Site icon Duncan Bucknell

Pharmaceutical & Biotech Lifecycle Management (I)

I recently put together a pilot study to test some views on the factors which affect success in the ongoing war between ‘innovator’ and ‘generic’ companies. In this, the first in a series of articles, I look at one of the interesting (but expected) outcomes from the study – that over time, generic companies have become better at getting on to the market earlier. To comment on this article, please go to the equivalent blog post on my site. If you are reading the blog, then you can read the full article in the article section of the site.


The study looked at 15 of the globally top selling pharmaceutical products on the market today to identify possible trends which might explain, and potentially predict what can be done to affect the length of monopoly. Future articles will explore some of the other interesting findiings, and provide updates as more data and aspects of lifecycle management are analysed. (Raw patent filing data was supplied by the team at GenericsWeb.)

‘Generics’ seem to be launching earlier than in the past

In the graph which accompanies this article, the X axis shows the number of years of monopoly achieved by each of the drugs. The Y axis shows the number of years ago that the first Active Pharmaceutical Ingredient (API) or Composition of Matter (COM) patent was filed in relation to the product.

The bottom left of the graph shows the products in this study for which the composition of matter patent was filed more recently (17 to 20 years ago), and the top right shows the products for which the COM / API patent was filed the longest ago (31 years). The graph goes up to the right – the oldest products in this study received the longest periods of monopoly.

The implication here is clearly that if you discovered a drug 30 years ago, you would have been more likely to get a longer period of monopoly (23 years) than if you discovered it 20 years ago. Note that this is 23 years after marketing authorisation (which took on average 10-13 years in this study) – so 33 to 36 years after the priority date of the original composition of matter patent.

Why has this happened?

There are no doubt many reasons why this trend is apparent (and please let me know your thoughts). Here are some:

1 – The Hatch-Waxman legislation came into effect in 1984 – during the period of this study. This provided an enormous incentive for ‘generic’ companies to seek to launch as early as possible in the US, in return for 180 days generic exclusivity.

2 – Generic companies have become more aggressive over time – the enormous return balancing the risk.

3 – Generic companies have become much better at launching in countries outside the USA.

4 – The courts today are more likely to find yesterday’s technological advances as obvious. Thus, certain types of patent which would have worked to extend a monopoly in the past are now considered obvious (for example, simple enantiomeric separations, simple dosage form switches, related indications, etc).


The distinction between ‘innovator’ and ‘generic’ companies is rapidly disappearing. Many traditional ‘innovator’ companies have their own generic subsidiaries, and of course will routinely allow authorized generic products. Similarly, the larger ‘generic’ companies are increasingly engaging in drug discovery and coming up with their own new chemical entities, and / or in-licensing products from smaller firms, etc.

This pilot study was designed to generate discussion, and so it has not been designed to be statistically bullet-proof. Consequently, you will not see R squared values on any of the lines of best fit – there are only 15 data points so far.

Iin this study, ‘years of monopoly’ was defined as time from first marketing authorisation in any country, until launch by a generic company in any country. (As we all know, the monopoly increases over time as marketing authorisation is granted in each country, and then decays over time as generic competitors are able to launch in new countries. So the measure used in this study is an indicator but not equivalent to the actual monopoly gained.)

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