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May
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Telmisartan: no double-dipping says CJEU, as it avoids answering all the questions – Courtesy (The SPC Blog)
Intellectual Property Rights, Pharma News, Regulatory Affairs
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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.



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