Pharma reading suggestions, please!

A serious student of intellectual property has written to the IPKat with the following request:
"The controversy surrounding authorised generic/pseudo-generic drugs these days is very much in the air in the United states and Canada, especially in relation to the antitrust concerns that arise from them. However, there is very little literature on the subject, especially in UK/Europe.

I have tried to find some material in the European context but have not been able to do so, I was wondering if you could guide me towards some reading materials".
Although he has seen some newsy items on the subject, this member of the IPKat team can't think of any legal analysis that he could confidently recommend, so he wonders if his readers - especially those from the pharmaceutical sector - can make any suggestions. Adds Merpel, if there are any people out there who are currently writing on the topic and want to share their thoughts with others, perhaps through the medium of this weblog we can make some contacts. The IPKat's email address is and he's (almost) always happy to hear from readers.
Pharma reading suggestions, please! Pharma reading suggestions, please! Reviewed by Jeremy on Wednesday, September 05, 2007 Rating: 5


  1. I am not sure there is anything to be confidently recommended, if recommendation would imply a warranty of legal correctness. But things worth reading probably include the European Commission's Article 82 infringement decision (until appeal to the CFI) on AstraZeneca. All 214 pages (PDF) here.

    There are also a lot of papers around about drugs parallel trade and competition law in Europe, although they are almost always pushing one side or other of the argument rather than providing a fair legal analysis -- does the Kat's reader want links to those?

  2. Authorised generics are not such a useful strategy in Europe as there's no Hatch-Waxman legislation, and no generic exclusivity.
    So, the more usual rules apply. If you're the innovator, you look at the litigation cost and see what fraction it is of the net revenue for the drug in that jurisdiction - usually a small fraction. So you litigate to enforce your patent rights, and thus delay generic entry.
    If you're a generic, you can always avoid this by litigating ahead of time - as is the practice in the UK.

  3. One of my anonymous correspondents has written: "Jeremy - as I think we have discussed in the past, this is definitely the IP issue that dare not speak its name (at least in Europe)!

    I'm afraid I don't know of any reported cases or decent articles which deal with the issue, although they are definitely an issue on the market in Europe as well as the US/Canada. The Kalten litigation (Doncaster v Bolton) is marginally relevant, I suppose.

    However, the Commission is known to be investigating settlements in the pharmaceutical sector so I'd expect to see some reference to such deals in a Commission decision or two over the next few years".


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