Nanotechnology: small could be big
pharmafile | October 27, 2004 | Feature | |Â Â Â
Nanotechnology is starting to fuel the imagination and commercial aspirations of pharma companies, but sound strategies for intellectual property protection are needed if they are to make the most of their leap into the future of medicine.
Nanotechnology has attracted a growing band of supporters and interested parties in recent years – stock markets, particularly in the US, are reacting very positively to all things ano which is reminiscent of the hype surrounding the dot-com era.
Meanwhile, governments in Europe, the US and Asia recently announced measures to increase investment in the advancement of nanotechnology.
Maximise the commercial potential
Over the past five years, there has been a sharp increase in patent filings in relation to 'nano' inventions, indicating a general 'land grab' to ensure the commercial possibilities of nanotechnology are maximised.
But patent filings don't tell the whole story of the boom in the technology. With many parties wanting to get onto the bandwagon before it leaves, the term 'nano' seems to cover many developments drawn from technologies which, although still very small, would not have the scientific description of nano dimensions – one billionth of a millimetre.
Those involved in drug development have been lured, in some way, by the hype and, more importantly, real opportunities within the nanotechnology field.
With nanotechnology evolving rapidly, observers will be watching closely to see which pharma companies exploit nanotechnology and carve the greatest market share and who will be left to pursue a strategy in more niche markets – the 20 year exclusivity provided by a patent means implementing the right intellectual property strategy will be crucial in determining the winners and the losers in the race.
Patent protection at heart of drug development
Patent protection lies at the heart of drug development – very few pharma companies need a lecture highlighting the importance of intellectual property rights to the success of drug development or invention. Focusing on ways to extend a patent's life often known as 'evergreening' is therefore a high priority.
Nanoparticles promise improvements in drug delivery, thus providing many opportunities to extend the life of the drug – enhanced formulations allowing for slower, sustained delivery of Zantac, the anti-ulcer drug, for example.
Nanotechnology has attracted pharma companies to the possibility of augmenting and extending the value of an original invention and maintaining some of the revenue from the sales of a particular drug.
Patent offices around the world that have granted patents for inventions based on the use of nanoparticles have been increasing at a remarkable year on year growth rate , but there are some inherent issues surrounding such a fast moving technology.
Unlike more established entities, nanotechnology has not yet found a uniform language and this anomaly is a double-edged sword for the inventors and developers. On the one hand, there is the possibility that certain patent applications may be approved that a more sophisticated eye would reject.
But organisations looking to build a sustained patent portfolio should be wary of viewing this as a benefit. Given the exponential increase in the number of 'nano' patents filed over the past five years, many patent owners may find themselves, sometime in the future, embroiled in infringement disputes because a competitor holds a similar claim that has used a different form of language.
Pharma companies implementing a 'prevention is better than a cure' strategy are least likely to encounter difficulties. It is vital to commit wholeheartedly to a comprehensive process of searching for existing disclosures and patents to ensure that no one has got there first. This process of due diligence is even more important with nanotechnology developments as many could find their development has already been patented, something not immediately obvious to the untrained eye if the claims have been filed using a different phraseology.
It is perfectly plausible that a patent will be contested at any stage in the filing process or after the patent is granted. Consequently, companies and their patent agents should not rely solely on the patent office to take responsibility for ensuring patents aren't filed for the same or similar drug technologies. Only through their own thorough searches can an inventor ensure that their patent application really does warrant an nventive step
Lucrative intellectual property rights
Looking into the future, the race to develop new technology will hold some incredibly lucrative intellectual property rights. This is because breakthrough platform drug delivery technologies could afford very broad claims for the patent owner. For instance, developing an alternative to injecting insulin would be a potentially lucrative patent for a pharma company to own.
This is not a new issue – there have been trials of oral insulin for many years, with varying degrees of success. But the fact that nothing has been marketed after years of experimentation suggests that conventional tableting is not the way to go. Nanotechnology could well provide the path to this particular Holy Grail. For instance, insulin with coated or encapsulated nanoparticles for inhalation directly into the lungs would allow the insulin to get into the bloodstream quickly.
Holding the patent for a platform technology such as this does present some very exciting possibilities for pharma companies to gain first mover advantage in nanotechnology. A patent with broad claims means that any further developments in that field will be likely to infringe upon the original patent, and therefore any secondary development will owe licence fees to the original owner.
Building market domination
Furthermore, it is then more straightforward for the owner of the patent on the breakthrough technology to build a wall of patents – a technique that is much more effective than simply planting a single stake in the ground ensuring the possibility of greater market domination.
The company that wins the race in developing a technology with broad claims can afford to sit back and just wait for the fees to come rolling in. With broad claims, it is more than likely that the patent holder may need to assert their rights by instigating an infringement action. A common defence to such an allegation is to assert that the patent should not have been granted in the first place, and should be revoked. This means that the owner should be fully prepared for the prospect of some litigation and/or bargaining.
In nanotechnology, Affymetrix is a case in point. The US company owns many DNA microarray patents, such as US 5,744,305. covering its company's GeneChip system which incorporates disposable probe arrays to screen DNA and help tailor treatment according to specific genetic makeup.
Over the past five years, Affymetrix has been embroiled in litigation and bargaining in various jurisdictions to maintain its first mover advantage in this cutting edge technology and to augment its advantage through acquisition of patent licences.
Litigation shouldn always be seen as entirely negative: it is very difficult to draw a line under the disputes, but this level of litigation/licensing has probably cemented Affymetrix's estimated 90% market share dominance.
What can and can't be patented?
However, with the more cutting edge technologies, confusion often arises over what can and can't be patented, and individual patent authorities throughout the world are evolving different approaches to the patentability of nanotechnology.
For example, discord arises over the method of treatment or diagnosis inventions, which rely upon nanoparticles. The US often grants patents that include claims relating to methods of treatment or diagnosis, yet in Europe or many other countries these would not be granted as method of treatment or diagnosis of the human or animal body are not patentable.
Until recently, one could obtain method of diagnosis claims in Europe if the results were of an intermediate nature (eg, an MRI scan, which provides a physician with information, but needs interpreting to obtain a diagnosis). There are a number of patent applications relating to method of diagnosis employing nanoparticles, which could fit into this category.
Nevertheless, the European Patent Office recently refused claims that would have been considered to be of this intermediate type. Consequently, any patent applications containing claims for the use of nanoparticles in a diagnostic area are currently on hold until the European Patent Office makes a decision on this issue. Those involved in intellectual property rights in the pharma industry are very much 'watching this space' to monitor developments.
Innovators can afford to hesitate in the race to move into this rapidly growing field. At the moment the opportunities are there and the funding is more than available, but the prospect for winning a sizeable market share will shrink over time. The rules governing intellectual property protection are constantly evolving, so it pays to be aware of the options available at the outset of development.
In the long run, the protection provided by registering intellectual property rights allows firms to fully exploit the fruits of their labour.
