An Israeli Court Overturns the Patent Registrar’s Decision on Lack of Inventive Step
by Avraham Hermon, Senior Partner, JMB Davis Ben-David
Very few decisions are issued by courts in Israel regarding patents. One recent decision was an important one, in that it overturned the Israel Patent Registrar’s decision of refusal of a patent application, relating to crystalline forms of a drug on the market.
In April 2022, the District Court of Tel Aviv, acting as a Court of Appeals, issued a decision overturning the refusal of patent application 207772 by Mr. Ofir Alon, the Israel Patent Registrar. The background for this decision is as follows: In 2010, Intra-Cellular Therapies Inc. had filed patent application 207772 as a national phase of the PCT patent application PCT/US2009/001608, relating to crystalline forms of the lumateperone tosylate, an atypical antipsychotic drug used for treating bipolar depression and schizophrenia. In April 2020, after a prolonged examination and a proceeding before the Registrar, the patent application was refused. The Registrar’s decision was then appealed by the applicant at the District Court of Tel Aviv.
During the prosecution of the application and the proceeding in front of the Israel Patent Registrar, the claims were limited to a specific crystalline form (polymorph) of the tosylate salt of lumateperone, defined by a large number of peaks shown in X-Ray Diffraction analysis, and methods for making the tosylate salt. The reason for rejection of the claims was based on D1, US Patent Publication 2006/0148808, a prior patent application publication by the same applicant, which described the lumateperone free base, and contained a general description that “pharmaceutically acceptable salts could be made, and listed about 30 salts, including the tosylate (toluene-sulfonic) salt. D1 also discloses a general method for making salts, listing five solvents which could be used, two of which were used by the applicant to successfully make the salt.
One of the applicant’s arguments for inventive step of the claimed polymorph is that obtaining the tosylate form, which is a stable salt form, was not an easy task. The applicant attempted more than 100 combinations of acids, solvents, and crystallization conditions to obtain a stable crystalline form, and the tosylate form was the only stable salt form formed.
The Registrar rejected this argument, maintaining that salt formation is standard procedure for a person of skill in the art. The fact that the applicant made various attempts to form salts does not change this fact that salt formation is mere routine experimentation. The Registrar added that at the time of the filing of the application, there was no known difficulty relating to preparing salt forms of lumateperone, and that the formation of the tosylate salt did not require any special conditions for its formation.
Judge Gershon Gotovnik, of the Tel Aviv District Court, disagreed with the Registrar on a number of issues. In a floral illustration of the difficulty of crystallization of salts, he described a fictional French restaurant called L’entrecote de Paris, in a fancy location in France’s capital. The restaurant has a famous steak with a special sauce, which is kept as a secret recipe which no competitors are able to duplicate. At some point, the list of ingredients in the secret sauce is published, and attempts are made to recreate the steak sauce, but to no avail. How is it possible that no expert chef privy to the ingredients in the steak sauce was able to recreate the steak sauce? The answer lies in the fact that the list of ingredients is not sufficient. The process of crystallization and salt formation of pharmaceutical compounds is complicated according to Judge Gotovnik. No two chemical compounds are identical, and there is no single formula which exists for guaranteeing a stable salt compound having properties acceptable for the pharmaceutical industry. Knowing the ingredients (the active pharmaceutical and the counter ion) of the salt that can be formed is not sufficient to allow someone to make it.
Judge Gotovnik pointed out that the question of inventive step revolves around whether a person of skill in the art would require inventive judgement to obtain the claimed crystal. The more difficult obtaining an invention is, the easier it is to support an argument of inventive step. He added that the fact that the prior art does not show difficulty of obtaining the invention does not negate the inventive step. Furthermore, according to the decision, a lack of showing of difficulty to obtain the invention during the prosecution procedure does not itself negate inventive step. The applicant should have the ability to show difficulty of obtaining the invention at a later stage.
The decision further points out that the Examination Guidelines of the Israel Patent Office indicate that the number of experimental pathways and possible ways of obtaining the outcome which is the invention is relevant when making a determination of inventive step.
While being critical of the decision of the Registrar, Judge Gotovnik also notes that the applicant could have made stronger arguments in support of inventive step. The difficulties in obtaining the claimed crystalline form presented by the applicant were described in a general way, and were not specifically described. Although the applicant made general arguments in the proceeding regarding the non-trivial nature of the process used to obtain the tosylate salt, this non-trivial aspect was not demonstrated with concrete evidence.
In his decision, Judge Gotovnik accepted the appeal and reversed the decision of the Registrar, allowing the applicant to further support his argument in front of the Registrar, by providing declarations and concrete evidence supporting inventive step.
From this decision, it appears that there are a few important lessons that can be learned for applicants prosecuting Israeli patents, especially in the pharmaceutical industry
- Patent decisions by Israeli courts are rather rare. This decision shows that it is possible to effectively appeal a decision of the Patent Office in court, and a decision can be given within a reasonable time frame of about two years. It is possible that in light of this decision, more such appeal proceedings will be filed.
- Judge Gotovnik, in his decision, hinted to the fact that throughout prosecution and the hearing before the Registrar, general arguments were made, without backing up the arguments with concrete evidence. Applicants can and should use evidence in the form of declarations and expert witness statements to back up arguments of inventive step.
- Polymorph patent prosecution in Israel typically differs from prosecution in other jurisdictions with regard to the strict requirement of description of the polymorphic forms in the claims, making prosecution of such patents more complicated than in many other jurisdictions. In many polymorph patents, the prior art available before the filing of the polymorph patent describes the active free compound and sometimes generally describes how to make salts of the free compound. The decision of the Registrar, if left to stand, could have negatively impacted other polymorph patents or patent applications in Israel. The decision by the Tel Aviv District Court, may have a long-lasting effect affirming the patentability of other polymorph patents in Israel.