A Medical Device Daily

Guidant (Indianapolis) reported the U.S. District Court for the District of Delaware has issued a number of rulings in a patent infringement case involving stent patents disputed by Guidant and Medtronic (Minneapolis).

Medtronic filed suit in February 1998 alleging that the sale of Guidant's balloon-expandable coronary and peripheral stents infringed the Boneau patents owned by Arterial Vascular Engineering (AVE; Santa Rosa, California), which subsequently was acquired by Medtronic. The litigation was consolidated with a suit by Guidant, filed in the same year, alleging infringement by Medtronic of Guidant's Lau stent patents.

On Wednesday, Guidant reported that the court had ruled that none of its stents infringed any of Medtronic's asserted Boneau patents. In addition, it said, “the court ruled that Medtronic's S7 and Driver coronary stents infringe one of Guidant's Lau patent claims.“

Guidant said that the court made “several other rulings“ also favorable to it, “including those related to claim construction, inventorship and misappropriation.“

Medtronic issued its own statement regarding the ruling as well as on stent litigation between itself and Boston Scientific (Natick, Massachusetts).

It agreed that Guidant's Multi-Link family of coronary and peripheral stents do not infringe its Boneau patents and that its S7 and Driver coronary stents infringe one claim of Guidant's Lau patent.

It said that Guidant's motion for summary judgment that the Medtronic Boneau patents are invalid was denied.

Medtronic said that regarding the patent litigation between it and Boston Scientific, the court ruled that Boston Scientific's NIR and Express stents do not infringe the Boneau patents; and that Boston Scientific's motion for summary judgment that the Medtronic Boneau patents are invalid was denied.

Medtronic said it “disagrees with the court's infringement decisions and intends to pursue all available legal remedies, including its right to challenge the validity of the Lau patents and to exercise its right to appeal.“

In other legalities:

• Artes Medical (San Diego) reported that the U.S. Patent and Trademark Office (USPTO) has granted its request for reexamination of the Aventis (Strasbourg, France) patent covering injectable skin fillers using poly-lactic-acid (PLA) microspheres, marketed in the U.S. under the Sculptra trademark and in Europe as New-Fill. Reexamination is a USPTO procedure through which a patent that may have been granted as the result of error or oversight can be reconsidered and, if warranted, canceled.

In granting the request, the USPTO agreed with Artes that there was a substantial question of whether the subject matter claimed in Aventis' patent No. 6,716,251, issued in April 2004, was actually patentable, it said, “especially in view of Artes Medical's own patent that was issued nearly 10 years earlier covering injectable microspheres for soft tissue augmentation made from either polymeric or non-polymeric materials.“

The request for reexamination submitted by Artes Medical cited an additional seven scientific articles and/or patent documents, all of which the USPTO agreed raised at least 12 new issues that question the novelty of the Aventis technology and place in question the validity of the corresponding Aventis patent.

Artes is focused on the facial aesthetics market, its lead product being ArteFill, a combination of precision filtered synthetic microspheres suspended in Ultra-Purified Collagen.

• Tenet Healthcare (Dallas) said it has learned that Mina Nazaryan, former associate administrator at Alvarado Hospital Medical Center (San Diego), a facility that is owned by a Tenet subsidiary, has pled guilty to one count of conspiracy in an ongoing federal trial in San Diego. The continuing defendants in the federal case are the hospital, a Tenet subsidiary and Barry Weinbaum, Alvarado's former CEO.

Tenet, in a statement, said, “Nazaryan's plea is hers alone. It will not affect our decision to vigorously defend the hospital and its chief executive officer. As we have said before, Tenet believes that its physician relocation policies were appropriate and legal under federal laws and regulations.“

Tenet, through subsidiaries, owns and operates acute-care hospitals and related healthcare services.

Clarification

The article headlined “Durect, Voyager win IND for use of Durin implant for Alzheimer's“ in the Dec. 27, 2004, issue of Medical Device Daily incorrectly stated that Voyager Pharmaceutical is conducting Phase II trials with Durect's Durin leuprolide drug implant. While Voyager is conducting two ongoing Phase II trials investigating leuprolide as a treatment for Alzheimer's disease, these studies are utilizing the active agent and not the actual Durin implant. These two leuprolide Phase II studies with active agents, along with the recently initiated Phase I trial of the Durin leuprolide implant, will serve as the basis for the “end of Phase II“ meeting with the FDA. The article also incorrectly said that Durect has been working on the development of drug-loaded implants for controlled release for more than 20 years. Durect is a six-year-old company whose scientists have been working in this field for more than 20 years.