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IP analysis: The High Court held that Alexion’s patent for eculizumab, which claimed a light chain sequence including a 22-amino acid leader, was invalid and not infringed by biosimilars from Samsung Bioepis and Amgen. Although the biosimilars matched the therapeutic sequence of eculizumab, they lacked the leader sequence specified in the patent. Central to the dispute was whether the claimed sequence covered the clinically used eculizumab, which lacks the leader sequence. The court rejected Alexion’s purposive construction, and the claimants conceded the patent should be revoked on that basis. Even if infringement had been found, the patent would have failed for obviousness. The case underscores the importance of precise sequence drafting in biologic patents, especially where production processes remove non-functional regions. It shows the risks of relying on broad claim constructions that diverge from the literal sequence disclosed and used in practice. The multi-jurisdictional nature of these proceedings (including before the UPC) served to highlight deficiencies in Alexion’s case, where inconsistent arguments across different fora impacted on credibility. While decisions of other courts, including the UPC, should be brought before the UK court, they will not be material to the judge’s decision making. Written by Jennifer McDowall, associate at Pinsent Masons.
Q&As
This Q&A assumes that jurisdiction has already been considered and it has been decided that the Courts of England and Wales have jurisdiction to resolve the dispute and that the defendant is domiciled within England or Wales. It also assumes that the appointment of a litigation friend is being considered because the claimant is a protected party (CPR 21.2(1)). This Q&A does not consider whether the Courts of England and Wales have jurisdiction to resolve the dispute and the procedure for appointing a litigation friend is not considered in detail. For guidance regarding jurisdiction, see Practice Note: Determining whether the courts of England and Wales have jurisdiction. The CPR does not specify any particular procedural steps to be taken where it is the claimant who is domiciled outside England and Wales. However, the claimant
Q&As
When to serve a response pack There is no requirement to serve the response pack with the claim form. The response pack must be served with the particulars of claim. Therefore, if the claim form sets out the particulars of claim, the response pack must be served at the same time as the claim form. This can be seen in CPR 7.8, which provides that when serving the particulars of claim on a defendant, the claimant must serve the following documents: • a form for defending the claim • a form for admitting the claim, and • a form acknowledging service These documents are collectively known as the response pack. Failure to serve the response pack While there is a requirement for the
Q&As
The first point to note is that tenant must comply strictly with any requirements set down in the lease for the exercise of the break clause. In United Scientific Holdings Ltd v Burnley Borough Council the House of Lords made clear that in both the context of a break clause and a rent review provision, a landlord could insist upon strict compliance with any provisions as to the time by which a notice had to be served. The landlord was entitled to know with certainly whether the tenant was
Q&As
It is assumed that the UK defendant is domiciled in the jurisdiction of the courts of England and Wales rather than any other part of the UK. Service of the claim form in England and Wales When serving a claim form on a defendant in England and Wales the provisions in CPR 6 and CPR 7 apply. The claim form will need to be served on the defendant within four months and one day of the date of issue. There are a number of different issues to consider when serving a claim form. For guidance, see Practice Note: Service in England and Wales—a guide for dispute resolution practitioners. Service of the claim form in BVI When serving a claim form on a defendant in the British Virgin Islands (BVI) permission will be required to serve the claim form out of the jurisdiction. Note that, generally, permission will also provide permission for service
Q&As
This Q&A addresses the question of whether a landlord who is an executor and who wishes to serve notice on a tenant to contract out of the provisions of Part II of the Landlord and Tenant Act 1954 (LTA 1954), Pt II can be described in that notice as ‘the executors of X’ or whether the executors need specifically to be named. The Q&A will also address the impact of this question on the validity of any notice which has been served and which names the landlord as ‘the executors of X’. Contracting out of Part II of the LTA 1954 Part II of the LTA 1954, Pt 2 makes provision
Q&As
We have assumed that you are acting for a defendant in a case in which there are other defendants. There is no provision in the Civil Procedure Rules to deal with circumstances in which a defendant is required to serve documents on a party that is out of the jurisdiction. The only provision we were able to identify was that in CPR 6.38, which deals with
Q&As
A business tenancy may be terminated by service of a tenant's request for a new tenancy under section 26 of the Landlord and Tenant Act 1954 (LTA 1954). The s 26 request (LTA 1954, s 26) must specify a date for such a new tenancy to begin. Termination of the existing tenancy takes place (subject to interim continuance under LTA 1954, s 64) immediately before the date specified in that notice. To be effective, among other things, the s 26 request must satisfy the following requirements. First, it must be in the prescribed form, or 'substantially to the like effect': see LTA 1954, s 26(3). The prescribed form states ‘1. This notice relates to the following property:…’ and then requires the tenant to ‘insert
Q&As
The Renting Homes (Wales) Act 2016 (RH(W)A 2016) is devolved legislation which had the effect of replacing Assured Shorthold Tenancies of residential properties in Wales with ‘occupation contracts’. It provides for secure occupation contracts, which apply to the public sector, and standard occupation contracts, which apply to the private sector (RH(W)A 2016, s 1). It is mandatory to issue a w ritten statement of the occupation contract (RH(W)A 2016, s 31), which must contain all of the terms (RH(W)A 2016, s 32). Model written statements of contract are prescribed by regulations (RH(W)A 2016, s 29). The ability to obtain possession on a no-fault basis
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A tenant wishing to claim an extended lease of their house under the Leasehold Reform Act 1967 (LRA 1967) will first serve a notice of claim on the landlord. The service of the notice creates a contract between the landlord and the tenant for the grant of the new extended lease. See Practice Note: Guide to the right to enfranchisement and lease extensions of houses under the Leasehold Reform Act 1967 (LRA 1967). Part II of the Schedule to the Leasehold Reform (Enfranchisement and Extension) Regulations 1967 (LR(EE) Regs 1967), SI 1967/1879,
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Case study A landlord wishes to terminate a farm business tenancy, which was originally granted for a term of ten years. The term commencement date was some six months before the date of the lease. The tenant remained in occupation as an annual periodic tenant following expiry of the fixed term. The 1995 Act and the yearly tenancy A tenancy beginning after 1 September 1995 will be a ‘farm business tenancy’ and therefore subject to the provisions of the Agricultural Tenancies Act 1995 (ATA 1995) if it satisfies the conditions set out in ATA 1995, s 1. The test is not once and for all, and it is possible for a tenancy to cease to be a ‘farm business tenancy’. Essentially, at least part of the land must have been farmed since the beginning of the tenancy and, unless a notice was given in advance,
Q&As
A company voluntary arrangement (CVA) is a contractual agreement between a company (the tenant) and its creditors (including the landlord). Once the CVA has been approved by the requisite majority of creditors, it is binding on creditors, including the landlord. In relation to notices to be provided to the company subject to a CVA, there are two points that you will need to consider: • is the schedule of dilapidations and notice to reinstate to be served in connection with a right arising under the CVA? For example, if the landlord were seeking to terminate the lease under the terms of the CVA, notice