Trade Wars we have known and loved: Brand EFPIA v Korea

November, 11, 2013 | 5 Comments


  1. Roger Warren Evans commented on the Conversation version:

    “Professor Healy – your insights into the world of Big Pharma and its processes were indeed eye-opening, but to a battle-scarred lawyer like myself, not entirely surprising. The whole system of the ownership of “intellectual property (IP)” (in this case medicinal patents) has moved to the centre of the global corporate exploitation system – partly because of the huge profits which they can generate (provided that the “private ownership” of the IP can be legally upheld) and partly because of their easy “fungibility” – a patent, if properly maintained and defended, is easy to sell and exploit from scratch – it is the ideal capitalist “good” and asset.

    The same conditions are found in the world of GM crops, where natural strains of plant are deliberately subject to genetic modification (GM) with the sole purpose of creating a distinctive “new” patentable (=ownable) object – the same is true of commercial “brands” and “copyrights”. They are all eminently fungible assets, and they are moving to the very core of modern capitalism. It is clearly very “old hat” for the corporations (except perhaps Warren Buffett) to worry about the ownership of physical objects and processes – running factories, extracting metals, building buildings. Controlling the world market – therefore the world – via its “intellectual property” is much easier…

    Roger Warren Evans Retired lawyer Swansea UK”

  2. After watching the video of that meeting in Brussels, I’m not at all sure that Richard Bergstrom of EFPIA was spilling the beans about the “real” reason for their campaign to hide clinical trial results. It could be just the opposite – Parker had been all too honest about Pharma’s willingness to hide adverse events from patients and their doctors. Bergstrom was swooping in to perform some damage control.

    Our friend Neal, he says, is in an unusual situation, because his company makes biologic drugs and is involved in extremely cut-throat competition with potential generic competitors. Those are the people he’s worried about nosing around in the data – not, god forbid, doctors and patients. That’s why the rest of us are “quite relaxed” about opening up the clinical trial data, Bergstrom assured us.

    Oh really? Then why is InterMune AbbVie’s partner in this lawsuit? Their drug Esbriet (pirfenidone) is not a biologic, and is brand-new, years away from generic competition. Yet it’s poised to sell for even more than AbbVie’s Humira – at least $40,000 per year compared to Humira’s $25,000. It carries serious risks to patients. And if Humira’s effectiveness for Crohn’s disease (the subject of the studies) is in question, Esbriet’s ability to make a real difference to people with Idiopathic Pulmonary Fibrosis is even more questionable. Nosy doctors and patients would be the main “enemies” on their radar, not generic drugmakers.

    Finally, these were clinical studies. If there’s any “special” competitive issue around biologics, it concerns the secrets of how they’re synthesized from living organisms. That’s the big patent issue for AbbVie in the U.S. – Parker and his colleagues have argued that in order to license biosimilars, the FDA will have to give its competitors so much proprietary information about how Humira is made that it will be an unconstitutional “taking” of (intellectual) property without compensation, in violation of the Fourth Amendment.

    Clinical trial results don’t give any details about how to spin a monoclonal antibody from a batch of yeast or the blood of Peruvian llamas. They only tell you what happens when the finished product is put into the bodies of patients. And that’s what AbbVie wants suppressed, I think, for very conventional and obvious reasons. That’s why, when Jim Murray pressed Neal Parker about what information AbbVie wanted hidden from doctors, Parker didn’t respond with worries about the details being shared with his rivals’ R&D teams. He told Murray he didn’t want some doctor sharing information about side effects with a goddamn reporter.

    I’m sure Bergstrom isn’t exactly lying when he stresses their worries about competitors getting ahold of the data. He just wants us to think EFPIA would never dream of hiding important information from patients – which we’d be fools to believe. If any patient advocates in the room had a rude awakening from Parker’s remarks, Bergstrom was rushing in to sing them back to sleep. Best to stay wide awake.

  3. Jo

    All good points. The question is what to AbbVie really want. Asserting Corporate Privacy Rights is something to be desired. But more desirable that exerting the right kind of pressure on EMA that leads to them not licensing Inflectra? Perhaps Mel Gibson could tell us what AbbVie really want.

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