Opinion ID: 203621
Heading Depth: 2
Heading Rank: 2

Heading: The Patent Application Process

Text: We come now to the patent application process, another major strand of the dispute between the parties. Because Dr. Miller disclosed important facets of her research results in abstracts published on March 15, 1993, a patent application had to be filed by March 15, 1994. See 35 U.S.C. § 102(b). In late February and early March of 1994, MEEI informed QLT that it wanted to patent the process that Drs. Miller's and Gragoudas' research had spawned. QLT suggested the use of its patent attorney but indicated that it did not see itself as an inventor of the process. Moreover, QLT reiterated its desire to license the treatment from MEEI. QLT memorialized these comments in several letters. In addition, although QLT noted the possibility that non-QLT employees might claim co-inventorship status, QLT promised to compensate MEEI based on MEEI's sole ownership of the contemplated patent. Based primarily on her discussions with Dr. Miller, QLT's patent attorney drafted patent application 08/209,473 (the '473 application). [8] The '473 application named only three inventors, all affiliated with MEEI: Drs. Miller, Gragoudas, and Lucy Young (another MEEI researcher). Soon after the '473 application was filed, Dr. Hassan learned that she had not been named an inventor, and she objected. Further complicating matters, QLT argued that the portion of the '473 application dealing with age-related macular degeneration had to be refocused in light of the prior art. In a contemporaneous letter to CIBA, however, QLT clarified that its concern went beyond determining the proper scope and inventorship of a potential Visudyne patent; QLT wanted to maintain control of the application process. Dr. Ed Levy wrote: At one point we verbally conveyed to MEEI a more negative view of the prospects [of the '473 application] and our willingness to continue funding the application. Their response was roughly send us the file. We chose to soften our position so that we could maintain control of the process.... Dr. Levy further explained that QLT was not yet in a propitious position to challenge Dr. Miller or MEEI because the '473 application listed only MEEI inventors: What all this amounts to is that there will be additional negotiations with Joan [Dr. Miller] and MEEI over these matters, so even though we hold almost all of the cards, we do not want to muddy the waters. For all I know there may be other reasons not to get into a pissing match with Joan (excuse the technical language)-e.g. she made important contributions to the preclinical proof of principle and she could be an extremely valuable clinical investigator  but it seems to me that the patent negotiations alone are a sufficient reason for all of us to proceed carefully with Joan and her colleagues. Having retained control of the patent application process, QLT suggested amending the application to cover narrower claims involving liposomal preparations of BPD. (The original application involved LDL-based BPD). Such a limitation would permit Dr. Julia Levy to be added to the patent application as a co-inventor. Initially, QLT's patent attorney rejected this limitation. The parties remained unable to reach agreement on the proper scope of the Visudyne patent application. Stymied, Dr. Murashige, QLT's patent attorney, suggested that all concerned parties  MGH, MEEI, and QLT  meet in December 1994 to resolve the inventorship dispute. Prior to the meeting, MEEI researchers were resistant to broadening the inventorship of Visudyne because of concerns that added inventors would reduce the amount of future royalties that MEEI could expect. To counter these concerns, QLT assured MEEI that a fair business arrangement would be made regardless of how inventorship was sorted out. At the meeting, all those claiming potential co-inventor status, each with the guidance of independent counsel, explained their claimed roles in the process. Rather than argue about who did what, Dr. Murashige suggested that the parties file a broader patent application that would include additional inventors. It was understood that this broadened patent application would be jointly assigned to MEEI, MGH, and QLT because personnel from all three institutions were co-inventors under this broadened application. MEEI and its researchers remained wary of this prospect. Following the meeting, Dr. Miller continued to express her concerns about dropping the '473 application and filing a broader application listing additional inventors. But the Levys again reassured her that QLT would compensate MEEI as the sole inventor, regardless of how the patent application was ultimately drafted. As a result of these assurances, MEEI, Drs. Miller, and Gragoudas acquiesced to QLT's preferred approach. Consequently, QLT's patent attorney filed continuations-in-part canceling the '473 application and reworked the canceled claims, which she filed as part of a broader patent application, the '591 application. Thus, based on QLT's promise that MEEI would be treated as the sole owner of the treatment method for age-related macular degeneration, MEEI agreed to merge its patent claims into two dependent claims (numbers 7 and 14) of the '591 application, with the consequent addition of researchers from MGH and Dr. Julia Levy of QLT as co-inventors.