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UPC ratification process in Germany put on hold following constitutional complaint

Joachim Feldges

In March 2017, a constitutional complaint was filed against both the German bill for ratifying the UPC Agreement and the UPC Agreement itself with the German Federal Constitutional Court (“Bundesverfassungsgericht”). Many stakeholders have been speculating on the grounds for this constitutional complaint. Now, the German Federal Constitutional Court has disclosed the main line of argumentation Read More

Falsifying drug regulatory submission may be a criminal offence in China

David Shen

In China’s latest effort to limit substandard drugs being approved using falsified clinical and non-clinical data, the Supreme People’s Court and the Supreme People’s Procuratorate jointly issued Judicial Interpretations that expressly provide that falsifying a drug regulatory submission may be a criminal offence which can be sanctioned with a penalty of up to 10 years imprisonment.  The Read More

BeneluxA collaboration joint pricing negotiations fail

Eveline Van Keymeulen

The first joint pricing negotiations for a medicinal product in the context of the BeneluxA collaboration with respect to health technology assessment and pricing and reimbursement have failed. On 23 May 2017, the Belgian Minister of Health announced that the Belgian National Institute for Health and Disability Insurance (RIZIV), joined by the Dutch competent authorities, Read More

A CRISPR patent pool – one step closer to reality?

Robyn Trigg

In a press release on 10 July 2017, the Broad Institute announced that is has, with joint patent owners Harvard University, the Massachusetts Institute of Technology and the Rockefeller University, entered discussions about a potential CRISPR patent pool.  The institutions collectively submitted 22 patents (from 10 patent families) for consideration to be included in a Read More

CJEU to rule on milestone in European GMO legislation: the legal classification of mutagenesis in plant breeding

Geert Glas

With the development of new plant breeding techniques, the European plant breeding sector is tackling the world’s crucial challenge of feeding the 21st-century world. New plant breeding techniques allow for much faster and more precise results than traditional plant breeding techniques, and allow for more food to be produced with fewer inputs.  However, the novel Read More