China’s state council issued State Council Degree No. 769 on December 21, 2023 to enact the Implementing Regulations of the Patent Law (Amended in 2023) (hereinafter referred to as “the Implementing Regulations (Amended in...more
Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more
As of June 2024, Milan will begin hearing cases regarding patents classified in IPC Section (A), which includes pharmaceuticals. Milan will have competence to hear revocation actions, as well as actions for declaration of...more
The European Commission has published its long awaited (and delayed) proposals for a substantial revision of the EU regulation on Supplementary Protection Certificates (“SPCs”), which wraps up a series of various legislative...more
1. Introduction The Unified Patent Court (UPC) is a new patent court that will be fully in force starting June 2023 and, along with the Unitary Patent system, represents the biggest change in European patent practice in...more
Patents protect intellectual property, but they are most effective when the holder is willing to defend them using litigation. It may involve jury trials, bench trials or even a subsequent appeal to the Circuit Court....more
The previously contemplated fee for opting out of "classical" European patents from the Unified Patent Court ("UPC") system has been abolished by the UPC Preparatory Committee. The UPC Case Management System will also allow...more
After a myriad of challenges, delays, and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction. On January 19, 2022, the UPC came into existence as an...more
15 Years of Pharma & Biotech Patent Litigation in Europe - C5’s Pharma & Biotech Patent Litigation in Europe will take place 23–24 February, 2022 in Amsterdam, the Netherlands. This is the only industry-shaping event that...more
How to interpret the notion of second medical use with regards to SPCs? This is the question which was asked of the Court of Justice of the European Union (CJEU) by the court of appeal of Paris on behalf of the French...more
Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more
The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...more
This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more
On 6 February 2019 the House of Commons and House of Lords approved The Patents (Amendment) (EU Exit) Regulations 2018 (Patent SI), which, if it is signed into law, will come into force on Brexit day (i.e. 29 March 2019 or...more
Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more
In light of a possible no deal Brexit, businesses need to consider the impact such a scenario would have on their intellectual property rights, in particular trade marks, designs, patents and copyrights. For the majority of...more
On Monday the UK government published a series of notices on the impact of a no-deal Brexit on intellectual property right-holders....more
Cour de cassation, Commercial Chamber, 16 May 2018, No. 16-21638 - The French Cour de cassation upholds the Paris Court of Appeal’s decision to reject an SPC application for a biological medicinal product which was based...more
The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more
On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more
The European Patent Office (EPO) applies the same basic patentability criteria to antibodies as to other inventions, but it can sometimes appear that antibodies are treated as a special case. Originally published in J A...more
The Situation: The French Intellectual Property Office ("IPO") previously refused to adjust the expiration date of a granted supplementary protection certificate ("SPCs") when it had been calculated on the date of grant of...more
The UK government’s draft EU Withdrawal Bill (the “Brexit Bill“) aims to incorporate EU directives and regulations into UK domestic law in their current form immediately following Brexit (“Retained EU Law“). This article...more
Please see list of Countries and their rules regarding offering Patent Term Extensions and Supplementary Protection Certificates. ...more
What are SPCs? A Supplementary Protection Certificate (SPC) is an intellectual property right available for active ingredients of human and veterinary medicinal products requiring marketing authorisation. Originally...more