Narrower Patents for Biotech Inventions?

By Robert Games
The European Court of Justice (ECJ) has made a controversial decision to hand down judgement on a case which had requested a preliminary ruling on the biotechnology Directive's legal protection regarding genetic material.

The case, which has been of great political and commercial interest on an international scale, centres round the company Monsanto, holders of a patent which claims a DNA sequence coding for an enzyme that protects plants from glyphosate-containing herbicides (CP4-EPSPS).

With this enzyme, Monsanto have developed a soy plant, "Roundup Ready", which is resistant to Monsanto's own non-selective herbicide, Roundup, and is widely cultivated in Argentina.

A large cargo of the plant, which had been processed into soy meal, was seized on arrival at Amsterdam in 2005 and 2006 and on testing, revealed both the presence of the enzyme CP4-EPSPS, and the DNA sequence encoding it.

The issue at hand was that the patent protection only applied to the DNA sequence coding in a form in which it could be expressed into a plant, and not when it was present in harvested goods or as isolated DNA. On a general scale, Article 9 of the Directive 98/44 does not confer patent protection when the patented product no longer performs its function but has the potential to do so again if extracted and introduced into a living organism.

Despite the fact that Monsanto's patent was applied for and granted before the Directives adoption, absolute protection would only apply under the national legislation at the time of grant.

The ECJ concluded that patent protection only extends to a situation where DNA performs the function for which it is patented, within the product within which it is incorporated.

Despite the Directive's aim, which was to clarify existing patent laws and provide more protection, the Directive may have simply narrowed the protection afforded to biotechnological inventions.

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