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In this issue: Intellectual property Pharmaceutical—regulatory framework Research and development Competition in life sciences Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Haemophilia gene therapy patent valid and infringed (Pfizer v uniQure) The Patents Court rejected Pfizer’s attempt to revoke uniQure’s EP(UK) 3,581,650 (EP 650), which claims a “Factor IX polypeptide mutant and a method for its production” and underpins uniQure’s haemophilia therapy, Hemgenix. As a consequence, Pfizer cannot, for now, introduce its gene therapy Beqvez—approved by the EMA on 24 July 2024—in the UK, although it has indicated it will appeal. Pfizer accepted that, if EP 650 stood, it would infringe, but maintained the patent was invalid, alleging the particular amino acid substitution was obvious and devoid of inventive step in light of a single prior art reference. The court placed considerable reliance on secondary evidence reflecting what research groups were actually doing...
Our observations so far suggest the Unified Patent Court’s approach to inventive step is more all-encompassing, concentrating on whether the skilled person would have been prompted to contemplate the claimed solution and adopt it as a natural progression from the prior art. Further, in contrast to the EPO’s problem–solution methodology, the UPC does not yet appear persuaded that a reasonable expectation of success must be shown to establish obviousness. Given these differing frameworks, there is scope for divergent outcomes on identical facts. Even so, both the UPC and the EPO seem conscious of the danger of inconsistent rulings between the two systems. In this piece, we consider four EPO practices which, though not invariably applied today, may gain traction in the interests of harmonisation, as they arguably align more closely with the UPC’s stance on inventive step. Background The EPO routinely employs the problem and solution approach when assessing whether an invention involves an inventive step. As confirmed by the Enlarged Board of Appeal in Syngenta v HGF,...
In this issue: Copyright & associated rights Trade marks/passing off Patents General IP LexTalk®IP: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Copyright & associated rights IPO confirms approach for foreign artists’ public performance rights The Intellectual Property Office (IPO) has released its response to an early‑2024 consultation on how best to ensure overseas performers and producers receive the public performance rights (PPR) payments due when their sound recordings are broadcast or played in public in the UK. Historically, UK law’s treatment of this right did not fully mirror the nation’s international commitments. After the consultation and engagement with industry stakeholders, the government has chosen Option 0A. Under this approach, targeted adjustments will be made to the criteria for foreign performers’ PPR eligibility, extending PPR to foreign performers where the producer of the recording of their performance is a UK national or...
Note: Brazil judgments below are not reported by LexisNexis®. What constitutes a foreign arbitral award in Brazil? The Brazilian Arbitration Act (Federal Law No. 9,307/96, (BAA)) identifies two categories of arbitral awards: domestic and foreign. Foreign awards are those issued outside Brazil (BAA, art 34, para 1) and must undergo recognition before they can be enforced locally. Domestic awards are those delivered within Brazil and are enforceable as a domestic judgment without any need for court confirmation. Accordingly, for the recognition and enforcement of foreign awards, the arbitral seat is pivotal in determining where the award is rendered and whether prior confirmation is required in Brazil. How to enforce a foreign arbitral award in Brazil To enforce a foreign arbitral award in Brazil, it must first be submitted for recognition before the Brazilian Superior Court of Justice (Superior Tribunal de Justiça, (STJ)). The governing rules and conditions for recognition are set out in articles 963 and 964 of the Brazilian Code of Civil Procedure (BCCP), articles...
This Practice Note addresses arbitration solely under the CIETAC Arbitration Rules 2024 (CIETAC Rules). As a general rule, those Rules govern arbitrations accepted by CIETAC on or after 1 January 2024, or where the parties have agreed to adopt the 2024 Rules (CIETAC, art 88). The 2015 rules continue to apply to any arbitrations accepted by CIETAC between 1 January 2015 and 31 December 2023. This Practice Note applies to international or foreign related disputes, as well as matters connected with Hong Kong SAR, Macao SAR or the Taiwan region (CIETAC, art 3.2). CIETAC has distinct provisions for summary arbitration—see Practice Note: CIETAC (2024)—summary procedure (and early dismissal)—and for domestic arbitration; these are not addressed in this Practice Note. There are also separate provisions for cases administered by the CIETAC Hong Kong Arbitration Centre, which are not covered here. Prior to commencing arbitration Before initiating arbitration under any set of rules (or on an ad hoc basis), reflect on the following: does the arbitration clause...
Use this Practice Note when identifying the applicable law for agreements made on or after 17 December 2009. It outlines when and for what reasons Regulation (EC) 593/2008, Rome I was brought in. The Note reviews the implementation of Regulation (EC) 593/2008, Rome I, the states that have signed up and are therefore bound by it, together with any reservations those states have entered. It explains why the regulation governs contractual disputes within the UK. Guidance is given on interpreting Regulation (EC) 593/2008, Rome I, followed by consideration of the universal application rule (art 2) and the breadth of the applicable law (art 12). It sets out the general principles alongside rules tailored to particular categories of contract. It also identifies matters excluded from Regulation (EC) 593/2008, Rome I, including arbitration and questions relating to the status and legal capacity of companies. Throughout, the instrument is referred to as Regulation (EC) 593/2008, Rome I, or simply Rome I. Purpose of Rome I The aim of Rome I is...