Perhaps more than any other industry, the pharma sector has historically relied on long-term, high-risk R&D projects. It also faces the unique challenges of innovating within a strictly regulated framework, often under intense public scrutiny.

Medicines in some form have existed since the beginnings of human civilisation but it was not until the 19th century that the pharmaceutical industry, as we know it today, emerged from the amalgamation of modern biology, synthetic chemistry and free enterprise.

The basic goal - to find new and better medicines to treat patients - has of course remained unchanged. However, the challenges associated with meeting that goal are always evolving, as are the research tools available to do so. Demand for medicines globally is rising, and is likely to continue to rise, due to factors such as aging populations, obesity-related illnesses and increasing life expectancy and incomes in emerging economies.

The landscape is also changing. Targeted or precision medicines, matched to the patients most likely to benefit from them, are becoming the gold standard. This trend has been greatly assisted by the mapping of the human genome, as well as advances in diagnostic methods. Other game-changing strategies, such as the exploitation of targeted protein degradation (e.g. with proteolysis targeting chimeric drugs, or PROTACs) are also emerging to enable the development of more potent and selective treatments for cancer and other intractable diseases.

In the current pandemic, governments, research organisations and pharmaceutical companies are taking action to streamline the research and development (R&D) and clinical trials processes for treatments aimed at COVID-19. This has led some to question whether this rapidity will translate, post-COVID-19, to the wider industry, with emergence of a new paradigm for fast-track R&D and approval.

The concept that ‘prevention is better than cure’, a fundamental principle of modern healthcare, is also now a focus for pharmaceutical companies, who are increasingly seeking drugs which prevent disease, as well as treating it (the famous example being Truvada, for pre-exposure prophylaxis (PrEP) for HIV). The rise of  so-called ‘superbugs’ (antibiotic-resistant microbes) is also a growing concern, as the rate at which resistance to existing drugs is emerging appears to be speeding up.

Pharmaceutical companies spend on average 17% of revenues on research and development (R&D), one of the highest R&D spends of any industry. However, it is important to remember that the sector does not comprise only ‘Big Pharma’. A huge amount of pharmaceutical innovation originates in the laboratories of universities and research organisations.

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Special Report

Pharma and Life Sciences Patent Extensions in Europe

Having compiled and analysed real-world data, this Special Report sets out to provide valuable insights into the following questions that may face decision-makers handling SPC protection for a new drug:

  1. What do the headline SPC statistics tell us?
  2. How to approach the decision of which patent to extend?
  3. What forms of medical technology are being protected by SPCs?
  4. What SPC periods are typically obtained?
  5. How do SPC periods vary with technology type?
  6. How do SPC periods overlay with regulatory protection?
  7. What commercial value can arise from SPCs?
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Mewburn Ellis

FORWARD MAGAZINE

Mewburn Ellis Forward is a biannual publication that celebrates the best of innovation and exploration. Through its pages we hope to inform and entertain, but also to encourage discussion about the most compelling developments taking place in the scientific and entrepreneurial world. Along the way, we’ll engage with the IP challenges that international organisations face every day.

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