Gilead’s remdesivir granted conditional Marketing Authorisation by the European Commission
Webinar: Medical device regulation (MDR) and cyber security
Further guidance from the Advocate General: ‘Pay-for-delay’ agreements
On 11 June 2020 the European Court of Justice (ECJ) delivered judgment on Ratiopharm v...
On 19 May 2020, the United Kingdom Government published draft negotiation documents (UK...
Meet the experts
Cell and gene therapies
26 May 2020 – a medical device milestone missed
UK government approach to COVID-19 therapeutics research
A lengthy back-and-forth about the patentability of plants, plant materials and animals...
It was reported on 13 May 2020 that Public Health England (PHE) has approved Roche’s...
DIY gene-editing CRISPR kits
Priorities for academic organisations in industry-academic partnerships – COVID-19 and beyond
Functional claims approved in principle as basis for SPCs
Our team’s recent blog on the impact of COVID-19 on competition law in the UK pharma...
The Medical Research Council (MRC) published new guidance on the anonymisation of data in the...
How is COVID-19 impacting competition law for the UK pharma sector?
MDR postponement staves off Swixit – for now
Government agrees to indemnify companies manufacturing ventilators for use by the NHS against IP infringement and product liability
As part of its efforts to ramp up production of medical ventilators by British manufacturing...
The topic for this article arose from an interesting discussion at a Roundtable Event that...
Arrow Declarations – How broad can they be?
UK and Europe back exemptions – more medical devices and PPE in the COVID-19 fight
Smoother sailing for sanitisers
Just in time for the European Commission to announce that it intends to postpone the date of...
Following a call from MedTech Europe to postpone the implementation of the Medical Device...
UK announce new ventilator requirements in the fight against COVID-19
Medical Devices – When is a change significant?
CBD – Could be done for?
Recently declared a ‘global threat’ by the World Health Organisation, the Coronavirus has...
The Judgment of the Court of Justice of the European Union in the Paroxetine...
First Brexit, now Swexit?
Competition between generics and originators – what’s the relevance of a patent?
Medtech Europe calls on EU institutions to speed up MDR implementation
EU Parliament confirms approval of a corrigendum to the EUMDR that has the effect of providing...
The Environment, Public Health and Food Safety Committee of the European Parliament approved a...
Medical devices: Updates galore!
Person Responsible for Regulatory Compliance – The confusion continues
Gene editing – A survey of public opinion
Professor Shanks’ 13 year skirmish with former employee Unilever has finally come to an end...
Following a presentation at Nesta UK, Viviane Boissy discusses Philip Ball's book "How to Grow...
Deciphering Rule 11: New guidance on the classification of software medical devices under the EU MDR
GSK’s passing off claims dismissed
Want to look like Kylie Jenner? Well, you probably can’t, says the ASA
As discussed in previous articles, the EU Medical Devices Regulation (MDR) comes into force...
Another Notified Body, UL UK, announced on Monday that not only it has not yet applied for EU...
Orphan designation: the General Court clarifies the meaning of significant benefit
Another one bites the dust…
Lloyd’s pulls out of the EU MDR/IVDR race
Alex Denoon and Zac Fargher discuss how a combination of the advent of the new EU Medical...
Alex Denoon and Zac Fargher discuss the TÜV SÜD's approval as the second Notified Body...
Medical Devices and No-Deal Brexit: where are we now?
NICE releases Evidence Standards Framework for Digital Health Tech
New guidance on the use of personal data in clinical trials
We reported on this blog about the General Court (GC)’s judgment in Servier on the day on...
The UK’s BioIndustry Association (BIA), together with Informa Pharma Intelligence, have...
Matt Hancock sets out the UK’s 20-year vision on tackling antimicrobial resistance
CRISPR gene editing technology and its many applications
A brief history of UCART-19
The General Court has today handed down its judgment in the long-running Servier patent...
The European Council has approved the text for a new Regulation that will overhaul the...
What is the best response to higher prices in the pharma sector?
CAR-T round-up: off-the-shelf challengers and avoiding the (cytokine) storm
“One Medicine” – A New Approach to Healthcare?
Whilst there has been much attention to data protection as a result of the EU General Data...
On 25 October 2018 the CJEU published their latest judgment[1] on the application of the SPC...
Fighting antimicrobial resistance – overall sales of antimicrobials for use in food-producing animals drops in the EU according to the EMA report
Request to re-open Glaxo ‘dual pricing’ case rejected by General Court: The end of the road for challenges to dual pricing?
CAR-T gets the green light in Europe
In case C-528/16 proceedings were brought between the French agricultural union and eight...
Last week, Concordia International released a management report in which it announced the...
Different types of CAR-T
The EMA’s clinical data publication policy: 1 year on
CJEU follows Advocate General’s Opinion to confirm the scope of the Specific Mechanism
The pace of development in the CAR-T world, both scientific and commercial, is showing no sign...
The Competition Appeal Tribunal (CAT) recently gave its judgment in Pfizer and Flynn’s...
Drafting leases for life sciences
Driving immunotherapy forward: More than CAR-Ts
Depression Delayed: CMA’s paroxetine pay-for-delay case heads to Luxembourg
Rachel Mumby and Jonathan Ross discuss highlights in the CAR-T world.
Of interest to our UK readers will be the announcement by Simon Stevens, the chief executive...
How the life sciences industry may be affected by Brexit
Side CAR-Ts
CAR-T rolls on
Sophie Lawrance and Edwin Bond give their summary on the different forms of value transfer...
CRISPR-Cas9 is heralded as a revolutionary gene editing technology that is regularly hitting...
AG Opinion: Organisms obtained by mutagenesis are GMOs exempt from the provisions of the GMO Directive
Specific Mechanism applies to extended SPC period opines AG Tanchev
Proposal to extend UK withholding tax on royalties – The start of a major shift in the UK’s approach to taxation?
Pat Treacy discusses 10 key points on parallel trade and pharma.
Matthew Warren and Alex Calver discuss how English courts construe written commercial...
Misleading information and competition law – Case C-179/16 CJEU Judgment of 23 January 2018 (Avastin/Lucentis –Italy)
Impact of Brexit on International Data Transfer Mechanisms
Patents Court rules on non-invasive prenatal diagnosis patents
Dominic Adair and Thomas Hendicott review Sandoz and Amgen, relating to the abbreviated...
On 7 December 2017 the Court of Justice of the European Union (“CJEU”) published its...
Biotech Review
UK Government announces a Life Sciences Sector Deal as part of its Industrial Strategy
NHS Pharmaceutical Procurement – Top 10 Tips
In November 2017, the French competition authority, the Autorité de la concurrence, announced...
In Case C-297/16 ‘CMVR’, the Romanian Court of Appeal referred two questions to the CJ...
Providing Misleading Information About Product Safety – a Restriction of Competition by Object?
Dosage Regimen Patent Held Invalid
Is there such a thing as Substitution or Interchangeability for Biosimilars?
‘Product hopping’, or ‘evergreening’, are expressions used (by competition authorities...
The discovery of CRISPR five years ago has revolutionised the way we can manipulate and edit...
Arrow Declarations post Actavis v Eli Lilly
Construction and novelty post Actavis v Eli Lilly
Unjustified Threats Act comes into force
The Brucellosis Vaccine Prize, an innovative $30 million prize competition, is designed to...
CAR-T technology Chimeric antigen receptor T cell (CAR-T) therapy is currently the hot topic...
Excessive Pricing – Pfizer/Flynn in light of the CJEU’s recent decision
Biosimilars: NHS approach to procurement
European Court says scientific proof of causation is not required under the EU Product Liability Directive
Collaboration with competitors can be an effective strategy for pharma companies seeking to...
Rebate systems are commonly used by pharmaceutical companies. A quantity-based rebate system,...
UK competition enforcement in the Pharma sector: A priority area for the CMA
EPO takes an ‘about turn’ on the patentability of products obtained by essentially biological processes
FDA approves first GM individualised cell therapy
In this important case from July of this year, the Supreme Court reintroduced a true form of...
The UK has a world leading life sciences sector which is underpinned by an array of...
Clustering and Innovation Districts
Patent licences – some key features
CRISPR-Cas9 – An update
On 21st August 2017 the European Commission published responses to the question regarding the...
Hilary Jones and Michaela Herron examine the use of mobile apps as software as a form of...
The ICO’s approach to consent under the GDPR and how it relates to digital health
Case Analysis: Elisabeth Schmitt v TUV Rheinland LGA Products GmbH
How the CJEU has interpreted “protected” in the SPC regulation
This article was first published in Competition Law Insight, March 2017 On 7 December 2016, in...
Bristows’ Patent Review of the Year reports each year on important decisions from both...
Clinical trial data transparency: the EU inches closer to legal certainty
Second medical use issues—where are we now and where should we be going?
NICE and NHS England Consultation on proposals for changes to the evaluation and funding of drugs
The future role of the UK in the Unified Patent Court (UPC), if any, has been brought to the...
Legal Framework Public procurement rules apply to the purchase of goods, works or services by...
First CMA competition decision on excessive pricing in the pharmaceutical sector
The Research and Development Block Exemption (RDBE)
Science in architecture – the opportunities and challenges
Introduction On 20 September 2016, the Council of the European Union accepted the European...
This article was first published in Life Sciences Intellectual Property Review, March 2016 In...
Arrow declarations – a second shot at the target
First Borderline Decision of the EU Commission: Is this a welcome approach for industry?
Actavis v ICOS – clearing the way between a rock and a hard place?
On 26 August 2016, the UKIPO issued its decision rejecting Abraxis Bioscience’s application...
This article was first published in Journal of the Law Society of Scotland, April 2016 Why the...
Lyrica continues – The Court of Appeal considers infringement and validity of Pfizer’s second medical use patent
Painfully objective decision of the Court of Appeal in Warner Lambert v Actavis tortuously applied by the Patents Court
A recent KPMG survey[1] of companies operating in the medical devices sector found that over...
In a decision dated 24 February 2016, the Court of Appeal (Lewison LJ giving the leading...
Life Sciences under the GDPR
Antimicrobial resistance – a global threat triggering a global response
Regeneron Pharmaceuticals Inc v (1) Kymab Ltd (2) Novo Nordisk A/S
As reported in the October edition of On The Pulse, on 10 September 2015 Arnold J found...
Ono is the proprietor of a patent for the use of anti-PD-1 antibodies which inhibit the...
Introduction to the regulatory legal framework applicable to Orphan medicinal products
Has the CJEU paved the way for parallel importation of veterinary medicines by livestock farmers (Case C-114/15)?
UK – Mylan v. Warner-Lambert / Abuse
This article was first published in EPLAW Patent Blog, December 2015 Actavis Group PTC EHF...
The European Economic and Social Committee (EESC) has published Opinion (2015/C 24207) which...
Salt limitation leads to sweet and sour Court of Appeal judgment
CJEU confirms the broad scope of Article 6 of the Transparency Directive
English High Court considers infringement of second medical use claims
Background and Legislation The EFTA Court has jurisdiction with regard to the EFTA States...
Mr. Justice Arnold’s 1 December 2014 judgment in Idenix Pharmaceuticals v Gilead Sciences is...
Smith & Nephew v ConvaTec No 2: a well rounded performance
Amended claims must not be obvious or arbitrary
Eli Lilly v HGS – High court tries to implement CJEU decision regarding SPCs
Summary: In the recent case of AGA v Occlutech, the Court has held that clinical trials are...
Actavis v Eli Lilly & Co. [2014] EWHC 1511 – Arnold J granted a Declaration of...
