TPPA drug data protection term

One of the contentious issues in the Trans Pacific Partnership Agreement is the length of time stipulated for drug data protection – the period that drug companies are protected from generic competitors.

The TPPA sets it at five years but with some extensions possible . The MFAT factsheet on this says:

TPP requires New Zealand to continue to provide five years of data protection for small molecule pharmaceuticals. For biologics, New Zealand will be required to provide the five years of data protection together with further effective market protection through other measures, taking into account local market circumstances. Although these are new obligations for New Zealand, they can be met within existing policy settings and practice.

Patent term extension to compensate for unreasonable delays

Very few unreasonable delays are expected to occur in New Zealand, and only in exceptional circumstances, given the efficiency of patent grant and regulatory approval by the Intellectual Property Office of New Zealand (IPONZ) and Medsafe respectively. This is because the agreement requires an extension of the patent only for certain types of delay:

  • Patent office delays will only be counted if the patent has not been granted within five years of its filing date, or three years from the time the patent applicant requests its examination.
  • Delays attributable to actions of applicants and third parties do not require an extension, for both patent office delays and delays in Medsafe’s regulatory approval process.

Pharmaceutical companies had wanted 12 years and are unhappy with the shorter term of protection.

In general it would seem that the sooner that cheaper generic drug alternatives are available the better it is for those who need the drugs.

But there are some aspects of this I haven’t seen mentioned.

A shorter data protection period may mean we pay more for the drugs initially than if the period was longer.

If a drug company has to recover it’s research, development and testing costs over five years rather than twelve years then the cost of those drugs will have to be much higher during the initial five years. But then we get cheaper generic versions sooner.

Or a shorter protected period may also mean that pharmaceutical companies decide not to release drugs if they don’t think there’s a reasonable chance of recovering costs and making a profit.

I don’t think the issue is as simple as protection period shorter = better for us.

If there was no data protection period then companies would be financially discouraged from developing new and better drugs.

The ‘all corporations bad’ brigade forget that pharmaceutical corporations save a lot of lives and improve the quality of life for many people.

Sure new drugs can be prohibitively expensive if unsubsidised by the Government, but at least they are becoming available.

How many of us wouldn’t have survived without capitalist pharmaceutical company products?

Sure, if a  new drug becomes available that could save my life I would prefer not to be priced out of the market. But something expensive available is better than nothing.

Leave a comment

27 Comments

  1. mrMan

     /  16th February 2016

    ‘Data protection’ and and ‘Patent’ are two different things. Data protection, does what it says on the box, it protects data. The data that is obtained during research and lab trials, data that has to be made ‘public’ (not ‘public domain’) in scientific journals, patent applications etc. Data Protection places a 5 – 8 year limit on competing companies accusing this data to start working on their own ‘generic’ version of the drug.
    The original maker of the drug still has 20 years protection from the patent on the drug. So the generic drug maker can start work sooner, but they can’t get to market any sooner.

    Reply
    • mrMan

       /  16th February 2016

      It’s thing because, quite rightly, copyright does not protect facts so there is no other protection for this information. That said, copyright term extends to 70 years un TPP so if the drug companies could put their data under copyright it would be tied up much much longer.

      Reply
      • mrMan

         /  16th February 2016

        This site has a good run down on the difference between the two.

        A more worrying aspect of the TPP, in terms of getting generics to market, is the Patent Term Extensions. As I said before, patents give 20 years protection. At present in New Zealand that is all you get. In the US, however, pharma’s can get a patent extension to cover delays caused by FDA approval e.t.c.
        So a drug is made, and gets it’s patent. Then it goes to testing – say this takes 7 years, the patent is extended by those 7 years. Here in New Zealand the patent started when it was first approved and has 13 years left to run, in the US it has been reset, and now is back to 20 years.

        Reply
      • Alan Wilkinson

         /  16th February 2016

        Copyright protects form not substance. It’s not applicable for pharmaceuticals.

        Reply
        • mrMan

           /  16th February 2016

          Copyright protects form not substance

          ¿¿¿Pardon??? Copyright protects original works.

          Reply
          • Alan Wilkinson

             /  16th February 2016

            Educate yourself, it’s not hard:

            “Copyright does not protect ideas or information. It protects the expression or form that those ideas or information take. For example, an idea for a novel or screen play is not protected by copyright, nor is the subject matter of a photograph or painting.

            However, ideas may be protected by other laws including where there is a duty of confidentiality and under the law of patents. Patent protection is available for products, processes, improvements and testing methods related to manufacturing that are useful, new, novel and inventive. Patent protection requires registration. In New Zealand, patents are registered with the Intellectual Property Office of New Zealand.”

            http://www.copyright.org.nz/viewFaq.php?faq=354

            Reply
            • mrMan

               /  16th February 2016

              Firstly, I said that copyright don’t come into play as you can’t copyright a fact. To which you say “Copyright protects form not substance”.
              What does that mean? But no, instead of explain yourself, which I doubt you can, you copy and paste another government fact sheet . which kind of contradicts you, because yes copyright protects the form of an idea, but it also protects the substance of that idea, the written words of a novel, the words and music of a song.
              I’m still not sure what point you’re trying to make. Notice you’ve got nothing to say about anything else I wrote here.

              Or do you mean substances, like pills?? I think you’re trying to trip me up on something I didn’t say.

  2. Blazer

     /  16th February 2016

    ‘If a drug company has to recover it’s research, development and testing costs over five years rather than twelve years then the cost of those drugs will have to be much higher during the initial five years. But then we get cheaper generic versions sooner.’

    I don’t think many seem to be aware of the margins drug companies operate on….they would make your eyes water.!

    Reply
    • Alan Wilkinson

       /  16th February 2016

      You are talking about production margins. But the costs are all in the R&D and approval process including all the drugs that never make it through these to market. Hard to quantify these to know whether the patent settings are right or wrong.

      Reply
  3. jamie

     /  16th February 2016

    We have drugs because generations of talented scientists and researchers have worked and built on each others work.

    What does this have to do with the corporate structure? The same work is done whether they are employed by a publicly funded research agency or by a publicly funded corporation.

    Reply
    • Alan Wilkinson

       /  16th February 2016

      It has to do with skin in the game. A publicly funded agency doesn’t have its managers’ own money on the line. A private corporation can take bigger risks for bigger gains but has a greater incentive to get it right.

      Reply
      • jamie

         /  16th February 2016

        A corporation doesn’t have its own manager’s money on the line either.

        And I question the relevance of taking bigger risks for bigger gains. That’s just not how research functions.

        Now I know you’ll probably assume I’m just anti capitalism but I’m absolutely not. I’m just not dogmatic about it being the SOLE ultimate solution to every problem, and I think medicine is one example.

        Reply
        • Alan Wilkinson

           /  16th February 2016

          Most CEO’s are on performance related packages and certainly get fired if they fail.

          All research is a risk because the eventual benefits are unknowable. Corporations in competition take a wide variety of angles of attack on problems. Many fail, a few succeed. Public research faculties can’t match that variety. They can work on “open sky” research though which doesn’t have to produce any immediate commercial payback but may prove of immense value in the long term.

          Reply
          • Blazer

             /  16th February 2016

            ‘Most CEO’s are on performance related packages and certainly get fired if they fail.’………….can you name some from Wall St that got ‘fired’…or maybe closer to home …like Solid Energy,Air NZ ,Sth Cant….Feltex,Dick Smiths…I could go on…and…on.

            Reply
          • Mefrostate

             /  16th February 2016

            I thought you were a classical liberal, Alan, so it’s nice to see some acknowledgement of the role of public drug research. I think this role could be expanded (e.g. I would support greater taxation in order to publicly fund more drug research), as private firms have an incentive to develop the drugs that will have the best financial return, rather than those that will generate the largest public benefits (in prevented loss of QALYs).

            Reply
            • kittycatkin

               /  16th February 2016

              I don’t know where the idea comes from that CEOs are on big salaries from the goodness of the companies’ hearts. They are not. The company wants its money’s worth, and they get it-or the CEO doesn’t have their contract renewed.

            • Alan Wilkinson

               /  16th February 2016

              @Mefrostate, I wasn’t limiting public research to drugs at all – far from it. Basic research in all kinds of science increases our understanding of our world and our existence and thereby our opportunities and technologies. I once was a very small fish in that pond.

      • Blazer

         /  16th February 2016

        thats the theory,but we know that in practice many private corporations…get bailed out at the expense of the taxpayer.Big bonus’ are a big incentive but sadly no measure of…performance.

        Reply
        • Alan Wilkinson

           /  16th February 2016

          Corrupt politicians are a constant risk and the only protection is sunlight and vigilance. However, that vigilance has to be informed, intelligent and balanced – not just ideological.

          Reply
          • kittycatkin

             /  16th February 2016

            Very few companies are bailed out at taxpayers’ expense, and if they are it’s in very particular circumstances. If it was common, companies wouldn’t need to worry too much about going belly-up.

            Reply
  4. http://www.henryhughes.co.nz/Site/News_Articles_Case_Notes/Pharmaceuticals-Patents-Data-protection-and-the-.aspx

    AN interesting primer written by NZ lawyers in August 2015, which explains the differences between Patent and data protection plus discusses some pros and cons of the various approaches to the issues here and overseas…. its about 7-8 minutes of reading and a reasonable backgrounder if you’re interested…

    The timings around patent granted, marketing approval and data protection are interesting in the whole debate and would provide quite different periods before generics can enter a market depending on how long from patent grant to marketing approval is….

    Reply
    • mrMan

       /  16th February 2016

      That was written before the document was made public, so it relies on guesswork as to what the final document will contain.

      Reply
      • Yes hence why I said Aug 2015 … but what is of more interest is defining terms, explaining how it works and how data protection, patent grant and marketing approval interact ….hence why I said a primer and didn’t mention TTPA mrMan…

        It was intended as a go explore and get and understanding post for those who haven’t got the knowledge in the area – we aren’t all legally trained or being reading in the area for awhile….. is that ok by you??

        Reply

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