Regulatory and cultural challenges for IT and outsourcing services in the healthcare and life sciences sectors
Has the UK device revolution begun? The New MHRA Brexit Guidance for devices explained
Medicines and Medical Devices Bill comes under scrutiny in the House of Lords
On 1 September 2020, the Medicines and Healthcare products Regulatory Agency released new...
The team is currently working through the new MHRA guidance and will publish summaries in the...
Meet the experts
European Commission publishes Common Specifications for the reprocessing of single use devices
Government writes to medicine suppliers requesting a six week stockpile
MHRA warning about “certificates of compliance” & “Attestations of Compliance”
Now more than ever,there is a pressing need to crack down on excessively high prices in the...
Charlie French provides a short update of the outcome of the UK Governments response to the...
UK Government opens consultation on the power to depart from EU case law
Gilead’s remdesivir granted conditional Marketing Authorisation by the European Commission
Webinar: Medical device regulation (MDR) and cyber security
Pat Treacy and Olivia Henry discuss the Opinion of Advocate General Kokott in Case C-591/16 P...
On 11 June 2020 the European Court of Justice (ECJ) delivered judgment on Ratiopharm v...
Back to Brexit – An update on medical devices
Cell and gene therapies
26 May 2020 – a medical device milestone missed
As part of its ongoing engagement with the life sciences and pharmaceutical industry during...
A lengthy back-and-forth about the patentability of plants, plant materials and animals...
Public Health England ‘approves’ Roche COVID-19 antibody test
DIY gene-editing CRISPR kits
Priorities for academic organisations in industry-academic partnerships – COVID-19 and beyond
On Thursday 30 April the CJEU handed down its decision in the SPC referral Royalty Pharma...
Our team’s recent blog on the impact of COVID-19 on competition law in the UK pharma...
Medical Research Council’s guidance on identifiability/ anonymisation
How is COVID-19 impacting competition law for the UK pharma sector?
MDR postponement staves off Swixit – for now
It has been reported in the Financial Times (16 April 2020) that the UK government will shield...
As part of its efforts to ramp up production of medical ventilators by British manufacturing...
Moving on from consent? The legal ground for disclosing transfers of value to HCPs
Arrow Declarations – How broad can they be?
UK and Europe back exemptions – more medical devices and PPE in the COVID-19 fight
COVID-19 has resulted in a shortage of hand sanitiser. As well as the risk this presents to...
Just in time for the European Commission to announce that it intends to postpone the date of...
Commission delays MDR by 12 months
UK announce new ventilator requirements in the fight against COVID-19
Medical Devices – When is a change significant?
Today the Food Standards Agency (FSA) announced that products containing cannabidiol (CBD)...
Recently declared a ‘global threat’ by the World Health Organisation, the Coronavirus has...
Competition between generics and originators – what’s the relevance of a patent?(Part II)
First Brexit, now Swexit?
Competition between generics and originators – what’s the relevance of a patent?
The MDR comes into force on 26 May 2020, replacing the outgoing Medical Devices Directive...
EU Parliament confirms approval of a corrigendum to the EUMDR that has the effect of providing...
Good news for manufacturers of up-classified Class I medical devices
Medical devices: Updates galore!
Person Responsible for Regulatory Compliance – The confusion continues
Since the CRISPR breakthrough in 2012, genome editing has been the focus of a huge amount of...
Professor Shanks’ 13 year skirmish with former employee Unilever has finally come to an end...
Nesta Talks: ‘How to Grow a Human’, with Philip Ball
Deciphering Rule 11: New guidance on the classification of software medical devices under the EU MDR
GSK’s passing off claims dismissed
Do you want to look like Kylie Jenner? Unfortunately, the Advertising Standards Authority...
As discussed in previous articles, the EU Medical Devices Regulation (MDR) comes into force...
NO-tified Bodies? UL UK ceases Medical Devices Directive operations
Orphan designation: the General Court clarifies the meaning of significant benefit
Another one bites the dust…
There are currently only two notified bodies authorised to assess against the new EU Medical...
Alex Denoon and Zac Fargher discuss how a combination of the advent of the new EU Medical...
TÜV SÜD gets the Greenlight on EU MDR
Medical Devices and No-Deal Brexit: where are we now?
NICE releases Evidence Standards Framework for Digital Health Tech
Following the implementation of the EU General Data Protection Regulation (GDPR), there has...
We reported on this blog about the General Court (GC)’s judgment in Servier on the day on...
Record investment in UK biotech
Matt Hancock sets out the UK’s 20-year vision on tackling antimicrobial resistance
CRISPR gene editing technology and its many applications
The rapid development of the immunotherapy landscape has driven increased numbers of...
The General Court has today handed down its judgment in the long-running Servier patent...
New EU Regulation for Veterinary Medicinal Products
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” is a revolutionary approach to healthcare, which involves sharing knowledge...
Whilst there has been much attention to data protection as a result of the EU General Data...
One more piece in the SPC puzzle – Medical devices with ancillary substances do not qualify for an 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?
On Monday 27 August, the first two CAR-T therapies were authorised for use in the European...
In case C-528/16 proceedings were brought between the French agricultural union and eight...
Concordia and the CMA – a drama in (at least) three parts
Different types of CAR-T
The EMA’s clinical data publication policy: 1 year on
On 21 June 2018 the CJEU gave its judgment in a preliminary reference from the Düsseldorf...
The pace of development in the CAR-T world, both scientific and commercial, is showing no sign...
The CAT sets a clear framework for excessive and unfair prices in its Pfizer/Flynn judgment
Drafting leases for life sciences
Driving immunotherapy forward: More than CAR-Ts
On 8 March 2018, the Competition Appeal Tribunal (CAT) gave an initial judgment in appeals...
Rachel Mumby and Jonathan Ross discuss highlights in the CAR-T world.
The NHS gets on the bandwagon with CAR-T
How the life sciences industry may be affected by Brexit
Side CAR-Ts
Various new cellular immunotherapy acquisitions and collaborations have been announced over...
Sophie Lawrance and Edwin Bond give their summary on the different forms of value transfer...
The competition law issues of the CRISPR patent pool
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
Following the autumn 2017 Budget announcement, the UK Government has launched a consultation...
Pat Treacy discusses 10 key points on parallel trade and pharma.
Evolving how English courts construe written commercial contracts (Teva v AstraZeneca)
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
Claire Wilson discusses Illumina v Premaitha where 5 patents, all of which were concerned with...
Dominic Adair and Thomas Hendicott review Sandoz and Amgen, relating to the abbreviated...
Digital Health – The CJEU’ s first decision on standalone software as a medical device
Biotech Review
UK Government announces a Life Sciences Sector Deal as part of its Industrial Strategy
This article considers key public procurement issues that arise for pharmaceutical and medical...
In November 2017, the French competition authority, the Autorité de la concurrence, announced...
Lifting restrictions on veterinary medicine retail channels and veterinary practice ownership in Europe (Case C-297/16)
Providing Misleading Information About Product Safety – a Restriction of Competition by Object?
Dosage Regimen Patent Held Invalid
Biological medicinal products have rapidly become one of the fastest growing areas of medicine...
‘Product hopping’, or ‘evergreening’, are expressions used (by competition authorities...
CRISPR undergoes exciting new developments
Arrow Declarations post Actavis v Eli Lilly
Construction and novelty post Actavis v Eli Lilly
Letters before action are encouraged by the Courts in the UK as a way of potentially avoiding...
The Brucellosis Vaccine Prize, an innovative $30 million prize competition, is designed to...
CAR-T Therapy: the Current Landscape
Excessive Pricing – Pfizer/Flynn in light of the CJEU’s recent decision
Biosimilars: NHS approach to procurement
On 21 June 2017 the Court of Justice of the European Union (the CJEU) delivered its judgment...
Collaboration with competitors can be an effective strategy for pharma companies seeking to...
Are pharmaceutical companies using rebates at risk of being investigated by the competition authorities?
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
Novartis has received FDA approval for its CAR-T cell therapy, marketed as Kymriah, for the...
In this important case from July of this year, the Supreme Court reintroduced a true form of...
The lure of the US for UK biotech
Clustering and Innovation Districts
Patent licences – some key features
CRISPR-Cas9 editing, the technology which gives scientists the ability to selectively edit...
On 21st August 2017 the European Commission published responses to the question regarding the...
The use of mobile apps and software as a form of healthcare within the NHS
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
Bristows partner Brian Cordery and associate Steven Willis look at how the CJEU has approached...
This article was first published in Competition Law Insight, March 2017 On 7 December 2016, in...
Patent Review of the Year
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?
In October 2016 NICE (National Institute for Health and Care Excellence) and NHS England...
The future role of the UK in the Unified Patent Court (UPC), if any, has been brought to the...
Public Procurement Regimes in the UK and EU
First CMA competition decision on excessive pricing in the pharmaceutical sector
The Research and Development Block Exemption (RDBE)
Buildings that can repair themselves and cities powered by micro-organisms – these are...
Introduction On 20 September 2016, the Council of the European Union accepted the European...
A sense of relief: enforcing second medical use patents
Arrow declarations – a second shot at the target
First Borderline Decision of the EU Commission: Is this a welcome approach for industry?
On 10 August 2016, judgment in Actavis v ICOS was handed down. This was a patent action...
On 26 August 2016, the UKIPO issued its decision rejecting Abraxis Bioscience’s application...
Electronic cigarettes: the medicine of tomorrow?
Lyrica continues – The Court of Appeal considers infringement and validity of Pfizer’s second medical use patent
NICE and NHS England Consultation on proposals for changes to the evaluation and funding of drugs
The Warner Lambert v Actavis cases on pregabalin-based medicines have been before the UK...
A recent KPMG survey[1] of companies operating in the medical devices sector found that over...
Court of Appeal provides guidance on determining an account of profits
Life Sciences under the GDPR
Antimicrobial resistance – a global threat triggering a global response
This article was first published in Kluwer Patent Blog, February 2016 Mr Justice Carr is only...
As reported in the October edition of On The Pulse, on 10 September 2015 Arnold J found...
Plausibility in immunotherapy – is PD-1 the way forward?
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)?
The article was first published in EPLAW Patent Blog, December 2015 Generics (UK) Limited...
This article was first published in EPLAW Patent Blog, December 2015 Actavis Group PTC EHF...
One step closer to decoupling veterinary medicines from the human medicines legislation
Salt limitation leads to sweet and sour Court of Appeal judgment
CJEU confirms the broad scope of Article 6 of the Transparency Directive
The last few years has seen a notable increase in the number of disputes concerning second...
Background and Legislation The EFTA Court has jurisdiction with regard to the EFTA States...
No invention in setting a research project and claiming the results
Smith & Nephew v ConvaTec No 2: a well rounded performance
Amended claims must not be obvious or arbitrary
Summary: This summer the Eli Lilly v HGS case came back before the High Court, following the...
Summary: In the recent case of AGA v Occlutech, the Court has held that clinical trials are...
The English Court – the one-stop shop for DNIs across Europe?
