Dr Reddy’s R&D IP team members GVS Sesha Kumar and Rakesh Mishra have just published a thought provoking piece in Managing IP magazine (How pharma companies can leverage their IP rights). They wrote in asking for comments on the article and inviting a discussion on this blog.
Here are some brief comments to get the ball rolling, please do come and add your comments:
1 – I totally agree that timing and coordinating your patent filing strategy and R&D strategy are critical. No doubt by ‘R&D strategy’ they are referring to the entire development program – including scientific, regulatory, clinical, marketing, etc etc.
2 – Just to clarify – the patent term extension obviously runs from the end of the current expiry, not the date of approval (but this is the date that triggers the term extension calculation).
3 – As they say, patents other than the original molecule patent don’t usually attract a patent term extension. However, you might be surprised how often this actually does happen and where.
4 – I agree with the point about the pressure not to file patents in the first five years after the full (PCT?) application of the original molecule patent is filed.
Note however, that a previous study we did – Pharmaceutical & Biotech Lifecycle Management (II) – suggests that the earliest non-innovator patents (almost always synthetic process patents) are being filed at about this time as well – ie 5 years before the innovator launches the product. In that study we suggested that 3rd party patents are an indicator of the research activity being undertaken by other (usually sophisticated) entities in relation to the product. The earlier they become sophisticated about that product, the more likely they are to be able to successfully deal with any patent barriers put up to sustain a monopoly.
5 – I don’t think that the authors are suggesting this, but clearly there is a great risk in simply delaying filing for patents once the technology has in fact been developed.
6 – The strategic alliances and licensing comments in the article all make good sense to me and have been applied to great effect.