If you'd like to makes comments that will guide the UK government as to whether it should make representations in this reference, you have until Friday to do so.We have received notification of a new case reference to the ECJ. ... In GlaxoSmithKline v Comptroller General of Patents  EWHC 619 (Pat) the following questions were referred:1. Is an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, an 'active ingredient' within the meaning of Article 1(b) of Regulation 469/2009/EC?
2. If the answer to question 1 is no, can the combination of such an adjuvant with an antigen nevertheless be regarded as a 'combination of active ingredients' within the meaning of Article 1(b) of Regulation 469/2009/EC?"
Case summary:The appellant applied for an SPC relating to the product "an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", an adjuvant known as AS03. An additional application was filed for a pandemic influenza vaccine containing the adjuvant AS03.Question 1 concerns whether or not an adjuvant, such as that common to these applications, can be considered an active ingredient within the meaning of Article 1(b) of the Regulation. Question 2 seeks to determine if the combination of an antigen, such as the influenza vaccine component of the latter application, and the adjuvant may be considered an active ingredient if the adjuvant alone may not.This case and the questions referred to the court can be viewed on our website at:If you would like to comment on this case please email firstname.lastname@example.org by 14 June 2013.
The SPC blog
A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Monday, 10 June 2013
Sunday, 9 June 2013
You can access and read Alice's SPC News, all seven pages of it, here.
Wednesday, 22 May 2013
|This is what the cover of this year's invitation looks like. For the operative|
link to the click-through for further details and registration, read on ...
This year's seminar, the fifth, is built around the responses of blog readers to our earlier request for suggestions. It will be taking a focused look at how national patent offices are implementing the Court of Justice (CJEU) rulings in Neurim and Medeva, the pharmaceutical regulatory process and its interface with SPC law. We'll also review and analyse the pending CJEU referrals and discuss a range of hot topics including the Unified Patent Court (UPC), SPC economics and so-called piggyback SPCs. There will be plenty of time for questions and a drink afterwards.
To view the detailed programme and register your interest please click here. We will confirm acceptances by email, so please hold off from booking your travel arrangements until you have heard back from us that we can squeeze you in. If you require any further information, please contact Natasha Dubes at email@example.com
We do hope that you will join us for the usual series of topical presentations and the best Q+A on SPCs anywhere!
Tuesday, 23 April 2013
Patent term extensions are available in Costa Rica as an adjustment of the patent term due to delays in the patent registration process or regulatory approval of a pharmaceutical product.Patent term extension is not the only area in which Costa Rica has been raising its level of IP protection. Following a free trade agreement with Europe, that country is also beefing up its provisions for the protection of geographical indications and appellations of origin. This blogger hopes that Costa Rica's attitude is matched by increased investor confidence in IP-based industries, both in the pharma sector and beyond it.
The Costa Rican Patent Law provides that patent term extensions are available for patents filed after April 25th 2008 and in the following cases:
* When the Patent Office takes more the 5 years to grant the patent, from the date of filing in Costa Rica, or from the date it entered the national phase in Costa Rica for PCT applications.
* When the Patent Office takes more than 3 years to grant the patent, from the date examination was requested.
For pharmaceutical products, when the approval for sale by the Ministry of Health has taken more than 3 years from the application.
Actions attributed to the applicant will not be taken into account to calculate the delays. The term to compensate will be 1 day per day of delay, as long as the remaining term of the patent does not exceed 12 years. Nevertheless, the total term to compensate shall never be more than 18 months.
The request to apply for patent term compensation shall be filed by the applicant with the Patent Office no later than 3 months after the patent was granted, or 3 months after the marketing approval was issued by the Ministry of Health.
An interesting fact is that patent term compensation was introduced into the Costa Rican Patent Law as a consequence of the enactment of DR-CAFTA, the Central American-Dominican Republic Free Trade Agreement with the United States, which means it should also be available in all the other countries party to the agreement, which are Guatemala, Honduras, El Salvador, Nicaragua, Dominican Republic and the United States.
Source: "Patent term extensions in Costa Rica" by Luis Diego Castro Chavarría (CastroPal Abogados, Costa Rica), first published in Lexology
In short, in 2004 a number of new Member States (the 'accession states') joined the European Union. Some of those states had not historically permitted the patenting of pharmaceutical products. By 2004, such patents were permitted, but there remained a number of cases where patents or supplementary protection certificates had been granted in other Member States for pharmaceutical products at a time when no such protection had been available in one or more of the accession states. Accordingly, a special derogation from the normal free movement rules was negotiated as part of the accession arrangements.
This derogation, known as the 'Specific Mechanism', was appended to the Act of Accession. It permitted the owner of a pharma patent or SPC to prevent the parallel importation of the patented product from one of the accession states if, at the time of filing, such protection was unavailable in that accession state. It also anyone who intended to import such a product to demonstrate to the relevant national authority that he had given notice of that intention to the holder or beneficiary of the protection.
Sigma, a parallel importer of pharma products into the United Kingdom. In June 2009 Pharma XL, an associated company of Sigma that was responsible for applying for parallel import authorisations for the Sigma group of companies, sent a letter to Merck Sharp Dohme which stated that it intended to import Singulair into the UK from Poland. This letter referred to the Specific Mechanism and asked whether there were any objections to importation. Merck Sharp Dohme did not respond. In September 2009 PXL applied to the Medicines and Health Regulatory Agency (MHRA) for parallel importation licences. This application required confirmation that either the Specific Mechanism did not apply or that one months’ prior notification had been given to the patent holder. Pharma XL indicated that one months’ notice had been given. In May 2010 the MHRA granted Pharma XL a licence in respect of the 5mg dose of Singulair. In June and July, Pharma XL wrote to Merck Sharp Dohme, saying it planned to import Singulair from Poland and enclosed copies of the intended representation of the repackaged products. Again Merck Sharp Dohme did not respond, so Sigma began to import 5mg Singulair. In September, Pharma XL was granted a second licence in respect of the 10mg dose. Pharma XL wrote two further notification letters to Merck Sharp Dohme in respect of the 10mg dosage, but again there was no response, so Sigma began to import the 10mg form of Singulair too.
In December, Merck Canada wrote to Pharma XL objecting to the importation of Singulair under the specific mechanism and asserting that its patent had been infringed. Sigma stopped its activity, but Merck Canada nonetheless sued for infringement of both the patent and the SPC.
Sigma's primary defence was that the Specific Mechanism merely conferred upon a patent holder the option of preventing imports: the derogating provisions were inapplicable unless and until the patent holder demonstrated his intention to exercise that option -- which did not happen till December 2010. In any event, having failed to respond to the letters from Pharma XL, Merck Canada was estopped from asserting its rights.
When the case came before the Patents County Court, Judge Birss QC rejected both these defences. In his view, the Specific Mechanism did not require the patent holder to demonstrate his intention to oppose importation before that activity was rendered an infringement -- and he declined to refer any issue concerning the proper interpretation of the Specific Mechanism to the CJEU. Also, he found on the facts that Merck Canada was not estopped from relying on its patent rights. He granted an injunction and ordered Sigma to deliver up its unsold stocks of Singular. Sigma appealed.
The Court of Appeal also agreed that Judge Birss QC was right to make the order for delivery up, on the basis that his finding of infringement had been correct.
However, this action raised three groups of questions that concerned the proper interpretation of the specific mechanism. These had to be answered by the CJEU before the Court of Appeal could decide the appeal. As Lord Justice Kitchin, giving judgment for the Court, explained:
- Under Article 267 of the TFEU this court may submit a request to the Court of Justice for a ruling on a question concerning the interpretation of a rule of EU law if it considers it necessary to do so in order to resolve a dispute before it. In my judgment this case raises three groups of questions concerning the proper interpretation of the Specific Mechanism which must be answered for this court to decide this appeal.
- The first concerns the conditions which must be satisfied before a patent holder may bring infringement proceedings under the Specific Mechanism and, in particular, whether the derogation confers upon the patent holder an option of preventing imports falling in its scope; and whether the derogation is inapplicable unless and until the patent holder demonstrates his intention to exercise that option.
- The second concerns the identity of the person who must give the notice under the second paragraph of the Specific Mechanism and, in particular, whether a notification is compliant if it is given by an applicant for regulatory approval in the Member State into which the products are to be imported; and whether it makes any difference if the notification is given and the application for regulatory approval is made by one legal entity within a group of companies which form a single economic unit, and the acts of importation are to be carried out by another legal entity within that group under licence from the first legal entity.
- The third concerns the identity of the person to whom the notice must be given under the second paragraph of the Specific Mechanism and, in particular, whether, in a case where a group of companies form a single economic unit comprising a number of legal entities, it is sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group which has legal ownership of or an exclusive licence under the patent. A subsidiary question also arises as to whether a notification which is otherwise compliant is rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs".
- I recognise that this court is not obliged to make a reference but I believe it is appropriate to do so for the following reasons. First, these questions are not acte clair. Second, the Specific Mechanism has not yet been considered by the Court of Justice and, although its Iberian predecessor was considered by the Court in Case C-191/90 Generics and Harris Pharmaceuticals, there is uncertainty as to how the decision of the Court in that case should be understood. Finally, the parties helpfully provided to us after the hearing an agreed table which shows that the Specific Mechanism will continue to be relevant until 2019. In all these circumstances I believe it to be desirable that the questions raised in this case are answered authoritatively as soon as possible.
- I would therefore make a reference to the Court of Justice for a preliminary ruling on each of the three groups of questions posed at ,  and  above. They are currently formulated in general terms on the basis of questions originally proposed by Sigma. We have not had the benefit of any comments from Merck. Accordingly, I would invite the parties to consider them further in the light of this judgment and to propose draft questions and a draft reference for our consideration.
The SPC Blog awaits the questions with keen interest.
Friday, 19 April 2013
The first "new" consultation, which helpfully gives interested parties some background information concerning the questions referred and also gives them more time in which to respond, is in relation to an SPC case, GlaxoSmithKline v Comptroller General of Patents, noted here on The SPC Blog.
Wednesday, 17 April 2013
Before we set the event in stone, we'd be delighted to hear from you if there are any topics you particularly want to see on the programme. If you'd like to tell us what you want, just email Rob Stephen here and let him know.
Sunday, 14 April 2013
As the judge explained by way of background, Escitalopram is the S or (+) enantiomer of citalopram. Citalopram is an anti-depressant drug of the selective serotonin re-uptake inhibitor (SSRI) type which was first synthesised by Lundbeck in 1972 and launched in 1989. Some time after it developed citalopram, Lundbeck devised the method for synthesising escitalopram described and claimed in the Patent and discovered that escitalopram was the active enantiomer of the racemate. This led to it launching escitalopram in 2002. Escitalopram has been hugely successful. Lundbeck was also the proprietor of a number of patents for citalopram and methods of making it which have since expired.
On 3 January 2013, in response to Resolution's application for revocation, Lundbeck issued an application seeking:
i) summary judgment on the ground that Resolution was precluded from bringing its claim and/or relying on allegations in its claim by reason of cause of action estoppel or issue estoppel or abuse of process;In short, after three days of hearings and a judgment of 164 paragraphs, laid out with that judge's usual clarity and attention to detail, Arnold J ruled as follows:
ii) alternatively, summary judgment on the ground that Resolution's claim had no real prospect of success; and
iii) in the further alternative, a conditional order that Resolution provide security for Lundbeck's costs of these proceedings.
i) Resolution was not precluded from challenging the validity of the Patent, and hence the SPC, on the ground that it was a privy of either Arrow Generics or Teva UK/Teva PI and therefore bound by the decisions adverse to those parties in the earlier escitalopram litigation.The judgment is a long one which raises numerous issues. This blogpost seeks to alert readers to the existence and substance of the ruling, but does not attempt at this very early stage to analyse and evaluate it.
ii) Resolution had a real prospect of successfully contending that all the claims of the Patent were obvious over 884 and that claims 1-5 were obvious over Bigler. Accordingly, Lundbeck's application for summary judgment was dismissed and Resolution's application for permission to amend its Grounds of Invalidity was allowed.
iii) Resolution would not be ordered to provide security for Lundbeck's costs.
Thursday, 11 April 2013
|Neurim's conduct was found, on the facts,|
not to be a "baa" to patent extension
To cut a long story short (the full tale is there for all to read on Michael's weblog), Unipharm opposed the patent term extension of Neurim's Circadin patent and Commissioner King was required to consider three issues:
- Whether an extension could lawfully be granted on account of Neurim's inequitable behaviour
- Whether the patent in question was to be considered the “basic patent” under Section 64a of Israel's Patent Law
- Whether Circadin was the first drug containing the active ingredient as required by 64d of the Israel Law
The Commissioner rejected the opposition and extended the patent till 22 April 2017. A large part of the IP Factor report deals with inequitable conduct, in particular the allegation that, in its ex parte application for patent extension, the company had behaved improperly and withheld or suppressed relevant information. The Commissioner confirmed that an applicant was required to behave in an equitable manner, but did not consider that any breach by Neurim of that requirement was sufficient to prevent the extension.
Wednesday, 3 April 2013
"This discussion document takes a look at the issues surrounding introducing an Appointed Person appeal route for patents matters (and, by extension, matters relating to supplementary protection certificates)".It is difficult to imagine why proprietary pharma companies and their generic counterparts would wish to opt for an appeal against which there is no appeal in an area of law which is so complex and uncertain -- but we won't know for a while what the outcome of this consultation will be, since the closing date for the submission of responses is 21 May 2013.
Click here for a little more background
Click here for the consultation paper