Thursday, 26 January 2017

Biogen Skinned by a Patent Troll

Pharma don't always get their way and when there is money to be made the vultures are out.


It is reported (click) that Biogen has agreed to pay $1.25 billion in cash to Forward Pharma a Copenhagen-based firm that has no approved products.


The legal battle centers on Biogen's multiple sclerosis treatment Tecfidera, which raked in $4 billion in 2016 sales.

Forward Pharma has been arguing that its patents on dimethyl fumarate (DMF), the active ingredient in Tecfidera, were filed before Biogen's and that the firm therefore has royalty rights to the drug. These are suits still going through the courts

Under the deal, Biogen would also pay Forward 10% royalties from Tecfidera sales between 2021 and 2028, and a 20% royalty thereafter (if Forward is able to secure the patents on its Tecfidera competitor). The deal would end once one of the drugs' patents lapse.

I am led to believe that the Danish person found an university patent and picked it up,  and had the financial clout to take on big pharma.

A few years ago someone came to me to ask if I would do some work on a compound in EAE, which is in phase II now, as they had picked up the patent rights via trawling the Japanese patent database. (If you don't have a translation and you don't read Japanese, stuff can get missed). So  maybe someone else will also get a shock in the future if the clinical development is successful. Sorry I can't tell you what it was.

Did you know that it costs over £10,000 to get a patent translated from English into Japanese....this patent stuff is a real cash cow mainly to lawyers who never lose out.

Patents are essential to developing treatments and without protection of a patent drugs don't get developed. This is one of the reasons why rituximab was dropped in favour of ocrelizumab

                                        *********

However this action is not victimless and whilst the fat cats get rich, you will pay for this. 

Has this anything to do with the 8% Price Hike of Biogen Drugs reported earlier this week (click)? 

This will give Biogen about an extra $400,000,000 (based on $4 billions sales) from the sale of tecfidera, then add the extra revenue from avonex, plegridy, natalizumab and the patent troll is being paid.

14 comments:

  1. A happy Forward Pharma shareholder here...

    Have you seen the latest Lundbeck announcement yesterday on the brain barrier crossing compound?

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  2. One might wonder whether those at Forward Pharma might contribute some of their huge windfall to MS Research? We'd love to hear from you?
    I won't be holding my breath though.

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  3. Forward Pharma: unlikely: they are professional speculators but nonetheless important for a working financial system (please don't challenge me on this last statement as not keen to debate the ethics of arbitration)

    I personally bought the stock upon learning that Seth Klarman did. I admire his work.

    I am contributing to MS research indirectly by consuming Tysabri on a monthly basis: I am a regular Tysabri buyer > 13% of tysabri sales go directly to R&D > A good chunk of that into MS research considering that it is the main pillar of Biogen.

    Now did you guys have a chance to look into this Lundbeck announcement? It is all over the FT this morning? Could it be of help for MSers? I think it deserves a post.

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    1. The thing is this isn't a victimless "crime" Biogen will merely jack up its prices to compensate for the hit from Forward Pharma and once again pwMS lose out.
      To say I think the business model of Forward Pharma though less egregious than the likes of Martin Shkreli (I hope you wouldn't invest in him) its still pretty distasteful.

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  4. Someone should do an expose: world without lawyers.

    I bet you justice would be more prevalent if only it wasn't for us. Economists and accountants are next lol. I want to include pharma in my equation: but are they a symptom of the global problem or the chicken that started the problem?

    Funny thing, when i became a lawyer, i wanted to help people. that was only 8 years ago.

    Cinara caught me on a particularly depressing day: funnily enough it's 26 Jan - Australia Day.

    Cinara mentioned selfishness: I'm so much less interested in MS prevention than I am in MS treatments.... I'm in a lesbian relationship and the younger partner who will have the children so I don't have to worry about passing on MS...

    We are all selfish in our own little ways. And if society is the greater sum of our individual parts... well then, we are in all sorts of trouble.

    I should have been a beauty model: I wish for world peace, justice and health for all.

    lol.

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  5. It has potential you could directly get at the plasma cells and destroy the B cell follicles in the brain that ProfB wants to destroy

    Lundbeck have purchased a company specializing in delivery of antibodies into the CNS. T

    hey use bispecific (two targets) antibodies on to target drug into CNS via binding to the transferrin receptor, an iron channel in the brain blood vessles and the other to the target.

    The concept is as old has the hills but I guess the shark antibodies make the this a possibility.

    How I will decline to post as this has possible financial implications and I have no desire to give Lundbeck shareholders a boost by over egging the pie.

    Indeed I suspect this is not as good as it sounds as it is highly likely that the shark antibody fragments will be immunogenic as hell and will be rejected within 6-8 days.

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    Replies
    1. Interesting! Thanks for your thoughts.

      Tony

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  6. I do not like Biogen, but I hope that Danish trolls don't get their way. It is horrid when guys who don't actually make anything blackmail guys who do. MouseDoctor, do you know what the basis of this Danish "patent" is?

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    1. sounds like they have to the tune of a few billion.
      I dont know the detail but I guess there is an inventive step that is prior art over the biogen patent. However may be the end of any more development of tecfidera in MS why would biogen develop it to pay a patent troll

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  7. What sort of evidence is needed to patent a drug/potential mode of action? Because neither Biogen or the trolls developed the molecule - dimethyl fumarate is dirt cheap.
    Is it enough that you as MouseDoctor think of a potential mode of action and then apply for the patent? Or do you have to do some experiments in the beasties that prove you were right and things work as you thought they would? Or are the beasties not enough and one has to do something in humans?

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    1. It's complicated. There are 100s+ of patenting blogs, 100s+ of arbitration blogs, 100s+ on pricing economics, 1000s+ on pharma bashing and other forms of cheap populism.

      I beg the MDs for the nth time: Keep this blog focused on the interpretation of MS medical research (The good, bad and ugly per your mission statement). This is what you know best and this is why we love you so much!

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    2. What sort of evidence is needed..it depends on the country of what can and can't be filed. It is whether the patent can convince a lawyer of a few things like inventiveness obviousness etc. There are tons of patents where the supporting data is a pile of pants. The work can be in animals and doesn have to be in humans.

      I went to the European Court for a patent case, only the lawyers could speak. It was one of the most frustrating days i've experienced. The case was won/lost on a paper used as prior art where the content was mushroom food, but the rubbish data was used to support a claim in the discussion and because it was claimed, this nullified the inventive data. Its complicated.

      When you file a patent and it is challenged they look for the prior art to ask whether it would be obvious to do your experiment based on this knowledge.

      You can file on ideas without much evidence, in some countries the key is how easy it can be protect.

      I saw the story of the trolling and it interested me, I dont understand business but has massive influence on whether or not things get developed in MS.

      People, sometimes including ProfG, may prefer us not to talk about this stuff as invariably it leaves a bad taste in our mouths and we shoot from the hip.Possibly without affecting the full picture.

      Maybe it brings science/clinical science into disrepute and we should say it is all amazing ave a united front and they we will be like any corporate blog an be PC and dull.. but the truth is it isnt. It shocks me when I hear it and am sure it shocks you the readers.

      Off course there is loads more you hear and we dont say.

      Paying science writers to write papers or what is happening to rules on pharma support and how neurologist get to ECTRIMS is gob smacking

      We have to look for content but we generaly don't comment on press releases as it may support the companies getting air-time and shares.

      It has been said that my tongue in cheek "new mechanism of the week" by a certain compound is simply adding to the marketing by keepin said compound in the minds eye.

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    3. I am really really glad that you do write about things that may be perceived as controversial - it is totally wrong to shove this stuff under the carpet and pretend everything is fine. People need to see how medicines get developed and the mechanisms involved and the financial side of it all as well. So big thanks, MouseDoctor :-)

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    4. I repeated hear from different sources that Pharma are divesting their interest in MS research and are off to pastuers new.

      This is bad news for MS, if true, as you will be stuck with the treatments we have and not get new ones.

      Acts such as the patent troll, I suspect helps the company to decide not to invest in research.

      Why spend millions to do trial in progressive MS only to have to pay a patent troll, who has done nothing but out-lawyered you.

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