Spotlight on IVDR — Circumventing the Notified Body bottleneck
Alex Denoon, Jamie Hatzel and Harry Woodcock continue the discussion on the new IVDR – Our experts outline and...
Spotlight on IVDR – Why we keep banging on about Notified Bodies
Harry Woodcock, Jamie Hatzel and Alex Denoon continue the discussion on the new IVDR - explaining the importance of...
Spotlight on IVDR – Cheers Slovakia! Seventh Notified Body designated under IVDR
Spotlight on IVDR - Seventh Notified Body designated although “still far short of where it needs to be”. With...
Updates to the blood, tissues and cells legislation
First published in our Biotech Review of the year – issue 9. What impact might this have on patients and BTC-based...
National Security and Investment Act: Impact on the Life Sciences sector
First published in our Biotech Review of the year – issue 9. The NS&I Act “is likely to have a significant...
Looking ahead to the EU In Vitro Diagnostic Medical Device Regulation
First published in our Biotech Review of the year – issue 9. "May 2022 will still herald a significant increase...
Pharma beware: EU consults on tighter rules for joint innovation
Proposed changes to the R&D Block Exemption and Horizontal Guidelines could see businesses struggling to self-assess...
Why is anonymisation an important topic when using genomic data in scientific research?
First published in our Biotech Review of the year – issue 9. Why is anonymisation an important topic when using...
Releasing the Therapeutic GMO
First published in our Biotech Review of the year – issue 9. Releasing the Therapeutic GMO: “If we can unblock...
What will the European framework for orphan medicinal products look like in the future?
First published in our Biotech Review of the year – issue 9. The EU Orphan Regulation fosters innovation to the...
‘Full throttle’: venture capital in 2021
First published in our Biotech Review of the year – issue 9. Venture capital has “real momentum” across the...
Pricing of branded medicines: Amendments to the Statutory Scheme
Pricing of branded medicines: Proposal to “increase the Statutory Scheme rebate for 2022 and 2023 to 14.3% (from...
Viral vectors: shortages and innovation
First published in our Biotech Review of the year – issue 9. What are viral vectors used for and what does the...
The new UK MDR draws near, and we’re all still clueless about the rules
Still no outcome to the MHRA’s consultation on future amendments to the UK’s Medical Devices Regulations? With...
A Franco-German clarion call to ease the burden of the MDR and IVDR
Still not nearly enough Notified Body capacity - SNITEM and BVMed announce initiative to avert a “collapse” of...
They are out to get you
First published in our Biotech Review of the year – issue 9. The enforcement of both EU and UK merger control is...
Lawfully running a red light: aneuploidy testing
In a recent press statement on the use of preimplantation genetic testing (PGT) of human embryos, the Human...
MHRA gets our hopes up for new UK Approved Bodies
Alex Denoon and Jamie Hatzel highlight “the UK Approved Body capacity bottleneck” and discuss their hopes for...
Autumn Budget 2021 and a new age of optimism: changes to the UK’s R&D tax relief regime
In view of the draft legislation on new tax measures expected this summer, our experts review the Government’s R&D...
European Commission consults on draft common specifications for certain high-risk in vitro diagnostic medical devices
Manufacturers of legacy devices may need to adjust their IVDR transition plans as European Commission publishes...
AI – commercial models and value recognition in life sciences transactions
First published in our Biotech Review of the year – issue 9. The use of AI will become widespread in the...
VPAS: One-off repayment rate for 2022 announced
VPAS: Repayment percentage for 2022 to be capped at 15%. Hugo Kent-Egan and Alex Magnusdottir discuss after 2021 saw...
Five Life Sciences trends for 2022
Read our top 5 life sciences trends in 2022 from decentralised clinical trials to AI and personalised medicine -...
Supply of medicines in Northern Ireland: the EC and UK come closer to a solution
Ensuring medicines are available in Northern Ireland at the same time as in the rest of the UK - the European...
Seminar: “Trust me, I am an algorithm.” Is AI the future of healthcare?
What are the most promising applications of AI in medicine? Watch the Bristows Debate 2021 when leading experts...
Advertising medicines and medical devices in the UK: Who’s who?
How are consumers protected and standards maintained when it comes to medicines and medical devices in the UK? Hugo...
What’s the wait? – Number of MDR and IVDR notified bodies remains stubbornly low
Where have all the notified bodies gone? Alex Denoon and Ewan MacAulay comment on the number of MDR and IVDR...
Spotlight on mRNA – Regulation of mRNA vaccines and therapies
How are mRNA therapies currently regulated? In this final article in our series: “mRNA: a new era in genetic...
EC proposals for Northern Ireland: A way forward for medicines?
European Commission’s new proposals for the implementation of the Northern Ireland Protocol - How will this impact...
Spotlight on mRNA – Recent deal activity
Curious about the partnering and M&A activity in the mRNA field, including some recent deals? Read the fourth...
Hallelujah! Plans to extend IVDR transitional period announced
European Commission announces plans to extend IVDR transitional period, however “this proposal is not a silver...
Going live – New rules on publication of clinical trials results-related information under the EU Clinical Trials Regulation
More than six years after its publication, Regulation (EU) No 536/2014 on clinical trials (the “EU Clinical Trials...
What’s new in the future UK regulation of medical devices?
What does the future regulation of medical devices in the UK have in store? Our experts share five key areas worth...
Spotlight on mRNA – IP landscape
Interested in the IP landscape around mRNA? Read the third article in our mini-series ”mRNA: a new era in genetic...
Spotlight on mRNA – What is mRNA and what can it be used for?
What is mRNA and what can it be used for? Ellen Lambrix explores in our mini-series 'Spotlight on mRNA: a new era in...
Spotlight on mRNA – A brief history of mRNA research
In this prologue to our mRNA Spotlight series focusing on mRNA biotechnology, Ellen Lambrix explores the history of...
Consultation on the future of medical device regulation opens
MHRA launches public consultation to gather stakeholder views on changes to future regulation of medical devices in...
IVDR Notified Bodies – here comes the crunch
“53% of IVD Device manufacturers do not have a Notified Body”. Key pipeline of Notified Bodies await designation...
MDR Notified Bodies – the stroll-out continues
Key pipeline of Notified Bodies await designation under the IVDR - Alex Denoon and Jamie Hatzel share their thoughts...
Animal vaccines: COVID-19 and beyond
Knowing “three in every four new human diseases originate in animals”, what’s the case for vaccinating animals...
The CAT’s latest Paroxetine “pay-for-delay” judgment: market definition confusion
The 10 May 2021 supplementary judgment of the Competition Appeal Tribunal (CAT) in the Paroxetine case upholds the...
Cell therapies without cells?
Cells or drugs? Julian Hitchcock looks at the regulatory questions for businesses researching stem cell medicines
Pharma industry joins calls for delay to IVDR application date
Pharma industry joins calls for delay to IVDR application date as “necessary infrastructure for the regulatory...
The modern space race: Vaccine rollout and the regulatory regime
We explain the different types of vaccines and the regulatory journey to get them to the general population. Read...
MHRA approves Janssen COVID-19 vaccine
Fourth COVID-19 vaccine to be approved for use in the UK. Alex Denoon and Hugo Kent-Egan review the route to...
The small difference making big waves: Why ‘genetically engineered’ is not the same as ‘genetically modified’
First published in our Biotech Review of the year – issue 8.
Horizon Europe: An update on funding for UK research and innovation post-Brexit
Ellen Lambrix discusses the importance of the confirmation that the UK will be able to participate in Horizon...
Parallel imports: The road ahead
As with many issues arising from Brexit, parallel imports are raising some questions, especially in such an IP-rich...
What has changed for orphan medicinal products in the UK after Brexit?
Xisca Borrás reviews the “important changes affecting orphan medicinal products in the UK” since Brexit .
CRISPR-Cas9 – from Nobel prizes to priority
With ground-breaking technology comes disputes concerning intellectual property. We explore CRISPR-Cas9 in our...
Another year of SPC updates: Functional claims and new therapeutic applications
In our latest Biotech Review of the year, we summarise SPC updates over 2020, pinpointing specific CJEU decisions...
Data Transfers: bump or mountain in the road?
Collecting and transferring personal data is vital to biotech. What should companies keep an eye on when it comes to...
Avoiding bias and increasing diversity in AI and health research – Part 2
What can be done to decrease bias and increase diversity in health research? Fiona Campbell reviews in part 2 of our...
Avoiding bias and increasing diversity in AI and health research – Part 1
Can inanimate drugs and medical devices be biased? Fiona Campbell explores the need to increase diversity in AI and...
EU Clinical Trials Regulation and portal expected to “go live” 31 January 2022
EMA announces new Clinical Trials Information System to go “live” on 31 January 2022. What will this “missing...
A growing trend of smaller, early-stage investments in UK life sciences
Increasing volume of seed investments into the life sciences sector looks set to have a material effect throughout...
Northern Ireland and EU Medical Devices Regulation: Importer update
Hospitals and dentists to be deemed the Importer? Those who move medical devices from Great Britain to Northern...
International regulation for genome editing in 2021 and beyond
Heritable Human Genome Editing is not just a question of scientific capability, but rather one of society and...
Will the new pharmaceutical strategy for Europe bring changes to the biopharmaceutical rewards system?
Will the new strategy for Europe bring changes to the biopharmaceutical rewards system? Xisca Borrás reviews the EU...
Medical Devices Regulation: UK Conformity Assessment Bodies
How is the medical devices regulatory landscape in the UK looking? Alex Denoon and Hugo Kent-Egan explore some of...
Collaboration: Sustainable future or dangerous pathway?
One of the unexpected positives arising from the COVID-19 pandemic has been the number of collaborations between...
AI in drug discovery: do you know the value of your healthcare data?
With AI-driven research into new drugs, how can this data be protected and how can value be extracted? Claire Smith,...
Biotech is in for a rollercoaster 2021
Gregory Bacon reviews the biotech landscape in our Biotech Review of the year – issue 8. Read more
Top 10 information sharing risks in relation to the distribution of pharmaceuticals – Lexon v CMA [2021] CAT 5
Lessons from Lexon v CMA. This article focusses on the learnings in relation to anti-competitive information sharing...
Will Private Equity make waves in the life sciences sector in 2021?
There was a significant expansion of Private Equity activity in the wider life sciences sector in 2020 - Read Alex...
Notified Bodies – An update
Is there a shortage of Notified Bodies in the medical device industry in the run up to EU MDR becoming applicable?...
EU Medical Devices Regulation: Application date looms large
On 26 May 2021, the EU Medical Device Regulation will become fully applicable. What potential issues is this...
Ground-breaking inventions: A tale of transgenic mice
Regeneron Pharmaceuticals v Kymab. Andrew Bowler and Kathryn Hambly explore how this one Supreme Court ruling had an...
Brexit Britain: Dumping ground or proving ground?
First published in our Biotech Review of the year – issue 8. Introduced in March 2019, the Medicines and...
UK Government’s call for views on artificial intelligence and intellectual property
“Should IP protect inventions or works that are made by machines?” The UK government published response to views...
European Commission issues new medical devices software flowchart
When does software qualify as a medical device? Alex Denoon and Emilia Richards review the European Commission new...
Ten things to think about when settling patent litigation
Members from our competition and patent litigation teams have come together to provide this concise list of ten...
European Commission accepts Aspen pricing commitments
The European Commission has accepted Aspen’s commitments to reduce its prices in Europe for six cancer medicines...
A US perspective – should the patent procurement process fall under the remit of antitrust law?
An amicus curiae brief recently filed by the US Department of Justice (“DoJ”) has provided insight into the...
Innovation Passports and the ILAP: A new and flexible pathway to approval
First “Innovation Passport” awarded to new drug under the recently established Innovative Licensing and Access...
AI and medical devices – Our experts answer three common questions
What are the issues of the use of artificial intelligence in medical devices and more generally in the medical...
Medicines and Medical Devices Act 2021 and what it means for the UK regulatory landscape
Recently becoming UK law, Partner Alex Denoon and trainee Hugo Kent-Egan review the new Medicines and Medical...
Equity stakes, revenue shares and more: how universities are deriving value from their spinouts
The Royal Academy of Engineering’s Enterprise Hub publish interesting analysis of the UK’s academic spinout...
BIA announces another record year of UK biotech investment
The UK Bioindustry Association (BIA) has today released its annual figures for investment activity in the UK biotech...
Uncertain times: Changes to the UK’s tax regime
“It is said that tax is one of life’s two certainties.” Looking back at 2020, Miranda Cass and Rachel Arnison...
AI and Life Sciences: Has protein folding been solved?
The technology to read (and indeed edit) DNA sequences and thus the amino acids sequences that they encode has...
Neurim and Flynn v Mylan: The price spiral argument under scrutiny
Neurim and Flynn v Mylan: The price spiral argument under scrutiny. What might they mean for pharmaceutical cases...
Team-NB issues a cry for help and some slight relief
Team-NB propose two changes that could bring some much needed relief to the Notified Bodies. Hugo Kent-Egan reviews.
Spin-outs: What will 2021 hold for UK universities?
As we progress through 2021, we take a look back out our latest Biotech Review of the year where we share thoughts...
MDCG releases guidance on classification rules for IVDs
MDCG releases guidance on classification rules for IVDs. Alex Denoon and Hugo Kent-Egan explore.
MedTech Europe urges European Commission to delay implementation of IVDR
MedTech Europe calls for the EU to delay the implementation of the In Vitro Diagnostics Regulation (IVDR). Alex...
Number of IVDR Notified Bodies grows to five
The In Vitro Diagnostic Regulation (IVDR) takes effect in May 2022. This means manufacturers only have 18 months to...
Impacts of Brexit on Horizon Europe
The EU’s new flagship programme for research grants, Horizon Europe, is set to launch in 2021, but the UK’s...
Test and trace apps: are there any privacy impacts?
Fiona Campbell explores the test and trace apps and how they work alongside other tracing software. What are the...
The UK’s genomic future
Adrian Sim and Alex Magnusdottir discuss the UK’s genomic future.
What are “endeavour” clauses?
Mark Brown, Max Palmer and Sukanya Majumdar explore the different forms of endeavour clauses and discuss how they...
Regulatory and cultural challenges for IT and outsourcing services in the healthcare and life sciences sectors
Our commercial technology and regulatory teams explore the regulatory and cultural challenges for IT and outsourcing...
Has the UK device revolution begun? The New MHRA Brexit Guidance for devices explained
Alex Denoon and Zac Fargher explore the devices section of the new Brexit guidance released on 1 September 2020.
Medicines and Medical Devices Bill comes under scrutiny in the House of Lords
Concerns raised in the House of Lords as the second reading of the Medicines and Medical Devices Bill took place on...
New MHRA Brexit guidance…Northern Ireland FMD to come!
On 1 September 2020, the Medicines and Healthcare products Regulatory Agency released new Brexit guidance. Alex...
New MHRA Brexit guidance…more to come!
The team is currently working through the new MHRA guidance and will publish summaries in the near future.
European Commission publishes Common Specifications for the reprocessing of single use devices
European Commission publishes common specifications for the reprocessing of single use devices. Partner Alex Denoon...
Government writes to medicine suppliers requesting a six week stockpile
On 3 August 2020, the Department of Health & Social Care (DHSC) wrote to medicine suppliers in the UK requesting...
MHRA warning about “certificates of compliance” & “Attestations of Compliance”
On 23 July 2020, the MHRA published a news story warning about largely meaningless “certificates of compliance”...
Competition authorities continue to address excessive pricing in the pharmaceutical sector
Now more than ever,there is a pressing need to crack down on excessively high prices 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
Charlie French provides a short update of the outcome of the UK Governments response to the public consultation on...
UK Government opens consultation on the power to depart from EU case law
On 2 July 2020, the UK Ministry of Justice published a consultation on the departure from retained EU case law by UK...
Gilead’s remdesivir granted conditional Marketing Authorisation by the European Commission
Earlier today, the European Commission granted[1] a conditional Marketing Authorisation (MA) in respect of...
Further guidance from the Advocate General: ‘Pay-for-delay’ agreements
Pat Treacy and Olivia Henry discuss the Opinion of Advocate General Kokott in Case C-591/16 P H. Lundbeck A/S and...
The Schmerzgel Redemption
On 11 June 2020 the European Court of Justice (ECJ) delivered judgment on Ratiopharm v Novartis (C-786/18) relating...
Back to Brexit – An update on medical devices
On 19 May 2020, the United Kingdom Government published draft negotiation documents (UK Positions) summarising its...
Cell and gene therapies
In recent years, we have seen a trend towards the launch of new gene and cell therapies with record-breaking price...
26 May 2020 – a medical device milestone missed
Today is 26 May 2020. To some, just another Tuesday coming to terms with post-bank holiday blues, but for those in...
The interplay between the Clinical Trials Regulation and the GDPR
Hannah Crowther discusses the interplay between the Clinical Trials Regulation and the GDPR in Biotech Review 2019.
The Court of Justice confirms the EMA’s approach to transparency
The Court of Justice confirms the EMA’s approach to transparency. Xisca Borrás discusses in our Biotech Review...
The CMA’s director disqualification power – a power now being put to use
Sophie Lawrance and Aimee Brookes discuss the CMA making more use of their ability to disqualify directors of...
UK government approach to COVID-19 therapeutics research
As part of its ongoing engagement with the life sciences and pharmaceutical industry during the COVID-19 pandemic,...
The regulation of software medical devices
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
A lengthy back-and-forth about the patentability of plants, plant materials and animals derived from essentially...
“Pay-for-delay” settlement agreements in biotech: a European perspective on the US Humira litigation
Sophie Lawrance and Helena Connors
High Court dismisses GSK’s claim that Sandoz’s AirFluSal Forspiro inhaler passes off GSK’s Seretide Accuhaler
High Court dismisses GSK’s claim that Sandoz’s AirFluSal Forspiro inhaler passes off GSK’s Seretide Accuhaler....
Using CRISPR and the implications of human genome editing
Alex Denoon and Christopher Stubbs discuss CRISPR and the implications of human genome editing in our Biotech Review...
Public Health England ‘approves’ Roche COVID-19 antibody test
It was reported on 13 May 2020 that Public Health England (PHE) has approved Roche’s Elecsys® Anti-SARS-CoV-2...
Jurisdiction challenge succeeds on appeal as contractual exclusive jurisdiction clause has priority
Jurisdiction challenge succeeds on appeal as contractual exclusive jurisdiction clause has priority. Olivia Henry...
DIY gene-editing CRISPR kits
In the few short years since its discovery, CRISPR-Cas9 has transformed bioscience like no other invention in the...
Bristows’ genome editing debate 2019: The quest for the perfect human?
Last November, a week of international meetings to discuss global responses to the impact of gene editing began with...
Pfizer v Hoffman-La Roche – evading Arrow declarations
Pfizer v Hoffman-La Roche – evading Arrow declarations. Gregory Bacon and Viviane Boissy explore in Biotech Review...
Clarity sought on plant patentability
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
Mammoth judgment on IL-17A/F antibodies leads to patent revocation and brief SPC excursion to the CJEU. Kate...
Dosage regimen research; is it worth it?
Adrian Chew discusses dosage regimen research; is it worth it? Biotech review 2019
Priorities for academic organisations in industry-academic partnerships – COVID-19 and beyond
In response to the current coronavirus crisis, we have seen a number of high profile academic-industry partnerships...
Takeda revokes Roche patent to glycosylation pattern extending to Entyvio
Takeda revokes Roche patent to glycosylation pattern extending to Entyvio. Gregory Bacon and Chloe Dickson explore...
Brexit is upon us – what does it all mean?
Gregory Bacon and Xisca Borrás discuss "Brexit is upon us – what does it all mean?£ Biotech review 2019.
Functional claims approved in principle as basis for SPCs
On Thursday 30 April the CJEU handed down its decision in the SPC referral Royalty Pharma (C-650/17) (here[1]); its...
In response to COVID-19, the European Commission resurrects comfort letters
Our team’s recent blog on the impact of COVID-19 on competition law in the UK pharma sector, shed light on the...
Medical Research Council’s guidance on identifiability/ anonymisation
The Medical Research Council (MRC) published new guidance on the anonymisation of data in the sphere of scientific...
How is COVID-19 impacting competition law for the UK pharma sector?
With COVID-19 now a global problem, the life sciences industry is facing pressure and challenges to treat patients...
MDR postponement staves off Swixit – for now
Last week, the European Parliament approved at first reading a legislative proposal (the Amending Regulation) to...
Government agrees to indemnify companies manufacturing ventilators for use by the NHS against IP infringement and product liability
It has been reported in the Financial Times (16 April 2020) that the UK government will shield manufacturers of new...
Government updates ventilator challenge minimum specifications in response to new COVID-19 clinical information
As part of its efforts to ramp up production of medical ventilators by British manufacturing firms in response to...
Moving on from consent? The legal ground for disclosing transfers of value to HCPs
The topic for this article arose from an interesting discussion at a Roundtable Event that Bristows hosted with...
Arrow declarations – How broad can they be?
On 1 April 2020, the Court of Appeal, led by Floyd LJ, handed down judgment concerning the strike out of an Arrow...
UK and Europe back exemptions – more medical devices and PPE in the COVID-19 fight
From 25 March, the MHRA is inviting medical device manufacturers to apply for fast-track approval of any medical...
Smoother sailing for sanitisers
COVID-19 has resulted in a shortage of hand sanitiser. As well as the risk this presents to healthcare professionals...
12 notified bodies now designated under MDR
Just in time for the European Commission to announce that it intends to postpone the date of application of the...
Commission delays MDR by 12 months
Following a call from MedTech Europe to postpone the implementation of the Medical Device Regulation (MDR) and In...
UK announce new ventilator requirements in the fight against COVID-19
On Friday 20 March 2020, the Medicines and Healthcare Regulatory Authority (MHRA) issued guidance on ‘Rapidly...
Medical Devices – When is a change significant?
The Medical Device Coordination Group today published guidance explaining what constitutes a “significant...
CBD – Could be done for?
Today the Food Standards Agency (FSA) announced that products containing cannabidiol (CBD) extracts must be the...
Coronavirus; the growing threat to the global pharmaceutical supply chain
Recently declared a ‘global threat’ by the World Health Organisation, the Coronavirus has spread rapidly, from...
Competition between generics and originators – what’s the relevance of a patent?(Part II)
The Judgment of the Court of Justice of the European Union in the Paroxetine “pay-for-delay” litigation (Case...
First Brexit, now Swexit?
Brexit has dominated the political headlines since the 2016 referendum, and finally came to fruition on 31 January...
Competition between generics and originators – what’s the relevance of a patent?
The Paroxetine case arises from familiar circumstances and has a familiar cast of characters: a blockbuster drug;...
Medtech Europe calls on EU institutions to speed up MDR implementation
The MDR comes into force on 26 May 2020, replacing the outgoing Medical Devices Directive (MDD) and changing the...
Grace period for up-classified Class I medical devices receives green light at European Parliament
EU Parliament confirms approval of a corrigendum to the EUMDR that has the effect of providing a four-year ‘grace...
Good news for manufacturers of up-classified Class I medical devices
The Environment, Public Health and Food Safety Committee of the European Parliament approved a corrigendum to the EU...
Medical devices: Updates galore!
Of the many changes introduced by the EU Medical Device Regulations (EU MDR), one of the most significant is the...
Person Responsible for Regulatory Compliance – The confusion continues
One of the many new requirements to be introduced under the Medical Device Regulation (MDR) is the introduction of...
Gene editing – A survey of public opinion
Since the CRISPR breakthrough in 2012, genome editing has been the focus of a huge amount of attention and debate,...
Supreme Court awards employee inventor £2 million compensation for his “outstanding” invention
Professor Shanks’ 13 year skirmish with former employee Unilever has finally come to an end with the Supreme...
Nesta Talks: ‘How to Grow a Human’, with Philip Ball
Following a presentation at Nesta UK, Viviane Boissy discusses Philip Ball's book "How to Grow a Human", on how...
Deciphering Rule 11: New guidance on the classification of software medical devices under the EU MDR
As discussed in our previous articles on the topic, the incoming EU Medical Devices Regulation (2017/745) (EU MDR)...
GSK’s passing off claims dismissed
On Friday 4 October, Mr. Justice Arnold handed down his judgment in the long running passing off saga concerning the...
Want to look like Kylie Jenner? Well, you probably can’t, says the ASA
Do you want to look like Kylie Jenner? Unfortunately, the Advertising Standards Authority (ASA) thinks that is...
Medical devices: An encouraging September
As discussed in previous articles, the EU Medical Devices Regulation (MDR) comes into force on 26 May 2020, which...
NO-tified Bodies? UL UK ceases Medical Devices Directive operations
Another Notified Body, UL UK, announced on Monday that not only it has not yet applied for EU MDR/IVDR approval, but...
Orphan designation: the General Court clarifies the meaning of significant benefit
Last month the General Court issued its judgment in case T-773/17 dismissing the action brought by GMP-Orphan.
Another one bites the dust…
Alex Denoon and Zac Fargher discuss how Switzerland-based QS Zürich AG has decided not to pursue designation under...
Lloyd’s pulls out of the EU MDR/IVDR race
There are currently only two notified bodies authorised to assess against the new EU Medical Device Regulations (EU...
Notified Bodies: eyes on the up-line
Alex Denoon and Zac Fargher discuss how a combination of the advent of the new EU Medical Device Regulations (EU...
TÜV SÜD gets the Greenlight on EU MDR
Alex Denoon and Zac Fargher discuss the TÜV SÜD's approval as the second Notified Body capable of certifying...
Medical Devices and No-Deal Brexit: where are we now?
This article sets out the salient features of the most recent guidance on the regulation of medical devices in the...
NICE releases Evidence Standards Framework for Digital Health Tech
The purpose of the Framework is to: provide advice to DHT innovators; assist NHS commissioners; and improve DHT...
New guidance on the use of personal data in clinical trials
Following the implementation of the EU General Data Protection Regulation (GDPR), there has been concern about the...
The General Court’s judgment in Krka – some welcome clarity over licensing in the context of patent settlements
We reported on this blog about the General Court (GC)’s judgment in Servier on the day on which that judgment was...
Record investment in UK biotech
The UK’s BioIndustry Association (BIA), together with Informa Pharma Intelligence, have recently published figures...
Matt Hancock sets out the UK’s 20-year vision on tackling antimicrobial resistance
Do you lie awake at night worrying about that last pack of antibiotics? Matt Hancock sets out the UK’s 20-year...
CRISPR gene editing technology and its many applications
The revolutionary CRISPR-Cas9 gene editing technology is regularly in the headlines, much of the time in the context...
A brief history of UCART-19
The rapid development of the immunotherapy landscape has driven increased numbers of acquisitions and collaborations...
Partial annulment of Servier decision by the General Court – some good news for pharma innovators at last
The General Court has today handed down its judgment in the long-running Servier patent settlement case.
New EU Regulation for Veterinary Medicinal Products
The European Council has approved the text for a new Regulation that will overhaul the existing rules on the...
What is the best response to higher prices in the pharma sector?
Pricing issues in the pharmaceutical industry continue to keep European competition authorities busy.
CAR-T round-up: off-the-shelf challengers and avoiding the (cytokine) storm
Charlie French gives a round up of CAR-T therapies.
“One Medicine” – A new approach to healthcare?
“One Medicine” is a revolutionary approach to healthcare, which involves sharing knowledge between doctors and...
Ethics and Data Privacy
Whilst there has been much attention to data protection as a result of the EU General Data Protection Regulation as...
One more piece in the SPC puzzle – Medical devices with ancillary substances do not qualify for an SPC
On 25 October 2018 the CJEU published their latest judgment[1] on the application of the SPC Regulation (Regulation...
Fighting antimicrobial resistance – overall sales of antimicrobials for use in food-producing animals drops in the EU according to the EMA report
The EMA has a Committee for Medicinal Products for Veterinary Use (CVMP)[1] and one of their key objectives is to...
Request to re-open Glaxo ‘dual pricing’ case rejected by General Court: The end of the road for challenges to dual pricing?
Entering into agreements that erect barriers to parallel exports between EU markets is generally a high-risk...
CAR-T gets the green light in Europe
On Monday 27 August, the first two CAR-T therapies were authorised for use in the European Union, following EMA...
Are organisms that are the product of mutagenesis subject to the GMO Directive on deliberate release?
In case C-528/16 proceedings were brought between the French agricultural union and eight associations (the...
Concordia and the CMA – a drama in (at least) three parts
Last week, Concordia International released a management report in which it announced the names of six drugs...
Different types of CAR-T
CAR-T cell therapy remains an exciting area in healthcare, and a potentially very lucrative one - a recent market...
The EMA’s clinical data publication policy: 1 year on
On 16 July 2018, the EMA published a report on the first year (Oct 2016 – Oct 2017) of its clinical data...
Funding for UK research and innovation post-Brexit: Hope on the Horizon?
An update on the UK’s participation in Horizon 2020 and its successor Horizon Europe in light of Brexit
CJEU follows Advocate General’s Opinion to confirm the scope of the Specific Mechanism
On 21 June 2018 the CJEU gave its judgment in a preliminary reference from the Düsseldorf Court seeking clarity on...
CAR-T keeps driving forward: a round-up of recent scientific and commercial developments
The pace of development in the CAR-T world, both scientific and commercial, is showing no sign of letting up. We...
The CAT sets a clear framework for excessive and unfair prices in its Pfizer/Flynn judgment
The Competition Appeal Tribunal (CAT) recently gave its judgment in Pfizer and Flynn’s appeal of the...
Drafting leases for life sciences
Over the past decade, the UK life sciences sector has enjoyed rapid expansion, aided by a 41% annualised increase in...
Driving immunotherapy forward: More than CAR-Ts
With two therapies already on the market and many more in the pipeline, this exciting new treatment is...
Depression Delayed: CMA’s paroxetine pay-for-delay case heads to Luxembourg
On 8 March 2018, the Competition Appeal Tribunal (CAT) gave an initial judgment in appeals brought by...
Can’t stop the CAR-T
Rachel Mumby and Jonathan Ross discuss highlights in the CAR-T world.
The NHS gets on the bandwagon with CAR-T
Of interest to our UK readers will be the announcement by Simon Stevens, the chief executive of the NHS, in a speech...
How the life sciences industry may be affected by Brexit
The European Commission published a Draft Withdrawal Agreement (the Agreement) on 19 March 2018.
Side CAR-Ts
Greg Bacon and Rachel Mumby discuss how different the CAR-T space is for big pharma, whose companies have...
CAR-T rolls on
Various new cellular immunotherapy acquisitions and collaborations have been announced over recent months, as well...
Different types of value transfer in ‘reverse payment’ settlement agreements
Sophie Lawrance and Edwin Bond give their summary on the different forms of value transfer that competition...
The competition law issues of the CRISPR patent pool
CRISPR-Cas9 is heralded as a revolutionary gene editing technology that is regularly hitting the headlines for both...
AG Opinion: Organisms obtained by mutagenesis are GMOs exempt from the provisions of the GMO Directive
Advocate General Bobek’s opinion in a reference from the Conseil d’État to the CJEU[1] for a preliminary ruling...
Specific Mechanism applies to extended SPC period opines AG Tanchev
On 7 February 2018 Advocate General Tanchev delivered his opinion in Pfizer Ireland Pharmaceuticals v Orifarm...
Proposal to extend UK withholding tax on royalties – The start of a major shift in the UK’s approach to taxation?
Following the autumn 2017 Budget announcement, the UK Government has launched a consultation looking at extending...
10 key points on Parallel Trade and Pharma
Pat Treacy discusses 10 key points on parallel trade and pharma.
Evolving how English courts construe written commercial contracts (Teva v AstraZeneca)
Matthew Warren and Alex Calver discuss how English courts construe written commercial contracts, in the caseof Teva...
Misleading information and competition law – Case C-179/16 CJEU Judgment of 23 January 2018 (Avastin/Lucentis –Italy)
Pat Treacy discusses the interplay between EU competition law and the pharmaceutical regulatory regime.
Impact of Brexit on International Data Transfer Mechanisms
Robert Bond discusses how the GDPR simplifies the mechanisms available to protect the rights of individuals in...
Patents Court rules on non-invasive prenatal diagnosis patents
Claire Wilson discusses Illumina v Premaitha where 5 patents, all of which were concerned with non-invasive prenatal...
Sandoz v Amgen: An update
Dominic Adair and Thomas Hendicott review Sandoz and Amgen, relating to the abbreviated pathway for obtaining FDA...
Digital Health – The CJEU’ s first decision on standalone software as a medical device
On 7 December 2017 the Court of Justice of the European Union (“CJEU”) published its decision on the case...
Biotech Review
Bristows' Biotech Review of the Year is an overview of some of the recent key developments in this sector. From...
UK Government announces a Life Sciences Sector Deal as part of its Industrial Strategy
The UK Government has today announced a Life Sciences Sector Deal as part of its new Industrial Strategy. The...
NHS Pharmaceutical Procurement – Top 10 Tips
This article considers key public procurement issues that arise for pharmaceutical and medical device companies...
Pharma Sector Inquiry ‘Encore’
In November 2017, the French competition authority, the Autorité de la concurrence, announced a new enquiry into...
Lifting restrictions on veterinary medicine retail channels and veterinary practice ownership in Europe (Case C-297/16)
In Case C-297/16 ‘CMVR’, the Romanian Court of Appeal referred two questions to the CJ stemming from Romanian...
Providing Misleading Information About Product Safety – a Restriction of Competition by Object?
“A dispute … [with] unusual characteristics …”[1] is how AG Saugmandsgaard described this case.
Dosage Regimen Patent Held Invalid
Last year, Actavis, Teva and Mylan (“Actavis”) sought revocation in the English Patents Court of two patents...
Is there such a thing as Substitution or Interchangeability for Biosimilars?
Biological medicinal products have rapidly become one of the fastest growing areas of medicine and for many...
Product hopping: The competition law risks of launching new product formulations
‘Product hopping’, or ‘evergreening’, are expressions used (by competition authorities and industry...
CRISPR undergoes exciting new developments
The discovery of CRISPR five years ago has revolutionised the way we can manipulate and edit DNA. The use of the...
Arrow declarations post Actavis v Eli Lilly
An issue which has been the subject of much discussion since the judgment of the Supreme Court in Actavis v Eli...
Construction and novelty post Actavis v Eli Lilly
On 26 October 2017, Arnold J handed down judgment in Generics (UK) Ltd v Yeda [2017] EWHC 2629 (Pat), the first...
Unjustified Threats Act comes into force
Letters before action are encouraged by the Courts in the UK as a way of potentially avoiding the need for...
Brucellosis Vaccine Prize
The Brucellosis Vaccine Prize, an innovative $30 million prize competition, is designed to encourage the development...
CAR-T Therapy: the current landscape
CAR-T technology Chimeric antigen receptor T cell (CAR-T) therapy is currently the hot topic in the pharma world....
Excessive Pricing – Pfizer/Flynn in light of the CJEU’s recent decision
Excessive pricing has become a hot topic for the pharmaceutical sector in the last year, having been ignited by...
Biosimilars: NHS approach to procurement
The financial pressures on the NHS have resulted in some questionable strategies in the use of framework contracts...
European Court says scientific proof of causation is not required under the EU Product Liability Directive
On 21 June 2017 the Court of Justice of the European Union (the CJEU) delivered its judgment in Case C-621/15, a...
Standardisation agreements in pharma – Competition law tips for collaboration between pharma companies
Collaboration with competitors can be an effective strategy for pharma companies seeking to develop common standards...
Are pharmaceutical companies using rebates at risk of being investigated by the competition authorities?
Rebate systems are commonly used by pharmaceutical companies. A quantity-based rebate system, where a customer is...
UK competition enforcement in the Pharma sector: A priority area for the CMA
In the last couple of years, the UK competition authority has investigated the conduct of several companies in the...
EPO takes an ‘about turn’ on the patentability of products obtained by essentially biological processes
At the end of June the EPO published a notice (see here) stating from 1 July 2017 plants and animals exclusively...
FDA approves first GM individualised cell therapy
Novartis has received FDA approval for its CAR-T cell therapy, marketed as Kymriah, for the treatment of a...
Supreme Court “improves” upon the Improver/Protocol Questions in Actavis v Eli Lilly
In this important case from July of this year, the Supreme Court reintroduced a true form of the doctrine of...
The lure of the US for UK biotech
The UK has a world leading life sciences sector which is underpinned by an array of second-to-none research, world...
Clustering and Innovation Districts
Clustering, where several entities in the same or complementary industries locate themselves within close proximity...
CRISPR-Cas9 – An update
CRISPR-Cas9 editing, the technology which gives scientists the ability to selectively edit genes with relative ease,...
Free movement of health data and data protection implications
On 21st August 2017 the European Commission published responses to the question regarding the free movement of data...
The use of mobile apps and software as a form of healthcare within the NHS
Hilary Jones and Michaela Herron examine the use of mobile apps as 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
The UK Information Commissioner’s Offce (‘ICO’) closed on 31 March 2017 the consultation on its draft guidance...
Case Analysis: Elisabeth Schmitt v TUV Rheinland LGA Products GmbH
Introduction On 26 February 2017, the Court of Justice of the European Union (CJEU) delivered a preliminary ruling...
How the CJEU has interpreted “protected” in the SPC regulation
Bristows partner Brian Cordery and associate Steven Willis look at how the CJEU has approached Article 3(a) of the...
Excessive pharma pricing
This article was first published in Competition Law Insight, March 2017 On 7 December 2016, in an unusual...
Patent Review of the Year
Bristows’ Patent Review of the Year reports each year on important decisions from both the High Court and the...
Clinical trial data transparency: the EU inches closer to legal certainty
On 1 March 2017, the Vice-President of the Court of justice issued a ruling that sets up the opportunity for a much...
Second medical use issues—where are we now and where should we be going?
The enforcement of second medical use patents is currently one of the hottest topics in European patent litigation....
NICE and NHS England Consultation on proposals for changes to the evaluation and funding of drugs
In October 2016 NICE (National Institute for Health and Care Excellence) and NHS England issued a public...
Opening Life Sciences’ Unified Patent Court war chest
The future role of the UK in the Unified Patent Court (UPC), if any, has been brought to the forefront as the battle...
Public Procurement Regimes in the UK and EU
Legal Framework Public procurement rules apply to the purchase of goods, works or services by governments and other...
First CMA competition decision on excessive pricing in the pharmaceutical sector
As a body of law, competition law is unusual in the extent to which it is susceptible to the influence of wider...
The Research and Development Block Exemption (RDBE)
Application of the RDBE Many R&D agreements are outside the scope of Article 101 altogether: R&D agreements...
Science in architecture – the opportunities and challenges
Buildings that can repair themselves and cities powered by micro-organisms – these are examples of the potential...
Modernising EU legislation for medical devices: the new Medical Devices Regulation
Introduction On 20 September 2016, the Council of the European Union accepted the European Parliament’s first...
A sense of relief: enforcing second medical use patents
This article was first published in Life Sciences Intellectual Property Review, March 2016 In the last year the...
Arrow declarations – a second shot at the target
2016 is the year that the Arrow declaration has made its comeback. These declarations concern pending patent...
First Borderline Decision of the EU Commission: Is this a welcome approach for industry?
Introduction On 22 February 2016, the European Commission released a draft version of its first borderline decision...
Actavis v ICOS – clearing the way between a rock and a hard place?
On 10 August 2016, judgment in Actavis v ICOS was handed down. This was a patent action relating to the compound...
Can you obtain an SPC for a new formulation of a medicine? The UKIPO considers the CJEU decisions in MIT and Neurim
On 26 August 2016, the UKIPO issued its decision rejecting Abraxis Bioscience’s application for an SPC for...
Electronic cigarettes: the medicine of tomorrow?
This article was first published in Journal of the Law Society of Scotland, April 2016 Why the implementation of...
Lyrica continues – The Court of Appeal considers infringement and validity of Pfizer’s second medical use patent
On 13 October 2016 the Court of Appeal handed down judgment in relation to a second medical use patent with claims...
Painfully objective decision of the Court of Appeal in Warner Lambert v Actavis tortuously applied by the Patents Court
The Warner Lambert v Actavis cases on pregabalin-based medicines have been before the UK Courts on no less than...
Collaborate to accumulate: exciting commercial collaborations in the medical devices sector
A recent KPMG survey[1] of companies operating in the medical devices sector found that over 80% of respondents...
Court of Appeal provides guidance on determining an account of profits
In a decision dated 24 February 2016, the Court of Appeal (Lewison LJ giving the leading judgment) allowed an appeal...
Life Sciences under the GDPR
On 25 May 2018, the current UK Data Protection Act 1998 (and all the other implementing laws across the EU) will be...
Antimicrobial resistance – a global threat triggering a global response
What is antimicrobial resistance? Antimicrobial resistance is resistance of a microorganism to an antimicrobial drug...
Regeneron Pharmaceuticals Inc v (1) Kymab Ltd (2) Novo Nordisk A/S
This article was first published in Kluwer Patent Blog, February 2016 Mr Justice Carr is only a few months into his...
Peripheral Decisions in the Lyrica (pregabalin) Saga
As reported in the October edition of On The Pulse, on 10 September 2015 Arnold J found Warner-Lambert’s patent...
Plausibility in immunotherapy – is PD-1 the way forward?
Ono is the proprietor of a patent for the use of anti-PD-1 antibodies which inhibit the immunosuppressive signal of...
Has the CJEU paved the way for parallel importation of veterinary medicines by livestock farmers (Case C-114/15)?
In the context of criminal proceedings concerning the potential violation of the legal requirements applicable to...
UK – Mylan v. Warner-Lambert/Abuse
The article was first published in EPLAW Patent Blog, December 2015 Generics (UK) Limited trading as Mylan v...
UK – Actavis v. Eli Lilly
This article was first published in EPLAW Patent Blog, December 2015 Actavis Group PTC EHF & Anor v Eli Lilly...
One step closer to decoupling veterinary medicines from the human medicines legislation
The European Economic and Social Committee (EESC) has published Opinion (2015/C 24207) which broadly endorses...
Salt limitation leads to sweet and sour Court of Appeal judgment
This article was first published in Kluwer Patent Blog, July 2015 The Actavis v Eli Lilly UK litigation concerning...
CJEU confirms the broad scope of Article 6 of the Transparency Directive
On 16 April 2015, the CJEU handed down its decision in conjoined cases LFB Biomédicaments SA (“LFB”) (C-271/14)...
English High Court considers infringement of second medical use claims
The last few years has seen a notable increase in the number of disputes concerning second medical use patents. At...
The EFTA Court provides an Advisory Opinion on the validity and scope of SPCs for veterinary medicinal products
Background and legislation The EFTA Court has jurisdiction with regard to the EFTA States which are also party to...
No invention in setting a research project and claiming the results
Mr. Justice Arnold’s 1 December 2014 judgment in Idenix Pharmaceuticals v Gilead Sciences is notable for many...
Smith & Nephew v ConvaTec No 2: a well rounded performance
On 12 December 2013, the Patents Court handed down its judgment in Smith & Nephew v ConvaTec No.2. The court...
Amended claims must not be obvious or arbitrary
In a decision dated 21 October 2015, the Patents Court (Morgan J) held that Boehringer Ingelheim’s unconditionally...
Eli Lilly v HGS – High court tries to implement CJEU decision regarding SPCs
This summer the Eli Lilly v HGS case came back before the High Court, following the CJEU’s ruling that SPCs could...
The Patents Court confirms that clinical trials are not necessarily confidential
Summary: In the recent case of AGA v Occlutech, the Court has held that clinical trials are not prima facie...
The English Court – the one-stop shop for DNIs across Europe?
Actavis v Eli Lilly & Co. [2014] EWHC 1511 – Arnold J granted a Declaration of Non-Infringement in...
