Drug Price Competition and Patent Term Restoration Act

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

Retrieved on: 
Tuesday, November 7, 2023
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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.

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.

Lathrop GPM LLP to Host IP Roundtable at ALM General Counsel Conference

Retrieved on: 
Tuesday, April 18, 2023
Intellectual property, Mechanical engineering, Mick DeGiulio, Southern Methodist University, Mechanical, Molecular biology, Genetics, ALM, Patent, Arizona State University, Methodist University, Drug Price Competition and Patent Term Restoration Act, Conference, Swissôtel, Biology

CHICAGO, April 18, 2023 /PRNewswire-PRWeb/ -- Lathrop GPM LLP Partner James DeGiulio, Ph.D., and Director of Pricing Paige Keith will moderate a roundtable at ALM General Counsel Conference Midwest. The roundtable, titled "Capitalizing IP Cost-Effectively: Sophisticated IP Counsel & Creative Pricing," will be held from 12:35-2 p.m. on April 19.

Key Points: 
  • The roundtable, titled "Capitalizing IP Cost-Effectively: Sophisticated IP Counsel & Creative Pricing," will be held from 12:35-2 p.m. on April 19.
  • CHICAGO, April 18, 2023 /PRNewswire-PRWeb/ -- Lathrop GPM LLP Partner James DeGiulio, Ph.D ., and Director of Pricing Paige Keith will moderate a roundtable at ALM General Counsel Conference Midwest .
  • The roundtable, titled "Capitalizing IP Cost-Effectively: Sophisticated IP Counsel & Creative Pricing," will be held from 12:35-2 p.m. on April 19.
  • The 2023 ALM General Counsel Conference Midwest will take place April 19-20 at the Swissotel in Chicago.

Patent Trial and Appeal Board (PTAB) Reaffirms Decision to Invalidate All Claims of United Therapeutics (UTHR) Patent No. 10,716,793 (‘793 Patent)

Retrieved on: 
Thursday, February 2, 2023
IPR, Drug, Publication, Patient, United States Court of Appeals for the Federal Circuit, UTHR, Patent, District court, Drug Price Competition and Patent Term Restoration Act, Douglas v. U.S. District Court ex rel Talk America, PTAB, Generic drug

Roger Jeffs, Chief Executive Officer of Liquidia, stated: “We are pleased that the PTAB has confirmed its earlier determination that all claims of the ‘793 patent are invalid.

Key Points: 
  • Roger Jeffs, Chief Executive Officer of Liquidia, stated: “We are pleased that the PTAB has confirmed its earlier determination that all claims of the ‘793 patent are invalid.
  • Our focus remains to bring YUTREPIA™ (treprostinil) inhalation powder as a differentiated treatment choice to patients and their providers.
  • This decision takes us one important step closer to that goal as the countdown towards final resolution of the litigation, and potential full approval of YUTREPIA, has now begun.
  • The deadline for UTHR’s appeal is 63 days from the date on which UTHR’s rehearing request was denied.

Catalyst Pharmaceuticals Notified of Abbreviated New Drug Application Filing for FIRDAPSE®

Retrieved on: 
Monday, January 23, 2023
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CORAL GABLES, Fla., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that it has received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Teva Pharmaceuticals, Inc. ("Teva") advising that Teva had submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") seeking authorization from the FDA to manufacture, use or sell a generic version of FIRDAPSE® in the United States.

Key Points: 
  • CORAL GABLES, Fla., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that it has received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Teva Pharmaceuticals, Inc. ("Teva") advising that Teva had submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") seeking authorization from the FDA to manufacture, use or sell a generic version of FIRDAPSE® in the United States.
  • In the Notice Letter, Teva states that it intends to market a generic version of FIRDAPSE® before the expiration of Catalyst’s patents listed in the FDA Orange Book covering FIRDAPSE®: U.S. Patent Numbers 10,626,088 (expiring February 2037); 10,793,893 (expiring May 2034); 11,060,128 (expiring June 2032); 11,268,128 (expiring June 2032); 11,274,331 (expiring June 2032); and 11,274,332 (expiring June 2032).
  • Teva’s Notice Letter states that its ANDA contains a Paragraph IV Certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Teva’s ANDA submission.
  • Under the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, Catalyst has 45 days from receipt of the Notice Letter to commence a patent infringement lawsuit in a federal district court against Teva to trigger a stay precluding FDA from approving Teva’s ANDA until May 2026 or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.

Haug Partners Successfully Defends Takeda’s Vyvanse® Patents At Trial Against Generic Challenge

Retrieved on: 
Wednesday, December 28, 2022
Pharmaceutical, Legal, Professional Services, Health, Exclusivity, Dr. C.A. Thigpen House, Opinion, Pharmacokinetics, POSA, Patent, ANDA, Water, Lisdexamfetamine, United States Court of Appeals for the Federal Circuit, Salt, CM/ECF, LLP, ADHD, Court, Prodrug, Gibbons P.C., Orange Book, Drug Price Competition and Patent Term Restoration Act, ECF, 1836 U.S. Patent Office fire, History, Binge eating, Generic drug, Pharmaceutical industry, Takeda

Judge Chesler held that all of Takeda’s asserted patents were infringed, not invalid under 35 U.S.C.

Key Points: 
  • Judge Chesler held that all of Takeda’s asserted patents were infringed, not invalid under 35 U.S.C.
  • As a result, Judge Chesler enjoined Defendant Norwich from bringing its generic product to market until August 24, 2023, upon expiration of Takeda’s Pediatric Exclusivity period for Vyvanse®.
  • The trial focused on fourteen claims asserted across nine Orange Book-listed patents.
  • The Court also afforded significant weight to admissions by Norwich’s Rule 30(b)(6) witnesses elicited during depositions and played at trial.

Greenberg Traurig's Global Intellectual Property & Technology Practice Adds Life Sciences Patent Litigator Jay R. Deshmukh

Retrieved on: 
Thursday, January 5, 2023
Manipal Institute of Technology, IP, Food, Research, Rheumatoid arthritis, Intellectual property, City, Patient, Medicine, Kasowitz Benson Torres, LLP, FDA, Laboratory, Drug Price Competition and Patent Term Restoration Act, Deshmukh, Food and Drug Administration, Patent, Innovation Act, Cleveland State University, Crohn's disease, Affordable Care Act, Ranbaxy Laboratories, Generic drug, Pharmaceutical industry, Greenberg Traurig

NEW YORK, Jan. 5, 2023 /PRNewswire-PRWeb/ -- Global Law Firm Greenberg Traurig, LLP expands its global Intellectual Property (IP) & Technology capabilities with the addition of Jayadeep "Jay" R. Deshmukh as a shareholder in the New York office. He joins from Kasowitz Benson Torres and previously served as senior vice president of Global IP at Ranbaxy Laboratories, an international pharmaceutical company.

Key Points: 
  • Global Law Firm Greenberg Traurig, LLP expands its global Intellectual Property (IP) & Technology capabilities with the addition of Jayadeep "Jay" R. Deshmukh as a shareholder in the New York office.
  • NEW YORK, Jan. 5, 2023 /PRNewswire-PRWeb/ -- Global Law Firm Greenberg Traurig, LLP expands its global Intellectual Property (IP) & Technology capabilities with the addition of Jayadeep "Jay" R. Deshmukh as a shareholder in the New York office.
  • He joins from Kasowitz Benson Torres and previously served as senior vice president of Global IP at Ranbaxy Laboratories, an international pharmaceutical company.
  • I know the possibilities to grow my practice and benefit my clients are limitless here," Deshmukh said.

Is FTC v. Actavis Causing Pharma Companies to Change Their Behavior?

Retrieved on: 
Saturday, December 3, 2022
Supreme Court of the United Kingdom, Time, Improvement, United States Court of Appeals for the Third Circuit, Supreme, Supreme court, DOJ, Medicare Prescription Drug, Improvement, and Modernization Act, MMA, Review, Competition, FTC, Incidence, Goal, Commission, AG, Annual report, Law of the United Kingdom, Use, Empirical research, Third Circuit Court of the Supreme People's Court, Drug Price Competition and Patent Term Restoration Act, Congress, SGR Repeal and Medicare Provider Payment Modernization Act of 2014, Patent, Medicare, Bureau, Generic drug, Pharmaceutical industry, Actavis
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EQS-News: What Does Sunshine Biopharma’s Acquisition Of Nora Pharma Mean For The Generic Prescription Drugs Market?

Retrieved on: 
Monday, November 7, 2022
OBI Pharma, Inc., Health Canada, Growth, RNA transfection, Food, Ibuprofen, McGill, General Hospital, CAGR, Regulation of tobacco by the U.S. Food and Drug Administration, Squamous cell carcinoma, FDA, Breast, Safety, Metoprolol, Health, COVID-19, Patient, University, Metformin, Pancreatic cancer, Breast cancer, Viatris, Famotidine, Combined small-cell lung carcinoma, NASDAQ, Acquisition, Drug Price Competition and Patent Term Restoration Act, Sunlight, Advertising, News, Generic, Generic drug, Pharmaceutical industry, Fine chemical, Vaccine

What Does Sunshine Biopharmas Acquisition Of Nora Pharma Mean For The Generic Prescription Drugs Market?

Key Points: 
  • What Does Sunshine Biopharmas Acquisition Of Nora Pharma Mean For The Generic Prescription Drugs Market?
  • Nora Pharma is now a wholly owned subsidiary of Sunshine after the acquisition of its outstanding shares.
  • This acquisition allows Sunshine Biopharma to expand its operations into generic prescription drugs and biosimilars.
  • This acquisition gives Sunshine a solid position in the generic prescription drugs industry and brings us closer to our objective of becoming a fully integrated pharma company.

Haug Partners LLP Welcomes New Partner, Wan Chieh (Jenny) Lee

Retrieved on: 
Tuesday, October 4, 2022
Legal, Professional Services, King & Spalding, Data science, Polymer, Vaccine, Biopharmaceutical, Partner, Antibody, Counsel, King, Locke Lord, Morgan, Biologics Price Competition and Innovation Act of 2009, Patent, Drug Price Competition and Patent Term Restoration Act, Innovation Act, Intellectual property, LLP, FDA, Cosmetics

Haug Partners LLP today announced that Wan Chieh (Jenny) Lee has joined the firm as a partner in its New York City office.

Key Points: 
  • Haug Partners LLP today announced that Wan Chieh (Jenny) Lee has joined the firm as a partner in its New York City office.
  • Ms. Lee was formerly Counsel at Fay Kaplun & Marcin, LLP and was a Senior Associate at King & Spalding, LLP.
  • Prior, she was as an Associate at Morgan & Finnegan, LLP.
  • Ms. Lee is an experienced patent attorney whose practice focuses on strategic counseling, procurement of worldwide patent rights, due diligence, freedom to operate, and intellectual property transactions.