The SPC blog

"All you need to know": SPC Blog seminar 2013 now open for booking

2013-05-22T08:57:00.003+01:00

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 ...

The SPC Blog is delighted to announce the launch of "SPC Law and Practice 2013: All you need to know" -- the title of this year's seminar. The date is Tuesday, 2 July 2013, when prospects of snow interfering with participants' travel arrangements are low, and once again we are pleased to acknowledge the kind hospitality of Olswang LLP in agreeing to host this event at its London office.

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 natasha.dubes@olswang.com

We do hope that you will join us for the usual series of topical presentations and the best Q+A on SPCs anywhere!

Costa Rica and patent term extensions

2013-04-23T12:30:00.000+01:00

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 Chavarría (CastroPal Abogados, Costa Rica), first published in Lexology

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

2013-04-23T08:08:00.002+01:00

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:

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 [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.

GlaxoSmithKline reference: UK consultation

2013-04-19T11:33:00.001+01:00

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.

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

2013-04-17T17:18:00.000+01:00

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.

Resolution not barred from seeking to revoke escitalopram SPC

2013-04-14T22:40:00.001+01:00

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.

Circadin patent extended in Israel despite opposition

2013-04-11T20:33:00.003+01:00

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.

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

2013-04-03T21:25:00.001+01:00

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

"Dysfunctional" SPC system needs revision, says judge

2013-03-22T13:08:00.002Z

Glaxosmithkline Biologicals SA v Comptroller-General of Patents, Designs and Trade Marks [2013] EWHC 619 (Pat), a Patents Court for England and Wales ruling of Mr Justice Arnold, has become the latest SPC case to be the subject of a reference to the Court of Justice of the European Union for a preliminary ruling.

In short, GSK applied for a supplementary protection certificate for "an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", an adjuvant known as AS03 protected by European Patent (UK) No 0 868 918. Later, GSK applied for a supplementary protection certificate for "an adjuvanted influenza vaccine comprising an influenza virus component which is an influenza virus antigen from an influenza virus strain that is associated with a pandemic outbreak or has the potential to be associated with a pandemic outbreak, wherein the adjuvant is an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", a vaccine comprising an antigen and AS03 protected by European Patent (UK) No 1 618 889. In both cases GSK relied upon marketing authorisation EU/1/08/453/001 for a pre-pandemic influenza vaccine against the H5N1 subtype of influenza A virus marketed by GSK under the trade mark Prepandrix. In decision BL O/506/12 the UK IPO decided that neither application was allowable: AS03 was not an "active ingredient" of Prepandrix. GSK appealed to the Patents Court and Arnold J decided to refer the following questions to the Court of Justice:

"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?

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?"

Andrew Waugh QC (3 New Square) and Emma Fulton (Hogan Lovells International LLP) both emailed to draw the attention of this blogger to the text which we have reproduced in bold type.

84. In case it assists, I shall state my own view on these questions. While I acknowledge the force of counsel for GSK's argument that the primary purpose of the SPC Regulation is to reward innovative research of the kind that led to the development of AS03 and Prepandrix, I find the arguments presented by counsel for the Comptroller more convincing. In particular, I consider that the SPC Regulation was intended to provide a simple and predictable system that could be operated by the competent authorities of the Member States, and in particular the national patent offices, in a uniform manner. To achieve those objectives, it is necessary to have bright-line rules. Article 1(b) is such a rule. In my view the Court of Justice was correct to hold in Pharmacia, MIT and Yissum that it should be strictly interpreted. The result of a strict interpretation is to deny extended protection for what may well be meritorious inventions, but the price of not adopting a strict interpretation is a level of uncertainty and inconsistency which in my opinion is unacceptable. Accordingly, I would answer both questions no.

85. It is worth adding that, as counsel for the Comptroller pointed out, GSK may be able to obtain an SPC for the antigen contained in Prepandrix based on the 889 patent and the marketing authorisation for Prepandrix. Thus refusal of the appeal would not necessarily leave GSK bereft of protection.

86. Finally, I would observe that this is the third time in six months that I have had to refer questions of interpretation of the SPC Regulation to the CJEU. I do so with considerable regret. That this should be necessary demonstrates the dysfunctional state of the SPC system at present. This is primarily due to the poor drafting of the SPC Regulation and to the failure of the European Commission, Council and Parliament to revise it to address the problems which have emerged. Matters have not been assisted, however, by the fact that the Court of Justice's recent case law interpreting the SPC Regulation has not provided the level of clarity and consistency that is required.

This blogger is fully in agreement with the judge's comments.

Switzerland, Liechtenstein and the AstraZeneca reference: your chance to comment

2013-02-25T22:34:00.001Z

Readers of The SPC Blog will be familiar with the UK litigation between AstraZeneca AB and the Comptroller of Patents, Designs and Trade Marks since this blog posted a note on it back in October of last year. This case has now resurfaced as a reference to the Court of Justice of the European Union with the new designation of Case C-617/12 AstraZeneca.

The UK's Intellectual Property Office reminds us that the referring court has asked the following questions:

"1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC?

2. Does it make a difference to the answer to the first question if:

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?

3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?".

If you would like to comment on this case and, by doing so, encourage the UK government to take a position on whether to make observations to the CJEU, please email policy@ipo.gsi.gov.uk by 28 February 2013. We know there's not much time, but ...

Isoxadifen and SPCs for safeners: UK invites comments

2013-02-18T10:07:00.001Z

Following on from The SPC Blog's earlier posts here and here, the UK Intellectual Property Office has now issued a circular inviting interested parties to comment on the Court of Justice of the European Union reference in Case C-11/13 Bayer CropScience so that the UK government can decide what, if any, position it wishes to take with regard to the question referred. To jog readers' memories, the IPO explains:

The appellant is seeking a supplementary protection certificate for ‘Isoxadifen and the salts and esters thereof’. Isoxadifen is a ‘safener’, that is, a substance added to a product to prevent the harmful action of an herbicide in plants.

The referring Court asks whether such a safener falls within the meaning of the terms ‘product’ in Article 3(1) and Article 1(8), and ‘active substance’ in Article 1(3) of the Regulation.

While the precise official English version of the reference from the German Bundespatentgericht does not appear to be available, the gist of the question is clear.

If you would like to comment on this case please email policy@ipo.gsi.gov.uk by 25 February 2013.

Isoxadifen: here's the original reference

2013-01-28T14:26:00.002Z

Following our earlier post this morning, it is with great thanks to Justizhauptsekretärin Elke Höchner of the German Bundespatentgericht that The SPC Blog is delighted to be able to offer readers the full text of the decision -- in German -- in which the status of safeners was referred to the Court of Justice of the European Union for a preliminary ruling in Case C-11/13 Bayer CropScience. You can read it here.

Isoxadifen reference: can you help?

2013-01-28T11:48:00.000Z

One of our readers has written in to ask:

"Would it be possible to ask the SPC community for a copy of the decision of the German Federal Patent Court (BPatG; file number: 15 W (pat) 14/07 with regard to the corn safener Isoxadifen from Bayer) with regard to the recent referral to the Court of Justice of the European Union in Case C-11/13 Bayer CropScience? The referred question seems to ask whether a "safener" can be a product and an active ingredient according to Article 3(1) and Article 1 No. 8 and No. 3 of Regulation 1610/96. Unfortunately (although the court decided the referral as long ago as July 2012) the decision has not yet been published".

While this weblog is inevitably much more focused on pharma products than on the agrochemical sector, we do have some readers on that side too. Can they, or indeed anyone, help?

Denmark's new post-Medeva guidelines on "specified"

2013-01-28T09:43:00.003Z

From our friend Sidsel Hauge (Partner and European Patent Attorney, Awapatent A/S, Copenhagen) comes news of the Danish Patent Office's new guidelines on the interpretation of "identified/specified" after Medeva. The following is Sidsel's unofficial translation:

Protection by a basic patent, particularly for combination products (Last update: 17‐12‐2012)

___________________________________________________

Before a product which consists of a composition of two or more active ingredients, known as a combination product, can be considered to be protected by a basic patent according to the Regulation, the combination of the active ingredients must be specified by the wording of the claims of the basic patent in accordance with the judgment of 24 November 2011 in Case C‐322/10 (Medeva) of Court of Justice of the European Union.

For example, a combination product consisting of the two active ingredients A and B is considered to be protected by a basic patent, if the combination A and B appear in the wording of the claims.

The product is considered to be specified in the wording of the claims when the product is described by a chemical name or a structural formula, i.e. specifically mentioned or being comprised by a Markush formula.

A product may in some cases be considered to be specified in the wording of the claims of the basic patent, if the product is specified by functional terms. The actual protection will always be decided from case to case on a case by case basis.

If the basic patent in an administrative re‐examination could be limited so that the combination of the active ingredients remains in wording of the claims of the basic patent, we also consider the combination product to be protected by the basic patent and thus Article 3, point a, to be fulfilled.

You can read more about the effects of the foregoing for applications for a certificate for combination products under Combination products.

Valsartan: France back in line with the rest of Europe

2013-01-27T23:11:00.003Z

From our good friend Laëtitia Bénard (Partner, Allen & Overy LLP, Paris) comes some more fascinating and instructive material for our readers. Laëtitia (whose firm acted as counsel to Novartis in the Valsartan case, and to MSD and Du Pont in the Losartan case) writes:

Novartis v Actavis on the Valsartan SPC: the French Supreme Court has quashed the decision of the Paris Court of Appeals and has put France back in line with the CJEU and national courts in Europe by ruling that an SPC covering Valsartan confers the same rights as the basic patent and is infringed by a medicinal product comprising Valsartan in combination with another active ingredient

Further to a preliminary injunction rendered against Actavis on 28 January 2011, which ruled that Actavis' generic medicines containing a combination of Valsartan and HCTZ infringed the SPC of Novartis for Valsartan, the Paris Court of Appeals rendered a decision on 16 September 2011 inconsistent with the almost unanimous interpretation of the SPC Regulation across Europe on the subject matter and effects of an SPC, including France, reversing the preliminary injunction measures ordered in first instance.

On 15 January 2013, ruling on Novartis' appeal, the French Supreme Court quashed the decision of the Paris Court of Appeals, aligning at the highest level the French case law with the interpretation of the SPC Regulation by the CJEU in its Reasoned Orders of 9 February 2012 (C-442/11 and C-574/11), as previously did the Paris First Instance Court ruling on the merits on 8 June 2012 in the Losartan case (decision now final -- you can read the French decision of 8 June 2012 here and the English translation here).

The French Supreme Court ruled that an SPC covering Valsartan confers the same rights as the basic patent and is infringed by a medicinal product comprising Valsartan in combination with another active ingredient.

The main findings of the French Supreme Court are as follows:

"Whereas by order of 9 February 2012 (C-442/11), the Court of Justice of the European Union ruled and held to be law that Articles 4 and 5 of Regulation No. 469/2009 must be interpreted as meaning that, where a product consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that product in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, an SPC granted for that product enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the product, as a medicinal product, which was authorised before that certificate expired;

Whereas the decision considers, in order to dismiss Novartis' claims, that the litigious generic medicinal product, comprising Valsartan associated with HCTZ, does not constitute the same product as Valsartan, solely covered by SPC No. 97C0050, and consequently that it does not appear likely that any marketing of a medicinal product containing Valsartan as an active ingredient constitutes an infringement and violates the rights owned by Novartis over this active ingredient;

Whereas, by deciding so, without considering whether the rights owned by Novartis on patent No. EP 0 443 983 would have allowed them to oppose the use of Valsartan, as a medicinal product, in the litigious generic medicinal products associating it with HCTZ, and whether, consequently, these generic products would infringe SPC No. 97C0050, covering, as the basic patent, Valsartan, and conferring to Novartis the same rights as the patent, the Court of Appeals rendered a decision without legal basis;".

This decision of the French Supreme Court is final.

You can read the French decision of the French Supreme Court here and the English translation here.

Paris in the springtime

2013-01-15T20:02:00.000Z

It's third time around for FORUM's English SPC advanced course, 'Supplementary Protection Certificates', featuring our good friend Dr Christopher Brückner.

Christopher, regular readers may recall, is the author of this SPC commentary (which participants will receive on top of course documentation). This year's event will take place on 14 and 15 March 2012 in Paris. More information is available here.

SPC Blog readers are entitled to benefit from a 10% discount for this event (€ 1,160 instead of € 1,290).

VALSARTAN HCT France: Court of Appeals reverses trial court decision granting Novartis ex parte injunction

2013-01-11T14:47:00.002Z

The SPC Blog would like to thank Floriane Codevelle and Arnaud Casalonga (Casalonga Avocats, Paris) for sharing the following information, which is of particularly interesting with regard to the availability of interim injunctive relief in France:

Alleging infringement of the European patent and the SPC by the product Valsartan hydrochlorothiazide, Zentivalab 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg, the NOVARTIS companies submitted an application for ex parte interim measures against the companies SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS before the President of the Regional Court of Paris which, by order of 27 October 2011, granted the request.

SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS summoned NOVARTIS for rescission of the order and alternatively for the provision of a guarantee.

By order of 31 October 2011, the judge in chambers maintained the order on application in all of its provisions -- with the exception of those relating to the obligation to communicate information intended to determine the origin and the distribution networks of the pharmaceutical compositions reproducing the claims of the patent EP0443983 and of the SPC No. 97C0050.

SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS made appeal of this decision and asked the Court of Appeal, inter alia, to state that the conditions of Article L 615-3 of the Intellectual Property Code, authorizing under specific conditions ex partes interim measures, were not met.

In its decision issued on December 11, 2012, the Court annulled the order issued on October 31, 2011 and in a new ruling rescinds the order on application of 27 October 2011.

After finding that:

- the documents at the Court’s disposal, which would be those submitted as proof of the infringement to the applications judge in support of the injunction request, did not sufficiently prove the imminent marketing of the products in question;

- interim measures could have been ordered through inter parte proceedings, since there are urgent short-notice summary proceedings which make it possible to observe the requirements of inter partes proceedings within a shortened period;

- the “irremediable prejudice” invoked by NOVARTIS was not sufficient to grant ex parte interim measures, in addition to not being irremediable;

The Court stated that

“ … the grounds invoked in support of the application for authorization of non‑compliance with the principle of inter partes proceedings are insufficient; whereas they could not allow recourse to ex partes proceedings, since inter partes proceedings were essential, the interests at stake being significant and the injunction measures sought themselves having serious consequences for the opposing parties. … it follows that as the grounds presented for justifying the departure from the principle of inter partes proceedings are unreasonable, the referred order which had to examine the ground set out for justifying the departure from this principle could only rescind the application and whereas it must therefore be annulled on this basis”.

The full text of the French decisions can be accessed in the original French (here) and in English translation (here).

Thanks so much, Floriane and Arnaud: we are most grateful to you.

Hague Court's Georgetown questions

2012-12-20T17:42:00.003Z

The SPC Blog posted this piece towards the end of October on the five questions which the District Court in The Hague was referring to the Court of Justice of the European Union for a preliminary ruling in a case which has now been designated by Curia as Case C-484/12 Georgetown University. The official English version of the questions, as cut-and-pasted from the UK IPO and mildly edited, appears below:

"1. Does Article 3(c) of the Regulation preclude, in a situation where there is a basic patent in force which protects several products, the holder of the basic patent from being granted a certificate for each of the protected products?

2. If so, how should Article 3(C) be interpreted in the situation where there is one basic patent in force which protects several products, and where, at the date of the application for a certificate in respect of one of the products (A) protected by the basic patent, no certificates had in fact yet been granted in respect of other products (B, C) protected by the same basic patent, but where certificates were nevertheless granted in respect of those applications in respect of the products (B, C) before a decision was made with regard to the application for a certificate in respect of the first-mentioned product (A)?

3. Is it significant for the answer to the second question whether the application in respect of one of the products (A) protected by the basic patent was submitted on the same date as the applications in respect of other products (B, C) protected by the same basic patent?

4. If the answer to question one is in the affirmative, may a certificate be granted for a product protected by a basic patent which is in force if a certificate had already been granted earlier for another product protected by the same basic patent, but where the applicant surrenders the latter certificate with a view to obtaining a new certificate on the basis of the same basic patent?

5. If the issue of whether the surrender has retroactive effect is relevant for the purpose of answering question four, is the question of whether surrender has retroactive effect governed by Article 14(b) of the Regulation or by national law? If it is governed by Article 14(b), should that provision be interpreted to mean that surrender does have retroactive effect?".

If you would like to comment on this case and advise the UK government whether it should make any representations, please email policy@ipo.gsi.gov.uk by the agreeably generous deadline of 10 January 2013 -- a welcome change from the three or four days within which one usually needs to respond.

Lipitor paediatric extension surprise: judge doesn't refer questions to CJEU

2012-12-20T17:23:00.001Z

Dr Reddy's Laboratories (UK) Ltd & Another v Warner-Lambert Company LLC [2012] EWHC 3715 (Pat) is a Patents Court for England and Wales ruling of Mr Justice Roth -- who is not one of the usual Patents Court judges [though it seems that he is now officially a Patents Court judge: see the Comment posted below this article]. This action however required the judge to exercise purely legal skills rather than to possess technical knowledge of the field in which the patent had been granted.

In brief, Pfizer applied for and was granted a paediatric extension for Atorvastatin (Lipitor). Dr Reddy's challenged the grant of the paediatric extension on three grounds:

(1) The European Medicines Agency (EMA) acted ultra vires it powers under the Paediatric Regulation by approving a paediatric investigation plan (PIP) that let Pfizer to defer completion of the third of its three required studies. The circumstances in which studies in a PIP may be started but not finished are expressly defined by the Regulation and must be covered by a deferral under Article 20. No such deferral was applied for by Pfizer or granted in this case. Accordingly, the PIP was not lawfully approved under the Paediatric Regulation and Pfizer was therefore not entitled to the extension.

(2) Under Article 45(3), a paediatric extension should be granted only when significant studies contained in the PIP have been completed. Here, none of the relevant bodies made an assessment as to whether either of the two studies which had been completed was significant; and, on the facts, they were clearly not significant.

(3) Even if, contrary to ground (1), it was legitimate for the EMA to approve a PIP that required the initiation but not the completion of the third study, under Article 36 Pfizer was not entitled to a paediatric extension unless it included, within its application for a marketing authorisation, the results of the completed third study.

The learned judge dismissed all three challenges, describing the third as "misconceived", and declined to follow what seems almost standard practice these days when he decided that there was no need to make a reference to the Court of Justice of the European Union relating to the second ground.

The decision is quite long -- some 76 paragraphs -- and would have benefited from being just a little bit longer, if Roth J had added a short paragraph at the end which summarised what he actually decided.

Case C-493/12: referring decision now available

2012-12-14T09:08:00.002Z

Following yesterday's post, The SPC Blog can confirm that the mystery judgment leading to the reference to the Court of Justice of the European Union in Case C-493/12 is that of Mr Justice Warren of 10 October 2012 in Eli Lilly v HGS. The ever-helpful Micaela Modiano has even rooted out a copy for readers' consideration here (thanks, Micaela -- and thanks to our readers for their comments posted on the earlier item).

C-493/12: Where is the referring decision?

2012-12-13T07:12:00.001Z

Can you help a reader of The SPC Blog who has written as follows:

I am trying to track down the decision that leads to the reference C-493/12 [on which see The SPC Blog post here] but cannot find it on BAILII or Curia. I have emailed the UKIPO policy unit but have had no reply. Are you able to put out a request on the blog for the decision or order for reference?

I understand from another source that it is a Patents Court decision dated 24 October 2012. I would have thought that those involved in it are assiduous blog readers and might be happy to share the information (which should be in the public domain, surely).

One further thought. Why doesn’t the CJEU put the reference from the national court onto the relevant part of Curia? All it says in the relevant bit of C-493/12 is:

Source of the question referred for a preliminary ruling High Court of Justice (Chancery Division) - United Kingdom

If you can shed any light on this, please do so!

Rivastigmine patent, SPC confirmed invalid on appeal

2012-12-13T06:52:00.001Z

Yesterday, in Novartis AG v Generics (UK)Ltd t/a Mylan [2012] EWCA Civ 1623 CA (Civ Div), a three-man Court of Appeal for England and Wales consisting of Lords Justices Munby, Lewison and Kitchin dismissed Novartis's appeal against the decision of Mr Justice Floyd (noted here on The SPC Blog) that Novartis's Rivastigmine patent and SPC were invalid.

The main focus of the appeal was not specifically related to the law or practice with regard to SPCs, but rather to whether the trial judge had taken the correct approach to the question of inventive step. An analysis of the Court of Appeal's reasoning on this point has been written for the IPKat weblog by David Brophy (FR Kelly), here.

Eli Lilly: another batch of SPC questions for CJEU

2012-12-11T12:23:00.000Z

The UK Intellectual Property Office is soliciting comments from interested parties that might persuade it to become involved in Case C-493/12 Eli Lilly & Co, the latest SPC case to go to the Court of Justice of the European Union for a preliminary ruling. There have been so many cases involving Eli Lilly in recent times that this blogger is uncertain precisely which of them has led to this reference, but he suspects that this reference is of British origin, emanating from the Patents Court ...

The questions posed of the Luxembourg tribunal have at least some familiarity to them:

" (1) What are the criteria for deciding whether the product is protected by a basic patent in force in Article 3(a) of Regulation 469/2009/EC;

(2) Are the criteria different where the product is not a combination product, and if so, what are the criteria?

(3) In the case of a claim to an antibody or a class of antibodies, is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?".

If you would like to comment on this case, please email policy@ipo.gsi.gov.uk by 17 December 2012. This may interfere with your end-of-year ~~partying~~ urgent work, but not too much!

AstraZeneca fine upheld: legal team comments

2012-12-06T11:04:00.001Z

AZ: probably feeling
a bit blue today ...

The Court of Justice of the European Union, as expected, dismissed AstraZeneca's appeal against the aggregate of 54.5 million euros which it was fined for abuse of dominant position. The acts to which objection was taken included the making of deliberate misrepresentations to national patent offices in order to secure and sustain SPC protection for its Losec anti-ulcer product.

The decision, in Case C-457/10 P AstraZeneca v Commission, is neatly summarised in the Curia press release here.

Lawyers for Bristows LLP, who have been keeping a watchful eye on this case on behalf of their clients, have been quick to comment. Said Marie Manley, head of Bristows’ Pharmaceutical Regulatory team:

“The Commission will be delighted with the endorsement to its approach; innovative pharma less so. The pharmaceutical industry is now subject to a set of onerous but not fully clear obligations. Ensuring compliance will require pharmaceutical companies to build in more checks and balances to their internal procedures. Strategic corporate decisions when a product is close to patent expiry should be particularly carefully scrutinised”

Pat Treacy, head of Bristows’ competition team, added:

"The effects of this judgment resonate beyond the pharmaceutical sector. Companies which may be dominant now have an obligation to conduct themselves transparently when dealing with the public authorities. AstraZeneca has been penalised for making arguments that favoured its position when the issue was legally unclear. The Commission, in a position which has been endorsed by the courts, believes that AstraZeneca should have made the uncertainty about the legal position clear to the patent authority. This has wide implications for the way dominant companies conduct themselves".

You can't be right all the time ...

2012-11-30T12:30:00.001Z

Luxembourg: home to the Court of Justice
and place where AGs sometimes get it right ...

Yesterday the IPKat weblog posted this item on the retirement of Verica Trstenjak as an Advocate General of the Court of Justice of the European Union. A correspondent, who has prudently asked not to be identified adds:

"Verica is is the AG who caused all the confusion over “one SPC per patent” and “subject matter of the invention” in Medeva. If she is off the scene, then perhaps these ideas will have fewer supporters in the referrals on these points in Actavis v Sanofi, Lilly v HGS etc. Credit where credit is due, though - she got Neurim absolutely right!"