United States District Court for the Eastern District of Texas

Liquidia Corporation Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
Type, United Therapeutics, United States District Court for the Eastern District of Texas, FDA, Research, Sale, New Drug Application, Drug Price Competition and Patent Term Restoration Act, IND, PDUFA, Food, Patent, CAFC, Silicon, PRINT, Prescription Drug User Fee Act, Security, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Certification, Peru–United States Trade Promotion Agreement, Orthostatic hypertension, The Orange Book, United States Court of Appeals for the Federal Circuit, Orange Book, Promotion, UTHR, Pulmonary hypertension, District court, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Patent Trial and Appeal Board, Douglas v. U.S. District Court ex rel Talk America, PAH, Lender option borrower option, NDA, PTAB, Patient, Treprostinil, Pharmaceutical industry, Cryptocurrency

Oral arguments in appeal of ‘793 PTAB decision set for December 4, 2023

Key Points: 
  • Oral arguments in appeal of ‘793 PTAB decision set for December 4, 2023
    PDUFA goal date to add PH-ILD indication to YUTREPIA label is January 24, 2024
    MORRISVILLE, N.C., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the third quarter ended September 30, 2023.
  • ET to discuss the financial results and provide a corporate update.
  • Cash totaled $76.2 million as of September 30, 2023, compared to $93.3 million as of December 31, 2022.
  • Total other expense, net was $0.9 million for the three months ended September 30, 2023, compared with $0.3 million for the three months ended September 30, 2022.

Clark Hill & Irwin IP Announce Federal Court Finding on Eleanor Car, Denice Halicki Owns the Copyrights and Trademarks to Gone in 60 Seconds Movie Trilogy and All Merchandising Rights to Eleanor Car as She Appears in the Remake

Retrieved on: 
Friday, November 3, 2023
Legal, Automotive, Entertainment, Automotive Manufacturing, Professional Services, Other Automotive, Manufacturing, Film & Motion Pictures, Performance & Special Interest, Licensing (Entertainment), United States District Court for the Eastern District of Texas, Universal Pictures, United States Court of Appeals for the Ninth Circuit, Theft, Originality, Denice, State, Court, H. B. Halicki, Ninth, Multimedia, Judgement, DC Comics, VIN, District court, Warner Bros., Central District, Auction, Remake, The Walt Disney Company

As the District Court itself previously noted, the Ninth Circuit has twice strongly suggested that the Remake Eleanor car character is protectible as a copyrighted character.

Key Points: 
  • As the District Court itself previously noted, the Ninth Circuit has twice strongly suggested that the Remake Eleanor car character is protectible as a copyrighted character.
  • Denice Halicki has three Official Eleanor Licensee that restore, build and sell Official Eleanor cars: “Fusion Motors”, “Eleanor Garage” and “Brand New Eleanor”.
  • Carroll Shelby had nothing to do with Gone in 60 Seconds or Eleanor car from the Remake.
  • The Eleanor car character’s demand and popularity are greater than ever.” Denice Halicki
    View source version on businesswire.com: https://www.businesswire.com/news/home/20231103331364/en/

United Therapeutics Corporation Files Lawsuit Alleging Infringement of Tyvaso Patent Already Found to Be Invalid by U.S. Patent Office

Retrieved on: 
Wednesday, September 6, 2023
IPR, United States Court of Appeals for the Federal Circuit, New Drug Application, NDA, PTAB, District court, Patent, Patient, United Therapeutics, Drug Price Competition and Patent Term Restoration Act, United States District Court for the Eastern District of Texas, Therapy, Douglas v. U.S. District Court ex rel Talk America, UTHR, Generic drug, United

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.

Key Points: 
  • 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.
  • While we are disappointed that United Therapeutics has elected to file this lawsuit alleging that YUTREPIA infringes this same patent that has already been litigated and already found by the PTAB to be invalid, it was expected.
  • The appeal of the PTAB decision is expected to be completed in the fourth quarter of 2023 or the first half of 2024.

Statement on Ouster’s Ongoing Enforcement of its Patents Against Hesai

Retrieved on: 
Monday, August 28, 2023
Technology, Patent Law, Vehicle Technology, Automotive, General Automotive, Automotive Manufacturing, Professional Services, Software, Manufacturing, Hardware, ALJ, Administrative law judge, NYSE, Timeline of reactions to the Hong Kong national security law (January 2021), District court, Motion, Patent, Engineering, Administrative law, ITC, United States District Court for the Eastern District of Texas, Velodyne

The initial determination is not a decision on the merits of Ouster’s ongoing patent infringement case against Hesai.

Key Points: 
  • The initial determination is not a decision on the merits of Ouster’s ongoing patent infringement case against Hesai.
  • Ouster invented digital lidar technology following an engineering breakthrough and holds one of the largest patent families in the lidar industry.
  • Ouster's complaint sets forth how, after the market shifted toward Ouster’s digital lidar, Hesai stole Ouster’s revolutionary patented technologies and incorporated them into Hesai’s competing products.
  • The company will continue to vigorously enforce its patents and seeks to bar all infringing products from the United States.

Lawsuit: Montessori School Endangered North Texas Toddler Left Alone in Dark Classroom

Retrieved on: 
Monday, July 31, 2023
Beginnings, Arm, Next friend, Clan Henderson, Complaint, District court, Child protective services, Child, Texas Department of Family and Protective Services, United States District Court for the Eastern District of Texas, Family, Toy

MELISSA, Texas, July 31, 2023 /PRNewswire/ -- In March 2022, North Texas parents Rick and Jessica Henderson were shocked to discover the school they trusted to protect their toddler had let them down. When Rick went to pick up their 2-year-old son from Pinnacle Montessori of Melissa, he found the child crying alone in the corner of a dark classroom. The family is now suing the school claiming that the facility and its workers violated multiple childcare laws and endangered their young son by leaving him unsupervised and isolated from his classmates for an inappropriately long period of time for a child.

Key Points: 
  • MELISSA, Texas, July 31, 2023 /PRNewswire/ -- In March 2022, North Texas parents Rick and Jessica Henderson were shocked to discover the school they trusted to protect their toddler had let them down.
  • When Rick went to pick up their 2-year-old son from Pinnacle Montessori of Melissa, he found the child crying alone in the corner of a dark classroom.
  • The complaint states that Pinnacle Montessori of Melissa positions itself as a safe and nurturing school for children.
  • The complaint continues that the Pinnacle Montessori worker then purposely turned off the lights, traumatizing the boy by leaving him in the dark classroom alone without a caregiver or teacher watching him.

Orexo's patent win for ZUBSOLV® appealed

Retrieved on: 
Monday, July 24, 2023
US Foods, Abbreviated New Drug Application, United States Court of Appeals for the Federal Circuit, The Orange Book, Naloxone, Sun Pharma, Buprenorphine, Sun, SUN, ORX, Orexo, CIII, SEK, Tablet, United States district court, Orange Book, District court, Patent, United States District Court for the Eastern District of Texas, Food, Generic drug, Appeal

The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.

Key Points: 
  • The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.
  • Sun has now appealed the district court's decision to the US Court of Appeals for the Federal Circuit.
  • We remain very confident in the strength of the patent portfolio and that the Court of Appeals will come to the same conclusion."
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

Orexo's patent win for ZUBSOLV® appealed

Retrieved on: 
Monday, July 24, 2023
US Foods, Abbreviated New Drug Application, United States Court of Appeals for the Federal Circuit, The Orange Book, Naloxone, Sun Pharma, Buprenorphine, Sun, SUN, ORX, Orexo, CIII, SEK, Tablet, United States district court, Orange Book, District court, Patent, United States District Court for the Eastern District of Texas, Food, Generic drug, Appeal

The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.

Key Points: 
  • The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.
  • Sun has now appealed the district court's decision to the US Court of Appeals for the Federal Circuit.
  • We remain very confident in the strength of the patent portfolio and that the Court of Appeals will come to the same conclusion."
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

Exelixis Announces First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, May 9, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Orange, Share repurchase, District court, Investigational New Drug, Royalty payment, Patent, Checkmate, Ipilimumab, News, Software, Calendar, MSN, DC, Pharmacokinetics, Orange Book, IMDC, FDA, IND, Conference, Safety, 1836 U.S. Patent Office fire, Allele, Cabozantinib, Antibody, PIN, Webcast, Acceleration, RCC, Exelixis, OS, Trial of the century, ASCO, American Society of Clinical Oncology, ANDA, United States District Court for the Eastern District of Texas, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Douglas v. U.S. District Court ex rel Talk America, Tumor microenvironment, Society, Food, Nivolumab, Online shopping, Pharmaceutical industry, Patient

Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended March 31, 2023, Exelixis earned $32.7 million in royalty revenues.

Key Points: 
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended March 31, 2023, Exelixis earned $32.7 million in royalty revenues.
  • Cabozantinib Data at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (ASCO GU 2023).
  • This IND clearance triggered a $35.0 million milestone payment to Sairopa, paid in the first quarter of 2023.
  • Exelixis management will discuss the company’s financial results for the first quarter of 2023 and provide a general business update during a conference call beginning at 5:00 p.m.

Liquidia Corporation Reports Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 16, 2023
Silicon, Acquisition, Peru–United States Trade Promotion Agreement, SVB, Silicon Valley Bank, 1836 U.S. Patent Office fire, United Therapeutics, Exercise, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Partnership, Promotion, Patent Trial and Appeal Board, Orthostatic hypertension, Patent, United States Court of Appeals for the Federal Circuit, Treprostinil, Black Rock, Patient, Insulin, Pharmacy, District court, Pulmonary hypertension, Physician, IPR, Research, FDA, PTAB, United States District Court for the Eastern District of Texas, Drug, Marketing, Food, PAH, UTC, Cryptocurrency, Pharmaceutical industry, Generic drug, Bank, Novartis

ET

Key Points: 
  • ET
    MORRISVILLE, N.C., March 16, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”) today reported financial results for the full year ended December 31, 2022.
  • ET to discuss the 2022 financial results and provide a corporate update.
  • Roger Jeffs, Liquidia’s Chief Executive Officer, said: “We made notable strides toward unlocking the full potential of Liquidia in 2022.
  • If every decision in favor of Liquidia is affirmed on appeal by UTC, then Liquidia would be clear to seek final regulatory approval of YUTREPIA.

Exelixis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 7, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Orange, Neoplasm, Bristol Myers Squibb, Calendar, ADC, District court, News, 1836 U.S. Patent Office fire, Clinical trial, Absorption, United States District Court for the Eastern District of Texas, Partnership, Orange Book, Relatlimab, IMDC, Toxicity, Patent, Checkmate, Trial of the century, Acceleration, Breast, Potential, RECIST, Catalent, Software, Tumor microenvironment, SIRP, Antibody, FDA, Progression-free survival, DC, MSN, Douglas v. U.S. District Court ex rel Talk America, Society, Ipilimumab, T helper cell, PDC, RCC, ASCO, OS, CDK7, BMS, Webcast, Investigational New Drug, Royalty payment, ANDA, Initial, ENA, Allele, Cabozantinib, Blinded, LAG-3, Conjugation, Conference, IND, Online shopping, Pharmaceutical industry, Communications satellite, Nivolumab, Exelixis, Patient, Exatecan

In 2022, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $1.9 billion.

Key Points: 
  • In 2022, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $1.9 billion.
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2022, Exelixis earned $33.9 million and $121.4 million, respectively, in royalty revenues.
  • Exelixis expects its partner Sairopa to file an Investigational New Drug application (IND) for ADU-1805 in the first quarter of 2023.
  • Exelixis management will discuss the company’s financial results for the fourth quarter and full year of 2022 and provide a general business update during a conference call beginning at 5:00 p.m.