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Antibiotics, R&D and patent reform

gram stained Staph aureus

I followed the link from Derek Lowe’s blog, In the Pipeline, to this abstract of a paper that was published in May of this year  about the dearth of antibiotics in big pharma’s pipeline:

The world is running out of antibiotics. Between 1940 and 1962, more than 20 new classes of antibiotics were marketed. Since then, only two new classes have reached the market. Analogue development kept pace with the emergence of resistant bacteria until 10-20 years ago. Now, not enough analogues are reaching the market to stem the tide of antibiotic resistance, particularly among gram-negative bacteria. This review examines the existing systemic antibiotic pipeline in the public domain, and reveals that 27 compounds are in clinical development, of which two are new classes, both of which are in Phase I clinical trials. In view of the high attrition rate of drugs in early clinical development, particularly new classes and the current regulatory hurdles, it does not seem likely that new classes will be marketed soon. This paper suggests that, if the world is to return to a situation in which there are enough antibiotics to cope with the inevitable ongoing emergence of bacterial resistance, we need to recreate the prolific antibiotic discovery period between 1940 and 1962, which produced 20 classes that served the world well for 60 years. If another 20 classes and their analogues, particularly targeting gram-negatives could be produced soon, they might last us for the next 60 years. How can this be achieved? Only a huge effort by governments in the form of finance, legislation and providing industry with real incentives will reverse this. Industry needs to re-enter the market on a much larger scale, and academia should rebuild its antibiotic discovery infrastructure to support this effort. The alternative is Medicine without effective antibiotics.

Imagine a world without effective antibiotics.  {{shivver}}

Note that the abstract says that the industry could be developing “another 20 classes and their analogues“.  To the public, those analogues might look an awful lot like “me too” drugs.  But that’s ok in this area because bacteria mutate at such a good clip that a moderately modified analogue could seriously throw them off kilter.  So, while it is important to also develop drugs that hit different bacterial targets, the analogues are still very necessary and important.

It’s not like there is a shortage of projects that the nation’s laid off overeducated geeks could be working on and like I said before, if the big pharma entities want to pass on antibiotics because they are too expensive and litigious, there are more than enough of those geeks who would happily work for the government for decent wages commensurate with the level of difficulty of our work.

What I’m worried about is patent reform.  There are proposals right now that would reform the patent system so that the patent goes to the person who files first and not the first to innovate.  The issue is of special importance to the software and cellular data industry who are getting tired of being sidelined by patent trolls.  But what if you’re a tiny biotech that just spent your kid’s college fund and granny’s nest egg discovering a potential drug?  On the surface, this seems very fair until you realize that many entrepreneurs, some of them involuntarily liberated from big pharma, don’t have large departments of expensive patent lawyers they can call upon to file an air tight patent.

Getting to the first to file stage may be close to impossible for many small biotechs to achieve without making a deal with a very big devil who is making them an offer they can’t refuse.  It could seriously dampen any enthusiasm for drug discovery in small companies especially if those companies are doing research in therapeutic areas that big pharma has abandoned like antibiotics and CNS drugs.

I just wish I had the confidence that the Congress members who are reviewing the reform legislation knew what they were doing and were committed to making the system fair for the little guy.  At the very least, we should study whether the “first to innovate” patent structure leads to more innovation than the “first to file” system of other countries.   What may save social media may end up causing a lot of infections down the road.