Patent ruling could lead to ideas race

A recent landmark ruling by the House of Lords could have far-reaching implications for pharmaceutical and chemical companies, making it easier for them to seek patent protection in the UK for product developments and innovations.

After a legal battle lasting more than three years, the ruling upheld the British patent for an item of medical equipment called a Taxus® stent - a stent coated with an anti-cancer drug called Taxol® - despite the fact that full data showing that the stent worked in the manner described was not provided.

The stent itself was originally patented by Angiotech Pharmaceuticals in 1997 and a US competitor was challenging the company's recent move to file for patent protection for the coated stent on the grounds it was ‘obvious' and not novel. The House of Lords disagreed and ultimately concluded that as long as the patent discloses enough information to make the invention ‘plausible', for example, the invention can be backed up by logical argument and scientific reason, then it can be considered valid based on preliminary research data alone.

Pharmaceutical and chemical industry research is notoriously costly. In particular, the costs involved in conducting extensive human trials of new drugs or medical devices can be very high indeed, with hundreds, if not thousands of inventions failing to reach market each year because they are unlikely to obtain the necessary regulatory approval.  Furthermore, due to high levels of competition, there is substantial pressure to file patent applications as early as possible to establish a position within the market.

Amid such cost and time pressures, the House of Lords ruling will be especially welcomed by pharmaceutical and chemical companies in the UK as, in some instances, it means that they can file for patent protection at an earlier stage. In the Taxus® stent case, a patent was being sought for a stent commonly used to prop open narrowed coronary arteries, when coated with the successful anti-cancer drug Taxol®. Taxol® prevents subsequent re-narrowing of the arteries following insertion of the stent. 

The patent was filed without any data showing that the coated stent prevented subsequent blockage of the arteries.  Instead, the patent contained data showing that Taxol® was particularly good at preventing the growth of new blood vessels and stated that compounds that prevented the growth of new blood vessels would be good at preventing subsequent blockage of arteries.

It has long been the case that European patent law requires that the patent contains information that makes it at least plausible that an invention works as described.  However, concerns have been raised in the industry about how much data is required to meet this plausibility requirement.  For example, for a new pharmaceutical compound, do you need to include data from clinical trials on humans?  The House of Lords' ruling indicates that the UK courts are following the European requirement for a patent to contain sufficient data to render the invention plausible and further indicates that the level of plausibility is relatively low.  Therefore it should be possible to obtain patent protection for an invention, based on preliminary research data only, as long as it is ‘plausible' that the invention will ultimately work.

What difference will this ruling make in practice? While it is unlikely to have a widespread impact, the ruling may encourage a number of companies to file patent applications at an early stage, based on preliminary data.  This is especially important in competitive industries where a number of companies are vying to achieve the same goal.  As it is all comes down to being the first past the post, the company that succeeds in filing a valid patent application at the earliest opportunity will obtain the rights to the invention in most countries around the world. Therefore, proactivity and speed of response is critical.

For companies seeking patent protection in Europe, changes to the European patent process, introduced earlier this year as a result of the ‘London Agreement', have helped to reduce the cost burden for companies.  The main change is reduced translation costs and according to the European patent office, the new process is up to 40% cheaper and allows companies to obtain protection in up to 14 participating European countries. While such changes will make a difference, the pharmaceutical and chemical industries would undoubtedly benefit from a more unified European patent system, where fewer discrepancies exist in the way European patent law is implemented at a national level. However, such changes remain a long way off.

Companies in the pharmaceutical and chemical industries should take the opportunity to review their intellectual property and patent protection strategies to ensure that their current and planned activities take into account the House of Lords' ruling and the recent changes to the European patent process.  In particular, it may be possible to obtain patent protection for inventions at an earlier stage than would previously have been considered possible.

Adrian Tombling patent attorney

20 July 2008