C-121/17 - Teva ruling out now

The CJEU gave its ruling today in C-121/17 (here), Teva UK Ltd and others v Gilead Sciences Inc.

In brief, the question referred by Justice Arnold, was:

What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation No. 469/2009?

The Court has ruled as follows:

"Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent: 

–        the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
–        each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent."

More pay-days for pharma patents, thanks to Seattle Genetics ruling

Today, in a very short judgment of just 41 paragraphs, the Court of Justice of the European Union (CJEU) confirmed the Advocate General’s Opinion in Case C-471/14 Seattle Genetics Inc, by holding that:

Article 13(1) of Regulation (EC) No 469/2009 concerning the SPC for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.

And that is to the provision is to be interpreted as meaning the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.

Many thanks go to Axel Paul Ringelhann for being the first of our readers to spot the ruling.

An early press release from London-based law firm Bristows observes that the ruling will be welcomed by innovative (= patent-owning) pharmaceutical companies, explaining the decision like this:

The issue concerned the duration of supplementary patent protection afforded to the innovative pharmaceutical industry. EU legislation provides the possibility of a supplementary protection certificate (“SPC”) to compensate a patent holder for the erosion of patent protection suffered due to the lengthy regulatory process leading to the grant of marketing authorisation (“MA”). In the EU, no medicinal product may be commercially exploited before the relevant authority has issued an MA.

However, there was confusion as to how the duration of an SPC should be calculated. EU legislation provides that the SPC is to be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”. But what constitutes the date of the first MA? Is it the date when the decision granting the MA is adopted by the relevant authority? Or, is it the date on which the applicant is notified of the decision?

Following a preliminary reference from Austria, the CJEU has cleared all confusion: the relevant date is the date on which the decision is notified to the applicant.

Why will the decision benefit the pharmaceutical industry?

Not only has the CJEU’s ruling put an end to the uncertainty faced by both the innovative and generic pharmaceutical industries regarding the duration of effective patent protection afforded to medicinal products, the additional two to five days typically seen between grant of an MA and notification to the applicant can be of significant commercial value. This is particularly so as the market for a medicinal product will often reach its peak towards the end of the patent term. Taking this into consideration, the additional days per product, in every member state in which the product is marketed, potentially multiplied by several products is not insignificant!

Furthermore, although the SPC regime is harmonised throughout the EU, patents remain a national right and SPCs are granted by national patent offices. Following the CJEU’s ruling, divergence should no longer exist between member states regarding the relevant date for calculation of the SPC term allowing patent holders to be certain of a uniform SPC duration throughout the EU and, similarly, allowing competing generic companies certainty as to when patent protection will expire.

There follows a quick word from Mark Sandbaken, VP, Intellectual Property for Seattle Genetics, who was clearly quite chuffed by the decision:

“The CJEU’s ruling will benefit all those at Seattle Genetics, its partner Takeda, and other companies who have invested significant time and efforts in the development of many innovative products that benefit patients. Seattle Genetics is grateful to the Commission and those member states that submitted written observations in support of Seattle Genetics’ position and for the timely response from both the Advocate General and CJEU on this matter”.

Representing Seattle Genetics, Marie Manley (Partner and Head of Bristows' Regulatory Practice added:

“This is a decision of significant importance for the innovative pharmaceutical industry which invests millions in developing a medicinal product. As such, the duration of SPC protection is essential for their medicinal products. Importantly the decision provides certainty to both innovative and generic pharmaceutical companies by clarifying when SPCs expire”.

Telmisartan: no double-dipping says CJEU, as it avoids answering all the questions

This morning the Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG, this being a request for a preliminary ruling from the Patents Court, England and Wales.

In short, this is a tale of a European patent application for ‘Benzimidazol derivatives, medicaments containing them and process for their preparation’ which Boehringer filed 23 years ago, in 31 January 1992 and which was granted in May 1998 (the ‘basic patent’). This patent disclosed and claimed numerous molecules, one of which is telmisartan -- an active ingredient for treating high blood pressure and to reduce cardiovascular morbidity (a fancy term for 'heart disease') in adults.  Claims 5 and 8 of the basic patent were for telmisartan alone and for one of its salts.

On the basis of that patent and a marketing authorisation granted on in December 1998 for the medicinal product Micardis, which contained telmisartan as the sole active ingredient, Boehringer obtained in August 1990 a supplementary protection certificate (SPC -- a patent term extention) for it. The product description for this SPC was ‘[t]elmisartan, optionally in the form of a pharmaceutically acceptable salt’. This SPC expired in December 2013.

Meanwhile, in April 2002 a company in the Boehringer group secured a marketing authorisation for a combination of telmisartan and hydrochlorothiazide (a diuretic that acts by inhibiting the kidney’s ability to retain water). The hydrochlorothiazide molecule has been known since 1958 and is in the public domain. Telmisartan and hydrochlorothiazide are the sole active ingredients of the medicinal product sold by Boehringer as MicardisPlus. In September 2002 Boehringer applied to the UK  Intellectual Property Office (UKIPO) for an SPC for the combination of the active ingredients telmisartan and hydrochlorothiazide. Hold on, said the UKIPO, the combination must be clearly claimed in the patent if it is to be regarded as requiring protection as such -- but the basic patent contained only claims which related to telmisartan by itself. So why not apply to amend the basic patent by inserting a claim to the combination of telmisartan and hydrochlorothiazide?

Boehringer, taking the UKIPO up on this suggestion, asked for the application for the combination SPC to be suspended and, in November 2003, applied to the UKIPO to amend the basic patent by inserting a new claim 12, relating to a pharmaceutical combination of telmisartan and hydrochlorothiazide. The UKIPO agreed to all of this, granting the application to amend in November 2004: the patent as amended expired on 30 January 2012.

As soon as the amendment was allowed, Boehringer asked the UK IPO to revive its suspended application for the combination SPC application. Fine, said the UKIPO, and the combination SPC was granted in January 2005. It is due to expire on 30 January 2017.

This all looks so straightforward that it is hard to imagine that anything might go wrong.  But we have not yet reached the end of the story.

Actavis, a generic medicinal products manufacturer, claimed that the combination SPC was invalid since, at the date on which the application was originally made for it back in September 2002, claim 12 did not yet exist and the product in question was not therefore specified anywhere in the claims of Boehringer’s basic patent. But this is no problem, responded Boehringer. After all, is it not allowed under both EU and national legislation to amend patents after they have been granted?  Since the result of an amendment has retrospective effect, the basic patent retrospectively protected the product for which the combination SPC application was originally made before the amendment.

Actavis's action, lodged with the Patents Court, England and Wales, come before Mr Justice Birss who decided to pose the following questions for a preliminary ruling:

‘(1) (a) If a patent does not, upon grant, contain a claim that explicitly identifies two active ingredients in combination, but the patent could be amended so as to include such a claim, could this patent, whether or not such an amendment is made, be relied upon as a “a basic patent in force” for a product comprising those ingredients in combination pursuant to Article 3(a) of Regulation No 469/2009/EC?

(b) Can a patent that has been amended after the grant of the patent and either (i) before and/or (ii) after the grant of the SPC be relied upon as the “basic patent in force” for the purposes of fulfilling the conditions set out in Article 3(a) of Regulation No 469/2009?

(c) Where an applicant applies for an SPC for a product comprised of active ingredients A and B in circumstances where:

(i) after the date of application for the SPC but before the grant of the SPC, the basic patent in force, being a European Patent (UK) is amended so as to include a claim which explicitly identifies A and B;

and

(ii) the amendment is deemed, as a matter of national law, always to have had effect from the grant of the patent;

is the applicant for the SPC entitled to rely upon the patent in its amended form for the purposes of fulfilling the [Regulation No 469/2009] Article 3(a) condition?

(2) For the purposes of determining whether the conditions in Article 3 [of Regulation No 469/2009] are made out at the date of the application for an SPC for a product comprised of the combination of active ingredients A and B, where:

(a) the basic patent in force includes a claim to a product comprising active ingredient A and a further claim to a product comprising the combination of active ingredients A and B, and

(b) there is already an SPC for a product comprising active ingredient A (“Product X”), is it necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone?

(3) Where the basic patent in force “protects” pursuant to Article 3(a) [of Regulation No 469/2009]:

(a) a product comprising active ingredient A (Product X); and

(b) a product comprising a combination of active ingredient A and active ingredient B (“Product Y”);

and where:

(c) an authorisation to place Product X on the market as a medicinal product has been granted;

(d) an SPC has been granted in respect of Product X; and

(e) a separate authorisation to place Product Y on the market as a medicinal product has subsequently been granted,

does … Regulation [No 469/2009], in particular Articles 3(c) and (d) and/or 13(1), preclude the proprietor of the patent being issued with an SPC in respect of Product Y? Alternatively, if an SPC can be granted in respect of Product Y, should its duration be assessed by reference to the grant of the authorisation for Product X or the authorisation for Product Y?

(4) If the answer to Question 1(a) is in the negative and the answer to Question 1(b)(i) is positive and the answer to Question 1(b)(ii) is negative, then in circumstances where:

(a) in accordance with Article 7(1) of … Regulation [No 469/2009], an application for an SPC for a product is lodged within six months of the date on which a valid authorisation to place that product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1)];

(b) following the lodging of the application for the SPC, the competent industrial property office raises a potential objection to the grant of the SPC under Article 3(a) of … Regulation [No 469/2009];

(c) following and in order to meet the aforesaid potential objection by the competent industrial property office, an application to amend the basic patent in force relied upon by the SPC applicant is made and granted;

(d) upon amendment of the basic patent in force, the said amended patent complies with Article 3(a) [of Regulation No 469/2009];

does Regulation [No 469/2009] prevent the competent industrial property office from applying national procedural provisions to enable (a) suspension of the application for the SPC in order to allow the SPC applicant to apply to amend the basic patent, and (b) recommencement of the said application at a later date once the amendment has been granted, the said date of recommencement being

– after six months from the date on which a valid authorisation to place that product on the market as a medicinal product was granted, but

– within six months of the date on which the application to amend the basic patent in force was granted?’

This morning the CJEU cut to the chase and answered all these questions with a brevity which will be commendable if it provides the information that the trial judge actually needs in order to make his decision:

Article 3(a) and (c) of Regulation ... 469/2009 ... must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a supplementary protection certificate, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second supplementary protection certificate for that combination.

Comments on this decision are, as usual, welcomed.

Synflorix: SPC can be based on covalently bound active ingredient -- in principle ...

This morning the Court of Justice of the European Union (CJEU) delivered its judgment in Case C‑631/13, Arne Forsgren v Österreichisches Patentamt, a request for a preliminary ruling under Article 267 TFEU from the Oberster Patent- und Markensenat, Austria. The CJEU obviously didn't consider this a tough case to decide, since it dispensed with an Opinion from Advocate General Bot.

The factual background runs as follows. Forsgren owned a European patent (EP0594610B1, ‘the basic patent’) relating to ‘Protein D ‒ an IgD-binding protein of Haemophilus influenzae’.  Protein D is present in a pneumococcal vaccine for paediatric use, ‘Synflorix’, the marketing of which was authorised by Commission Decision C(2009) 2563 for ‘Synflorix — Pneumococcal polysaccharide conjugate vaccine (adsorbed)’. From the wording of the marketing authorisation (MA) for Synflorix, it appears that Synflorix was composed of 10 pneumococcal polysaccharide serotypes which were conjugated to carrier proteins and adsorbed on to aluminium phosphate. In eight of those serotypes, Protein D was the carrier protein. The therapeutic indications set out in the MA were for

‘Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 2 years of age’. 

According to the MA, the excipients of that vaccine were sodium chloride and water for injections.

In September 2009 Forsgren applied to the Österreichisches Patentamt for an SPC for Protein D. No, said the office, since Protein D was just an excipient. On appeal, the Board of Appeal of the Österreichisches Patentamt agreed: while Protein D had a therapeutic effect against the Haemophilus influenzae bacterium, it wasn't present as such in Synflorix, being covalently bonded to other active ingredients. Accordingly, Protein D couldn't be authorised as a medicinal product within the meaning of the SPC Regulation. Forsgren appealed further to the Oberster Patent- und Markensenat, which decided to stay proceedings and to refer to the CJEU the following questions for a preliminary ruling:

‘1. Under Article 1(b) and Article 3(a) and (b) of [Regulation 469/2009], provided that the other conditions are met, may [an SPC] be granted for an active ingredient protected by a basic patent (in this case, Protein D) where that active ingredient is present in a medicinal product (in this case, Synflorix) as part of a covalent (molecular) bond with other active ingredients but none the less retains an effect of its own?

2. If Question 1 is answered in the affirmative:

(a) Under Article 3(a) and (b) of [Regulation No 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) where that substance has a therapeutic effect of its own (in this case, as a vaccine against the Haemophilus influenzae bacterium) but the marketing authorisation for the medicinal product does not relate to that effect?

(b) Under Article 3(a) and (b) of [Regulation 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) where the marketing authorisation describes that substance as a ‘carrier’ for the actual active ingredients (in this case, pneumococcal polysaccharides), where the substance, as an adjuvant, enhances the effect of those substances, but where that effect is not expressly mentioned in the marketing authorisation for the medicinal product?’

This morning the CJEU (Eighth Chamber) ruled:

1. Articles 1(b) and 3(a) of Regulation 469/2009 ...  must be interpreted as not precluding, in principle, the possibility that an active ingredient can give rise to the grant of a supplementary protection certificate where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product.

2. Article 3(b) of Regulation 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.

Article 1(b) of Regulation 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation, a matter which it is for the referring court to determine, in the light of all the facts of the dispute in the main proceedings.

There may be some further comment from the blog team but, in the meantime your comments are most welcome.

Merck and the Specific Mechanism: the Advocate General offers some guidance

Just over a year ago, the Court of Appeal for England and Wales made a reference for a preliminary ruling to the Court of Justice of the European Union (CJEU) in Case C-539/13, Merck Canada Inc., Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals PLC (as noted by The SPC Blog, here). The questions referred are somewhat wordy and relate to the Specific Mechanism -- a derogation from the principle of free movement of goods which was appended to the Act of Accession when a whole batch of new members -- the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and the Slovak Republic -- joined the European Union. 

This Special Mechanism allowed the owner of a pharma patent or an 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; anyone who intended to import such a product was required to demonstrate to the relevant national authority that he had given notice of that intention to the holder or beneficiary of the protection.

The questions read as follows:

1 May the holder, or his beneficiary, of a patent or supplementary protection certificate rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so? 

2 If the answer to Question 1 is yes:

(a) How must that intention be demonstrated?

(b) Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights? 

3 Who must give the prior notification to the holder or beneficiary of a patent or supplementary protection certificate under the second paragraph of the Specific Mechanism? In particular:

(a) Must the prior notification be given by the person intending to import or market the pharmaceutical product?

or

(b) Where. as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant's regulatory approval?;  and

(i) Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product?

(ii) Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product? 

4 To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular:

(a) Is the beneficiary of a patent or supplementary protection certificate limited to persons who have a legal right under national law to bring proceedings to enforce that patent or supplementary protection certification?

or

(b) In a case where a group of companies forms a single economic unit comprising a number of legal entities, is it 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 that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate, on the basis either that such legal entity may be characterised as a beneficiary of the patent or SPC, or that it is to be expected that such notification in the ordinary course of events will to come to the attention of the persons who make decisions on behalf of the patent or SPC holder?

If the answer to Question 4(b) is yes, 

(c) is a notification which is otherwise compliant rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs" of a company when that company is not the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate but is the operating subsidiary or marketing authorisation holder in the Member State of importation and when that Regulatory Affairs department in practice regularly receives notifications from parallel importers regarding the Specific Mechanism and other matters?

Yesterday the CJEU's Advocate General offered the following Opinion as to how these questions should be answered:

Questions 1 and 2

A holder of a patent or a supplementary protection certificate, or his beneficiary, duly notified of an intention to import and market pharmaceutical products covered by the Specific Mechanism ... is required to respond to the notification, so as to demonstrate an intention to oppose the proposed importation and placing on the market, within the period prescribed in the second paragraph of the Specific Mechanism, in order to be entitled to enforce any restriction on the import and marketing of the products concerned. A holder of a patent or a supplementary protection certificate, or his beneficiary, is precluded from relying upon his rights with respect to any import and marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights.

Question 3

The notification required under the second paragraph of the aforementioned Specific Mechanism may be carried out by someone other than the potential importer and marketer provided that the identity of the latter is clearly identified by the notifying entity.

Question 4

Prior notification under the second paragraph of the aforementioned Specific Mechanism must be given to a person who has a legal right under national law to bring proceedings to enforce the patent or supplementary protection certificate.

It is now for the CJEU to decide whether to adopt this Opinion, on which it is expected to give a ruling in the next few months.

Bayer CropScience: case note published

The just-published current issue of the Bio-Science Law Review (six times a year from Lawtext Publishing, Oxford),vol.14, issue 1, pp 21-24, contains a case note, "The meaning of 'Active Ingredient' for SPC Protection is again uncertain: Bayer CropScience AG (Case 11/13)" by our friend Paul England (Taylor Wessing LLP's London office).

Paul incidentally furnished a note for this blog on the Advocate General's Opinion in this case which was not initially published in English. The SPC Blog's note on the ruling can be found here.

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

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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.

EU trumps Member States over TRIPS

Case C‑414/11, Daiichi Sankyo Co. Ltd, Sanofi-Aventis Deutschland GmbH v DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon, a reference to the Court of Justice of the European Union from the Greek Polimeles Protodikio Athinon, resulted in a ruling last week.

While this case does involve an SPC (for levofloxacin hemihydrate, marketed as Tavanic), the reference was not so much about SPCs as about the relationship of EU law and the law of EU Member States to the Agreement on Trade-Related Intellectual Property Rights (TRIPS). The CJEU concluded that TRIPS does not have retrospective effect in EU Member States and that it falls within the exclusive competence of the EU and not the Member States.

To get a swift summary of the decision, you can speed-read through the Curia press release here.

Case C-493/12: referring decision now available

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).

A more “fit for purpose” SPC Regulation?

Apart from the various comments posted at the foot of yesterday's blog item on Case C-130/11 Neurim Pharmaceuticals,  The SPC Blog has also received the following observations from Andrew Hutchinson (Associate Solicitor, Simmons & Simmons LLP)

A more “fit for purpose” SPC Regulation?

The CJEU’s judgment has allowed Neurim to obtain an SPC and so in that sense has followed the Court of Appeal (England and Wales) and the Opinion of Advocate General (AG) Trstenjak of 3 May 2012. However, while the CJEU has allowed Neurim’s application to proceed, as is now a common theme in SPC decisions, it seems to have struggled to formulate a legal test that can be applied generally and simply to all cases.

The CJEU has not applied the same test or gone into the detailed reasoning of the AG’s Opinion, which suggested that an earlier authorisation should be ignored if it did not fall within the scope of the protection of the later basic patent. This test required the assessment of the scope of protection of the basic patent in question and a determination of whether any earlier authorisations fell within it. The clear water between Neurim’s patent and the earlier authorisation was not in dispute. However, the CJEU may have been reluctant to apply this test given that finer distinctions may arise and an assessment of the scope of protection of a basic patent could overburden the SPC-granting authorities. The CJEU may have also been concerned about causing conflicts with its own earlier decisions, in particular Pharmacia (case C-31/03) and Yissum (case C-202/05), which the High Court for England and Wales had already assessed and considered, acte clair, to preclude Neurim’s SPC.

While the CJEU has held that the mere existence of an earlier authorisation can no longer be said to be automatically relevant to (and perhaps preclude) a later SPC application for the same product, the CJEU has provided hardly any test at all. As a result, it is not completely clear how similar to Neurim a subsequent case will need to be to benefit from this decision. In this sense, the decision provides for a specific exception to the stricter, literal interpretation of Articles 3(d) and 13(1), as opposed to applying a wider, more general teleological interpretation.

The requirements for benefiting from Neurim are split into two parts, which are closely connected: (1) is your SPC application for an old product with a “different application" and (2) do you have a “new patent” for that different application as your basic patent (paras 25-27). The central question is therefore: what is covered by "a different application"? A second medical use appears to qualify. There is no mention of the need for there to be a different species (as was the case in Neurim) but, as this is not addressed, it may be argued that this is a further limitation. This also leaves open the issues of any non-active components, new formulations, inventive excipients, etc.

Overall, some will seek to limit the scope of this decision while others will seek to extend it, so the circumstances of the case in question will be paramount. Another common theme in SPC decision continues: more referrals are likely.  It remains to be seen whether, as Jacob LJ commented when referring Neurim to the CJEU, cannot yet be ascertained whether allowing Neurim’s SPC will create a more “fit for purpose” SPC Regulation. It may only be a small step in that direction.

Neurim judgment liberalises SPC system

Today marked the publication of the eagerly-awaited decision of the Court of Justice of the European Union (CJEU) in Case C-130/11 Neurim Phamaceuticals, which the Court of Appeal for England and Wales sent for a preliminary ruling on the basis that it was up to the CJEU to determine whether the SPC Regulation was "fit for purpose" or not.

The full text of the judgment of the CJEU can be read here. Meanwhile, the following note has been kindly provided for The SPC Blog by Edward Oates (Carpmaels & Ransford). Edward writes:

Earlier this morning the CJEU, Europe’s highest court, issued its ruling in case C-130/11 Neurim Pharmaceuticals. The CJEU’s judgment has a liberalising effect on supplementary protection certificate (“SPC”) law and presents new opportunities for extending patents through SPC filings.

Prior to today, and based on a line of CJEU jurisprudence (C-31/03 Pharmacia, C-431/04 MIT, C-202/05 Yissum, C-195/09 Synthon and C-427/09 Generics), it was generally thought that an SPC was precluded (or its duration was truncated) if the active ingredient in question had been authorised in any earlier marketing authorisation within the EU, even if the earlier authorisation related to a different use in a different species. Today’s ruling clarifies that that is not the case and thereby provides an incentive for companies to engage in the research of new uses of previously authorised actives. The precise terms of the Court’s ruling are as follows.

1. Articles 3 and 4 of Regulation ... 469/2009 ... concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

2. Article 13(1) of Regulation ... 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

In referring to “a case such as that in the main proceedings” and “an earlier marketing authorisation obtained for a veterinary medicinal product”, the above ruling at first sight avoids explicitly addressing the question of whether the CJEU would have reached the same conclusion had the earlier marketing authorisation related to human use. However, the CJEU’s reasoning makes it clear that the CJEU would indeed have reached the same conclusion had the earlier marketing authorisation related to human use (emphasis added):

“25 Therefore, if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product.

26 In such a situation, only the MA of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may be considered to be the first MA of ‘that product’ as a medicinal product exploiting that new use within the meaning of Article 3(d) of the SPC Regulation…

30 … Therefore, the MA referred to in Article 13(1) of the SPC Regulation is the authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.”

As such, today’s judgment widens the possibility of obtaining SPC protection and will be enthusiastically received by holders of pharmaceutical and agrochemical patents.