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Regulations of patent law in relation to generic drugs – international aspects and Polish law

Publication date: February 23, 2023

What is a generic drug?

A generic drug is one that has been created in the same way as a branded drug in terms of dosage, safety, efficacy, route of administration, quality, properties of action and intended use. These similarities help demonstrate adequate bioequivalence, meaning that the medicine will work in the same way as the original medicine. In other words, the original drug is equal to the generic substitute.

Generic drugs typically cost significantly less than their original counterparts because they take much less time to produce and eliminate the costs associated with animal testing and clinical trials. Often such a shortened drug registration path is called “shortened application of a new drug”. As a result of reducing the research costs associated with generic drugs, their final price is much lower than the price of the original product (usually they are 80 to 85% cheaper than the original ones), which makes them much more willingly bought by customers and generate much higher profits than generic products original. According to the IMS Health Institute, these drugs saved more than $2.2 trillion to the healthcare system between 2009 and 2019.

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REPowerEU Plan

Publication date: February 23, 2023

On 12th of May of 2022, this new plan drawn up by the European Commission comes in the context of the ongoing war in Ukraine. This conflict has allowed to see the dangerous ties of dependence that had been forged in recent years towards Russian energy resources. To this there must be added the fundamental importance of the climate crisis we are experiencing due to our massive use of fossil fuels. Hence, the European organization has elaborated a short-term and medium-term action plan to put an end to our consumption of fossil resources on the basis of previous energy projects.

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Data governance in a digital world and moving data do the cloud – legal aspects

Publication date: February 23, 2023

In today’s legal world, new technologies are being used more and more often, which are aimed at modernizing the work of lawyers. Data privacy and protection is a priority in today’s increasingly digital world, where a rapidly changing regulatory landscape creating challenges for business and more and more data is sent to the cloud. The momentum towards digital transformation is moving fast in many countries and this is another changing space that is exciting and challenging.

What sorts of challenges we are seeing being created by changes in digital world?

Cloud and retail technologies have advanced significantly, including customer understanding of the level of robustness and security of these solutions. A market of new technologies is changing at a great speed. There is a proposal for more demand and many large enterprises needs for cloud solutions that can be offered to law firms or businesses – and what happened during the pandemic is that many companies made efforts to digitize their space and realized that digitization is no longer a luxury area.

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KIEŁTYKA GŁADKOWSKI had participated in Invest USA – A tale of two US regions

Publication date: February 23, 2023

Last Tuesday, 21st February 2023 our law firm attended a Black Country Chamber of Commerce https://www.blackcountrychamber.co.uk/ webinar. The main theme of the conference was the principal consideration of European companies entering the U.S. market. The webinar was focused on British companies, yet it is easy to extrapolate to companies from other European countries such as Polish companies.

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Tendencies in venture capital transactions in the US market – overview

Publication date: February 22, 2023

Only in 2021, the value of venture capital investments in the USA amounted to approx. USD 344 billion, almost twice as much as the year before. The year 2022 also looks very interesting, according to PichBook, although the pace slowed down slightly compared to 2021, the value of investments still exceeded the $200 billion mark, making 2022 the second highest year in the history of venture capital investments.

In 2022, companies in the early phase of the venture cycle, supported by business angels, and companies in the seed phase did quite well, despite the fact that the market was struggling with inflation and rising interest rates.

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