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Latest Life Sciences News

Roche Diabetes Care succeeds in UK Medtech patent dispute against Insulet (Insulet v Roche Diabetes Care)

The following IP news provides comprehensive and up to date legal information on Roche Diabetes Care succeeds in UK Medtech patent dispute against Insulet (Insulet v Roche Diabetes Care)

Life Sciences weekly highlights—29 July 2021

The following Life Sciences news provides comprehensive and up to date legal information on Life Sciences weekly highlights—29 July 2021

Anonymity for claimants refused as being unjustified and insufficiently evidenced (Various Claimants v Independent Parliamentary Standards Authority)

The following Commercial news provides comprehensive and up to date legal information on Anonymity for claimants refused as being unjustified and insufficiently evidenced (Various Claimants v Independent Parliamentary Standards Authority)

Patent for pneumococci vaccine deemed obvious to try (Wyeth v Merck)

The following IP news provides comprehensive and up to date legal information on Patent for pneumococci vaccine deemed obvious to try (Wyeth v Merck)

Featured Life Sciences content

Joint, several, and joint and several liability

Joint, several, and joint and several liabilityContractWhere a contract is made by two or more parties it may contain a promise or obligation made by...

Conditions precedent in commercial contracts

Conditions precedent in commercial contractsThis Practice Note considers the meaning and use of conditions precedent in commercial arrangements. It...

Sub-licensing intellectual property rights

An intellectual property (IP) owner may choose to license its IP to a third party. This can be an effective route to generating revenue while...

Co-operative and community benefit societies

Co-operative and community benefit societiesWhat is a co-operative or community benefit society?A co-operative society or community benefit society...

Practice notes

Rome II—application and interpretation

Rome II—application and interpretationThis Practice Note is for use when determining applicable law in respect of events giving rise to damage, where...

19th May

Q&As

Can a third party rely on ostensible/apparent authority where they know the person signing a document is an employee of a company not a director and they sign as a director and in the name of that director?

Can a third party rely on ostensible/apparent authority where they know the person signing a document is an employee of a company not a director and...

19th May

Practice notes

Brexit—exiting the EU under Article 50 [Archived]

Brexit—exiting the EU under Article 50 [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.This Practice Note contains...

Produced in partnership with Adam Cygan of University of Leicester 19th May

Brexit

Practice notes

Antibiotic drug Nitrofurantoin (AMCo, Morningside Healthcare, Morningside Pharmaceuticals and Alliance Healthcare) (50507)

Antibiotic drug Nitrofurantoin (AMCo, Morningside Healthcare, Morningside Pharmaceuticals and Alliance Healthcare) (50507)CASE HUB See further,...

19th May

Q&As

Can the board of a co-operative and community benefit society (a registered society) delegate powers to any third party, and can the registered society grant a power of attorney to a third party to execute documents on its behalf?

Can the board of a co-operative and community benefit society (a registered society) delegate powers to any third party, and can the registered...

19th May

Practice notes

Rome Convention—introduction and interpretation [Archived]

Rome Convention—introduction and interpretation [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.The UK is no longer...

19th May

Precedents

Force majeure clause

Coronavirus (COVID-19): In addition to the below content on force majeure generally, see also: • Coronavirus (COVID-19)...

19th May

COVID-19

In-house

Practice notes

Managing a breach of confidentiality or information security

Many companies and government bodies (such as HMRC) have been exposed to loss of confidential information and many other breaches of confidentiality...

19th May

Practice notes

Introduction to retained EU law

Introduction to retained EU lawThis Practice Note provides an introduction to retained EU law. It provides an overview of the key definitions and...

Produced in partnership with Dr. Kieran Laird of Gowling WLG 19th May

Brexit

Precedents

Counterparts clause

1 Counterparts—agreement 1.1 This agreement may be signed in any number of separate counterparts, each of which when...

19th May

In-house

Practice notes

Model ADR clauses

Model ADR clausesThis Practice Note considers model form alternative dispute resolution (ADR) clauses provided by a number of service providers,...

19th May

Precedents

Execution clause—company—contract

Option 1—contract signed on behalf of a company, where the authorised signatory is an individual Signed by [insert name of...

19th May

In-house

Practice notes

Requirements of the company seal

Requirements of the company sealThis Practice Note provides practical guidance regarding the requirements of the company seal. Where a company has a...

19th May

Practice notes

Brexit implementation period—enforcement [Archived]

Brexit implementation period—enforcement [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.This Practice Note considers...

19th May

Brexit

Practice notes

Subcontracting

SubcontractingThis Practice Note examines the following legal and practical matters in relation to entering into a subcontract or when granting...

19th May

Practice notes

Parallel imports

ScopeThis Practice Note explains trade mark law on parallel trade. Parallel imports, or ‘grey market’ goods, are genuine goods that are placed on the...

Produced in partnership with Taylor Wessing LLP 19th May

Most recent Manufacture, marketing and sale content

Q&As

Could the remuneration (or career advancement) of a medical officer employed by a pharmaceutical company be tied to actual sales of drugs by that company?

Could the remuneration (or career advancement) of a medical officer employed by a pharmaceutical company be tied to actual sales of drugs by that...

31st Jul

Q&As

Would an app designed to aid clinicians to calculate the risk of patient deterioration and likelihood of developing sepsis be considered a medical device and as such require registration with the MHRA? If so, what class of device would it fall into under the Medical Devices Regulations 2002?

Would an app designed to aid clinicians to calculate the risk of patient deterioration and likelihood of developing sepsis be considered a medical...

31st Jul

Q&As

What action can a Member State competent authority take in the event that they discover a non-compliance during an inspection of a medical device manufacturing facility?

What action can a Member State competent authority take in the event that they discover a non-compliance during an inspection of a medical device...

Produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn 31st Jul

Practice notes

An introduction to the regulation of medicinal products

An introduction to the regulation of medicinal productsEU and UK legal framework governing medicinal productsA complex array of requirements and...

31st Jul

Practice notes

Brexit—implications of the Withdrawal Agreement for the life sciences sector [Archived]

Brexit—implications of the Withdrawal Agreement for the life sciences sector [Archived]ARCHIVED: This Practice Note has been archived and is not...

31st Jul

Brexit

Q&As

Does a marketing authorisation holder (MAH) of a medicinal product need to collect information on individual cases of ‘off-label’ use if there is no adverse reaction? If so, how?

Does a marketing authorisation holder (MAH) of a medicinal product need to collect information on individual cases of ‘off-label’ use if there is no...

31st Jul

Practice notes

Clinical evaluation and performance evaluation of medical devices in the EU

Clinical evaluation and performance evaluation of medical devices in the EUThis Practice Note describes key changes to the requisite clinical...

Produced in partnership with Alison Dennis of Taylor Wessing LLP 31st Jul

Practice notes

Enforcement of the rules on advertising and promotion of medicinal products

Enforcement of the rules on advertising and promotion of medicinal productsIP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the...

31st Jul

Practice notes

An introduction to the regulation of medical devices—EU Directives regime

An introduction to the regulation of medical devices—EU Directives regimeIn the EU, medical devices are tightly regulated by laws that govern their...

Produced in partnership with Jane Summerfield of Hogan Lovells, Elisabethann Wright BL of Cooley (UK) LLP and Fabien Roy of Hogan Lovells 31st Jul

Practice notes

Biosimilars

BiosimilarsIP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the...

Produced in partnership with Eleanor Denny, associate, and Claire Phipps-Jones, senior associate, of Bristows LLP 31st Jul

Practice notes

Pharmaceutical trade marks and parallel imports

Pharmaceutical trade marks and parallel importsAt 11 pm on 31 December 2020 (IP completion day), the UK ceased to be subject to EU law. The UK’s...

Produced in partnership with Oscar Benito of Gavi, the Vaccines Alliance 31st Jul

Q&As

How are online sales of medicinal products regulated?

How are online sales of medicinal products regulated?Any organisation based in the UK which offers medicines for sale to the public in the UK or in...

31st Jul

Practice notes

Pharmaceutical pricing and reimbursement

Pharmaceutical pricing and reimbursementEuropean level rules on pricing and reimbursement of medicinal productsThe pricing and reimbursement of...

31st Jul

Practice notes

The regulation of medical software, including mHealth apps

The regulation of medical software, including mHealth appsIP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit...

31st Jul

Q&As

Are there any rules that dictate a strict separation of the medical and commercial roles in a pharmaceutical company, particularly with a view to avoiding the risk of such company being accused of 'off-label' promotion?

Are there any rules that dictate a strict separation of the medical and commercial roles in a pharmaceutical company, particularly with a view to...

31st Jul

Practice notes

Marketing authorisations in the EU—regulatory procedures for approval of medicinal products

Marketing authorisations in the EU—regulatory procedures for approval of medicinal productsNo medicinal product may be placed on the market without...

31st Jul

Practice notes

Regulation of e-cigarettes

Regulation of e-cigarettesIP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into...

Produced in partnership with Jaspreet Takhar of Baker McKenzie 31st Jul

Practice notes

UK regulation of cannabis-based medicinal products

UK regulation of cannabis-based medicinal productsThe cannabis plant can be used to produce a wide range of products with versatile purposes from...

31st Jul

Practice notes

Advertising and promotion of medicinal products

Advertising and promotion of medicinal productsIP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation...

31st Jul

Practice notes