01 januari 1970

​SUPPLEMENTARY PROTECTION CERTIFICATES (SPCS)

Supplementary Protection Certificates (SPCs) are governed by EU law and provide an extension of the patent term for medicaments and plant protection products. It is intended to compensate for delays due to regulatory approval. After a relatively calm period, the last few weeks saw several referrals from national courts to the Court of Justice of the European Union (CJEU), seeking clarifications on the SPC regulation. Two referrals, both originating from the UK, stand out for their possibility to seriously affect the interpretation of the SPC regulation. The decisions could impact the possibility for obtaining patent term extensions on combination products and new formulations.


Teva v Gilead

The product underlying the court proceedings is Gilead’s Truvada for the treatment of HIV. Truvada contains a combination of tenovir disoproxil and emtricitabine. The SPC application was based on a European patent on tenovir disoproxil (further referred to as the monotherapy patent). This patent does not mention emtricitabine. A European patent on the combination of tenovir disoproxil and emtricitabine was revoked in opposition.

Gilead also markets tenovir disoproxil as a monotherapy (Viread). However, as it would not have provided a real benefit, Gilead did not request an SPC extension for the monotherapy European patent based on this monotherapy drug.

An important criterion for obtaining an SPC is that ‘the product is protected by a basic patent in force’ (Article 3(a) of the SPC regulation). The monotherapy patent contained a claim covering tenovir disoproxil and optionally other therapeutic ingredients. While that claim generically embraces the combination with emtricitabine, the referring judge doubts if that is enough to conclude that the combination is protected by the patent within the meaning of the SPC regulation. Reference is also made to among others previous CJEU decisions that state that the product should be “identified” or “specified” in the wording of the claims. The question referred to the CJEU is therefore “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’”.

The referring judge provides his own suggested answer. In his opinion, one should look to the “inventive advance” of the basic patent. Where the product is a combination product (such as Truvada), the combination should embody the inventive advance of the basic patent (instead of only one ingredient of them as is the case in the monotherapy patent). It remains to be seen if the CJEU will follow this suggestion or take another approach.


Abraxis

Abraxis identified a new way of formulating paclitaxel (a known anti-cancer therapeutic). By formulating it as albumin bound nanoparticles, it behaves materially different (increased effectiveness, better tolerability,…). Abraxis obtained both a patent and a marketing authorization for this formulation (Abraxane), resulting in the question if SPC extensions are available for new, inventive formulations of old active ingredients.

While several CJEU decisions suggest that it would not be possible to obtain an SPC extension on a new formulation of an old active ingredient, Abraxis referred to the Neurim decision to cause doubt (we previously discussed the potential impacts of the Neurim decision here: http://ipimediaworld.com/extending-your-patent-on-a-new-application-for-an-old-drug/). While that case allowed an SPC extension on a new therapeutic use of an old active ingredient, Abraxis contended that it similarly applies to new formulations of old active ingredients. The CJEU will now have to decide if that is indeed the case.


Other SPC referrals

Incyte (C-492/16) concerns the rectification of SPC expiry dates in view of the Seattle Genetics (C-471/14) decision.

In Merck (C-567/16), the question at stake is if an SPC extension requires a Marketing Authorization or if an End of Procedure Notice suffices and if this can be rectified retrospectively.

Pfizer (C-681/16) relates to the interaction of an SPC with a specific mechanism to prevent importation from accession states into Germany.


Our Firm

LC Patents is closely monitoring these and other SPC-related decisions. Do not hesitate to contact us for more information.


01 januari 1970
E-BIKES - MOBILITEITSPROJECT

Fase 2 in ons mobiliteitsproject bij LC Patents. E-bikes voor de woon-werk-verplaatsingen van 10-15km. Iedereen tevreden en nu maar fietsen. Drie wagens minder op de weg.

01 januari 1970
VISIT MEXICAN AGENT - 2019

We had the pleasure to welcome our Mexican Agent on the 26th of July, 2019. After a respectful collaboration period with a number of overseas mailing correspondence, we finally had the...

01 januari 1970
ECTA 2019 AWARD WINNER - EDINBURGH

We are proud to announce that our colleague Lars Nysten has won the annual prestigious award in the student category at the 2019 European Communities Trade Mark Association (ECTA) conference in...

01 januari 1970
LC PATENTS AT KNOWLEDGE FOR GROWTH - 9/05/2019

the 9th of May, 2019, LC Patents will be attending the Knowledge for Growth exhibition at Flanders Expo booth 109 , Ghent, Belgium. "Researchers working on a research project within the broad...

01 januari 1970
INTERVIEW MET ONZE KLANT IN STERCK MAGAZINE

Met enige trots tonen we het interview met onze klant in het Sterck Magazine. Proficiat Armen ! Fijn dat we van dit mooie verhaal deel kunnen uitmaken. Hartelijk dank !

01 januari 1970
BEST WISHES FOR 2019!

01 januari 1970
EXCLUSIVE INTERVIEW OF MAGAZINE STERCK MERCK WITH CEO BART LAENEN

We zijn trots om dit interview met oprichter en CEO van LC Patents, Bart Laenen , over zijn gedurfde carrièrepad, met jullie te delen. Bart licht in deze editie van Magazine Sterck Merck,...

01 januari 1970
​CONGRATULATIONS SARA

We are pleased to announce that Sara has become qualified as Belgian Patent Attorney and successfully passed the exam. Please join us in congratulating Sara in this important professional career...

01 januari 1970
CONGRATULATIONS LIEVE!

We are pleased to announce that Lieve passed the full European Qualifying Examination with great success to become a Registered European Patent Attorney. Please join us in congratulating...

01 januari 1970
NEW PATENT CANCELLATION SYSTEM FOR SOUTH-KOREA

In South-Korea, the validity of a patent can be challenged regardless of an infringement litigation. A granted patent can be revoked only by the Korean Intellectual Property Office (KIPO), and...

01 januari 1970
DECISION AGAINST DUTCH FIRM IS KEY VICTORY FOR BRAND IN LONG-RUNNING TRADEMARK BATTLE

BRUSSELS (Reuters) - Christian Louboutin’s battle to protect the distinctive red soles on the shoes he designs got a boost on Tuesday when the European Union’s top court said their red color was...

01 januari 1970
TOMATOES II AND BROCCOLI II - PATENTABILITY OF PLANTS AND ANIMALS

The Regulations of the European Patent Office will be amended with immediate effect and will exclude the patentability of plants and animals exclusively obtained by an essentially biological...

01 januari 1970
BOARD OF APPEAL - DECISION MARCH 22, 2017 - ASSIGNMENT OF PRIORITY RIGHT

Board of Appeal sends reminder that assigning a priority right in time is not to be considered lightly. Retroactive assignment between companies from the same corporate group six days after the...

01 januari 1970
A FEW MORE DAYS OF PATENT PROTECTION FOR PHARMACEUTICALS

The lengthy procedure for obtaining a regulatory approval to introduce a new drug on the European market significantly affects the effective duration of patent protection for these drugs. In order...

01 januari 1970
CONGRATULATIONS - EQE 2015

We are pleased to announce that Stijn passed the European Qualifying Examination with great success to become a Registered European Patent Attorney. Not only for Stijn, but also for our company...