Agrochemicals, generics and competition

Writing for Farmers' Weekly Interactive ("Do generic pesticides deliver the same control as big brand products?"), Philip Case discusses the strategies employed by major agrochemical companies in seeking to extend the protection rights of their products, as well as the fact that absence of patent protection does not automatically lead to competition in the marketplace. Citing Nigel Uttley (Enigma Marketing Research) he writes:

"... One popular way is mixing the active ingredient with other active ingredients to make new mixtures or formulations, which they then protect under new patents.

Therefore, although the active ingredient may no longer be protected against generic competition, it may still be protected under different patents.

For example, the active ingredient patent for cyprodinil expired in 2008 but a UK Supplementary Protection Certificate (SPC) for a mixture product with picoxystrobin extended patent protection until 2013.

The potential benefit of that practice is that it drives the R&D firm's innovation, whether the original active comes off-patent or not.

For example, BASF has produced two new fungicides based on epoxiconazole, Ennobe (epoxiconazole + prochloraz) and Brutus (epoxiconazole + metconazole) that HGCA trials suggest perform better than Opus alone.

... About 35 active ingredients are due to come off patent in the next five years that are used in the UK or EU, Dr Uttley says.

The list includes major crop protection products popular with UK growers, such as azoxystrobin, flufenacet, clothianidin, cyprodinil and spiroxamine.

"But it's not an easy task for a generic manufacturer to get a product to the market," he stresses.

"You have still got mixtures, formulation and process patents to consider before a 'freedom to operate' scenario can be achieved and in addition registration issues can create a barrier to generics entering the market."

He has identified about 120 active ingredients that have lost patent protection over the past 10 years but some, as a result of these barriers, still have no generic competition".