Make IP information more freely available
• Make available, at minimal or no cost to all users, a readily searchable database of US, European, and international (PCT) patents augmented by advisory and educational services so that end users can decide upon appropriate IP management tactics, such as whether to invent around or to negotiate with a patent owner.
Integrate IP/legal issues regarding FDCs of both HIV and TB
• The epidemics of HIV/AIDS and tuberculosis have converged in much of the world. To combat the seemingly inexorable march of antimicrobial resistance, new anti-TB FDCs as well as new ARVs are needed, with an integrated approach to treating both diseases. An integrated approach, involving collective R&D and IP ownership (See Section 5), that can manage R&D and the resulting IP for both TB and HIV would complement this;
• To assist in this, there already exist dedicated groups of IP specialists who provide advice on IPR “access” issues to NGOs, developing countries. Specialists in agricultural biotechnology have developed interesting views on this topic23;
• Contractually or legislatively require non-exclusive licenses for critically needed IP such as FDC components;
• Create voluntary or compulsory patent pools;
• Create an FDC IP clearinghouse to reduce costs of transacting for IP rights, stimulate private sector incentives, education in practical policy/legal IP issues, conduct objective “due diligence”, coordinate IP policies. Again, we can look to agricultural biotechnology for models24.
Incentivize private sector FDC development
Previously suggested private sector incentives might be modified for FDCs to include:
1) The development of federal consortia to expedite and partially fund the development of a new selected FDCs, thereby reducing costs of development to a given pharmaceutical company;
2) Wild Card Exclusivity where the patent life of an agent, such as a lipid lowering agent, would be extended for a short time, if a valuable FDC were developed;
3) A Modified Wild Card Exclusivity where a short-term patent extension would be given to another drug in the same class (such as an anti-malarial) as a newer FDC;
4) Possible tax credits for the development of antimicrobials;
5) The adjustment of business loan rates for companies pursuing FDCs.
More controversial suggestions might include requiring regulatory agencies (i.e., the FDA) to make sure that FDCs are created as a vehicle for certain anti-infective agents or to treat certain diseases. Since it is always in the best long-term business interests of the private sector to extend their market share, this can be accomplished by combining a new drug with an off-patent generic into an FDC, as has been done with Malarone®25. For less developed countries, mechanisms of price differentiation26 should be developed so that the private sector will get to extend market share and recoup R&D expenses (which are likely to be small for old drug combinations) in the developed countries, and the less developed nations will receive a low-cost FDC drug.
Even more radical proposals would include new forms of public support for FDC R&D and new types of collaborative partnerships, fueled by public funds. With regard to FDCs, one can imagine a consortium of private and public actors creating a clearinghouse for creating FDC drugs whose components are from different owners. The organization will sponsor clinical trials and/or provide quality assurance/quality control expertise and/or contract out manufacturing capacity. Initial support might come from pharmaceutical companies and international donors or NGOs. The respective governments would create tax incentives for the pharmaceutical companies. Some portion of the profits realized from IP licensing fees and drug sales would be placed into a global fund to be used to provide grants to developing countries to improve efforts to combat antimicrobial resistance.