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

Tuesday 23 April 2013

Costa Rica and patent term extensions

The SPC Blog doesn't often hear from Central America, so it's heartening to see some positive news on patent term extension from a zone in much of which hostility towards IP rights is sadly endemic.
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.

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.
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.

Source: "Patent term extensions in Costa Rica" by Luis Diego Castro ChavarrĂ­a (CastroPal Abogados, Costa Rica), first published in Lexology

Singulair and the Specific Mechanism for accession states: some questions for the CJEU

Merck Canada Inc and another v Sigma Pharmaceuticals plc [2013] EWCA Civ 326 is yet another SPC-flavoured case to go to the Court of Justice of the European Union (CJEU) -- but it's quite different from the rest.  It involves the "Specific Mechanism".

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.

Merck Canada, which was incorporated in Canada, was the registered proprietor of apatent and SPC for montelukast sodium, an active ingredient in a product called 'Singulair'. The second claimant, Merck Sharp Dohme, was a UK company and its exclusive licensee. Merck filed for protection when montelukast sodium could not be patented in Poland.

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 for England and Wales (Lord Justice Patten, Lady Justice Black and Lord Justice Kitchin) upheld the trial judge's decision relating to estoppel: this was because there was no suggestion that Merck Canada had been, or ought to have been, aware of Sigma's existing state of mind and, in particular, the misunderstanding which Sigma had already formed as to Merck Canada's attitude to the importation of patented pharmaceutical products from Poland. There was no pre-existing relationship, contractual or otherwise, that could have imposed a duty on Merck to respond to Pharma XL's letters and Merck Canada had not acted unconscionably in delaying its decision to bring proceedings within the legal time limit.

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:

  1. 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.

  2. 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.

  3. 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.

  4. 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".

  5. 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.

  6. 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 [97], [98] and [99] 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

GlaxoSmithKline reference: UK consultation

Readers of the IPKat weblog will already have seen the news that the United Kingdom's Intellectual Property Office has improved the mechanics of its procedures for consulting interested parties over intellectual property references to the Court of Justice of the European Union.

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

This year's SPC Blog seminar: tell us what you want

The annual SPC Blog seminar, which once again will be kindly hosted by Olswang LLP in its London office, has been pencilled in -- but fairly heavily pencilled in -- for Tuesday 2 July, when there is little risk of snow.  We have also compiled a provisional list of topics that seem worthy of careful treatment, ranging from those that are specifically legal and IP-flavoured to those that address more regulatory, competition and policy issues.

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

Resolution not barred from seeking to revoke escitalopram SPC

In Resolution Chemicals Ltd v H. Lundbeck A/S [2013] EWHC 739 (Pat), a trial of preliminary issues ahead of a full trial scheduled for November 2013, Mr Justice Arnold (Patents Court, England and Wales) was asked to rule in an action in which Resolution sought revocation of Lundbeck's SPC/GB02/049 for escitalopram, alleging invalidity of the basic patent (European Patent (UK) No. 0 347 066).

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;

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.
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:
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.

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.
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.

Thursday 11 April 2013

Circadin patent extended in Israel despite opposition

Neurim's conduct was found, on the facts,
not to be a "baa" to patent extension
"Unipharm Challenges Validity of Patent Term Extension for Neurim’s Circadin in Israel" is the title of this blogpost by Israeli patent attorney Michael Factor on his eponymous blog The IP Factor ("Opinionated Intellectual Property News Blog with an Israel Slant").

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

IPO consults on extending 'Appointed Person' facility to SPC appeals

The United Kingdom Intellectual Property Office (IPO) has published a consultation paper on whether to extend the use of Appointed Persons from trade mark law to to patents. At present, trade mark appeals from the decisions of IPO hearing officers may be made to the High Court (of which the Patents Court forms part) or to a specially designated Appointed Person. In the former case, further appeals may be made to the Court of Appeal and Supreme Court, while in the latter case -- as a means of preventing the costs of an appeal from spiralling upwards -- the decision of the Appointed Person is final and no appeal may be made on substantive legal grounds. According to the IPO:
"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