Lawsuits ensue as companies attempt to bring 30-day contact lenses to U.S. market

Issue: April 1999

NEW YORK — The focus of the extended wear contact lens marketplace shifted from the laboratory to the courtroom as Bausch & Lomb and Ciba Vision positioned themselves for the eventual opening of the 30-day extended wear lens market.

Both Bausch & Lomb and Ciba Vision claim patent rights for extended wear technology and materials. Also entering the legal arena is Vistakon, manufacturer of the popular Acuvue lens, which filed suit challenging Bausch & Lomb’s marketing claims.

Although these actions are directed at Bausch & Lomb’s new PureVision 7-day lens, at stake is the potential for a lens that can be worn continuously for 30 days and nights without removal or cleaning. In its marketing materials, Bausch & Lomb cited a study conducted by BASES International, which reported that 62% of current contact lens wearers polled in the United States would buy a continuous wear lens if recommended by an eye care professional.

Legal proceedings came to a head the weekend of March 19, when the ophthalmic industry was gathered in New York for International Vision Expo East, where Bausch & Lomb announced the release of PureVision. The lens received Food and Drug Administration (FDA) marketing approval Feb. 23 for 7-day wear, and Bausch & Lomb is planning 30-day wear trials.

B&L files for declaratory judgment

Bausch & Lomb had attempted to substantiate its right to market the PureVision lens by filing for a Declaratory Judgment Action in U.S. District Court in Rochester, N.Y., on Dec. 21, 1998. In the filing, Bausch & Lomb asked the court to determine that the PureVision lens did not infringe on Ciba Vision patents or trademarks. This case was dismissed March 18.

Ciba Vision, which had already begun its own legal action, claimed victory in the first legal confrontation.

“The dismissal of this case illustrates that the suit filed by Bausch & Lomb in New York was inappropriate,” said Scott Meece, Ciba Vision general counsel.

Ciba Vision began the legal defense of patents related to the development of its extended wear lens, Focus Night & Day, by seeking a temporary restraining order in Federal District Court for the Northern District of Georgia on March 8. The company wanted to prevent Bausch & Lomb from manufacturing and marketing the PureVision lenses, which Ciba Vision claims infringe on several Ciba Vision-held patents.

In initial proceedings on March 18, Ciba Vision set aside this request at the court’s suggestion that the companies attempt to reach a settlement. At press time, the companies had begun discussing a schedule for negotiations, but no date had been set, Ann Bailey Berry of Ciba Vision’s corporate communications department told Primary Care Optometry News.

Carl Sassano, president and chief executive officer of Bausch & Lomb, said at a Vision Expo press conference: “If there’s an amiable way to resolve whatever differences we have, we will do that.”

Ciba continues with lawsuit

Ciba Vision is continuing with its patent infringement lawsuit, which alleges that Bausch & Lomb’s PureVision infringes on U.S. patent numbers 5,760,100, 5,849,811, 5,776,999 and 5,789,461, which relate to the development of an extended wear contact lens and are held by Ciba Vision. The applications for these patents were filed in 1994 and the patents were issued in 1998. The company also claims that Bausch & Lomb’s PureVision trademark infringes on the trademarks for “Pure Eyes” and “Ciba Vision,” both held by Ciba Vision.

“Ciba Vision’s Focus Night & Day lenses are a breakthrough in extended wear material development, setting a new industry standard for high oxygen transmissibility,” said Steven T. Schuster, president of Ciba Vision North America, in a written statement to Primary Care Optometry News. “We will vigorously and aggressively enforce Ciba Vision’s patents and trademark rights which protect our discoveries in the development of this lens.”

Bausch & Lomb claims it patented the PureVision material in 1993, a year before Ciba Vision filed its patent application and 5 years before Ciba Vision’s patents were issued.

Despite the ruling in U.S. District Court in Rochester, Mr. Sassano was confident Bausch & Lomb’s patents would survive Ciba Vision’s court challenge. “They’re still 2 years behind us,” he told the audience at Bausch & Lomb’s Vision Expo press conference.

Bausch & Lomb announced it is in the final stages of having its 30-day study protocol approved by the FDA. These clinical trials will last for 1 year, and it may be 2 years before the FDA approves the lenses for 30-day wear, Bausch & Lomb predicts. The company has received CE mark approval in the European Union for continuous wear up to 30 days. The commercial launch there has not been scheduled.

Ciba Vision’s Focus Night & Day lens has been launched in Mexico and Spain for wear up to 6 nights and is being test-marketed in Mexico for 30-night wear. The company is awaiting CE mark approval in Europe and has begun FDA clinical trials for 6-night and 30-night wear.

Vistakon challenges marketing statement

In addition to Ciba Vision’s patent in fringe ment allegations, Bausch & Lomb’s marketing materials have been called “false and misleading” by Vistakon, a Johnson & Johnson company, in a lawsuit filed in U.S. District Court in the Southern District of New York on March 19.

The suit questions Bausch & Lomb’s assertion in marketing materials and an advertisement that the PureVision lens reflects a “new level of ocular health.” Vistakon alleges that Bausch & Lomb’s clinical studies, which compared the PureVision lens to both Vistakon’s Acuvue lenses and the Optima lens from Bausch & Lomb, did not establish that Pure Vision lenses significantly improved ocular health.

“We felt, as the leader of the industry, we couldn’t allow that misleading comparison or false statements to be made,” Philip R. Keefer, president, Americas, Vistakon/Johnson & Johnson Vision Products Inc., told an audience at a Vistakon-sponsored press conference during the Vision Expo meeting.

In the suit, Vistakon contends that Bausch & Lomb bases its claim on clinical studies that found significantly less overnight corneal swelling and a significantly lower level of hypoxia-related effects compared to a conventional extended wear lens, and that there was no increase in bacterial binding to epithelial cells with PureVision.

According to Vistakon, the only known health risk of using an extended wear lens is ulcerative keratitis, which was not studied by Bausch & Lomb. The lawsuit also cites an article in the Jan. 15, 1999, issue of Ophthalmology Times, which described a 12-month contralateral eye study conducted by Bausch & Lomb comparing Acuvue and PureVision lenses. In the article, Brian Levy, OD, MSc, Bausch & Lomb’s Vice-President of Biological and Clinical Research, said, “There was no statistically significant differences between [Acuvue and Pure Vision] in terms of safety and efficacy.”

As of March 19, Bausch & Lomb had not received a copy of the lawsuit Vistakon filed, but the company generally declines to discuss specifics of pending litigation, said Barbara Kelley, vice-president of corporate communications. “We are very comfortable that the claims we have made for the PureVision lens are well substantiated, and we seem to have made some of our competitors a little nervous with the introduction of this breakthrough technology,” Ms. Kelley told Primary Care Optometry News.

Strong clinical results

Taking a back seat to the courtroom challenges are recent clinical evaluations that have indicated a 30-day extended wear lens may be at hand.

Early comments from patients and doctors involved in both 7-day and 30-day clinical trials for Bausch & Lomb’s PureVision lens have been largely positive, Tim Comstock, OD, MS, director, global clinical research, told Primary Care Optometry News.

“Practitioners are very encouraged by the lack of hypoxic effects they normally see with overnight wear,” Dr. Comstock said. Patient complaints in trials have mostly been related to conditions not associated with hypoxia and have occurred at equivalent rates to those found in control groups, he said.

Patients also have overwhelmingly chosen PureVision lenses over the control lens, generally the Acuvue lens, in the company’s multicenter trials conducted in the United States, Europe, Canada, Australia and South Africa, according to Dr. Comstock. In both the assessment scale, where the patient is asked to rate each lens individually, and the preference scale, where patients compare the Pure Vision and control lenses, Pure Vision consistently is the favorite.

Dr. Comstock attributed the positive response to the PureVision lenses to its higher Dk/t, which is 110 in –3 D lenses. Other factors contributing to this response are the balance of lens characteristics, including the lens material, surface and lens design. PureVision lenses are made from balafilcon A, a material that incorporates oxygen-transmissible silicone with a traditional hydrogel material.

In addition to 6-night marketing in Mexico and Spain, trials for 30-night wear of Ciba Vision’s Focus Night & Day lenses are continuing at the Cooperative Research Centre for Eye Research and Technology in Australia, as well as two other sites, said Tim Grant, BOptom, MBA, executive director of clinical and regulatory affairs, in an interview with Primary Care Optometry News.

Focus Night & Day is made of lotrafilcon A, a biphasic material consisting of channels of fluorosiloxane, which is responsible for the material’s high Dk/t of 175, and hydrogel, which transmits water and ions. Because the hydrogel is not the main source of oxygen for the cornea, the lens has a relatively low water content of 24%. The channels in the material are microsized so they do not scatter light.

“This Dk/t of 175 is higher than any other soft contact lens and exceeds the Dk/t threshold of 125, which new research suggests is the range required to avoid stromal hypoxia. We’ve done overnight trials where we’ve shown the lens has edema equivalent to no lens wear,” Dr. Grant.

Results from clinical trials have been promising, according to Dr. Grant. “The response from patients and practitioners has been outstanding, with a clear preference for this lens,” he said.

For Your Information:

Carl Sassano, president and chief executive officer;

Barbara Kelley, vice-president of corporate communications and

Tim Comstock, OD, MS, director, global clinical research, can be contacted at Bausch & Lomb, 1400 N. Goodman St., PO Box 450, Rochester, NY 14692; (716) 338-6000; fax: (716) 338-6481.

Scott Meece, Ciba Vision general counsel;

Ann Bailey Berry, corporate communications;

Steven T. Schuster, president of Ciba Vision, North America, and

Tim Grant, BOptom, MBA, executive director of clinical and regulatory affairs, can be contacted at Ciba Vision, 11460 Johns Creek Parkway, Duluth, GA 30097-1556; (770) 476-3937; fax: (770) 813-2039.

Philip R. Keefer, president, Americas, Vistakon/Johnson & Johnson Vision Products Inc., can be contacted at Vistakon, PO Box 10157, Jacksonville, FL 32247; (904) 443-1000.