Powered by Lexis+®
Jurisdiction(s):
United Kingdom

Life sciences legal update for 10 October 2024: Moderna v Pfizer mRNA patent; Article 22 EUMR curtailed; MHRA and EMA strategies; medtech guidance, policy and R&D

Published on: 10 October 2024

Published by a LexisNexis Life Sciences expert
Legal News
imgtext
Article summary

In this issue:

  • Intellectual property
  • Competition in life sciences
  • Pharmaceuticals—regulatory framework
  • Medical devices
  • Research and development
  • Daily and weekly news alerts
  • New and updated content
  • Dates for your diary
  • Trackers
  • Useful information

Intellectual property

Pfizer/BioNTech COVID-19 vaccine infringes a valid Moderna mRNA patent (Moderna v Pfizer/BioNTech)

Ian Turner, senior associate, and Sarah Taylor, senior practice development lawyer at Pinsent Masons LLP, provide commentary on the mRNA coronavirus vaccine patent clash initiated by Moderna against Pfizer and BioNTech. The Patents Court ruled that one Moderna patent, EP (UK) 3 718 565 (EP565), was invalid for obviousness and added matter, while a second, EP (UK) 3 590 949 (EP949), remained valid and, by admission, Pfizer/BioNTech’s Comirnaty sat within its claim scope. Mr Justice Meade also offered practical observations on managing trials spanning multiple patents and legal teams, as well as on instructing experts. In a separate judgment, the court concluded that Moderna’s undertaking not to enforce its patents against makers of coronavirus vaccines (the ‘Pledge’) served as an unusual partial defence to the infringement case. The Pledge decision...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Popular documents

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

Read More Right Arrow

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

Read More Right Arrow

Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

Read More Right Arrow

I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...

Read More Right Arrow