NO-tified Bodies? UL UK ceases Medical Devices Directive operations
Orphan designation: the General Court clarifies the meaning of significant benefit
Alex Denoon and Zac Fargher discuss how Switzerland-based QS Zürich AG has decided not to pu...
Alex Denoon and Zac Fargher discuss how Switzerland-based QS Zürich AG has decided not to pursue designation under the EU MDR, citing the "investment was too high."
Meet the experts
Lloyd’s pulls out of the EU MDR/IVDR race
Alex Denoon and Zac Fargher discuss how a combination of the advent of the new EU Medical De...
Alex Denoon and Zac Fargher discuss how a combination of the advent of the new EU Medical Device Regulations (EU M...
TÜV SÜD gets the Greenlight on EU MDR
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 development and commissioning. This article provides a brief overview of the Framework.
New guidance on the use of personal data in clinical trials
We reported on this blog about the General Court (GC)’s judgment in Servier on the day on wh...
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
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 context of its use in the editing of human DNA.
A brief history of UCART-19
The General Court has today handed down its judgment in the long-running Servier patent sett...
The General Court has today handed down its judgment in the long-running Servier patent settlement case.
New EU Regulation for Veterinary Medicinal Products
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?
Whilst there has been much attention to data protection as a result of the EU General Data P...
Whilst there has been much attention to data protection as a result of the EU General Data Protection Regulation a...
One more piece in the SPC puzzle – Medical devices with ancillary substances do not qualify for an SPC
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 endeavour, which is likely to attract the attention of the competition authorities. Nevertheless, in the pharmaceutical ind...
CAR-T gets the green light in Europe
In case C-528/16 proceedings were brought between the French agricultural union and eight as...
In case C-528/16 proceedings were brought between the French agricultural union and eight associations (the Applic...
Concordia and the CMA – a drama in (at least) three parts
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 publication policy (Policy 0070). The purpose of Policy 0070 was to give open access to clinical data submitted by pharmaceutic...
CJEU follows Advocate General’s Opinion to confirm the scope of the Specific Mechanism
The pace of development in the CAR-T world, both scientific and commercial, is showing no si...
The pace of development in the CAR-T world, both scientific and commercial, is showing no sign of letting up. We h...
The CAT sets a clear framework for excessive and unfair prices in its Pfizer/Flynn judgment
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 understandably grabbing the headlines. However, CAR-T therapy is by no means the whole story and there are a number of related im...
Depression Delayed: CMA’s paroxetine pay-for-delay case heads to Luxembourg
Rachel Mumby and Jonathan Ross discuss highlights in the CAR-T world.
The NHS gets on the bandwagon with CAR-T
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 historically lived outside of the small molecule world.
CAR-T rolls on
Sophie Lawrance and Edwin Bond give their summary on the different forms of value transfer t...
Sophie Lawrance and Edwin Bond give their summary on the different forms of value transfer that competition author...
The competition law issues of the CRISPR patent pool
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-681/16) regarding the protection afforded by the Specific Mechanism to holders of Supplementary Protection Certificates...
Proposal to extend UK withholding tax on royalties – The start of a major shift in the UK’s approach to taxation?
Pat Treacy discusses 10 key points on parallel trade and pharma.
Evolving how English courts construe written commercial contracts (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 relation to international data transfers, in particular health data.
Patents Court rules on non-invasive prenatal diagnosis patents
Dominic Adair and Thomas Hendicott review Sandoz and Amgen, relating to the abbreviated path...
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
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 Government says that “This draws substantial investment into the sector from across the world, ensuring that the next wave...
NHS Pharmaceutical Procurement – Top 10 Tips
In November 2017, the French competition authority, the Autorité de la concurrence, announce...
In November 2017, the French competition authority, the Autorité de la concurrence, announced a new enquiry into t...
Lifting restrictions on veterinary medicine retail channels and veterinary practice ownership in Europe (Case C-297/16)
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 relating to tadalafil, which is sold by Eli Lilly (“Lilly”) as the active ingredient in CIALIS® to treat erectile dysfuncti...
Is there such a thing as Substitution or Interchangeability for Biosimilars?
‘Product hopping’, or ‘evergreening’, are expressions used (by competition authorities and i...
‘Product hopping’, or ‘evergreening’, are expressions used (by competition authorities and industry respectively) ...
CRISPR undergoes exciting new developments
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 judgment from the Patents Court following the much discussed judgment of the Supreme Court in Actavis v Eli Lilly[2017] ...
Unjustified Threats Act comes into force
The Brucellosis Vaccine Prize, an innovative $30 million prize competition, is designed to e...
The Brucellosis Vaccine Prize, an innovative $30 million prize competition, is designed to encourage the developme...
CAR-T Therapy: the Current Landscape
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 to procure biosimilar medicines. The NHS’s Commercial Medicines Unit (“CMU”) has been known to use the (usually small...
European Court says scientific proof of causation is not required under the EU Product Liability Directive
Collaboration with competitors can be an effective strategy for pharma companies seeking to ...
Collaboration with competitors can be an effective strategy for pharma companies seeking to develop common standar...
Are pharmaceutical companies using rebates at risk of being investigated by the competition authorities?
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 obtained by means of an essentially biological process will no longer be patentable. As many readers will be aware, thi...
FDA approves first GM individualised cell therapy
In this important case from July of this year, the Supreme Court reintroduced a true form of...
In this important case from July of this year, the Supreme Court reintroduced a true form of the doctrine of equiv...
The lure of the US for UK biotech
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
On 21st August 2017 the European Commission published responses to the question regarding th...
On 21st August 2017 the European Commission published responses to the question regarding the free movement of dat...
The use of mobile apps and 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
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 in Case C-219/15 which confirms that the purpose of the role of a notified body under the Medical Products Directive ...
How the CJEU has interpreted “protected” in the SPC regulation
This article was first published in Competition Law Insight, March 2017 On 7 December 2016, ...
This article was first published in Competition Law Insight, March 2017 On 7 December 2016, in an unusual two-comp...
Patent Review of the Year
Clinical trial data transparency: the EU inches closer to legal certainty
The enforcement of second medical use patents is currently one of the hottest topics in Euro...
The enforcement of second medical use patents is currently one of the hottest topics in European patent litigation. The dispute concerning Warner-Lambert’s patent for the use of pregabalin to treat pain has been very active in Europ...
NICE and NHS England Consultation on proposals for changes to the evaluation and funding of drugs
The future role of the UK in the Unified Patent Court (UPC), if any, has been brought to the...
The future role of the UK in the Unified Patent Court (UPC), if any, has been brought to the forefront as the batt...
Public Procurement Regimes in the UK and EU
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 agreements at a ‘theoretical’ stage; • agreements between non-competitors; • outsourcing to specialist R&D organisatio...
Science in architecture – the opportunities and challenges
Introduction On 20 September 2016, the Council of the European Union accepted the European P...
Introduction On 20 September 2016, the Council of the European Union accepted the European Parliament’s first read...
A sense of relief: enforcing second medical use patents
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 decision under Article 13(1)(d) of the Medical Device Directive. Since the judgment in Laboratoires Lyocentre (Case C-109/12)...
Actavis v ICOS – clearing the way between a rock and a hard place?
On 26 August 2016, the UKIPO issued its decision rejecting Abraxis Bioscience’s application ...
On 26 August 2016, the UKIPO issued its decision rejecting Abraxis Bioscience’s application for an SPC for “paclit...
Electronic cigarettes: the medicine of tomorrow?
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 consultation relating to proposals for changes to the arrangements for evaluating and funding drugs and other health technologi...
Painfully objective decision of the Court of Appeal in Warner Lambert v Actavis tortuously applied by the Patents Court
A recent KPMG survey[1] of companies operating in the medical devices sector found that over...
A recent KPMG survey[1] of companies operating in the medical devices sector found that over 80% of respondents ex...
Court of Appeal provides guidance on determining an account of profits
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 agenda. It is likely that novel financial and regulatory incentives will have to be implemented in order to drive innov...
Regeneron Pharmaceuticals Inc v (1) Kymab Ltd (2) Novo Nordisk A/S
As reported in the October edition of On The Pulse, on 10 September 2015 Arnold J found Warn...
As reported in the October edition of On The Pulse, on 10 September 2015 Arnold J found Warner-Lambert’s patent fo...
Plausibility in immunotherapy – is PD-1 the way forward?
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 applicable to the importation of veterinary medicines from Spain into France (so-called ‘parallel trade’), the Court of...
UK – Mylan v. Warner-Lambert / Abuse
This article was first published in EPLAW Patent Blog, December 2015 Actavis Group PTC EHF &...
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
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) and Pierres Fabre Médicament SA (“PFM”) (C-273/14). The cases concerned the interpretation of Articles 6(3) and (5) of D...
English High Court considers infringement of second medical use claims
Background and Legislation The EFTA Court has jurisdiction with regard to the EFTA States wh...
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
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 amended patent claims covering capsules for use in an inhaler to deliver tiotropium to the lung of an individual with...
Eli Lilly v HGS – High court tries to implement CJEU decision regarding SPCs
Summary: In the recent case of AGA v Occlutech, the Court has held that clinical trials are ...
Summary: In the recent case of AGA v Occlutech, the Court has held that clinical trials are not prima facie confid...
The English Court – the one-stop shop for DNIs across Europe?
