Israel filed a NIS 340 million lawsuit against Teva for violating intellectual property rights

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by Ifi Reporter Category:Law May 11, 2022

The State of Israel, through the State Attorney's Office, filed a NIS 340 million lawsuit against the Teva District Court for violating the state's intellectual property rights due to non-payment of royalties from the sale of Copaxone preparation in its renewed version for multiple sclerosis.
The lawsuit was filed as part of the activities of the Civil Enforcement Unit of the State Attorney's Office, the Accountant General's Division of the Ministry of Finance and the Ministry of Health for the protection of state assets and rights, including intellectual property rights through civil law enforcement.

The lawsuit alleges that the drug Copaxone for multiple sclerosis was developed by the Weizmann Institute and that its marketing rights belong to Teva. The drug was given as a subcutaneous injection of the patient in a one-day dosing regimen of 20 mg. It was alleged that close to the expiration of the patents on the active substance, Teva launched the drug Copaxone in a new version of a 40 mg dosing regimen given three times a week. The new dosing regimen has significant benefits for patients, it improves patient response to treatment, reduces side effects and also has an improved safety profile. The new version of the drug has been approved by the FDA, has been a huge success and has been sold for an estimated billions of dollars. Teva has also registered worldwide patents protecting the drug's new dosage regimen.
Appropriate return for "use of public resources that brought nature a very large amount of revenue"
The State, represented by attorneys Osnat Dafna and Inbal Toaf from the Civil Enforcement Unit of the State Attorney's Office and attorneys Liad Wachstein and Amira Manglos from the firm of Yaad Wachstein & Co., claims in its lawsuit that And did not pay her royalties estimated at millions of shekels.
The lawsuit states that "the state has no choice but to take legal action against Teva in order to ensure that it receives adequate compensation for the use of a public resource that has brought Teva a very large amount of revenue."
The lawsuit alleges that the state believes that Copaxone's new product is based on pioneering and groundbreaking research conducted by Prof. Korczyn (former director of the neurology department at Ichilov Hospital) and Dr. Fletcher (director of the clinical service for diagnosis and research in multiple sclerosis at Assaf Harofeh Hospital). All rights in the product are vested in the state.At the state's stand, Teva relied on the study as proof of feasibility for the new dosing regimen, including patent applications it filed and as also determined in U.S. proceedings, even in support of an FDA request for approval of the new dosing regimen. The lawsuit alleges that Teva exploited the research products in the product, filed a patent application in its name and then abandoned the application, all behind the state's back and without reporting to the state or obtaining its consent and without paying the state royalties as required. It was alleged that for many years, Teva continued to conceal the state’s plunder of property rights, until the affair was revealed to the state by accident following a personal lawsuit filed by investigators against Teva in 2018.
According to the lawsuit, "Teva's actions are also a clear case of making wealth and not in a lawsuit because Teva received, not according to a legal right, a benefit of immense value - the products and knowledge resulting from the groundbreaking research of Prof. Korczyn and Dr. Fletcher Which were proof of the feasibility of the new dosing regimen which had significant medical benefits and allowed nature to maintain a few more years of exclusivity in a market valued at billions of dollars. Therefore, Teva must pay the creditor (the state) the value of the benefit derived in such cases from the payment of royalties on sales. "
In the statement of claim, the state asks the district court to order Teva to pay monetary compensation to the state, at this stage, in a rough estimate based only on conservative estimates of the amount of royalties and product sales, in the amount of NIS 340 million ($ 100 million), while the state retains its rights to The amount below in accordance with the reports and financial information that Teva will provide. A letter of defense has not yet been filed.
Teva stated that "this is a lawsuit that recycles baseless allegations made against it in the past, in a lawsuit pending since 2018. Teva will respond to their claims in the legal proceedings as usual."

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