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Commercializing pharmaceuticals through collaboration - the Kirin Model

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Gemini Science is a wholly-owned U.S. subsidiary of Kirin Pharmaceuticals, located in San Diego and is Kirin's sole agent in the United States for facilitating Kirin's pharmaceutical business development efforts.

These activities involve identification of novel technologies and pharmaceutical products for partnering and licensing. The therapeutic focus of these activities are on human antibody and cell therapy in the areas of oncology, nephrology, and immunology.

A major focus of Gemini's business activities is to identify and build relationships with potential collaboration partners for in-licensing antigens, which can be used in Kirin's unique human antibody platform.

Kirin has developed an advanced technology that allows for the production of fully human monoclonal antibodies and polyclonal antibodies in proprietary transgenic strains of mice and bovine, respectively, which contain human antibody genes.

Upon immunization of these animals with foreign antigen, the immunological response of these animals results in the production of fully human antibodies. Because these antibodies contain only human material, they can be used in various human therapeutic applications without concern for adverse reaction.

Examples where these antibodies may prove to have particular utility is in passive immunotherapy against various human diseases and genetic disorders. The production of a polyclonal antibody response in the transgenic bovine animals may be particularly useful in the treatment of infectious disease.

A key business objective of Gemini is to help Kirin identify partners in the United States who have unique antigens that can be used in collaboration with Kirin to develop fully human monoclonal antibody therapeutics.

Kirin will also consider in-licensing potential target antigens from the academic sector. In these circumstances, Kirin would negotiate an exclusive worldwide right to use the target for development of fully human monoclonal or polyclonal antibodies.

The test targets coming from academia are usually early stage and have had very little validation. In some instances, Kirin may decide to enter into an initial sponsored research/option agreement to fund further academic research on the target before committing to a broad licensing agreement.

Regardless of how new and exciting a potential collaborator's technology may be a key component in Kirin's decision to proceed with a collaboration is an analysis of the intellectual property embracing the technology to be in-licensed.

In the world of successful biotechnology commercialization, intellectual property and financing are now inextricably intertwined. A primary reason for this close association is the tremendous amount of research and funding which must be expended in order to eventually bring a pharmaceutical product to market.

In addition to utilizing Kirin's in-house patent department, Kirin relies heavily on its relationship with outside counsel to assist in rigorously evaluating the intellectual property landscape of the potential partner's technology.

Kirin works closely with experienced legal practitioners in not only sorting through the various legal issues associated with the intellectual property, but also, in addressing issues such as the size of the targeted market and the revenue model which can be driven by the intellectual property.

Because Kirin's commercial emphasis is on human antibodies, a key component in the selection of external IP counsel is counsel's knowledge of advanced immunology and molecular biology. Outside counsel also assists Kirin through their familiarity with competing companies in this area. By bringing to the analysis both its legal, scientific, and business skills, outside counsel allows Kirin to make a well-reasoned decision regarding the types of technology and scope of claims that may eventually be obtained.

Ultimately, the utilization of counsel having not only a strong legal background, but also, a focused scientific and business background, results in a net saving of time, energy, and costs.

A key component in Kirin's analysis of whether to establish the collaborative third-party relationship is the sophistication of the intellectual property portfolio of the potential partner.

This analysis involves consideration of not only the number of patents held by the potential partner, but more importantly, the quality of the patent applications and determination of the likelihood that meaningful commercial claims may issue. Kirin also will look at the issue of the validity of the patent portfolio, especially as it pertains to the target antigen or other specific technology being licensed.

Finally, Kirin will work with outside counsel to identify and evaluate third party patents, which might hinder the commercialization of the technology. Kirin achieves these goals by performing extensive searches of the prior art, as well as third party patents in the relevant area, to ascertain whether the commercialization of the product could be encumbered or barred entirely.

Other intellectual property issues that are examined by the company relate to whether the potential collaborator has encumbered the technology through prior license agreements with other entities.

This can raise sensitive issues as to what fields have already been licensed or whether there are geographic limitations attached to the technology that would affect Kirin's ability to further commercialize the technology.

In biotechnology in particular, another issue that has become increasingly important to address is whether there may have been some form of material transfer agreement entered into by the potential collaboration partner, which affects the ability of the potential partner to commercialize the technology.

In the model that has been developed by Kirin, the approach to addressing the issue of whether a potential collaborator's technology is one which would be of mutual benefit to the parties involves the use of a highly-integrated and complementary team of both in-house and external talent which works synergistically to help Kirin develop products in those areas that lie within the company's overall commercial strategy.

Ultimately, the intellectual property position, including the patent portfolio, exists as a business tool that will act as both a sword and a shield to allow the commercialization of the technology and hopefully provide the public new and exciting pharmaceutical agents.

Tanaka is the director of business development for Gemini Science Inc. Wetherell is a partner with Pillsbury Winthrop Shaw Pittman LLP and head of Intellectual Property for the National Life Sciences Practice Section.

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