Blog March 23, 2020
Baxter Files First Pharmaceutical ITC Complaint of 2015 to Block Importation of Novo Nordisk's Hemophilia A Treatment
- Person title
In a potential indicator of the pharmaceutical industry's increasing interest in the ITC as a litigation forum, on April 16 Baxter International Inc., Baxter Healthcare Corporation and Baxter Healthcare SA filed an ITC complaint against Novo Nordisk A/S, Denmark and Novo Nordisk Inc. concerning Novo's forthcoming hemophilia treatment, Novoeight®.
Baxter's ITC complaint comes less than a month after Novo Nordisk filed a declaratory judgment complaint against Baxter in the United States District Court, District of New Jersey. Apparently triggered by a letter sent by Baxter concerning Novoeight®, Novo Nordisk's DJ complaint urged that seven Baxter patents are invalid and not infringed by Novoeight®. Baxter's ITC complaint alleges infringement of two of those seven patents. The patents in the ITC case cover manufacturing techniques allegedly practiced in Novo Nordisk's Denmark-based manufacture of Novoeight®.
ITC cases between pharmaceutical companies are historically rare. One reason is that the 30-month FDA stay available under the Hatch-Waxman Act for brand suits against generic manufacturers is not available for ITC cases. For cases such as this one between two brand companies, the ITC may be an increasingly-attractive forum where the alleged infringer manufactures overseas. Because the sole relief for ITC complainants is an order barring importation of infringing goods, the ITC has limited use as a forum against companies whose manufacturing is domestic. Further, to obtain relief, an ITC complainant must show a "domestic industry" in the asserted patent beyond simple sales of the patented product, e.g., licensed manufacturing of the product.MIn this case, Baxter alleges that it can satisfy the domestic industry requirement via activities in Thousand Oaks, California, in connection with the manufacture of its own anti-hemophilia treatment, Advate.
The ITC has requested comments no later than May 1 on any public interest issues raised by Baxter's complaint. A decision on institution is expected no later than May 18, 2015.
Authors: Rob Courtney, Rebecca L. Shult
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Blog November 4, 2019
Legal Alert: Arthrex, Inc. v. Smith & Nephew, Inc. - What Did the Federal Circuit Do?
Blog November 4, 2019
Legal Alert | Arthrex, Inc. v. Smith & Nephew, Inc. — What Did the Federal Circuit Do?
Blog August 17, 2018
En Banc Federal Circuit: Patentee's Service of Complaint, Followed by Voluntary Dismissal, Triggers IPR Clock
Blog October 5, 2017
Legal Alert: Federal Circuit Faults PTO's Approach to Claim Amendments During IPR, But Allows PTO to Try to Fix the Problem
Blog May 16, 2016
Software Claims Directed to Specific Improvements in Computer Operations May be "Non-Abstract"
Blog May 2, 2016
Corporate Residence Definition in Patent Cases Unchanged by Congressional Revisions to Venue Statute; Minimum Contacts Under Beverly Hills Fan Reaffirmed
Blog April 11, 2016
Claims Directed to Detection of Gene Variants Patent-Ineligible, Notwithstanding Mental Activity Requirement
Blog July 27, 2015
Judicial Review Available for Decision that a Patent Qualified for CBM Review; § 101 Review Appropriate in CBM Review
Blog July 8, 2015
Software Claim Addressing Concepts Long Known in Other Fields and Lacking Other Inventive Concept Is Not Patent Eligible
Blog May 19, 2023
Legal Alert: Amgen v. Sanofi
Blog May 16, 2023
ITC Monthly Wrap-Up: April 2023
Blog May 15, 2023
Legal Alert: Minimizing Patent TRO and PI Risk in Europe
Blog May 12, 2023
Texas Patent Litigation Monthly Wrap-Up: April 2023
Blog April 18, 2023
Texas Patent Litigation Monthly Wrap-Up: March 2023
Blog April 10, 2023
ITC Monthly Wrap-Up: March 2023
Blog February 10, 2023
President Biden Signs "Protecting American Intellectual Property Act of 2022" Into Law
Blog February 7, 2023
ITC Monthly Wrap-Up: January 2023
Article January 4, 2023
Attorneys Daniel Tishman and Joshua Rosefelt Author "ITC Year in Review" Article in IPWatchdog
Blog January 4, 2023
Texas Patent Litigation Monthly Wrap-Up: December 2022