Finding Vredo (pat. pending): The Dutch Supreme Court Decision on 'Escitalopram' in Lundbeck v. Tiefenbacher et al.
Berichten Industriële Eigendom 2014/2 p. 41-45
5 Pages Posted: 11 Mar 2014 Last revised: 17 Jun 2014
Date Written: February 12, 2014
This article is about the pharma patent litigation sparked by Lundbeck's blockbuster drug for 'escitalopram', a well-known anti-depressant drug used for treating depression and generalized anxiety disorder. The litigation was triggered by the various efforts by generic pharmaceutical companies to invalidate Lundbeck's patent for 'escitalopram' on the grounds that it lacked inventive step as it was directly derived from its predecessor 'citalopram'. According to Lundbeck, this was merely a case of generic competitors trying to 'clear the way' into their lucrative market, free-riding on its R&D efforts. Conversely, Tiefenbacher c.s. alleged that this was a case of making 'new drugs from old', as 'escitalopram' was merely a purified clone, consisting of the separated (+) enantiomer of Lundbeck's existing non-separated (±) racemic compound citalopram.
The article focuses on the trials and tribulations before the Dutch Patent Court of Appeal and the Supreme Court, while also briefly contrasting and comparing this with the decisions in Germany and the United Kingdom. From a policy perspective, the article focuces on the legal debate surrounding pharmaceutical patents, balancing the need of the patentee for fair protection, amidst alleged concerns voiced by generic companies of 'ever-greening' (extending patent monopolies by making 'new' drugs from old) with all the drawbacks and expenditure on public health systems this entails.
Particular attention is given to novel substances which can be fully envisaged but not yet made. Under the doctrine, set out by the Technical Boards of Appeal, such envisaged substance can still be considered to be non-obvious and therefore patented if the claimed method for preparing such substance is the first to achieve this in an inventive manner. The Dutch Supreme Court follows this doctrine and therefore held Lundbeck's patent for 'escitalopram' to be valid.
The author criticizes the lack of explanation provided by the Supreme Court in reversing the decision of the Court of Appeal. By merely referring to foreign precedent, the Supreme Court violates its (own) duty to state (its own) reasons.
The article concludes by outlining the practical impact of the decision of the Supreme Court: inventors developing a (novel and) inventive process for obtaining a (novel) product which can be fully envisaged but not yet made, can obtain not only a process claim for inventing the process, but also monopolize the substance under a product claim.
Following independent peer-review, a slightly revised version of this article also appeared in the Journal of Intellectual Property Law and Practice 2014, available at SSRN here: http://ssrn.com/abstract=2451438
Keywords: patents, patent, pharma, pharmaceutical, substance, substance protection, inventive step, non-obviousness, claim, T-595/90, escitalopram, citalopram, Lundbeck, Tiefenbacher, European Patent Convention, EPC, Tsoutsanis
JEL Classification: K06, K10, K11, K13, K19, K29, K32, K39, K40, K41, K42, K49, H51, I10, I11, I19, L12, L43, L50, L65
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