Inventive step meaning

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,...

From Munich, the UPC’s office issued a decision that wiped out an Amgen patent across all 17 EU Member States, covering key patent venues including Germany, France, the Netherlands and Italy. The outcome represents a significant victory for Regeneron and Sanofi, which produce Praluent, a cholesterol therapy that competes with Repatha. According to the UPC, ‘The patent as granted is invalid because it does not involve an inventive step’. Since 2014, the companies have been locked in a dispute with Amgen, which has maintained that the manufacture of Praluent infringes wording in multiple patents held by Amgen. In the US, the case appeared before a jury in a Delaware federal court, was subsequently overturned, and later proceeded to the highest court in the US in 2023, after many years of legal wrangling...

This Practice Note outlines the requirements and procedural steps for European patent applications at the European Patent Office (EPO), covering EPO post‑grant opposition and limitation procedures. It further explains that, once a European patent is granted, the proprietor may lodge a ‘request for unitary effect’ with the EPO to obtain a unitary patent. European patents There are two types of European patents: European bundle patents—often called ‘classic’ or ‘traditional’ European patents, or simply European patents or EPs for short, and European patents with unitary effect—commonly known as unitary patents European bundle patents The European Patent Convention (EPC) created a single route for securing patents in multiple countries from one patent application. The EPC is applied by the EPO, which serves as the executive arm of the European Patent Organisation, an international organisation with 39 member states, including all 27 EU Member States plus certain non‑EU members such as the UK, Norway, Switzerland and Turkey. European bundle patents can confer protection...

This Practice Note outlines which biotechnological inventions may and may not be patented. It cites Directive 98/44/EC (commonly called the Biotechnology Directive) and Schedule A2 to the Patents Act 1977 (PA 1977), which allow patents for biotechnological inventions while setting key exceptions. Those exceptions have been interpreted by the Court of Justice in cases including Oliver Brüstle v Greenpeace and Monsanto v Cefetra. The Note also reviews exclusions from patentability under Article 52(b) of the European Patent Convention (EPC) and pertinent European Patent Office (EPO) decisions, Tomatoes I, Tomatoes II and Broccoli II. It also takes account of the 2017 European Commission Notice on biotechnological inventions. Patenting biotechnological inventions As a general rule, biotechnological inventions are patentable. Although neither PA 1977 nor the EPC imposes a blanket prohibition, specific provisions control when such inventions can be protected (see: The regulatory framework for biotechnology patents below). Additionally, in practice, some biotechnological subject-matter, even if not expressly barred, may fail the standard thresholds of novelty, inventive step and industrial applicability....

ARCHIVED: This Practice Note is archived and not maintained. It was originally prepared for LexisAdvance® Practical Guidance Hong Kong. Hong Kong is a special administrative region of the People’s Republic of China (Mainland China). Under the one country, two systems framework, Hong Kong maintains its own patent regime, distinct from that of Mainland China. The Intellectual Property Department (IPD) of the Hong Kong government manages the administration of patent applications, registrations and maintenance. There are two types of patent in Hong Kong: standard patents short-term patents The Paris Convention and the Patent Co-operation Treaty (PCT) apply in Hong Kong by virtue of Mainland China’s membership. The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) is implemented in Hong Kong through its World Trade Organisation (WTO) membership. A short-term patent application may serve as a priority founding application under the Paris Convention or TRIPS, but a standard patent application may not. Patents can be filed in Chinese or in English. Legislation...

Claim No : [ insert claim number ] IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY COURTS OF ENGLAND & WALESINTELLECTUAL PROPERTY LIST (ChD)[ Patents Court OR Intellectual Property Enterprise Court ] Between:[ insert name ] Claimant/Part 20 Defendantand[ insert name ] First Defendant/Part 20 Claimant[ insert name ] Second Defendant/Part 20 Claimant Grounds of invalidity Set out below are the Grounds of Invalidity for [ GB Patent OR European Patent (UK) ] [ number ] (the Patent), as identified in the Defence and Counterclaim accompanying these Grounds, and on which the Defendants/Part 20 Claimants intend to rely. The purported invention, in all claims of the Patent, is not patentable because its subject matter lacked novelty in view of the state of the art at the Patent’s priority date [ and common general knowledge ]...