In April 2023, the European Commission (EC) published the pharmaceutical legislation package, including the proposal for a Pharmaceutical Directive[1] , and further proposals for regulations on SPCs[2]. Article 85 of the proposed Directive aims at providing an amended provision for the so-called Bolar exemption, currently codified in Article 10(6) of Directive 2001/83/EC. The initial EC proposal…
From time to time, one may find publications that seek to explore the influence that the Bible may have had on patent law. A classic example is Exodus 20:15: “You shall not steal.” Another sometimes-cited example is Deuteronomy 27:17: “Cursed is he who removes his neighbor’s landmark.” Of course, Matthew 5:39 would not be the…
In a precedent case before the Russian Intellectual Property Court, the judges pointed out that mere registration of a generic drug long before the patent expiry may constitute a threat of infringement that is prohibited under domestic law. This position in this case may result in an extra defense against unfair registrations. On 24 April 2018,…
Ukraine has always been the subject of interest of innovators and generic manufacturers trying to maximize profits from selling their medicines, and ordinary consumers who just want to recover from any diseases. Being a developing country [1]According to ISI research, effective from 1 January till 31 December 2015 http://www.isi-web.org/component/content/article/5-root/root/81-developing Ukraine should make every effort just…
After the implementation of the “Bolar provision”, introduced into Spanish law through Directive 2004/27, the Courts of Appeal of Navarra, Madrid and Barcelona decided that the new provision should be applied retrospectively since, in their opinion, the law that incorporated the Directive simply “clarified” that the acts exempted from patent infringement by the “Bolar provision”…
