The Burden of Persuasion Rests With the Opponent, When a Negative is Claimed, the District Court Ruled
On 7 October 2007, the Tel-Aviv District Court decided to deny Unipharm's appeal against the decision of the Deputy Registrar of Patents, rejecting the Appellant's opposition to the Israeli Patent Application that claims the active material of EVISTAŽ.
Israeli Patent Application No. 115314 (hereinafter: "the Application"), which was filed by Eli Lilly and Company on September 14, 1995, claims, inter alia, a novel non-solvated crystalline form of Raloxifene Hydrochloride, substantially free of various contaminants and impurities. The material, claimed in the Application, is also defined by a specific x-ray diffraction pattern, and it was produced using a method which was unknown in the prior art. The material covered by the Application is the commercial form of the active material of EVISTAŽ - a blockbuster drug used for the prevention and treatment of osteoporosis in post-menopausal women.
Following the successful examination of the Application and its acceptance by the Israeli Patent Office, Unipharm (an Israeli generic pharmaceutical company) filed an opposition against the Application. The opposition was based on two prior art publications which refer to Raloxifene HCL. The cited publications do not indicate whether the material described therein is solvated or non-solvated and they also do not provide its x-ray diffraction pattern. According to Unipharm, the fact that the prior publications do not indicate whether material is solvated or non-solvated teaches that the same material is non-solvated and identical to the material claimed by the Application. Following this reasoning, Unipharm argued that the material claimed by the Application lacks novelty and inventive step.
The Deputy Registrar held that the prior publications do not negate the novelty of the invention, as they do not describe the invention in a clear and unambiguous manner and do not provide clear instructions for producing the material claimed in the Application. He further held that due to the ambiguity in the publications, Unipharm should not have been satisfied with the mere presentation of the prior publications. The Opponent should have supplied positive evidence proving that the substances described therein are identical to the one claimed in the Application, in spite of the fact that the burden of persuasion in opposition proceedings rests on the patent applicant. In light of the above, the Deputy Registrar ruled that Eli Lilly had met the burden of persuasion regarding the novelty of the invention, and that Unipharm had failed to submit any positive evidence to the contrary. The Opposition was thus rejected.
The District Court decided to adopt the position of the Deputy Registrar and to uphold his decision to reject the opposition. The Court held that it was sufficient for Lilly to prove the negative element, namely, that the prior publications do not include the gist of the invention. Once this element had been proven, the burden of bringing evidence, to prove that the materials described in the prior publications are identical to the one claimed in the Application, was shifted to Unipharm. The Court also held that there was no room to intervene in the factual findings of the Deputy Registrar, who examined the prior publications on their merits and thoroughly analyzed the evidence presented to him.
Unipharm does not have a vested right to appeal against the Judgment of the District Court and a leave for appeal against the same Judgment should be obtained from the Supreme Court. The deadline for filing an application for leave to appeal is 30 days of the date on which the Judgment was delivered to Unipharm.
