Competition in life sciences

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Competition in life sciences

Latest Life Sciences News

MDCG updates guidance on IVD verification and vigilance reporting

MDCG updates guidance on IVD verification and vigilance reporting
FDA issues draft guidance on AI-enabled medical device software

FDA issues draft guidance on AI-enabled medical device software
UK medical devices regulatory reform—where are we now and what’s next for 2025?

UK medical devices regulatory reform—where are we now and what’s next for 2025?

The following Life Sciences news provides comprehensive and up to date legal information on UK medical devices regulatory reform—where are we now and what’s next for 2025?

UPC Court of Appeal remits Meril’s request to stay infringement proceedings pending the outcome of EPO opposition

UPC Court of Appeal remits Meril’s request to stay infringement proceedings pending the outcome of EPO opposition

The following EU Law news provides comprehensive and up to date legal information on UPC Court of Appeal remits Meril’s request to stay infringement proceedings pending the outcome of EPO opposition

Featured Life Sciences content

The regulation of medical devices in the UK

The regulation of medical devices in the UK

The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...

Regulation of e-cigarettes

Regulation of e-cigarettes

Regulation of e-cigarettes31 December 2020 marked the end of the Brexit implementation period following the UK’s decision to withdraw from the EU. At...

Clinical evaluation and performance evaluation of medical devices in the EU

Clinical evaluation and performance evaluation of medical devices in the EU

Clinical evaluation and performance evaluation of medical devices in the EUThis Practice Note describes key changes to the requisite clinical...

Unlicensed medicinal products and off-label use of medicinal products

Unlicensed medicinal products and off-label use of medicinal products

Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...

Practice notes

Second and subsequent medical use patent claims

Second and subsequent medical use patent claimsBackground to medical use claimsSecond (and subsequent) medical use patent claims are specific to the...
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Produced in partnership with Andrew Bowler of Bristows and Adrian Chew of Bristows
1st Mar
Practice notes

Post-market surveillance of medical devices in the EU

Post-market surveillance of medical devices in the EUPost-market surveillance is the monitoring by manufacturers of medical devices to ensure their...
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Produced in partnership with Alison Dennis of Taylor Wessing LLP
1st Mar
Practice notes

Intellectual property protection for medical devices

Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...
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Produced in partnership with Reuben E. Jacob of Maucher Jenkins and Dr Edward Rainsford of Maucher Jenkins
1st Mar
Practice notes

Medicines and Medical Devices Act 2021

Medicines and Medical Devices Act 2021This Practice Note provides an overview of the Medicines and Medical Devices Act 2021 (MMDA 2021) which, in...
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1st Mar
tag iconBrexit
Practice notes

Introduction to borderline products

Introduction to borderline productsThis Practice Note provides an introduction to the concept of borderline products, how the regulatory status of...
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2nd Mar
Precedents

Clinical Research Organisation (CRO) master services agreement

Clinical Research Organisation (CRO) master services agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
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1st Mar
Practice notes

Pharmacovigilance

PharmacovigilancePharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product...
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Produced in partnership with Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins
2nd Mar
News

The UK medical devices regime and the impact of the Northern Ireland Protocol

Life Sciences analysis: Peter Rudd-Clarke, partner, and Anna Lundy, associate director, at Osborne Clarke discuss how the medical device industry is...
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2nd Mar
Precedents

Medical devices due diligence questionnaire

Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
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2nd Mar
News

Life Sciences weekly highlights—11 August 2022

This week's edition of Life Sciences weekly highlights includes analysis of the English court’s jurisdiction to decide COVID-related business...
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2nd Mar
Practice notes

The regulation of advanced therapy medicinal products

The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
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Produced in partnership with Geneviève Michaux of King & Spalding
2nd Mar
Practice notes

The experimental use and Bolar-type exemptions to patent infringement

The experimental use and Bolar-type exemptions to patent infringementPatent systems are intended to foster innovation, not to impede it. For this...
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Produced in partnership with Selina Badiani of Bristows and Charlie French of Bristows LLP
1st Mar
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News

Life Sciences weekly highlights—18 August 2022

This week's edition of Life Sciences weekly highlights includes consideration of the arguments put forward against DeepMind, Google’s subsidiary, for...
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2nd Mar
Practice notes

Pharma and medical device regulation—Colombia—Q&A guide

Pharma and medical device regulation—Colombia—Q&A guideThis Practice Note contains a jurisdiction-specific Q&A guide to pharma and medical device...
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2nd Mar
Practice notes

Biotechnology patents

Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
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Produced in partnership with Nicole Jadeja of Pinsent Masons and Christopher Leung of Fieldfisher
1st Mar
Practice notes

The EU Clinical Trials Regulation

The EU Clinical Trials RegulationThis Practice Note looks at Regulation (EU) 536/2014, the EU Clinical Trials Regulation (CTR), which governs clinical...
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Produced in partnership with Eveline Van Keymeulen of Latham & Watkins
2nd Mar

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Micklefield clauses

Micklefield clausesWhat is a Micklefield clause?It is common for employee share plans to provide that, on termination of employment (or when an employee is given or receives notice of termination of employment), subsisting share awards will be forfeited and subsisting share options will lapse.It is

Late payment penalties—inheritance tax

Late payment penalties—inheritance taxWhile interest often accrues on overdue tax, the late payment of certain taxes may also attract a penalty. For information on the interest accruing on overdue tax, see Practice Notes: IHT—payment deadlines on death—Interest on IHT and Interest on late paid

Brussels I (recast)—domicile (Arts 4 and 63) [Archived]

Brussels I (recast)—domicile (Arts 4 and 63) [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.This Practice Note considers the general rule set out in Article 4 of Regulation (EU) 1215/2012, Brussels I (recast) when determining the relevance of a defendant’s domicile to

Where are misrepresentations made? Jurisdictional traps for the unwary (Bellmare Holdings Ltd v Wells)

Dispute Resolution analysis: The High Court has provided concise guidance as to how misrepresentation should be analysed when considering jurisdictional gateways. Under Article 5(3) of the Lugano Convention, in negligent misstatement cases, the place of the event giving rise to damage is normally