Another Boost For Generics: Brazilian Judge Annuls Patent On Key AIDS Drug

from the keep-taking-the-medicine dept

Fri, Mar 23rd 2012 1:23am — Glyn Moody

Last week Techdirt reported on an important decision in India to allow the production of a generic version of a kidney and liver cancer drug, with huge savings for the Indian health system, and major effects in terms of lives likely to be saved. Now Intellectual Property Watch has news of a court case in Brazil that could have equally important consequences for the local use of generics:

Word is spreading of a recent decision by a Brazilian judge to annul a patent on a key AIDS drug, effectively allowing less expensive generic versions into the country, and calling into question other such patents.

Here's why the case is setting a precedent: A leading feature of the case is that the patent was granted under the "pipeline" process, which allowed "revalidation" of patents granted in other countries while Brazil was modifying its patent law for certain new areas including pharmaceuticals.

The judge in this case ruled that the pipeline process was unconstitutional, according to sources.
The "pipeline" process refers to a mechanism for granting patents in technological fields that had earlier been excluded under Brazilian law, using the date of the first filing for patents elsewhere. This allowed companies to extend the reach of patent monopolies already obtained outside Brazil without needing to go through that country's patent application process.

Lack of constitutionality had been raised back in 2008 because of the way that pipeline patents diminished the public domain:

"The concession of pipeline patents also violates the acquired right of the collectivity by removing from the public domain knowledge belonging to everyone, which once again goes against society’s interest," said Renata Reis, an attorney at the non-governmental Brazilian Interdisciplinary AIDS Organization.

Among the drugs that were removed from the public domain by the pipeline process is the ritonavir/lopinavir combination, the subject of the judge's order annulling Abbott Laboratories' patent. Not surprisingly, the company has said that it will appeal the decision. But if the ruling is upheld it may lead to other patents granted to drugs through the pipeline process being invalidated too.

Taken together with the Indian decision, this latest ruling emphasizes the increasingly important role of generics in global healthcare. That's another reason why both ACTA and the Trans-Pacific Partnership agreement are problematic.

ACTA, for example, allows generics to be seized in transit on the basis of complaints about names that are "confusingly similar" to a brand-name drug. TPP, meanwhile, would bring in a range of measures to make it substantially harder for companies to produce generic versions of patented drugs in signatory nations. The divergence between what the BRICS countries are doing in this area, and what plurilateral treaties like ACTA and TPP seek to mandate, is another reason why it is unlikely the former will ever sign up to the latter.

Follow me @glynmoody on Twitter or identi.ca, and on Google+

Thank you for reading this Techdirt post. With so many things competing for everyone’s attention these days, we really appreciate you giving us your time. We work hard every day to put quality content out there for our community.

Techdirt is one of the few remaining truly independent media outlets. We do not have a giant corporation behind us, and we rely heavily on our community to support us, in an age when advertisers are increasingly uninterested in sponsoring small, independent sites — especially a site like ours that is unwilling to pull punches in its reporting and analysis.

While other websites have resorted to paywalls, registration requirements, and increasingly annoying/intrusive advertising, we have always kept Techdirt open and available to anyone. But in order to continue doing so, we need your support. We offer a variety of ways for our readers to support us, from direct donations to special subscriptions and cool merchandise — and every little bit helps. Thank you.

–The Techdirt Team

Filed Under: access to medicines, aids, brazil, generics, healthcare, patents, pipeline
Companies: abbott labs

50 Comments

If you liked this post, you may also be interested in...

Reader Comments

Subscribe: RSS

View by: Time | Thread

Drew (profile), 23 Mar 2012 @ 1:43am

Any person that will let others die so they can get richer is nothing but pure scum. I mean a waste of life they should just go us all a favor and put themselves out of our misery.

This is the problem we all have to deal with and it sucks..
The corporations patent shit just to say were the only one that can help people! Who cares if a generic is cheaper especially when it's a drug that can actually decide how many more years you're going to live.

I hope these scumbags get dealt with soon it's technically genocide. They deserve death and nothing less for the countless lives they took. If there was a generic around at a fraction of the cost I'm sure there would be a lot of families that would not have been torn apart just because they're poor.
[ link to this | view in chronology ]
- Hephaestus (profile), 23 Mar 2012 @ 9:51am
  
  Re:
  It reminds me of the way organized crime makes people pay protection money.
  [ link to this | view in chronology ]
- timmaguire42 (profile), 23 Mar 2012 @ 11:08am
  
  Re:
  Yes, patents should be ignored whenever ignoring them is convenient. From each according to his abilities, to each according to his needs. Right?
  
  What's that...did you hear that? Why, I do believe that is the Law of Unintended Consequences clearing its throat.
  
  Shhh....everybody quiet. I think it's about to say something...
  [ link to this | view in chronology ]
  - Anonymous Coward, 23 Mar 2012 @ 5:21pm
    
    Re: Re:
    That isn't what the comment said, as you well know. Overpricing of medications that would save lives is an abomination. It is perfectly reasonable to price the drugs in a reasonable manner. So it takes a few more years to recoup. At least you aren't killing people for profit.
    [ link to this | view in chronology ]
- Alexio, 23 Mar 2012 @ 11:58am
  
  Re:
  That's a strong statement. These drugs were created by hundreds of people who spend their whole lives learning about the disease, designing it, testing... I guess, according to you, they all better be dead, as they all got paid for creating these meds. Yeah, nobody to hate then, right?
  [ link to this | view in chronology ]
  - Anonymous Coward, 23 Mar 2012 @ 5:21pm
    
    Re: Re:
    That isn't what the comment said, as you well know. Overpricing of medications that would save lives is an abomination. It is perfectly reasonable to price the drugs in a reasonable manner. So it takes a few more years to recoup. At least you aren't killing people for profit.
    [ link to this | view in chronology ]
Anonymous Coward, 23 Mar 2012 @ 5:16am

"Lack of constitutionality had been raised back in 2008 because of the way that pipeline patents diminished the public domain:"

Sadly, the public domain would be effectively empty if the drug companies and researchers were not working on it. The pipeline process was made so that things like drugs could come to market without the patent holder risking unfair competition from generic makers in the country, pending their patent system getting these areas resolved.

Now they have effectively given then Pharma companies a pig in a poke, they have entered the market, made their drugs available, the drugs have become common use, and now any generic company that wants will be able to bang them out without having to pay for the research or development.

Seems more than a little unfair.
[ link to this | view in chronology ]
- Anonymous Coward, 23 Mar 2012 @ 5:41am
  
  Re:
  I think what is unfair is that people make a profit out of other people's suffering
  [ link to this | view in chronology ]
  - Anonymous Coward, 23 Mar 2012 @ 4:39pm
    
    Re: Re:
    that has gone on since two people were on this planet, it will never change
    [ link to this | view in chronology ]
  - Anonymous Coward, 1 Apr 2012 @ 7:47pm
    
    Re: Re:
    Regardless of right or wrong, or what you think, medicine IS a business. Businesses exist to make money, not to give everything out for free because their products can benefit humanity. Many of the people in this industry go to school for years, 10+ probably if they are a doctor. They should be payed above average for putting that kind of effort in. Nobody would be a doctor or the scientist that has to put years of work into making a drug if all they would make is the same average salary everyone else with a much easier job makes.
    [ link to this | view in chronology ]
- E. Zachary Knight (profile), 23 Mar 2012 @ 7:20am
  
  Re:
  Funny. I don't remember patents being the driver behind the Small pox and Polio vaccines. Last I checked those were created out of a desire to benefit humanity. I guess I need to retake history class.
  [ link to this | view in chronology ]
  - Anonymous Coward, 23 Mar 2012 @ 7:27am
    
    Re: Re:
    Vaccines are essentially just weakened strains of the infecting virus. They aren't drug therapies.
    [ link to this | view in chronology ]
    - Ninja (profile), 23 Mar 2012 @ 7:33am
      
      Re: Re: Re:
      Yes, and developing vaccines costs zero, nill whereas developing drugs costs billions. Try again.
      [ link to this | view in chronology ]
    - Anonymous Coward, 23 Mar 2012 @ 8:03am
      
      Re: Re: Re:
      I don't remember penicillin(the first wonder drug) being developed because of patents.
      [ link to this | view in chronology ]
    - E. Zachary Knight (profile), 23 Mar 2012 @ 8:54am
      
      Re: Re: Re:
      I guess I should add to that the basic antibiotic. Even though it was created by accident, the research resulting in its creation was not done because of patents.
      [ link to this | view in chronology ]
    - Anonymous Coward, 23 Mar 2012 @ 4:47pm
      
      Re: Re: Re:
      but the process to mass produce it was patented
      [ link to this | view in chronology ]
      - Anonymous Coward, 23 Mar 2012 @ 10:52pm
        
        Re: Re: Re: Re:
        You do understand that the process used to mass produce any drug today is based on brewing right?
        
        All you need is to control the temperature basically inside a tank adding some filters.
        [ link to this | view in chronology ]
    - Anonymous Coward, 23 Mar 2012 @ 6:12pm
      
      Re: Re: Re:
      >Vaccines are essentially just weakened strains of the infecting virus.
      
      Is that so? That might actually make for another IP-litigation opportunity. "You can't use this vaccine because the developer didn't pay his virus licence!"
      [ link to this | view in chronology ]
  - Anonymous Coward, 24 Mar 2012 @ 7:35pm
    
    Re: Re:
    You need to get out of the low hanging fruit era of medicine and get into modern times. I suggest you take a nice historical look at what it took to get trials and then move those vaccuines into production back in the day, and what it would take now.
    
    Maybe, just maybe, your eyes will open and you will understand. You might have to push Mike's ass out of the way to see, but you can do it!
    [ link to this | view in chronology ]
    - Anonymous Coward, 26 Mar 2012 @ 9:06pm
      
      Re: Re: Re:
      So your excuse is now "but but but different now"?
      
      Sounds like grounds for repealing the Statute of Anne.
      [ link to this | view in chronology ]
Anonymous Coward, 23 Mar 2012 @ 6:31am

Get a Clue
This has nothing to do with saving lives and everything to do with stealing U.S. patents to enrich and develop local Indian industry. This might be a good strategy in the short term, but in the long run will discourage innovation by Indian companies.
[ link to this | view in chronology ]
- Dog On a Teflon Floor (profile), 23 Mar 2012 @ 6:57am
  
  Re: Get Your Priorities Straight
  It may be hard to understand but some countries do put their people and their health above the profit motive, even see it as a basic right. The Indian industry and humanity in general are enriched by sharing advances in science. That's how it works.
  [ link to this | view in chronology ]
  - Anonymous Coward, 23 Mar 2012 @ 7:02am
    
    Re: Re: Get Your Priorities Straight
    In the end these countries hurt the development of new treatment options because pharma companies won't make the big investments necessary to develop new drugs.
    [ link to this | view in chronology ]
    - The dude, 23 Mar 2012 @ 7:30am
      
      Re: Re: Re: Get Your Priorities Straight
      You mean they aren't going to use tax funded university research anymore?.
      [ link to this | view in chronology ]
    - Atkray (profile), 23 Mar 2012 @ 7:38am
      
      Re: Re: Re: Get Your Priorities Straight
      You say that like it is a bad thing.
      
      I say bring it. Let the research go back to universities where it belongs and to people with a genuine interest in benefiting mankind instead of their patent portfolio.
      
      I'm more afraid of Howie Mandel dragging me under my bed that I am of the lack of patents killing innovation. I've seen enough examples to know a fairy tale when I see one, and the whole "without_________(fill in your favorite IP) there will be no___________(fill in your favorite parasitic industry)" is a fairy tale.
      [ link to this | view in chronology ]
- Anonymous Coward, 23 Mar 2012 @ 5:24pm
  
  Re: Get a Clue
  You didn't read the article, did you? There's a few thousand miles between the country written about (Brazil) and the one you are talking about (India). Completely different continents.
  
  Please do at least read before you spew. Thank you.
  [ link to this | view in chronology ]
Anonymous Coward, 23 Mar 2012 @ 6:52am

Lets just end all drug patents. That way we wont get any new drugs. I think we have enough "cures" or at least treatments. Do we really need a cure for cancer? Do we really need a cure for AIDS? Do we really need a cure for obesity? Do we really need a cure for Parkinson's, Luekemia, Spina Bifida, Sickle Cell Anemia, Lou Gerhig's Disease?

I garantee you that if you end drug patents or take patents away from the pharma industry you WILL see a far fewer companies willing to invest the hundreds of millions of dollars necessary to develop, test, and approve groundbreaking treatments for diseases.
[ link to this | view in chronology ]
- Anonymous Coward, 23 Mar 2012 @ 5:32pm
  
  Re:
  Pharma doesn't even do the bulk of research, anymore. Universities do.
  [ link to this | view in chronology ]
- Anonymous Coward, 23 Mar 2012 @ 10:54pm
  
  Re:
  You be surprised with the graph plot of the release of really new drugs on the market, it hasn't gone up.
  [ link to this | view in chronology ]
- Balaknair, 24 Mar 2012 @ 11:12am
  
  Re:
  Ha. As a doctor, let me tell you what drugs the reps market the most(they're also what the pharma companies spend most in developing)- the ones for lifestyle illnesses- obesity, hypertension, diabetes, insomnia, and of course the gold mine, anti-anxiety and antidepressants. These are what you'd see in more affluent people. Diseases like AIDS, TB and other 'third world' infectious diseases are not a high priority, you rarely find these in rich people.
  [ link to this | view in chronology ]
- Anonymous Coward, 27 Mar 2012 @ 1:37pm
  
  Re:
  Well if some AC with an agenda grantees it while hiding behind the shroud of anonymity then it must be true right? We should probably take your anonymous word for it and just accept that patents are important huh.
  
  For future reference: putting the words 'I garantee[sic]' below the name 'Anonymous Coward' is at best humorous.
  [ link to this | view in chronology ]
Ninja (profile), 23 Mar 2012 @ 7:18am

The IP monopolies are broken. They allow for price abuses and these decisions are just the natural course. All IP as it is today must be abolished and started from scrap, with the ppl on the table for the discussions.
[ link to this | view in chronology ]
Kevin, 23 Mar 2012 @ 7:34am

If I were "Big Pharma"
If I were Abbott Labs or another "big pharma" company and read enough nonsense statements like "I think what is unfair is that people make a profit out of other people's suffering" I would be SO TEMPTED to just pull a John Galt and go home instead of listening to this idealistic crap.

Kaletra / Aluvia cost Abbott Labs a small fortune to develop and get approved. And what if, at the last minute, a snag developed and approval could not be granted? All that money would have been gone, and that happens all of the time with medications which seem promising but never come to market.

If you take away the profit incentive to take these risks, then fewer risks will be taken and fewer new drugs will be developed. When the new-drug pipeline dries up, people will die.

The case of Kaletra / Aluvia is even more disturbing. When Abbott developed original formulation of ritonavir / lopinavir, it worked just fine. But other countries, such as INDIA, BRAZIL, and African nations went back to Abbott and said "we need a version that doesn't have to be refrigerated, that requires fewer pills a day, and can be taken without regard to meals." ABBOTT DID THIS FOR THEM. Spent more zillions of dollars creating this new formulation. Even produced a lower-cost version (Aluvia) for these developing nations. And now they want to take this thing that Abbott created and sell it as a generic.

Abbott Lab's CEO is on record as being committed to the developing world. He's a better man than I. I would probably get out of the business of developing life-saving drugs and go to the beach.
[ link to this | view in chronology ]
- Anonymous Coward, 23 Mar 2012 @ 7:57am
  
  Re: If I were "Big Pharma"
  I'm genuinely curious how much research for Kaletra/Aluvia came from universities funded by tax dollars.
  [ link to this | view in chronology ]
  - Anonymous Coward, 23 Mar 2012 @ 11:04am
    
    Re: Re: If I were "Big Pharma"
    Please provide us with those details, I'm sure the records for PUBLIC funded research is PUBLIC. So please find out for us and report back. If you don't I assume that is because it wasn't ANY.
    [ link to this | view in chronology ]
    - Valkor, 26 Mar 2012 @ 5:57am
      
      Re: Re: Re: If I were "Big Pharma"
      The information in question can be easily both public and obscure. Tracking down that research would require expertise both in biotech and the byzantine world or university funding, because you'd have to consider direct research for Lopinavir, and also foundational research into knowledge that made ARV drugs possible.
      
      That said, Abbot at least used state of the art equipment provided by the United State Department of Energy at the Argonne National Laboratory - a direct contribution from taxpayers.
      http://www.physorg.com/news76606766.html
      [ link to this | view in chronology ]
- Anonymous Coward, 23 Mar 2012 @ 8:01am
  
  Re: If I were "Big Pharma"
  Fewer risks? fewer drugs?
  
  You mean like those companies actually do right now, only investing in things they already know are going to work?
  [ link to this | view in chronology ]
- Anonymous Coward, 23 Mar 2012 @ 9:47am
  
  Re: If I were "Big Pharma"
  I would probably get out of the business of developing life-saving drugs and go to the beach.
  
  Which is why folks like you can get jobs as IP lawyers, and folks like him can do research.
  
  Pro Tip: Not everyone in the world has the same motives as you ($$).
  [ link to this | view in chronology ]
  - Kevin Holbrook (profile), 23 Mar 2012 @ 11:04am
    
    Re: Re: If I were "Big Pharma"
    Actually, I'm a PHYSICIAN, not an IP Lawyer. Semi-retired, work at a free / income-based clinic a couple of days a week and don't get paid. I pay my own malpractice insurance, license fees, and other expenses in order to do so. If it were to get too expensive or require too much red tape, I would have to stop helping those patients.
    
    I'm glad that for-profit drug companies have given me tools to improve and save lives. If they were to stop doing so, people would suffer.
    
    Pro Tip: don't pick my motives based on your preconceived notions.
    [ link to this | view in chronology ]
    - Anonymous Coward, 23 Mar 2012 @ 11:09am
      
      Re: Re: Re: If I were "Big Pharma"
      Don't bother, Kevin, TechDirt is full of freetards. They think that businesses should spend billions developing drugs, movies, music, books, games, software, etc.. and then freely give them away. And that the businesses should be glad that they stole from them because someone they talk to might buy something from the buisness. That's how the pirates are able to sleep at night - with the dream that maybe, just maybe, someone they talk to will buy from the company so they feel better about providing "free publicity". It's very delusional.
      [ link to this | view in chronology ]
    - Anonymous Coward, 23 Mar 2012 @ 5:41pm
      
      Re: Re: Re: If I were "Big Pharma"
      You might be a doctor, but you surely are an idiot. The article is talking about a constitutional issue, not abolishing all drug patents. You are just as guilty of spew as anyone else, here. Calm down, take a pill (sic), and get the stick out of your ass.
      [ link to this | view in chronology ]
    - Anonymous Coward, 27 Mar 2012 @ 1:47pm
      
      Re: Re: Re: If I were "Big Pharma"
      So you just blindly believe that whatever the current for-profit drug companies want is good for you saving lives? Doesn't even occur to you that maybe this narrative they've constructed where medicine is some kind of house of cards that will topple if drug patents are removed might be a bit overstated? No? Pitty.
      [ link to this | view in chronology ]
- Anonymous Coward, 27 Mar 2012 @ 1:42pm
  
  Re: If I were "Big Pharma"
  Because without patents there can be no profits! It seems so obvious now...
  [ link to this | view in chronology ]
Jeffrey Nonken (profile), 23 Mar 2012 @ 9:11am

It's all about killing and impoverishing people in the name of protecting profits.

When humanity is wiped out by a virulent plague that could have been stopped with a drug that nobody could afford, the pharmaceutical executives will be smugly counting their beans and congratulating themselves.

Oh sorry, that was melodramatic, wasn't it?
[ link to this | view in chronology ]
- MikeVx (profile), 23 Mar 2012 @ 9:34am
  
  Being wiped out by a virulent plague...
  When humanity is wiped out by a virulent plague that could have been stopped with a drug that nobody could afford, the pharmaceutical executives will be smugly counting their beans and congratulating themselves.
  
  Or, we could create the new job classification of Telephone Sanitizer, and be safe from virulent plagues that manage to evade all that expensive research.
  [ link to this | view in chronology ]
Anonymous Coward, 23 Mar 2012 @ 11:10am

Why is TechDirt CENSORING comments in this thread?
[ link to this | view in chronology ]
- E. Zachary Knight (profile), 23 Mar 2012 @ 11:38am
  
  Re:
  What comments are being censored?
  [ link to this | view in chronology ]
- The dude, 23 Mar 2012 @ 12:21pm
  
  Re:
  Because you only spout nonsense?
  [ link to this | view in chronology ]
Anonymous Coward, 23 Mar 2012 @ 4:21pm

so the big pharma should stop spending millions to billions to create the drugs that save lives, then where would you be?
[ link to this | view in chronology ]
- Anonymous Coward, 23 Mar 2012 @ 7:51pm
  
  Re:
  The fuck are you talking about? No one is asking big pharma to stop creating drugs. People are finding it a good thing that big pharma can't use drug patents to shut down cheaper drugs that do the same thing and are more accessible by - you know, the people whose lives the drugs are intended to save?
  [ link to this | view in chronology ]