Originator meaning

Merck Serono SA v The Comptroller-General of Patents, Designs and Trade Marks [2023] EWHC 3240 (Ch) What are the practical implications of this case? The judgment affirms the settled principle from Court of Justice Case C-61/79, Denkavit Italiana: the default position is that Court of Justice judgments take effect ex tunc, and only in rare, exceptional situations will a deviation from that rule be warranted. The Court further indicated that it will generally be insufficient for a party to contend that its conduct, or the steps it adopted, rested on a legitimate expectation that a particular course would be followed (here, the grant of Merck’s SPC application) under the law as it then stood. In practical terms, parties—most notably originator pharmaceutical companies—should recognise that CJEU rulings issued after an SPC filing can still influence whether the SPC is ultimately granted, even where the application was lodged in line with the applicant’s understanding of earlier authorities and prevailing case law. Accordingly, reliance on the law at the filing...

In this issue: Copyright & associated rights Designs Trade marks/passing off Patents Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Copyright & associated rights Chancery Division grants anti-suit injunction and related order preventing threat of proceedings (Crypto Open Patent Alliance v Wright; Wright v Coinbase Global Inc; Wright v Payward, Inc) The Chancery Division in Crypto Open Patent Alliance v Wright; Wright v Coinbase Global Inc; Wright v Payward, Inc [2024] EWHC 1809 (Ch) issued determinations in litigation addressing who created Bitcoin. The court had previously found that W, who asserted he was the inventor (Satoshi), was not the originator and had relied on falsified documents to bolster his position. Among other matters, the court decided that the claimant in one of the relevant actions was entitled to an anti‑suit injunction restraining W, and the other claimants in the connected claims, from commencing further proceedings in...

Following referrals from the Finland Market Court and Ireland’s Supreme Court arising from disputes featuring Teva and Merck Sharp & Dohme, the EU’s highest court ruled last month that a product may obtain an SPC even where a previously patented active substance is combined with a known, public‑domain ingredient, provided the regulatory requirements are satisfied (see here). The decision bolsters originator, brand‑name manufacturers that create and own pioneering drug patents. By permitting SPCs for combination therapies, the Court of Justice of the EU granted those brands as much as five extra years of exclusivity across a wider spectrum of treatments, postponing generic rivalry from companies that have traditionally waited for patent expiry before incorporating such substances into medicinal products. As Matthieu Dhenne, founding partner at Paris‑based Dhenne Avocats, told MLex, for pharmaceutical businesses the judgment favours SPC holders and originators because they will be able to safeguard more medicines; conversely, it will become harder for new entrants to access markets since overturning SPCs on combination products will be more challenging...

Background and introduction to SEPA After the euro was introduced in 11 EU countries in 1999, it became evident that domestic and cross-border retail payment services did not deliver comparable service levels. In September 1999, the European Central Bank (ECB) issued a report on enhancing cross-border retail payment services (the ECB 1999 Report). The report recognised that cross-border credit transfers within the euro area lagged significantly behind domestic credit transfers, even though a single currency environment called for a Single European Payment Area (SEPA). To initiate the debate and send a clear signal to the banking and payment systems industry, the Eurosystem (consisting of the ECB and the national central banks of countries that had adopted the euro) set out seven objectives for the industry to meet: Improved systems/services to be in place by 1 January 2002 Place priority on cross-border credit transfers Substantially lower the price of cross-border credit transfers Ensure settlement times are comparable for domestic and cross-border payments As...

This Practice Note sets out what are termed ‘biosimilars’, meaning comparable biological medicinal products. It outlines the commercial significance of biosimilars and highlights key challenges encountered by biosimilar manufacturers and biologic originator companies. It reviews the UK and EU regulatory regimes for these medicines and covers matters relating to biosimilar marketing authorisations (MAs), pharmacovigilance monitoring, and the manufacture and market access of biosimilars, eg pricing and reimbursement considerations. It also briefly addresses the position in the US and sets out the US Food and Drug Administration (FDA) procedures for biosimilars. In addition, it examines certain patent issues connected with biosimilars, including application of the Bolar-type exemption, considerations around the ‘clearing the way’ principle, and the Unified Patent Court (UPC), together with the scope for development of its jurisprudence concerning biosimilars. What is a biosimilar? A biosimilar is a biological medicinal product that is similar to a biological medicinal product—the originator, also referred to as the reference medicinal product—which has already been granted a MA on the basis of...

Rationale Securitisation is the transfer of sizeable portfolios of income‑generating assets to a special purpose vehicle (SPV). The SPV finances the purchase price by issuing interest‑bearing securities—commonly termed ‘bonds’ or ‘notes’—into the capital markets. These securities benefit from security over the assets and/or the cashflows they produce (the ‘receivables’). Cashflows from the receivables are applied to pay interest and to repay principal on the securities. Types of receivables that can be securitised include: mortgage payments bank loan repayments lease/rental payments credit card repayments insurance premium payments Benefits of securitisation include: cheaper borrowing—the SPV may achieve a higher credit rating than the debtor company (originator). Either the obligors for the receivables carry a stronger rating than the originator, or credit rating agencies may find it simpler to rate a single asset (the receivables) rather than the originator, which presents more variables...