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 ...
Alex Denoon and Zac Fargher discuss the TÜV SÜD's approval as the second Notified Body capable of certifying against the incoming EU Medical Device Regulation (EU MDR).
Meet the experts
Medical Devices and No-Deal Brexit: where are we now?
The purpose of the Framework is to: provide advice to DHT innovators; assist NHS commissione...
The purpose of the Framework is to: provide advice to DHT innovators; assist NHS commissioners; and improve DHT de...
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 rece...
The UK’s BioIndustry Association (BIA), together with Informa Pharma Intelligence, have recently published figures which reveal that the UK biotech sector raised a record £2.2bn in 2018, up from £1.2bn the year before.
Matt Hancock sets out the UK’s 20-year vision on tackling antimicrobial resistance
The revolutionary CRISPR-Cas9 gene editing technology is regularly in the headlines, much of...
The revolutionary CRISPR-Cas9 gene editing technology is regularly in the headlines, much of the time in the conte...
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 exist...
The European Council has approved the text for a new Regulation that will overhaul the existing rules on the authorisation and use of veterinary medicinal products in the EU. The main changes being introduced are an extension of reg...
What is the best response to higher prices in the pharma sector?
Charlie French gives a round up of CAR-T therapies.
“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...
On 25 October 2018 the CJEU published their latest judgment[1] on the application of the SPC Regulation (Regulation (EC) No 469/2009).
Fighting antimicrobial resistance – overall sales of antimicrobials for use in food-producing animals drops in the EU according to the EMA report
Entering into agreements that erect barriers to parallel exports between EU markets is gener...
Entering into agreements that erect barriers to parallel exports between EU markets is generally a high-risk endea...
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 na...
Last week, Concordia International released a management report in which it announced the names of six drugs currently under investigation by the Competition and Markets Authority (“CMA”). This relates to an investigation into Conco...
Different types of CAR-T
On 16 July 2018, the EMA published a report on the first year (Oct 2016 – Oct 2017) of its c...
On 16 July 2018, the EMA published a report on the first year (Oct 2016 – Oct 2017) of its clinical data publicati...
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 appea...
The Competition Appeal Tribunal (CAT) recently gave its judgment in Pfizer and Flynn’s appeal of the ground-breaking excessive pricing Decision by the Competition and Markets Authority (CMA). While the findings of dominance (based o...
Drafting leases for life sciences
With two therapies already on the market and many more in the pipeline, this exciting new tr...
With two therapies already on the market and many more in the pipeline, this exciting new treatment is understanda...
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...
Of interest to our UK readers will be the announcement by Simon Stevens, the chief executive of the NHS, in a speech to the Association of the British Pharmaceutical Industry on 26 April 2018, that preparations are underway to asses...
How the life sciences industry may be affected by Brexit
Greg Bacon and Rachel Mumby discuss how different the CAR-T space is for big pharma, whose c...
Greg Bacon and Rachel Mumby discuss how different the CAR-T space is for big pharma, whose companies have historic...
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...
CRISPR-Cas9 is heralded as a revolutionary gene editing technology that is regularly hitting the headlines for both its scientific promise and fiercely fought patent wars.
AG Opinion: Organisms obtained by mutagenesis are GMOs exempt from the provisions of the GMO Directive
On 7 February 2018 Advocate General Tanchev delivered his opinion in Pfizer Ireland Pharmace...
On 7 February 2018 Advocate General Tanchev delivered his opinion in Pfizer Ireland Pharmaceuticals v Orifarm (C-6...
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 contra...
Matthew Warren and Alex Calver discuss how English courts construe written commercial contracts, in the caseof Teva v AstraZeneca.
Misleading information and competition law – Case C-179/16 CJEU Judgment of 23 January 2018 (Avastin/Lucentis –Italy)
Robert Bond discusses how the GDPR simplifies the mechanisms available to protect the rights...
Robert Bond discusses how the GDPR simplifies the mechanisms available to protect the rights of individuals in rel...
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 decisio...
On 7 December 2017 the Court of Justice of the European Union (“CJEU”) published its decision on the case C-329/16 Snitem and Philips France[1], the first instance in which the CJEU has ruled on standalone software within the medica...
Biotech Review
The UK Government has today announced a Life Sciences Sector Deal as part of its new Industr...
The UK Government has today announced a Life Sciences Sector Deal as part of its new Industrial Strategy. The Gove...
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 stemm...
In Case C-297/16 ‘CMVR’, the Romanian Court of Appeal referred two questions to the CJ stemming from Romanian national laws which grant veterinary practitioners an exclusive right to retail and use veterinary medicinal products and ...
Providing Misleading Information About Product Safety – a Restriction of Competition by Object?
Last year, Actavis, Teva and Mylan (“Actavis”) sought revocation in the English Patents Cour...
Last year, Actavis, Teva and Mylan (“Actavis”) sought revocation in the English Patents Court of two patents relat...
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...
The discovery of CRISPR five years ago has revolutionised the way we can manipulate and edit DNA. The use of the technology in clinical trials has exploded, primarily in China, where, as at June 2017, as many as 20 human trials were...
Arrow Declarations post Actavis v Eli Lilly
On 26 October 2017, Arnold J handed down judgment in Generics (UK) Ltd v Yeda [2017] EWHC 26...
On 26 October 2017, Arnold J handed down judgment in Generics (UK) Ltd v Yeda [2017] EWHC 2629 (Pat), the first ju...
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...
CAR-T technology Chimeric antigen receptor T cell (CAR-T) therapy is currently the hot topic in the pharma world. The therapy involves treating patients with T cells engineered to express a chimeric antigen receptor that allows the ...
Excessive Pricing – Pfizer/Flynn in light of the CJEU’s recent decision
The financial pressures on the NHS have resulted in some questionable strategies in the use ...
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
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...
Rebate systems are commonly used by pharmaceutical companies. A quantity-based rebate system, where a customer is offered lower prices on further units once a particular volume has been purchased, incentivises the customer to purcha...
UK competition enforcement in the Pharma sector: A priority area for the CMA
At the end of June the EPO published a notice (see here) stating from 1 July 2017 plants and...
At the end of June the EPO published a notice (see here) stating from 1 July 2017 plants and animals exclusively o...
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 second-t...
The UK has a world leading life sciences sector which is underpinned by an array of second-to-none research, world leading universities and a nurturing environment for funding and growing start-ups. Yet, although the UK is evidently...
Clustering and Innovation Districts
http://bristowsotp.modulemedia.co.uk/assets/pdf/Licensing presentation – 13 September ...
http://bristowsotp.modulemedia.co.uk/assets/pdf/Licensing presentation – 13 September 2017-72744.pdf
CRISPR-Cas9 – An update
Free movement of health data and data protection implications
This article was first published in Digital Health Legal, July 2017 Further utilisation by t...
This article was first published in Digital Health Legal, July 2017 Further utilisation by the UK’s NHS of mobile apps and software is steadily growing; for instance earlier this year the NHS announced a pilot program involving the ...
The ICO’s approach to consent under the GDPR and how it relates to digital health
Introduction On 26 February 2017, the Court of Justice of the European Union (CJEU) delivere...
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
Excessive pharma pricing
Bristows’ Patent Review of the Year reports each year on important decisions from both...
Bristows’ Patent Review of the Year reports each year on important decisions from both the High Court and the Court of Appeal, particularly with regards to the law of obviousness and certain procedural issues. If you would lik...
Clinical trial data transparency: the EU inches closer to legal certainty
This article was first published on Lexis®PSL Corporate Crime on 22 February 2017. Click for...
This article was first published on Lexis®PSL Corporate Crime on 22 February 2017. Click for a free trial of Lexis...
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 b...
Legal Framework Public procurement rules apply to the purchase of goods, works or services by governments and other public bodies (referred to as a ‘contracting authority’). The over-arching EU objective is to safeguard the free mo...
First CMA competition decision on excessive pricing in the pharmaceutical sector
Application of the RDBE Many R&D agreements are outside the scope of Article 101 altoge...
Application of the RDBE Many R&D agreements are outside the scope of Article 101 altogether: • R&D agree...
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 I...
This article was first published in Life Sciences Intellectual Property Review, March 2016 In the last year the English courts have produced several judgments on infringement of second medical use claims as part of the continuing li...
Arrow declarations – a second shot at the target
Introduction On 22 February 2016, the European Commission released a draft version of its fi...
Introduction On 22 February 2016, the European Commission released a draft version of its first borderline decisio...
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 t...
This article was first published in Journal of the Law Society of Scotland, April 2016 Why the implementation of the new Tobacco Products Directive may present a regulatory conundrum for manufacturers of electronic cigarettes Since ...
Lyrica continues – The Court of Appeal considers infringement and validity of Pfizer’s second medical use patent
In October 2016 NICE (National Institute for Health and Care Excellence) and NHS England iss...
In October 2016 NICE (National Institute for Health and Care Excellence) and NHS England issued a public consultat...
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 jud...
In a decision dated 24 February 2016, the Court of Appeal (Lewison LJ giving the leading judgment) allowed an appeal of the decision of HHJ Hacon in the Intellectual Property Enterprise Court (“IPEC”) in Design & Display Limite...
Life Sciences under the GDPR
Antimicrobial resistance is a major public health challenge that is rapidly climbing the int...
Antimicrobial resistance is a major public health challenge that is rapidly climbing the international political a...
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 immu...
Ono is the proprietor of a patent for the use of anti-PD-1 antibodies which inhibit the immunosuppressive signal of PD-1 in the treatment of cancer. Ono developed such a monoclonal antibody, nivolumab, which it branded as Otivo. M...
Introduction to the regulatory legal framework applicable to Orphan medicinal products
Introduction In the context of criminal proceedings concerning the potential violation of th...
Introduction In the context of criminal proceedings concerning the potential violation of the legal requirements a...
UK – Mylan v. Warner-Lambert / Abuse
UK – Actavis v. Eli Lilly
The European Economic and Social Committee (EESC) has published Opinion (2015/C 24207) which...
The European Economic and Social Committee (EESC) has published Opinion (2015/C 24207) which broadly endorses proposals for three new regulations which decouple veterinary medicines from Regulation 726/2004, consolidate and update t...
Salt limitation leads to sweet and sour Court of Appeal judgment
On 16 April 2015, the CJEU handed down its decision in conjoined cases LFB Biomédicaments SA...
On 16 April 2015, the CJEU handed down its decision in conjoined cases LFB Biomédicaments SA (“LFB”) (C-271/14) an...
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
Mr. Justice Arnold’s 1 December 2014 judgment in Idenix Pharmaceuticals v Gilead Sciences is...
Mr. Justice Arnold’s 1 December 2014 judgment in Idenix Pharmaceuticals v Gilead Sciences is notable for many reasons other than its length and complexity. Perhaps chief among these is that it was delivered within nine months of the...
Smith & Nephew v ConvaTec No 2: a well rounded performance
In a decision dated 21 October 2015, the Patents Court (Morgan J) held that Boehringer Ingel...
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
The Patents Court confirms that clinical trials are not necessarily confidential
Actavis v Eli Lilly & Co. [2014] EWHC 1511 – Arnold J granted a Declaration of No...
Actavis v Eli Lilly & Co. [2014] EWHC 1511 – Arnold J granted a Declaration of Non-Infringement in relation to the UK, French, Italian and Spanish designations of Eli Lilly’s EP. The case of Actavis v Eli Lilly & Co....
