Astellas Pharma: your chance to comment

If pharmaceutical patent law is the focal point of your interest, take heed! Case C-661/13 Astellas Pharma Inc, a reference for a preliminary ruling to the Court of Justice of the European Union (CJEU) from the Oberlandesgericht Düsseldorf, Germany, came into the IPKat's line of vision in mid-January thanks to katfriend Paul England (see earlier Katpost here). It's asking some deep Bolar questions about the circumstances in which exemptions in respect of experimental use of patented products may extend to the supplier of those products to a third party. To remind readers, the court has referred the following questions for a preliminary ruling:

1. Is Article 10(6) of Directive 2001/83 [of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use] to be interpreted as meaning that the exclusion from patent protection also applies to acts of provision by which a third party for purely commercial reasons offers or supplies to a manufacturer of generic medicinal products a patent-protected active substance which that generic pharmaceutical undertaking has planned to use for conducting studies or trials for a marketing authorisation under medicinal product law as provided for in Article 10(6)?

2. If the first question is to be answered in the affirmative:

(a) Does the third party's enjoyment of the exemption depend on the manufacturer of generic medicinal products who is supplied by him actually using the provided active substance for exempted studies or trials under Article 10(6) of Directive 2001/83? Does the exclusion from patent protection apply in such a case even where the third party has no knowledge of the intentions of his customer to use the active substance for purposes covered by the exemption and has also not satisfied himself in this regard?

Or, in order for the third party to enjoy the exemption, does it matter only that at the time of his act of provision he can legitimately assume on the basis of all the circumstances (for example, the focus of the undertaking supplied, the small quantity of the active substance provided, the imminent expiry of the patent protection for the active substance in question, experiences as to the customer's reliability) that the generic pharmaceutical undertaking supplied will use the active substance provided exclusively for exempted trials or studies in the context of a marketing authorisation?

(b) Must the third party, in connection with performance of his act of provision, take measures of his own to ensure that the active substance is actually used by his customer only for exempted trials or studies and do the measures to be taken by him differ according to whether the patent-protected active substance is only offered or also supplied?

As usual, the UK Intellectual Property Office (IPO) is seeking your comments, which will enable it to decide whether and, if so, how, it will make representations to the CJEU. Given the massive importance of the pharma industry in the UK, it is inconceivable that the British government will sit on the sidelines and do nothing, so for once you may be certain of having a chance to influence its thinking.  To comment, email policy@ipo.gov.uk by 11 February 2014.  Don't worry if you can't get all your comments in by that date. As the IPO says:

"We understand how difficult it is to provide detailed comments in the time available. The IPO has tight time limits in which to consider and provide advice to ministers on ECJ cases. In order to help us provide the right advice, we just need a short email by the deadline stating whether you think the UK should intervene and some general points about how you think we should answer the questions.

You are welcome to follow this email up with more detailed comments after the deadline, which can be taken into consideration if we have chosen to submit observations or if we decide to attend a hearing".