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July 12, 2007

Teardrop

Visudyne is a light-activated drug treatment for a particular form of age-related vision loss, specifically, "wet" macular degeneration. Visudyne's development began with a serendipitous discovery, and ended in acrimony between the those involved in development of the treatment that came to fruition over a decade after initiation. A blockbuster with cumulative sales over $2.3 billion from product launch in 2000 through March 2007, there was plenty of money to go around. Tuesday, Judge William Young of Massachusetts district court adopted a patient jury's verdict in sorting out a very complex story to set a reasonable royalty, and, as a kicker, scolding the litigants for their pettiness. (MA 10783-WGY)

The story of Visudyne begins in the late 1970s. Dr. Julia Levy, an immunologist at the University of British Columbia, and her husband Ed Levy, had a cottage on a remote island north of Vancouver. Their children would play in a field of cow parsley outside the cabin. Dr. Levy noticed that sometimes after play, the children would develop lesions on their legs and torsos that looked like scalds. She did not know what it was. When the Levys returned to Vancouver, she called a friend who was the head of the botany department at the University of British Columbia. Her friend explained that cow parsley contains a photosensitizer chemical that was activated by light and that the children had likely gotten burned after they got sap on their skin and sunlight activated the chemical.

Dr. Levy’s friend then told her about photodynamic therapy, which uses light-activated drugs in medical treatment. Photodynamic therapy works by shining light on a chemical called a photosensitizer. When light is shined on the photosensitizer, the chemical becomes energized. In this energized state, the photosensitizer is toxic. When the photosensitizer is targeted, it will kill only unwanted cells.

Dr. Levy became very interested in incorporating photodynamic therapy into her work on cancer immunology.

Dr. Levy's work in the 1980s at the University of British Columbia resulted in patents, and collaboration with others to further developments, including researchers at Massachusetts General Hospital (MGH), Massachusetts Eye and Ear Infirmary (MEEI), and Ciba Vision.

What was developed was verteporfin, a drug put in the eye, and activated by a low-level laser to destroy abnormal, leaky blood vessels. The condition, untreated, results in vision loss from a number of eye diseases, including macular degeneration, which is a leading cause of blindness in the elderly.

Patents were granted. Various agreements signed. Then began bickering over inventorship.

In December 1997, representatives from QLT, MGH, MEEI, and CIBA Vision met in Boston to negotiate a license agreement. QLT negotiated from the position that it didn’t really need a license to the patent but wished to recognize the contributions that MGH and MEEI had made to the development of Visudyne.

QLT played rough hardball with MEEI and tried to get MEEI to accept a low royalty rate on the basis of a weak bargaining position. Despite these unscrupulous tactics, however, QLT always intended to pay MEEI something for its contributions to the development of Visudyne. After the low offer of a $200,000 royalty rate, QLT offered successively higher royalty rates, up to and including the 0.5% royalty rate that MGH had proposed to QLT. QLT increased its offers in attempt to reach agreement; QLT did not intend for negotiations ultimately to break down.

In April 2000, MEEI sued QLT to establish itself as the sole owner of 5,798,349, which claims vetreporfin, the active ingredient in Visudyne. Before the district court, QLT was granted summary judgment on all eight of MEEI's complaint assertions, a decision MEEI had partly overturned on appeal, and remanded. The three remaining counts were misappropriation of trade secrets, unfair trade practices, and unjust enrichment. The jury pitched the trade secrets accusation, and unfair trade also went by the boards. But the jury found, and the judge concurred, that QLT "was unjustly enriched to MEEI's detriment when QLT disclosed... confidential information to CIBA Vision."

Compared to the 0.5% royalty QLT had offered, MEEI had sought a 13.5% rate. Though he would have gone higher, to 3.5%, Judge William adopted the jury-determined rate of 3.01% for past, present, and future worldwide sales of Visudyne, along with prejudgment interest on past royalties of 12%, as well as $14 million to MEEI for attorneys' fees. Given the blockbuster sales, QLT figures, at 3.01%, it could be liable for nearly $70 million, plus royalties on future sales.

The judge's conclusion -

The story of Visudyne is one of serendipity that would not have been possible without the contributions of every one of the researchers who entered the picture. Dr. Levy helped discover BPD. Dr. Hasan and Dr. Birngruber thought to apply BPD to the eye. Dr. Schmidt-Erfurth carried out much of the early work. Dr. Gragoudas provided the link to Dr. Miller, who applied Dr. Schmidt-Erfurth’s work to age-related macular degeneration. The resulting treatment, Visudyne, should have been a cause for the celebration of the extraordinary contributions that each of these scientists made.

Instead, the parties have squabbled over inventorship, minimizing and even dismissing outright the contributions made by others. This dispute over inventorship is exceptionally unseemly, all the more so because determining correct inventorship was not necessary to a just determination of the case. This dispute does not befit the advancement of science, which builds on the contributions of all. Unless the parties can repair their relationships in the name of science, the losers may well be those who should have been the biggest winners -- those who suffer from eye diseases such as age-related macular degeneration.

Posted by Patent Hawk at July 12, 2007 1:29 AM | Damages