Pharmaceutical & Biotech Lifecycle Management (II)

Author:Mr Duncan Bucknell
Profession:Duncan Bucknell

How does timing of 1st non-innovator patent affect the period of monopoly for a new drug?

This is the second in a series of articles on Pharmaceutical & Biotech Lifecycle Management, the

first article looked at whether generics are launching earlier than ever.

The series comes from a pilot study I put together to test some views on the factors which affect success in the ongoing war between 'innovator' and 'generic' companies. In this article I look at how early non-innovator companies are filing patents covering a drug and the effect that this has on the period of monopoly for the drug.

Please join the discussion about this article at the

equivalent blog post at IP Thinktank.


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.)

Other people are filing patents incredibly early

There's a pdf document with three slides which accompanies this article - you can find it at -

Slide 1 shows the time from marketing authorisation until the first non-innovator patent is filed. By 'non-innovators' or '3rd party', I mean companies other than the innovator for that particular drug.

The yellow markers each represent a different product. The X axis shows years of monopoly that the innovator has obtained in each instance while the Y axis shows the number of years away from Marketing authorisation.

The first thing to note about the slide is that the values are all negative. That's right - other people are filing patents covering a new pharmaceutical product before the innovator obtains Marketing Authorisation.

The second thing to note about Slide 1 is that there seems to be a reasonable trend upwards and to the right. In other words, the longest monopolies went to those products for which there was minimal delay between 3rd party patent filings and Marketing Authorisation. (Presumably this trend would continue above the X axis - so that a product for which there are no 3rd party patents prior to marketing authorisation would obtain a still longer monopoly - 25 years?)

Slide 2...

To continue reading