Source: Grill IP patents news
The legal recognition and protection of compounds, processes, and products helps propel research and development schemes for the creation of life-saving drugs. Medicines for Malaria Venture (MMV) is one product development scheme, which partners with pharmaceutical companies to rectify the market failure that results from a lack of research on malaria. This Venture provides varying degrees of intellectual property protection in the R&D process, providing antimalarial drugs at the lowest possible price. MMV serves as model for intellectual property protection in the realm of drug development for Type III diseases.
Generally, patent owners are afforded the right to prevent others from making and selling their patented drug, allowing these owners to recoup their investment. Control over drug protection is lost when a company loses its patent protection, as most drugs and drug related products are easily copied and can be marketed for a fraction of their original price. This framework has made it too pricey for significant innovation to occur in tackling Type III diseases, which are prevalent in a number of developing states. These diseases have a return on investment of about zero, since those afflicted often lack the means to pay for necessary drugs. As a result, until the 1990s, innovation in the antimalarial realm was virtually nonexistent.
Currently, the global stock of antimalarials involves over 40 antimalarial projects, in varying phases of the clinical, preclinical, approval, or registration process. Most of these projects can be attributed to the work of MMV. Created in 1999, MMV’s goal is to work with partners from both the public and private sector, in order to discover, develop and deliver antimalarial drugs that are accessible to all who need them. MMV operates by offering expertise on malaria drug development to its partners, supporting joint research projects with funding from philanthropic and government actors. Today, MMV’s network consists of over 400 policy partners.
These partnerships are built on a strategic approach to intellectual property, one utilizing the leveraging power of intellectual property to ensure that antimalarials reach their market. This intellectual property protection rests on a model whereby MMV partner research is conducted with a degree of openness contingent on the stage of research undertaken. For the early stages of malaria research MMV maintains a relatively free IP outlook, with three different approaches.
The first, the Open Source Drug Discovery program involves the free reporting and sharing of research online. This permits researchers tackling the same issue to openly collaborate and thus accelerate drug development. The following approach, Open Access, makes data, compounds, and publications are available to researchers for the sake of maximizing their use across diseases. MMV’s “Malaria Box” is an example of Open Access. This “Box” gives research partners the cost-free opportunity to screen antimalarial compounds against other diseases. Researchers are then requested to enter their resulting data into the public domain. The final and favored approach is Open Innovation, where projects operate within a contractual environment allowing confidentiality to be secured, permitting partners to assemble intellectual property and register patents. MMV and its academic partners have the right to co-own this property. Additionally, MMV can secure an exclusive, royalty-free, sub-licensable license for the development of antimalarial compounds. In select cases, all rights to intellectual property are assigned to MMV by its academic collaborators. When a pharmaceutical partner is involved, then it assumes ownership of the property, but provides an exclusive license to MMV in the field of antimalarial development, if the pharma partner should withdraw from the collaboration. In this model, cost, effort and risk are shared equally among partners. Since 2010, Open Innovation collaborations have resulted in seventeen antimalarial candidate molecules.
Should a compound seem promising, demonstrating a new mechanism of action in fighting malaria, MMV will get involved in its patent application. If a pharmaceutical partner is involved in the collaboration, this partner will decide the patent strategy. In contrast, where MMV is pursuing the development of a drug alone, that is, with the help of academia while searching for pharmaceutical collaborators, it will invariably seek legal protection for its candidate drugs, increasing the value of its assets. Most of MMV’s antimalarial candidates have well-defined ownership of intellectual property, whether through MMV’s protection or that which is done by one of its partners.
While the agreements between MMV and its pharmaceutical partners is shaped by the value delivered to the intellectual property, these agreements always ensure that the antimalarial products are affordable, with a basis of “no-profit, no loss” guiding the operations of all partners. This involves a third party audit, confirming the cost structure of the pharmaceutical company’s activities.
In terns of patent strategy, protection does not extend to malaria-rife countries, except in the case of India, China and Brazil. Protection is regularly pursued in these “large economies,” as there is the possibility that a compound has a more pressing and lucrative role outside of malaria treatment. Another case for patent protection for Type III drugs is quality control. Like other medical ventures, MMV uses patent protection to deter the development of suboptimal products.
In sum, MMV’s two-prong approach, combining Open Innovation with IP protection exemplifies the strategic use of legal protection to attract industry partners and advance public health initiatives.Tags: antimalarial development, intellectual property protection, International IP law, Malaria Box, Medicines for Malaria Venture, MMV, Open Acces, Open Innovation, Open Source Drug Discovery, pharmaceutical partners, Type III diseases