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Amarin Corporation plc Message Board

  • jesse.livermore jesse.livermore Nov 14, 2012 6:13 PM Flag

    Exclusivity, NCEs patents, generics..

    Recent post questioned whether it was worthwhile for AMRN to continue the REDUCE-IT outcomes study if the the NCE was denied...Some clarification...

    There is a lot of confusion Re. the NCE, it relationship to the patents, its importance as a barrier to entry, its effect on the FDA H-W exclusions, and to the REDUCE-IT study...

    To begin with the PTO and the FDA are separate government agencies, and the PTO is less than marginally interested in what the FDA thinks about a drug or a medical device that applies for a patent..The PTO determines the novelty of the drug-device and to a lesser degree the utility, to determine whether a patent will be allowed. The PTO might reference the FDA, but does not consult them. The FDA lists patents in the OB, but does not offer legal opinions on their significance or relevance. The listed patents do trigger the H-W exclusions. The patent(s) listed can be challenged by competitors and if the competition can show the patents are invalid or infringe on their as determined earlier in the courts...Then the FDA can retract the NDA...The FDA does not use the PTO as a consultant do determine the H-W to determine whether a drug is a NCE..

    Though stated many times on the board, the REDUCE-IT outcomes study does meet the criteria for the New Clinical Studies three year exclusion...The NCE five years..Sounds pretty simple, but it is more complicated. In filing for an aNDA a generic must demonstrate "bio equivalence" with the brand drug. Because Vascepa is a naturally occurring biochemical...There is no currently recognized way to prove bio equivalence. The company must also file a paragraph 4, a legal document stating it is not infringing on any of AMRN's patents, or they are invalid...AMRN then has 45 days to a rebuttal to the generics claims. This triggers a 30 month stay of the FDA granting any aNDA...


    ": ) JL

    Sentiment: Strong Buy

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    • bmup to avoid reading all mousemouse one line posts

    • "Continuing with having to shoot down the opinions (not facts) made by other media contributors, patent data and information is ABSOLUTELY 100% considered by FDA when examining chemical entities, especially when they are comparing different products head to head -- whether for or against NCE, this data is essential. If AMRN has additional patent data, it would be considered if they allow to accept it."

      From Rosenman's article that nm1066 was referring to.

      • 1 Reply to venus537
      • venus....

        So Rossman is "shooting down opinions" by others...To post his 100% fact...LOL...I would be a lot more impressed if he told me he was an active member of the FDA's CDER.

        I have had one scheduled meeting with the FDA regarding a medical device. My partner and I sat at a conference table with representatives of the different intra-agency departments. These included medical, legal, compliance, safety and a couple more I do not remember. What I do remember was the obvious scarcely concealed hostility between the department heads.This was related to turf...How does this relate to Rossman ABSOLUTELY 100%..? Well..the H-W defines an NCE in terms of the FDAs NCE being defined as a chemical entity that has no active moiety that has been approved by the FDA in any other application...This is determination of the NCE is made by the FDA's CDER committee. Their decisions can be more subjective than the strict definition provided bi H-W, but CDER is the sole determiner and my personal experience would leave me to doubt they bring in even outside members of FDA into the discussions, and certainly not the PTO...THis is MHO...The subjectivity would take in earlier decisions by the FDA...but the point is this is an FDA thing, and not a PTO thing...

        Finally IMHO the NCE is not really very important anyway...

        ": ) JL

        ": ) JL

        Sentiment: Strong Buy

    • In the case of Lovasa is there not a generic that has proven bioequivalency?

    • Read Rossman's new article-he said the Patent's have everything to do with approval of NCE. I don't know but you should read his blog.

      Sentiment: Hold

    • cont...

      So the stated H-W exclusivity periods are actually shorter than the real times required for a generic to launch...In reality the listing of a drug in the Orange Book (It was originally Orange, because it first came out around Halloween...true) usually results in about seven and a half years of exclusivity even without the NCE.

      But AMRN has more going for it than the defense of lawyers and agencies...Generics' main strategy revolves around the fact they can sell the drug for a substantially lower price than the brand can, because for the most part there actions are mainly on paper...So commonly generics sell for 50-70% the price of the brand...This is not likely to work in the case of Vascepa, a lot of the drugs generics attack are drugs with limited sales volumes, the type that the brand has to mark up to cover the seven or so years of research and FDA costs...Vascepa with a potential 40mil plus patient pool will and should employ a strategy of thin profit margins which will still provde huge earnings because of the volume, but destroy the incentive of the me toos...

      Then there is the the requirement for supply...we are talking about tonnes of reined product..No generic can afford to tie up suppliers for the years of exclusivity which puts AMRN squarely in the driver's seat...And catching up after AMRN has five or so years of garnering refiners is not going to be feasable..

      IMHO...the NCE simply fades to black in this scenario

      ": ) JL

      Sentiment: Strong Buy

    • Can't thank you enough for each and everyone of your posts. Now I will go back and try to understand exactly what you are trying to tell us. Thank you thank you and thank you!!!

    • JL, Nice explanation. Do you think we have a reasonable chance at NCE, and how much do you think NCE is worth in PPS?

    • what are your thoughts on an appeal by, say, Glaxo, of the NCE, if granted ? who hears the appeal ? is it expensive ? how long may it take ??

      thanks in advance…keep up the good work

      • 1 Reply to quantum_duck
      • GSK doesn't have a case, since Lovaza's "moiety" is NOT the EPA molecule. It is BOTH the EPA and the DHA molecules.

        (Of course, GSK could try to prove Lovaza's "moiety" is JUST the EPA molecule alone; but that will take some time. And the giant might also have to do away with the DHA molecule in its pill, literally, or medicinally declaring it to be an non-active ingredient... then, yes, Lovaza would be just another Vascepa.)

        But Vascepa's "moiety" is just the EPA molecule alone. There is actually a good reason why introductory logic needs to be taught in all colleges.

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