Linkage of marketing and legal theories for secondary pharma patents: seminar report

Azithromycin: a case in point

Yesterday's IPKat seminar on "Linkages between legal and marketing theories regarding secondary patents for pharmaceuticals" was a very special event for all those who were privileged to attend it.  The substance of the seminar was provided by Dr Galit Gonen (who heads up the European patent litigation team at Teva Pharmaceuticals), the presentation being based on her doctoral thesis. The research exercise was designed to achieve various objectives: these included an examination of corporate behaviour regarding 'innovative' patents for entirely new products and attempts to prolong their period of profitable exploitation through the subsequent patenting of variation-on-the-same-theme inventions involving essentially the same product. Secondary patenting -- and the manner in which the USPTO and the courts applied the law to them -- was considered also from a jurisprudential angle (natural law versus positive law) and in terms of the benefits of applying a universalist one-size-fits-all approach to secondary patents rather than a more fact-specific approach.

A capacity audience of nearly 100 (thanks to a batch of late registrations from local practitioners and an unusually low level of no-shows, despite the torrential rain) heard Galit give an account not only of her findings but, in some detail, of her methodology in constructing a model for the analysis of her target group of specific types of secondary pharmaceutical patent applications and their subsequent fate, using data drawn from the United States during the years 2001-2006.  This model, Galit averred during question time, should be capable of application to other markets and databases once any necessary adjustments had been made [readers will instantly recognise at this point that the IPKat is thinking: "to what extent does research based on US data and models reflect reality in other jurisdictions?"].   Once Galit had explained her thesis, she then had to defend it, as questions and comments from the expert panellists (Mr Justice Arnold, from the Patents Court, England and Wales) and Professor Jo Gibson (Queen Mary and the Intellectual Property Institute) gave Galit the chance to clarify, to explain and to demonstrate both her mastery of the topic and her palpable enthusiasm for it.

If this Kat were allowed just one take-away gem from this treasure-trove of fascinating fact, it would be the astonishing (to him, at any rate) revelation that two-thirds of the applications for secondary patents during the sample period were made not by the innovator company which patented the pharma product in the first place but by a generic competitor.  Well, that's one cherished illusion gone!

A blog post cannot really do justice to a presentation of this quality, but readers can read the entire PhD thesis for themselves since Galit has kindly made it available here (it's 'read only').  Galit's PowerPoint presentation is available here.