Circuit court blocks sales of PureVision lens during appeal
In response to the ruling, Bausch & Lomb has announced plans to manufacture the 30-day lens in Ireland for now.
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WASHINGTON A federal court ruling has once again stopped Bausch & Lomb from selling its PureVision contact lenses in the United States.
The ruling, by the U.S. Court of Appeals for the Federal Circuit, reinstated an injunction that will permanently force Bausch & Lomb to halt sales and manufacturing of the lens in this country.
The circuit court denied Bausch & Lombs request for a stay pending appeal of an injunction issued by the U.S. District Court for the District of Delaware.
Bausch & Lomb is appealing the June 26 ruling in favor of Wesley Jessen and its parent company, CIBA Vision. In the litigation, CIBA Vision claimed that Bausch & Lombs PureVision contact lens infringed on U.S. Patent No. 4,711,943, also known as the Harvey patent, which is owned by Wesley Jessen.
Following the injunction ruling in Delaware, Bausch & Lomb asked for and received a temporary stay of the injunction from the federal circuit court on June 28. The recently denied request had been for a stay pending appeal, which would have allowed the manufacture and sale of the lenses throughout the 12- to 18-month appeals process.
If Bausch & Lomb loses its appeal of this case, the company would not be able to manufacture or sell the product in the United States until 2005, when the Harvey patent expires.
CIBA Vision contests
The Harvey patent was filed in 1985 by Sola, a predecessor to Wesley Jessen. Neither Wesley Jessen nor CIBA Vision has developed a contact lens under the patent, but they still hold exclusive rights to the contact lens materials detailed in the patent. This right of ownership excludes any other company from copying these contact lens materials until the patent expires.
Considering these circumstances, Scott Meece, vice president and general counsel for CIBA Vision, believes the federal courts decision was appropriate.
This was a sound and well-reasoned ruling, showing that our patent is valid, enforceable and infringed by Bausch & Lomb, he said.
According to Mr. Meece, the PureVision infringes the Harvey patent claims. In addition, it infringes claims of the Nicolson patents, which arose from CIBA Visions Focus Night & Day extended wear lens development.
The Harvey patent was a fundamental step in the process of the development of extended wear lenses, Mr. Meece explained. U.S. patent law stimulates innovation by protecting a companys unique developments and preventing other companies from manufacturing or selling an infringing product during the period the patent covers, and the courts ruling supports innovation by enforcing these laws.
Bausch & Lomb defends
Bausch & Lomb denies the allegations brought against it by CIBA Vision.
Our patented PureVision lens is the result of more than a decade of original science and investment of more than $60 million, said Robert B. Stiles, senior vice president and general counsel for Bausch & Lomb. Our PureVision lens does not infringe on the patent in question, and we believe the patent is not valid. We are asking the Court of Appeals to reverse the decision of the lower court.
However, while denying Bausch & Lombs request for a stay during the appeal process, the federal circuit court announced that it was not persuaded by the papers submitted by Bausch & Lomb, and that the company has not shown a likelihood of success in the upcoming appeal trial.
We believe that the court erred, said Barbara Kelley, vice president of corporate communications and investor relations for Bausch & Lomb. We dont believe that the denial of the stay of injunction necessarily bodes for or against the appeal process. We continue to believe that we have a good case, which will be evaluated on the merits of written submissions and oral arguments presented to a panel of judges.
Production in Ireland
In response to the recent ruling, Bausch & Lomb has announced that it will manufacture its PureVision lenses in its plant in Waterford, Ireland.
According to Bausch & Lomb, the transfer of PureVision manufacturing from the U.S. plant in Rochester, N.Y. will allow Bausch & Lomb to meet the needs of eye care professionals and patients in Asia, Canada and Europe. The company will use current inventories of PureVision lenses to fill overseas customer orders during the transition of manufacturing.
The production of PureVision lenses will take place in Ireland for the duration of the appeal, which is expected to last an estimate 6 to 18 months, Ms. Kelley said. However, we are trying to expedite the appeal as quickly as possible, so that we can return to the U.S. market soon.
However, even if Bausch & Lomb wins the appeal and returns to the U.S. market before 2005, the two companies are engaged in other patent disputes related to the patents held by each side.
More to come
Since 1999, the possible infringement of Bausch & Lombs product on four other patents owned by CIBA Vision has also been in question. CIBA Vision argues that the Nicolson patent, filed in countries worldwide in 1994, has also been violated by the sales and marketing of the PureVision lens.
There are a variety of elements like the properties of oxygen and ion-permeable lens materials that have been disclosed in the four Nicolson patents, Mr. Meece said.
Regarding this issue, CIBA Vision has filed charges against Bausch & Lomb in the United States, Australia and Germany.
For this Nicolson patent, there are multiple lawsuits pending worldwide. And, if Bausch & Lomb decides to infringe in other countries as well, we will file as appropriate, he added.
Bausch & Lomb filed a patent lawsuit against CIBA Vision in November 2001, claiming that the Night & Day lens material infringes on a patent held by Bausch & Lomb (the Lai patent).
For Your Information:
- Scott Meece, vice president and general counsel for CIBA Vision, can be reached at CIBA Vision, 11460 Johnson Creek Pkwy., Duluth, GA 30097-1556; (678) 415-3646; fax: (678) 415-3592.
- Robert B. Stiles, senior vice president and general counsel for Bausch & Lomb, can be reached at One Bausch & Lomb Place, Rochester, NY 14604; fax: (800) 356-8056.
- Barbara Kelley, vice president for corporate communications and investigator relations for Bausch & Lomb, can be reached at One Bausch & Lomb Place, Rochester, NY 14604; (585) 338-5386; fax: (585) 338-0949.