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 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".
Astellas Pharma: your chance to comment Astellas Pharma: your chance to comment Reviewed by Jeremy on Wednesday, February 05, 2014 Rating: 5


  1. 3rd pparty supply is not exempt and the CJEU should make this clear. Any lack of fairness should be fixed by a change in the law, if desired.

    Same principle applies under the UK experimental use exemption S.60(6).

    Good of the UKIPO to be wishing to make representations to the CJEU, but they could concentrate on having UK law amended instead.

  2. CJEU can rule that British law is incompatible with European law. Therefore representations in this case are a valid way of achieving a change in the law.

    And in answer to the question - third party supply should also be exempt, because there is no economic distinction between enterprise A having divisions Aa and Ab, Aa who makes the patented product and Ab who uses the product in accordance with the exemption, and enterprise A contracting with outsourcer B to procure the patented product from B, and the A subsequently using it in accordance with the exemption.

    However, the exemption should be grounded in A's actual actions, regardless of B's state of mind, and issues of liability should then be dealt with by appropriate warranties from A in the material transfer agreement governing the supply, or otherwise should be at B's risk if A uses the product otherwise than in accordance with the exemption.

    To do otherwise would disadvantage those who cannot and do not own production labs, who must thus rely on outsourcing to 3rd party labs to produce product for use in accordance with the exemption.

  3. To Anonymous at 11.28, if you want to go ahead and kill European API manufacturing, then go ahead. The natural consequence of the CJEU conclusing that 3rd party supply is not exempted will mean that all API manufacturing for pharmaceutical products will be gifted to the Indians and the Chinese.


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