12 November 2019
PI for Tadalafil Dosage Patent refused in Italy
www.twobirds.com/en/news/articles/2019/italy/pi-for-tadalafil-dosage-patent-refused-in-italy

By decisions dated 30 July 2018, then confirmed in the appeal by decisions dated 30 August 2018, the Court of Milan dismissed PI requested by ICOS and its licensee Eli Lilly against Sandoz, ascertaining the prima facie ...

07 October 2019
Dutch competition authority ACM publishes a sector report on the impact of biosimilars on competition between TNF-alfa inhibitors
www.twobirds.com/en/news/articles/2019/netherlands/dutch-competition-authority-acm-publishes-a-sector

The Dutch competition authority, ACM, initiated a market study in 2018 into the effect of the introduction of biosimilars on the competition between TNF alfa inhibitors. TNF-alfa inhibitors are biological medicines that ...

30 September 2019
Bird & Bird secures win in preliminary injunction patent case before the Düsseldorf Courts
www.twobirds.com/en/news/articles/2019/germany/bird-and-bird-secures-win-in-preliminary-injunction-patent-case-before-the-dusseldorf-courts

On September 26, 2019, the Higher Regional Court of Düsseldorf confirmed on appeal that Teva Pharmaceutical Industries Ltd. (“Teva”) – one of Bird & Bird’s key clients – is entitled to a preliminary injunction against ...

04 November 2019
Are German Courts the “Spoilsport” of the “Divisional Game” when it comes to Preliminary Injunction Requests?
www.twobirds.com/en/news/articles/2019/germany/are-germany-courts-the-spoilsport-of-the-divisional-game-when-it-comes-to

If a patentee undertakes actions with respect to a patent of the same patent family (e.g. waiving the parent patent of a divisional patent), this is often negatively characterised as playing the “Divisional Game”. We ...

02 July 2019
Transfer of value: amendments to the French “anti-gift” provisions by the draft Health Act
www.twobirds.com/en/news/articles/2019/global/transfer-of-value-amendments-to-the-french-anti-gift-provisions-by-the-draft-health-act

The French so-called “anti-gift” provisions strictly frame the conditions under which companies in the health sector are allowed to provide advantages, in cash or in kind, to healthcare professionals ("HCPs”)

06 September 2019
China passed new amendments to the Drug Administration Law
www.twobirds.com/en/news/articles/2019/global/china-passed-new-amendments-to-the-drug-administration-law

On 26 August 2019, China's National People's Congress passed the final amendments to the Drug Administration Law ("DAL"), which will take effect on 1 December 2019. The DAL was first enacted in 1984, then substantively ...

11 July 2019
French healthcare system reform: The final steps of the legislative process are expected soon
www.twobirds.com/en/news/articles/2019/france/french-healthcare-system-reform-the-final-steps-of-the-legislative-process-are-expected-soon

The Bill of the Law on the organization and transformation of the French healthcare system at the French parliament, adoption of the final version is expected for the end of July.

30 October 2019
The allocation of BSPCEs (Bons de Souscription de Parts de Créateurs d’Entreprise) to independent board directors: a small revolution for joint stock companies, a real breakthrough for the biotech world
www.twobirds.com/en/news/articles/2019/france/the-allocation-of-bspces

Biotech and medtech companies operate in an international environment where the composition of their governance bodies is a key criterion of credibility.

02 December 2019
The French Health Data Hub becomes reality
www.twobirds.com/en/news/articles/2019/france/the-french-health-data-hub-becomes-reality

The French Health Data Hub was born officially with the publication on 30 November 2019 of a ministerial decision (arrêté).

18 March 2019
French Legal Framework for the exchange of health data by secured health messaging systems
www.twobirds.com/en/news/articles/2019/france/french-legal-framework-for-the-exchange-of-health-data-by-secured-health-messaging-systems

Before the entry into force of the GDPR on May 25th 2018, healthcare professionals and facilities and professionals in medico-social sectors empowered by law in France had to comply with the provisions stated in the ...