SPCs Based on Functional Claims

Article by Dimitar Batakliev, Associate at PETOŠEVIĆ Bulgaria, first published in The Patent Lawyer, November/December 2016

In a judgment of June 23, 2016, in case no. 5362/2015, the Supreme Administrative Court of Bulgaria (SAC) upheld a decision of the Sofia-City Administrative Court on the grant of a supplementary protection certificate (SPC) for the product Denosumab. The main issue under dispute was whether Denosumab was covered by the claims of the patent BG 65242, which utilized a functional definition to identify the protected product.

Denosumab is a human monoclonal antibody specifically binding the osteoprotegerin binding protein. This slows down the process of bone resorption by preventing the development of osteoclasts, which are cells that break down bone tissue. Denosumab is therefore suitable for treatment of osteoporosis.

In the proceedings, Amgen Inc. was the proprietor of the patent BG 65242 for “Osteoprotegerin binding proteins and receptors”. On the basis of this patent, it filed with the Bulgarian Patent Office (BPO) an application for an SPC for the product Denosumab under Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the Regulation). Denosumab was described as a human monoclonal antibody for the treatment of osteoporosis marketed under the name Prolia. The examining department of BPO found that the product was not protected by the patent and therefore did not meet one of the main requirements for the grant of an SPC specified in Article 3(a) of the Regulation. According to the examiner, none of the patent claims related to a human monoclonal antibody with the characteristics of Denosumab. The claims related to an antibody, which is capable to specifically bind osteoprotegerin binding protein. However, Denosumab was not the only such antibody. Therefore, the claims did not identify Denosumab specifically, clearly and necessarily.

Amgen Inc. brought an appeal before the Disputes Department of the Office, which upheld the decision of the examiner. The three-member expert panel of the Disputes Department construed the claims as relating to monoclonal antibodies functionally defined by their capability of specifically binding osteoprotegerin binding protein. Claim 24 of the basic patent related to “an antibody or a fragment thereof, specifically binding the osteoprotegerin binding protein according to claim 17” and claim 25 covered “an antibody according to claim 24, which is a monoclonal antibody”. The panel concluded that although Denosumab is indeed an antibody with such capabilities, it was not sufficiently specified in the wording of the claims.

The Office applied the test defined in the CJEU judgment in the Eli Lilly case (C-493/12), according to which functional definitions can, in principle, be sufficient to bring an active ingredient within the protection of a basic patent, on the condition that, interpreted in the light of the description, the claims relate, implicitly but necessarily and specifically, to the active ingredient in question. According to the panel of the Disputes Department the claims of the basic patent construed in light of the description did not relate specifically and necessarily to the product at issue. The Office found that there was nothing in the patent description, which could lead to the conclusion that claims 24 and 25 related necessarily and specifically to an antibody with the features of Denosumab.

Amgen Inc, appealed further and took the case to the Sofia-City Administrative Court. It requested an expert to assist the court as the contentious issues required specialized knowledge in the field of molecular biology, chemistry, and pharmaceutics. The court appointed an expert who issued an opinion on the question whether the product from the SPC application fell within the scope of the patent claims. The expert clarified that Denosumab is an international nonproprietary name, which as a rule should not be used in the patent description and claims. The expert stated that the primary feature of an antibody was its capability of binding certain protein (antigen). Consequently, the identification of the antigen was sufficient to obtain the corresponding antibody through standard technologies. In the case at issue the basic patent disclosed the antigen – osteoprotegerin binding protein – and claimed an antibody capable of binding it. Given that Denosumab was an antibody with the same characteristics, it should be deemed sufficiently identified in the wording of claims 24 and 25.

In addition, the expert concluded that Denosumab was obtainable through one of the processes disclosed in the examples of carrying out the invention provided in the patent description. The antibody was also referred to in the use claims 33 and 35 which related to the use of a modulator of the osteoprotegerin binding protein for treatment of a bone disease of a mammal. It was clear from the documentation of the medicinal product that Denosumab had the same therapeutic application. Finally, the expert concluded that the patent claims covered Denosumab and it was protected by patent BG 65242.

In a decision of March 23, 2015 (case 11005/2015) the Sofia-City Administrative Court observed that the primary contentious question in the case was decided in the opinion of the court-appointed expert. Resorting to her opinion, the court found that Denosumab was an antibody as described by the patent and that the process of obtaining Denosumab coincided with the main stages of the process of obtaining antibodies with the same characteristics disclosed in the patent description. Furthermore, Denosumab had the same therapeutic application as the one defined in the use claims 33-35 of the basic patent. This was sufficient for the court to conclude that Denosumab was protected by the basic patent and to reverse the case to the Patent Office for the grant of an SPC.

The Office appealed the court’s ruling before the Supreme Administrative Court. The latter held that the Office was not sufficiently precise in reasoning its refusal to grant an SPC and ruled that its decision was correctly remanded. The patent description specified not only monoclonal antibodies but also their functioning and their therapeutic effect. Therefore, on the basis of the description and the general knowledge of court expert appointed by the lower court it was beyond doubt that the active substance, for which a certificate was requested, corresponded to the functional definition of the invention. Because the Patent Office contested the expert opinion, the court considered that given the court’s lack of knowledge in the field of molecular biology, organic chemistry, pharmaceutics, the expert was properly appointed at the first instance stage of the litigation. Furthermore, the Supreme Administrative Court pointed out the procedural possibility to request a second opinion, which the Office failed to do.

The Supreme Administrative Court agreed that, indeed, Amgen Inc. did not specify the claimed active ingredient in its basic patent. However, in the court’s understanding the identification of the product in the specification or the claims was not an absolute requirement for obtaining an SPC. The issue had to be decided in the context of all circumstances of the case and in the light of the Regulation objectives. The court ruled that the lack of specific disclosure of the product in the patent could not be raised as a primary reason for refusal. Eventually, the Supreme Administrative Court concluded that the court of first instance did not err in finding that the product was protected by the basic patent, and upheld its judgment.

This decision is significant as the courts in Bulgaria, and more specifically the Supreme Administrative Court, rarely decide on SPC and patent matters due to the low level of patent litigation activity. This has considerably influenced the manner in which the courts in Bulgaria approach patent-related disputes. As it is obvious from the summary of the Denosumab case the courts exclusively rely on the opinion of a court-appointed expert. The experts are involved not only to assist the judge with their technical knowledge on matters of fact but also on questions that span outside the merely fact-finding duties of experts, often stretching out into the area of application of the law. In the case at issue the expert was entrusted with the main question under dispute – was Denosumab protected by the basic patent? The courts both on first-instance and supreme-court level exclusively relied on the expert’s opinion without venturing into their own analysis on claim construction and identification of the product features. The arguments of the Patent Office against the opinion were rejected, the court itself being reluctant to freely evaluate the opinion. The only way to override an expert opinion was to request a second one. The importance of the role of the court-appointed expert is even more obvious from another aspect. A single opinion of such expert is sufficient to outweigh the opinion of four qualified patent examiners of the Patent Office – the patent examiner and the three member panel of the Disputes Department.

The situation calls for reassessment of the roles of the judge and the expert in patent-related matters in Bulgaria. As the law and practice do not provide equal qualification, independence and impartiality guarantees for judges and experts, the inordinate role of the expert witness may cast a shade on the objectivity of the judicial process and the quality of justice.