Licensing Agreement Pharmaceutical Industry

On the page you represent, make sure your client takes this issue into account when negotiating the license agreement. From the licensee`s point of view, he wants access and use of the basic drug file, ideally free, under each early termination scenario. From the licensee`s point of view, he tries to recover his investment in the event that the basic drug file would benefit the licensee or a third party. Because of prohibitive costs and the long chances of opposing the development of a pharmaceutical product, non-exclusive licenses of compounds with therapeutic potential are rare, as a licensee would not carry out the development without the advantage of the legal monopoly created by an exclusive license. It should be noted, however, that an exclusive license of a compound limited to a restricted scope, such as. B an indication of specific illness raises some of the same concerns as that of a non-exclusive license, since the licensee may grant „exclusive” licenses for other areas of use. This can cause problems because of the potential for off-label use of pharmaceuticals. To take a blatant and unlikely example, we assume that Baby Biotech has granted your client an exclusive license to its proprietary XYZ peptide for „therapeutic use in humans, but not other applications.” Suppose Baby Biotech then grants another exclusive XYZ license for animal health products for „therapeutic use in animals, but not for other uses.” Let`s also assume that your customer and animal health products develop the same formulation or essentially the same formulation of XYZ and each put a product on the market. Two things are for sure: Animal Health has spent much less to develop its product than your customer has; and the market price of Animal Health`s product is much less than the price of your customer`s product. What prevents potential consumers of your product from buying the animal product? As the costs of developing and marketing medicines and equipment continue to rise, the focus on cooperation and licensing agreements will only increase.