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Life Sciences & Healthcare

Spain

CMS Albiñana & Suárez de Lezo provides advice on all aspects affecting the pharmaceutical industry, including domestic and international corporate transactions as well as regulatory, intellectual property and dispute resolution matters relating to product or other forms of liability.

We boast a team of more than 200 lawyers specialising in healthcare and pharmaceutical law with the support of the Lifesciences Asia-Pacific Network (LAN), enabling us to understand the scientific, commercial and legal obligations affecting pharmaceutical companies. We work with the 100 most important pharmaceutical, medical equipment, biotechnology, agriculture and food companies, including 20 pharmaceutical multinationals and nine of the ten biggest medical equipment enterprises.

With active members in key sector associations such as ABPI, ABPI, BIVDA, PAGB, EUCOMED and EFPIA, we contribute to the design of regulatory frameworks affecting the pharmaceutical and healthcare sectors. We advise clients on their daily operational needs, including advertising and promotion, as well as public procurement, price and refund policies, the use of patents, commercial agreements and clinical trials. Moreover, we also provide regulatory advice on complex issues relating to strategic agreements, corporate transactions and legal proceedings for product or other forms of liability.

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08/07/2008
CMS Life Sci­ences Mono­graph Clin­ic­al Tri­als
13/06/2019
SPC Man­u­fac­tur­ing Waiver to come in­to ef­fect 1 Ju­ly 2019
Gen­er­ics com­pan­ies will soon be able to man­u­fac­ture SPC-pro­tec­ted drugs for ex­port out­side the EU un­der new man­u­fac­tur­ing waiver pro­vi­sions. In the last six months of the SPC life­time, it will also be al­low­able to man­u­fac­ture gen­er­ics for stock­pil­ing for “day.
30/05/2019
EPO's strict ap­proach to de­cid­ing if a com­pos­i­tion can be­ne­fit from...
The EPO Tech­nic­al Board of Ap­peal (TBA) re­viewed the law around nov­elty of use, and de­term­ined that in the case of Car­di­oPoly­mer, Inc. 's European pat­ent ap­plic­a­tion (EP07837908. 8), the claimed chem­ic­al en­tity did not qual­i­fy as a 'sub­stance or com­pos­i­tion'.
27/03/2019
Judg­ment on Ab­rax­is C-443/17; 21st March 2019
The CJEU de­livered its judg­ment last week on the case of Ab­rax­is v Comp­troller Gen­er­al of Pat­ents con­cern­ing Sup­ple­ment­ary Pro­tec­tion Cer­ti­fic­ates (SPCs) for new for­mu­la­tions of medi­cin­al products. The Court has ruled that Art­icle 3(d) of Reg­u­la­tion No 469/2009,.
24/08/2018
Gov­ern­ment Is­sues Brexit Tech­nic­al No­tice for Life Sci­ences
On 23 Au­gust 2018, the UK Gov­ern­ment (the "Gov­ern­ment") is­sued the first wave of its tech­nic­al pa­pers de­signed to provide guid­ance to com­pan­ies to help pre­pare for a "No Deal" Brexit. In this scen­ario, there will be no "trans­ition peri­od" but rather the UK.
18/05/2018
EU Product Li­ab­il­ity Dir­ect­ive still an ad­equate tool, ac­cord­ing to...
On 7 May 2018, the European Com­mis­sion pub­lished its fifth re­port on the per­form­ance of the EU Product Li­ab­il­ity Dir­ect­ive (Dir­ect­ive/85/374/EEC) in the mem­ber states. The dir­ect­ive in­tro­duced the concept of strict li­ab­il­ity for pro­du­cers of de­fect­ive products.
17/04/2018
NGOs can ask the Com­mis­sion to re­view its de­cision on ge­net­ic­ally...
The Gen­er­al Court de­cided in its de­cision of 14 March 2018 that non-gov­ern­ment­al or­gan­iz­a­tions (“NGOs”) can ask the Com­mis­sion to re­view its de­cision on au­thor­iz­ing the pla­cing on the mar­ket of ge­net­ic­ally mod­i­fied food and feed.
07/10/2016
Gen­er­al Court of the EU con­firms the Lun­d­beck de­cision of the European...
On 8 Septem­ber 2016, the Gen­er­al Court of the EU ad­op­ted for the first time a judg­ment in a pay-for-delay case in the phar­ma­ceut­ic­al in­dustry. The Court thereby con­firmed the de­cision of the European Com­mis­sion of 19 June 2013 whereby it im­posed a total fine.