A pharmaceutical company against Teva: “It wants to steal our drug”

“Neurim” to the court: “Teva is marketing our drug against sleep disorders, and now intends to replicate the patent and launch an imitation”. Teva: “We’ll respond through legal channels”

20.11.17 | Lital Zobvobizki

Neurim Pharmaceuticals, controlled by Prof. Nava Zisapel and Yehuda Zisapel, one of the founders of the RAD Group, is suing Teva. Neurim is the developer of the novel drug Circadin for sleep disorders. The advantage of the drug is that it is not addictive. In the lawsuit, Neurim asks the Tel Aviv District Court to declare that Teva and any company on its behalf is prevented from launching a generic version of Circadin in view of its explicit commitments to Neurim.

“Lack of good faith”

In a lawsuit filed against Teva and Abic Marketing, Adv. Gabi Moyal-Maor and Adv. Eleanor Stark of law firm Hamburger Evron & Co. wrote that “the heart of this lawsuit lies in the attempt, demonstrating a lack of good faith on the part of giant pharmaceutical company Teva, which is attempting to steal the intellectual property of Neurim in the drug Circadin that it developed, by means of a generic imitation of the drug. The steps taken by Teva express shameful exploitation of its status as the sole marketer and distributor of the drug in Israel for almost a decade, by virtue of which it is exposed to all the confidential information related to the drug and its development. Now, in violation of the contract, Teva has set itself the goal of appropriating the drug for itself by launching a generic version that will compete with Circadin worldwide to the point of it mortal damage,” the lawsuit states. Neurim asks the court to instruct Teva to refrain from producing and marketing a generic product that competes with Circadin and to refrain from using any confidential Neurim information outside the scope of the agreement.

Neurim was founded and is managed by Prof. Nava Zisapel, a professor of neurobiology and the inventor of Circadin, which is sold in Israel and in 45 countries. The lawsuit states that in 2007, after approximately 17 years of intensive work, Neurim completed the development of Circadin. “This is a breakthrough product with prolonged release of substances including melatonin, which it releases in a manner that mimics the release of the natural hormone, thus supplementing what is missing in the sleep control mechanism, which presents in older adults. The product is protected by patents registered by Neurim worldwide, including in Israel.”

Circadin was approved for marketing in Israel in December 2008. According to Neurim, with the exception of Switzerland, it does not have a marketing arm in the various countries and it is tied into marketing and distribution agreements with recognized international drug companies, which market and distribute the product in countries where they have received a franchise. “In accordance with Neurim’s marketing policy, Neurim and Teva entered into a licensing and distribution agreement, in which the plaintiff granted Teva an exclusive license to distribute the product in Israel. Teva enjoys the exclusivity granted to it in the agreement, where the agreement is valid until March 2019 (at the earliest).”

It is also claimed in the lawsuit that “in the years since the signing of the agreement, and based on it, close ongoing relations were forged between Neurim and Teva. Neurim gave Teva confidential and sensitive information about the product. Teva was exposed to Neurim’s future development plans with regard to the product.” But according to Neurim, “Recently, Neurim found itself under unprecedented attack in Europe which, surprisingly and of grave concern, is being driven by none other than Teva, in flagrant violation of its obligations under the agreement and trampling of its duties towards the party that put its faith and its property into it hands, with exclusivity. In September 2017, it became apparent to Neurim that Teva (through another company) had filed an application for approval of a generic version of Circadin.

Moreover, at this time, in the correspondence exchanged between Teva (through Teva Europe, which it controls) and Neurim, it became clear that Teva intends to launch a generic version of Circadin in Europe. There is no need to elaborate on the mortal injury that is expected to occur to Neurim if and when the generic product is launched by Teva during the patent period.”

“We’ll respond through legal channels”

Neurim also claims that since the revenues from sales of the product are invested in Neurim’s follow-up study, financing, among others, the development of a new product for treatment of Alzheimer’s and another sleep product for autistic children, the damage is not confined only to Neurim, but to general public interest as well. A statement of defense has not yet been filed.

Teva responded by saying, “Teva has not yet received the lawsuit. When it is received, the company will respond via legal channels.”