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Intellectual Property Issues

Evergreening

What is evergreening? Is it allowed under the patent system?

Evergreening is a term that now includes the process by which patent protection for (typically) a pharmaceutical compound is extended by patenting improvements over the original active compound, such as new uses of the compound, methods for its production, crystalline forms, drug combinations, dosage regimes or re-formulations.

It is sometimes argued by generic manufacturers that even though these additional patents may be vulnerable to attack, challenging them can be prohibitively time-consuming and expensive, causing delays in the entry of their (cheaper) products to the market.  

The innovator pharmaceutical companies argue, however, that the generic manufacturers are free to use any methods, formulations and dosage regimes disclosed in the original patent once it expires.  They also emphasise that any additional patents must in any event meet the fundamental requirements for patentability, particularly with regard to novelty and non-obviousness, and therefore, provided these criteria are satisfied, the protection afforded to the additional inventions is warranted.  

The patent system has evolved to encourage innovators to seek patent protection on the proviso that the innovator discloses the best method of performing the invention so that others are free to fully use the invention when patent rights expire.  On that basis, there is a good argument that encouraging innovators to disclose their inventions is generally desirable, as it allows others to use that information to further develop the technology.

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Intellectual Property Issues: Evergreening

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