22nd August 2017

Wynne-Jones IP – Why an IP strategy is vital to the pharmaceutical industry

An effective intellectual property (IP) strategy is integral to preserving innovation and continuous progression in the pharmaceutical industry.

Nowhere is an efficient and targeted plan more productive than protecting the rights of medical researchers and firms involved in developing the latest industry-leading drugs, techniques, and medical equipment through clinical trials.

These transformative creations not only have an intellectual value, which could enhance the care of millions of people across the world, but also a commercial value, which is realised when the products are introduced across the pharmaceutical industry.

During development, over £500 million is typically invested by firms to bring their creations to fruition, figures show. After such significant investment, the aim is ultimately to make a profit when the product is marketed so as to return a dividend to investors and help fund future R&D work.

However, without adequate IP protection in place, researchers may find their work liable to infringement, and consequently fail to enjoy the associated commercial monopolies.

Jim Robertson, Patent Attorney specialising in the life sciences sector at Wynne Jones IP, has put together some key considerations when creating an effective IP strategy and how to develop it to ensure maximum protection and commercial reward.

1. What is an IP strategy?

An IP strategy helps a company to identify what intellectual property it possesses, why it should be protected, and where it can be protected. In the case of the pharmaceutical industry, intellectual property can protect a product (such as a drug, enzyme or antibody), a method (e.g. a synthetic pathway, an enhanced manufacturing process, or a diagnostic test method), equipment, a design, or a brand (e.g. a product name or logo).

And with endless potential for innovation in this field, a well-structured and effective strategy is vital in determining who owns the rights to a discovery, and how the information can be utilised for maximum success.

Overall, intellectual property is defined as protecting something which has arisen from creativity, hence anything which has come into being through this method can be protected. There are two primary forms of intellectual property; the first being a patent, which is used to protect an inventive creation (typically, a technical solution to a technical problem); while trademarks safeguard the identifiable characteristics of a brand including logos/symbols, names and associated words, and other features which distinguish a product in the eyes of the consumer.

In order to attain maximum success through an IP strategy, the plan should be aligned with the aims of the business. This allows inventors to pinpoint exactly which features they feel warrant protection, and potentially achieve the most lucrative results for the business.

Having an effective strategy in place also allows companies to focus on which aspects of the process are the most commercially lucrative, consequently helping to hone and further their market potential.

Identifying the niche from the start ensures it is sufficiently protected, to enable investment in further R&D and commercialisation without fear of infringement from competitors. In essence, an effective IP strategy explores all possibilities associated with the creation of intellectual property, to ensure the inventor is afforded maximum credit, resulting from their significant personal and financial investment.

1. Why do you need an IP strategy?

Intellectual property is often overlooked as an unnecessary expense when companies are exploring the idea of developing a product.

However, this is a common misconception, as a professionally crafted IP strategy is a wise investment in terms of succeeding in protecting your brand’s initial development, success, and longevity.

The expense of investing in creating a viable asset, carrying out research to enhance its marketability, and finally launching it into a competitive industry requires an ongoing financial commitment.

This significant initial investment in research and development is particularly evident across the pharmaceutical and medical industries, where millions of pounds can be spent on creating industry-leading techniques or treatments to revolutionise patient care. As such, a strong and targeted IP strategy is particularly essential to ensuring those in the medical profession receive the deserved rights to their intellectual property and also enjoy the eventual commercial monopoly.

Putting a strategy in place also highlights the monetary value of intellectual property as a commercial tool. In doing so, key decision makers are better informed about where to allocate vital funding for research and development to better achieve ongoing business goals.

Recognising the importance of IP and adequately protecting it can also have a beneficial impact on the value of the company which has established the drug, treatment, or equipment, which could encourage further investment by enhancing the reputation of the business. This is particularly positive for the medical industry which is reliant on attracting external funding and grants to support the continuation of extensive research.

Having a thoroughly researched IP strategy demonstrates to potential investors that the intellectual property is worth investing in.

Understanding the activities of other companies and organisations in the technical sector can also be critical in understanding where risk and opportunity exists. This can be done by undertaking “patent landscaping” – searching patent publications within the relevant technical sector to understand what other people are doing.

1. How to develop your IP strategy

Once the initial focus is determined, it is then essential to develop the strategy further to afford the invention the freedom to grow and evolve. This is particularly relevant within the pharmaceutical and medical sector, with new research being conducted daily, and increasing competition within the sector, resulting in the need for ongoing flexibility.

One of the first roles to undertake when developing an IP strategy is to conduct an audit of the company’s existing intellectual property, including any utility patents, trademarks, copyrights or design patents. The extent to which they are currently protected should also be outlined to help identify any vulnerabilities in developing the strategy. Weaknesses in the plan should consistently be considered while it is being developed to help minimise the risk of infringement.

Developing a product or drug at great expense and then discovering it has breached an existing patent could result in the abandonment of an invention without realising its commercial potential; finding out that the brand you have committed to selling under breaches an existing registered trademark could lead to significant unnecessary costs.

Having an effective plan in place from the beginning helps to negate the likelihood of infringement of a previous discovery or product, and reduces the risk of facing a dispute further into the process. It can also help to prevent the invention from being targeted by potential competitors keen to profit from it, without incurring the costs of the initial financial investment.

As part of the initial plan, an intellectual property expert will conduct thorough research, and (as appropriate) a freedom to operate search, across the industry to help prevent this eventuality and reduce the associated risks. In the medical industry, a strategy can also help to sharpen the focus in what can often be a multi-faceted approach.

For example, the administration of a particular drug could be revolutionised through the use of a newly discovered technique, a new dosage regime, or a new piece of equipment, therefore it is vital that the rights to this are covered in an IP strategy. If it has significantly added value and profitability, then it should be protected through the strategy.

Lines can often become blurred, however, as drug development travels through different channels, with external collaborators including chemists, researchers, scientists, and developers all potentially involved.

As a result, the rights to the intellectual property must be clearly defined in the strategy and in commercial agreements with third party researchers, suppliers and collaborators, in order to avoid consequent conflict at a later stage. The strategy should also clearly address the issue of confidentiality in working alongside outside parties.

In order to protect the exclusivity and marketability of the product, the strategy should include details including – where and how the confidential information can be used; and who owns the rights to any subsequent discoveries.

When compiling an IP strategy, Prior Art should also be considered to ensure the creation has space to evolve while protecting the inventor’s initial investment and market exclusivity. “Prior Art” is anything relevant to an invention which is already in the public domain.

This can be anything from a published historic invention to discussions surrounding a use of technology that is very similar to a previous invention. By understanding the relevant prior art, the patent application can be crafted to provide the best possible protection for the new invention whilst stepping around protection provided by prior art patents.

Wynne-Jones IP is a UK firm of intellectual property specialists, with offices in Cardiff, Cheltenham and Telford. Trading for over fifty years, the firm advises businesses and inventors in a wide range of sectors worldwide on all aspects of patents, trademarks, design rights and copyright. View their profile here.