A Medical Device Daily

Smith & Nephew (S&N; Memphis, Tennessee) reported that the Federal District Court for the Western District of Tennessee has granted its request for a permanent injunction directed at the Trochanteric Fixation Nail (TFN) and Proximal Femoral Nail (PFN) intermedullary nail products manufactured by Synthes (Westchester, Pennsylvania).

S&N said that the ruling prevents Synthes from distributing or selling in the U.S. its TFN and PFN products indicated for treatment of inter-trochanteric fractures.

Intramedullary nails are placed inside the bone to aid in the healing of fractures.

The court had previously ruled on Aug. 28, 2005, that the Synthes TFN and PFN products infringed upon U.S. patents 5,167,663 and 5,312,406, owned by S&N, and upheld the validity of the patents.

On Sept. 28 the court concluded that Synthes' infringement caused S&N to lose sales for its competing products and damaged S&N's market share for orthopedic implants "in ways that cannot be fully compensated by monetary damages alone. S&N said that the damage inflicted on it satisfied the U.S. Supreme Court's recently announced, more stringent, standard for granting permanent injunctions in patent infringement cases," S&N said.

Mark Augusti, president of S&N's Orthopaedic Trauma & Clinical Therapies division, said, "We believe the court's ruling recognizes the strength and merit of Smith & Nephew's case as innovators in trauma surgery." And he promised continued vigorous defense of its patents.

S&N filed the suit against Synthes in November 2002. A non-jury trial that began in December 2004 concluded in March of 2005, with a judge issuing his findings supporting the injunction order on Sept. 28.

S&N's Trigen Nail system is used in the healing of proximal femoral fractures (upper leg bone fractures).

In other legalities: Nektar Therapeutics (San Carlos, California) issued a statement regarding the status of an ongoing administrative proceeding with Ellen Leznik, former corporate counsel, who left Nektar in February 2005.

Nektar said that in May 2005 Leznik filed a whistle-blower complaint with the U.S. Department of Labor (DOL) claiming that she had engaged in protected activity under the Sarbanes-Oxley Act during her employment with Nektar. Following applicable procedures, the complaint was referred to the Occupational Safety and Health Administration (OSHA) of the DOL for investigation.

Nektar said that on or about May 1, OSHA issued its decision finding in favor of Nektar and against Leznik and dismissed her complaint. Leznik currently has an appeal pending before the Office of Administrative Law Judges at the DOL.

"We agree with OSHA's decision in favor of Nektar and believe that Ms. Leznik's action is without merit and therefore we will continue to vigorously defend ourselves in this proceeding," said Gil Labrucherie, chief compliance officer of Nektar.

Nektar is a developer of drug delivery technologies, currently best known for development of the inhaler used to deliver Exubera inhaled insulin.