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Gasp - Mylan ordered to provide sample inhaler

David Knight
01/04/2019

Locations

United Kingdom

It is generally well known that the saisie-contrefaçon procedures in France and Belgium provide an easy route by which patentees can obtain samples of products thought to be infringing before commencing formal proceedings and the information thereby obtained can usually be used in proceedings in other jurisdictions.

It is generally well-known that the saisie-contrefaçon procedures in France and Belgium provide an easy route by which patentees can obtain samples of products thought to be infringing before commencing formal legal proceedings.  The information obtained can usually then be used in proceedings in other jurisdictions.

Similar, albeit more restrictive, procedures are available in the English courts, as illustrated by the recent decision in Boehringer Ingelheim Pharma GmbH & Co. KG v Generics (UK) Ltd T/A Mylan and another [2019] EWHC 584 (Ch).

In this case, Boehringer, the patentee, wished to have samples of Mylan's generic tiotropiuym bromide product for the treatment of chronic obstructive pulmonary disease and asthma.   Through correspondence, Boehringer requested that Mylan provide samples so that Boehringer could test whether there was indeed infringement, and when that failed, Boehringer applied to the court.  Before the application was heard, Mylan partly acquiesced by offering to provide some samples of capsules containing the product to Boehringer.  For reasons which were not explained to the judge hearing the application and which remain unclear, Mylan refused to supply to Boehringer the inhaler used in conjunction with the capsules to deliver the active ingredient to the patient.

Boehringer contended that the nature of the product was that any one of the acts of removing the capsule from its blister pack, piercing the capsule in the inhaler and the delivery to the patient (as well as previous acts between manufacture and such use) could have a bearing on infringement.  This was because the patent claim required a monohydrate (i.e. one molecule of water for each molecule of substance), whereas Mylan claimed that their product was anhydrous (i.e. contains no water).  Conceivably, so Boehringer argued, the manner in which the drug was delivered to the patient using the inhaler could change the water content from an (alleged) non-infringing variant to an infringing one.  Therefore, in order to carry out representative experiments, it was necessary for Boehringer to replicate the drug's delivery for which they needed to have a sample of the inhaler.  Such experiments could then have the effect of either avoiding proceedings altogether, if Boehringer's fears as to infringement were not justified or, alternatively, if Boehringer wished to proceed, then this procedure would enable the parties to focus on the correct issues in a timely manner.  For this reason the judge ordered Mylan also to provide a sample inhaler.

Boehringer also applied for permission to use the samples and the results of such experiments for the purpose of commencing proceedings in other jurisdictions.   The default setting in English legal proceedings is that documents etc. produced in disclosure should not be used for such collateral purposes.  Boehringer argued that if not so constrained they, and Mylan, would be spared the cost and inconvenience of taking similar steps in other jurisdictions.  The judge, however, concluded that "… at this stage any such application is premature.   At the moment Boehringer Ingelheim does not know whether it wishes to use any results in any foreign proceedings and does not know where it would wish to do so and what the jurisdictional advantage that it would obtain as a result of such use would be."   He did not, however, rule out the possibility that Boehringer might make such an application in future.

Comment

The case demonstrates that the English Courts will assist patentees in obtaining evidence of infringement before proceedings are issued.  This is done with the objective of either avoiding proceedings if it transpires there is no infringement, or enabling any subsequent proceedings to be more streamlined if the patentee concludes to the contrary.  It is not, however, quite the open door for a patentee that the saisie-contrefaçon procedures provide in France and Belgium.

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