by Diego Federico Martin

IP News, IP NewsOctober 30, 20240 comments 0 Likes

The Unified Patent Court (UPC) in Europe issues judgments related to biotechnological inventions

With the relatively recent establishment of the Unified Patent Court (UPC) in Europe, which has jurisdiction over the territories of the European countries that have signed the Agreement on a Unified Patent Court (UPCA), there is great anticipation among professionals in the field of industrial property regarding the judgments issued by this Court, that will lay the foundation for the precedent to be followed in patent litigation across the European continent in the years to come.

In this regard, the Court of First Instance of the UPC issued two judgments in July of this year related to patents in the field of biotechnology, a field of great relevance today and one that represents a particularly thriving and innovative industry in our country. Although the judgments in question are not final, as they are first-instance decisions and therefore subject to appeal, it is worthwhile to analyze the Court’s considerations when reaching its decisions.

1. “Amycel” judgment

This judgment addresses a preliminary injunction requested by the plaintiff Amycel LLC (hereinafter, “Amycel”), against the alleged infringer of its European patent EP 1 993 350 B2, which claims a hybrid strain of the fungus Agaricus bisporus. This strain is defined in the claim by its deposit number in the American Type Culture Collection (ATCC), a recognized biological material depository institution in accordance with the Budapest Treaty.

The alleged infringer, a Polish farmer engaged in mushroom cultivation and commercialization, marketed a mushroom of the Agaricus bisporus species in the Netherlands—a country under the UPC’s jurisdiction—under the brand name “Cayene,” which Amycel claims infringes its EP 1 993 350 B2 patent. As a result of this commercialization, Amycel sought a preliminary injunction against the alleged infringer before the UPC, requesting the Court to order the alleged infringer to cease the unauthorized use, withdraw the infringing products, and pay damages.

The judgment text emphasizes that both parties agreed that the condition for infringement to exist was that the allegedly infringing product must be genetically identical to the strain claimed in the patent. The difference in the positions adopted by the parties lies in the interpretation of what it means for both organisms to be genetically identical: the defendant argued that for genetic identity to exist between the Cayene product and the BR06 strain, both products must exhibit 100% genetic similarity. Amycel, however, contended that due to technical and biological factors, it is inevitable that even two identical samples will yield a genetic sequencing result of less than 100% identity, supporting its argument with experimental data.

Considering that the experimental results presented by both parties indicate that the observed genetic similarity between the disputed product and the claimed strain falls within the expected margin of error for identical samples, the Court held that it is more likely than not that the commercialization of Cayene infringes EP 1 993 350 B2. Consequently, it found no reason to dismiss the request for provisional reliefpreliminary injunction and ordered the defendant to cease commercialization and withdraw the infringing product from the market.

Based on the analysis of the “Amycel” judgment, it can be concluded that, in the eyes of the UPC, it is clear that for there to be an infringement of a patent protecting a specific strain of an organism deposited in an institution such as the ATCC, experimental results obtained by competent third parties, as well as the opinion of experts in the field interpreting those results, are of fundamental importance in determining the existence of genetic identity between the products in dispute.

2. “Sanofi v. Amgen” judgment

This judgment addresses a request for the invalidation of patent EP 3 666 797 B1, held by Amgen, Inc. (hereinafter, “Amgen”), filed by a group of companies from the Sanofi group (hereinafter, collectively referred to as “Sanofi”) within the framework of an infringement lawsuit initiated by Amgen against Sanofi.

The patent claims a monoclonal antibody defined by functional features, which are essentially:

• that the antibody is for use in the treatment or prevention of hypercholesterolemia, or to treat atherosclerotic disease or reduce the risk of a cardiovascular event associated with elevated blood cholesterol levels;
• that the antibody binds to the catalytic domain of the PCSK9 protein with a specific amino acid sequence and prevents PCSK9 from binding to LDLR (a protein involved in cholesterol metabolism and blood cholesterol levels).

European practice allows for claiming antibodies defined by their “target,” that is, by the entity to which they bind. When defining the invention in this way, it is particularly relevant to demonstrate that the achieved technical effect results, on the one hand, results from the antibody’s binding to the specified target, regardless of the specific sequence of the antibody used, and on the other, that it is not obvious from the prior art.

In this case, the Court ruled that the claimed invention lacks an inventive step in view of a scientific article describing several experiments aimed at establishing the relationship between the PCSK9 protein and LDLR.

The article in question suggests that neutralizing PCSK9 activity, including developing antibodies to block its interaction with LDLR, could be useful in treating hypercholesterolemia. Therefore, the Court concluded that a person skilled in the art, considering the teachings of the cited article, would have been motivated to develop antibodies that block the interaction between PCSK9 and LDLR for the treatment of hypercholesterolemia. According to the Court, generating and selecting such antibodies would be a routine task for a skilled practitioner.

Notably, the Court did not consider the characteristic of the antibody binding to the catalytic domain of PCSK9 to contribute to an inventive step, as no causal technical link was demonstrated between this characteristic and the reduction of PCSK9-LDLR binding, making binding to the catalytic domain an arbitrary selection among several options.

This judgment is particularly interesting given that a parallel case in the U.S. also resulted in the patent being declared invalid, albeit on different grounds. The U.S. Supreme Court rendered the patent invalid not on the grounds of obviousness over prior art, but due to a lack of “enablement”. The Court found that the description provided in the patent did not enable a person skilled in the art to make and use the claimed invention across its full scope. Two key factors for the Court’s decision were: (i) the patent provides examples of the preparation and characterization of 26 antibodies, while its claims potentially cover millions of antibodies, and (ii) the instructions provided in the patent for obtaining antibodies beyond the 26 exemplified amount to, according to the Court, merely “research projects” that would force a person skilled in the art to undertake an undue level of experimentation to determine which potential embodiments of the invention achieve the intended purpose.

This judgment serves as a particularly relevant case study on how different jurisdictions interpret the requirements a patent must meet to be considered valid.