Thursday, 1 October 2015

Kadcyla & Crown Use

An article in the Grauniad today reports a letter written by The Coalition for Affordable T-DM1 to the Health Secretary Jeremy Hunt.

The letter asks Mr Hunt to "authorise the domestic manufacture and/or importation, use and sale of biosimilar versions of trastuzumab emtansine (T­DM1) used in the treatment of breast cancer, to be supplied to the government for use and sale in the UK", which they argue can be done under the Crown Use provisions of the UK Patents Act 1977 (sections 55 to 59). This is apparently necessary because the medicine is very expensive and unaffordable to patients in the UK, costing in the region of £100k for a year's treatment.

The letter does not indicate what patent would need to be authorised for use, which seems to me a bit strange. I have, however, found one that seems to fit the bill: EP1689846B1, which was granted in March 2013 to ImmunoGen, Inc., claiming a cell-binding agent maytansinoid conjugate with the formula shown above, where Ab is trastuzumab.

T-DM1, more commonly known by its trade name Kadcyla, is an antibody-drug conjugate, being a combination of the monoclonal antibody trastuzumab (trade name Herceptin) with a cytotoxic agent DM1, a maytansinoid. The drug can apparently be of some use in treating HER2-positive metastatic breast cancer, although is not a cure and results show that it might be able to extend life by typically a few months. The National Institute for Health and Care Excellence (NICE) have indicated that the drug is not worth funding, finding last year that it is not recommended for treatment because it was not a cost-effective use of NHS resources.

To my knowledge, the Crown Use provisions in the UK Patents Act 1977* have never been applied to the provision of drugs (although I would be happy for someone to prove me wrong). It would be interesting to see whether this case will establish a precedent, but I strongly suspect that it will not.

*As pointed out in the comments below, Crown Use provisions in the 1949 Act were used. However, apart from the case of Henry Brothers v MOD [1997] RPC 693, which was not about drugs, I am not aware of any cases under the 1977 act relating to sections 55 to 59 and do not know of any patents that have been the subject of an order under section 55. Making an order in this case would therefore seem to be setting a precedent, which I suspect the current government would be very unwilling to do.


  1. Hi Tufty, I think that Crown Use has been applied to supply of drugs. However, the case I am aware of (Pfizer v Ministry of Health, House of Lords, [1965] RPC 261) was by importation. I think that such a practice became commonplace after this case. However, the Crown Use provisions were changed to increase the compensation payable to the patentee (to include compensation for the loss of profit by the patentee not themselves supplying the patented product) by new s 57A of the Patents Act, added by the CDPA 1988, so that it became no longer economic to supply drugs that way. My lecturer on this stated that the amendment was introduced by Margaret Thatcher as a result of lobbying by Dennis Thatcher who was a shareholder in (I think) ICI, but I don't know whether that is true. In any case, the EU principle of exhaustion of rights has allowed importation without needing Crown Use anyway.

    I will get my coat.

    1. Thanks for some interesting points Darren. You don't need to get your coat yet. I noticed the Pfizer case too, but since this was under the old act I didn't think it was particularly relevant. I should have made it clearer that the Crown Use provisions under the 1977 Act had never to my knowledge been used for drugs. There has only been, AFAIK, one case involving Crown Use (Henry Brothers) and this was not really about getting permission under s55 and didn't relate to drugs.

      Although the story about Thatcher sounds plausible, I suspect your lecturer was probably a bit left biased, as academics often are. There will definitely have been lobbying by drug companies though, as there always is.

  2. Thanks Tufty - just to clarify with a bit more pedantry, I think that the Crown Use provisions under the 1977 Act continued to be used for supply of drugs to the NHS until the 1988 amendment to it, after which my understanding is that it no longer resulted in a financial saving that was worth seeking.

    1. Thanks Darren. Maybe a bit more research is needed. Someone must have written about it. Given how much some patented drugs cost now, perhaps the financial savings could be worth it again in some cases.