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The Hep C Field Gets Nastier By the Minute

What a mess there is in the hepatitis C world. Gilead is, famously, dominating the market with Sovaldi, whose price has set off all sorts of cost/benefit debates. The companies competing with them are scrambling to claim positions, and the Wall Street Journal says that AbbVie is really pulling out all the stops. Try this strategy on for size:

In a lawsuit filed in February, AbbVie noted it patented the idea of combining two of Gilead’s drugs—Sovaldi and an experimental drug called ledipasvir, which Gilead plans to combine into one treatment—and is therefore entitled to monetary damages if Gilead brings the combination pill to market. Legally, AbbVie can’t market Sovaldi or ledipasvir because it doesn’t have the patents on the underlying compounds. But it is legal for companies to seek and obtain patents describing a particular “method of use” of products that don’t belong to them.
Gilead disputes the claims of AbbVie and the other companies. A spokeswoman said Gilead believes it has the sole right to commercialize Sovaldi and products containing Sovaldi’s active ingredient, known as sofosbuvir. An AbbVie spokeswoman said the company believes Gilead infringes its patents, and that it stands behind the validity and enforceability of those patents.

You don’t see that very often, and it’s a good thing. Gilead is, naturally, suing Abbvie over this as well, saying that Abbvie has knowing mispresented to the USPTO that they invented the Gilead therapies. I’m not sure how that’s going to play out: Abbvie didn’t have to invent the drugs to get a method-of-use patent on them. At the same time, I don’t know what sort of enablement Abbvie’s patent claims might have behind them, given that these are, well, Gilead’s compounds. The company is apparently claiming that a “sophisticated computer model” allows them to make a case that these combinations would be the effective ones, but I really don’t know if that’s going to cut it (and in fact, I sort of hope it doesn’t). But even though I’m not enough of a patent-law guy to say either way, I’m enough of one to say, with great confidence, that this is going to be a very expensive mess to sort out. Gilead’s also in court with Merck (and was with Idenix before Merck bought them), and with Roche, and will probably be in court with everyone else before all this is over.
This whole situation reminds me of one of those wildlife documentaries set around a shrinking African watering hole. A lot of lucrative drugs have gone off patent over the last few years, and a lot of them are heading that way soon. So any new therapeutic area with a lot of commercial promise is going to get a lot of attention, and start a lot of fighting. Legal battles aren’t cheap on the absolute scale, but on the relative scale of the potential profits, they are. So why not? Claim this, claim that, sue everybody. It might work; you never know. Meanwhile, we have a line forming on the right of ticked-off insurance companies and government health plans, complaining about the Hep C prices, and while they wait they can watch the companies involved throwing buckets of slop on each other and hitting everyone over the head with lawsuits. What a spectacle.

43 comments on “The Hep C Field Gets Nastier By the Minute”

  1. Hap says:

    It probably gets even better when the people in the line on the right realize they’re paying for the spectacle on the left above and beyond whatever they were paying to annoy them enough to be in the line on the right. Perhaps a feeding frenzy or a rugby scrum is a more accurate picture.

  2. Anon says:

    The problem is that most animals in our story have the ability to dig a new watering hole…yet the executive teams take on the shortsighted strategy of modifying corp tax structure, laying off R&D, make [what they believe are clever] transactions, etc. as though the only way to get water is hold out until it rains. In our scenario though, rain doesn’t fall from the sky, its dug from the earth. It always has been.

  3. Puff the mutant dragon says:

    This whole hep C business is going to generate a nasty backlash against the pharma industry again — you can feel it building now. It’s kind of sad because here Gilead/Pharmasset have developed a truly fantastic drug — orally bioavailable and remarkably high cure rate — for what used to be a very nasty disease; this is rational drug design at its finest. but the remarkable nature of their achievement has been almost totally forgotten because of the controversy over the price (and now over who has rights to what apparently)

  4. Anonymous academic says:

    It takes some real balls to file a patent on someone else’s drugs – I’d never heard of this before. If AbbVie isn’t going to actually make its own drugs, can’t it at least stick to the industry-standard practice of buying up smaller companies like everyone else?

  5. Anonymous says:

    Like monkeys fighting each other to steal their bananas instead of growing their own. This sort of destructive, short-term risk-averse competition (the bad anti-social side of capitalism, to contrast with value-adding innovation-based competition) is what will ultimately destroy our whole society, it makes me sick.

  6. Toad says:

    I’d like to hear from readers in the patent field on this, but shouldn’t it be readily feasible and legal for AbbVie to enable their method of use in this case by simply demonstrating effectiveness of the combination, since they can make Gilead’s two drugs and test them under the Merck v. Integra decision from a few years ago?
    Shouldn’t innovation be allowed from anyone, whether it’s your drug or someone else’s?
    Derek, any thoughts?

  7. John Wayne says:

    I reminded my team to keep great laboratory notebooks, and not just for science. If we are successful we are going to be sued by … everybody. If it is hard to attack our discoveries then the inevitable settlements will be more in our favor.

  8. Anchor says:

    @5, I agree! One word comes to my mind and that is, greed! A football analogy is apt here. While the so called major pharmaceutical companies are competing and the spotlight was on them, Gilead came from nowhere and they are still running with the ball. Others are trying hard to catch up to it and they are nowhere near. None like it and am relishing it all. It shows desperation on the part of big pharmaceutical companies and they are getting downright nasty. Hey, as long as I get a piece (big one in this race) of pie!

  9. petros says:

    US-8,466,159 details the “invention”

  10. Anonymous says:

    “Sophisticated computer model” is clearly AbbVie’s argument to suggest that the idea to combine to two or more drugs acting by different mechanisms was not completely and utterly obvious, which is clearly bullshit but hard to prove otherwise. They should be forced to show evidence that this model was actually used, and gave a specific and surprising result that went against all common sense predictions, otherwise they are just patenting the obvious and acting as a patent troll without any means to commercialize the combination.

  11. johnnyboy says:

    That’s right – if you can’t hack as a pharma R&D company, just relocate to TaxShelterLand and become a patent troll. Abbvie, the new Valeant.

  12. JAB says:

    Never seen so many references in a patent before, and I’ve read a lot!

  13. Anonymous says:

    #4, AbbVie does indeed have it’s own HepC product, which is currently awaiting FDA approval. The Phase 3 data is at least as impressive as Gilead’s, if not more so. (Not that it excuses this!)

  14. Anonymous says:

    @10: I would be surprised if their “sophisticated computer model” was any more sophisticated than a single multiplication in Excel:
    Expected efficacy of combination = Sum or product of efficacy of individual components
    I agree, the use of such an obviously basic “sophisticated computer model” is a ridiculously disingenuous argument for non-obviousness, and should be thoroughly scrutinized in court. They are certainly not pulling the wool over my eyes, let’s hope that Gilead’s lawyers push hard on this.

  15. NoDrugsNoJobs says:

    It is not just the combination they claim but the shortened treatment regimen which at that time may not have been contemplated. Prior to the new efficacy compounds, the standard treatment was like 48 weeks. It appears they modeled the drug efficacy against viral load taking into account several factors and were able to predict the high efficacy in only 8 weeks or 12 weeks. Inventions take many shapes and forms, there is more involved in getting a drug to market than making a compound and showing in vitro activity. Given the very lengthy clinical development timelines pharma companies are up against, it certainly makes sense to try and capture ingenuity and invention thru the whole process.

  16. Jal_Frezi says:

    Am I missing something, but hasn’t someone at Gilead dropped the ball by not covering the combination of Sovaldi and ledipasvir themselves before AbbVie?

  17. David Young MD says:

    All this while hundreds of Hepatitis C patients go untreated.
    I have dozens of patients with mild hematologic conditions that I find have Hepatitis C. Most of these patients are on Medicaid or more likely a Medicaid HMO. Most of them are candidates for Hepatitis C treatment, but do any of them get Hepatitis C treatment? No, not a single one. Not a chance. Their insurance would not think of paying for treatment.
    Gilead said that a liver transplant for liver failure costs a lot more then their Hep C treatment. True, but not treating the patient at all is the most cost-effective strategy.

  18. Chrispy says:

    It doesn’t seem like much more will have to happen before the entire drug discovery enterprise becomes completely unsustainable. It has become so expensive to develop a drug that their cost is now what grabs the headlines, not the triumph of overcoming a disease. The New York Times had an article two days ago titled “The $300,000 Drug” about Kalydeco, Vertex’s cystic fibrosis drug, in which the company comes across as greedy and opportunistic. It was suggested that the price was so high “in part, to recoup not just the research and development that led to Kalydeco but all the company’s R&D.” Why does this seem unreasonable? We don’t get to just pay for the stuff that works because we don’t know in advance what will work. And one of the few things left that keep the drug discovery wheels turning at all is the profitability of an effective, patented drug. All we need is a bunch of patent trolls (lookin’ at you, AbbVie) driving up costs without contributing one whit to discovery. @7John Wayne — good luck with your notebooks now that we’ve gone first-to-file. And lotsa luck to the scientists at Idenix now that Merck has just purchased a ticket to the patent troll party. If the patent system breaks much more it will be the final nail in the coffin of our industry.

  19. Oblarg says:

    Even if this patent is upheld, so what? Gilead still holds the patents for the two constituent drugs; nothing is preventing doctors from prescribing both medications (what, are the doctors going to pay damages for patent infringement?). I might be missing something, but it seems the only thing at stake is putting both medications in the same pill or marketing them together. Doesn’t seem too profitable for AbbVie in any case.

  20. annonie says:

    Certainly a clever and brazen move by AbbVie. If it works in their favor, I can only imagine the growing attempts to make such applications in the future across the industry….and it’s just what we need to complicate the business even more.

  21. annon 2 says:

    “Sophisticated computer model”: and some folks still question the value of investing in calculational and modelling chemistry.

  22. PharmaIP says:

    Patent attorney here – issue probably won’t be enablement. Solvaldi clearly works, and it shouldn’t be hard to demonstrate that the experimental drug (and therefore combination) works as well. Keep in mind that for the purposes of getting a patent, showing that the compound or combination “works” is much easier than complying with the standard set by FDA for drug approval.
    Big issue for the patent will amost certainly be obviousness. A few years ago certain pharma attorneys were even wondering whether it was worth filing combination applications on known drugs. Pendulum has swung back somewhat from that extreme, but 100 times out of 100 a generic company will base their invalidity attack against a combination patent on obviousness.

  23. doug steinman says:

    Maybe AbbVie should have tried to but Gilead instead of going after Shire. It seems like that would have made more sense although most pharma managements don’t seem to have much sense.The losers here are the patients who would be helped by a lower price for the medication. The winners are the lawyers who argue these cases who are hired by the lawyers who run the pharma companies.

  24. Anonymous says:

    @21: What, you mean investing in a basic pocket calculator? Because that’s probably all they used in this case…

  25. Anonymous says:

    Like Derek, not a patent lawyer…..
    But isn’t a ‘sophisticated computer model’ generated using historical data. Therefore not an inventive step. Therefore not patentable?

  26. CMCguy says:

    Come on people with all the R&D layoffs further decreasing new discovery productivity don’t you think the Pharma’s Patent lawyers have to justify their salaries some how? Even if the claims are suspect all the litigation generated keeps them busy. Maybe not a classical Ambulance Chasers approach but per usual the lawyers seem to benefit form such circumstances while most others do not.

  27. MDACC gs says:

    Just skimmed the the patent:
    1. They based their patent on a model that has been in the public domain for some time. To me this means it would be obvious to someone in the HCV (or antiviral) field.
    2. They spelt Prichard wrong “Pritchard and Shipman model”
    3. They site Pharmasset and Gilead (as well as Vertex)…if they didn’t see this coming, they should fire their IP counsel.
    http://www.google.com/patents/US8466159

  28. Anonymous says:

    As the Federal Circuit explained more than 25 years ago in Kingsdown Medical Consultants v. Hollister, Inc.:
    It should be made clear at the outset of the present discussion that there is nothing improper, illegal or inequitable in filing a patent application for the purpose of obtaining a right to exclude a known competitor’s product from the market; nor is it in any manner improper to amend or insert claims intended to cover a competitor’s product the applicant’s attorney has learned about during the prosecution of a patent application. Any such amendment or insertion must comply with all statutes and regulations, of course, but, if it does, its genesis in the marketplace is simply irrelevant and cannot of itself evidence deceitful intent.

  29. alig says:

    @23 Gilead market cap 136 billion; Abbvie market cap 85 billion. Gilead is way too expensive for Abbvie to buy (55 billion was price for Shire).

  30. Hap says:

    1) legal != not slimy
    2) They can file a patent on combinations of someone else’s products, but they’re probably going to have to show that it wasn’t obvious that the combination would be active over a shorter time span. If they were using a known model, then it seems nontrivial to show that their invention wasn’t obvious, unless they have an implementation that works differently than those of others.
    Merck hasn’t exactly covered itself in glory in the Hep C saga, either. It’s pretty sad that a set of novel, useful, and groundbreaking inventions (precisely what people want from pharma) is instead giving pharma the chance to look even worse than before while giving lots of money to people who can’t do it any good. It doesn’t bode well for anyone else wanting to do something useful and new in pharma.

  31. Anonymous says:

    Then Gilead should buy AbbVie and then fire ALL of its employees while taking over its portfolio, just to teach them a lesson.

  32. Anonymous says:

    … and then offer to hire a few of them back on half the salary, because most will not have a choice but to accept in the current market.

  33. Anonymous says:

    Good one, #31. Then they should tell their mommy that they were being mean!

  34. Team-Liber8 says:

    Gilead bought Pharmasset with $11B hush money to go away and shut up about getting the basic research from John Hopkins paid for by US taxpayers.
    This is incremental science that EVERYBODY is working on. It is not new, it is the next OBVIOUS STEP that anybody in this field must pursue. OBVIOUSNESS to a worker skilled in the art is a bar to patentability, as are minor incremental steps.

  35. DrunkenBuddha says:

    I had a comment written and then I found myself exhausted. So often we do this (simple unadorned, unadulterated greed) and it is us, not him or her or them or some corporation or government. We’re it, him, her and them and as soon as we say ‘not me’ we shirk it. Shame on me.

  36. Harrison says:

    This is just another round of everyone’s favorite game, “Let’s sue each other.” On a previous episode, you will recall that J&J sued Abbott (AbbVie) over the invention of Humira, after they used a loophole in patent law to amend an earlier patent. After filing in the patent troll friendly east district of Texas, they were awarded $1.7 billion. Of course it was overturned on appeal. I could see this going down similarly.
    On a separate note, I don’t think this will have any impact on the warehousing of patients by the insurance companies. They are just going to wait until someone is sick enough to require the treatment unless AbbVie undercuts Gilead’s pricing.

  37. tangent says:

    Wow. I tip my cap to AbbVie’s patent lawyers, and I can’t wait to try this combinatorial patentry in the software field.
    My sophisticated modeling shows that you should use the output of your invention A as input to one or more of your inventions B, C, and D. Also, I’m deposing you on what you’re doing internally because I think you might be infringing.

  38. petros says:

    Re #36.
    The field of mAb development is littered with infringement suits and licensing deals between the major Ab developers. J&J acquired Centocor, one of the major players, and thus a lot of IP in the field.
    AbbVie acquired Humira through its acquisition of Knoll from BASF, Knoll having previously licensed the antibody from CAT (subsequently acquired by AZ). Consequently the IP position was likely to be complicated.

  39. DDTea says:

    This reminds me of that line from Idiocracy, “Either you lead, you follow, or you get out of the way.”
    Gilead is leading. AbbVie is refusing to follow or get out of the way.

  40. NoDrugsNoJobs says:

    Or as Gilead might modify the statement, you lead, follow or buy pharmasett for >10 billion if you fall behind.
    Abbvie’s regimen is at least as effective as Gilead’s and uses Abbvie’s patented shortened treatment duration – according to analysts, the problem with Abbvies combo is that it requires swallowing 4 pills a day instead of 2.

  41. Jonathan says:

    I wonder if Gilead could get their patent invalidated following the Mayo, Myriad, and now Alice SCOTUS rulings? Alice says you can’t just take an abstract idea (using both drugs in combination) and saying “do it with a computer” and get a patent, and Mayo would probably make the “combine both drugs—neither of which are ours” dodgy.

  42. NoDrugsNoJobs says:

    I think the problem for Prometheus (Mayo) was it was a correlation without regard to a specific next step. Methods of treating using prescribed doses, administration schedules are clearly outside the scope of Mayo. The computer algorhithim in the Abbvie cases, if I understand correctly, were used to enable the invention but are not part of the claims which are simply to a method of treating with a specific combination, dose and/or treatment duration

  43. David Borhani says:

    @38: Knoll/BASF Pharma did not “license the antibody from CAT”. Rather, D2E7, a.k.a. Humira, was discovered on the basis of the collaborative project with CAT initiated by BASF: BASF brought the target and desire to create the drug to CAT, who supplied the needed (and excellent) phage-display technology.

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