Senate Proposal To Allow Generic Versions Of Biotech Drugs After 12 Years

A Senate proposal would strip biotech drugs of their patent-protected status after twelve years, opening the door to competition from generic drug makers. Patent protection determines how long obnoxious pharmaceutical CEOs can spend outside their competitor’s offices dancing with their drugs to MC Hammer’s 1990 hit, “U Can’t Touch This.” Unlike regular drugs made by chemical synthesis, biotech drugs are derived from human proteins.

According to the FDA, most brand-name drugs receive patent protection for 20 years, though there is a large lead time between the submission of a patent and the sale of a drug. Most drug companies enjoy their patent protection for only seven years, at which point generic drug makers, who do not need to recoup the cost of development or marketing, step in and offer the same drug for a third of the price.

The Senate Health, Education, Labor and Pensions Committee will mark up the proposal on Wednesday. — CAREY GREENBERG-BERGER

Lawmakers Offer U.S. Plan for Generic Biotech Drugs [Bloomberg]
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  1. TechnoDestructo says:

    WTF? I could see maybe banning patents on reformulations and different strengths of a drug (stuff which compounding pharmacists can do anytime they want…so it’s obvious and shouldn’t be patentable) when it’s nearing the end of the patent term, but patents are the least broken field of intellectual property.

    And if you’re going to do any legislation to do with patents, fixing the application and review system would be the first (and probably only) thing to bother with.


    Also, this could backfire BADLY. A company which suddenly is going to have 8 years less patent protection on its lifesaving drug is going to try to squeeze every dime it can out of it as fast as possible. “Oh, what’s that? You want to keep living? That’ll be 2000 dollars per month.”

  2. lincolnparadox says:


    Or the corps will just stop doing research themselves and start giving money to academics and institutes. That way, all the corporations will have to do is the testing and FDA cert, which still takes 18 months to 4 years.

    I think this is just a swift kick in the nuts of the pharm industry because some Congresspeople saw “Sicko” at Cannes.

  3. azntg says:

    How much do you want to bet this proposal is going to get shot down by lobbyists?

  4. VA_White says:

    The biologic medication I tried last year costs $38,000 a year. Thank god it didn’t work well.

  5. mac-phisto says:

    @lincolnparadox: & this is different from what they do now how?

  6. Hawk07 says:

    Part of me says this is good for consumers, the other part says it will ultimately lead to less research money spent on new drugs.

    Cheap drugs are great and all, but a lot of people don’t realize the millions and billions that are wasted on stuff that ends up not working and becomes a dead end.

    I don’t even want to know how many billions have been spent on a cure for AIDs.

  7. TechnoDestructo says:

    @azntg:

    I’m sure it will. And it should be. And it will hurt because it’s wasted momentum which could have been put towards something useful.

  8. bokononist says:

    The drug companies spend many times more on marketing and advertising than they do on research. They remain insanely profitable. The idea that they won’t continue to research drugs because they have to be a little less profitable does not make sense.

  9. castlecraver says:

    @Hawk07:

    About $2.9B per year since ’03 in the US. Before then, about a billion annually between 1990 and 2000.

    compare that to…

    $430B in Iraq since April ’03.

    There’s your dead end.

  10. Boo says:

    The average cost to develop a drug is $800 million dollars (which is generally a 12 year process) and out of 10,000 candidates only 1 will make it to FDA approval.

    The reason for patents is so that research companies will be able to finance more research. Getting rid of patents completely will not ensure low drug prices it ensures that people will stop developing new drugs.

    In generic drugs the time to market is very fast because they only have to replicate the molecule. With biotech drugs the production is very very complicated and just because you end up with a molecule that looks the same doesn’t mean it will do the same thing as the original with the same effects. It is not the lower patent time I am worried about it is the fact that the senate is considering waiving any FDA testing for the generic biotech compounds.

    And yes, I am a researcher in a biotechnology company so I do have some bias. I just get tired of hearing how we are all evil when work that I have done may have given someone you love a longer lifespan.

  11. Funklord says:

    @bokononist:

    Bingo! We have a winner. Apparently many here have bought into the myth that the poor, struggling drug companies spend all their money on research. Sorry, no, more is spent on marketing (and especially on those strange ads where they don’t tell you what exactly the drug does, but they do tell you all the side effects–those don’t come cheap).

    It’s not like they’ll decide to stop making money if their profits are cut short after 12 years, rather than 20.

  12. Boo says:

    Also, biotech and big pharma are two completely different entities. Most biotech companies are not and never will be profitable. I don’t think that this bill affects most big pharma companies because by definition they develop small molecules.

  13. Wormfather says:

    I’m too disgusted by this to comment.

  14. pestie says:

    obnoxious pharmaceutical CEOs can spend outside their competitor’s offices dancing with their drugs to MC Hammer’s 1990 hit, “U Can’t Touch This.”

    They totally do this, too. Fuckers!

  15. Wormfather says:

    @Funklord:

    Did you and boko forget that we live in a CAPITALIST society where companies are supposed to produce a profit?

    OK, so you’re upset because the company spends a ton of money on marketing (not as much as you propose, but we’ll get to that in a second). Do you think a company that doesnt have to advertise advertizes? Really, they have to make a profit to keep investers happy (because, ya know, they’ve invested in the company), to pay for research, employees, TAXES, lobbyest to protect there interest, etc.

    Oh, and to your comment about they’re advertising budget.

    Here, read it [www.pfizer.com]

  16. Charles Star says:

    That period between obtaining the patent on the molecule and bringing a product to market is often spent building a patent wall around the molecule so that when the molecule patent example expires, generic companies still can’t bring a product to market. The rest of the time is spent finding drugs that do the same thing so that they can switch people to the new (patented) drug when the “old” drug goes off-patent.

    I’m sure that there are other cases of this but Prilosec was protected just this way – and Nexium is essentially a patent-protected version of Prilosec with very thin data supporting any “advantage” for the new drug.

  17. QuantumRiff says:

    If you look at drug companies annual filings, you will see that they spend WAY more on marketing than they do on research and development of new drugs. Quite honestly, if the drugs they are touting as being so novel, life changing, and beneficial, do they really even need to advertise? Or should the data speak for itself?

  18. Hawk07 says:

    @Boo:

    Everything you said in there was true. I had forgotten about the 1 in 10,000 works stat, but I had read it before.

    @castlecraver:

    That’s fine and dandy, but you’re not the one paying for the research.

    Like I said, cheap drugs and healthcare are good and all, but a lot of people such as yourself don’t take in the costs of providing these services. You work in the context of talking points like Michael Moore. If you think you can provide pharmaceuticals cheaper than Merck, Pfizer, etc, start your own company. It’s the spirit of capitalism. If you have a good product at a good price, you better believe people will buy it.

  19. Hawk07 says:

    @QuantumRiff:

    Maybe we need to break it down more.

    It’s like Hollywood. For every profitable film, there will be 4, 5, 7 or whatever it is unprofitable films.

    The numbers are even more staggering with books. For every Harry Potter, there are tens of books that don’t break even.

    And as sad as it is, things like Viagra help cover the costs of more important medicines like AIDs vaccinations and cures.

  20. Hawk07 says:

    Like I said before, people like Michael Moore (and some on here) like to work in short talking points about how “bad we’ve gotz it in the US” in terms of healthcare.


    But, if this is true, why is it that the world’s richest, time and again choose America over any other nation for all their major healthcare needs. Even the socialist nations with their “universal healthcare” have wealthy citizens that come here to get treatment.

    When my mom use to work in the Texas Medical Center in Houston (42+ healthcare institutions, largest in the world), she said the Saudi’s would charter in a plane a week of people to be treated.

  21. castlecraver says:

    @Hawk07: Huh? The research I was referring to was directly from NIH budget numbers. I am paying for that.

    I’m just putting the costs in perspective, bro. Contrary to whatever you apparently gleaned from my statistics, nowhere did I imply anything regarding my feelings about capitalism, pharma companies, healthcare, or Michael Moore. See, you’re working in rabid misconstruations like a typical Michael Moore critic. (I’m not defending the guy, I just don’t see the need for straw men.)

    However I do take offense at someone stating that AIDS (and I would make a similar assertion for cancer, other endemic infectous diseases, and congenital diseases as well) research has been a dead end and is undeserving of the funding which it has received. This and this alone was the point to which I was responding. AIDS research has resulted in remarkable advances in anti-retroviral therapies, gene therapies, genomics, molecular signalling, and truly numerous other facets of molecular immunology.

    In the future, please take a moment to consider the response rather than immediately jumping to some tired old rhetoric that really doesn’t apply in this case.

  22. mac-phisto says:

    as much as i respect the advantages we’ve made in medicine, i don’t think i’m quite ready to bow down to the pill gods yet. these advancements don’t come entirely from private enterprise. many start in a college lab or are tested/perfected in research hospitals. clinical studies are performed by med students who might be lucky enough to get a pittance patent comp check but most likely are merely working on their mentor’s next journal article for a little extra credit.

    & for every true advancement, there’s a dozen designer drugs, fifty gov’t-subsidized vaccines & treatments, hundreds of prescription & non-prescription meds that generate steady income.

    come on here…a single day’s meds for a cancer patient can hit the $10K mark.

    somehow i fail to see how the pharmaceutical industry deserves my sympathy in any way.

  23. Thrust says:

    Hmmm… Let me try figure this whole drugs thing out. (Drugs are bad, M’Kay. If you do drugs, M’kay, its bad. So don’t do drugs M’kay.)…

    People (Who now appear to be suckers because of this sh!t) hand large sums of cash over to charities for every f*ing disease, condition, syndrome, and addiction out there, and once a possible treatment/cure is found, they dicker over who has rights to sell it for the best profit margin possible?

    This ain’t right. This stuff should be provided free, or was the fifteen billion a year shelled out for research just a down payment? The product of any research funded by charity or government sponsorship should not be for profit, unless everyone who donated gets their fair margin on the profits.

  24. mattbrown says:

    that was a good morning laugh.