- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
April 15, 2024Robins Kaplan Named to 2024 BTI Client Service A-Team
-
April 9, 2024Robins Kaplan LLP Files Complaint Against Social Media Giants Meta, Snap, TikTok on Behalf of Spirit Lake Nation, Menominee Indian Tribe of Wisconsin
-
April 8, 2024Tara Sutton, Emily Tremblay Shortlisted for Euromoney’s Women in Business Law Awards
-
April 24, 2024IP Leadership Executive Summit
-
April 24, 2024IP Odyssey: Navigating the Latest Developments in Intellectual Property Law
-
April 30, 2024Navigating Generational Dynamics
-
March 2024e-Commerce: Pitfalls and Protections
-
March 22, 2024‘In re Cellect’:
-
March 14, 2024How Many Cases Have You Tried to a Verdict?
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
United Therapeutics Corp. v. Sandoz, Inc. (D.N.J.) (4/16/14)
Summary judgment of non-infringement denied because amended ANDA label may still implicitly instruct physician and patients to practice claimed limitation.
Summer 2014
Case Name: United Therapeutics Corp. v. Sandoz, Inc., Case No. 12-cv-01617, 2014 U.S. Dist. LEXIS 52353 (D.N.J. Apr. 16, 2014) (Sheridan, J.)
Drug Product and Patent(s)-in-Suit: Remodulin® (treprostinil sodium); U.S. Patent No. 7,999,007 (“the ’007 patent”)
Nature of the Case and Issue(s) Presented: The ’007 patent covers pharmaceutical preparations in which treprostinil or treprostinil sodium is diluted with a high pH glycine buffer, and the methods of using those preparations in order to facilitate safer intravenous use of Remodulin for patients with pulmonary arterial hypertension. Remodulin’s drug label provides that the drug “must be diluted with either Sterile Water for Injection, or 0.9% Sodium Chloride Injection, or Flolan Sterile Diluent for Injection” prior to intravenous infusion.
Initially, Sandoz’s proposed ANDA product labeling copied the instructions from the Remodulin labeling. Sandoz however submitted a proposed amendment to its ANDA, in which it revised its proposed label to delete all references to dilution with the sterile diluent for Flolan. Sandoz also submitted a Section viii statement, stating that the ’007 patent does not claim uses for the treprostinil sodium ANDA products for which Sandoz is seeking FDA approval, namely use of treprostinil sodium diluted with sterile water or 0.9% sodium chloride for intravenous administration. Following this carve-out, Sandoz’s amended label instructs physicians and end-users that its ANDA product can either be administered as supplied for subcutaneous infusion or diluted “with Sterile Water” or “0.9% Sodium Chloride” for intravenous infusion; it does not instruct users that its ANDA product can or should be diluted with the sterile diluent for Flolan.
Sandoz moved for summary judgment of non-infringement on the basis that its label initially recommends subcutaneous infusion in which a buffer is not used, and secondly it recommends aseptic techniques when preparing/administering treprostinil (wiping hands with alcohol as opposed to using the Flolan diluent). The court denied Sandoz’s motion.
Why United Therapeutics Prevailed: The Court denied summary judgment because there was a question of fact as to infringement. Sandoz had removed all references to use of a diluent like Flolan. Nevertheless, the Sandoz label referred to a CDC survey regarding bloodstream infections for precautionary measures. This survey, according to the court, would lead a medical practitioner to review the medical research on the issue. This research includes articles that recommend using Flolan as a diluent with treprostinil. Thus, the court denied summary judgment because a question of fact existed as to whether the amended Sandoz label would implicitly instruct the use of Flolan.
Related Publications
Related News
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.