What is Cyclosporine and where does it come from?

Cyclosporine, also called cyclosporin A, is an eleven amino acid protein that was first extracted from the fungus, Tolypociadium inflatum Gams in 1970. Jean Borel, a scientist working at Sandoz in Basel, Switzerland discovered the immunosuppressive properties of cyclosporine in 1972. Cyclosporine was considered the prototype of a new generation of immunosuppressants and it heralded the beginning of successful organ transplantation in man. It was first registered in Switzerland in 1983. Minor modifications to the protein have been made creating other cyclosporins, which were named cyclosporin B, C, D… etc but none have been registered or proven more safe or effective than the original, cyclosporin A. The field of organ transplantation and much of the current knowledge of immunology stem from the discovery of this unique molecule.

Who owns the rights to the ophthalmic cyclosporine patents?

Renee Kaswan, DVM, MS, DACVO, spent twenty years pioneering the ophthalmic use of cyclosporine while she was a professor of ophthalmology at the University of Georgia College of Veterinary Medicine. Through this extensive research, three use patents were procured. For the field of human medicine, the patents were exclusively licensed to Sandoz. Sandoz sublicensed their rights to Allergan who produced the product Restasis®. For the field of veterinary medicine, UGARF licensed the patents to KB Visions, who exclusively sublicensed these rights to Schering Plough. Schering Plough developed Optimmune®, a 0.2 % ophthalmic ointment approved by FDA in 1995 for the treatment of canine KCS.

In late 2001, Schering Plough could not supply the product in the United States due to an FDA citation against its factory in Puerto Rico. KB Visions changed Schering's license to non-exclusive and began licensing compounders.

Prior to last year, many compounders were making cyclosporine drops, and infringing the patents, much to the consternation of Schering Plough, KB Visions and the University of Georgia.

What uses do the ophthalmic cyclosporine patents cover?

All ophthalmic uses of cyclosporine. The other uses of cyclosporine which are not administered ophthalmically and are not covered by these use patents include oral administration of cyclosporine for the treatment of organ rejection, oral rinse to treat lichen planus, topical application to the peri-rectal area to treat canine rectal fistula, and dermatological application to treat human psoriasis.

We have been compounding or using ophthalmic cyclosporine for years. Why are we now being asked to comply with use patents and pay royalties?

Renee Kaswan, DVM, MS, DACVO, spent twenty years pioneering the ophthalmic use of cyclosporine while on staff at the University of Georgia. Through this extensive research, three use patents were procured. These patents had been exclusively licensed to Schering-Plough, who manufauctured and sold a 0.2% cyclosporine ointment under the trade name Optimmune®. From 1996 to 2001, the enforcement of these patents to the field of veterinary medicine had been performed by the University of Georgia Research Foundation (UGARF). In late 2001, Schering-Plough suspended the distribution of Optimmune® in the United States and subsequently entered into a consent decree with the Food and Drug Administration. KB Visions then moved to make the license with Schering-Plough non-exclusive and began licensing compounding pharmacies who previously were not approached by KB Visions. Concurrent with these activities and based on the licensing activities of KB Visions, KB Visions was directed to assume the responsibilities associated with enforcing the intellectual property rights.

Previous to Schering-Plough’s inability to supply Optimmune®, many veterinarians and compounders were making cyclosporine drops and not purchasing the ointment from Schering-Plough. Why weren’t those people approached then, and why are they now being pursued for royalties?

When UGARF and KB Visions granted the exclusive license agreement to Schering-Plough, it was Schering-Plough who held the rights to the ophthalmic use of cyclosporine worldwide. Once the Schering Plough agreement was made non-exclusive, KB Visions was assigned the responsibility for patent enforcement.

How will a license agreement with KB Visions be affected when Optimmune® returns to the United States market?

Compounders are primarily regulated by their State Board of Pharmacy. The FDA Modernization Act of 1997 also addresses a number of issues regarding compounding. When Optimmune® is readily available to the U. S. market, compounding of 0.2% cyclosporine ointment will no longer be allowed in the KB Visions' agreement. However, compounding of ophthalmic cyclosporine drops (solution) will continue to be allowed and covered under KB Visions' agreement.

How many compounders is KB Visions intending to license?

It is KB Visions’ intention to license enough compounders to effectively service the United States and to direct all ophthalmic cyclosporine prescriptions to those compounding pharmacies.

Can our pharmacy obtain a geographical exclusive license with KB Visions?

We are not offering exclusive licenses. Nevertheless, we are not interested in creating un-necessary competition within a geographical area or market niche so we will endeavor to limit licensees within the same marketplace. Consequently, those compounders who license early with us stand to benefit most.

How can we compete with pharmacies which have an unfair cost advantage because they are not licensed and are not paying royalties?

We are making every effort to contact every compounding pharmacy in the United States, however, this will take us several months to accomplish. You can assist us by identifying the pharmacy to us and we will confidentially contact them. Additionally, we will be contacting every veterinary office in the United States to inform them of the use patents and to refer them to our licensed compounders.

KB Visions, Inc.
6787 Riverside Dr. NW
Atlanta, Georgia 30328
©2002 KB Visions, Inc. All rights reserved.