Astellas appeal dismissed, with no reference to ECJ

Mr Justice Arnold has just given his ruling this morning in Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat), an appeal against the decision of the Intellectual Property Office, United Kingdom. At the time of writing this post, the decision has not yet been added to the decisions freely available on the BAILII website, but you can read it in full here.

Arnold J dismissed the appeal, considering the hearing officer's decision to be correct. He did not feel that this was a matter that was appropriate to refer to the Court of Justice of the European Communities for a preliminary ruling:

31. ... Astellas contends that Takeda was wrongly decided and that the correct test to apply under Article 3(a) of the Regulation is the infringement test.

32. Counsel for Astellas supported the five reasons given by Kitchin J in Gilead [see SPC Blog here] for questioning the correctness of Takeda. In particular, he submitted that Takeda is inconsistent with the ECJ’s ruling on the second question in Farmitalia that to determine whether a product is protected by a basic patent reference must be made to the national law governing the patent. He argued that this must mean determining whether the product falls within the scope of protection of the patent in accordance with section 125 of the Patents Act 1977 and Article 69, and the Protocol on the Interpretation of Article 69, of the European Patents Convention. He also submitted that, in the light of Kitchin J’s judgment, it could not be said that it was acte clair that the infringement test was wrong and that this question should be referred to the ECJ.

33. Counsel for the Comptroller submitted that none of the five points identified by Kitchin J justified the conclusion that the infringement test was the right test. In particular, she submitted that there is a distinction between the scope of protection of a patent and infringement: the scope of protection is limited to that specified in the relevant claim properly construed, whereas infringement is not so limited. A product which includes all the elements of the claim infringes, but so does a product which also includes additional elements which are not specified in the claim at all. Accordingly, she argued, it is the scope of protection which matters, not whether a product infringes. She also submitted that consideration of the Opinion of Advocate General Fennelly in Farmitalia leads to the conclusion that the ECJ rejected the infringement test in that case. Finally, she submitted that the matter remained acte clair. She acknowledged, however, that it is the Comptroller’s understanding that at least one Member State of the Community, namely Norway, applies the infringement test.

34. I am not convinced that Takeda is wrong. To my mind, Jacob J’s reasoning remains persuasive. Furthermore, I agree that there is a distinction between the scope of protection and the question of infringement. As to Farmitalia, it is not clear to me that the ECJ either endorsed or rejected the infringement test in that case. Nevertheless, I agree with Kitchin J that there are arguments in favour of the infringement test which do not appear to have been considered in Takeda and which merit consideration by a higher court and perhaps the ECJ.

35. I have considered whether it is appropriate to refer this question to the ECJ. If I were confident that the Court of Appeal would refer it, I would avoid delay by making a reference now. I am not confident that the Court of Appeal will refer it, however. I conclude that the decision whether to refer should be left to that Court.

On the same basis, Arnold J decided not to to refer a question about the correct treatment of applications for SPCs for combination products to the ECJ.

The SPC Blog's note on the original decision can be read here.

SPCs on the Isle of Man

Having been asked a question last week about the legal status of various forms of intellectual property on the Isle of Man, I took the opportunity of checking out what the position was with regard to SPCs. In the Isle of Man, intellectual property is administered by the Treasury Department. The relevant part of its website states:

"Patents

The Isle of Man does not have its own register of patents for inventions, but the Patents Acts 1949 and 1977 (Acts of Parliament) extend to the Isle of Man. Accordingly patents registered in the United Kingdom Patent Office or in the European Patent Office are thus protected under Manx law for 20 years from application for registration.

"Supplementary protection certificates" giving an extended period of protection for medicinal products and plant protection products under Regulation (EEC) 1768/92 and Regulation (EC) 1610/96 are given legal effect in the Isle of Man".

Date fixed for AHP ruling

According to the Curia website, at 9.30am on Thursday 3 September the Court of Justice of the European Communities will be giving judgment in Case C-482/07 AHP Manufacturing BV v Bureau voor de Industriële Eigendom, also operating under the name Octrooicentrum Nederland, a reference for a preliminary ruling from the Rechtbank 's-Gravenhage (Netherlands) lodged on 2 November 2007. The questions referred for a preliminary ruling are as follows:

"1. Does Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as subsequently amended, and more specifically Article 3(1)(c) thereof, preclude the grant of a certificate to the holder of a basic patent for a product for which, at the time of the submission of the application for a certificate, one or more certificates have already been granted to one or more holders of one or more other basic patents?

2. Does Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, as subsequently amended, and more specifically recital 17 and the second sentence of Article 3(2) thereof, give rise to a different answer to Question 1?

3. When answering the previous questions, is it relevant whether the last application submitted, like the previous application or applications, is submitted within the period prescribed by Article 7(1) of Regulation (EEC) No 1768/92 or that prescribed by Article 7(2) of Regulation (EEC) No 1768/92?

4. When answering the previous questions, is it relevant whether the period of protection afforded by the grant of a certificate pursuant to Article 13 of Regulation (EEC) No 1768/92 expires at the same time as, or at a later time than, under one or more certificates already granted for the product concerned?

5. When answering the previous questions, is it relevant that Regulation (EEC) No 1768/92 does not specify the period within which the competent authority, as referred to in Article 9(1) of that Regulation, must process the application for a certificate and ultimately grant a certificate, as a result of which a difference in the speed with which the authorities concerned in the Member States process applications may lead to differences between them as to the possibility of a certificate being granted?"

It does not appear from the information available on the Curia website that this reference has been given the benefit of an Advocate General's Opinion.

Almirall vs. Mylan -Belgian Court of Appeal Decision

Benito Boone of Crowell & Moring (Brussels) has kindly provided us with the recent Belgian decision on the calculation of the duration of an SPC in the case Almirall vs. Mylan (aceclofenac). In short,

"the Brussels Court of Appeal confirmed an earlier judgement, which stated that the starting point of the calculation of the duration of the SPC (article 13 of the Regulation), is not the first MA granted in accordance with Dir. 65/65/EEC (now 2001/83/EC), but a national MA which dates from before the entry into force
of Dir. 65/65/EEC (even if the national MA was granted without a full assessment: see p. 33, § 22 in fine of the judgment).

The court also refuses to refer the case to the ECJ for a preliminary ruling. "

For a copy of the judgement in Dutch, here. Let us know if you would be interested in a more detailed summary by emailing us here.

Plant protection products -- any interest?

Browsing over the 120 or so posts that this weblog has posted over the past year, I was struck by the fact that the entire focal point of interests has been the extension of patents in the pharma sector. In contrast, while SPCs are available for agrochemical patents too, that sector appears to generate little controversy, news or even interest.

Accordingly I thought it would be a good idea to test out the readership and ask: "is there anyone out there who is actively involved in the extension of patents for herbicides, pesticides and the like?". If so, please don't feel shy about making yourselves known: just email me here and let me know. If there's sufficient interest, we'll see if we can provide more content.

A few things to celebrate...

Almost 13 months after it went live, the SPC blog is delighted to announce that 500 SPC aficionados have joined in to receive the email circulars.

To mark this anniversary, we are launching the SPC Resources website, where you will be able to find both national and European case law relating to SPCs organised thematically and nationally. We are open for comments on the setup of this page - if you think the page can be improved in any way, please let us know.

We have put in links to copies of the decision where we have them but there are still plenty of cases where we don't have copies of the decision - if you do, please forward them over!

Generics (UK) Ltd v Synaptech Inc - on what first authorisation means

In the relatively recent decision of Generics (UK) Ltd v Synaptech Inc [2009] EWHC 659 (Ch), 20 May 2009, the England and Wales High Court has held that the term "the first authorisation to place the product on the market" should be interpreted wherever it occurs in the European supplementary protection certificate (SPC) Regulation as referring to the first authorisation compliant with Directive 65/65/EEC. This meant that the Intellectual Property Office had correctly granted an SPC with a term calculated on the basis of a first Directive 65/65/EEC authorisation in 2000, rather than earlier non-compliant authorisations.

In the case in question, Synaptech Inc. obtained European patent EP (UK) 0236684 which protected galantamine or analogues thereof for treating Alzheimer's disease. The patent expired on 16th January 2007. Galantamine has been on sale in Europe as a medicine for more than 40 years. There was a marketing authorisation for it as a treatment for polio in the 1960s under the trade mark "Nivalin" in Austria prior to its accession to the EEA. Nivalin went on to be authorised in West Germany in 1978.

Synaptech obtained an SPC (SPC/GB00/033) which is due to expire on 15th January 2012. They argued that the first authorisation was a Swedish authorisation granted in 2000 in accordance with Directive 65/65.

Generics (UK) Limited contended that the SPC ought to have expired, at the latest, on 31st December 2008 because previous marketing authoriations in Germany and Austria.

In his decision, Roger Wyand QC, sitting as a Deputy High Court Judge, reviewed the case law around the calculation of SPC terms, including the ECJ decision in Hässle AB v Ratiopharm GmbH, Case C-127/00 and Novartis v Comptroller-General Case, C-207/03. In the Hässle case, the ECJ held that the expression "first authorisation to place [a product] on the market as a medicinal product in the Community" in Article 19(1) of the SPC Regulation referred solely to the first authorisation required under the EC provisions on the authorisation of medicinal products, and suggested that the words had the same meaning wherever they appeared in the Regulation. Even though the court in Hässle was considering a different argument, Roger Wyand held that the wording of the judgment was clear and binding. He also held that he Novartis case was not directly relevant here, because the Swiss authorisation in that case was treated as Directive 65/65/EEC compliant under the 1992 EEA Agreement.

Pharma sector report: a first view

Today's Pharmaceutical Sector Report by the European Commission's DG Competition has been published here (press release here). The Introduction makes it plain that SPCs fall within the report's remit:

"(3) The sector inquiry dealt with the alleged obstacles to market entry for prescription medicines for human use. It focused on obstacles for generic products, i.e. products that can enter the market upon loss of exclusivity of the original product (i.e. upon patent expiry, possibly extended by SPC, or expiry of the exclusivity period pursuant to pharmaceutical law). It also concerned obstacles for innovative products, i.e. obstacles to competition between originator companies. As it is a competition inquiry, it focused on the behaviour of companies. However it is acknowledged that behaviour of companies always takes place against the background of the regulatory environment ...

(9) Intellectual property rights are a key element in the promotion of innovation. The protection of intellectual property rights is important for all sectors of economic life and is paramount to Europe’s competitiveness. However, it is particularly important for the pharmaceutical sector because of the necessity to address current and emerging health problems and the long life cycle of products (including long development periods). The pharmaceutical sector in the EU indeed has one of the highest investments in R&D in Europe and relies significantly on intellectual property rights to protect innovation. The exclusivity periods granted through patent law and other mechanisms (SPC, data exclusivity) provide incentives to originator companies to continue innovating".

A swift and immediate perusal of the main document, which runs to 533 pages, suggests that SPCs are not singled out for attention and that the report does not treat them as playing any role other than that of enabling patent term to be extended. There does not to be any specific criticism of paediatric extensions either.

No curmudgeons in the Court of Appeal

Now for a bit more on last week's Court of Appeal for England and Wales ruling in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and another [2009] EWCA Civ 646 (see previous post for links to the full text of the judgment and to earlier comments).

In short, Daiichi owned European Patent (UK) No. 0206283 and supplementary protection certificate no. SPC/GB97/085. The patent related to ofloxacin, the (-) enantiomer of a racemic compound which belonged to the quinolone class of anti-microbial agents. The S(-) enantiomer of ofloxacin was called levofloxacin.

This patent, which claimed priority from three Japanese filings, was applied for on 20 June 1986 and was granted on 27 January 1993. UK marketing authorisations were granted for levofloxacin on 6 June 1997. On 23 October of that year Daiichi applied for the SPC, identifying this patent as the basic patent, levofloxacin as the product and the UK marketing authorisations in respect of levofloxacin as the first authorisations to place the product on the market. The SPC was granted on 13 July 1998. The patent expired on 20 June 2006. The SPC came into force and was due to expire on 19 June 2011.

In this action Generics sought a declaration of invalidity of (or rectification of the register in respect of) the SPC and a declaration that certain claims of the patent were invalid. At trial, Kitchin J found that the skilled man "would have considered it worthwhile exploring whether ofloxacin could be resolved, but only to a point". He held that Daiichi's patent, which had by then expired, was valid, as was the SPC.

Generics appealed, basing its appeal on a single point relating to the alleged obviousness: as a result of extra information contained in a poster that had been displayed for a couple of hours by a doctor in a symposium in Toronto in 1982, concerning how the enantiomers of flumequine had been made, the skilled man would recognise that the same method would probably work for ofloxacin. The skilled man would therefore follow that lead up by experiment and would then find out that it did indeed have the required result. Generics added that the authorisation to sell ofloxacin was really the first authorisation to sell levofloxacin because levofloxacin was by far the most active component of ofloxacin, and sought to bolster their argument by reference to case-law (using the ECJ BASF and MIT cases and the German Patent Court Fusilade case). Accordingly the date of authorisation for levofloxacin did not count because it was not the relevant first authorisation.

The Court of Appeal dismissed the appeal. In their Lordships' view, the decision that the skilled man "would have considered it worthwhile exploring whether ofloxacin could be resolved, but only to a point" was a perfect example of a judge properly carrying out the balancing task of forming an overall value judgment which trial judges so often had to perform. In doing so, the the trial judge committed no error of principle.

The patent, whilst it had subsisted, had been valid. Daiichi's work had led to a better medicine than ofloxacin, since levofloxacin was not just twice as active as ofloxacin (as one might have expected) but was far more soluble and less toxic than could be predicted. It could also be used in higher dosages than might have been expected, with corresponding medical benefit. As Jacob LJ eloquently put it: "Only a curmudgeon would say there was no invention here".

Court dismisses Levofloxacin appeal

The Court of Appeal for England and Wales has just given its judgment today in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and Daiichi Sankyo Co Ltd [2009] EWCA Civ 646. The Court, in a judgment delivered on behalf of all their Lordships by Lord Justice Jacob (sitting with Ward and Lloyd LJJ), upheld the decision of Mr Justice Kitchin of 15 October 2008 that Daichi's levofloxacin patent and the SPC which was based upon it were both valid (see notes on the earlier decision here and here).

Having held that the original patent was valid, the Court of Appeal reviewed the validity of the SPC grant at great length (at paras 46 to 83) before upholding it.

The SPC Blog looks forward to discussing this case in greater depth once it has had the chance of reading it carefully. In the meantime, readers should feel free to post their observations below.