Even if your patent is close to expiry, it is worth being vigilant against infringers, as even a short time advantage can be valuable when a market first opens up to competition.

My patent is about to expire. Is there any point in being vigilant about infringement?

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The twilight of a pharmaceutical patent can be a time of considerable activity. Firms that manufacture generic products will be seeking marketing authorisations: these will enable them to move into the patentee’s market as soon as the patent expires. Simultaneously, the patentee itself may be looking for an authorisation and patent to cover an improvement to the product, in the hope that the improved product will be capable of maintaining the market lead position. Competitors may also be looking to introduce an improvement as soon as the base patent has expired.

Patent expiry may be seen as the starting pistol. The imperative of being first to enter the newly open market may tempt competitors to ‘jump the gun’ – starting the race to commercialisation while the patent remains in force.

Is it worth pursuing infringers when a patent is about to expire?

The answer is often ‘yes’. The imperative to protect, and the effect of successful protection, is illustrated by the effect on AstraZeneca’s share price when it successfully enforced its Prilosec patent in the US. One week after AstraZeneca’s victory against three competitors, Ł5.3bn was added to the company’s value.

With the huge investment in patented products, coupled with the dramatic drop in prices of products once generics enter the market, even short periods of exclusivity are worth fighting for. This is particularly so, given that pharmaceutical companies, for example, tend to have a limited number of new products in the pipeline as potential replacements.

How can exclusivity be protected?

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Achieving and maintaining exclusivity involves reliance on intellectual property rights and pharmaceutical regulation. Litigation may be best used tactically around either, or both, of these two elements.

Trade marks can be a really robust and effective weapon following patent expiry. Subject to earlier revocation due to invalidity issues, trade marks only expire upon failure to pay renewal fees. Accordingly, trade mark protection is capable of lasting for as long as a product remains economically marketable.

Will the courts grant remedies after patents have expired?

There are circumstances in which patent owners will be granted remedies even beyond the term of the patent.

In the case of Generics BV v. SmithKline & French Laboratories Limited [Case – 316/95], the patent in question was a manufacturing process for a pharmaceutical preparation. The product was marketed in the Netherlands under the brand name Tagamet. The patent expired in September 1993. Less than a month before, in August 1993, SmithKline French (SKF) applied to the Dutch court for an injunction to stop Generics from offering or supplying a generic version of Tagamet on the Netherlands market or transferring relevant product registrations to third parties. SKF asked for an injunction to stop Generics until November 1994; ie, 14 months after the patent had expired.

An injunction was granted. The infringement might have given an advantage to the infringer unless the extended injunction was granted. The infringer was not allowed to benefit from infringing activities carried out before the patent had expired.

This approach was followed in the UK, when an injunction was granted to prevent Hoover from commercialising a product that infringed Dyson’s patent. The injunction lasted until such time, post-patent-expiry, when it could have entered the market if there had been no pre-expiry infringement.

Infringers should not be allowed to establish a ‘springboard’ advantage, measurable against law-abiding competitors. The courts will protect those who are disadvantaged by such premature infringing activity.

 

Dr Ros Cook is a partner at Eversheds. Research by Alexa Sartouris (www.eversheds.com)

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