Dealmaking in the cardiovascular sector was essentially nonexistent over the past month, but action on the legal front was not lacking, with a variety of lawsuits and settlements suggesting the heated scramble for product position in this device arena.
Among the new suits filed:
Boston Scientific (Natick, Massachusetts) filed a patent infringement lawsuit against Johnson & Johnson (J&J; New Brunswick, New Jersey) to enforce its rights for the NIR family of stents which Boston Scientific has licensed from Medinol. Filed in the U.S. District Court for Delaware, the suit charges that J&J's BX Velocity Coronary Stent System infringes upon the Medinol patents, and seeks damages as well as preliminary and permanent injunctive relief. The Medinol patents cover proprietary flexible, cellular stent designs which enable "a flexible stent with optimized vessel wall coverage and minimal foreshortening," according to Boston Scientific. Jim Tobin, Boston Scientific president and CEO, said his company had made "a major commitment" to the NIR technologies. "Their innovative design is protected by U.S. patents, and Boston Scientific has the exclusive right to sell stents using that design."
Spectranetics (Colorado Springs, Colorado), a laser manufacturer with focus on cardiovascular applications, said that a federal district court in Virginia issued a permanent injunction against White Star Holdings. The order, according to Spectranetics, "follows previous court decisions finding that Spectranetics is the valid holder of a patent license entitling the company to develop, manufacture, market, and distribute its CVX-300 excimer laser system." The CVX-300 excimer laser is the only system FDA-approved for multiple cardiovascular procedures, including coronary angioplasty and the removal of cardiac pacemaker and defibrillator leads. Spectranetics said that previous decisions "also determined that White Star has no rights in the license or the licensed patents." The injunction prevents White Star from terminating Spectranetics' patent license agreement, contacting the company's customers for any purpose related to the patents or license agreement, and instituting any legal proceedings regarding the patents or the license agreement. Joseph Largey, president and CEO of Spectranetics, said the company "will continue to defend itself vigorously against attacks on its intellectual property rights and will prevail when challenged in a frivolous way."
In the "lawsuits settled" category:
Guidant (Indianapolis, Indiana) and Boston Scientific in late May said they had settled a patent litigation suit filed March 29. The two companies said they have agreed to license to each other certain patents related to coronary stent systems and dilatation catheters. They also have agreed to various financial terms dependent upon the outcome of motions pending in Guidant's lawsuit against Boston Scientific related to Guidant's stent patents and Boston Scientific's suit against Guidant related to Boston Scientific's dilatation catheter and stent delivery system patents. All other disputes between the companies were immediately dismissed. "Guidant is pleased to reach this agreement with Boston Scientific," said Ron Dollens, Guidant president and CEO. "We've eliminated the enormous expense and uncertainty that is associated with litigation, while once again taking a leadership position in creating a mutually agreeable situation that ensures that patients will continue to have access to the life-saving technologies at issue in these cases.'"
Nycomed Amersham (Buckinghamshire, England) and Mallinckrodt (St. Louis, Missouri) agreed to a major intellectual property settlement that also involves Molecular Biosystems (San Diego, California), Mallinckrodt's ultrasound contrast product development partner; and Sonus Pharmaceuticals (Bothell, Washington). The agreement covers all international markets, except those in the Pacific Rim, and resolves key intellectual property disputes between the parties, including ultrasound bubble composition. Nycomed Amersham will receive from Mallinckrodt a $10 Million license fee plus royalties of an undisclosed amount on future ultrasound contrast sales. Nycomed Amersham also will receive immediate joint access to Optison, the ultrasound contrast agent currently marketed by Mallinckrodt for diagnosis of cardiac wall abnormalities. The two companies also have agreed to collaborate on further joint development and commercialization of Mallinckrodt's Optison and of Nycomed Amersham's Sonazoid, currently under FDA review. In return, Nycomed Amersham grants Mallinckrodt a nonexclusive license under the Nycomed and Sonus patents and Mallinckrodt and Molecular Biosystems grant Nycomed Amersham and Sonus the right to practice under their ultrasound patents.
Edwards recalls Lifepath graft system
Just weeks after Edwards Lifesciences (Irvine, California) was spun off by Baxter International (Deerfield, Illinois) as a separate unit, the company halted sales of its Lifepath endovascular graft system outside the U.S. and issued a product recall. The actions came after discovery of flaws in the system, reported in two patients, with those flaws caused by a fracture of its wireform, according to Edwards. The Lifepath system is designed to treat abdominal aortic aneurysms (AAA), a ballooning of the aorta wall that may burst and often results in fatality. The company said that wireform fractures produced no adverse events in the patients.
Altogether, 235 patients have undergone aneurysm repair with the system, the company said, with Chairman and CEO Michael Mussallem calling the recall "purely precautionary." Mussallem added, "In fact, each patient's aneurysm has been shown to be shrinking – an indication that our product continues to function as intended, helping to treat this life-threatening condition. Nevertheless, our patients' health is always our primary concern, and we felt that voluntary suspension was the appropriate decision while we complete our evaluation."
The company has undertaken a review of all Lifepath AAA cases to determine whether any additional wireform fractures exist.
Guidant launches carotid stenting trial
Guidant (Indianapolis, Indiana) last month launched a clinical trial to evaluate the efficacy of carotid artery stenting as a minimally invasive alternative to surgery for treating carotid artery disease and to determine the incidence of stroke in high-risk patients.
Called ARCHeR (Acculink for Revascularization of Carotids in High-Risk Patients), the trial will treat about 400 patients at approximately 30 sites. As part of the trial, the first patient was successfully implanted with Guidant's investigational Acculink stent by L. Nelson Hopkins, MD, at the Millard Fillmore Hospital (Buffalo, New York).
Companies .... in brief
CryoCath Technologies (Kirkland, Quebec, Canada), a maker of catheter cryotherapy systems, reported that its Kirkland manufacturing facility has been certified to international quality system standards, ISO 9001/EN46001/ISO13485. The company said that the certification will speed compliance with FDA quality system regulations as well as with international regulatory agencies
Hemosol (Toronto, Ontario, Canada) last month said it will locate its proposed 200,000-unit production facility for its blood substitute Hemolink in Mississauga, Ontario. The new facility is slated for completion by late 2001 and will have a initial capacity of 200,000 units per year, later expanded to 600,000 units
MedAmicus (Plymouth, Minnesota), a developer of medical products for gynecology, urology, and cardiology markets, said that it will increase the size of its current headquarters and manufacturing facility by 45% and move into the new space June 1. MedAmicus' products include venous vessel introducers for use in implanting pacemakers, defibrillators and infusion catheters.