Category: medicines
Astra-Zeneca v EU – the vaccine row explained in straightforward terms – The 36 Group
‘On 1 February, AstraZeneca told the EU that it would deliver around 50% of the 80 million COVID-19 vaccine doses that it had previously told the EU for the first quarter of 2021.’
The 36 Group, 10th February 2021
Source: 36group.co.uk
Gosport hospital deaths: Families ‘need Hillsborough-style inquests’ – BBC News
‘Relatives of patients who died after receiving “dangerous” levels of painkillers at Gosport War Memorial Hospital have called for new inquests.’
BBC News, 5th February 2021
Source: www.bbc.co.uk
EP 128: The Cumberlege Review – Marina Wheeler QC – Law Pod UK
‘In Episode 128 Emma-Louise Fenelon talks to Marina Wheeler QC about the Cumberlege Review, which investigated the response of England’s healthcare system to patients’ reports of harm from drugs and medical devices.’
Law Pod UK, 22nd October 2020
Source: audioboom.com
Teenager’s death after being given antipsychotic was ‘potentially avoidable’ – The Guardian
‘The death of a teenager who was given antipsychotic medication though he and his family warned that the drug might cause him serious harm could have been avoided, an independent review has concluded.’
The Guardian, 20th October 2020
Source: www.theguardian.com
Parents of toddler with severe epilepsy seek legal review of cannabis oil guidelines – The Guardian
‘The parents of a toddler with severe epilepsy are seeking a landmark judicial review of rigid guidelines that effectively prevent the NHS from prescribing medical cannabis oil, a substance that they say has allowed their son to live a much healthier life, to thousands of sick children.’
The Guardian, 16th August 2020
Source: www.theguardian.com
Case Comment – General Pharmaceutical Council v Kellett & Gamble (2020) QBD (Admin) 01/07/20; 6 WLUK 456: Regulator’s application to extend interim suspension orders: – Park Square Barristers
‘This was an application by the GPhC to extend interim orders for the suspension of the respondent husband and wife pharmacists who were co-directors of a company which owned three pharmacies.’
Park Square Barristers, 6th July 2020
Source: www.parksquarebarristers.co.uk
New Judgment: Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27 – UKSC Blog
‘Regeneron Pharmaceuticals Inc filed patents for a new type of genetically modified mouse which was a hybrid version of the gene that produces antibodies, combining a section of the mouse’s genetic material with a section of the genetic material from a human. In 2013, Regeneron sued Kymab Ltd for infringements of its patents. Kymab was producing its own genetically modified mice, with a similar genetic structure to Regeneron’s mice. Kymab argued that the patents filed were invalid because they fell foul of a patent law rule called sufficiency which means that documents filed with the patent must be detailed enough to enable scientifically skilled readers to make the invention for themselves. The Court of Appeal upheld the patents and Kymab appealed to the Supreme Court.’
UKSC Blog, 24th June 2020
Source: ukscblog.com
Navigating Market Authorisation in the UK for the pharmaceutical industry – 3PB
‘‘Marketing Authorisation’ must be obtained in respect of any medicinal product that is to be sold, supplied or offered for sale or supply in the UK. This article looks at the different types of authorisation available, including when they might be appropriate for use in respect of the UK only before considering the process adopted in the UK for approving medicines into the market. It is designed to be a beginner’s guide to bringing new products to market in the UK as opposed to a full explanation of each step; ultimately how the application itself is make will depend on the product itself and the research behind it. If upon reading this article you gain an understanding of how to begin the Market Authorisation process, then this article has served its purpose.’
3PB, 4th June 2020
Source: www.3pb.co.uk
Patents – Neurim Pharmaceuticals v Mylan – NIPC Law
‘This was an application by Neurim Pharmaceuticals (1991) Ltd. (“Neurim”), the registered proprietor of European patent (UK) number 1441702 and Flynn Pharma Ltd. (“Flynn”) the proprietor’s exclusive licensee for an interim injunction to restrain until trial or further order the generics manufacturer, Mylan, from taking steps that might infringe that patent. The application was heard online by Mr Justice Marcus Smith on 20 May 2020. He handed down his judgment on 3 June 2020.’
NIPC Law, 4th June 2020
Source: nipclaw.blogspot.com
Products in a Pandemic: Liability for Medical Products and the Fight against COVID-19 – 11KBW
‘Marcus Pilgerstorfer QC has co-authored an article considering liability issues arising in relation to the production of medical products in response to the coronavirus pandemic.’
11KBW, 21st May 2020
Source: www.11kbw.com
COVID-19, Vaccines, BREXIT and Vaccine Damage Claims – Henderson Chambers
‘There is currently an enormous international effort in progress to invent, test and obtain regulatory approval for a COVID-19 vaccine (or more accurately, a vaccine against SARS-CoV-2, the underlying virus). It is right to consider now, how such a vaccine will get regulatory approval, how such approval might be affected by BREXIT, and if no-fault vaccine damage schemes may apply to any such novel vaccine.’
Henderson Chambers, 18th May 2020
Source: www.hendersonchambers.co.uk
Losing in CAT “not enough” for costs order against regulator – Litigation Futures
‘The starting point in the Competition Appeal Tribunal (CAT) is that no order for costs should be made against an unsuccessful regulator acting purely in its regulatory capacity, the Court of Appeal has ruled.’
Litigation Futures, 26th May 2020
Source: www.litigationfutures.com
Patents – Akebia Therapeutics Inc v Fibrogen, Inc – NIPC Law
‘This was a claim by Akebia Therapeutics Inc.(“Akebia”) and Otsuka Pharmaceutical Co. Ltd. (“Otsuka”) to revoke 6 patents held by FibroGen Inc. (“FibroGen”). The reason why they sought the revocation of those patents is that they wished to market their own product vadadustat. FibroGen’s exclusive licensee, Astellas Pharma Inc (“Astellas”) brought quia timet infringement proceedings against Akebia, Otsuka and FibroGen. The proceedings came on before Lord Justice Arnold between 2 and 19 March 2020. His lordship delivered judgment on 20 April 2020.’
NIPC Law, 5th May 2020
Source: nipclaw.blogspot.com
UK ad watchdog bans claims that IV drips can treat coronavirus – The Guardian
‘The advertising watchdog has cracked down on three companies for implying they could provide immune-boosting IV drips that could prevent or treat coronavirus.’
The Guardian, 22nd April 2020
Source: www.theguardian.com
Bayer v NHS Darlington Appeal – NIPC Law
‘This was an appeal by Bayer Plc and Novartis Pharmaceuticals UK Limited against Mrs Justice Whipple’s judgment in Bayer Plc v NHS Darlington Clinical Commissioning Groups and others : [2019] PTSR 922, [2018] WLR(D) 589, [2018] EWHC 2465 (Admin) which I blogged in Bayer Plc v NHS Darlington CCG and Others 2 Oct 2018. In her judgment, Mrs Justice Whipple dismissed applications for judicial review by Bayer and Novartis of a decision by NHS Darlington and other Clinical Commissioning Groups in Northeast England that the NHS Trusts from which they commission services should use a drug called Avastin as the preferred treatment option for an eye disease generally referred to as wet age-related macular degeneration (“WAMD”).’
NIPC Law, 7th April 2020
Source: nipclaw.blogspot.com
Eloise Parry: Man convicted over diet pill death – BBC News
‘An online dealer has been convicted of killing a woman who took toxic tablets sold to her as slimming pills.’
BBC News, 9th March 2020
Source: www.bbc.co.uk
Over £3m in fines and £1m for NHS in CMA pharma probe – gov.uk
‘Following an investigation, the CMA has found that 4 pharmaceutical companies broke competition law in relation to the supply of an antidepressant.’
gov,uk, 4th March 2020
Source: www.gov.uk
