For an industry as highly competitive and tightly regulated as pharma, invention – and its protection – is considered critical. Pharmaceutical patents can also be highly valuable, making a good patenting strategy all the more vital.
Some patent offices offer special benefits to the owners of a pharmaceutical patent, such as patent term extensions, supplementary protection certificates (SPCs) and paediatric extensions to SPCs.
These additional protections can be very valuable for patent owners by extending the period before generics companies enter the market for longer. They are only available, however, at the end of the original life of the granted patent. What options exist earlier on?
Patents offer a strong monopoly protection for the owner. Therefore, many patent offices require that a patent application undergo a stringent examination process before the patent is granted.
This process – which the applicant is usually actively involved in – typically lasts several years. Since patent rights cannot be asserted against an alleged infringer until grant of the patent, this means that there may be a long time between devising a new technology and attaining its full value.
In some cases, this slow procedure may be acceptable. For example, it may serve to spread out associated costs or extend the time available for making decisions driven by e.g. commercial considerations, pharmaceutical trials, or regulatory approval processes.
In other cases, there may be more value in increasing the speed of the examination process and thereby obtaining grant more quickly. For example, in cases involving a potential infringer, acceleration will mean that action may be taken against the potential infringer more quickly.
It can be difficult to control the speed of the patent examination process, especially if applicants want to increase it. Most patent acceleration processes are devised and implemented by individual patent offices, and local rules apply.
The 'Green Channel' is a patent acceleration program offered by the UK Intellectual Property Office (UK IPO). This program allows successful applicants the opportunity to accelerate the (whole of) the examination of their patent applications “having an environmental benefit” upon written, reasoned request, for free.
Our recent report found that using the Green Channel was a reliable way for applicants to speed up the examination timeline at the UK IPO, with more pronounced effects expected if used early in the examination process and in busy technology areas.
The Green Channel was introduced around 14 years ago in 2009, and so is now well established. Overall uptake is increasing, which seems to correspond with the perceived current international interest in “green” technologies.
We can therefore infer that many sectors – including the pharmaceutical sector – are aspiring to improve their environmental credentials, from starting materials to waste and everything in between.
The scope of the “environmental benefit” requirement is interpreted broadly, and applicants will find there is great – perhaps even surprising – flexibility in the kinds of environmental benefits that are acceptable.
Some pharmaceutical companies will be innovating in areas that will inevitably be accepted onto the Green Channel.
Examples of this kind of 'traditional' environmentally beneficial innovation might include more environmentally friendly packaging for pharmaceuticals, and methods of manufacture of pharmaceuticals or the packaging that result in less waste.
Pharmaceutical applicants might be interested to learn that the UK IPO accepts inventions to more environmentally friendly formulations – several applications already accepted onto the Green Channel cite, for example, reduced need for antibiotics or other chemicals as providing the environmental benefit.
Although not specifically in the pharmaceutical sphere, the UK IPO has also allowed a Green Channel acceleration request for an application relating to a product with an increased lifespan, thereby reducing waste because the product would be changed less often.
Therefore, even applicants innovating in less traditionally 'green' technologies could be accepted onto the Green Channel scheme.
Pharma companies of all sizes, as well as pharma start-ups should consider making the Green Channel part of their patenting toolkit.
Especially for smaller companies and start-ups, granted patents can help to attract investment. Additionally, for pharmaceutical companies putting laboratory consumables and similar products on the market, for example, the benefits of the UK’s “Patent Box” scheme could be obtained earlier allowing larger tax savings.
Those interested in using the scheme should be aware that the UK IPO maintains an online register of published applications accepted onto the Green Channel. This means that competitors can readily identify and monitor accelerated applications – a good thing for a competitor, but perhaps not so beneficial for an applicant!
As of 04 October 2023, the UK IPO’s publicly available register showed that of the 3527 published applications accepted onto the Green Channel, just 11 had a patent classification indicative of the pharmaceutical sector (A61K excluding A61K 8/*) – just over 0.3%.
The UK pharmaceutical industry is reported to generate £40.8bn in annual turnover, and 1% of the almost 70,000 UK IPO publications between 2012-2017 were in classified as pharmaceutical. There seems to be scope for innovators in the pharmaceutical sphere to make greater use of the Green Channel in the future.
While in general the UK IPO’s Green Channel is likely to be of primary interest to those first filing in the UK, it might also be used as a springboard for acceleration of other applications outside the UK.
For example, if a UK counterpart application, accepted onto the Green Channel, is granted quickly, then the granted UK case can be used e.g. under the global patent prosecution highway (PPH) program – to request acceleration of foreign members of the same patent family.
This could be particularly advantageously used in countries not offering another acceleration program, or those countries offering a scheme with more onerous acceleration requirements than the Green Channel.
Ultimately, deciding which applications to accelerate and which should stay on an unaccelerated path is not easy and should take account of all circumstances.
Elizabeth Dale is IP Director and Patent Attorney at Mewburn Ellis