The UK’s genomic future
What are “endeavour” clauses?
Regulatory and cultural challenges for IT and outsourcing services in the healthcare and life sciences sectors
Alex Denoon and Zac Fargher explore the devices section of the new Brexit guidance released on...
Concerns raised in the House of Lords as the second reading of the Medicines and Medical...
Meet the experts
New MHRA Brexit guidance…Northern Ireland FMD to come!
New MHRA Brexit guidance…more to come!
European Commission publishes Common Specifications for the reprocessing of single use devices
On 3 August 2020, the Department of Health & Social Care (DHSC) wrote to medicine suppliers in...
On 23 July 2020, the MHRA published a news story warning about largely meaningless...
Competition authorities continue to address excessive pricing in the pharmaceutical sector
SPC manufacturing waiver: UK Government responds to call for views on draft legislation to fix issues in the Waiver Regulation post-Brexit
UK Government opens consultation on the power to depart from EU case law
Earlier today, the European Commission granted[1] a conditional Marketing Authorisation (MA)...
In last week's webinar, Alex Denoon, Marc Dautlich and Charlie Hawes alongside expert...
Further guidance from the Advocate General: ‘Pay-for-delay’ agreements
The Schmerzgel Redemption
Back to Brexit – An update on medical devices
In recent years, we have seen a trend towards the launch of new gene and cell therapies with...
Today is 26 May 2020. To some, just another Tuesday coming to terms with post-bank holiday...
The interplay between the Clinical Trials Regulation and the GDPR
The Court of Justice confirms the EMA’s approach to transparency
The CMA’s director disqualification power – a power now being put to use
As part of its ongoing engagement with the life sciences and pharmaceutical industry during...
ac Fargher explores the regulation of software medical devices in our Biotech Review 2019.
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 GSK’s Seretide Accuhaler
Alex Denoon and Christopher Stubbs discuss CRISPR and the implications of human genome editing...
It was reported on 13 May 2020 that Public Health England (PHE) has approved Roche’s...
Jurisdiction challenge succeeds on appeal as contractual exclusive jurisdiction clause has priority
DIY gene-editing CRISPR kits
Bristows’ genome editing debate 2019: The quest for the perfect human?
Pfizer v Hoffman-La Roche – evading Arrow declarations. Gregory Bacon and Viviane Boissy...
Gregory Bacon discusses clarity sought on plant patentability in our Biotech Review 2019.
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?
Priorities for academic organisations in industry-academic partnerships – COVID-19 and beyond
Takeda revokes Roche patent to glycosylation pattern extending to Entyvio. Gregory Bacon and...
Gregory Bacon and Xisca Borrás discuss "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
Medical Research Council’s guidance on identifiability/ anonymisation
With COVID-19 now a global problem, the life sciences industry is facing pressure and...
Last week, the European Parliament approved at first reading a legislative proposal (the...
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
Moving on from consent? The legal ground for disclosing transfers of value to HCPs
On 1 April 2020, the Court of Appeal, led by Floyd LJ, handed down judgment concerning the...
From 25 March, the MHRA is inviting medical device manufacturers to apply for fast-track...
Smoother sailing for sanitisers
12 notified bodies now designated under MDR
Commission delays MDR by 12 months
On Friday 20 March 2020, the Medicines and Healthcare Regulatory Authority (MHRA) issued...
The Medical Device Coordination Group today published guidance explaining what constitutes a...
CBD – Could be done for?
Coronavirus; the growing threat to the global pharmaceutical supply chain
Competition between generics and originators – what’s the relevance of a patent?(Part II)
Brexit has dominated the political headlines since the 2016 referendum, and finally came to...
The Paroxetine case arises from familiar circumstances and has a familiar cast of characters:...
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
Good news for manufacturers of up-classified Class I medical devices
Of the many changes introduced by the EU Medical Device Regulations (EU MDR), one of the most...
One of the many new requirements to be introduced under the Medical Device Regulation (MDR) is...
Gene editing – A survey of public opinion
Supreme Court awards employee inventor £2 million compensation for his “outstanding” invention
Nesta Talks: ‘How to Grow a Human’, with Philip Ball
As discussed in our previous articles on the topic, the incoming EU Medical Devices Regulation...
On Friday 4 October, Mr. Justice Arnold handed down his judgment in the long running passing...
Want to look like Kylie Jenner? Well, you probably can’t, says the ASA
Medical devices: An encouraging September
NO-tified Bodies? UL UK ceases Medical Devices Directive operations
Last month the General Court issued its judgment in case T-773/17 dismissing the action...
Alex Denoon and Zac Fargher discuss how Switzerland-based QS Zürich AG has decided not to...
Lloyd’s pulls out of the EU MDR/IVDR race
Notified Bodies: eyes on the up-line
TÜV SÜD gets the Greenlight on EU MDR
This article sets out the salient features of the most recent guidance on the regulation of...
The purpose of the Framework is to: provide advice to DHT innovators; assist NHS...
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
Record investment in UK biotech
Do you lie awake at night worrying about that last pack of antibiotics? Matt Hancock sets out...
The revolutionary CRISPR-Cas9 gene editing technology is regularly in the headlines, much of...
A brief history of UCART-19
Partial annulment of Servier decision by the General Court – some good news for pharma innovators at last
New EU Regulation for Veterinary Medicinal Products
Pricing issues in the pharmaceutical industry continue to keep European competition...
Charlie French gives a round up of CAR-T therapies.
“One Medicine” – A New Approach to Healthcare?
Ethics and Data Privacy
One more piece in the SPC puzzle – Medical devices with ancillary substances do not qualify for an SPC
The EMA has a Committee for Medicinal Products for Veterinary Use (CVMP)[1] and one of their...
Entering into agreements that erect barriers to parallel exports between EU markets is...
CAR-T gets the green light in Europe
Are organisms that are the product of mutagenesis subject to the GMO Directive on deliberate release?
Concordia and the CMA – a drama in (at least) three parts
CAR-T cell therapy remains an exciting area in healthcare, and a potentially very lucrative...
On 16 July 2018, the EMA published a report on the first year (Oct 2016 – Oct 2017) of its...
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 CAT sets a clear framework for excessive and unfair prices in its Pfizer/Flynn judgment
Over the past decade, the UK life sciences sector has enjoyed rapid expansion, aided by a 41%...
With two therapies already on the market and many more in the pipeline, this exciting new...
Depression Delayed: CMA’s paroxetine pay-for-delay case heads to Luxembourg
Can’t stop the CAR-T
The NHS gets on the bandwagon with CAR-T
The European Commission published a Draft Withdrawal Agreement (the Agreement) on 19 March...
Greg Bacon and Rachel Mumby discuss how different the CAR-T space is for big pharma, whose...
CAR-T rolls on
Different types of value transfer in ‘reverse payment’ settlement agreements
The competition law issues of the CRISPR patent pool
Advocate General Bobek’s opinion in a reference from the Conseil d’État to the CJEU[1]...
On 7 February 2018 Advocate General Tanchev delivered his opinion in Pfizer Ireland...
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
Evolving how English courts construe written commercial contracts (Teva v AstraZeneca)
Pat Treacy discusses the interplay between EU competition law and the pharmaceutical...
Robert Bond discusses how the GDPR simplifies the mechanisms available to protect the rights...
Patents Court rules on non-invasive prenatal diagnosis patents
Sandoz v Amgen: An update
Digital Health – The CJEU’ s first decision on standalone software as a medical device
Bristows' Biotech Review of the Year is an overview of some of the recent key developments in...
The UK Government has today announced a Life Sciences Sector Deal as part of its new...
NHS Pharmaceutical Procurement – Top 10 Tips
Pharma Sector Inquiry ‘Encore’
Lifting restrictions on veterinary medicine retail channels and veterinary practice ownership in Europe (Case C-297/16)
“A dispute … [with] unusual characteristics …”[1] is how AG Saugmandsgaard...
Last year, Actavis, Teva and Mylan (“Actavis”) sought revocation in the English Patents...
Is there such a thing as Substitution or Interchangeability for Biosimilars?
Product hopping: The competition law risks of launching new product formulations
CRISPR undergoes exciting new developments
An issue which has been the subject of much discussion since the judgment of the Supreme Court...
On 26 October 2017, Arnold J handed down judgment in Generics (UK) Ltd v Yeda [2017] EWHC 2629...
Unjustified Threats Act comes into force
Brucellosis Vaccine Prize
CAR-T Therapy: the Current Landscape
Excessive pricing has become a hot topic for the pharmaceutical sector in the last year,...
The financial pressures on the NHS have resulted in some questionable strategies in the use of...
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
Are pharmaceutical companies using rebates at risk of being investigated by the competition authorities?
In the last couple of years, the UK competition authority has investigated the conduct of...
At the end of June the EPO published a notice (see here) stating from 1 July 2017 plants and...
FDA approves first GM individualised cell therapy
Supreme Court “improves” upon the Improver/Protocol Questions in Actavis v Eli Lilly.
The lure of the US for UK biotech
Clustering, where several entities in the same or complementary industries locate themselves...
http://bristowsotp.modulemedia.co.uk/assets/pdf/Licensing presentation - 13 September...
CRISPR-Cas9 – An update
Free movement of health data and data protection implications
The use of mobile apps and software as a form of healthcare within the NHS
The UK Information Commissioner’s Offce (‘ICO’) closed on 31 March 2017 the consultation...
Introduction On 26 February 2017, the Court of Justice of the European Union (CJEU) delivered...
How the CJEU has interpreted “protected” in the SPC regulation
Excessive pharma pricing
Patent Review of the Year
On 1 March 2017, the Vice-President of the Court of justice issued a ruling that sets up the...
The enforcement of second medical use patents is currently one of the hottest topics in...
NICE and NHS England Consultation on proposals for changes to the evaluation and funding of drugs
Opening Life Sciences’ Unified Patent Court war chest
Public Procurement Regimes in the UK and EU
As a body of law, competition law is unusual in the extent to which it is susceptible to the...
Application of the RDBE Many R&D agreements are outside the scope of Article 101...
Science in architecture – the opportunities and challenges
Modernising EU legislation for medical devices: the new Medical Devices Regulation
A sense of relief: enforcing second medical use patents
2016 is the year that the Arrow declaration has made its comeback. These declarations concern...
Introduction On 22 February 2016, the European Commission released a draft version of its...
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
Electronic cigarettes: the medicine of tomorrow?
On 13 October 2016 the Court of Appeal handed down judgment in relation to a second medical...
In October 2016 NICE (National Institute for Health and Care Excellence) and NHS England...
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
Court of Appeal provides guidance on determining an account of profits
On 25 May 2018, the current UK Data Protection Act 1998 (and all the other implementing laws...
Antimicrobial resistance is a major public health challenge that is rapidly climbing the...
Regeneron Pharmaceuticals Inc v (1) Kymab Ltd (2) Novo Nordisk A/S
Peripheral Decisions in the Lyrica (pregabalin) Saga
Plausibility in immunotherapy – is PD-1 the way forward?
Marie Manley, Partner, Head of the Regulatory Practice Watch video here
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 ConvaTec...
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?
