A Medical Device Daily

The FDA is seeking a permanent injunction against Endotec (Orlando, Florida) and Michael Pappas, PhD, company president; Frederick Buechel, MD, medical director of the company; and Jared Pappas, director of regulatory affairs, to stop the illegal distribution of unapproved total joint replacement devices.

The complaint, filed by the U.S. Department of Justice in the U.S. District Court for the Middle District of Florida, charges Endotec with distributing joint replacement devices without an approved premarket application or approved clinical studies. The FDA charges that the company has been distributing the unapproved devices since March 2002, despite FDA warnings.

The agency is advising consumers who have one of the Endotec replacement joints to continue “standard medical care” and report any adverse events or problems to their physicians, and, if they are unsure if they have an Endotec device, to check with their physicians. It is also asking physicians to report adverse events related to the devices to the FDA’s MedWatch Adverse Event Reporting program.

In other court action:

• QLT (Vancouver) reported that the U.S. Court of Appeals for the Federal Circuit issued a decision reversing the district court’s partial summary judgment on one issue of inventorship on the patent in dispute in the lawsuit launched in 2001 by Massachusetts Eye and Ear Infirmary (MEEI; Boston ) in the U.S. District Court of the District of Massachusetts.

MEEI in 2001 brought suit against both QLT and Novartis Ophthalmics (Basel, Switzerland) alleging infringement of U.S. Patent No. 6,225,303, issued in 2001, originally naming only MEEI researchers as inventors.

Massachusetts General Hospital (MGH; Boston) then intervened to seek correction of inventorship of the ‘303 patent to name researchers from both QLT and MGH as joint inventors and declaring that QLT and MGH are co-owners of the ‘303 patent. QLT and MGH then filed a motion for summary judgment concerning inventorship.

In early 2005 the court granted partial summary judgment ordering that the ‘303 patent be corrected to add QLT’s scientist Julia Levy as joint inventor, deferring ruling on MGH’s and QLT’s motion to add MGH inventors as well. The court ruled that Levy significantly contributed to the ‘303 patent. MEEI appealed the partial ruling.

In this week’s ruling the appeals court overturned the summary judgment, ruling that issues of fact still must be determined, the case remanded to the district court.

QLT said it expects the district court judge to decide “whether to rule on the remaining and previously undecided summary judgment motions brought by QLT and MGH with respect to their inventorship on the patent or to proceed to trial.”

In a related matter, a trial on three of eight claims that MEEI brought against QLT in a 2000 lawsuit in a dispute involving U.S. Patent No. 5,798,349 (the ‘349 patent) is to begin Oct. 16. The district court dismissed all of MEEI’s other claims in rulings affirmed by the Court of Appeals for the First Circuit in 2005.

In April 2000, MEEI filed a civil suit against QLT in Massachusetts seeking to establish exclusive rights for MEEI as the owner of certain inventions related to the use of verteporfin as the photoactive agent in the treatment of eye diseases. In 2002, QLT moved for summary judgment against MEEI on all eight counts of the complaint.

The court granted QLT’s motion dismissing all of MEEI’s claims. MEEI appealed the decision and in June 2005 an appeals court upheld the dismissal of five of MEEI’s eight claims and remanded for further proceedings concerning three MEEI claims.

QLT said that these claims are expected to be heard at trial beginning Oct. 16.

QLT develops treatments for eye diseases and dermatological conditions.

• In other legalities: Stanbio Laboratory (Boerne, Texas), a developer of diagnostic devices, reported that the U.S. Patent and Trademark Office has initially rejected all seven claims brought by Hemocue (Angelhorn, Sweden) of the patent review (U.S. Patent No. 5,674,457) of a microcuvette device. The microcuvette is a blood collecting and testing device used with Stanbio’s HemoPoint H2 Photometer, and Stanbio said that the panel found that Hemocue’s patent claims were invalid.

“This is a tremendous victory for our side regarding our rights to sell our HemoPoint H2 hemoglobin testing system,” said William Pippin, CEO of Stanbio.

On April 6 Stanbio filed a cross-complaint alleging that Hemocue, engaged in unfair business practices against Stanbio by telling customers that Stanbio was legally barred from selling its hemoglobin meters and microcuvettes.

Pippin said that “a great deal of misinformation circulated about patents once we introduced our HemoPoint H2 hemoglobin testing system. We believe the USPTO finding definitively supports our long-standing belief that Hemocue’s claims have no basis.” And he said that Hemocue is using its greater size to keep Hemocue’s customers from being free to choose Stanbio products.

Stanbio manufactures medical testing and diagnostic devices including clinical chemistry, pregnancy, drugs of abuse, serology, urinalysis, microbiology assays, and point-of-care blood hemoglobin tests, competing with Hemocue in these areas.