SAMSF, Merck, and Pamlab File New 337 Complaint Regarding Certain Reduced Folate Nutraceutical Products and L-methylfolate Raw Ingredients Used Therein

Author: 
Eric Schweibenz

On September 10, 2012, South Alabama Medical Science Foundation of Mobile, Alabama (“SAMSF”), Merck & Cie of Switzerland (“Merck”), and Pamlab LLC of Covington, Louisiana (“Pamlab”) (collectively, the “Complainants”) filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.
The complaint alleges that Gnosis SpA of Italy, Gnosis Bioresearch SA of Switzerland, and Gnosis USA Inc. of Doylestown, Pennsylvania (collectively, “Gnosis”) and Macoven Pharmaceuticals LLC of Magnolia, Texas (“Macoven”) unlawfully import into the U.S., sell for importation, and/or sell within the U.S. after importation certain reduced folate nutraceutical products and/or L-methylfolate raw ingredients used therein that infringe one or more claims of U.S. Patent Nos. 5,997,915 (the ‘915 patent), 6,673,381 (the ‘381 patent), 7,172,778 (the ‘778 patent), and/or 6,011,040 (the ‘040 patent) (collectively, the “asserted patents”).
According to the complaint, the ‘915 patent relates to compositions comprising reduced folates and other nutrients, and methods for administering the same.  The ‘381 patent relates to a method for treating and/or preventing vascular disease through administration of a composition that comprises a reduced folate.  The ‘778 patent relates to compositions comprising reduced folates for the treatment and/or prevention of various ailments.  The ‘040 patent relates to, inter alia, methods of decreasing homocysteine levels in the human body and methods for preventing or treating disease associated with increased homocysteine levels by administering at least one tetrahydrofolate in natural stereoisomeric form to a human subject.
In the complaint, the Complainants state that Gnosis and Macoven import and sell products that infringe the asserted patents.  The complaint specifically refers to Macoven’s Vitacirc-B, ALZ-NAC, and L-Methylfolate Calcium (all of which incorporate Gnosis’s Extrafolate-S) as infringing products.
Regarding domestic industry, the Complainants state that Pamlab’s Metanx, CerefolinNAC, and Deplin products practice at least one claim of each of the asserted patents.  As to the economic prong, the Complainants state that Pamlab has made and continues to make substantial investments in the U.S. to support its products that practice the asserted patents.  According to the complaint, these investments include expenditures for domestic plant and equipment, labor and capital, and the exploitation of the asserted patents through engineering and R&D activities.  The complaint specifically refers to facilities in Covington, Lousiana and Shreveport, Louisiana.
As to related litigation, the Complainants state that a case involving overlapping parties and patents is currently pending in the U.S. District Court for the Eastern District of Texas.
With respect to potential remedy, the Complainants request that the Commission issue a permanent exclusion order and permanent cease and desist orders directed at Gnosis and Macoven (and related entities).