"Superbugs Require Super Drugs: An Examination of Why Existing Incentive Programs Have Failed the Antibiotic Field" (Part 2 of 2)

Today's post 'Superbugs Require Super Drugs: An Examination of Why Existing Incentive Programs Have Failed the Antibiotic Field' is Part 2 of 2, and is adapted from a larger thesis of the same name.

In her last post, Ms. Alissa Fideli described some of the problems created by the current patent system for antibiotics. Today, more intriguingly, she provides some solutions.

Proposal

Antibiotic efficacy is akin to a natural resource that is threatening to run out; in order to preserve and rehabilitate this natural resource, global cooperation is necessary. My proposal is a treaty that would deal exclusively with encouraging research into new antibiotics and managing antimicrobial resistance. The treaty would require a certain measure of commitment to research and development into priority antibiotics from member states. It would employ a credit system, whereby member states would be able to acquire credits, through conducting certain valuable types of research or through providing technology transfer to developing countries that they could then use to meet their commitment targets. 1 The treaty would also provide a framework of potential incentives that members could employ, such as tax credits, public funding or grant options, guaranteed market and/or advance purchase commitments, and transferable priority review vouchers. 2 The treaty would require mandatory granting of “wild-card” patent extensions for companies engaged in research to combat any of the top five priority bacteria. The extension would be applicable to any preexisting patent and would serve as a strong incentive for private pharmaceutical companies.

The most controversial provision of the treaty would provide that the parties to it agree to conditionally reduce the term of patent protection for new antibiotics. The reduction is conditional on managing, or at least tempering, antibiotic resistance in bacteria. The treaty would reduce the term of patent protection until the governing body finds a substantial decrease in antibiotic resistance. Once this reduction in resistance is achieved, the treaty would allow an incremental increase in the patent term for antibiotics. The governing body would develop a sliding scale of patent protection that prescribed an initial shorter term of exclusivity with the potential to increase the term as resistance declined; the duration of exclusivity would be based on the collection and analysis of data on antibiotic resistance in the member states.

The rationale behind this provision is that if antibiotic resistance continues to increase along its current trajectory, bacteria will continue to mutate and develop resistance and science will continue to play catch up, always lagging behind. In this scenario, twenty years of patent protection is unnecessary; a long patent term could ultimately become a loss if it is made obsolete by rapidly mutating bacteria. Further, the cost of obtaining and enforcing a patent on such a product would far outweigh its short-term benefits. Additionally, market exclusivity is ultimately about recouping costs and making a profit. The incentives of tax credits, grants, patent extensions and promised markets will allow companies to recoup the losses that they otherwise could not with patent protection alone. This provision also encourages members to fully commit to prudent use and prohibition on misuse of antibiotics; the more vigilant they are about preventing new resistance from emerging, the better chance they have at obtaining increased patent protection.


The reduction in the term of patent exclusivity may raise concerns under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), which requires that all parties to the WTO provide patent protection regardless of the field of technology. 3 However, the TRIPs agreement also allows member states to exclude inventions from patentability when necessary to protect ordre public or morality. 4 Under this provision, members are explicitly allowed to prevent patent protection when necessary to protect human health; the antibiotic resistance crisis provides a strong argument for reducing patent protection to protect public health. 5

Conclusion

Antibiotic resistance, and particularly the resistance of Gram-negative bacteria, is a serious problem in global public health. Despite this significant threat, pharmaceutical companies are not developing drugs to address these problems. The incentives provided in the current laws, including patent protection and other specific exclusivities, have not spurred technology in this area. As such, there needs to be a new approach, and new incentives to create antibiotics to address and manage this potentially lethal threat. A multinational agreement, that can attack the problem from different angles throughout the world, is the best solution for this global problem.


1. See Medical Research and Development Treaty, Discussion draft 4, art. 8-11 (2005).
2. Transferable priority review vouchers allow a pharmaceutical company who has a voucher to receive expedited review at the FDA for any other patented drug product. For a more in depth discussion see Brad Spellberg et al., The Epidemic of Antibiotic-Resistant Infections: A Call to Action for the Medical Community from the Infectious Disease Society of America, 46 CLINICAL INFECTIOUS DISEASES, 155 at 161 (2007).
3. Agreement on Trade-Related Aspects of Intellectual Property Rights art. 27.1, Apr. 5, 1994.
4. Id. at 27.2.
5. Id.