Lawrence Cullen & Laura Starrs, Patent Examining Group Heads, IPO

Managing a patent portfolio requires, among many skills, the ability to anticipate the future. This is especially true in the fields of bioscience and pharma where, when drafting the patent, one must consider that the compound – biological or chemical – that looks the most promising now may not be the one that gets approved for public use.

In this article, we will consider the types of issues that a small start-up company may consider regarding when and where to file (or not file) a patent and the role of a national patent office such as UK Intellectual Property Office.

A patent allows its owner to prevent others from being able to work on the same compounds or processes that you are interested in. However, in the field of bioscience and pharma the patent application comes at a very early stage of the development of the product, many years before its efficacy and safety have been proven. Consequently, difficult decisions must be taken as to how broadly to draft the patent: too broad and the risk is the application is not capable of being granted, too narrow and you miss the key invention which needs protection. In the biological field, patents may relate to the properties that the protected compound would have, such as the presence of certain binding regions in an antibody capable of binding a specific antigen. In the small molecule area, it is common to use a general Markush structure to protect a family of compounds that all share the same structural properties. In both cases, the patent will have to include enough information to support what is claimed to have been invented. Working out how much evidence to include is a matter for the applicant working with their patent adviser.

For a small start-up company or university spin-out in the bioscience area, a granted patent will often be an early sign of progress and one of the company’s important assets. Sometimes such companies already have a significant investment from a larger company with the experience to manage clinical trials, other times the patent will be part of the process that the small spin-out/start-up uses to attract such inward investment. No matter what the situation, the value of the patent or patents in question is a key consideration and something that can be hard to quantify. Patent value can change over time, increasing in value as the results from clinical trials progress successfully through the various stages. It can also depend on the size of the market in which protection is sought.

The patent landscape in Europe offers choice of systems to an applicant that provide patent protection at national level via the various national Intellectual Property legislation, such as the UK Patents Act 1977; at regional level via the European Patent Convention (EPC); and at international level via the Patent Cooperation Treaty (PCT). The choice of which system to use is driven by size of market, cost of obtaining and maintaining patent protection in that market and value of the invention to the applicant.

The regional and international routes offer a more streamlined way of obtaining protection in many different countries more cheaply than applying to national IPOs in each country separately. Important considerations are to decide how many countries to seek protection in and how long to maintain that protection. For example, a new cancer treatment has a potential market all over the world while a vaccine to protect against a disease only found in specific climates may require protection in fewer countries. Companies in the biopharma and pharma fields are more likely to keep their patent in force for the full 20-year term. This reflects the length of time needed to obtain regulatory approval before the patent owner can start to exploit their invention and recover the significant costs of R&D. By contrast in faster changing technology areas such as telecommunications, an applicant may only pay renewal fees to keep a patent in force for 5-10 years.

Costs can quickly escalate as an application progresses and those costs come at an early stage of product development before a company has any certainty that their new product has commercial value. This presents an interesting question for the spin-out/start up – do they apply for a patent via the PCT route that can provide protection in up to 130 countries and pay the associated fees in terms of processing fees and fees for professional advice to prepare and draft the patent? There is no guarantee that they will attract a licence. Companies can, however, make use of the steps in the system which allow for decisions to be taken in stages and so help manage costs.

The first part of the process before the UK office, like many other national and regional offices, is to carry out a search to identify the most relevant published literature which describes aspects of the invention in the patent application. Making sure your invention is new and not obvious is the first step in obtaining a granted patent.

An applicant can make an initial application for a search to a national office such as the UK IPO and ask for the patent to be searched. This search will take usually about 6 months and depending on the documents found the applicant can then decide if they want to take the application further. If they only require protection in one country then the option to proceed to the next stage of examination and (hopefully) grant with the same national office exists. At present in the UK the process from application to grant takes on average 5 years in the bioscience/pharma field, but given that the search at the IPO is nearly always the first step in the process, the IPO is working hard to ensure the results of this initial search are available in 6-7 months to ensure sufficient time to allow the applicant to decide what next – stop the application or proceed to the next stage!

However, those interested in protection in a wider market, can use the national application as a priority application for another patent application concerning the same invention, adjusted to take account of the results of the earlier search, if necessary. That can be at a regional level – such as at the European Patent Office in Munich under the EPC, or at an international level via the PCT which is coordinated by the Geneva, Switzerland based World Intellectual Property Organisation (WIPO). This allows access to a greater potential market and with a clearer idea of the potential for a granted patent. This is a more attractive investment possibility.

The patent application made by the PCT route will enter what is known as the “national phase” or the “regional phase” after search at a time that can be selected by the applicant, that is 30 – 40 months after application date. This will require another input of funds for fees and handling. It is at this stage where a detailed examination of the application is made. This examination takes into account what was found in the search and determines whether the legal requirements for the grant of a valid patent have been met. The choice of regional phase or national phase will also depend on where and how much coverage and possibly also how quickly the applicant wants a granted patent.

Working out how much all this activity will cost, when the cost will be incurred and how much has to be laid out before there is the possibility of receiving any investment will depend on the specific circumstances of each company and application. Deciding how many countries you want to have patent protection in is key. Is UK or Europe enough or do you need wider coverage including, for example, the Americas, Asia? In general, it is cheaper to use the regional and international routes as the number of countries in which protection is sought increases. For example, if protection is wanted in more than seven countries then the PCT route may be cheaper than applying to seven national offices individually. At the European level, that cross over point is around 5 countries.

Official fees – such as those for handling at the UK Office, EPO or under the PCT – are only a part of the cost. Information about these and guidance on when they are incurred is available from most national patent offices1. While the use of professional advice can greatly improve the chances of gaining granted patents that provide a useful protection, such advice and knowledge comes at a cost. Some bioscience and pharma companies employ in-house patent experts to secure their continued progress and the development of their valuable IP assets.

Thus, the applicant can obtain a patent valid in the UK via a number of routes that allow them to take into account the potential size and value of the market and what will be most likely to attract investment. While requiring a significant investment up front, the system does provide ways to stagger costs while gaining more information on the potential usefulness of the product(s) protected by the patent. After all, a patent will only be as good as the product it protects.

www.gov.uk/government/publications/protecting-your-uk-intellectual-property-abroad 

1 For Information on national, regional and international Patent Fees at the UK IPO see:

About the authors
Dr Lawrence Cullen is a Deputy Director and Dr Laura Starrs is an Examining Group Head at the UK Intellectual Property Office (IPO).  Dr Cullen’s team searches, examines and grants patents in biotechnology and biopharma fields, while Dr Starrs’ team covers organic chemistry and pharma.  Both contribute to policy and practice development in these technical fields.

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