Schering-Plough licenser to sue patent violators

Atlanta-After swallowing the financial side effects of the Food and Drug Administration's $500 million fine on Schering-Plough, a patent holder for canine "dry eye" medication is, in turn, slapping lawsuits on negligent compounding pharmacies.

KB Visions Inc., which patented ophthalmic use of cyclosporine and exclusivelylicensed it to Schering-Plough (brand name Optimmune®), was not to blamefor Schering-Plough's penalties, which resulted in a consent decree to improvemanufacturing standards at its Puerto Rico and New Jersey plants as wellas fines. Yet resulting from its fines, Schering-Plough was forced to suspendproduction and sale of Optimmune, used to treat canine keratoconjunctivitissicca, or dry eyes.

Now that KB Visions has lost royalties from the drug, the company isseeking legal action against compounding pharmacists for patent violations,after establishing a licensing program and asking violators to cease anddesist.

"(Cyclosporine) is still under patent and can only be bought froma licensed source, whether that's an FDA-approved source or a compoundingpharmacist," says Dr. Renee Kaswan, president of KB Visions.

In interim

When Optimmune was taken off the market, KB Visions re-evaluated itsexclusive licensing agreement with Schering-Plough and made the agreementnon-exclusive.

The company is now licensing its patents to pharmacies in the UnitedStates that can make a substitute cyclosporine formulation.

Unlicensed companies will be notified of infringement, and will be liablefor three times the value of the sold products, according to Kaswan, whopioneered research on KCS and cyclosporine.

KB Visions is currently surveying veterinary ophthalmologists and askingwhere they're buying cyclosporine. If it's from an unlicensed source, Kaswansays the company will pursue litigation.

Awareness vital

Veterinarians, in many cases, are oblivious to patent violations.

"Veterinarians are not educated in patent law. The veterinariandoesn't even know he is infringing someone's patent when he is using that(illegally compounded) product," says Kaswan.

Currently, 30 pharmacies and veterinary ophthalmologists have a licenseto compound cyclosporine.

Schering plans to return Optimmune to the market by early 2003.