With the global shutdown that has occurred due to COVID-19, its presence has caused long-lasting effects in all aspects of our lives and the way businesses operate. To no surprise its presence is also interacting with exclusivity offered by IP rights. These discussions have appeared as major drug companies rush to develop vaccines to tackle this pandemic. Last month, (WHO) announced that remdesivir, an antiviral drug originally developed by Gilead sciences to treat ebola, might be effective in curing patients from the virus. GSK and Sanofi among others are developing vaccines to stop the sp ..read more

The German Federal Constitutional Court has published its long-awaited decision on Friday (20/03/20). In this announcement, the constitutional complaint against the legislation required for Germany to ratify the Unified Patent Court (UPC) Agreement was upheld. According to the Court , the German act by which it was to pass to the UPC, violates the Germans populace democratic rights under Article 38 Basic Law, because it was not passed with the parliamentary majority required. Article 1 of the UPC Agreement provides that “ A Unified Patent Court for the settlement of disputes relating to E ..read more

The UK government announced on the 27th February as it published its approach to Brexit negotiations that the UK will not be seeking involvement in the UP/UPC system. The statement was accompanied by the reasoning that participating in a court that applies EU law is inconsistent with the UKs aim of becoming an independent self-governing nation. This is a huge blow to the project, with the UK formally a key participant in the project with its formation framed around the UKs participation. Although the agreement has yet to be ratified by Germany, the remaining participant Member States will nee ..read more

The new strategy dubbed “Shaping Europe’s digital future”  is the EUs plan to shape the EU market with digital transformation. This new strategy builds upon the previous Commissions achievements in delivering its digital single market objectives. Data has been put as a prime focus with the Commission believing that data is the “lifeblood of economic development” and can/should be used to address challenges facing society and for driving economic growth. The Commissions first step is to bring forward proposals for an ‘enabling legislative framework for the governance of common European data s ..read more

The Digital Single market strategy is a wide-ranging group of individual legislative initiatives from the European Commission to adapt the European market to the digital age. The primary aim of this initiative is to create a pan-European framework of laws for the digital economy, with the core principles of the single market at focus. This includes free movement of goods, services, people and capital, fair competition and well harmonised level playing field for all stakeholders. The DSM will be built upon four very familiar EU rules: 1)      Harmonised rules: applying the same minimum stan ..read more

On the 13th February 2020, the UK’s Food Standard Agency issued a deadline for CBD businesses to provide more information about their CBD products. It also published safety advice to consumers particularly vulnerable groups not to take CBD and healthy adults not to take more than 70mg a day. This announcement comes as CBD products become more widely available on the high street but are not properly authorised. The FSA set a deadline of 31stMarch 2020, to submit valid novel food authorisation applications. After this deadline only products which have submitted a valid application will be all ..read more

A major contention between the two superpowers was the need for China to recognize and strengthen the protection of IP rights held by US companies in China. The first chapter of the phase agreement is of particular importance to pharmaceutical companies as it contains a broad range of measures, that if implemented into law could have a beneficial effect of IP rights owners in China. In the Agreement, China recognises “the importance of establishing and implementing a comprehensive legal system of intellectual property protection and enforcement” This is positive for all industries that have a ..read more

With the Coranavirus recently declared a ‘global threat’ by WHO and now officially surpassing the SARs virus for deaths and number of people affected. This pandemic now represents a real threat to the pharmaceutical supply chain as well as the health of the population at large. China is an integral part of the supply chain, with it being the world’s largest supplier of active pharmaceutical ingredients (APIs) being responsible for around 40% of global production to supply the ingredients for the makers of generic and innovator drugs alike. In the UK, 80—90% of the generic medicines used in the ..read more

The UK exits the EU on 31st January 2020. By virtue of the transitional period in the Withdrawal Agreement, EU law will continue to apply in and in relation to the UK only until the 31st December 2020. The EU Treaties, EU free movement rights and the general principles of EU law will then cease to apply in relation to the UK, and prior EU regulations will only continue to apply in domestic law  insofar as they are not modified or revoked by regulations under that 2018 Act.    IP law is one of the most harmonised law networks across the UK and Europe, with a large majority of the UK legisl ..read more

Pfizer is launching three Roche cancer blockbusters generics at discounts ranging from 22% to 24%. Pfizer is eyeing the lucrative combined $10bn that the three drugs accumulated at their peaks. With Pfizer having already rolled out its biosimilars to Roche’s Avastin and Rituxan at discounts of 23% and 24% respectively. The pharma company has now announced its plans to launch its biosimilar to Trazimera at a 22% discount on the February 15th. Pfizer has always been an active player in the biosimilar market and with this recent announcement it will be the first company to market three oncolog ..read more