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by Dr Duncan Curley, Head of Patents, Innovate Legal (London)
Patents – what is the problem?
Crop production globally relies on small molecule pesticides and other agrochemicals, many of which were first patented in the 1980s and the 1990s. A wave of these small molecule agrochemicals are now reaching the end of their patent life in high margin European markets. The problem is that many products are still subject to other forms of patent protection in Europe. In general, patents in Europe have a 20 year life, although even after the patent on the molecule itself has expired, it is sometimes possible for patent extensions (supplementary protection certificates) to be obtained, as well as further patents in relation to formulations, mixtures and other physical forms of the molecule. Another important and separate consideration is data exclusivity. This can make it difficult to determine when the relevant product is both available and ‘risk free’ (from a patent perspective) for importation into Europe.
What are secondary patents?
Some examples of the kinds of patents - often called ‘secondary patents’ – that can affect the date on which an agrochemical product can be marketed in Europe are as follows. The compound cyprodinil is an old molecule that is still marketed as the fungicide Unix® by Syngenta. This compound was patented in 1988. The patent on the compound expired in 2008, but there is a further patent that claims a particular crystalline form of cyprodinil called Form B. The patent on Form B does not expire in European markets until November 2014. Another example is fenvalerate, an old insecticide that was first invented and patented in 1973. Fenvalerate is actually composed of two related forms of the same chemical, that are generically called enantiomers. It is often the case that one enantiomer will be more biologically active than the other enantiomer. A later patent (now expired) filed in 1977 therefore claimed esfenvalerate, based on the purified, single enantiomer insecticide. Further active substances that have been patented in this way are fenoxaprop-P-ethyl and the herbicide metolachlor.
A tactic that is often used to prolong the lifecycle of an active substance is to patent a new formulation containing it. BASF have for example obtained a patent that is valid for a number of European markets that protects until 2019 a concentrated liquid composition that consists of an azole fungicide (most preferably metconazole) and one or more additional fungicidally active ingredients, including in particular chlorothalonil or kresoxim-methyl, existing as a suspension of fine particles in the composition, together with a solubilising agent and a dispersing agent.
A further patenting strategy that has been deployed heavily in the agrochemical sector is to patent mixtures of active substances, with a claim to synergistic activity. Examples of such patented mixtures include propamocarb and chlorothalonil, prothiconazole (Proline®) and various other fungicides in synergy (e.g. prothiconazole and fluoxastrobin, marketed as Fandango®), the herbicide halosulfuron-methyl with either atrazine or cyanazine and picoxystrobin and cyproconazole (marketed as Furlong®).
New uses
A final example is the patenting of a new use of an existing active substance. An example of this kind can be shown using the extremely valuable chemical patented by Syngenta called azoxystrobin. Azoxystrobin is the active substance in a $1 Billion per year fungicide product that is called in some countries Amistar®. Azoxystrobin is the subject of European patent number 0,382,375. This patent expired in several European countries in April 2011, but many further patents have been granted, which may prolong Syngenta’s exclusivity in relation to this molecule. For example, Syngenta has obtained a family of patents which claim a fungicidal composition that includes azoxystrobin for an application in an aquatic environment, including paddy fields, where it may be used to control fungal growth on rice plants.
How to avoid patent risks
These extended patent families can sometimes make it difficult for the growing number of Chinese companies involved in the manufacture of agrochemical products to enter the European market. However, these ‘patent thickets’ can sometimes be overcome by using the services of a good patent specialist, who should be able to advise companies on how to avoid any legal problems by suggesting a patent clearance strategy. So, what are the basic elements of a patent clearance strategy for European markets?
Implementing a patent clearance strategy
We recommend that the following six steps are undertaken in order to clear an agrochemical product of patent risks for importation into European markets.

1. Identify the active substance and check that data exclusivity does not apply.

2. Undertake basic checks on patent expiry dates and ascertain whether there are any supplementary protection certificates.

3. Commission a full search by a specialist patent searcher for any secondary patents.

4. Have a European patent specialist review the results of the patent search.

5. Finalise the patent clearance strategy and proceed with development.

6. Consider refreshing earlier patent search results and finalise product launch plans.

With an ever-increasing global demand for cheaper agrochemicals (caused by the global economics of crop production), there are some interesting possibilities for companies wishing to exploit the market for off-patent molecules. Copies of the patents referred to in this article are available by contacting the author, Dr Duncan Curley, by email: duncancurley@innovatelegal.co.uk.
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