"Patent searching can be time-consuming, laborious, and ultimately fruitless if a product still has many years of protection"

Dr Maxwell Davies (pictured) and Pardeep Sagoo are the authors of Agrow's New Generics 2007 Photo: Salina Christmas

Agrochemical manufacturers who have spent a fortune developing and marketing their active ingredients are not likely to publicise products that are about to come off patent. So how can the competitors and generic manufacturers find out about them? "Agrow's New Generics 2007 should take a lot of the pain out of such searches," says Dr Maxwell Davies, the editor of the report and of Agrow Intelligence.

What are the main factors determining whether a post-patent ai becomes generic (i.e. produced by the generic industry)?

There are a number of complex factors that determine whether a product becomes a successful generic product, so it's difficult to sum up simply all of these influences. However, a product that has a large market across the globe is ripe for development, but this also means that the originating company will defend its product from generic competition more aggressively. Therefore, the business strategies of the originating company, as well as the potential market and ease of manufacture of a particular active ingredient, all have a significant influence.

What are the most interesting ais likely to become generic over the next five years?

The insecticide imidacloprid is one of Bayer CropScience's biggest products and it is already being developed globally as a generic product. The insecticide fipronil is also being developed globally, although it is still subject to a number of supplementary protection certificates in Europe.

The fungicide epoxiconazole is another active ingredient that is rapidly losing its protection around the world and I expect it to become an important generic product very soon. In the next couple of years, azoxystrobin will start to come off patent and will be developed by a number of companies.

On the herbicides, halosulfuron-methyl is applied to rice and maize in Japan and the US, respectively, and I expect it to be a valuable generic herbicide.

Will these new generic ais offer any major manufacturing challenges to generic companies?

In a sense, all new generic compounds offer manufacturing challenges: generic manufacturers are competing on cost with companies who have been producing the same products for many years. Some proprietary companies protect the most efficient synthesis routes to a product through process patents. These process patents may be taken out a number of years after the original product patent, so the originator can extend its hold over the active ingredient.

"Generic manufacturers are competing on cost with companies who have been producing the same products for many years"

One of the generic aisles at the BCPC 2007 event in Glasgow, Scotland. The organizer says the number of generic companies attending the event has increased over the years Photo: Salina Christmas

Therefore, generic manufacturing companies have the extra hurdle of refining their own synthesis routes and setting up their manufacturing plants. On top of these expenses, there are plenty of regulatory obstacles to negotiate.

However, formulation technology is an area in which some of the larger generic manufacturers can use their expertise to make improvements on the activity of the final product.

Do you think that generic ais are becoming an increasingly important part of the global pesticide market?

The increasing costs associated with developing a new active ingredient and the more stringent conditions required for a product to gain regulatory approval has meant that there are fewer new active ingredients being developed by the major R&D-based companies. Post-patent and generic products will therefore make up a greater part of the arsenal that farmers can use to combat pests. Generic manufacturers have an important role to play in ensuring that there is a wide range of well-priced pesticides for the farmer to choose from.

"Agrow's New Generics should take a lot of the pain out of such searches"

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What was the rationale behind the decision to publish Agrow’s New Generics 2007?

As generic products play a more important role in the crop protection sector, there is a greater need for companies to get hold of accurate information about when a product comes off patent. When we at Agrow spoke to a number of representatives from the industry we recognised this need and responded accordingly by writing Agrow's New Generics.

Patent searching can be time-consuming, laborious, and ultimately fruitless if a product still has many years of protection. Agrow's New Generics should take a lot of the pain out of such searches.

What criteria did you use to choose the generic ais?

We chose compounds that have been successful in a large number of global markets and on a large number of crops, especially cereals, rice, maize, and cotton. We're looking to put economic data in future editions so that readers can examine this information before they decide which products to develop.

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