Introduction

In a judgement rendered on May 11, 2020 (last allowed for publication just recently), the Tel Aviv District Court dismissed a patent infringement action brought by Millennium Pharmaceuticals, Inc. ("Millennium") et al. against Teva Pharmaceutical Industries Ltd. ("Teva") and KS Kim International Ltd. ("KS Kim"), concerning Israel Patent No. 219853 (“the Patent"). In so doing, the court accepted most of Teva's defence arguments.

Background

Millennium, the main plaintiff, has developed Velcade®, a pharmaceutical drug for the treatment of multiple myeloma. The active ingredient in Velcade® is Bortezomib.

Even though the process for manufacturing Bortezomib was already known at the relevant time, Millennium nevertheless asserted that manufacturing large-scale quantities of the compound presented a major challenge. Millennium's purported novel process as described in the Patent, constituted the basis of several of Millennium's patents protecting the industrial-scale process for manufacturing Bortezomib.

The defendants, Teva and KS Kim, have both obtained marketing approval for generic products containing Bortezomib. Millennium asserted that the defendants are infringing the Patent by exploiting the "essence of the invention". In response, the defendants raised non-infringement as well as invalidity arguments.

The Decision

The court held that determining the "essence of the invention" should be based on the claims, as construed against the background of the specification, and in the context of the relevant prior art. To this end, the court emphasized that certainty is a fundamental principle in this respect and that the wording of the claims is of considerable importance. In light of the above, the court held that it would refrain from construing the claims broadly. In this sense the court remarked that only new components, which provide a substantial contribution to the invention and impart on it the unique advantages obtained by the invention, should form part of the "essence of the invention".

In examining Millennium's infringement assertion, the court needed to first determine the "essence of the invention" of the patented process. In so doing, the court rejected the plaintiffs' argument that the “essence of the invention” is embodied in the “telescoping” process and the isolation and crystallization of the HCl salt, as borne out in the manufacturing process of the Bortezomib molecule, and chose to agree with and adopt the opinion of the defendants’ expert.

The court also criticized the plaintiffs' inconsistency in presenting at least four versions of the "essence of the invention", which developed as the proceedings evolved and as became apparent from the defence arguments, without any satisfactory explanation having been forthcoming.

In addition, the court held that in large-scale processes, a person skilled in the art would have understood that each and every element in the process is essential and crucial to its success. In the particular circumstances of the case, the court found the "essence of the invention" to be embodied in the identity of the specific solvents used in the patented process, including the need to exchange them in the course of the process.

Based on its determinations on the question of the "essence of the invention", the court held that the differences between the claimed process and Teva's process cannot be considered insignificant or unessential. Due to confidentiality reasons, no further details or explanation about Teva’s process can be provided.

Taking into account all the above considerations, the court found that the Patent was not infringed. The court, therefore, dismissed the claim, without addressing the invalidity arguments any further.

Comment

An important aspect of the judgement is the emphasis on the connection between identifying the "essence of the invention" and the fundamental principle of certainty regarding the monopoly embodied in the relevant patent. Deriving from the principle of certainty are the rules of construction of the patent claims, identifying the "essence of the invention" embodied in the claims and evaluating the question of infringement of the essence of the patented invention.

Accordingly, the patent claims and their wording are of immense importance. They are what delineates the boundary between what is permitted and what is prohibited in so far as potential competitors are concerned. Based on the patent claims, a potential competitor should decide beforehand whether or not his activity falls within the scope of the claimed monopoly. The patentee, therefore, bears the burden of drafting the patent claims with reasonable accuracy and clarity so that the person skilled in the art will not have to rely on reference materials or outside sources.

The court further clarified, that by virtue of this fundamental principle of certainty and given the wide scope of monopoly embodied in the Patent, the court must refrain from adopting a broad interpretive approach in defining the patent protection, as this would lead to uncertainty among potential competitors as to the true scope of protection afforded by the patent.