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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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CMS Ex­pert Guide to a Leg­al Roadmap to Can­nabis
31 Jan 20
UK In­tel­lec­tu­al Prop­erty Of­fice finds that pat­ent law does not cater...
The UK In­tel­lec­tu­al Prop­erty Of­fice has found that DABUS is not a per­son and so can­not be con­sidered an in­vent­or of a pat­ent. DABUS is an ar­ti­fi­cial in­tel­li­gence (AI) ma­chine. The UKIPO ac­cep­ted the in­dic­a­tion...
17 Jan 20
New guid­ance on cy­ber­se­cur­ity for med­ic­al devices pub­lished
In Decem­ber 2019, the Med­ic­al Device Co­ordin­a­tion Group (“MD­CG”) is­sued a new guid­ance to help med­ic­al device man­u­fac­tur­ers meet the cy­ber­se­cur­ity re­quire­ments in the Med­ic­al Devices Reg­u­la­tion (“MDR”)...
15 Jan 20
Can newly dis­covered can­nabis com­pounds be pro­tec­ted by pat­ents?
A break­through dis­cov­ery has re­cently hit the news: tet­rahy­drocan­nabi­phorol (THCP) and can­na­bid­i­phorol (CB­DP), two new can­nabin­oid com­pounds, have been dis­covered in Can­nabis sativa and char­ac­ter­ised...
23 Dec 19
So­cial Me­dia and mHealth Data EMA / HMA Re­port
New and in­nov­at­ive tech­no­lo­gies have led to a huge in­crease in data com­ing from sources that haven’t pre­vi­ously been used with­in the reg­u­lated medi­cines in­dustry. In re­cog­ni­tion of this ex­plo­sion of...
20 Dec 19
‘Dar­unavir’ CJEU re­fer­ral with­drawn - Art­icle 3(a) of the SPC Reg­u­la­tion
At the end of Septem­ber, we re­por­ted here on the pub­lic­a­tion of AG Hogan’s Opin­ion on the joint re­fer­rals from the Ger­man Bundes­pat­ent­gericht (case C-650/17) for Mer­ck’s sitaglipt­in product and from...
17 Dec 19
The rise of pat­ent wars in Europe’s gene ther­apy space
The gene ther­apy in­dustry is in an ex­cit­ing phase of growth, un­der­go­ing sig­ni­fic­ant M&A activ­ity, product sales and new mar­ket­ing au­thor­isa­tions that are be­ing is­sued with in­creas­ing reg­u­lar­ity glob­ally....
15 Nov 19
Brexit and data pro­tec­tion: what to do next (when you don’t know what’s...
Whilst the threat of a no-deal Brexit has been aver­ted for now, the fu­ture is by no means cer­tain. We have high­lighted some of the key is­sues for UK-based or­gan­isa­tions, and the EEA or­gan­isa­tions that...
05 Nov 19
Whis­tleblow­ing Dir­ect­ive ad­op­ted by the EU Coun­cil
On 7 Oc­to­ber 2019, the EU Coun­cil ap­proved the word­ing of the "Dir­ect­ive of the European Par­lia­ment and of the Coun­cil on the pro­tec­tion of per­sons who re­port breaches of Uni­on law", also known as the...
13 Sep 19
SPC Double Whammy - In­ter­pret­ing Art­icle 3(a) of the SPC Reg­u­la­tion
Sum­mary At the end of June, the CJEU heard the joint re­fer­rals from the Ger­man Bundes­pat­ent­gericht (case C-650/17) for Mer­ck’s sitaglipt­in product and from the Eng­lish Court of Ap­peal for Searle’s...
30 May 19
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...
27 Mar 19
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...