Last month, Irish pharmaceutical concern Horizon Pharma PLC filed an action against two companies it alleges have infringed its patent for the drug Pennsaid.
The action was filed with the US District Court in New Jersey and names two companies: Actavis; a subsidiary of fellow Irish drug manufacturer Allergan, and Lupin Pharmaceuticals of Mumbai. Horizon’s legal action is a response to the filing of Abbreviated New Drug Applications (ANDAs) by both companies, who are seeking to produce a generic version of Pennsaid, a topical non-steroidal anti-inflammatory (NSAID).
Horizon markets Pennsaid in the US and is asserting its rights relating to four patents covering the solution and treatment applications of the drug. Actavis and Lupin had contended that two of the patents were invalid and unenforceable as part of their ANDAs applications.
As part of its legal action, Horizon is seeking monetary recompense in the event that Actavis or Lupin is granted approval for their generic versions of Pennsaid. The company is also asking the District Court to delay the date of any Food and Drugs Administration (FDA) approval until after the patents have expired, which it contends will not occur before October 2027 in the case of two patents and July 2029 for the others.
In previous similar cases, patent infringement suits have resulted in licensing agreements agreed out of court. As recently as May 2014, Actavis reached such an agreement with the generics manufacturer Valeant Pharmaceuticals over a generic version of acne drug Acanya, and that could be a possible outcome for both Actavis and Lupin in this case.
Horizon Pharma acquired the right to market Pennsaid from Nuvo Pharmaceuticals in October 2014, at a cost of around $45 million, and the drug has become the company’s biggest seller. Net sales for the quarter ending June 2016 stood at $72.7 million, a 147% increase on the previous quarter, which has been attributed to both higher net pricing and higher volumes of prescriptions. Horizon is one of the largest players in the topical NSAID sector and its portfolio is worth around 11.2% of the patent market.
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