Organon Starts Legal Proceedings In Portugal In Defence Of Livial

Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry;  Women's Health / Gynecology;  Endocrinology
Article Date: 27 Apr 2007 - 10:00 PDT

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Organon will today open legal proceedings against the suppliers of two drugs for infringement of its chemical purity and particle size patents for tibolone. The action will be filed in Portugal, where the infringements are alleged to have occurred.

Tibolone is a prescription medicine marketed by Organon in Portugal (and elsewhere in the world) as Livial®, an established therapy for the treatment of menopausal symptoms and prevention of osteoporosis in postmenopausal women.

Organon's legal action asserts that two drug distributors, Tecnimede-Sociedade Técnico-Medicinal S.A. of Portugal and Grünenthal S.A. of Portugal and the manufacturer of both generic drug products, West Pharma - Produçöes Especialidades Farmacéuticas S.A. of Portugal, infringed patents relating to chemically pure tibolone (expiring in Europe in October 2019) and to polymorphous tibolone having a small particle size (expiring in Europe in May 2024) in their production of generic (non-branded) tibolone tablets.

In recent years Livial has become an increasingly common target for generic drug companies, despite the patent protection still in force in both European and non- European jurisdictions. In addition to the two tibolone patents referred to above, Organon owns a crystalline purity patent for tibolone which is not due to expire in Europe until March 2010 (and in Portugal until November 2010).

Organon is determined to defend the rights conferred by these patents - in the courts (or before another forum) if necessary. Organon sought an injunction against a Korean manufacturer of a tibolone generic product for infringement of the crystalline purity patent not dissimilar to the legal action now started in Portugal. At the request of the court, the infringement is currently being investigated by an independent Korean institute. In Scotland and Korea, Organon is appealing decisions to revoke the crystalline purity patent covering Organon's branded product Livial. Organon is also appealing the European Patent Office's decision to revoke the chemical purity patent, which also covers Livial. In Mexico, Organon has recently obtained the grant of the chemical purity patent and has won a court decision ordering the publication of the crystalline purity patent in the patent Linkage Gazette.

1. Livial is currently available in 90 countries.
2. While almost all drug licensing processes now take place under a common mutual recognition procedure in Europe, decisions on patents are taken by individual national courts.
3. Organon's action in Portugal will specifically allege infringements of its patents EP(PT) 1121375 (relating to chemically pure tibolone), and EP(PT) 1499278 (relating to polymorphous tibolone having a small particle size).

About Organon

Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.
www.organon.com

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