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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.

12 Responses

  1. What we really need is the perfect waterproof glove that doesn’t give me contact dermatitis. Yes, I’ve tried nitrile. Didn’t work. My hands are all itchy and driving me crazy from two days in gloves.
    Yes, I know, benadryl, steroids, been there, done that.
    {{sigh}}

  2. http://www.nytimes.com/2011/08/30/science/30obcoriander.html

    I wonder if anyone’s jumped on the coriander patent yet?

    Would it have helped to use a cheap cotton glove (like an archivist glove) between you and the waterproof glove? I bought a box of them back during the bird-flu scare….

  3. The ones with the deepest pockets get to buy your Senators and Representative. Established companies have those deep pockets the little guys and gals are no longer in the stadium let alone the game.

  4. What is the thinking behind the first-to-file change? I’m at a loss to understand why this would be a good thing.

    • The first to file rule is the one that most countries in the world follow. I am not a patent lawyer but from what I understand, the date of the invention documentation, not the date the invention is filed, is the driving force for awarding the patent in this country. So, let’s say that you are an inventor and you are documenting your work. You go to file your patent with your documentation. The patent office is going to take into account the dates on your records and that will be the thing that decides who gets the patent. With this proposed reform, the patent will go to the person who files first regardless of date of the invention. This kind of thing plagues the pharmaceutical world. The big companies are constantly fighting off the patent claims of other inventors. Sometimes, huge stakes are on the line, especially if a blockbuster drug is dispute. But if you are a chemist and you put it down in a notebook somewhere for a specific purpose before Behemoth Pharma did, you are entitled and Behemoth Pharma has to license the patent from you. I’m not seeing how the change could cut down on patent trolls since if you file first, you still get the patent. But I *suspect* it will damage the small inventor. If you don’t have the money to hire a lawyer to file your patent and pay the fees to usher it through the system quickly, some bigger company will muscle you out of the way. It could be very, very tricky for small biotechs who collaborate with bigger companies. In fact, you would be crazy to even think about a collaboration. Any intellectual property you share with them that isn’t covered by an airtight confidentiality agreement could be used to file a patent before you do. Or the confidentiality agreement could be drafted by Behemoth Pharma and be 400 pages long with lots of clauses that cover everything and box the small biotech into a corner. Let’s just say that from what I heard happen at an ACS meeting back in May when it presented information on incubators, I don’t trust the venture capitalists who small start up biotechs get in bed with. They already take a huge chunk of proposed profits. With this change, I could see them take the rest of it. You’d have to add a patent attorney to your meager payroll almost immediately to make sure you have any claim at all on your own work. Who’s got that kind of money from the very start?

      • Hmm. It almost sounds like a license to steal.

        Is wanting to be in line with other countries what is pushing this, or is it just pressure from the big guys?

      • Mostly the change from “first to invent” to “first to file” is intended to harmonize with the rest of the world. (Why that should be a concern, I don’t know. There are lots of different patent laws all over the world. inventors and companies work with local patent counsel everywhere they file and the local counsel know all the rules of their jurisdiction.)

        It is not common but not rare for two inventors (or sets of inventors) to come up with the same invention and both patent it. But trying to determine which was first to invent can take a lot of court time and expense, as opposed to just looking at the date of the filing at the US Patent Office, so the “first to invent” rule arguably makes patent litigation more expensive, in the small number of cases where the issue comes up. (At what point did each conceive the invention and did they “reduce it to practice” using “due diligence”?)

        But yes, as solo inventors and small companies often need to wait to raise funds before they patent — especially if they plan to file in several countries, I think the “first to file” rule can hurt small inventors.

        I have not seen anything I particularly like about the patent reform bill. The idea that it will spur the economy is a joke.

        djmm

  5. What percent of rising bacterial immunity to antibiotics is due to the massive use of antibiotics of various kinds in large-scale animal confinement operations? Enough to matter? If so, how would we force the industry to reduce its use of antibiotics in agribussiness?
    Forcible land reform and the restoration of several million owner-operated family farms which didn’t “need” to confine thousands of animals in epidemigenic conditions? And would the “consumer” pay
    the higher prices necessary to keep family farms in bussiness using lower amounts of antibiotics?

    • yes, yes, let us argue about the morality of organically grown beef while people die from necrotizing faciitis.
      The genie is already out of the bottle. I suspect the real culprit is not agribusiness but other factors, like mothers who insist on antibiotics when their kid gets a cold. Antibiotics are useless against colds because colds are caused by viruses. Or when people are supposed to finish their course of antibiotics but don’t. That gives the suckers time to mutate and become resistant. Or when hospitals don’t follow strict hygenic procedures and bacteria get transmitted to immunocompromised patients where they can go a little crazy and pass their plasmids around.
      The point is that we are rapidly running out of effective antibiotics. This was bound to happen because of the nature of the beasties. Mutation is what they do. So, if you have companies stop making new ones, then you’re stuck with version 1.0 of the older drugs that the bugs are no longer afraid of.

  6. already got some bugs that are drug resistant, more to come

  7. The other factors are certainly very real. I have always avoided antibiotics for viruses whenever I have them. And I have always completed any course of antibiotics I needed when I needed them. So I have always done my part in that regard.

    I read a saying once: “reality is the stuff that won’t go away no matter how hard we believe it doesn’t exist.” Dismissing evidence of
    antibiotic resistance rising in high-density confinement feedlot animal operations as “arguing about the morality of organically grown beef while people die of necrotising fasciitis” will not make that specific problem go away. Nowhere did I suggest we should not bother to keep funding research into new antibiotics for necrotising fasciitis and other things. But neither will I cease wondering about the morality of
    mass antibiotic abuse in agribussiness which will keep destroying new antibiotics as researchers keep developing those new antibiotics.

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