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 brou...
Last month the General Court issued its judgment in case T-773/17 dismissing the action brought by GMP-Orphan.
Meet the experts
Another one bites the dust…
There are currently only two notified bodies authorised to assess against the new EU Medical...
There are currently only two notified bodies authorised to assess against the new EU Medical Device Regulations (E...
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 ...
This article sets out the salient features of the most recent guidance on the regulation of medical devices in the event of a no-deal Brexit.
NICE releases Evidence Standards Framework for Digital Health Tech
Following the implementation of the EU General Data Protection Regulation (GDPR), there has ...
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
Record investment in UK biotech
Do you lie awake at night worrying about that last pack of antibiotics? Matt Hancock sets ou...
Do you lie awake at night worrying about that last pack of antibiotics? Matt Hancock sets out the UK’s 20-year vision on tackling antimicrobial resistance.
CRISPR gene editing technology and its many applications
The rapid development of the immunotherapy landscape has driven increased numbers of acquisi...
The rapid development of the immunotherapy landscape has driven increased numbers of acquisitions and collaboratio...
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 authorit...
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
“One Medicine” is a revolutionary approach to healthcare, which involves sharing knowledge b...
“One Medicine” is a revolutionary approach to healthcare, which involves sharing knowledge between doctors and vet...
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...
The EMA has a Committee for Medicinal Products for Veterinary Use (CVMP)[1] and one of their key objectives is to protect the health and welfare of animals by promoting the availability of effective antibiotics.
Request to re-open Glaxo ‘dual pricing’ case rejected by General Court: The end of the road for challenges to dual pricing?
On Monday 27 August, the first two CAR-T therapies were authorised for use in the European U...
On Monday 27 August, the first two CAR-T therapies were authorised for use in the European Union, following EMA ap...
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 ...
CAR-T cell therapy remains an exciting area in healthcare, and a potentially very lucrative one - a recent market studyhas estimated the value to be $2.9 billion by 2023 worldwide.
The EMA’s clinical data publication policy: 1 year on
On 21 June 2018 the CJEU gave its judgment in a preliminary reference from the Düsseldorf Co...
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 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...
Over the past decade, the UK life sciences sector has enjoyed rapid expansion, aided by a 41% annualised increase in investment. Almost 6 million people in the UK (one in five British workers) are currently employed in the sector wh...
Driving immunotherapy forward: More than CAR-Ts
On 8 March 2018, the Competition Appeal Tribunal (CAT) gave an initial judgment in appeals b...
On 8 March 2018, the Competition Appeal Tribunal (CAT) gave an initial judgment in appeals brought by GlaxoSmithKl...
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 2...
The European Commission published a Draft Withdrawal Agreement (the Agreement) on 19 March 2018.
Side CAR-Ts
Various new cellular immunotherapy acquisitions and collaborations have been announced over ...
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
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] for a...
Advocate General Bobek’s opinion in a reference from the Conseil d’État to the CJEU[1] for a preliminary ruling concerning regulation of the release into the environment of genetically modified organisms (GMOs) obtained by mutagenes...
Specific Mechanism applies to extended SPC period opines AG Tanchev
Following the autumn 2017 Budget announcement, the UK Government has launched a consultation...
Following the autumn 2017 Budget announcement, the UK Government has launched a consultation looking at extending ...
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 regulat...
Pat Treacy discusses the interplay between EU competition law and the pharmaceutical regulatory regime.
Impact of Brexit on International Data Transfer Mechanisms
Claire Wilson discusses Illumina v Premaitha where 5 patents, all of which were concerned wi...
Claire Wilson discusses Illumina v Premaitha where 5 patents, all of which were concerned with non-invasive prenat...
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 developm...
Bristows’ Biotech Review of the Year is an overview of some of the recent key developments in this sector. From antibodies and the patentability of human genes to the transparency of data in clinical trials, we take a look at ...
UK Government announces a Life Sciences Sector Deal as part of its Industrial Strategy
This article considers key public procurement issues that arise for pharmaceutical and medic...
This article considers key public procurement issues that arise for pharmaceutical and medical device companies pa...
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 described this ca...
“A dispute … [with] unusual characteristics …”[1] is how AG Saugmandsgaard described this case. It relates to the decision of the Italian Antitrust Authority (the AGCM) that certain conduct affecting the off-label use of Avastin in...
Dosage Regimen Patent Held Invalid
Biological medicinal products have rapidly become one of the fastest growing areas of medici...
Biological medicinal products have rapidly become one of the fastest growing areas of medicine and for many condit...
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 Cou...
An issue which has been the subject of much discussion since the judgment of the Supreme Court in Actavis v Eli Lilly[2017] UKSC 48 is what this means for Arrow Declarations. In Fujifilm v AbbVie [2017] EWCA Civ 1, the Court of App...
Construction and novelty post Actavis v Eli Lilly
Letters before action are encouraged by the Courts in the UK as a way of potentially avoidin...
Letters before action are encouraged by the Courts in the UK as a way of potentially avoiding the need for litigat...
Brucellosis Vaccine Prize
CAR-T Therapy: the Current Landscape
Excessive pricing has become a hot topic for the pharmaceutical sector in the last year, hav...
Excessive pricing has become a hot topic for the pharmaceutical sector in the last year, having been ignited by regulatory investigations in the UK and Italy. In October last year, the Italian competition authority fined Aspen €5.2 ...
Biosimilars: NHS approach to procurement
On 21 June 2017 the Court of Justice of the European Union (the CJEU) delivered its judgment...
On 21 June 2017 the Court of Justice of the European Union (the CJEU) delivered its judgment in Case C-621/15, a r...
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 se...
In the last couple of years, the UK competition authority has investigated the conduct of several companies in the pharma sector, leading in some cases to significant fines. Indeed, the Competition and Markets Authority (CMA) has st...
EPO takes an ‘about turn’ on the patentability of products obtained by essentially biological processes
Novartis has received FDA approval for its CAR-T cell therapy, marketed as Kymriah, for the ...
Novartis has received FDA approval for its CAR-T cell therapy, marketed as Kymriah, for the treatment of a particu...
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...
Clustering, where several entities in the same or complementary industries locate themselves within close proximity to collaborate is widely adopted by those that work in the Life Sciences sector to share knowledge, expertise and ac...
Patent licences – some key features
CRISPR-Cas9 editing, the technology which gives scientists the ability to selectively edit g...
CRISPR-Cas9 editing, the technology which gives scientists the ability to selectively edit genes with relative eas...
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 on ...
The UK Information Commissioner’s Offce (‘ICO’) closed on 31 March 2017 the consultation on its draft guidance on its approach to consent under the EU General Data Protection Regulation (‘GDPR’). Crucially, as the ICO clarifies in i...
Case Analysis: Elisabeth Schmitt v TUV Rheinland LGA Products GmbH
Bristows partner Brian Cordery and associate Steven Willis look at how the CJEU has approach...
Bristows partner Brian Cordery and associate Steven Willis look at how the CJEU has approached Article 3(a) of the...
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...
On 1 March 2017, the Vice-President of the Court of justice issued a ruling that sets up the opportunity for a much needed final adjudication of the parameters of commercially confidential information within clinical trial data.1 Ba...
Second medical use issues—where are we now and where should we be going?
In October 2016 NICE (National Institute for Health and Care Excellence) and NHS England iss...
In October 2016 NICE (National Institute for Health and Care Excellence) and NHS England issued a public consultat...
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...
As a body of law, competition law is unusual in the extent to which it is susceptible to the influence of wider policy considerations. The enforcement priorities of the public regulators change over time, and, as a result, new form...
The Research and Development Block Exemption (RDBE)
Buildings that can repair themselves and cities powered by micro-organisms – these are examp...
Buildings that can repair themselves and cities powered by micro-organisms – these are examples of the potential a...
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 conce...
2016 is the year that the Arrow declaration has made its comeback. These declarations concern pending patent applications and are so named after a case from 2007, Arrow v Merck [2007] EWHC 1900 (Pat). In essence, a party seeking t...
First Borderline Decision of the EU Commission: Is this a welcome approach for industry?
On 10 August 2016, judgment in Actavis v ICOS was handed down. This was a patent action rela...
On 10 August 2016, judgment in Actavis v ICOS was handed down. This was a patent action relating to the compound t...
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 ...
On 13 October 2016 the Court of Appeal handed down judgment in relation to a second medical use patent with claims in the Swiss form. As readers may know the patent was owned by Warner-Lambert (Pfizer) and covered a compound called...
NICE and NHS England Consultation on proposals for changes to the evaluation and funding of drugs
The Warner Lambert v Actavis cases on pregabalin-based medicines have been before the UK Cou...
The Warner Lambert v Actavis cases on pregabalin-based medicines have been before the UK Courts on no less than se...
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...
On 25 May 2018, the current UK Data Protection Act 1998 (and all the other implementing laws across the EU) will be replaced by a new EU-wide General Data Protection Regulation (GDPR). The GDPR ‘comes into force’ (legally speaking) ...
Antimicrobial resistance – a global threat triggering a global response
This article was first published in Kluwer Patent Blog, February 2016 Mr Justice Carr is onl...
This article was first published in Kluwer Patent Blog, February 2016 Mr Justice Carr is only a few months into hi...
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
Has the CJEU paved the way for parallel importation of veterinary medicines by livestock farmers (Case C-114/15)?
The article was first published in EPLAW Patent Blog, December 2015 Generics (UK) Limited tr...
The article was first published in EPLAW Patent Blog, December 2015 Generics (UK) Limited trading as Mylan v Warne...
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...
This article was first published in Kluwer Patent Blog, July 2015 The Actavis v Eli Lilly UK litigation concerning pemetrexed (sold by Eli Lilly under the brand Alimta(®) has already been widely reported in light of Actavis’ innovat...
CJEU confirms the broad scope of Article 6 of the Transparency Directive
The last few years has seen a notable increase in the number of disputes concerning second m...
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
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 Con...
On 12 December 2013, the Patents Court handed down its judgment in Smith & Nephew v ConvaTec No.2. The court granted Smith & Nephew a declaration of non-infringement on a commercial process for the manufacture of silverise...
Amended claims must not be obvious or arbitrary
Summary: This summer the Eli Lilly v HGS case came back before the High Court, following the...
Summary: This summer the Eli Lilly v HGS case came back before the High Court, following the CJEU’s ruling that SP...
The Patents Court confirms that clinical trials are not necessarily confidential
The English Court – the one-stop shop for DNIs across Europe?
