A Medical Device Daily

Smith & Nephew (Memphis, Tennessee) reported that a three-judge panel of the U.S. Court of Appeals for the Federal Circuit has denied a stay of injunction while appeals are heard in a patent infringement suit.

S&N said that the permanent injunction was ordered on Sept. 28, 2006, and bars Synthes (Synthes USA, Westchester, Pennsylvania) and Synthes-Stratec (Oberdorf, Switzerland) from offering, selling or promoting Synthes Trochanteric Fixation Nail (TFN) and Proximal Fixation Nail (PFN) products in the U.S. for use in repairing intertrochanteric fractures.

“Once again the court has clearly affirmed the severity of this patent breach,” said Mark Augusti, president of S&N Orthopaedic Trauma & Clinical Therapies. “Upholding the injunction, especially during any appeals process, strongly supports the defense of our intellectual property.”

S&N filed the original suit against Synthes in November 2002. A non-jury trial that began in December 2004 concluded in March of 2005, with Judge Samuel Mays, Jr. issuing his findings supporting the injunction order on September 28, 2006.

Smith & Nephew’s Trigen Nail system is used in the healing of proximal femoral fractures (upper leg bone fractures). Intramedullary nails are placed inside the bone to aid in the healing of bone fractures.

In other legalities:

• Brinks Hofer Gilson & Lione (Chicago) reported that its client, MarcTec (Effingham, Illinois) has reached a settlement with ArthroCare (Austin, Texas), in a lawsuit involving 10 patents related to suture anchors used in rotator cuff surgery and other arthroscopic procedures.

Ralph Gabric, an attorney representing MarcTec, said ArthroCare will pay MarcTEc $2.75 million, plus future royalties, while not disclosing “the complete details of the settlement.”

MarcTec had asked the court to declare that its patents are valid, enforceable and infringed, and requested a permanent injunction to stop the manufacture and sale of the infringing product, as well as damages, attorneys’ fees and costs.

• Third Wave Technologies (Madison, Wisconsin) last week responded to a lawsuit filed against it by Digene (Gaithersburg, Maryland), alleging that Third Wave is infringing unidentified claims of U.S. Patent No. 5,643,715, relating to a single HPV type, 52, the prevalence of which is 0.5% of HPV-positive specimens in the U.S., according to Digene’s package insert.

The suit was filed in U.S. District Court for the Western District of Wisconsin in Madison.

Kevin Conroy, president/CEO of Third Wave, said, “We took great care to create a detection method free from the limited scope of the ‘715 patent’s claims. Third Wave’s Invader chemistry operates differently from any other nucleic acid analysis chemistry and is well-protected by intellectual property rights of its own.

He added: “Customers tell us that Digene’s test suffers from many challenges, and Third Wave’s dedicated team of scientists has developed HPV products, currently in clinical trials, that address those shortcomings and better meet the needs of clinical labs, physicians and their patients.”

Third Wave develops molecular diagnostic reagents for DNA and RNA analysis applications.

• Perry Hearn, MD, of Norwell, Massachusetts, has agreed to pay $150,000, and Affiliated Professional Services (APS; Wareham, Massachusetts), a medical billing company, has agreed to pay $100,000, to settle allegations that they submitted false claims to the Medicare and Medicaid programs for office and nursing home visits performed by nurse practitioners and physician assistants without any physician supervision.

“We cannot permit healthcare providers to cause the Medicare and Medicaid programs to pay more than is necessary, or more than is deserved given the actual service provided,” said a U.S. attorney in charge of the case.

According to the charges, while the nurse practitioners and physician assistants on Hearn’s staff commonly worked without any physician supervision, Hearn instructed APS to bill all of their services under his provider number, as if he had performed the services or had directly supervised them. APS allegedly did as instructed, even though it had information that Hearn’s nurse practitioners and physician assistants often did not work under physician supervision of a physician.

Hearn has entered into a compliance program with the Office of the Inspector General for the Department of Health and Human Services.