Metafolin: Merck settles ITC probe against Macoven and Viva, but no agreement with Gnosis yet


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Dietary folate supplementation is recommended for women of child-bearing age seeking to prevent fetal neural tube defects.
Dietary folate supplementation is recommended for women of child-bearing age seeking to prevent fetal neural tube defects.

Related tags: Folic acid

The probe filed at the US International Trade Commission (ITC) by Merck & Cie, a Swiss subsidiary of Merck KGaA, against Macoven Pharmaceuticals, LLC, and Viva Pharmaceutical, Inc. has been settled.

The probe alleging Section 337 violations against Macoven and Gnosis S.p.A. was initiated by Merck & Cie, Pamlab Inc. (today a subsidiary of Nestlé Health Science), and the South Alabama Medical School Foundation over alleged patent infringement of four patents covering reduced folate dietary supplements, as well as the raw ingredient - L-Methylfolate - marketed by Merck under the brand name Metafolin.

According to the terms of the settlement: Macoven and Viva agree and acknowledge that Merck's patents are valid and enforceable; Macoven and Viva will cease manufacturing, selling, importing and distributing the accused products; and Macoven will stop linking its products to Pamlab's products Deplin; Metanx, and Cerefolin.

While the probe against Macoven and Viva has been settled, Merck and Gnosis have not reached an agreement, explained Tom Parker, intellectual property litigation lawyer at Alston & Bird LLP, the NY-based firm that represented Merck.

Resolution of the Gnosis case is expected around June 2014, he said.

Merck & Cie: ‘We’ll vigorously defend our IP’

Dr. Rudolf Moser, Managing Director of Merck & Cie, told us: “Merck & Cie takes very seriously its intellectual property rights and, as recently shown in our cases against Macoven and Viva, we vigorously enforce them.

“However, we are happy that we have successfully resolved the cases between Merck & Cie, Macoven and Viva. Merck & Cie can now return its full attention to delivering innovative L-methylfolate to consumers, physicians and scientists worldwide.”

MetaFolin is the calcium salt of the folic acid derivative, [6S]-5-methyltetrahydrofolate ([6S-5-MTHF). Studies have shown​ that it is even more bioavailable when given as supplements than folic acid. The ingredient is currently used in dietary supplements, medical foods, and prescription prenatal products.

Dietary folate supplementation is recommended for women of child-bearing age seeking to prevent fetal neural tube defects. Folate supplementation is also of interest in relation to blood formation, cell growth and repair, cognitive enhancement, certain psychiatric illnesses, and cardiovascular conditions.

The ingredient provides exclusive marketing rights to Merck’s customers, said Dr Moser. “This settlement highlights the strength of Metafolin and its IP, as Macoven and Viva acknowledge that the involved patents are valid and enforceable.”

Wider trend

Several nutraceuticals have been at the center of patent disputes in recent times. Only last year, the US ITC was involved in a dispute between CoQ10 suppliers, while some krill oil players recently settled a dispute based on IP.

Parker noted that nutraceuticals are a very robust market, but expects this kind of legal action to go in cycles, much like what we are observing in the cell phone industry. “I expect it will slow down at some point,”​ he said. 

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