Eran Bareket and Maya Eshkol of Reinhold Cohn Group provide answers to some questions about the impact of COVID-19 on IP law and practice in Israel.
Yes. The Israeli government invoked the State use provisions under the Patents Act to authorise the importation of generic versions of AbbVie’s drug Kaletra, which is protected by at least three Israeli patents. Shortly thereafter, it was reported that AbbVie and the Israeli government reached an agreement on this issue.
Section 104 provides that the government may permit the exploitation of an invention claimed in a patent (or patent application) by one of the government’s ministries or a State enterprise or institution if the minister deems it necessary for the protection of the State or for the supply of essential goods or services. Section 105 provides that the government may extend the exemption set forth in section 104 to persons operating under a contract with the government. A patentee whose patent has been exploited may apply to a special tribunal at the Patent Office for compensation.
According to section 106 of the Patents Act, if a permit was granted, the minister will then notify the owner of the invention/patent and the exclusive licensee regarding the grant of the permit and the scope of use which was permitted, unless the protection of the State demands otherwise. It follows that in such circumstances, no compensation will be paid and the mere fact of the exploitation will remain confidential. This means that, at least hypothetically, the government may have invoked its rights conditionally and no details are available.
The government published a bill proposing to extend the deadlines before various administrative bodies, including the Israeli IP Office. However, as at the date of writing (April 28), this was not pursued.
In terms of regulatory law, the health ministry relaxed certain requirements for clinical trials. The Regulation of Research into Biological Disease Agents Law (2008) was amended to cover experiments on COVID-19, including the requirement to seek approval of such activities.
We believe that the single exercise of the State use exemption is unlikely to affect IP holders and rights in Israel. The unique circumstances of COVID-19 coupled by the limited exercise of such power does not seem to reflect a significant change in the Israeli IP landscape.
The restrictions imposed by the government on March 22 2020 affected civil proceedings. According to the Courts and Execution Offices Regulations (Special Emergency Procedures), if the justice minister issues a notice due to a state of emergency, then only hearings on specific matters which are listed in the regulations will be heard; for example, motions for urgent interim injunctions. In addition, most deadlines are automatically extended.
The justice minister has issued such notices three times since the outbreak. The provisions of the regulations became effective on March 15 2020, and they are currently set to expire on May 10 2020.
The IP tribunal continues to operate as usual. Hearings scheduled for May onwards will take place as scheduled, with a maximum of eight people in attendance (the Registrar and his or her assistant and three representatives for each party in the proceedings). A party with a large number of representatives can submit an application to postpone the hearing.
Deadlines falling between April 2 2020 and May 1 2020 are automatically extended to June 15, while deadlines from May 2 2020 to May 15 2020 are automatically extended to June 30.
According to the Registrar’s notice dated March 22 2020, the IP Office will continue to grant patent, trade mark and design rights as well as publish the journals. The IP Office was closed to the public and half of its employees were put on leave. Services normally provided by the IP Office were suspended from the end of March until April 16 2020; they include: transfer of ownership of rights; licensing and examination of patent attorneys; and issuing of notices of formal deficiencies in entries to national phases of patent applications.
Scheduled deadlines in contentious proceedings before the Registrar were delayed until June 15 2020 or June 30 2020 (depending on the original deadlines). Some deadlines which are set by law and non-extendable, such as the three-month deadline for filing a notice of opposition, remain the same.
With regard to deadlines for examination and other ex-parte proceedings, according to the Registrar’s notice dated March 22 2020, applicants who cannot meet the scheduled deadlines for actions and submission of documents because of the pandemic may apply for an extension. Each request will be examined on its own merits to ensure there is a link between the pandemic and the delay, and it will be “favorably considered in light of the circumstances”. The extensions can be submitted before or after the deadline.
According to a notice on April 19 2020, the IP Office announced that patent applications for inventions for diagnosing, treating, preventing or otherwise eradicating COVID-19 will be considered as “green” applications and therefore prioritised so that its examination will commence within three months from the date the application was classified as “green”. The decision to expedite the examination of patent applications disclosing solutions to COVID-19 is generally useful and appropriate. The Office is also prioritising the examination of urgent applications.
Since the government requested for the necessary products, companies may believe that they are protected from infringement claims since they are working under government’s instructions. However, such manufacturers and dealers are not protected unless the government uses its authority under section 104 with respect to the specific patent. It is, however, less likely that the IP holder will apply to the courts seeking injunctive relief at this time, but after the crisis companies may well face demands for compensation as well as injunctive relief.
Due to the unique circumstances of COVID-19, the testing of medical devices and treatment procedures (including new indications) became more frequent, relying on certain exemptions. Such activity probably presents a low risk for a claim by the State for working without a proper licence since many of the activities are in collaboration with the State. However, such actors may still face the risk of negligence claims filed by any person who suffered damage because he or she was diagnosed or treated with poor medical products. We are not aware if any immunity or indemnity scheme for this.
The Israeli Innovation Authority issued a request for proposals to fund research and development programmes relating to the prevention and treatment of COVID-19. The first round of the programme has been announced.
Generally, we see a wave innovation, both in the healthcare field and in patenting activity. The activities include:
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, any other of its practitioners, its clients, or any of its or their respective affiliates. This article is for general information purposes only and is not intended to be and should not be taken as legal advice. Please contact the author(s) if you have any questions about this article.
Eran Bareket (Senior partner)
Maya Eshkol (Advocate)