Featured in PharmaTimes, Julie Carlisle and Robert Watson dig deep into the maelstrom of intellectual property in pharma.
In this article, we explore:
One key issue that has emerged recently in UK and European patent law is the concept of ‘plausibility’.
It can be particularly relevant to pharmaceutical patents, especially those for medical uses, where definitive proof of efficacy (i.e. clinical trial data) is typically not available when the earliest patent filings in a drug discovery programme are being considered.
Perhaps one of the most challenging recent discussions about IP was at the World Trade Organization (WTO), about waiving IP associated with COVID-19 vaccines and treatments. South Africa and India proposed a broad patent waiver in October 2020, considering that patents were an impediment to the manufacture and distribution of COVID-19 vaccines.
Their position was reportedly backed by over 100 states, including the USA, but was opposed by others including the European Union and the UK.
Unitary Patent Court and Unified Patent
The main IP topic on everyone’s mind is the imminent (and long-awaited) arrival of the Unified Patents Court (UPC) and the EU Unitary Patent (UP). The start date is 1 June 2023, with the ‘sunrise period’ having commenced on 1 March 2023. Make no mistake, the European patent landscape is about to change dramatically.
The pharmaceutical field often sees relatively broad EP validation strategies, especially for patents covering approved products or clinical candidates.
Read the full column in PharmaTimes.
See our other PharmaTimes columns.
About the authors
This article was co-authored by Julie Carlisle and Robert Watson.
Julie specialises in the drafting and prosecution of patent applications with a particular emphasis on both organic and pharmaceutical chemistry. She has extensive experience of advising on infringement and validity issues, in particular providing Freedom-to-Operate searches and opinions. She also represents clients in EPO opposition proceedings and provides general advice to intellectual property, including international portfolio management, IP strategy and IP litigation.
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