The direct product of a Swiss-type claim is packaged and provided with instructions

In the appeal underlying the decision T 1673/11 (Treatment of Pompe's disease/GENZYME) of 20.10.2015, the patent had been granted with  a Swiss-type claim to a process of manufacture of a pharmaceutical product. The patentee wanted to change the claim category from a claim under the provisions of the EPC 1973 invoking the legal fiction according to G 5/83 to a claim under the provisions of Article 54(5) EPC 2000, i.e. to purpose-limited product claim and the question arose whether this extends the scope of protection.

Though the products covered by the claims may be identical from a pharmaceutical point of view, the difference lies in the packaging and information leaflet:

8. The respondent disagreed with the approach taken in decision T 1780/12 in as far as it was based on a comparison of the claim categories and the principle that a process claim was inherently narrower than a product claim. In the respondent's opinion, such an approach did not take into account the extension of protection by virtue of Article 64(2) EPC and the delimitation of the subject-matter claimed by the technical features. A purpose-limited process claim in the format of a Swiss-type claim was directed to a process of manufacture of a product. According to Article 64(2) EPC the protection conferred by such a process extended to the products directly obtained. Because the manufacturing process in a Swiss-type claim was not limited by any technical feature, the manufacture could not be limiting on the product obtained by it. The medical use as limiting feature was the same whether the claim was drafted in the format of a Swiss-type claim or as a purpose-limited product claim in accordance with Article 54(5) EPC. As a consequence, the protection conferred by both types of claims was the same.  

9. The board does not agree. First, the comparison of the the protection conferred by the categories of claims in the patent before amendment with the protection conferred by the new category of claims introduced by amendment is in line with the test set out in decision G 2/88 (see point 5 above). Second, the protection conferred by a Swiss-type claim in accordance with decision G 5/83 and a purpose-limited product claim in accordance with Article 54(5) EPC is not the same even if, for the sake of argument, it is accepted that Article 64(2) EPC is to be taken into account when assessing the extent of protection conferred by a Swiss-type claim (see decision T 1635/09 of 27 October 2010, point 14.2).  

9.1 Claim 1 as granted is directed to the use of human acid alpha glucosidase in the 100 to 110 kD form in the manufacture of a medicament for the treatment of infantile Pompe's disease. Inasmuch as this use may be regarded as a manufacturing process, the claim would, pursuant to Article 64(2) EPC, confer protection on the product directly obtained thereby. The board judges that the product directly obtained is the manufactured medicament which contains as an active substance human acid alpha glucosidase in the 100 to 110 kD form and which is packaged and/or provided with instructions for use in the treatment of infantile Pompe's disease. Indeed, in a Swiss-type claim, the medicament is characterised by the functional feature of the specified therapeutic application. Contrary to the respondent's opinion, this implies limitations to the product directly obtained, although the manufacturing steps are characterised by the use of a defined compound only.

9.2 Claim 1 of the main request being drafted as a purpose-limited product claim, on the other hand, confers protection on the human acid alpha glucosidase in the 100 to 110 kD form, whenever it is being used for the treatment of infantile Pompe's disease. Since the claim does not refer to a step of manufacture of a medicament, the product claimed, i.e. the human acid alpha glucosidase in the 100 to 110 kD form, is not limited to a manufactured medicament, packaged and/or with instructions for use in the treatment of infantile Pompe's disease.

9.3 It follows from the above that even if, by virtue of Article 64(2) EPC, the protection conferred by granted claim 1 extended to the product directly obtained by the manufacturing process referred to in said claim, the protection conferred by claim 1 of the main request is broader.

9.4 Nor can the board follow the appellant's argument that since the use limitation of the claims of the main request and of the granted claims was the same, their scope of protection was identical. The board takes the position that, for example, a medicament containing human acid alpha glucosidase in the 100 to 110 kD form packaged and provided with instructions for the use in a treatment other than that of infantile Pompe's disease is encompassed by the scope of claim 1 of the main request when said medicament is being used for the treatment of infantile Pompe's disease. The protection conferred by granted claim 1 does not encompass such use.  

9.5 Consequently, claim 1 of the main request would amend the contested patent in such a way as to extend the protection it confers, contrary to Article 123(3) EPC.

TRIPS and trade winds:Spanish injunctions and chemical-pharmaceutical patents

From Fidel Porcuna de la Rosa (Senior Associate, Bird & Bird's Madrid office) comes this fascinating note about the efforts that have been made to delineate the scope of patent protection for chemical and pharmaceutical compounds under pre-TRIPS era Spanish patent law. Fidel writes as follows:

"New winds blow for chemical-pharmaceutical patents in Spain

For almost the past two years, the Supreme Court has been repeatedly reversing the Spanish PTO's dismissal decisions to admit and advertise new revised translations of old --but still in force-- EP pharmaceutical patents so as to include product claims. The decisions, regarding a number of active ingredients (voriconazole, sildenafil, tolterodine, ziprasidone, racemic atorvastatin, etc.), were based on the Supreme Court's interpretation by which the direct applicability of the TRIPS Agreement, in force in Spain as of January 1 1996, anticipated the derogation of the prohibition to protect chemical and pharmaceutical compounds under the old Spanish patent law. Although the prohibition was derogated by the time Spain joined the European Community and the European Patent Convention Treaty in 1986, its effects were extended to patents filed up till October 7 1992 following a temporal reservation introduced by the Spanish Kingdom. For the owners of such patents, this would mean in practice that they had no exclusive right over the chemical or pharmaceutical compound, but just to the method to obtain it.

These judicial decisions seemed to provide new enforceable patent rights over old EP patents for pharmaceutical companies which were then able to seek injunctions and damages derived from marketing of generic drugs that would fall under the restored scope of such rights. This has had a quite negative impact in the generic drug industry, as well as causing legal uncertainty. Indeed the Barcelona Commercial Court no. 7 granted preliminary injunctions against generic companies under the above legal grounds (Judgment 21 Feb 2012 31 Pfizer Inc. and Pfizer SLU v Kern Pharma, S.L. and others JUR2012/82689).

However, a recent decision of the Barcelona Commercial Court no. 4 (Judgment 7 May 2012, no. 130/2012) offers a fresh interpretation which, while in principle not incompatible with the Supreme Court decisions, could force innovative laboratories to step aside. The judgment dismissed an application for a preliminary injunction sought by H.Lundbeck A/S, Lundbeck España S.A. and Almirall S.A. against the use of Escitalopram by Sandoz Farmaceútica, S.A.. Bexal Faramcéutica, S.A., Cinfa, S.A., Laboratorios Stada, S.L., Actavis Spain, S.A. and many other generic drug laboratories.

The facts are essentially as follows: In 2 February 1995 Lundbeck obtained the EP 347066 on Escitalopram, which expired on 1 June 2009 but for which a SPC was granted until 1 June 2014. Lundbeck's EP 347066 consisted of three different set of claims corresponding to three different groups of the Contracting states designated in the application. While in the first group (AT, BE, CH, DE, FR, GB, IT, LI, LU, NL, SE) Lundbeck protected product claims, in the second (ES) and third group (GR) it obtained method claims. This was due to Spain and Greece's reservations to the European Patent Convention Treaty against patentability of chemical and pharmaceutical compounds. In 30 March 1995 Lundbeck validated the EP in Spain by filing along with the corresponding petition a translation into Spanish of the process claims just granted by the EPO. More than a decade later (24 August 2006), convinced that the derogation of the prohibition to protect chemical and pharmaceutical compounds under the old Spanish patent law was anticipated by the TRIPS Agreement, Lundbeck petitioned to the Spanish PTO to advertise a new translation into Spanish of the EP 347066. This time it was about the set of claims granted for the first group of Contracting states. After much to-ing and fro-ing with the Spanish PTO and the Administrative Courts, the Supreme Court approved the petition and the new product claims were advertised. Lundbeck then addressed the now unauthorized use of Escitalopram products and filed preliminary injunctions before the Barcelona Court against the above companies, some of which would have by then have been marketing Escitalopram products for some time.

The Barcelona Court considered that Lundbeck's manoeuvre failed. The Court noted that the Spanish set of claims was narrower than the set of claims of the first group of Contracting states because it only contained method claims, and not product claims, and so was the subject matter of the validation of the EP 347066 in Spain. It added that Lundbeck requested the Spanish PTO, after several years of the patent being granted, to admit and advertise a new translation of the EP 347066 including product claims which corresponded to the original set of claims for the first group of Contracting states. In the view of the Court, seeking protection for such product claims would extent the original scope of the Spanish portion of the EP. For such translation to be valid, Lundbeck should have first requested the EPO to extent the scope of the set of claims granted for Spain. But the Court reminded that neither the EPO nor national patent office can extend the scope of the EP claims. In particular they can't extend the scope of any of the original set of claims corresponding to each group of Contracting states. This being so, the translation was no more than a circumvention leading to to a dead-end. Additionally, whether the Supreme Court accepted such new translation to be admitted and advertised in the Spanish official gazette, that would not mean to be enforceable for the new translation could never be considered narrower than the original version of the Spanish set of claims, and hence these --composed only by method claims -- would always prevail as the authentic text (section 11 Implementing regulation no. 2424/1986 of the European Patent Convention Treaty in Spain)".