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UK High Court orders pre-action delivery up of samples for infringement testing and considers use in other jurisdictions

In Boehringer Ingelheim v Generics,* the English High Court ordered the rarely-used remedy of pre-action inspection of property, for the purpose of allowing experiments needed to assess patent infringement. The case provides a useful reminder of the powers of the Court in this area, as well as providing a reference as to how the Court might exercise its discretion in similar cases in future.

The hearing arose because, as is not uncommon in pharmaceutical patent cases, the patentee (Boehringer Ingelheim Pharma GmbH & Co KG (“BI”) ) was unable to assess infringement properly without access to the would-be Defendant’s product. Accordingly, aware that Mylan intended to launch, BI requested samples of Mylan’s generic tiotropium bromide product and inhaler device, to enable BI to assess potential infringement of BI’s patent (relating to crystalline tiotropium bromide monohydrate).

Having initially resisted this, upon BI issuing its application Mylan agreed to provide a limited number of samples of its packaged product capsules. In so far as it went, the judge commended this agreed approach as sensible, noting that such pre-action conduct could avoid proceedings altogether, or at least enable the parties to focus on the correct issues.

The key issues remaining to be decided at the hearing were then: (1) whether the samples should be of the product as supplied to patients, which comprised both the capsules and the inhaler with which they would be used; and (2) whether the samples/experimental results could be used in other jurisdictions (BI having submitted that the law in this regard was not settled and that it should be allowed to do so).

As to the first issue, BI relied upon evidence including an expert report, concerning possible changes to the physical state of the drug substance as a result of the use of the inhaler, in order to justify the disclosure of the inhaler as well as the capsules. In contrast, Mylan’s position was that BI had not provided sufficient evidence to justify the Court exercising its discretion to order disclosure of the inhaler. The judge disagreed, however, finding that, although the evidence relied upon by BI was at a high level of generality, it was not appropriate to engage in a detailed analysis of the merits of BI’s case. Furthermore, the judge noted that Mylan had not provided any reason as to why the inhaler should not be provided. It was therefore appropriate to make an order for the supply of packs as they would be supplied and used by patients, which included the inhaler.

The second issue was considered in light of the policy considerations applicable to disclosure of documents. The Court held that, although there was no express provision in the relevant legislation or Civil Procedure Rules placing a restriction on collateral use of such samples or experimental results, the element of compulsion on the part of the supplying party means that there would be an implied obligation on the receiving party not to make collateral use of the samples or results. However, the judge (Mr Justice Henry Carr) went on to state: “That does not mean that there is no jurisdiction to allow use of the results of experiments for infringement proceedings under [other] jurisdictions, however,… there needs to be special circumstances to justify such an order”.

The Court did not rule on whether such special circumstances existed in the present case, nor did it consider what such circumstances could be. The door has therefore been left open for BI to make such an application after it has completed its experiments once it knows whether it wishes to use the results in foreign proceedings and, if so, in which jurisdictions.

*Boehringer Ingelheim Pharma GmbH & Co. KG v Generics (UK) Ltd. t/a Mylan & Anor [2019] EWHC 584 (Ch)