We are pleased to announce that 13 intellectual property offices will start a pilot called Global Patent Prosecution Highway (GPPH). The GPPH will commence Monday 6 January 2014. The 13 countries involved in the GPPH are AU, CA, DK, FI, JP, KR, Nordic Patent Institute (NPI), NO, PT, RU, ES, UK, and US. The GPPH pilot will take precedence over existing bi-lateral arrangement.
European Patent Attorney
What Patents are Qualifying patents?
The proposed legislation limits qualifying patents to those currently valid and granted by the UK Intellectual Property Office or the European Patent Office or currently valid and granted in any of the following jurisdictions:
Austria, Bulgaria, The Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Poland, Portugal, Romania, Slovakia and Sweden.
Supplementary Protection Certificates, regulatory data protection and plant variety rights also qualify (however utility patents or similar “second tier rights” do not).
What profits are Qualifying profits?
Qualifying profits include worldwide income and cover profits from both the sale of products covered by a qualifying patent and the sale of products incorporating an invention covered by a qualifying patent (e.g. for a patented printer cartridge designed to be installed into a printer and not removed until empty, the income from the sale of a printer including the cartridge as part of the package can qualify!)
Examples of the type of income that will qualify are:
- sales of patented items
- patent royalties and other income from licensing
- income from products incorporating a patented element
- income from the sale of patents and infringement income
- sales of spare parts
Where the qualifying patent is for a process the income from the sale of products made by that process are not directly included in the patent box. Instead, a notional royalty rate can be used to determine the amount of qualifying profit that is eligible for the lower tax rate.
The regime is due to begin 1 April 2013. There will however be transitional provisions phasing in benefits over the first 5 years. 60% relief will be available in 2013/2014 increasing annually by 10 to 100% relief available in 2017/2018.
This provides only a basic overview of the Patent Box benefits. Please contact Claire Rutherford for more details.
European Patent Attorney
The new “Patent Box” tax regime is due to come into force in 1 April 2013, giving the opportunity to UK companies to reduce their UK corporation tax rate on qualifying profits to 10% (rather than the current 26% rate, reducing to 23% in April 2013). Qualifying profits are those attributable to qualifying Patents.
The main objectives of the Patent Box are to incentivize companies to invest in the UK and to retain and commercialise innovation within the UK.
How do we qualify?
A company must hold a qualifying patent either as an applicant/owner or as an exclusive licensee (exclusivity must be across one or more countries or territories). The legislation also allows for ownership within a group structure or via cost sharing arrangements.
The company must also receive qualifying profits relating to the qualifying patent(s).
Companies must also fulfill a development condition. They (or a group member) must have been involved in the creation of the patented invention or have performed a significant amount of activity to develop to patented invention, a product incorporating the patented invention or the way in which the invention is applied.
Note- if the development conditions are only met due to another group member the company must show active management of the qualifying patents (which may include deciding where to maintain protection, granting licenses or researching alternative uses for the invention.
For further information please contact Claire Rutherford.
Unitary Patent: Advocate General’s Opinion in Joined Cases C-274/11 and C295/11: Spain and Italy v Council
In March 2011, the European Council (decision no. 167) authorized enhanced cooperation under Art. 20 TEU in the area of the creation of unitary patent protection.
Italy and Spain have challenged the validity of the application of the enhanced co-operation procedure with regard to the Unitary Patent before the Court of Justice of the European Union. Both countries are strongly against the decision to adopt English, French and German as the sole binding languages and they argue they believe this will to distort competition within the European Union.
On December 11, the Advocate General rendered his opinion in C-274/11 and C-295/11 suggesting that the Court of Justice should reject all the pleas put forward by Spain and Italy and has consequently dismissed both actions.
The Advocate General’s opinion, although often in fact followed, is not binding on the Court. The decision of the EU Court of Justice is expected in the next few weeks.
Independently of the EU court of Justice’s Decision, Spain and Italy could decide to join the enhanced cooperation and be part of the Unitary Patent at any time.
On 19 July 2012, the European Court of Justice issued a key decision on SPC in Neurim Pharmaceuticals (C-130/11), which will impact the life science industry.
Neurim Pharmaceuticals have developed melatonin for treating insomnia, obtaining a marketing authorisation (MA) for their product Circadia® which contains melatonin as the active ingredient. Neurim then applied for an SPC based on this MA and their European patent for their formulation, the claims of which were limited to its use in treating nocturnal melatonin deficiency or distortions in humans.
Article 3(d) of the SPC regulation (469/2009) states that an SPC may be granted if, among other things, a marketing authorisation has been granted and that authorisation is the first authorisation to place the product on the market as a medicinal product.
The UK Intellectual Property Office refused Neurim’s SPC application in view of an earlier granted MA (to a different company) for the use of melatonin as a veterinary product for regulating reproduction in sheep. The UK High Court confirmed this refusal.
The UK Court of Appeal referred questions to the Court of Justice of the European Union (CJEU) essentially for a ruling on the question of: which MA is to be considered as being a “first“ MA pursuant to Art 3 of the SPC regulation.
CJEU decided that the prior MA for use as a veterinary product did not preclude the grant of a later SPC for a different use provided that use fell within the limits of the basic patent on which the SPC was based.
CJEU considered the date of the later MA to be the relevant date for calculating the term of the SPC.
Further, the decision appears not to be limited to situations where the earlier approval is veterinary and the new approval is for human use:
“Therefore, if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of the product”
It follows, that an SPC may be granted despite the existence of an earlier marketing authorisation for the same active ingredient, provided that the previously authorised use does not fall within the scope of the protection of the basic patent on which the later SPC application is based.
Thus, in principle a new medical use for a known active ingredient can be eligible for a new SPC, even where an SPC has been granted previously for a drug containing the same active ingredient.
This may offer new opportunities to patent proprietors for obtaining an SPC in cases where the active ingredient has already been commercialized.
Whilst the Neurim decision appears to have relaxed the requirements for obtaining an SPC, it is still unclear how broadly this decision will be applied. For example it is still unclear whether new formulations, new routes of administration, dosage regimes or unit dosage forms fall within the meaning of the “new therapeutic application”
European Patent Attorney
How many members of the public are comfortable reading a language other than their mother tongue? Probably a significant proportion in most European countries one might expect.
How many members of the public are comfortable reading a legal document in a language other than their mother tongue? I anticipate that this number will not be so great.
How many members of the public are comfortable reading a patent in a language other than their mother tongue? Now you can stop laughing, because it is a serious issue. Businesses cannot take account of other parties’ legal rights to control exploitation of technology if they cannot understand them.
So serious is this taken that Google and the European Patent Office are jointly developing and promoting a machine based translation service dedicated to providing translations of patents in certain languages.
Now the good news is that the European Patent Office is already making this service freely available to users of its excellent Espacenet service
Who can benefit from this? Any person having reading comprehension of two of the following languages: English, German, French, Italian, Portuguese, Spanish and Swedish. However, the current plan is to extend the service to all 28 languages of the European Patent by 2014.
The European Patent Office is also cooperating with the Japanese Patent Office with the aim of providing users of the patent system with better machine translations of patents from Japanese into English and then optionally into German and French.
Japio an organisation already entrusted with certain business operations entrusted to it by the Japanese Patent Office has been independently seeking the most effective way of applying machine translation technologies to its practical patent document translations including the production of PAJ (Patent Abstracts of Japan). That service will be familiar to many through its provision of English language translations of abstracts of Japanese patent publications and also Japanese language translations of US and European patent applications.
A report (Elan December 2006) prepared for the European Commission highlighted that language skills will be important in achieving European policy goals, citing survey research of nearly 2000 European companies and commenting on loss of business attributable at least in part to lack of language skills. Given that other reports suggest that many people do not have even dual language skills with regard to business needs, despite opportunities and encouragement to acquire such skills, the potential use of “machine translators” may render the findings of such reports irrelevant in a new business environment where communication is facilitated by technology.
Looking further ahead into the future, it is anticipated that our interaction with artificial or machine intelligence might be realised not through encountering robots or thinking machines from an extraterrestrial source but rather through better communication with other humans facilitated by machine “linguists”!
European Patent Attorney
The following decisions, recently issued, represent the first effects of the recent changes of interpretation of key Articles of SPC Regulation as set forth in ECJ Medeva and Geogetown judgments.
1. The scope of SPC –
ECJ Case C-442/11 Novartis v Actavis
ECJ Case C-442/11 (March 2012), confirming ECJ Medeva and Geogetown decisions, held that the same rights conferred on the Proprietor by the basic patent must exist for the SPC. Consequently an SPC covering “X” can be enforced against a competitor marketing “X + Y”, as long as the claims of the basic patent do not explicitly exclude the presence of another active ingredient.
Art. 3 of SPC Regulation-
- MedImmune v Novartis February 2012
This decision relates to the validity of ranibizumab SPC and represents the firstUK Court consideration of Art 3(a) in view of ECJ Medeva and Geogetown decisions.
Even though the Court have acknowledged that there is still a great deal of uncertainty about the appropriate test to use to assess compliance with Article 3(a) of the SPC Regulation and that further references will be required to clarify what is meant by “specified or identified in the wording of the claims “, the SPC for ranibizumab was declared invalid, as no adequate “specification” of the active ingredient in Lucentis (the ranibizumab monoclonal antibody) was considered to be present in either in the claims or in the specification.
As a matter of fact the Court stated:
57. […] In the present case, claim 1 merely identifies the product of the method as “a molecule with binding specificity for a particular target”. This covers millions of different molecules of various kinds. It is not even limited to antibodies. Although ranibizumab falls within this extremely broad class of products, there is nothing at all in the wording of the claim, or even the lengthy specification of the Patent, to identify ranibizumab as the product of the process in question.
- Merck&Co SPC for antiviral product (Aripla) February 2012
The SPC for Aripla, which is a combination of three active ingredients namely efavirenz, emtrycitabine and tenofovir dizoproxil, was refused by the Polish Patent Office on the grounds that the combination of the three ingredients does not fall within the patent claims.Such a decision was upheld by District Adimistrative Court in Warsaw (DAC)and by the Polish Supreme Administrative Court (“SAC”). Specifically SAC stated that an SPC could not be granted for a product which extends over the literal meaning of the patent claims.
3. Number of SPCs-Queensland v CSL and UK Intellectual Property Office, February 2012
It has been confirmed that in the UK, at least, Medeva does not change the law set down in Biogen (C-181/95) and that the rule remains as more than one SPC is allowable per patent provided that each SPC is directed towards a different active ingredient.
It will be interesting to see how the different national Courts inEuropewill rule on the above points .
Finally, I would like to draw your attention to the analysis and its outcomes made by genericsweb(see the link below) concerning SPCs directed to combinations of active ingredients with an expiry date after 01.01. 12. Specifically one needs to check if the compounds subjected to SPCs are “specified or identified in the wording of the claims”.
Anna Pezzoli 24 April 2012.
As from 01 March 2012, a new PPH project has been started between the German Patent and Trademark Office (DPMA) and the United Kingdom Intellectual property Office (UKIPO). The project is currently running for one year, but from experience with other PPH projects it is likely, that this term will be extended.
Like other PPH projects, this PPH pilot program enables an application whose claims have been determined to be patentable in the Office of First Filing (OFF) to undergo an accelerated examination in the Office of Second Filing (OSF) with a simple procedure according to a request from an applicant. However, please note that this new project between the UKIPO and the DPMA does not fall under the MOTTANAI PPH programme easing the priority requirements involved which has been discussed here (http://www.eupatent.com/relaxation-of-the-priority-requirements-for-the-patent-prosecution-highway-pph/ ).
Further information may be found on the respective pages of the UKIPO , i.e.
a) http://www.ipo.gov.uk/types/patent/p-applying/p-after/p-pph/p-pph-dpma.htm (general information)
b) http://www.ipo.gov.uk/ukprocedure-dpma.pdf (procedure)
c) http://www.ipo.gov.uk/pph-checklist-dpma.pdf (checklist for request),
or the DPMA (in English), i.e.
a) http://www.dpma.de/english/patent/procedures/pph/index.html (general information)
b) http://www.dpma.de/docs/service/formulare_eng/patent_eng/pph1025_1.pdf (guide lines for request)
An exhaustive overview of all existing PPH projects including all respective guidelines offered by the national authorities can be found at
European Patent Attorney
There is little to learn about the proposed unified patent court without subconsciously reaching for an aspirin and a glass of water. The recent discussions in the House of Commons provide no comfort to those hoping for a good outcome. Issues such as the potential expense of the court (currently unknown) and potential delay in resolving a patent case completely were discussed. The transcript conveys an impression of the witnesses participating in a political debate rather than offering evidence, and of an overwhelming sense of frustration in the Committee. The Committee was not satisfied and the session had to be adjourned because Baroness Wilcox was required to leave for Copenhagen. However for those wondering wishing to gain some insight on the debate, extracts from the recently published uncorrected transcript* of oral evidence are presented below.
Liz Coleman, Divisional Director, Intellectual Property Office:
The EU is no longer funding the court because it is not party to the agreement, but it is certainly the case that the UK was aware that there would need to be contributions from member states, and we were factoring that into our calculations. In the Government, we have always taken the view that the court should be self-funding from user fees, so we thought it was a perfectly acceptable way forward to go with member states’ funding rather than it coming from the EU budget, which we contribute to anyway. The funding mechanism, then, as far as the UK is concerned, does not make a lot of difference in terms of how the money actually gets there.
Baroness Wilcox: The Unified Patent Court is going to proceed. If we do not take part in that, it will be written and drawn up in a way that we may not be happy with. We think that we should be in the room, we should be part of it, and we should be designing it. ……we, of course, would like it in London. …. if we decide not to be part of it, it will go ahead. It will go ahead without us. It seems foolish for us not to be in the room. If at the end of the day it turns out that it is not going to work, we do not think it is going to be right and we cannot agree on the court, then, of course that will be something completely different, but you can be sure that one thing the Department for Business is not going to be doing is wanting to make small and medium-sized businesses disadvantaged.
There is scope all the way along for amendment. I find it very difficult to work in this way in the Competitiveness Council……..but it does seem that, if you keep talking and if you stay in the room long enough, you are likely to get the things that will help the process forward. We are fortunate that there are countries that feel as we do and, therefore, are prepared to support us.
Stephen Phillips (Scrutiny Committee): The evidence that you are giving seems to be to come to this: the Department’s position in negotiations, and the Government’s position in negotiations, is that you are prepared to purchase a Unified Patent Court at the potential cost of exposing British business to the same inefficiencies as presently exist in bifurcated jurisdictions like Germany. Is that right?
Neil Feinson, Director of International Policy, Intellectual Property Office: No. What I was trying to explain was that we need to get the rules of procedure right so that you do not get the delay. I admit, if we had our way, we would not allow for bifurcation in this agreement.
*These extracts are from an uncorrected transcript of evidence taken in public and reported to the House. Neither witnesses nor Members have had the opportunity to correct the record. The transcript is not yet an approved formal record of these proceedings.
The full extract can be found here
To contact Eric Ede, please click here