2.1Op 26 november 2007 heeft VIB (op verzoek van Ablynx) het volgende aan Unilever geschreven:
We are writing to you as the entity that is currently responsible for the VUB patent portfolio that relates to the Camelldae heavy chain antibody fragment (VHH's or Nanobodies) technology.
As you are aware, these VUB patents were originally licensed to your company by the VUB (…)
Subsequently, responsibility for licensing these patents was transferred from the VUB to us, and we have licensed these patents to Ablynx for the following applications (translated from Dutch):
"to develop, make, have made, let make by third parties. use, import, export, offer and sell products and processes to predict, diagnose, follow. prevent and treat human and animal diseases."
We understand that your company is developing a VHH product against rotavirus, a virus that infects human beings and in so doing causes disease in humans. We also understand that your VHH product is currently the subject of clinical trials in Bangladesh, performed at the International Centre for Diarrhoeal Disease Research (ICDDR).
We have studied the publications and other Information that have become publicly available on your program, on the product that you are developing, and on the trials that you are performing. These include the scientific publications that are mentioned in the attached memo, as well as the 2006 annual report of the ICDDR. We have noted that, according to the annual report of the ICDDR, the trial of your product is designed to [emphasis added]:
“evaluate the safety and tolerability of a novel Llama-derived anti-rotavirus VHH fragment in human volunteers (Part-I)and its therapeutic efficacyin children with rotavirus diarrhea (Part-II)”
We have also noted that in your own scientific publications, you make various statements and claims about the therapeutic and prophylactic effect that your product has on rotavirus infection in humans. (…)
On the basis of these statements and claims, which clearly present your product as having a therapeutic and prophylactic activity against a specific disease in humans, we believe that your product constitutes a “medicinal product” as defined by the various European Directives applicable to medicinal products (…).
We would like to inform you that, in our opinion, "medicinal products" as defined in Directive 2001/83 fall outside of the scope of the rights licensed to you. The right to develop and commercialize such medicinal products under the VUB patents has been exclusively licensed to Ablynx.
Ablynx has contacted us and expressed its grave concerns about the impact that any negative findings resulting from your current activities and clinical trials may have on the opportunities to apply the technology in the healthcare field, and thus on Ablynx's business and its interests as a licensee to the technology. We share Ablynx's concerns in this respect, also because we understand that you may not have subjected your product to the kind of preclinical tests and approvals that would normally be required for a proposed medicinal product (for example, in Europe), before you embarked on the clinical trials of your product in Bangladesh. It is VIB's mission to translate our research results into products for the benefit of society and we therefore adhere high value to the safe development of medicinal products based on our research. We would deeply regret anything which would go wrong with the nanobodies, not only from the commercial viewpoint but also and in particular from the viewpoint that we would encumber the access of patients to a very promising novel class of drugs.
I can also inform you that we have extensively discussed the present situation with the VUB, and that the VUB also shares the concerns outlined above.
We understand from Ablynx that they have already initiated steps to defend their interests in this matter. As you will appreciate, as the entity that is currently responsible for licensing the technology, we would - if still possible - prefer to avoid any conflict between the existing licensees, and we would be willing to play an active role in ensuring that any potential conflicts are resolved. However, in the meantime, we would like to receive confirmation from you that you will not embark on any activities that would infringe upon the rights licensed to Ablynx. Also, as we believe that you are currently developing a medicinal product, we would like to hear from you what steps you are intending to take to ensure that the current situation is resolved in a manner that is acceptable to all parties involved.