Cipher Pharmaceuticals Inc., a rapidly growing specialty pharmaceutical dermatology company, announced that the Court has issued an opinion in the claim construction hearing (commonly referred to as a 'Markman hearing') for the patent infringement suit by Ranbaxy Inc, Ranbaxy Pharmaceuticals Inc, (Ranbaxy), a Sun Pharma company, Galephar Pharmaceutical Research Inc, and Cipher against Watson Laboratories, Inc (Watson, now Actavis plc) related to Watson's Abbreviated New Drug Application (ANDA) for a generic version of Absorica (isotretinoin capsules).
The purpose of a Markman hearing is to determine the precise meaning of words from patent claims that are in dispute in a patent infringement lawsuit. No ultimate determination of infringement or validity of the patents has been determined at this point.
"We are pleased with the outcome of the Markman hearing, which ultimately has bearing on the determination of infringement and validity when the matter goes to trial," said Shawn O'Brien , president and chief executive officer, Cipher Pharmaceuticals Inc.
"With the hearing completed, we look forward to the scheduling of a trial date as Cipher and Ranbaxy continue our vigorous defense of Absorica's intellectual property rights. Recently, we further strengthened our intellectual property for Absorica with the addition of a third patent in the FDA's Orange Book and we will continue to do so through all available legal and regulatory pathways."
Background: In September 2013, Ranbaxy received a Paragraph IV certification notice of filing from Watson Laboratories, Inc. of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for a generic version of Absorica, which is marketed in the US by Ranbaxy. Absorica is currently protected by three issued patents, which are listed in the FDA's approved drug products list (Orange Book), which expire in September 2021.
There are three additional new patent applications pending with the US Patent and Trademark Office. Cipher has been advised by Ranbaxy that the Paragraph IV filing has no impact on the current sales and marketing plans for the product and that Ranbaxy plans to continue to invest significantly in Absorica.
Cipher Pharmaceuticals is a rapidly growing specialty pharmaceutical dermatology company with a diversified portfolio of commercial-stage products that is on pace to achieve its goal of becoming the most customer-centric dermatology company in North America.