Journal Article

<i>Saint Gobain</i>—patron of pharmaceutical patentees?

Paul England

in Journal of Intellectual Property Law & Practice

Volume 2, issue 8, pages 532-539
Published in print August 2007 | ISSN: 1747-1532
Published online July 2007 | e-ISSN: 1747-1540 | DOI: http://dx.doi.org/10.1093/jiplp/jpm099
Saint Gobain—patron of pharmaceutical patentees?

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In recent years there has been much complaint from originating pharmaceutical companies that the test of obviousness applied in the UK, as evidenced by decisions of the Patent Court on pharmaceutical related patents, is set unfairly low. This is of particular impact where ‘formulation’ type patents are concerned. That is, typically, those patents that claim an existing active ingredient mixed, formulated, or combined with other known components or in a different way. Pharmaceutical companies complain that the vulnerability of such patents against invalidity proceedings in the UK fails to protect the considerable investment made in the development of these formulations against generic competition.

This article looks at whether the reasons for this concern can be traced to particular sub-tests that have been used by the courts to try to answer the statutory test for obviousness. In particular, the sub-tests of ‘lying in the road’ and ‘obvious to try’ are examined and the question of whether there has been an imbalance between these two sub-tests is explored. Further, it is argued that the decisions in the recent cases of Saint-Gobain and Angiotech suggest that there has been a shift in how the Court of Appeal assesses obviousness. This is away from the ‘obvious to try with a reasonable expectation of success’ standard to one of ‘obvious to try if success is self-evident’.

If the Court of Appeal follows the line taken in these two cases then pharmaceutical patents of the formulations kind should a face better prospect of surviving invalidity challenges based on obviousness in future.

Keywords: Every patent system that makes a degree of inventive step, a criterion for the grant of a patent is faced with two inevitable and critical problems: how to formulate a test for the presence or absence of inventiveness and how to apply that test on the facts of individual cases?; A successful resolution of these problems is the fulcrum upon which the patent system turns: a low and undemanding threshold of obviousness creates trivial and arguably unmeritorious patents, while a high and demanding test fails to reward much intellectual effort that goes into the development of a new product or process.; This article reviews some of the recent case law from the UK on this issue, with special reference to pharmaceutical formulation patents.

Journal Article.  5464 words. 

Subjects: Arbitration ; Intellectual Property Law

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