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A recent judgment from the Court of Appeal (Warner-Lambert Company, LLC v Actavis Group PTC and others  EWCA Civ 556) has shed some further light on how the England and Wales Courts interpret so-called ‘Swiss-type’ pharmaceutical manufacturing method claims.
Swiss-type claims take the general form:
“The use of [compound X] in the manufacture of a medicament for the treatment of [indication Y]”
In the latest judgment, Warner-Lambert has a European Patent EP0934061 which claims:
“Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for [treating pain]”
Warner-Lambert asserted that this claim was infringed by a generic Actavis product of the same compound (pregabalin).
Actavis had applied for a marketing authorisation, now granted, for sale of pregabalin with a ‘skinny’ label limited to the treatment of epilepsy and general anxiety disorders.
In a first judgment earlier this year, Justice Arnold deemed that there was potentially a case for direct infringement of Warner-Lambert’s claim by the sale of the Actavis product but he denied interim relief to Warner Lambert, holding that a Swiss-type claim required subjective intent on the part of a infringer that the particular component would be used for the treatment described in the claim.
In the latest judgment handed down by the Court of Appeal (led by Lord Justice Floyd), the Appeal judges put forward a different test for the infringement of Swiss-type patent claims. Lord Justice Floyd deemed that Justice Arnold’s ‘subjective intent’ test amounted to requiring that the Patentee must prove that the generic manufacturer had a “wish or desire” to sell the medicine for the patented indication. In contrast, Lord Justice Floyd concluded that instead the test for infringement of Swiss-type patent claims should determine whether the producer “knows or can reasonably foresee” that the generic product would ultimately be intentionally used for the treatment of the patented indication.
The new test proposed by Lord Justice Floyd is arguably much wider than that proposed by Justice Arnold, and would capture any generic manufacturer that could ‘reasonably foresee’ that a party downstream of the manufacturing process, such as an importer, labeller, etc., could market or use the product in the manner claimed by a Swiss-type claim.
The Court of Appeal will hand down its judgment on whether Actavis has infringed the Warner-Lambert patent later this month, and we will keep you updated with a further news bulletin as soon as the judgment is handed down.
If you need more information on Swiss-type patent claims or are considering obtaining patent protection for the same, please contact us and one of our patent attorneys will be able to discuss this with you.