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Kundl - Austria, 24 September 2014 - Today, despite the fact that research and clinical trials of these new weapons against disease are on-going, the patent on the first generation of biopharmaceuticals on the market has expired.
The loss of patent protection has allowed the entry on the scene of so-called therapeutic biosimilars, medicines similar to the original biopharmaceutical drugs, which can be produced and marketed by pharmaceutical companies at lower prices than branded products, due to savings on already performed costs of research.
For several years, biopharmaceuticals developed through the use of modern biotechnology have given one more chance to the possibility of treating inflammatory diseases, autoimmune diseases, neurological degenerative diseases, kidney disease, growth disorders and cancers. These drugs consist of more complex molecules, which have required more difficult and expensive studies to develop. They are, in effect, drugs and products derived from living organisms, such as bacteria and cells. Unlike traditional drugs, which are produced chemically and therefore reproducible (as long as the formula is known), biopharmaceuticals can not be reproduced in an "identical" manner if the source of bacteria used, the production process or even the place where production is started is changed.
Biosimilars are, therefore, biological medicines similar to a biopharmaceutical already authorised for trade and whose patent has expired.
Permission to enter the market is given by the European Medicines Agency (EMA) and is based on a control designed to assess the similarity with the reference product in terms of quality, efficacy and safety. The development and use of biosimilars represents an important opportunity in improving the efficiency of health systems and care, having the potential to meet a growing demand for health, in terms of effectiveness and customisation of treatment and safety of use. Biosimilar medicines are, therefore, an indispensable tool for the development of a competitive market in biological medicines required for the sustainability of the health system and innovative treatments, while retaining guarantees of safety and quality for patients and ensuring them consistent and timely access to innovative drugs, in a context of rationalisation of public spending.
The recession also hurts trademarks and patents; here is what has emerged from the data on domestic filing of inventions, trademarks and designs in the first half of 2014, disclosed by the Italian Patent and Trademark Office (UIBM) of the Ministry of Economic Development. Between January and June 2014, there was a slight recovery in the filing of inventions, compared to the same period of 2013, up by 2.8%. In particular, there was an increase in the north, with an increase of 3.76%, for a share of 76.8% of the total. The rates were stable, however, in the centre and south. Similarly, utility models saw a negative trend in the first half, from 1,413 to 1,279 filings (-9.55% over the same period in 2013). There were only slight variations, however, with regard to the registration of trademarks, -0.31% nationwide in the first half of 2014 compared to the same period of 2013.
The new Communication for teacher training was published, provided by the memorandum of understanding between the Ministry of Economic Development and the Ministry of Education, University and Research, with the aim of promoting knowledge, use and respect of industrial property rights and gaining awareness about the risks of counterfeiting. The course, which comprises 100 hours of on-line learning in blended mode (synchronous training and e-learning), is designed to raise awareness in the national school system (trainers and students in primary and secondary schools and universities) on the issues of protection of industrial property and the fight against counterfeiting. In detail, the knowledge acquired by the teaching staff is to be used in training activities aimed at disseminating the following to students: the value of creativity as a lever of progress and development; the negative effects of counterfeiting which stop creativity and are a source of criminal activity; a better approach to scientific knowledge and the culture of patents, trademarks and designs, such as the protection of Intellectual/Industrial Property Rights at the national, EU and international level. The training is delivered by the Università Telematica Universitas Mercatorum, attending the course provides teachers with 4 training credits after passing a final exam (optional), the course was also recognised by the Universitas Mercatorum as a University Specialisation Course
The training programme is open to a maximum of three teachers, appointed by the Headmaster/mistress, for each institution. Those eligible to take part in the programme are: 50 primary schools (TOT 150 teachers), 50 (lower) secondary schools (TOT 150 teachers) and 50 (upper) secondary schools (TOT 150 teachers).
For further information:
APPLICATION for PARTICIPATION
Published in the Official Gazette of 8 August 2014 - No. 183
"Incentives to Companies for the enhancement of Designs and Models"
A concessionary intervention in favour of micro, small and medium enterprises for the exploitation of Industrial Property titles, from the DG for the Fight against Counterfeiting - Italian Patent and Trademark Office of the Ministry of Economic Development. The intervention, called DISEGNI + 2, aims to support the innovation capacity and competitiveness of SMEs through the development and economic exploitation of industrial designs/models in domestic and international markets, through incentives for the purchase of specialist services, such as:
Phase 1 - Production - putting new products related to a registered design/model into production;
Phase 2 - Marketing - marketing of a registered design/model.
The provision is for 5 million Euros and the maximum contribution paid out is 65,000 euros for the production phase and 15,000 euros for the marketing phase.
To get the incentives, a registered model is necessary, and expenses incurred after 08.08.2014 are taken into account.
The following expenses incurred after 08/08/2014 for the acquisition of the following services are eligible:
The information for participation will not be published until 6 November 2014, by which date it will all be included in the request form.