Overview

Legislation

What is the primary law governing trademarks in your jurisdiction?

The primary legislation governing trademarks in Israel is:

  • the 1972 Trademark Ordinance [New Version];
  • the 1940 Trademark Regulations;
  • the 1987 Trademark Regulations (Appeals before the District Court);
  • the 2007 Trademark Regulations (Implementation of the Madrid Protocol);
  • the 1929 Merchandise Marks Ordinance;
  • the 1965 Protection of Appellation of Origin and Geographical Indications Law;
  • the 1999 Commercial Civil Wrongs Law, Section 1 – Passing Off;
  • the 1981 Pharmacists Ordinance [New Version]; and
  • the 1986 Pharmacists Regulations (Preparations).
Agencies

Which agency is responsible for the grant and registration of pharmaceutical trademarks?

The Israel Patent Office is responsible for the grant and registration of pharmaceutical trademarks.

Regulators

What are the relevant national and international regulatory bodies and requirements that need to be considered when clearing a pharmaceutical trademark?

The Israeli Trademark Register, which is managed by the Israel Patent Office, and the Israeli Drug Registry, which is managed by the Ministry of Health. The basic requirement is that the propounded mark would be sufficiently different from prior registered (or applied for) trademarks, so as to prevent any likelihood of confusion. This requirement is based on both the 1972 Trademark Ordinance [New Version] and the 1986 Pharmacists Regulations (Preparations), since while the trademark has to be accepted for registration in the Israeli Trademark Register by the Israel Patent Office, a name of pharmaceutical preparation must also be accepted for registration in the Israel Drug Registry by a designated team at the Ministry of Health.

Non-traditional trademarks

What non-traditional trademarks are available in your jurisdiction and how are they registered?

The following are available:

  • colour marks (ie, marks consisting of one or more colours only, without wording or design);
  • 3D trademarks, including product and packaging shapes;
  • motion marks (ie, a mark that makes a series of motions);
  • holographic marks; and
  • sound marks.

 

No scent or taste marks have been registered as yet.

Cannabis-derived products

Does your jurisdiction allow the registration of cannabis-derived products?

Yes.

Parallel imports

Regulation

What are the rules governing parallel imports of pharmaceutical goods?

Parallel importation of pharmaceutical goods to Israel is permitted, provided that a permit for the importation is issued by the Ministry of Health (MOH).

Since an amendment of the Pharmacists Ordinance 1981 (the Pharmacists Ordinance) at the end of 2000, any person or entity can apply for an importation permit of pharmaceutical goods registered in the Israeli Drug Registry.

The Pharmacists Ordinance and the MOH allow the parallel importation of matching pharmaceuticals, namely, a pharmaceutical preparation which is identical to a registered preparation manufactured by the same manufacturer. Traders in pharmaceuticals in Israel or a recognised institution are allowed to import the matching pharmaceuticals also from different production sites.

The matching pharmaceuticals can only be imported from specific countries recognised by the MOH, in conformity with the Pharmacists Regulations 1986 (the Pharmacists Regulations), namely, the United States, Canada, EU member states, Switzerland, Norway, Iceland, Australia, New Zealand and Japan or from licensed wholesalers from such recognised countries.

Strategies against parallel imports

What strategies are available to police and enforce against parallel imports?

In general terms, Israeli courts accept the doctrine of exhaustion of IP Trademark rights after the first sale of goods anywhere in the world.

As the legal situation in Israel is favourable to parallel importation, the courses of action available to stop the parallel importation and distribution of goods to Israel are restricted. The situation is the same in regards to the pharmaceutical industry where the importation process requires a special process of requirement of approvals and authorisations from the MOH.

Accordingly, the recommendation is to constantly conduct private investigations checking the activities of the parallel importers to evaluate the specific circumstances of each matter concerned.

While there may be other causes of action available that need to be evaluated according to the specific circumstances of each case, the sporadic cases in which plaintiffs successfully stopped the parallel importation of general goods in Israel were mainly based on the three following areas of the law: trademark law, unjust enrichment and commercial torts law.

Excessive and unnecessary use of the trademark by the parallel importer and other actions of the parallel importer may create a likelihood of commercial association with the manufacturer and constitute a solid cause of action to stop parallel importation.

Alterations made with respect to the physical condition of the pharmaceutical goods imported such as repackaging of the pharmaceutical goods may be considered trademark infringement. The removal of bar codes from the packaging of the parallel imported goods also requires attention. In a case involving the removal of bar codes, part of a parallel importer’s attempt to conceal a breach of distribution contract limitations which were also reflected on the product packages, stating that distribution could only be made by authorised retailers, amounted to tortious interference, also satisfying the additional element required for establishing a claim based on unjust enrichment.

Anti-counterfeiting and enforcement

Types of proceedings

What types of legal or administrative proceedings are available to enforce against infringing products?

A trademark owner may enforce its rights against an alleged infringer or dilutive use of a mark with an action before the court. The action may be filed with a motion requesting interim relief.

Owners of well-known registered and unregistered trademarks as well as owners of registered trademarks may base their action on trademark infringement. Owners of trademark rights acquired through use of the mark need to base their action on other causes of action to obtain protection, such as the tort of passing off, which is defined under the 1999 Commercial Civil Wrongs Law.

The Israeli judicial system consists of three different instances, namely, magistrates’ courts, district courts and the Supreme Court, and while there are no specialised courts, intellectual property matters are usually heard before district courts (the second instance).

The owner of a registered mark whose rights have been infringed or faces infringement may be able to resort to administrative measures of protection, such as filing a complaint with customs to detain future shipments of goods likely to infringe upon its registered trademark.

In addition, several acts involving unauthorised use of registered trademarks and their imitations incur criminal liability under different trademark laws. For instance, according to the provisions of the Trademark Ordinance several acts incur criminal liability and corporate officers are also liable to penal measures. These criminal offences include unauthorised commercial marking of goods bearing a registered trademark with respect to the same goods covered in the registration, which is likely to create confusion; the unauthorised commercial import of goods bearing a registered trademark with respect to the same goods or imitation of such mark, which is likely to create confusion; the commercial sale, distribution or rent of goods marked or imported to Israel bearing a registered trademark with respect to the same goods; and possession of goods so marked or imported for trade purposes.

Other criminal offences are stipulated by the Merchandise Marks Ordinance, such as the prohibition on selling or possessing goods or items bearing a fake trademark for commercial or industrial purposes.

To open a criminal proceeding, the mark owner may either file a complaint with the police regarding the infringement of a registered trademark or a private criminal complaint with the court.

An additional available course of action is to file a complaint to the MOH reporting about counterfeits, stolen medicines, preparations and medical equipment. The complaint may be made anonymously but must include the following information:

  • any information about the selling of counterfeit medicines, dietary supplements and medical devices;
  • any information about the sale of kiosk-sold drugs or party drugs by a person or a business;
  • any information about hospitalisation or medical treatment after taking medicines that are suspected of being counterfeit, or as a result of taking party drugs or kiosk-sold drugs; and
  • sale of medicines, medicinal preparations and dietary supplements by a person suspected of posing as a physician, pharmacist or qualified treatment provider.
Remedies

What are the available remedies for infringement?

The remedies available to a successful party in an action for trademark infringement or dilution include permanent injunction, compensation for damages caused to the trademark owner such as loss of profit or alternatively an accounting for profits and profits unjustly made by the defendant. An award of damages may be based on proof of damage suffered by the owner or by way of judicial assessment. In trademark infringement and dilution cases involving the tort of passing off, the plaintiff may be entitled to statutory damages without proof in a sum of up to 100,000 Israeli shekels for each tort. The amount of statutory damages awarded takes into account, among other things, the gravity of the matter, the number and duration of the infringing actions, the infringer’s conduct and the size of its business.

It is also possible to obtain an order for the destruction of the infringing goods or their disposition to the trademark holder, as well as any other order that the court may deem prudent in the case circumstances, including different declarative judgments such as recognition of well-known trademarks.

In cases of infringement of unregistered well-known trademarks, the only remedy available in a cause of action based on trademark infringement is injunction; however, other remedies are available under different causes of action such as passing off and unjust enrichment.

In appropriate cases it is possible to file a motion requesting different preliminary remedies such as orders for interlocutory injunction, search and seizure orders and orders restricting disposition with respect to an asset. The motion for interim relief must be requested simultaneously with or shortly after filing the statement of claims; and in extraordinary circumstances of urgency, the interim relief may be granted ex parte, before the inter partes hearing.

There are several technical and substantial conditions to be met in order to have the interim reliefs granted and to avoid the motion being denied. The motion needs to be filed with an affidavit that supports the factual claims, and the applicant needs to file a personal undertaking not limited to an amount and a third-party guarantee at an amount set by the court to indemnify the defendant for its eventual damages if the claim terminates or if it is found to be unjustified and is revoked.

The motion for interim relief must persuade the judge that the interim relief is crucial to prevent irreparable damages and to keep the status quo, demonstrating reasonable chances of success in the main case and that the balance of convenience is in the plaintiff’s favour. Moreover, the plaintiff must draft the motion in good faith, disclosing all important facts and documents to the court, in a timely manner, since excessive delay in seeking the relief may amount to laches and dismissal of the motion.

There are different penalties applied in connection to offences related to the infringement of trademarks such as the imposition of fines and imprisonment of up to three years.

Border enforcement

What border enforcement measures are available to halt the import and export of infringing goods?

The owner of a registered mark whose rights have been infringed or who faces ‘reasonable suspicion’ that their rights will be infringed may file a complaint with the customs authorities to detain the release of allegedly infringing goods which are being imported to Israel and to the Palestinian authorities.

The customs authorities may, either upon receiving such notice or at their own initiative, detain imported goods that prima facie infringe registered trademark rights. Detention by customs is subject to the deposit of an indemnification guarantee by the trademark owner and, depending on the size of the shipment detained, may be cancelled if the owner fails to deposit a guarantee and bring a legal action within 10 days of the notice of detention.

There are no available border enforcement measures with the customs authorities in relation to the exportation of infringing goods from Israel.

Due to the territoriality of trademark rights, the courts are likely to limit their considerations to actions done in the territory of the State of Israel. Eventually, a blatant infringement of trademark rights or other bad conducts made outside the territory of Israel may increase the chances of successfully establishing the element of bad faith, for instance, the personal knowledge of the defendant regarding an unregistered trademark which has acquired an international reputation outside Israel.

Online pharmacy regulation

What rules are in place to govern online pharmacies?

Regulations issued by the Ministry of Health (MOH) govern the services provided by online pharmacies including the operation of websites, transportation and delivery of drugs and services provided during emergencies.

Only a pharmacy that operates according to the law can manage a website, and only if it receives a special permit from the District Pharmacist.

OTC drugs need to be displayed online separately from other products next to a full consumer leaflet approved by the MOH and a clear picture of the packaging of the drug including a written description.

It is forbidden to display prescription drugs on the website, except for their price, size, packaging and the consumer leaflet approved by the MOH.

Every page needs to contain warnings stating that the information on the website does not substitute consultation with doctors or pharmacists, calling the public to read the leaflet before using the drug and to consult a pharmacist concerning the aims and how to use the medicine, side effects and interactions with other drugs.

The main page of the website will show the name and address of the pharmacy, contact details, the name and licence number of the pharmacist in charge and the hours of operation of the pharmacy.

The regulations deal with other important issues related to the activities of online pharmacies, including but not limited to the provision of consultation to patients by pharmacists, preparation and distribution of medical preparations including prescription drugs, transportation and delivery of drugs, documentation of all deliveries provided online, return of drugs, marketing, dangerous drugs and drugs that require freezing or special refrigeration, psychotropic drugs and management of the pharmacies during emergency periods and home front command operations.

Recent cases

What are the most notable recent cases regarding the enforcement of pharmaceutical marks?

The local case law concerning the enforcement of pharmaceuticals is relatively scarce, as in most infringement cases a settlement is successfully negotiated, and the infringing goods are destroyed.

The most notable recent case in Israel was international operation Pangea 4, handled by the Unit against Pharmaceutical Crime at the MOH and the Customs Authorities’ Management.

During the operation approximately 100,000 tablets, pills and drugs suspected of being counterfeit were seized. Most of the counterfeited seized drugs were erectile dysfunction pills infringing registered marks such as CIALIS®, VIAGRA® and LEVITRA®, dietary supplements containing forbidden medical active ingredients and other drugs for which importation to Israel is forbidden.

Many countries took part in the operation in collaboration with the Permanent Forum on International Pharmaceutical Crime (PFIC), the World Customs Organization (WCO) and the World Health Organization (WHO), for the purposes of preventing the import, export and trade of counterfeits, stolen and barred drugs (which pose a real danger to public health) and warning the public about the dangers involved in taking these drugs.

Advertising

Regulatory bodies

Which bodies are responsible for oversight of pharmaceutical advertising in your jurisdiction (and what are their powers)?

The Pharmacists Ordinance provides the Minister of Health (MOH) with the authority to legislate regulations relating to prohibitions and restrictions concerning pharmaceutical advertising.

The MOH is the body responsible for providing or rejecting authorisations to pharmaceutical advertisements.

The Director General of the MOH may oblige the advertiser to correct the advertisement, to publish clarification that the advertisement was misleading and inaccurate, and to cancel or prohibit the advertising of a preparation.

Advertising rules

What specific rules are in place regarding the advertising of pharmaceutical products?

All pharmaceutical advertisements need to pre-obtain special permits from the MOH. As a rule, permits are only provided to OTC pharmaceuticals. Permits to advertise prescription pharmaceuticals are provided in exceptional cases, upon the filing of special applications specifying the special reasons that will be analysed by an extended committee of the MOH.

Specific regulations issued by the MOH focus on the publication of OTC drugs and set out detailed instructions regarding the method of advertising, the content to be included in the advertising, and more. According to the procedure, approval for advertising will be given only after an in-depth examination of the advertising by a special team on behalf of the Pharmacy Division of the MOH. Approval for advertising will be given only after the staff is aware that the advertising meets the conditions set out in the procedure. For example, the advertising needs to include the name of the preparation, its activity, the names of the active ingredients, restrictions, significant warnings, and a reference to the leaflet of use.

The Pharmacists Regulations (sales of OTC preparations not by pharmacies or pharmacists), 2004 entail several additional restrictions to the advertisement of OTC pharmaceuticals, including, among others, the prohibition on advertising pharmaceuticals:

  • different from the prescriptions and indications of the pharmaceutical registered in the Registry of Drugs;
  • in a manner that may mislead, intimidate, create tension or imply that the preparation will provide the consumer with features or benefits that are not in accordance with the indication approved for it in the register;
  • in a manner that may stimulate or cause children to consume pharmaceuticals on their own or in a manner that is not clear and accurate. The advertising should provide a consumer leaflet and a clear warning stating that it is recommended to consult a doctor or pharmacist and review the leaflet before consuming the active ingredient in the drug;
  • on TV programmes, online, in the press or in any other format intended primarily for children and adolescents up to the age of 16, in army accommodations, in prisons or schools;
  • in connection with lotteries or distribution of samples of OTC preparations to patients or consumers and in connection with other promotional efforts for sales; and
  • in comparative advertisements, with the exception of when both preparations contain identical active ingredients and there is a unique basis for comparison between the preparations, based on clinical scientific research published in professional journals.

 

Finally, the regulations provide specific guidelines regarding the size, clarity, colour and language of the letters in the warnings concerning the use of the preparations appearing in the OTC advertisement.

Generic substitution

Legality

Is generic substitution permitted in your jurisdiction?

Generic substitution is permitted in Israel.

Regulations

Which regulations govern generic substitution by pharmacists of brand-name drugs?

According to the provisions of the Pharmacists Ordinance if a prescription does not include the commercial name of the drug, the pharmacist may substitute a generic medication, but only if the substitute has the same active ingredients, form, strength and medical effect as the original.

Moreover, a pharmacist must inform the buyer of the existence of other identical registered preparations in their possession at the pharmacy.

Update and trends

Key developments and future prospects

What were the key judicial, legislative, regulatory and policy developments of the past year in relation to the protection and enforcement of pharmaceutical trademarks? What are the prospects for future developments?

 No updates at this time.

Law stated date

Correct on

Give the date on which the above information is accurate.