Introduction

Generally, "Judicial Notice" is a rule in the law of evidence whereby the court is able to make an unequivocal finding without the need for the introduction into evidence of any fact or material  that is deemed obvious, common sense or well-known by every average and well-educated person. In essence, citing Judicial Notice, is in a sense a shortcut, whereby a party is exempted from the requirement of submitting evidence in court. The doctrine was adopted into Israeli law from the Common Law and may be relied upon in both civil and criminal proceedings.

In a decision rendered on January 27, 2021, the Deputy Commissioner of Patents, Ms. Jacqueline Bracha, accepted an application filed by Teva Pharmaceutical Industries Ltd. ("Teva"), and rejected, inter alia, the claim raised by the patent applicant, Bayer Intellectual Property GmbH ("Bayer"), to the effect that Judicial Notice exists with regard to the extent of the use of the direct compression method in the pharmaceutical industry in so far as tablet manufacturing processes are concerned.

Factual Background

On May 23, 2006, Bayer filed a patent application in Israel, directed to a method for the production of a solid, orally applicable pharmaceutical composition.

The patent application relates to a process for the preparation of a solid, orally administrable pharmaceutical composition, comprising the active ingredientRivaroxaban (Xarelto) in hydrophilized form. The hydrophilization method that is claimed in the patent application includes a two-step process of wet granulation: (1) producing the granules comprising the active ingredient by fluidized bed granulation; and (2) converting the granules into a solid pharmaceutical composition.

Within the ambit of the proceedings, Teva argued that given the known properties of Rivaroxaban, which has poor aqueous solubility, and given the advantages of the wet granulation process, a person of ordinary skill in the art would have chosen wet granulation as a starting point for developing a pharmaceutical composition of Rivaroxaban in general, and fluidized bed granulation, in particular.

In rebuttal of Teva's arguments, Bayer claimed that a person of ordinary skill in the art would have chosen direct compression as a starting point for developing a pharmaceutical composition of Rivaroxaban. According to Bayer, use of the direct compression method was very common among persons of ordinary skill in the art, at the priority date. Inter alia, Bayer claimed that this "fact" falls within the ambit of Judicial Notice for which no proof is required. In support of the "Judicial Notice" claim, Bayer attached to its summations two decisions of the Commissioner of Patents, in which reference was made to the direct compression method.

In light of this, Teva filed an application for deletion of the new evidence attached to the summations, as well as for deletion of the claims and clauses referring to the alleged Judicial Notice. Within the context of its application, Teva explained that Bayer’s claim with regard to the direct compression method being very common among persons of ordinary skill in the art, does not meet the conditions for the existence and proof of Judicial Notice.

The Decision

The Deputy Commissioner held that the extent of the direct compression method being common among persons of ordinary skill in the art at the priority date, does not fall within the realm of Judicial Notice. According to the Deputy Commissioner, this is not a fact that is in the possession of everyone or a fact that can be clarified by reviewing the sources that are not in dispute, since it is the sources for clarifying this claim that are in dispute between the parties. In addition, it is not a scientific principle, but a factual-empirical question. The Deputy Commissioner also held that although the Commissioner of Patents is a professional tribunal in the field of patents, he does not possess the scientific knowledge in all fields that are discussed before him. Moreover, other decisions of the Commissioner of Patents cannot teach about Judicial Notice, as they are based on specific evidence that was filed in other proceedings.

In light of the above, the Deputy Commissioner ordered Bayer to delete both the new evidence as well as the claims and clauses citing the alleged Judicial Notice.

Comment

Although this is an interim decision and the proceedings are not yet over, it is nonetheless of considerable importance, for example:

  • In legal proceedings before professional tribunals specializing in the field of patents, one cannot rely on the presumption that the tribunal possesses Judicial Notice with regard to scientific claims that are in dispute between the parties. Therefore, each claim must be proven by means of experts or other evidence.
  • Judicial Notice that can be attributed to professional tribunals specializing in the field of patents encompasses, inter alia, facts that are in the possession of any person (such as historical facts, facts in basic physics, geography, known research results, etc.) as well as facts that can be clarified immediately and accurately by examining authoritative sources that are not in dispute.
  • The Commissioner of Patents is a professional tribunal in the field of patents; nonetheless, he does not possess the scientific knowledge in all fields that are discussed before him.
  • It is not possible to rely on factual and scientific holdings in rulings in the field of patents for proving a factual or scientific claim in other proceedings, when citing Judicial Notice.