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SUNY, NYU, Galderma Sue Indian Generics Pharma Lupin for Allegedly Infringing Rosacea Rx IP

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By Ben Butkus

The State University of New York, New York University, and L'Oreal subsidiary Galderma Laboratories are suing Indian generic drugmaker Lupin for allegedly infringing four patents related to Oracea, Galderma's orally administered treatment for rosacea.

The suit, filed last week in the US District Court for the District of Delaware, claims that Lupin has infringed the patents by submitting an abbreviated new drug application with the US Food and Drug Administration for a generic version of Oracea.

This is the second lawsuit filed this year by SUNY, NYU, and Galderma against a generic drug manufacturer for allegedly infringing the Oracea patents: In March, the plaintiffs sued Mylan Pharmaceuticals for allegedly infringing the patents by filing an ANDA for a generic version of the drug.

Trial in the Mylan suit is scheduled for December 2010, according to court documents.

As in the Mylan suit, the plaintiffs' complaint against Mumbai-based Lupin revolves around US Patent Nos. 5,789,395 and 5,919,775, which are jointly issued to SUNY and NYU's Hospital for Joint Diseases and licensed exclusively to Galderma predecessor Collagenex; and US Patent Nos. 7,211,267 and 7,232,572, which are assigned directly to Collagenex.

Galderma acquired Collagenex in April 2008 for $420 million, thus assuming possession of both the SUNY/NYU licensing agreement and Collagenex patents.

The SUNY/NYU patents both cover methods of inhibiting nitric oxide with tetracycline compounds, while the Collagenex patents cover methods for treating acne and rosacea by using low concentrations of tetracycline compounds.

The complaint alleges that Lupin Pharmaceuticals, Lupin's Baltimore, Md.-based subsidiary, has infringed all four patents by filing an ANDA for the commercial manufacture, use, and sale of generic doxycycline delayed-release capsules for oral administration.

The plaintiffs received notice of the ANDA filing in a letter dated May 29, according to the complaint. In the letter, Lupin alleged that claims in the quartet of patents are invalid and/or not infringed by the commercial manufacture, use, or sale of generic products.

The plaintiffs are seeking judgment from the court that Lupin has infringed the patents; that the effective date of any approval of the ANDA not be earlier than the expiration dates of the patents, including any extensions; and that Lupin be permanently enjoined from manufacturing and selling a generic version of Oracea prior to the expiration of the patents.

The oldest of the four patents, No. '395, was filed on Aug. 30, 1996, and thus would expire on Aug. 30, 2016; while the youngest, No. '267, was filed on Feb. 18, 2005, and would expire on Feb. 18, 2025, barring any extensions.

In both lawsuits, SUNY and NYU are seeking to protect an undisclosed royalty stream that dates back to a 1992 licensing agreement with Collagenix for the '395 and '775 patents.

According to regulatory filings, the licensing agreement gave Collagenex an exclusive worldwide license to make and sell products employing tetracyclines (of which doxycycline is one) that are designed or used to alter a biological process.

In exchange for these rights, Collagenex issued SUNY nearly 80,000 shares of its common stock in 1992; and agreed to pay SUNY undisclosed royalties on net sales of licensed products, with minimum annual royalty payments of $50,000 per year. The license also stipulated that Collagenex was entitled to deduct any costs incurred while defending the SUNY patents from its royalty stream.

If SUNY is the lead institution on the licensing agreement, as is implied in early Collagenix regulatory filings, it would likely have a pre-existing agreement with NYU as to how royalties from Oracea are shared.

Oracea, the only FDA-approved therapy for treating inflammatory lesions associated with rosacea, had $52.5 million in net sales in 2007, the last year for which full sales figures are available.

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