Ukraine's leading English-language newspaper since 1995

Permission not granted to produce Tamiflu generic.

As Ukraine scrambles to contain an escalating flu epidemic, pharmaceutical giant Roche has expressed “significant concerns” that a Ukrainian competitor could be violating international patent laws by launching production of a generic version of its Tamiflu medication, the most popular drug for treating patients infected with the A/H1N1 virus.

The brewing intellectual property rights dispute is over osteltamivir, the product name for Roche’s Tamiflu branded medication, which the World Health Organization recommends as an effective treatment option for the A/H1N1 swine flu strain.

Zdorovya, a Kharkiv-based pharmaceutical company, announced on Nov. 10 that it had produced its first lot of what it touted as “a 100 percent copy” of Tamiflu. Some 18, 000 packs of the drug have already been shipped to Ukraine’s Health Ministry and an additional 46, 000 packs will be distributed to hospitals in the Kharkiv Oblast.

Roche spokeswoman Martina Rupp told the Kyiv Post on Nov. 10 that the company has patent coverage for oseltamivir in Ukraine and has not provided permission “to this company [Zdorovya]” to produce a generic version of the drug.

“We have significant concerns that this company is reported to be using the name Tamivir. This is actually part of the generic name (oseltamivir) and is very close to the name Tamiflu,” Rupp said, adding: “Roche does have a valid granted product patent for Tamiflu in Ukraine, not just for the brand name.”

Zdorovya marketing director Dennis Spizhevoy told the Kyiv Post on Nov. 10 that the plant had an agreement with Roche to manufacture oseltamivir. But he retracted the assertion the next day, saying the company “is seeking clarification” with state authorities in Kyiv.

Spizhevoy’s boss, Zdorovya Director Oleksandr Zdorovskiy, told the Kharkiv-based news agency Obyektyv the same day that his pharmaceutical plant spent around $80, 000 (Hr 650, 000) “importing ingredients” to make the drug, which the company plans to sell for $13-14 per pack. The ingredients came from Switzerland, he added.

By Nov. 12, the Kyiv Post had not received a response from Ukraine’s Health Ministry to a written request about clinical trials of Tamivir and its registration status in the country.

Stocking up on supplies of flu drugs has been a central concern for Ukraine’s government this fall.

The anti-viral drug most desired by Ukraine at the outset of the crisis in mid-October was oseltamivir. Ukraine’s government in early November arranged the delivery of 500, 000 packs of oseltamivir from Roche at the bargain price of $8 (Hr 67) per pack.

The $4 million deal was arranged under a special program advertised by Roche in July “as a pandemic insurance policy for developing countries.”

More than 200 Ukrainians have died and in excess of one million have fallen sick since Oct. 29 with sicknesses linked to seasonal flu and the A/H1N1 virus. First Deputy Health Minister Vasyl Lazoryshynets on Nov. 11 attributed 17 deaths to the A/H1N1 flu, also known as swine flu.

Prime Minister Yulia Tymoshenko on Nov. 10 said health officials expect the second and third waves of the flu epidemic to hit in January and March next year.

“I propose by that time to build up a stockpile of drugs available for the country’s hospitals. If we don’t need them, fine. Their shelf life is 17 years,” Tymoshenko said.

The California-based biopharmaceutical company Gilead Sciences licensed Roche to manufacture and sell oseltamivir in 1996. International patent rights for the drug are in force until 2016.