Astellas v Polpharma: can a third party sell the patented active ingredient to a generic company for its trials?

What was decided

Astellas held European patent 0 801 067 for solifenacin succinate, the active ingredient of its overactive-bladder medicine Vesicare. Polpharma, a Polish manufacturer, made the substance and sold 30.5 kg of it, for about EUR 127,000, to a German generics company that said it would use it for the studies and trials needed for a generic authorisation. Polpharma also advertised in Scrip, in Generics Bulletin and on its own website that it could supply solifenacin. Astellas sued in Poland and in Germany. Polpharma’s defence in both countries was the Bolar exemption: the substance was going into exempt work, so supplying it could not infringe.

Poland. The case went through the Gdańsk courts to the Supreme Court, which on 23 October 2013 rejected the defence. The exemption, in Poland’s Industrial Property Law, protects the person who conducts the studies and trials; a third party that makes and sells the patented substance for money is doing something else, a commercial act of the kind the patent exists to control, and the buyer’s purpose does not change its character. The advertisements were held to be offers of the patented product, themselves an infringement. The court refused Polpharma’s request to put the question to the Court of Justice.

Germany. The Düsseldorf Regional Court had reached a similar result on 26 July 2012: a supplier is liable for contributory infringement unless it has the same interest in the trials as the generic company, in effect as a co-sponsor. On appeal the Düsseldorf Higher Regional Court took a wider view. The German provision, it reasoned, does not necessarily exclude a supplier, provided the supplier applies reasonable precautions to ensure that what it delivers is used only for exempt purposes while the patent runs. Because the point turned on the meaning of Article 10(6) of the Directive, the court referred it to the Court of Justice on 5 December 2013, asking whether a purely commercial supply of a patented active ingredient to a generic company intending exempt use is covered, and if so whether the supplier’s protection depends on what the buyer actually does, on what the supplier could reasonably assume from the customer, the quantity and the timing, or on precautions the supplier must take.

The reference was lodged as C-661/13 on 13 December 2013. Before the Court could hear it, Astellas and Polpharma settled and the claim was withdrawn, and the President of the Court removed the case from the register on 7 May 2014. The two national readings, Poland’s and Düsseldorf’s, remain on the books, unreconciled.

Timeline

Date	Event
2010	Polpharma supplies solifenacin to a German generics company; Astellas sues in Poland and Germany
26 July 2012	Düsseldorf Regional Court: supplier covered only as co-sponsor of the trials
23 October 2013	Supreme Court of Poland: commercial supply and advertising are outside the exemption; no reference to Luxembourg
5 December 2013	Düsseldorf Higher Regional Court refers the question to the Court of Justice
13 December 2013	Reference lodged as C-661/13
7 May 2014	Case removed from the register after settlement
28 September 2026	Council adopts the pharmaceutical Directive whose Bolar article names active-ingredient makers expressly

What it means if you are…

A generics or biosimilar planner. Your own studies are covered. Your supplier’s position is not settled, and in Poland it is settled against the supplier. The Düsseldorf court’s test is the practical one to work to: contracts that confine the substance to exempt use, quantities that match the trial programme, and timing consistent with a launch after expiry. Where the supplier is nervous, the alternatives are to make the substance in-house, to buy from a country where the patent has already expired, or to buy from a supplier outside Europe.

An active-ingredient manufacturer. A commercial sale of a patented substance into Europe is your risk, not your customer’s, until the new Directive applies. Advertising that you can make a substance still under patent was itself held to infringe in Poland. The pharmaceutical package’s Bolar article will cover you from around the end of 2028 where your supply serves exempt purposes exclusively; until then, document the purpose and the precautions.

A parallel trader, wholesaler or buyer. Nothing here touches finished product moving in the market; the case is about the supply chain behind a generic before it exists. Its relevance is to timing: a generic whose active ingredient must come from outside Europe, or wait for the supplier’s own patent position to clear, may be later to market than its authorisation date suggests.

Status and what to watch

Still the state of the law. The Court of Justice has never ruled on Article 10(6), so Poland’s narrow reading and Düsseldorf’s wider one both stand, and other member states’ courts have not been asked. The new pharmaceutical Directive names active-ingredient manufacturers, contract manufacturers and research organisations as covered where their work serves the exempt purposes exclusively, which answers the question for supplies made after it applies but leaves open the mixed case, a supplier selling for trials and for commercial launch elsewhere. Until then a supplier’s protection is the Düsseldorf test at best. This note is a summary for commercial readers and is not legal advice.