Complaint accuses Macoven Pharmaceuticals, subsidiary of Pernix Therapeutics, and others of infringing on patents and Gnosis SpA of unlawfully importing infringing products; requests investigation

Pamlab-header.jpgWASHINGTON, D.C., September 12, 2012 – Pamlab LLC, a specialty pharmaceutical company that provides medical foods and foods for special dietary use, has joined Merck & Cie and South Alabama Medical Science Foundation (SAMSF) in a formal complaint filed with the U.S. International Trade Commission to protect patents on certain medical food products and ingredients. The complaint asks the Commission to block Macoven Pharmaceuticals, Inc., a subsidiary of Pernix Therapeutics Holdings, Inc. (ASE: PTX), as well as Gnosis SpA, Gnosis Bioresearch SA and Gnosis USA, from unlawfully importing products that infringe on the complainants’ patents.

Pamlab, Merck and SAMSF have each spent decades and invested tens of millions of dollars in research and development, which have led to numerous inventions related to reduced folates, several of which are patented. To protect those investments, they are formally requesting that the U.S. International Trade Commission intervene.

The U.S. International Trade Commission is an independent, quasi-judicial federal agency with broad investigative responsibilities on matters of trade. The Commission investigates cases involving imports that allegedly infringe U.S. intellectual property rights, pursuant to Section 337 of the Tariff Act of 1930. The primary remedy available under Section 337 investigations is an exclusion order that directs U.S. Customs and Border Protection to stop the infringing imports from entering the U.S. In addition, the Commission may issue cease and desist orders against named importers and other persons engaged in unfair acts that violate the statute.

“We will not allow many years of work and many millions of dollars of R&D to be put at risk,” said Eric Wingerter, CEO of Pamlab. “We believe the efforts of Macoven and Gnosis to import medical food products and ingredients are unlawful and infringe on the patents that we license from Merck & Cie and South Alabama Medical Science Foundation. We are asking the U.S. International Trade Commission to institute an immediate investigation, issue a permanent exclusion order blocking the entry of the infringing products to the U.S. and issue permanent cease and desist orders prohibiting Macoven and Gnosis from importing, marketing, selling or using their infringing products or ingredients in the United States.”

The complaint names the allegedly infringing products as Gnosis’ Extrafolate-S™ product and Macoven’s Vitacirc-B, ALZ-NAC and L-Methylfolate Calcium (15 mg and 7.5 mg) products. This is the third legal action Pamlab and other companies have recently taken against Macoven and its suppliers of raw ingredients for patent infringement related to reduced folates. In December 2011, Pamlab joined Breckenridge Pharmaceutical, Inc. and Metabolite Laboratories, Inc. in filing suit against Macoven in U.S. District Court for the Southern District of New York seeking damages for patent infringement and false advertising. In January 2012, Pamlab joined Merck and SAMSF in filing suit against Macoven and Gnosis in the U.S. District Court for the Eastern District of Texas alleging patent violations.

Reduced folates, along with other B vitamins, play a valuable role in human health and are prescribed by physicians for diabetic peripheral neuropathy, dementia, depression, high-risk pregnancy and other medical conditions. Pamlab uses Merck’s reduced folate, METAFOLIN®, as an ingredient in several high quality medical foods, such as Metanx®, Cerefolin-NAC® and Deplin®.

About Pamlab

Pamlab is a fully integrated pharmaceutical company, employing over 300 employees in its corporate, manufacturing and distribution facilities. It was founded in 1987. Pamlab's products are marketed and sold nationally, helping hundreds of thousands of patients with diabetic peripheral neuropathy, dementia, depression, high-risk pregnancy and other medical conditions.