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Life Sciences & Healthcare

Portugal

Health, medical devices, pharmaceutics area and the new branches of science such as biotechnology raise several legal issues and show a high complexity and specificity.

The diversity of entities involved in this sector, the existing regulation and the own operation of the market require from the lawyers a strong knowledge of the specificities of this area. Our team works in particular within the following areas:

  • Regulation
  • Licensing
  • Finance / Mergers and acquisitions
  • Business restructuring
  • Litigation
  • Clinical research
  • Distribution
  • Patents protection and enforcement
  • Labelling
  • Safety and Health
  • Competition
  • Public offers
  • Environment
  • Immigration

We have a multidisciplinary team with a strong curriculum in pharmaceutical area and well positioned to give an answer to the several intervening players in this sector.

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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...
13 Jun 19
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...
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...
24 Aug 18
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,...