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Life Sciences & Healthcare

Croatia

With over 150 international specialist lawyers across CMS and the support of the Life Sciences Asia-Pacific Network (LAN), we understand the scientific and commercial as well as the legal imperatives affecting your life sciences & healthcare business. We work with and have established long-term relationships with the top 100 life sciences & healthcare companies in the areas of pharmaceuticals, medical devices, biotechnology, agriculture and food, including the top 20 global pharmaceutical companies and nine out of the top ten global medical device companies.

Our experts, many of whom have worked in-house in your sector, have developed a shared capability in the areas of pharmaceuticals, biotechnology, medical devices and diagnostics. With active memberships in major industry associations we help shape the legal frameworks impacting the life sciences & healthcare sector.

We regularly advise our clients on their day-to-day operational needs such as support with advertisement and promotion of medicine, public sector procurement, pricing and reimbursement, patent enforcement, commercial and clinical trial agreements as well as regulatory advice and compliance. Equally, when you need life sciences & healthcare specialist advice for strategic agreements, planning a corporate transaction or embarking on litigation (whether product liability or otherwise), we have a team that is well versed in the industry issues to help you.

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13/09/2019
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 dar­unavir product (case C-114/18).
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,.
08/02/2019
Dead­line for seri­al­isa­tion in pharma in­dustry
Seri­al­iz­a­tion is the as­sign­ing of a unique seri­al num­ber (unique iden­ti­fi­er) to each pack of medi­cin­al product, which is linked to in­form­a­tion about the product’s ori­gin, batch num­ber and ex­pir­a­tion date.