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Related news & insights - Amanda Easey
EMA seeks feedback on draft guidance for when biologics qualify as new active substances
Posted: 14/04/2023
On 10 November 2022, the European Medicines Agency (EMA) published a draft of its reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances. The paper provides an insight to the EMA’s likely approach in assessing evidence supporting an application for new active......>>
The ‘net zero’ supplier roadmap: new requirements for NHS contractors
Posted: 04/04/2023
There is an increasing focus on environmental, social and governance (ESG) issues within the pharmaceutical industry. In particular, the environmental impact of businesses’ supply chain, manufacturing methods, transport, distribution and waste management processes are being brought into the spotlight. As part of the UK government’s Net Zero......>>
Opting out of the jurisdiction of the UPC: the sunrise period has begun
Posted: 04/04/2023
The Unified Patent Court (UPC) is set to open its doors on 1 June 2023, when the Agreement on the Unified Patent Court (UPCA) enters fully into force. The UPC will have jurisdiction to decide on the infringement and validity of both ‘classic’ non-unitary European patents and new unitary patents. Decisions of the UPC relating to unitary patents......>>
The Moderna v Pfizer-Biontech COVID-19 vaccine dispute: a brief explanation
Posted: 30/11/2022
Moderna’s patent infringement claim against Pfizer and BioNTech about its COVID-19 vaccine technology has been widely reported. After filing lawsuits in August 2022 in the US and Germany, Moderna has now launched related proceedings in the UK Patents Court. In response, Pfizer and BioNTech have issued separate UK claims......>>
Patents to biological medicines in combination: is two really better than one?
Posted: 23/09/2022
New medicines are usually protected by a patent covering the active molecule. These basic or “primary” patents usually provide robust protection for the relevant product, provided that the compound is genuinely new and inventive......>>
The UK moves into the fast lane for biosimilar regulatory approvals
Posted: 29/07/2022
Biological medicines (‘biologics’) contain active substances from a biological source such as living cells, tissues, or organisms such as bacteria or yeast. Most contain active molecules which are proteins which may vary in size and structural complexity, from relatively simple proteins like insulin to relatively large and complex monoclonal antibodies......>>
Unitary Supplementary Protection Certificates (SPCS) may become a reality
Posted: 27/04/2022
The European Commission has recently closed a call for evidence on proposals to introduce a single procedure for granting supplementary protection certificates (SPCs) across the European Union (EU), in order to prepare an impact assessment and any necessary legislation......>>
Specialist IP litigation trio joins Penningtons Manches Cooper
Posted: 12/04/2022
Top 50 law firm Penningtons Manches Cooper has recruited a team of three senior lawyers to spearhead the growth of its intellectual property (IP) litigation practice. Based in the firm’s London office, Dr Duncan Curley, Dr Amanda Easey and Cheng Tan’s extensive expertise spans all contentious IP matters, including patent disputes, trademark disputes, patent analysis, freedom to operate, and regulatory issues......>>
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