafuntennis on Oct 8, 2021 16:32:05 GMT -5
Didn't you stay at a Holiday Inn Express a while ago, Porkiny?
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Post by wyattdog on Oct 8, 2021 17:11:03 GMT -5
MORRISVILLE, N.C., Oct. 08, 2021 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Patent Trial and Appeal Board (PTAB) ruled in its favor in the Inter Partes Review (IPR) proceeding against U.S. Patent No. 9,604,901 (‘901 patent) owned by United Therapeutics Corporation (UTC) and listed in the Orange Book for Tyvaso® (treprostinil inhalation solution). In its ruling, the PTAB found that seven of the nine claims were unpatentable. Only the narrower dependent claims 6 and 7 remain, both of which require actual storage at ambient temperature of treprostinil sodium. The PTAB’s decision primarily relates to the issue of patentability based on a review of prior art. This decision does not preclude the invalidation of the remaining claims on other grounds as part of the ongoing Hatch Waxman litigation, nor does it mean that Liquidia infringes either of the surviving claims. Damian deGoa, President and Chief Executive Officer of Liquidia said: “We are very pleased with this decision by the PTAB. This is a clear win in our on-going patent dispute with United Therapeutics, and we remain confident that we will ultimately prevail on all patent claims they have asserted against us. We will continue to vigorously defend our right to commercialize LIQ861 as soon as possible.” The PTAB’s decision with respect to the ‘901 patent does not resolve the on-going litigation brought by UTC related to LIQ861. In June 2020, UTC filed a lawsuit against Liquidia under the Hatch-Waxman Act for infringement of three Tyvaso® patents, including the ‘901 patent, referenced in the 505(b)(2) regulatory filing for the LIQ861 New Drug Application (NDA). The lawsuit triggered a 30-month stay on an FDA regulatory approval of LIQ861, which expires on the earlier of October 24, 2022, or resolution of the litigation. Tyvaso® is a registered trademark of United Therapeutics. About LIQ861 LIQ861 is an investigational inhaled dry powder formulation of treprostinil designed using Liquidia’s PRINT® technology with the goal of enhancing deep-lung delivery using a convenient, palm-sized dry powder inhaler for the treatment of pulmonary arterial hypertension (PAH). PRINT® technology enables the development of drug particles that are precise and uniform in size, shape and composition, and that are engineered for optimal deposition in the lung following oral inhalation. Liquidia believes LIQ861 can overcome the limitations of current inhaled therapies and has the potential to maximize the therapeutic benefits of treprostinil in treating PAH by safely delivering higher doses into the lungs. Liquidia has completed an open-label, multi-center phase 3 clinical study of LIQ861 in patients diagnosed with PAH known as INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil. About Liquidia Corporation Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT® Technology. The company operates through its two wholly owned subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC. Liquidia Technologies is developing LIQ861, an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH). Liquidia PAH provides the commercialization for rare disease pharmaceutical products, such as generic Treprostinil Injection. For more information, please visit www.liquidia.com. Cautionary Statements Regarding Forward-Looking Statements This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications and related submission contents and timelines, including our response to the Complete Response Letter received in November 2020, the potential for eventual FDA approval of the NDA for LIQ861, the timeline or outcome related to our patent litigation pending in the U.S. District Court for the District of Delaware or our inter partes review with the PTAB, the issuance of patents by the USPTO and our ability to execute on our strategic or financial initiatives, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. The favorable decision of the PTAB in the IPR for the ’901 patent is not determinative of the outcome of any appeal of that decision, any IPRs that have been instituted by the PTAB with respect to any other patents of UTC or the Hatch-Waxman litigation between Liquidia and UTC. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our filings with the SEC, including the impact of the coronavirus (COVID-19) outbreak on our Company and our financial condition and results of operations, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Media & Investors: Jason Adair Vice President, Corporate Development and Strategy 919.328.4400 |
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Post by mannmade on Oct 8, 2021 17:27:28 GMT -5
It seems from what I know the worst case is now; uthr is dry powder and Liquidia is a nebulizer. Uthr is the 800lb gorilla in the space. Now it seems they have an inferior competitor
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Post by cedafuntennis on Oct 8, 2021 17:40:17 GMT -5
It seems from what I know the worst case is now; uthr is dry powder and Liquidia is a nebulizer. Uthr is the 800lb gorilla in the space. Now it seems they have an inferior competitor Nebulizer is like the Model T vs the Tesla Roadster. Some people surely will prefer the Nebulizer for whatever reason, but given a choice, I would assert that most will prefer the Roadster. Or let's make that the Model Y for affordability purposes instead of the Roadster. |
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Post by Clement on Oct 9, 2021 6:30:52 GMT -5
It seems from what I know the worst case is now; uthr is dry powder and Liquidia is a nebulizer. Uthr is the 800lb gorilla in the space. Now it seems they have an inferior competitor from the Liquidia website: LIQ861 is "an inhalable dry powder formulation of treprostinil". www.liquidia.com/products-and-pipeline/overview |
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Post by uvula on Oct 9, 2021 7:30:38 GMT -5
Often in cases like this when companies are suing each other,the big company will buy the smaller company and it will disappear. The small company executive board gets millions and the rest of the employees get screwed.
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Post by mango on Oct 9, 2021 10:42:46 GMT -5
✅ The favorable judgement was for only 7 out of 9 claims, 2 claims still remain
✅ This patent ruling has absolutely nothing to do with the ongoing Hatch-Waxman Act litigation as it pertains to a completely different orange book patent
✅ FDA remains precluded from granting full regulatory approval of LIQ861 due to the federal law set forth by the Hatch-Waxman Act 30 month stay which is still in effect
✅ Liquidia has a court date set for next year, March 2022, for the Hatch-Waxman Act patent infringement case, as well as, Liquidia’s Trade Secret Theft crimes committed against MannKind’s partner
UTHR
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Post by itellthefuture777 on Oct 9, 2021 21:59:04 GMT -5
At the end of the day my guess is UTHR moves everyone over to Tyvaso DPI and in settlement gives to Liquida the remaining nebulized patients shutting down the nebulizer line. Let Liquida run that whip and buggy..change gears...
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Post by slapshot on Oct 10, 2021 6:16:16 GMT -5
I am no expert, not a lawyer, not a pharmacist or chemist... but the decision does not look good to me. The two claims that were upheld require a 3 month storage period for the pharmaceutical batch of a salt of treprostinil at ambient temperature prior to preparing the pharmaceutical product, due to file wrapper estoppel (arguments made during the patent prosecution).
i have no idea what the purpose of the storage period is, but it seems like anybody could avoid infringement by shortening the storage period or performing it at a different temperature...
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