Supreme Court Denies Access to Biological Material Deposited in Support of Laid-Open Patent Application
In a rather unique case the Israel Supreme Court issued an interlocutory injunction prohibiting the company Hazera from requesting access to watermelon seeds of the company Origene Seeds, deposited for the purpose of patent procedure under the Budapest Treaty, and thereby cancelled a previous decision of the Tel Aviv District Court.
Israel is a signatory to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (“the Budapest Treaty”), and its patent law allows patent applicants in the field of biotechnology to deposit biological materials under the Budapest Treaty in order to satisfy the requirement of enablement anchored in section 12 of the Israel Patent Law – 1967 (“the Patent Law”).
According to the Regulations under the Budapest Treaty, any samples deposited by patent applicants that are referred to in a granted patent may be available to third parties. As to pending patent application that incorporate reference to a deposited material under the treaty, the Regulations under the Budapest Treaty apply a so-called “renvoi” rule, and stipulate that the accessibility of deposited samples to third parties while a patent application is pending, is governed by the law in the jurisdiction of the patent application (Regulation 11 (3) (a)). According to said Regulation, a third party seeking the furnishing of samples mentioned in a given patent application, must generally provide the depository institute with a certificate in an approved format, signed by the relevant patent office, attesting that (i) the samples are indeed mentioned in the patent application, (ii) the patent application has been published and (iii) the third party is entitled to receive the samples. The system is arranged such that the depository institute need not exercise any discretion, and therefore it is imperative that the form will include all the required details.
Except for the above mentioned enablement provision of the Israel Patent Law and certain regulations related thereto, the Patent Law and the regulations thereunder do not include specific provisions relating to the accessibility to third parties of biological materials deposited under the Budapest Treaty and Regulations. Specifically, there are no provisions under Israeli law relating to the furnishing of samples of deposited materials to third parties, neither before grant nor thereafter, and there is no designated form to this effect available at the patent office.
Origene Seeds, an Israeli startup company, filed a patent application with respect to a watermelon that is resistant to a certain fungus, and deposited seeds thereof with a certain International Depository Authority (“the IDA”). A reference to the particulars of deposited seeds was made in the patent application.
Upon early publication, Hazera Company, a competitor of the applicant, approached the IDA and requested to be furnished with samples of the deposited watermelon seeds.
Consequently the IDA turned to the Israeli Patent Office (“ILPTO”) seeking guidance regarding the state of the law in Israel on the matter. Based on the ILPTO’s reply, the IDA sent the samples to the third party; a notification was concurrently sent to the patent applicant notifying it that samples of the seeds were sent to its competitor.
Pursuant to receipt of said notification the patent applicant moved for an ex parte interlocutory injunction that was granted. Consequently, the seeds were withheld at customs and the defendant was prohibited by court order to obtain said seeds.
Due to the importance of the issue, the most important Israeli research institutes (including the universities of Jerusalem, Tel-Aviv, Bar-Ilan, Weitzman Institute, the Technion in Haifa and Volcani Institute) sent a letter to the Minister of Justice urging the Minister to inform WIPO that the Israeli law does not allow for furnishing of samples of biological materials at the stage where the relevant patent application is pending.
The Attorney General of Israel also joined the proceedings and submitted his stance on the matter. The Attorney General’s position was that in the absence of specific provisions in the law, biological materials should be deemed “published” upon early publication of a patent application, and consequently samples may be furnished.
Eventually, the district court ruled in favor of the respondent and ordered the cancellation of the interim injunction within a given time, while allowing the applicants to seek extension of the order from the appellate court (the Supreme Court of Israel), in view of the irreparable damage expected to be caused.
Specifically, the district court held that although the applicant’s literal reading of the law seemed correct, namely that verbatim the law does not include a provision allowing third parties access to deposited biological material while the patent application is pending, purposive reading of the law leads to the conclusion that once a patent application becomes laid-open to public inspection, the entire application becomes accessible to the public, including the biological materials. In its decision the district court ignored the fact that the reference to the deposited seeds was removed from the patent specification after filing.
Origene Seeds filed with the Supreme Court a request for leave to appeal from the district court decision in conjunction with a request to extend the duration of the preliminary interim injunction, pending decision of the Supreme Court in the motion for leave to appeal. The Supreme Court subsequently extended the duration of the interim injunction until final decision in the appeal.
The Legal Questions on Appeal
Among the various legal questions raised in the appeal two were of particular interest:
Absent specific provision allowing access of third parties to the property (the deposited seeds) of the patent applicant, is the decision of the Patent Registrar to allow the furnishing of the samples in line with the law?
Should a distinction be made between written documents and deposited biological material relating to their availability to third parties? In this connection it was submitted by the appellant that in jurisdictions that enacted provisions regulating the access of third parties to deposited samples, in order to mitigate the potential damage to patent applicants, the substantial difference between mere written material biological material, namely that the latter is in fact a “living factory”, was taken into consideration.
The Supreme Court’s Decision
The Supreme Court (Honorable Justice Handel) decided to allow the request for appeal and decided in favor of the appellant on the basis of the balance of convenience, as the law in that matter was not clear-cut. The court ordered the cancellation of the district court ruling, prohibited Hazera from requesting or receiving samples of the deposited watermelon seeds of Origene, and awarded the appellant with costs.
Origene Seeds was represented by Gilat, Bareket & Co.
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