Mediaboss Marketing

19 May 2023

Herbert Smith Freehills

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As we reported last week (27 April 2023), theEuropean Commission has issued proposals for a new SPC regimeacross the EU. Under the new proposal, i) a new centralisedprocedure for the grant of SPCs is introduced for medicinalproducts that have been centrally authorised, and ii) a new unitarySPC to complement the Unitary Patent is introduced. The key pointsto note in this regard are as follows:

This route will only be available to medicinal products thathave been authorised centrally SPC applications on thebasis of decentralised and national authorisations cannot takeadvantage of this route:

Once the Unitary Patent comes into effect from 1 June 2023, itwill also be possible to seek a Unitary SPC on the basis of aUnitary Patent via the same centralised application procedurementioned above:

The changes to the SPC regime attempt to resolve problemsencountered owing to the variation in approach of national patentoffices in their assessment of SPC applications, and are aimed atsimplifying and streamlining the process for applicants. In theCommission's own words:

The cost of seeking additional protection will be greatlyreduced: estimated savings of 137 000 per applicant forreceiving EU27 wide, five-year-long SPC protection, bringing the EUcloser to its main trading partners. The increased transparencyresulting from this centralised procedure will also make it easierfor generics manufacturers to be informed of the protection statusof a given product across the EU, and to make business plansaccordingly.

The proposal requires the repeal and recast of the twoRegulations that currently deal with SPCs for medicinal productsand plant protection products, as well as the introduction of twonew Regulations creating a new unitary SPC, one each of medicinaland plant products. The proposed Regulations will still need to bediscussed and agreed by the European Parliament and the Council ofthe European Union in view of their adoption and entry intoforce.

What is an SPC? An SPC provides an extensionterm for a patent of up to five years, for a human or veterinarymedicinal product, or a plant protection product, that has beenauthorised by regulatory authorities. It provides a compensatoryextension of the monopoly to allow for the time it takes to getproducts to market via the regulatory system. SPCs are currentlyawarded at a national level individually for eachterritory. This has led to some variation in application of thecriteria for awarding SPCs, creating legal uncertainty, proceduralinefficiencies, and many referrals to the CJEU. It had also been asource of concern for stakeholders that in respect of the newEuropean patent with unitary effect (the unitary patent (UP) whichwill become available as an option at grant for European patentsfrom 1 June 2023 when the UPC comes into effect) as no SPC righthad been proposed to accompany the new unitary patent right.

The content of this article is intended to provide a generalguide to the subject matter. Specialist advice should be soughtabout your specific circumstances.

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Speakers discuss the impact of recent crises on Europe's global role at a two-day conference in Florence.

Building Europe in times of uncertainty was the main theme of the 13th edition of the State of the Union conference.

Speakers from around the world flocked to the Italian city of Florence for the two-day event to discuss how much the European Union has changed as a result of past and present crises.

Lessons learned from two years of the COVID-19 pandemic and the consequences of Russia's invasion of Ukraine were some of the issues covered on the first day of talks.

Renaud Dehousse is President of the European University Institute:

"The main lesson seems that united, the Europeans are stronger. But saying this is only one part of the answer. It is fine to say we need to be united but if you have to be unanimous, for instance, on any action plan, then at the very best the European answer will not be as quick.

And currently, migration and the lack of an EU defence policy remain divisive issues among member states

Sometimes Europe only focuses on small problems and therefore its not able to face bigger challenges," says Italian Foreign Minister Antonio Tajani. "Why has Italy highlighted the need to deal with migration? because its an issue that is shared by everyone. Its not just an Italian problem.

The rule of law and the digital transition are other themes that were debated during in-person sessions.

Panellists also answered questions about Europes global role and how it has changed as a result of recent events.

"Unfortunately," saysTimothy Garton Ash, Professor of European Studies at the University of Oxford, "while we've got a little bit stronger,other people got a whole lot stronger, so that relative to China, to Russia, to India, to other non-Western powers, I think that we relatively week and that is part of our problem."

On Friday, the focus shifted to Europes foreign policy and the energy crisis - the worst Europe has ever faced.

That's something that can be seen both as an opportunity and a challenge, says the bloc's Director-General for Energy, Ditte Juul Jorgensen.

"We have tried to make sure that our responses align with our longer-term climate interest; that our emergency response also becomes part of the energy transition. Because that energy transition, that green energy, that efficiency in the system, is the way to keep those energies secure, but also to get affordable energy and greener energy."

Uncertain times aren't over and next year's European elections will be key to determining the future of the European Union. In the meantime, this two-day conference has sent out a very clear message: lessons drawn from the recent crises alone won't be enough to secure Europe's position in the long term.

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The State of the Union: Building Europe's long-term security - Euronews

WARSAW, May 6 (Reuters) - Poland will demand European Union sanctions on imports of Russian farm products, its ambassador to the EU Andrzej Sados was quoted as saying on Saturday by PAP news agency.

"Europe isn't threatened by disruptions in supply chain of farm products now, contrary, we have a problem of surpluses. We are resolving a problem of increased imports of farm products from Ukraine," Sados said, according to PAP.

The European Commission earlier this week set restrictions until June 5 on imports of Ukrainian wheat, maize, rapeseed and sunflower seed to ease the excess supply of these commodities in Bulgaria, Hungary, Poland, Romania and Slovakia.

Since Russia launched its invasion of Ukraine last year, the EU has adopted 10 sanctions packages against Russian individuals and companies. Poland in April proposed a new set of punitive measures against Moscow, including a ban on pipeline oil and diamond imports.

Reporting by Marek StrzeleckiEditing by Peter Graff

Our Standards: The Thomson Reuters Trust Principles.

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Poland to call for EU sanctions on imports of Russian farm products - Reuters

May 7 (Reuters) - The European Union has proposed sanctions on Chinese companies accused of selling equipment that could be used in weapons to support Russia's war machine, the Financial Times reported on Sunday.

Seven Chinese businesses have been listed in a new package of sanctions that will be discussed by EU member states this week, the report said, citing a copy of the sanctions list seen by the FT.

According to the FT, the sanctions list includes two mainland Chinese companies, 3HC Semiconductors and King-Pai Technology, along with five from Hong Kong including Sinno Electronics, Sigma Technology, Asia Pacific Links, Tordan Industry and Alpha Trading Investments.

The European Commission did not immediately respond to a request for comment.

Some companies like King-Pai Technology have already been placed under sanctions by the United States, which said it was a China-based supplier for multiple entities in Russia's military-industrial complex.

Since Russia launched its invasion of Ukraine 14 months ago, which Russian President Vladimir Putin termed a "special military operation", the EU has adopted 10 sanctions packages against Russian individuals and companies, inflicting economic hardship and making financing the war more difficult.

Reporting by Jyoti Narayan in Bengaluru; Editing by Sandra Maler

Our Standards: The Thomson Reuters Trust Principles.

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Brussels plans to slap sanctions on Chinese companies aiding Russia's war machine, Financial Times reports - Reuters

The European Union, as part of the fight against circumventionof sanctions against Russia, should in the future be able torestrict the export of goods to third countries, includingArmenia.

According to Azernews with reference to foreignmedia, this is stated in the proposal of the European Commissionregarding the 11th EU sanctions package against Russia.

The proposal of the European Commission will be considered onMay 10 in Brussels by the permanent representatives of the 27 EUcountries. It is reported that Brussels plans to decide on theimposition of restrictions before the end of May.

Earlier, The Financial Times wrote that the European Union isdiscussing the introduction of export restrictions on countriesthat re-export sanctioned products to Russia. A surge in there-export of chips and other electronic components from Armenia toRussia was reported. Thus, eight specific types of these chips aresupplied to Russia, which are of key importance for the productionof weapons.

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