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Tag Archives: SPC

EU: New developments in the SPC manufacturing waiver legislative process

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 amendments to the Commission’s proposal. The Committee in essence supports the plan to introduce the manufacturing waiver but is asking for some clarifying amendments as

China: New national-level Appeal Court – Cautious hopes for improved consistency and efficiency in high-tech IP / patent cases

On 26 October 2018, the Standing Committee of China’s National People’s Congress (NPC) issued a Decision setting out the establishment of a new IP Court of Appeals at the national level within the Supreme People’s Court (SPC). This Decision will come into effect on 1 January 2019. The Decision provides that the SPC will have

Brexit and IP: impact of a no deal exit

On Monday the UK government published a series of notices on the impact of a no-deal Brexit on intellectual property right-holders. The notices are part of a series of notices the government has published recently setting out what would happen for key industries in the event of a no-deal Brexit and what industry should do

France – Rejection of a second SPC for a biological medicinal product

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 on the same patent as a first SPC but on a different market authorization. The Government of the United-States of

UPDATE: UK Government comments on Draft EU Withdrawal Agreement

On 19 March the EU and the UK agreed the terms of a Brexit transition period ending on 31 December 2020. An updated colour-coded version of the EU’s Draft Withdrawal Agreement was published by the negotiators indicating which articles are provisionally agreed (highlighted in green), agreed from a policy perspective but subject to the drafting

Italy: Formulation patents may prevent reimbursement of generics… but, are you innovative enough?

The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of reimbursement for medicinal generic products’ before expiry of the patent or SPC, in practice, according to Italian courts, it seems that the product must be covered

Brexit Bill – Impact on patents

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 considers the impact the Brexit Bill will have on some key patent issues. The Brexit Bill and EU Decisions In addition to

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the duration of a supplementary protection certificate (SPC) further to its recalculation on account of an earlier marketing authorisation. Background

Italy: Teva vs. Novartis – Paediatric extensions of SPCs valid following removal of orphan designation

By order issued on February 26th, 2016 and only recently made available in a public database, the Court of Milan declared the validity of the paediatric extension granted by the Italian Patent Office for Novartis’ SPC covering the medicinal product Glivec (imatinib mesilate), applied for after Novartis’ voluntary removal of the product from the EU

New on LimeGreen IP Knowhow: SPCs for pharmaceutical products – a European guide

We’ve added a new topic to Hogan Lovells’ LimeGreen IP: focused on guiding you through the regulatory regime governing Supplementary Protection Certificates  in Europe. SPCs have for many years proved a fertile area for dispute. This is due to a number of factors including: lack of clarity in the governing legislation; the evolution of new types of medicines leading to questions

China: SAIC enacts IPR abuse regulation

On 13 April 2015, the State Administration for Industry and Commerce (“SAIC“) released the Regulation on the Prohibition of Conduct Eliminating or Restricting Competition by Abusing Intellectual Property Rights (“SAIC IPR Abuse Regulation“). The regulation is dated 7 April, and will enter into force on 1 August 2015. The SAIC IPR Abuse Regulation implements the

China – The SPC irons out some wrinkles in its new judicial interpretation on patent disputes

The Supreme People’s Court (“SPC”) has recently issued a new judicial interpretation on patent disputes (“JI”). In this new JI, the SPC seeks to streamline its former JI with the Patent Law, and tweak some patent litigation rules. The SPC’s new JI – which came into effect on February 1, 2015 – replaces the former

China’s Judiciary Increases IP Savvy

The Chinese courts have long been criticized as unpredictable, but recent trends show the judicial system is gaining expertise in IP, making litigation an easier option to take. There has been an undeniable governmental and judicial focus on IP rights in China over the past decade. The vice president of the Supreme People’s Court of