17 April 2003. Memo from Charlotte Reader, marketing manager, to Prof Peter Dettmar, consultant:

ERIC ... is our Gaviscon generic strategy ... Over half our total NHS Gaviscon business is still in constant threat from the potential introduction of a generic ... There is a threat of a generic name ... The BNF are within their rights to consider awarding a generic name ... If we were to change the formulation of our current Gaviscon liquid ... with the rationale that we are doing so for health and safety reasons ... we could withdraw Gaviscon liquid from sale within the NHS and replace it with the new formulation ... We can also claim it is an improved product.

We could potentially apply for a new patent on this formulation and effectively protect all our Gaviscon liquid business within the NHS for another 20 years. This new product would then not fit into the proposed generic category ... The other ... option would be to see if there is anything we can do in the short term to muddy the waters in the face of the threat ... something else we have changed/tweaked that we could develop a selling rationale to the NHS/GPs around that ... could not be classified within a generic ... name.

I am sure there must be something we can dig out of the cupboard!

7 July 2003. Memo from Charlotte Reader to Tim Baxter, medical director:

The BNF have recently instigated a process to try and introduce a non-proprietary name for GL. We have successfully managed to stop this process by the BPC now agreeing to re-assess their stance on producing a BP monograph...Our strategy is to ensure that we encourage (in every way possible) the BPC to decide to work on producing a monograph ... Tim is leading the project and will be recruiting the help of Pete Dettmar to devise a plan to extend the development of a BP name for GL as long as possible ...

We are driving for the inevitable granting of a generic name but within a ... timescale we will try and control as far as possible ... We need to develop a plan to protect our £9m of Gav liquid NR for when this happens ... The plan is this - withdraw Gav liquid from sale within the NHS before the monograph is completed and a BP name is granted, and replace it with a new Gav Liquid ... that ... doesn't comply to the monograph that is being developed ... We can ensure that all GL repeat patients are switched and therefore protected.

23 July 2003. Memo from Anand Sharma, senior executive, to Ms Reader and Mr Baxter:

It is quite a clever idea to protect Gaviscon liquid from the generics threat ... The publishing of the monograph by BPC ... Why do we want to expedite its publication? Should we not drag it as long as we can? ... The risk is of a £9m business.

12 Aug 2003. Memo from Roland Featherstone, finance director, to Richard Williams, lobbyist:

We have at least managed to influence the BNF to defer to the BPC ... Naturally, we would like to work with them (slowly) to develop the spec ... We are considering developing a new formula for Gaviscon which would be patentable ... the plan would be to introduce the new formula ... then to withdraw the old pack.

Undated memo from Peter Dettmar

Single product monograph ... Advantages to RB. It would be long and complicated. This might lead to more disagreements and therefore take more time to achieve ... Separate monographs ... Advantages to RB ... A doubling of procedures may mean it would take longer ... more scope to set a tight raw material specification ... This would put pressure on generic product manufacturers using other raw material sources. More likely to be able to specify use of a GMP ... raw material, a further barrier to competitors.

Advantages of working with BP ... We are the best people ... to define tighter specifications which could restrict entry for new competitors ... Plan. Meet with the BP Commission and argue the case for a separate sodium alginate monograph.

Source: Medicines and Healthcare products Regulatory Agency

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