Out-Law Analysis 3 min. read

IP and regulatory strategies can help drugs reach the market faster

Life science researcher grafting bacteria

New technology is shaping the drug discovery process like never before, so it has become more important than ever for life sciences companies to have a plan for protecting and commercialising their intellectual property (IP), and engaging with regulators.

Without a strategy, life sciences companies risk missing out on the investment needed to take medical research forward through the final stages of development, or rivals getting their products to market first.

Good practices on IP and regulator engagement are central to the wider commercial pathway and route to market life sciences companies will want to pursue. This is particularly true at a time when new technologies are influencing how companies in the sector are operating.

Life sciences companies can therefore obtain a potentially lucrative commercial advantage if they understand how their IP can be used to attract investment and how open dialogue can help them overcome the regulatory hurdles that exist to obtaining marketing authorisation for new products.

The importance of IP

The drug discovery process has always been a lengthy and resource-intensive one. The market is competitive, as companies seek to be the first to uncover the next breakthrough medicine or treatment.

For biotechnology companies, the challenge is to develop their medical research to the point where investors or larger pharmaceutical companies are willing to take a risk on funding further development of the work – the so-called 'valley of death' – the gap between the investment needed and the capital small biotech companies have at their disposal – serving as a barrier to them doing so themselves. To attract such investment, biotechs must demonstrate that the work they have done is capable of being developed further into a medicine of safe and practical use, but also that the product offers the promise of a reasonable return on investment.

Major pharmaceutical companies are among those who will look for opportunities to take forward the research undertaken by biotechs where the business case is right, utilising the skills, facilities and financial resources at their disposal to do so.

At the heart of collaborations between biotechs, big pharma and other third party investors are out-licensing agreements which will set out the terms on which the benefits of IP will be shared. Biotechs that own IP rights in the research and have taken steps to preserve know-how will be attractive propositions for such investors and also be in a stronger position to negotiate the terms of those agreements. This is why having an IP strategy at the outset of new projects is important.

Supportive regulators

In the UK and Europe more broadly, it is clear that regulators appreciate the need for speed in the drug discovery process. It is in everyone's interests – doctors, patients and businesses – for new medicines to reach patients as quickly as possible, so long as they are safe and efficacious.

We have seen regulators adapt their processes and procedures in recognition of this. In a recent example, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France fast-tracked procedures to speed up the time it takes for pharmaceutical companies to get authorisation for clinical trials of new medicines.

On regulatory matters, businesses need to be thinking, in particular, about flexible clinical trials design. They should pursue an open dialogue with regulators so as to satisfy any concerns those regulators have and cut the time it takes to gain authorisation for the testing.

Why a strategy is needed now

Good practices on IP and regulator engagement are central to the wider commercial pathway and route to market life sciences companies will want to pursue. This is particularly true at a time when new technologies are influencing how companies in the sector are operating.

For example, experimental gene therapies are helping scientists to better understand how the biology of the human body can be altered to address disease, while artificial intelligence (AI) is touching on a wide-range of activities including the drug discovery process, where it is helping companies identify new molecules that can be used in the composition of medicines. AI is also been explored to accelerate the clinical trials process, by informing the recruitment process and enabling improved patient monitoring during testing.

It can be easy to be drawn into a potential future world where innovations in medicine are almost exclusively rooted in machine learning. In this respect there remains a great deal of potential for technology to be used as a force for good to address the health needs of society.

There remain major issues to be addressed too. AI, for example, raises ethical challenges and demands further clarity from policy makers and regulators.

AI also raises a big question of how investment in innovation in medicine should be incentivised.

Written in an analogue world, the UK's Patents Act 1977 does not envisage inventions created by machines. The legislation requires that inventions be attributed to 'a person' to be eligible for patent protection.

Pharmaceutical companies may be some way away still from patenting AI-led inventions but this did not stop the UK's Intellectual Property Office (IPO) from updating its formalities manual for patent examiners earlier this year to state that an 'AI inventor' would not meet the 'person' requirement and that such applications for patent protection are to be "taken to be withdrawn".

As machine learning becomes more sophisticated, so the IPO's policy is likely to come in for scrutiny. Calls to modernise legislation may follow.

These longer term issues should not distract life sciences companies from reviewing how they approach IP and regulatory challenges currently.

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