GlaxoSmithKline’s US Seroxat patent appeal lost

GlaxoSmithKline has lost its appeal against the generic manufacture of Seroxat in the US, where it is known as Paxil.

Britain’s largest pharmaceutical company and Apotex have been involved in a long-running dispute about the right to produce a generic version of Seroxat, a blockbuster-selling antidepressant, in the US.

Several years ago, Apotex, Canada’s largest pharmaceutical company, challenged what was then SmithKline Beecham over its use of patents to cover different uses of Seroxat, which Apotex saw as an attempt to stifle competition since the patents were not covering a new product, but one that had been in use for several years.

According to Bloomberg, GlaxoSmithKline’s appeal against a previous ruling in Apotex’s favour stated: “This kind of uncertainty inherently reduces incentives for research and disclosure and for product development in all sectors of the economy.”

Apotex, however, believed that Glaxo’s point of view was “antithetical to the most basic principles of patent law”.

In its 2005 annual report, GlaxoSmithKline said that total Seroxat sales fell by 42 per cent to 615 million pounds, due to new generic competition. Its original US patent runs out this year, although it has patented the drug for other applications. The company also blamed production problems for the controlled-release version of the drug, which caused the FDA to seize shipments after it was found that the pills split too easily.

Seroxat was first released in 1992 and has since become one of the world’s largest-selling antidepressants.

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