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Standard of Care? Not So Fast, Not in the United Kingdom

Did you know that in the UK, patent law says that using a competitor’s compound as a comparison in a clinical trial is an infringement? I sure didn’t. The government has realized that this rule is much stricter than most other countries, and is moving to change it in a bid to keep more clinical research in the country. Thanks to FierceBiotech for the heads-up on this.

11 comments on “Standard of Care? Not So Fast, Not in the United Kingdom”

  1. PP says:

    I do not know how you do it in the USA but in Europe is extremely hard to get competitor’s compounds to use in clinical trials.

  2. cynic says:

    Can someone offer a bit more explanation of the logic to the original law? In many clinical trials, one set of patients is treated using a commercially available drug. Isn’t that what hospitals do on a daily basis, treat these people with commercially available drugs and monitor their health? How does reporting patients’ medical information infringe on the commercially available drug’s patent? Does it also infringe upon patents for the food the patients ate and the smartphone they used during the treatment as well?

  3. ChristianKl says:

    What are we talking about? Buying the drugs of a competitor on the open market and then using them in a clinical trial? Or are we talking about synthesing them in a lab and using them in a clinical trial?

  4. Anonymous says:

    oooohhh, a smart move on the backwards islands. does that not contradict the UK policy of making science more difficult?

  5. Andy says:

    I believe even preparing a competitor’s compound in house and using it in your own assays is actually an infringement. How many people abide by this, I’m not sure.

  6. David Formerly Known as a Chemist says:

    @5 Andy…this was actually settled pretty conclusively by a Supreme Court decision in 2005 (Merck KGaA v. Integra Life Sciences). The Court upheld experimental use of patented compounds for preclinical as well as clinical research.
    “Justice Antonin Scalia delivered the Court’s unanimous opinion that federal law allowed the use of patented compounds in preclinical studies, as long as there was a reasonable basis to believe the compound could be the subject of an FDA submission. The Court reasoned that federal law provided “a wide berth for the use of patented drugs in activities related to the federal regulatiory process” and that “this necessarily included preclinical studies.” Because federal law required only a “reasonable relation” to FDA submission, information gathered on the patented invention (a compound in this case) did not necessarily need to be submitted to the FDA to be exempt from patent protection.”

  7. DatamonitorMark says:

    It’s more a case that there was a lack of certainty as to what situations constituted infringement, and this allegedly was putting people off even thinking about the UK as a location for certain trials.
    For discussion see http://www.mewburn.com/patents/focus-on-patents/experimental-use-exemption-in-the-pharmaceutical-and-biotech-industries and http://www.wragge.com/analysis_9338.asp
    The IPO’s attempt at summarizing the situation is “Trials carried out to discover something unknown, to test a hypothesis, or to find out whether something will work in specific conditions can be regarded as an experiment, but trials carried out to demonstrate to a third party that a product works, or to amass information to satisfy a third party that it works as claimed, are not regarded as acts done for experimental purposes and are therefore not acts which are exempt from infringement.”
    The two documents at the following IPO site provide background to the recent consultation and the responses they obtained. http://www.ipo.gov.uk/pro-policy/consult/consult-live/consult-2012-bolar.htm
    Given all the griping about how this was hindering R&D in the UK, the response to the IPO’s consultation was perhaps underwhelming. Their conclusions are drawn from a mere 20 responses.
    As the IPO notes: “Although a call for evidence was made, very little quantified evidence has been provided.”

  8. Wile E. Coyote, Genius says:

    I once worked on a preclinical toxicology study where the US regulatory agency aksed that additional tox groups be included on the study to compare two other already marketed drugs. This was a couple years before the 2005 Supreme Court decision. I think the US court got it right, as it is can be a relevant question to ask, in the right circumstances.

  9. fat old man says:

    I guess I must be slow I don’t get why there would be a patent infringement if the drug product was prescribed by a physician and sourced on the open market, paying the market rate, as was the custom on all projects I was familiar. Sometimes there was a deal with the other product’s company for a lower price, just in cases where the drug candidate would be marketed with the co-medication (a win-win for both in a successful trial). Does this have anything to do with importation from a different country for a UK-unapproved product? Or some weird complexity of their national health system?

  10. will says:

    @ 8 and 2 – The issue is almost certainly a patent on the method of using the drug for a particular therapy. The situation was the same in the US prior to the enactment of the Hatch Waxman act in 1984.

  11. Anonymous says:

    @10 – field of use is certainly part of the problem. Sometimes you would like to run your clinical trials while a FOU patent is in force – but by the time you have run the trials and got reg approval the patent will have lapsed. This change will enable this to happen though how often it is really a problem and how many litigations there have been I don’t have any data on.
    Also in a double blind trial you may wish to have your compound and comparitor look the same. Hence you would need to make it yourself and this would infringe. If you bought some ‘little blue diamonds’ as a comparitor for your ED trial I reckon everyone might guess which is which and this could affect your data…
    @9 this has nothing to do with the NHS. It does have something to do with politicians tinkering with laws to make it look like they are doing something to ‘save the life science industry in the UK’.

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