Patent linkage and the TPP. Commercial considerations relevant to TPP. Geraldine Storton Hospira Pty Ltd. Overview. Who is Hospira ? What is patent linkage? Relative market sizes of TPP members Patent linkage hypothetical financial analysis
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Commercial considerations relevant to TPP
Hospira Pty Ltd
Improving the safety, cost and productivity of patient care
Source: Business Monitor International, IMS Health
Compared to other countries in the TPP group, the annual market value
for pharmaceuticals in the US is significantly higher.
*Note no data available for Brunei
The current GMiA estimated typical cost of litigation in Australia is $5M*. Using typical industry ranges for market size, development cost, market share, price erosion and margins a financial model was created.
This model did not return a positive profit for the generic manufacturer unless the cost of litigation was low, or the exclusivity period was long.
Green shading signifies a positive pay-off (i.e. The pay-off, including the cost of litigating, returns a profit for the generic manufacturer)
A threshold value was determined to understand the market value of a drug
required to provide a positive return at USD 5M litigation cost and 0.5 years
Exclusivity. For the base case this was >USD 200M.
Source: Mean litigation cost estimates provided by GMiA. IMS data for number of molecules selling over $200 M pa
For the base case USD 50M product, we varied the input parameters across
plausible ranges to understand the sensitivity of the model.
We found that with higher value inputs, a negative return is still expected at
Current litigation costs and 6 months exclusivity (as the US has).
*Source: Legal Fee estimates from GMiA. IMS data for number of molecules selling over $50 M pa
Hospira Pty Ltd