In an important decision rendered on February 26, 2015, the Registrar of Patents, Mr. Asa Kling ("the Registrar"), denied a patent application which failed to fulfill the requirements of utility, sufficient description and reasonable support for claims.
The patent application forming the subject of the Registrar's decision, IL 142809, was submitted by Pharmacia AB (now owned by Pfizer Inc.), and claimed a controlled release formulation (in the form of beads), which relates (but is not limited) to tolterodine as an active ingredient. Claim 1 of the patent application reads as follows:
"1. A controlled release bead comprising:
(i) a core unit of a substantially water-soluble or water-swellable inert material;
(ii) a first layer on the core unit of a substantially water-insoluble polymer;
(iii) a second layer covering the first layer and containing an active ingredient; and
(iv) a third layer of polymer on the second layer effective for controlled release of the active ingredient,
wherein said first layer is adapted to control water penetration into the core."
The patent application exemplified use of the bead with tolterodine as the active pharmaceutical ingredient ("API"), but not limited to a bead with tolterodine as the API.
The opposition, filed by Teva Pharmaceutical Industries Ltd. ("Teva"), was based on several grounds, including obviousness, lack of utility, insufficient disclosure and covetous claims (or lack of support for claims).
With respect to inventive step or obviousness, the Registrar held that the controlled release bead, subject matter of the patent application ("the Bead") differs from the prior art beads in that the first layer on the core unit comprises a substantially water-insoluble polymer and that said layer is relatively thick (although the thickness is unspecified); whereas, in the prior art beads, the core unit was either water-insoluble or, in the case of a water-soluble core unit, the first layer on the core unit comprised a thin, water-soluble polymer.
The opponent, Teva, asserted that the Bead lacks inventive step, and was the equivalent of beads disclosed in the prior art having a water-insoluble core, inter alia, since it was stated in the patent application that the purpose of the first layer on the core unit is to substantially or completely eliminate water penetration into the core. Furthermore, Teva showed that the applicant itself noted, in the priority document, that when such bead contains an insoluble core, the first layer on the core unit may be omitted. Therefore, the Bead merely served as a substitute for a known bead having an insoluble core. The applicant replied that the Bead allows for controlled water penetration into the core, and that changing the thickness of the first layer affects the rate of release of the API. The Registrar held that it might be possible that a certain element of inventive step is present in the patent application; however, the Registrar neither explained nor supported this conclusion. In particular, the Registrar did not determine how a person skilled in the art would have solved the problem at hand; his sole reasoning was that the invention showed a rational attempt to deviate from the natural, ordinary preference of water-insoluble cores to water-soluble cores.
Unfortunately for the applicant, following the submission of its evidence, the former Deputy Registrar accepted Teva's motion for discovery, and ordered the applicant to disclose all the protocols, reports and laboratory notebooks relating to the experiments that were conducted for the opposition proceedings. The disclosed documents included a draft report, which revealed that – contrary to the final report which the applicant filed as evidence – the Bead was also tested in heat conditions, and with additional APIs. The results obtained from these experiments showed that the thickness of the first layer had no effect on the release of some of the APIs. With respect to testing with tolterodine, the experiment proved that the applicant was unable to repeat the example in the patent application. The Registrar thus concluded that as the applicant could not establish a correlation between the thickness of the first layer and the rate of API release, the patent application failed to satisfy the requirement of utility.
The opponent, Teva, also submitted a PCT application by the same applicant, which was published nearly five years after the priority date. This later application relates to the PCT application which constitutes the basis for the opposed patent application, and teaches that the age of the polymer used in the process of manufacture of the Bead influences the controlled release properties of the final product. The applicant's witness, who had supervised the experiments, admitted in cross-examination, that the age of the polymer influenced the experiments. The Registrar therefore held that a person skilled in the art would not have been able to perform the claimed invention absent the knowledge taught in the later PCT application – knowledge which the applicant itself claimed to be inventive. In addition, the patent application ascribes importance to the thickness of the first layer on the core unit, but fails to teach what the required thickness is. The Registrar noted that the applicant itself had encountered difficulties in repeating the example and obtaining the invention described in the patent application with respect to APIs other than tolterodine. Its witnesses also admitted that certain elements of the formulation would need to be altered, depending on the nature of the specific API. The Registrar further noted that the consequence of the applicant's inability to repeat the example demonstrates lack of utility and stated that even if utility was established with respect to the example (which was not the case), this would not mean that the patent protection should be limited to the exemplified API. In these circumstances, the Registrar saw no need to discuss the question of whether undue experimenting was required, since it was clear that the teaching was insufficient, since even the applicant could not make the invention as described and exemplified. The Registrar emphasized that the description must enable a person skilled in the art to make the invention encompassing the full set of claims. The Registrar therefore found the patent application as lacking sufficient description.
Finally, it was held that inasmuch as additional experiments will need to be conducted in order to perform the invention, the invention seems less like a solution to a problem, and more like guidance to finding a solution, that might become an invention someday. Bearing in mind that the claims are not limited to a specific API, in the absence of appropriate teachings as to how to perform the invention, the claims are not sufficiently supported in the description. The Registrar also found that portion of the content of the claims was incompatible with the description, e.g., the amount of API that is released over time. In addition, the claims were not limited to APIs with certain solubility properties, despite it being noted in the description that the preferred API is a soluble or moderately-water soluble drug. The Registrar therefore held that the claims are not reasonably supported by the description.
Comment: the importance of discovery in opposition proceedings
This case demonstrates the crucial role that discovery may play in opposition proceedings. In the past, the Registrar held that it was within his inherent authority to order for the discovery of documents, but such orders are rarely granted and, when granted, they are usually too narrow in scope. In this case, significant findings were made with respect to both utility and insufficient disclosure, solely on the basis of information which the applicant failed to present at its own initiative, but was compelled to discover. It is hoped that this decision will serve as guidance for future proceedings, and set a new benchmark for demanding applicants to prove the assertions made in patent applications, produce all appropriate and relevant documents and introduce more transparency to the process of obtaining a patent.
Comment: the importance of non-prior art documents for determining validity
The submission of documents that are published after the priority date is sometimes considered a mistake. This is because of the general rule that conclusions from the art must be drawn according to the information available at the priority date. Later publications are sometimes viewed as a form of hindsight bias. This case thus demonstrates the importance of non-prior art documents for determining validity. Such documents may reveal, for example, how a person skilled in the art (or, as in this case, the applicant itself) understood the prior art or the invention, and shed light on the validity of the claims.