News & Analysis as of September 18, 2024

European Union › Supplementary Protection Certificate

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

On Efficiency of China’s Drug-Related Patent Term Compensation System based on “Effective protection period”

Linda Liu & Partners on 6/26/2024

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

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

American Conference Institute (ACI) on 3/25/2024

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

European Union to implement a unitary SPC and centralised examination procedure for SPCs

A&O Shearman on 4/28/2023

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

The Unitary Patent Court: Opting European Patents Out

Morrison & Foerster LLP on 2/20/2023

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

Fee-Less Opt-Out for European Patents from the UPC

Jones Day on 5/11/2022

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

A Long Courtship For Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About A Unitary Supplementary...

MoFo Life Sciences on 4/8/2022

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

UK Life Sciences and Healthcare Newsletter: Life Sciences: What's new in France? The Santen case and the notion of second medical...

Dechert LLP on 1/28/2021

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

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Emery on 7/12/2019

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

EU SPC Manufacturing Waiver Now in Force

Hogan Lovells on 7/5/2019

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

Brexit: the impact on supplementary protection certificates (SPCs)

Hogan Lovells on 3/18/2019

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

EU: New developments in the SPC manufacturing waiver legislative process

Hogan Lovells on 1/15/2019

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

A No Deal Brexit and Its Impact on Intellectual Property Rights

Dechert LLP on 10/10/2018

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

Brexit and IP: impact of a no deal exit

Hogan Lovells on 9/28/2018

On Monday the UK government published a series of notices on the impact of a no-deal Brexit on intellectual property right-holders....more

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

Jones Day on 6/18/2018

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

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

Hogan Lovells on 6/12/2018

On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

News from Abroad: Antibodies in the European Patent Office -- Advanced Guide to Drafting and Prosecution

McDonnell Boehnen Hulbert & Berghoff LLP on 6/11/2018

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

French Intellectual Property Office Extends Granted SPC Expiration Date

Jones Day on 3/15/2018

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

Brexit Bill - Impact on patents

Hogan Lovells on 11/15/2017

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

News from Abroad -- Briefing on Supplementary Protection Certificates for Medicinal Products

McDonnell Boehnen Hulbert & Berghoff LLP on 8/10/2017

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

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

Hogan Lovells on 7/10/2017

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...more

Bill C-30 to implement CETA tabled in Canadian Parliament: implications for pharmaceuticals

Smart & Biggar on 11/2/2016

On October 31, 2016, the day following the signing of CETA, the Canadian Minister of International Trade, the Honourable Chrystia Freeland, tabled Bill C-30, An Act to implement the Comprehensive Economic and Trade Agreement...more

Continental patents a la carte or prix fixe? Biotechnology considerations for the unitary patent in Europe

Knobbe Martens on 9/7/2016

Unitary patents in Europe - The European unitary patent and Unitary Patent Court (UPC) are slated to go into effect in early 2017. These monumental changes will have a significant impact on the ways patent rights are...more

The Brexit and Patent Law: What You Need to Know

Foley & Lardner LLP on 8/26/2016

Now that some time has passed since the Brexit vote, some of the ways in which the vote is likely to impact British patent law are becoming clearer. Here is a quick summary of some of the primary concerns....more

Additional IP Considerations in Light of Brexit

Morgan Lewis on 7/7/2016

Pharmaceutical and agricultural companies in particular should consider the effect of Brexit on their European patent portfolios. Supplementary Protection Certificates (SPCs) are governed by EU regulations and are thus...more

Impact of Brexit for Intellectual Property Rights

Foley & Lardner LLP on 6/23/2016

A British vote to leave the European Union (EU)—the Brexit referendum issue scheduled for a vote June 23, 2016 — would have a significant effect on intellectual property right-holders, such as manufacturers doing business in...more

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European Union › Supplementary Protection Certificate

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