AI and Life Sciences: Has protein folding been solved?
Team-NB issues a cry for help and some slight relief
MDCG releases guidance on classification rules for IVDs
MedTech Europe calls for the EU to delay the implementation of the In Vitro Diagnostics...
The In Vitro Diagnostic Regulation (IVDR) takes effect in May 2022. This means manufacturers...
Meet the experts
Impacts of Brexit on Horizon Europe
Test and trace apps: are there any privacy impacts?
The UK’s genomic future
Mark Brown, Max Palmer and Sukanya Majumdar explore the different forms of endeavour clauses...
Our commercial technology and regulatory teams explore the regulatory and cultural challenges...
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
New MHRA Brexit guidance…Northern Ireland FMD to come!
The team is currently working through the new MHRA guidance and will publish summaries in the...
European Commission publishes common specifications for the reprocessing of single use...
Government writes to medicine suppliers requesting a six week stockpile
MHRA warning about “certificates of compliance” & “Attestations of Compliance”
Competition authorities continue to address excessive pricing in the pharmaceutical sector
Charlie French provides a short update of the outcome of the UK Governments response to the...
On 2 July 2020, the UK Ministry of Justice published a consultation on the departure from...
Gilead’s remdesivir granted conditional Marketing Authorisation by the European Commission
Further guidance from the Advocate General: ‘Pay-for-delay’ agreements
The Schmerzgel Redemption
On 19 May 2020, the United Kingdom Government published draft negotiation documents (UK...
In recent years, we have seen a trend towards the launch of new gene and cell therapies with...
26 May 2020 – a medical device milestone missed
The interplay between the Clinical Trials Regulation and the GDPR
The Court of Justice confirms the EMA’s approach to transparency
Sophie Lawrance and Aimee Brookes discuss the CMA making more use of their ability to...
As part of its ongoing engagement with the life sciences and pharmaceutical industry during...
The regulation of software medical devices
Art.53(b) EPC exception to patentability broadened by the Enlarged Board of Appeal
“Pay-for-delay” settlement agreements in biotech: a European perspective on the US Humira litigation
High Court dismisses GSK’s claim that Sandoz’s AirFluSal Forspiro inhaler passes off...
Alex Denoon and Christopher Stubbs discuss CRISPR and the implications of human genome editing...
Public Health England ‘approves’ Roche COVID-19 antibody test
Jurisdiction challenge succeeds on appeal as contractual exclusive jurisdiction clause has priority
DIY gene-editing CRISPR kits
Last November, a week of international meetings to discuss global responses to the impact of...
Pfizer v Hoffman-La Roche – evading Arrow declarations. Gregory Bacon and Viviane Boissy...
Clarity sought on plant patentability
Mammoth judgment on IL-17A/F antibodies leads to patent revocation and brief SPC excursion to the CJEU
Dosage regimen research; is it worth it?
In response to the current coronavirus crisis, we have seen a number of high profile...
Takeda revokes Roche patent to glycosylation pattern extending to Entyvio. Gregory Bacon and...
Brexit is upon us – what does it all mean?
Functional claims approved in principle as basis for SPCs
In response to COVID-19, the European Commission resurrects comfort letters
The Medical Research Council (MRC) published new guidance on the anonymisation of data in the...
With COVID-19 now a global problem, the life sciences industry is facing pressure and...
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
Government updates ventilator challenge minimum specifications in response to new COVID-19 clinical information
The topic for this article arose from an interesting discussion at a Roundtable Event that...
On 1 April 2020, the Court of Appeal, led by Floyd LJ, handed down judgment concerning the...
UK and Europe back exemptions – more medical devices and PPE in the COVID-19 fight
Smoother sailing for sanitisers
12 notified bodies now designated under MDR
Following a call from MedTech Europe to postpone the implementation of the Medical Device...
On Friday 20 March 2020, the Medicines and Healthcare Regulatory Authority (MHRA) issued...
Medical Devices – When is a change significant?
CBD – Could be done for?
Coronavirus; the growing threat to the global pharmaceutical supply chain
The Judgment of the Court of Justice of the European Union in the Paroxetine...
Brexit has dominated the political headlines since the 2016 referendum, and finally came to...
Competition between generics and originators – what’s the relevance of a patent?
Medtech Europe calls on EU institutions to speed up MDR implementation
Grace period for up-classified Class I medical devices receives green light at European Parliament
The Environment, Public Health and Food Safety Committee of the European Parliament approved a...
Of the many changes introduced by the EU Medical Device Regulations (EU MDR), one of the most...
Person Responsible for Regulatory Compliance – The confusion continues
Gene editing – A survey of public opinion
Supreme Court awards employee inventor £2 million compensation for his “outstanding” invention
Following a presentation at Nesta UK, Viviane Boissy discusses Philip Ball's book "How to Grow...
As discussed in our previous articles on the topic, the incoming EU Medical Devices Regulation...
GSK’s passing off claims dismissed
Want to look like Kylie Jenner? Well, you probably can’t, says the ASA
Medical devices: An encouraging September
Another Notified Body, UL UK, announced on Monday that not only it has not yet applied for EU...
Last month the General Court issued its judgment in case T-773/17 dismissing the action...
Another one bites the dust…
Lloyd’s pulls out of the EU MDR/IVDR race
Notified Bodies: eyes on the up-line
Alex Denoon and Zac Fargher discuss the TÜV SÜD's approval as the second Notified Body...
This article sets out the salient features of the most recent guidance on the regulation of...
NICE releases Evidence Standards Framework for Digital Health Tech
New guidance on the use of personal data in clinical trials
The General Court’s judgment in Krka – some welcome clarity over licensing in the context of patent settlements
The UK’s BioIndustry Association (BIA), together with Informa Pharma Intelligence, have...
Do you lie awake at night worrying about that last pack of antibiotics? Matt Hancock sets out...
CRISPR gene editing technology and its many applications
A brief history of UCART-19
Partial annulment of Servier decision by the General Court – some good news for pharma innovators at last
The European Council has approved the text for a new Regulation that will overhaul the...
Pricing issues in the pharmaceutical industry continue to keep European competition...
CAR-T round-up: off-the-shelf challengers and avoiding the (cytokine) storm
“One Medicine” – A New Approach to Healthcare?
Ethics and Data Privacy
On 25 October 2018 the CJEU published their latest judgment[1] on the application of the SPC...
The EMA has a Committee for Medicinal Products for Veterinary Use (CVMP)[1] and one of their...
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
Are organisms that are the product of mutagenesis subject to the GMO Directive on deliberate release?
Last week, Concordia International released a management report in which it announced the...
CAR-T cell therapy remains an exciting area in healthcare, and a potentially very lucrative...
The EMA’s clinical data publication policy: 1 year on
CJEU follows Advocate General’s Opinion to confirm the scope of the Specific Mechanism
CAR-T keeps driving forward: a round-up of recent scientific and commercial developments
The Competition Appeal Tribunal (CAT) recently gave its judgment in Pfizer and Flynn’s...
Over the past decade, the UK life sciences sector has enjoyed rapid expansion, aided by a 41%...
Driving immunotherapy forward: More than CAR-Ts
Depression Delayed: CMA’s paroxetine pay-for-delay case heads to Luxembourg
Can’t stop the CAR-T
Of interest to our UK readers will be the announcement by Simon Stevens, the chief executive...
The European Commission published a Draft Withdrawal Agreement (the Agreement) on 19 March...
Side CAR-Ts
CAR-T rolls on
Different types of value transfer in ‘reverse payment’ settlement agreements
CRISPR-Cas9 is heralded as a revolutionary gene editing technology that is regularly hitting...
Advocate General Bobek’s opinion in a reference from the Conseil d’État to the CJEU[1]...
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?
10 key points on Parallel Trade and Pharma
Matthew Warren and Alex Calver discuss how English courts construe written commercial...
Pat Treacy discusses the interplay between EU competition law and the pharmaceutical...
Impact of Brexit on International Data Transfer Mechanisms
Patents Court rules on non-invasive prenatal diagnosis patents
Sandoz v Amgen: An update
On 7 December 2017 the Court of Justice of the European Union (“CJEU”) published its...
Bristows' Biotech Review of the Year is an overview of some of the recent key developments in...
UK Government announces a Life Sciences Sector Deal as part of its Industrial Strategy
NHS Pharmaceutical Procurement – Top 10 Tips
Pharma Sector Inquiry ‘Encore’
In Case C-297/16 ‘CMVR’, the Romanian Court of Appeal referred two questions to the CJ...
“A dispute … [with] unusual characteristics …”[1] is how AG Saugmandsgaard...
Dosage Regimen Patent Held Invalid
Is there such a thing as Substitution or Interchangeability for Biosimilars?
Product hopping: The competition law risks of launching new product formulations
The discovery of CRISPR five years ago has revolutionised the way we can manipulate and edit...
An issue which has been the subject of much discussion since the judgment of the Supreme Court...
Construction and novelty post Actavis v Eli Lilly
Unjustified Threats Act comes into force
Brucellosis Vaccine Prize
CAR-T technology Chimeric antigen receptor T cell (CAR-T) therapy is currently the hot topic...
Excessive pricing has become a hot topic for the pharmaceutical sector in the last year,...
Biosimilars: NHS approach to procurement
European Court says scientific proof of causation is not required under the EU Product Liability Directive
Standardisation agreements in pharma – Competition law tips for collaboration between pharma companies
Rebate systems are commonly used by pharmaceutical companies. A quantity-based rebate system,...
In the last couple of years, the UK competition authority has investigated the conduct of...
EPO takes an ‘about turn’ on the patentability of products obtained by essentially biological processes
FDA approves first GM individualised cell therapy
Supreme Court “improves” upon the Improver/Protocol Questions in Actavis v Eli Lilly.
The UK has a world leading life sciences sector which is underpinned by an array of...
Clustering, where several entities in the same or complementary industries locate themselves...
Patent licences – some key features
CRISPR-Cas9 – An update
Free movement of health data and data protection implications
Hilary Jones and Michaela Herron examine the use of mobile apps as software as a form of...
The UK Information Commissioner’s Offce (‘ICO’) closed on 31 March 2017 the consultation...
Case Analysis: Elisabeth Schmitt v TUV Rheinland LGA Products GmbH
How the CJEU has interpreted “protected” in the SPC regulation
Excessive pharma pricing
Bristows’ Patent Review of the Year reports each year on important decisions from both...
On 1 March 2017, the Vice-President of the Court of justice issued a ruling that sets up the...
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
Opening Life Sciences’ Unified Patent Court war chest
Legal Framework Public procurement rules apply to the purchase of goods, works or services by...
As a body of law, competition law is unusual in the extent to which it is susceptible to the...
The Research and Development Block Exemption (RDBE)
Science in architecture – the opportunities and challenges
Modernising EU legislation for medical devices: the new Medical Devices Regulation
This article was first published in Life Sciences Intellectual Property Review, March 2016 In...
2016 is the year that the Arrow declaration has made its comeback. These declarations concern...
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?
Can you obtain an SPC for a new formulation of a medicine? The UKIPO considers the CJEU decisions in MIT and Neurim
This article was first published in Journal of the Law Society of Scotland, April 2016 Why the...
On 13 October 2016 the Court of Appeal handed down judgment in relation to a second medical...
Painfully objective decision of the Court of Appeal in Warner Lambert v Actavis tortuously applied by the Patents Court
Collaborate to accumulate: exciting commercial collaborations in the medical devices sector
In a decision dated 24 February 2016, the Court of Appeal (Lewison LJ giving the leading...
On 25 May 2018, the current UK Data Protection Act 1998 (and all the other implementing laws...
Antimicrobial resistance – a global threat triggering a global response
Regeneron Pharmaceuticals Inc v (1) Kymab Ltd (2) Novo Nordisk A/S
Peripheral Decisions in the Lyrica (pregabalin) Saga
Ono is the proprietor of a patent for the use of anti-PD-1 antibodies which inhibit the...
Introduction In the context of criminal proceedings concerning the potential violation of the...
UK – Mylan v. Warner-Lambert / Abuse
UK – Actavis v. Eli Lilly
One step closer to decoupling veterinary medicines from the human medicines legislation
This article was first published in Kluwer Patent Blog, July 2015 The Actavis v Eli Lilly UK...
On 16 April 2015, the CJEU handed down its decision in conjoined cases LFB Biomédicaments SA...
English High Court considers infringement of second medical use claims
The EFTA Court provides an Advisory Opinion on the validity and scope of SPCs for veterinary medicinal products
No invention in setting a research project and claiming the results
On 12 December 2013, the Patents Court handed down its judgment in Smith & Nephew v...
In a decision dated 21 October 2015, the Patents Court (Morgan J) held that Boehringer...
Eli Lilly v HGS – High court tries to implement CJEU decision regarding SPCs
The Patents Court confirms that clinical trials are not necessarily confidential
The English Court – the one-stop shop for DNIs across Europe?
