Syosset, New York
The Research Foundation of the State University of New York, (“The Research Foundation”), the technology licensing body for inventions emanating from the State University system, has successfully licensed a series of patents resulting from the discoveries of the team of scientists at the Dental School at Stony Brook. Drs. Lorne M. Golub, Thomas F. McNamara and Nungavaram S. Ramamurthy discovered that periodontal disease can be treated by using tetracyclines to inhibit enzymes which destroy periodontal support tissue and to increase the rate of bone protein synthesis. The licensed patents provided the basis for a new company, CollaGenex Pharmaceuticals, Inc. (“CollaGenex”) and its main product, which is known as PERIOSTATŽ. The drug was approved by the FDA in 1998 and has accounted for more than 80% of the company’s annual revenues.
The Research Foundation obtained a series of patents based on revolutionary discoveries regarding beneficial bioeffecting properties of tetracyclines used in treating periodontal disease. As a result of the invention, periodontal disease can be treated with low doses of the tetracycline known as doxycycline on a long-term basis without the unwanted side effects usually associated with antibiotic dosing levels of tetracycline. On April 14, 2004, Judge Sifton of the Eastern District of New York signed an Order which resolved the second of two (2) patent litigations enforcing these patents obtained on behalf of the Stony Brook researchers.
In recent years, two (2) generic drug companies, West-ward Pharmaceutical (“West-ward”) and Mutual Pharmaceutical Company, Inc./United Research Laboratory, Inc. (“Mutual/URL”) submitted abbreviated new drug applications (ANDAs) to the FDA for approval of a generic version of PERIOSTAT. The potential introduction of generic forms of PERIOSTAT posed a significant threat to CollaGenex and the fruits of the license arrangement with The Research Foundation.
The Intellectual Property Law firm of Hoffmann & Baron, LLP (located in Syosset, New York) spearheaded separate lawsuits against West-ward and Mutual/URL in the Eastern District of New York based on patent infringement. Both suits sought preliminary injunctive relief from the introduction of the generic form of PERIOSTAT. Another suit was filed in the District Court for the District of Columbia against the FDA to prevent approval of the generic form of PERIOSTAT.
As a result of the patent cases and the case against the FDA, West-ward and Mutual/URL were prevented from introducing a generic form of PERIOSTAT to the marketplace. West-ward settled its case with CollaGenex in November of 2003 and Mutual/URL entered into a settlement agreement which was signed by the Court on April 14, 2004. In both cases, the generic drug companies agreed that the CollaGenex’ PERIOSTAT patents are valid and would be infringed by the introduction of the generic form of PERIOSTAT.
Hoffmann & Baron, LLP has represented The Research Foundation in preparing and obtaining patents on behalf of the Stony Brook scientists in the United States and throughout the world.
About CollaGenex Pharmaceuticals, Inc.
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the Company’s dental pharmaceutical sales force markets PERIOSTAT, which is indicated as an adjunct to scaling and root planing for the treatment of adult periodontitis. PERIOSTAT is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues, and by enhancing bone protein synthesis. For additional information, visit www.collagenex.com.
About Hoffmann & Baron, LLP
Hoffmann & Baron, LLP is a leading full-service intellectual property law firm which specializes in all aspects of patent, trademark, unfair competition, copyright, and international trade law. The firm’s practice includes prosecution, counseling, licensing, and litigation of patent, trademark, and copyright-related issues worldwide. Based in Syosset, New York with offices in Parsippany, New Jersey, Hoffmann & Baron, LLP provides national and international clients with a distinguished level of service due to the strong legal experience, technical and academic credentials of the partners and associates. The firm serves clients in a wide range of fields, including pharmaceutical, chemical, biotechnology, electrical, mechanical, medical, petroleum processing, electro-mechanical, consumer products, waste disposal and treatment, nuclear, computer, superconductivity, optics, lasers, and e-commerce. For additional information, visit www.hoffmannbaron.com.
PERIOSTAT is a registered trademark of CollaGenex Pharmaceuticals, Inc.
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