View from the sharp end

Chris Every, ceo of Enhance Biotech, discusses how to protect intellectual property in the pharmaceutical industry

Patenting of ideas and ownership of intellectual property is absolutely critical in the pharmaceutical industry - arguably more so than in any other business.This is because the progression of new chemical entities (nces) to licensed products, through national and international regulatory pathways, takes literally years and depends on the de novo design of purification techniques, manufacturing processes, and design of clinical trials - all of which can demand millions of dollars in investment. The risks are immense.

At the same time, competitors will be working on closely related molecules and classes of compound, and are primed and ready to use the ideas that companies may believe are theirs - corporate survival depends on rigorous protection of each step in the process.

highly specialised

In healthcare, as elsewhere, the risk of not being adequately protected doesn't end with the company. In line with advancements in technology, the pharmaceutical industry of the future is set to become highly specialised with companies functioning at different stages of the product development process, e.g. initial screening, product development and end-marketing. Enhance is just one such example, with a bespoke focus on the development and trialling of products for marketing by end licensees.

It is therefore important to understand clearly the position of a company in the product development hierarchy, and the needs of its development partners. Should the company succeed in developing a product to high levels of safety and efficacy, the protection that is in place might be adequate for the needs but could leave an end-licensee unsure whether all the perceived risk is covered.

It is vital to be completely focused from the outset and ensure the company encompasses the needs of the end market - evidence of this will be high on the priority checklist for serious investors.

vulnerable areas

So, how do companies decide on what is rightfully theirs and how to protect it? As well as the obvious, such as product names, all chemical isolation processes and original manufacturing techniques need to be covered.

The type of protection available depends on the area a company feels is vulnerable. Three main areas covered by law are trademarks, patents and copyrights. Of particular importance to the pharma sector is the patenting of processes, equipment and products.

A patent for any product in development is essentially a form of Government authorisation giving the stakeholders involved, the right for a limited period to stop others from making, using or selling the invention without the permission. It becomes the property of the company and, like any other form of property or business asset, - can be bought, sold, rented or hired.

Additional complexity applies for international operators. Patents tend to be country specific, i.e. give the holder rights only to stop others from importing the patented products into country concerned. Development processes and clinical trials simultaneously taking place in a number of markets will often require multiple protection.

It is also important to consider the rights of consultants, clinical research organisations and development partners. The next generation pharmaceutical company, such as Enhance, is committed to showing investors faster returns by focusing on quicker ways of bringing products to market by carefully researching new indications, positive side effects and product switches.

With this in mind, it is often important to secure the targeted use of a product that may already be off patent and widely used for another condition - yet open to securing a further full patent life reformulated for the target condition.

Selection of the right patent strategy to secure this situation and make a commercially viable product is therefore vital to a company's success and should be highly influential in planning product development. This aspect of protection, in particular, demands experienced and proven expertise from patent advisors in this area.

industrial espionage

A wider consideration is security compromises - these should never be underestimated and a company should have internal systems to guard against them. Leaks always occur, no matter how watertight the systems in place. Emails can be intercepted, conventional post can go missing and industrial espionage is commonplace. They are facts of modern business life.

Many consultants work across various organisations and breaches of confidentiality can occur, no matter what safeguards are in place. In these situations, unless clearly defined from the start, the ownership of property might not be as easy to define as first thought. Staff on secondment to your laboratory from other institutions may well be under the legal jurisdiction of that organisation and not your own. As such, the original employer may protect the rights to any work they undertake.

Commercial success depends on new treatments making it through the development and regulatory channels intact and not ending up as casualties on the battlegrounds of the law courts.

Equally, legal protection must not be too restrictive.

The 'off patent' and 'generic' market can be a great way to move older treatments along profitably and make way for new - this option should always be within reach. The fact is, companies who protect their intellectual property show investors that they are in a unique position and worth backing. They know the same product development information is not available to competitors.

The protection of intellectual property rights in the pharmaceutical sector is highly complex and exists to protect the confidence of investors, the commercial success of biotechnology operators and profits of the big pharmaceutical companies keen to exploit the riches of the blockbuster market. It is a great case study for other industries.