SlideshowAttivita

Pharmaceutical

New European Trademark Regulation: what is new?

New Regulation on the European trademark (Reg. (EU) 2015/2424) come into force on  March 23th 2016, amending the previous regulation (Reg. (EC) n. 207/2009), with the aim to modernize the trademark legislation, in line with the latest technological developments. Numerous innovations have been introduced by the new Regulation, intended to have a significant impact on both existing trademarks and on those of next recording. Olfactory marks and sound marks can now be registered Legal requirements for the registration of the trade mark have been modified: under the previous version of Article 4 of the European Trademark Regulation, a sign… Continue reading

Farmaci, concorrenza ed equivalenza terapeutica

Il Consiglio di Stato interviene con un’articolata pronuncia (n. 1306 del 1 Aprile 2016) incentrata sulla nozione di “equivalenza terapeutica” tra farmaci, nozione che, come precisato dal giudice amministrativo, è concettualmente e giuridicamente distinta da quella di “farmaco equivalente” e di “farmaco biosimilare”. L’origine della nozione di “equivalenza terapeutica” La nozione legale di “equivalenza terapeutica” è nata in seguito ad una segnalazione (AS440 del 27/12/2007) dell’Autorità Garante della Concorrenza e del Mercato in materia di gare pubbliche per la fornitura di specialità medicinali. L’AGCM ha rilevato che non è corretto indire gare pubbliche “a pacchetto” per la fornitura di… Continue reading

Active ingredients which are biocides must be authorized

An important news for the chemical and pharmaceutical industries: from September 1, 2015 the sale of biocidal products not authorized under EU Regulation. 528/2012, is forbidden. A biocide is “any substance […] consisting of, containing or able to destroy, remove or render harmless, […], any harmful organism by any means other than mere physical or mechanical action” (art. 1, Reg . EU 528/2012). Thus, as of September 1 the purchase of an active substance containing – or made up of – biocides is legitimate only if the provider is entered into a special list made of entities duly authorized to… Continue reading

Pay-Back: the administrative Court repeals AIFA measures to write off the excess of expenditure

Since the beginning of 2015 more than twenty judgments have been rendered by the TAR Lazio offsetting the AIFA measures regarding pay-back. The context The health care reform of 2007 introduced a mechanism seeking to contain pharmaceutical spending, by assigning to each company holding marketing authorizations for medicines borne by the NHS, an annual expense budget. If the actual expenditure recorded for each company in a given calendar year is in excess of the relevant budget, the company will be required to write off the excess, returning the relevant amount to the NHS (so-called “pay-back”). In relation to medicines used… Continue reading