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, 21 July 2014

SPCs based on functional claims, tabalumab and Neutrokine-α

The decision of Mr Justice Warren in Eli Lilly v Human Genome Sciences Ltd [2014] 2404 EWHC (Pat) in the Patents Court, England and Wales, was handed down on Friday. While it's still not available on BAILII, this judgment is currently being kindly hosted by our friends at Powell Gilbert LLP who represented HGS (now part of GSK) in these proceedings. Powell Gilbert have also furnished us with the following note on this ruling which, with minor edits, we reproduce in full:

Lilly v HGS – Article 3(a) SPC Regulation – Guidance on obtaining SPCs based on functional claims

Summary

Article 3(a) of Regulation 469/2009 requires that a product which is the subject of an application for an SPC must be “protected by a basic patent in force”. This was held by the Court of Justice of the European Union (the “CJEU”) in Medeva (Case C-322/10 [noted on this weblog here]) to mean that the active ingredient must be “specified” in the wording of the claims.

In October 2012 the Patents Court for England and Wales (Warren J) in Eli Lilly and Company Ltd v Human Genome Sciences, Inc. referred further questions to the CJEU regarding the interpretation of Article 3(a). In December 2013 the CJEU handed down its judgment in the Lilly case (C-493/12), holding that it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Article 3(a) does not, in principle, preclude the grant of an SPC where the active ingredient is covered by a functional claim provided that “the claims relate, implicitly but necessarily and specifically” to the active ingredient in question.

The case returned to the Patents Court (Warren J) in May and June 2014. The judgment provides important guidance as to the interpretation of the CJEU’s decision and the circumstances in which SPCs may be obtained for products based on claims defined in functional terms.

Background

Human Genome Sciences, Inc. (“HGS” – now owned by GlaxoSmithKline) is the proprietor of European Patent (UK) No 0 939 804 which relates to and claims a novel protein called Neutrokine-α and antibodies which bind specifically to it. The patent has been held to be valid by the UK Courts (including the Court of Appeal and Supreme Court) and the Technical Board of Appeal of the European Patent Office. Of particular importance is the wording of claim 13 which claims:
“An isolated antibody or portion thereof that binds specifically to (a) the full length Neutrokine-α polypeptide … or (b) the extracellular domain of the Neutrokine-α polypeptide …”.
Eli Lilly and Company Ltd (“Lilly”) wishes to market, in due course, a product containing an antibody (known as tabalumab) that binds specifically to Neutrokine-α. Lilly has not yet received a marketing authorisation (“MA”) for tabalumab.

Lilly issued a claim against HGS seeking a declaration from the Patents Court that any SPC granted to HGS in respect of the patent and based upon any MA for tabalumab would be invalid.

Lilly’s case was that tabalumab is not “protected by” the patent for the purposes of Article 3(a) as tabalumab is not specified in the wording of the claims. That, Lilly submitted, would require a structural definition of the active ingredient in the claims of the patent. 
Lilly had originally sought to argue a further ground on which any SPC would be invalid, namely that HGS would not be able to obtain an SPC based on the HGS Patent and an MA held by a third party (Lilly) – the “Third Party Issue”. Lilly discontinued this aspect of the claim before the CJEU hearing in September 2013.

HGS’s case was that tabalumab fell within the scope of protection of claim 13 (as interpreted by section 125 of the UK Patents Act, Article 69 of the European Patent Convention (“EPC”) and the Protocol on the Interpretation of Article 69) and that that claim related “implicitly but necessarily and specifically” to tabalumab, as required by the CJEU.  
The judgment of Warren J

As with other decisions of the CJEU in relation to the SPC Regulation, regrettably the guidance given is not clear. This is reflected by the fact that both Lilly and HGS had applied to the Patents Court for judgment in their favour on the basis of the CJEU’s decision. The Court also observed that “one thing the [CJEU decision] does not give is the clear guidance which the reference was designed to obtain” (paragraph 4).

In dismissing Lilly’s claim for declaratory relief, the Court explains (paragraph 67) that the CJEU has clearly held that functional definitions can, in principle, be sufficient to bring an active ingredient within the protection of a basic patent. This is on the condition that the “claims relate implicitly but necessarily and specifically” to the active ingredient.

The Court held at paragraph 70 that the correct reading of the CJEU’s judgment required an application of the relevant rules (i.e. Article 69 EPC or Section 125 Patents Act 1977) to ascertain the extent of the invention and what the claims relate to. If the active ingredient in question is covered by the claims, it is protected for the purposes of Article 3(a) – subject to a proviso.

This proviso is explained at paragraph 66 of the Judgment and is necessary to reflect the approach of the CJEU in Medeva in relation to products containing combinations of active ingredients. A product is not protected within the meaning of Article 3(a) solely by virtue of a claim containing general wording that extends the claim beyond its principle scope (such as “comprises”). However, in the absence of such extending words, the Court held that “the claims have a focused scope and the question is simply whether the product falls within the scope of the claims” (paragraph 66). Lilly had conceded during the course of these proceedings that tabalumab falls within the scope of claim 13 of the patent, and the proviso did not apply since there were no extending words. Tabalumab was therefore “protected by” the patent within the meaning of Article 3(a).

Finally, the Court considered (at paragraphs 44-54 of the judgment) that paragraph 43 of the CJEU’s decision, which relates to whether a patent owner has made any investment in the research leading to the MA, is more relevant to the discontinued Third Party Issue than to the test under Article 3(a). However, the Court made clear that SPCs are intended to be available without discrimination for the type, or stage, of research leading to the grant of the basic patent. 
What next?

The judgment provides welcome guidance on the interpretation of Article 3(a) and confirms the availability of SPCs for products based on functional claim language (such as for antibodies defined by their binding target). On Friday Lilly was been granted leave to appeal, so the issues will be reviewed further in due course. 

Sunday, 20 July 2014

Recent developments: a new article from an old friend

"Recent developments in the area of supplementary protection certificates" is the title of a new article by our friend and reader Ulrich M. Gassner (Faculty of Law, University of Augsburg, Augsburg, Germany). This 28-page piece appears in Pharmaceuticals Policy and Law 16 (2014) at pages 45 to 72 (DOI 10.3233/PPL-140375). According to the abstract:
"The purpose of this paper is to set out and discuss the recent jurisdictional developments in the European Court of Justice (ECJ) with respect to supplementary protection certificates (SPCs) including paediatric extensions. During the past five years the ECJ has been particularly active and has clarified a number of highly controversial legal ambiguities, such as the availability of negative term SPCs".
You can check out the contents of the issue in which this article appears here, where you will spot the names and contributions of quite a few of our friends and blog-readers.

Monday, 14 July 2014

The 2014 SPC Blog seminar: early announcement

As readers will know, we've not yet been able to sort out a date for this year's SPC Blog Seminar but we are aiming for late October, a rather lovely time of year to be in London, in all its autumnal splendour.  Further details will be posted as soon as available.

Meanwhile, blog team member Robert Stephen is amenable to suggestions for topics and speakers. If you have suggestions for either, can you please email Rob at Robert.Stephen@olswang.com and let him know.

Monday, 30 June 2014

Xalatan in Italy: two recent case comments

The lengthy, complex and controversial litigation in Italy over Xalatan and Pfizer's attempts to preserve its market in Italy has been chronicled on this weblog (see earlier SPC Blog posts, listed here). It is also being written up in the legal literature. Here's news of two recent case notes.

  • "The Highest Italian Administrative Court has the Final Word on the Xalatan Case and Reinstates the Original Infringement Decision of the Italian Competition Authority", by Michele Giannino (Desogus Law Office) appears in the current issue of the Bio-Science Law Review (BSLR) which, incidentally, has a 20% reduction offer for new subscribers that finishes today.
  • "Pfizer's misuse of patent/SPC rights results in an abuse of dominant position", by Gian Paolo Di Santo (Studio Legale Pavia e Ansaldo) appears in the July 2014 issue of the Journal of Intellectual Property Law & Practice (JIPLP), Gian Paolo having acted in this case for Assogenerici and some of the original plaintiffs against Pfizer.

Navarra court upholds Spanish Telmisartan + hctz invalidity ruling

Almost two years ago to the day, The SPC Blog reported on the fate of the unhappy fate of the SPC for Telmisartan + hctz in Spain (see "Telmisartan + hctz: combination SPC revoked in Spain", 26 June 2012, here, and "Telmisartan + hctz: combination SPC in Spain -- now in English" (8 July 2012, here.

This decision, invalidating the SPC, has now been upheld on appeal: see "Navarra Court of Appeal confirms invalidity of Spanish SPC for telmisartan + hctz", written for today's International Law Office release by Sara Pelaz (Grau & Angulo), here. This helpful note adds that Boehringer still has the option of lodging an appeal with the Spanish Supreme Court.

Wednesday, 25 June 2014

Tell me about Telmisartan: latest decision, in German only

From Arno Markgraf comes news of another Telmisartan SPC decision, this one from the German Patent Court.  You can download the decision here.  Unfortunately, at the moment, no English translation is available.

Thanks Arno for passing this on to us!

A short, English-language summary of this decision will follow in due course.

Thursday, 19 June 2014

A safener can be an 'active substance', CJEU tells Bundespatentgericht

Add caption
The Court of Justice of the European Union (CJEU) today handed down its ruling in Case C‑11/13, Bayer CropScience AG, as to whether a safener can be the subject of a Supplementary Protection Certificate. In contrast with the Advocate General's Opinion (reported by the IPKat courtesy of Paul England, Taylor Wessing, here), it is available in English.

In short, a safener can indeed be the subject of an SPC. The slightly longer answer, according to the operative part of the CJEU's ruling, is this:
The term ‘product’ in Article 1.8 and Article 3(1) of Regulation ... 1610/96 ... concerning the creation of a supplementary protection certificate for plant protection products, and the term ‘active substances’ in Article 1.3 of that regulation, must be interpreted as meaning that those terms may cover a substance intended to be used as a safener, where that substance has a toxic, phytotoxic or plant protection action of its own.
This was the formal answer given to the referring Court (the Bundespatentgericht), which had referred to the CJEU the question:
Are the terms “product” in Article 3(1) and Article 1.8 and “active substances” in Article 1.3 of [Regulation No 1610/96] to be interpreted as covering a safener?
In a little more detail, Regulation 1610/96 deals with the granting of supplementary protection certificates for plant protection products, that is:
active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:
(a) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;
(b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
(c) preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives;
(d) destroy undesirable plants; or
(e) destroy parts of plants, check or prevent undesirable growth of plants;
In that Regulation, "active substances" are defined as:
substances or micro-organisms including viruses, having general or specific action:
(a) against harmful organisms; or
(b) on plants, parts of plants or plant products;
A safener, on the other hand, is a compound added to a herbicide product "intended to prevent the harmful effects of a herbicidal active substance, in order to increase its effectiveness" (according to the referring decision quoted by the CJEU) or ‘substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants’ (according to Article 2 of Regulation 1107/2009, which is a later Regulation concerning authorisation of plant protection products). So the issue was whether, based on a patent directed towards the safener, and a marketing authorisation for a herbicide comprising herbicidal compounds (in the particular case at issue, two herbicidal compounds Foramsulfuron and Iodosulfuron) and a safener falling within the scope of the patent, an SPC could be granted.

The CJEU considered that "no express provision of that regulation [1610/96] either specifically authorises or excludes such a possibility."  It then considered that, "It follows from the above that the term ‘active substances’ [definition quoted above], for the purposes of the application of Regulation 1610/96, relates to substances which have a toxic, phytotoxic or plant protection action of their own. In this regard, since Regulation 1610/96 makes no distinction according to whether that action is direct or indirect, there is no need to restrict the term ‘active substances’ to those whose action may be characterised as direct."

Accordingly, the judgment states:
The answer to the question whether a safener is an active substance, within the meaning of Article 1.3 of Regulation No 1610/96, therefore depends on whether that substance has a toxic, phytotoxic or plant protection action of its own. If that is the case, it falls within the concept of a ‘product’, within the meaning of Article 1.8 of that regulation and may therefore, provided the conditions set out in Article 3 of Regulation No 1610/96 are observed, give rise to the issue of a supplementary protection certificate.
While misleadingly stating:
It is for the national court before which the case in the main proceedings has been brought to ascertain, in the light of all the relevant factual and scientific evidence, whether the substance at issue in the main proceedings can, on account of its action as a safener, be classified as an ‘active substance’ within the meaning of Article 1.3 of Regulation No 1610/96.
thus giving the impression that it was not going to answer the question at issue, the Court went on, using factual information about the action of the safener at issue (Isoxadifen) given by the referring Court ("Isoxadifen was examined in connection with a procedure for a provisional MA for a product containing two other active substances and that the duration of that procedure reduced the effective duration of protection provided by the patent"), to conclude:
It follows from all the foregoing considerations that the answer to the question referred is that the term ‘product’ in Article 1.8 and Article 3(1) of Regulation No 1610/96, and the term ‘active substances’ in Article 1.3 of that regulation, must be interpreted as meaning that those terms may cover a substance intended to be used as a safener, where that substance has a toxic, phytotoxic or plant protection action of its own.
It then gave the answer presented at the beginning of this post.

This decision, which contains no great surprises, means that SPCs "safeners" in the plant protection field are not treated the same way as "excipients" in the field of medicinal products, but perhaps the two are not technically equivalent either.

The SPC Blog thanks Darren Smyth (EIP) for letting us use his IPKat post, here, as the basis for this post.

Monday, 19 May 2014

More references, more gaps?

... unless it has been
caused by the CJEU
"Two gaps instead of one: the CJEU's effect on Supplementary Protection Certificate jurisprudence" is the title of the June 2014 Guest Editorial in the Journal of Intellectual Property Law & Practice (JIPLP), written by editorial board member and patent attorney Darren Smyth (EIP, London). In keeping with normal JIPLP practice, the full text of this editorial is posted on the journal's informal jiplp weblog, here.

Darren concludes:
"You have all the guidance from the CJEU you are going to get. Every referral you make will result in more “gaps”, not fewer, in the legislative framework. Decide some cases; aim for consistency; but if there happen to be some anomalies, well, it is better than spending the time, effort, and money on a referral that will simply make the issues more complex than they were to begin with".

Friday, 16 May 2014

New home for SPCs on UK government portal

The UK Government's GOV.UK portal now has an SPC page, "Apply or extend a supplementary protection certificate", which you can check out here.  This page houses the 32-page guide for applicants which was last revised in November 2013.

The UK Intellectual Property Office still has its own website, but this too will soon be drawn into GOV.UK.

Thursday, 8 May 2014

Swiss paediatric extensions: a swift answer from the "crowd"

Following this morning's blogpost calling for a crowd-sourced response to a plea for information as to where Switzerland currently stands with regard to paediatric extensions, we have received the following response from a two-man crowd consisting of Simon Holzer & Kilian Schärli (meyerlustenberger | lachenal Rechtsanwälte) who write:
Crowds of Swiss Rechtsanwälte gather round to answer
readers' questions -- but Simon and Kilian were first!
On 7 May 2014, the Swiss National Council adopted the revision of the Swiss Therapeutic Products Act (see excerpt of the Official Bulletin of the National Council of 7 May 2014 [in German and French only]). The legislative proposal now goes to the Council of States. The Federal Office of Public Health, which is leading the revision of the Therapeutic Products Act, expects that the revised version will come into force on 1 January 2016. 
With regard to transitional provisions the new Art. 140o of the Swiss Patent Act stipulates that the application for the paediatric extension can be filed no earlier as with the application for the grant of an SPC and no later then two years before the expiry of the SPC, but no later than six months after the first authorization to place the product on the market as a medicinal product in the European Economic Area with the exception of the Principality of Liechtenstein, and only if the associated medicinal product information reflects the results of all studies that have been carried out in compliance with the paediatric investigation plan considered during the marketing authorization. Further, the new Art. 140s para. 2 sets forth that for the procedure (as well as for the register and for the publications) the rules of the European Union shall be taken into account. 
More information can be found on the following websites:
  • Federal Office of Public Health, here
  • Swiss Agency for Therapeutic Products, here
  • Swiss Federal Institute of Intellectual Property, here
Thanks so much, Simon and Kilian -- this is really helpful!