International Life Sciences Update - February 2015

19 February 2015

Organisms not capable of developing into a human being are not human embryos

On 18 December 2014, the Court of Justice of the European Union (CJEU) handed down its judgment holding that an organism that was incapable of developing into a human being did not constitute a human embryo within the meaning of Directive 98/44/EC (Case C-364/13).

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Subjective intention required to infringe Swiss form claims

Mr Justice Arnold refused Warner Lambert Company LLC’s request for an injunction against Actavis Group PTC EHF’s pregabalin product, which Actavis intended to launch around January 2015 for the treatment of epilepsy and generalised anxiety disorder (“GAD”) after receipt of its marketing authorisation.

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New policy on publication of clinical data for medicinal products for human use

In October 2014, a new policy on publication of clinical data for medicinal products for human use was unanimously approved by the management board of the EMA. The adoption of this policy forms an important milestone in the on-going debate on access to clinical research, data sharing and transparency.

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Italy: A recent decision of the Administrative Court on the reimbursement of a generic product before the expiry of the patent for the originator product

In 2012 Italy implemented a rule - Article 11 of the so-called "Balduzzi Decree", converted into Law no. 189/2012 – which provides that generic products cannot be classified as reimbursed [reimbursable?] by the National Health System before the expiry of the patent/Supplementary Protection Certificate (“SPC”) claiming the reference originator product.

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Granting a Supplementary Protection Certificate (SPC) for pharmaceutical compositions mismatching active ingredients protected by the patent – the practice of the Polish courts after the Medeva case.

In November 2010, the Polish Patent Office (PPO) granted Dr. Karl Thomae Gmbh (Dr. Karl Thomae) an SPC for a pharmaceutical composition of telmisartan and hydrochlorothiazide. The SPC was intended to prolong the protection conferred by a patent over a method of obtaining benzimidazoles (No. PL 169675).

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EU data protection regulators clarify scope of 'health data' and champion explicit consent for data processing in the context of scientific research

While medical researchers find innovative ways to gain valuable insights from large amounts of medical data, European data protection regulators have clarified their views on the scope of the definition of personal health data and on the processing thereof in the context of historical, statistical and scientific research.

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China: CFDA drafts guidelines for biosimilars

On 29 October 2014, the Centre for Drug Evaluation ("CDE") of the China Food and Drug Administration ("CFDA") published "Draft Technical Guidelines for Research, Development and Evaluation of Biosimilars" (the "Draft Guidelines") for public comments. The Draft Guidelines were published shortly after the announcement of biosimilar guidelines by the FDA and the EMA.

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Editors: Neil Jenkins & Dr. Anna Wolters