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Life Sciences & Healthcare

Ukraine

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 Life Sciences & Healthcare teams in Central and Eastern Europe advise leading global business groups in the sector on transactions, commercial agreements, compliance, investigations and litigation, very often across multiple jurisdictions in the region and beyond. We can help you to navigate the regulatory landscape and to ensure compliance with both local laws and global policies.

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. 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 such as the ABPI, ABHI, BIVDA, PAGB, EUCOMED and EFPIA, we help shape the legal frameworks impacting the Life Sciences & Healthcare sector. We regularly advise our clients on their day-to-day operational needs, providing support with advertisement and promotion of medicines, public sector procurement, pricing and reimbursement, patent enforcement and commercial and clinical trial agreements, as well as regulatory advice.

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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.