Switzerland’s La Roche AG has demanded a Vietnamese firm
to stop making Pegnano on allegations the hepatitis drug uses a compound
patented in Vietnam.
Roche has sent a letter to Ho Chi Minh City-based Nanogen Biopharmaceutical Ltd
Company, requesting the latter to stop producing, circulating and advertising
its Pegnano from December 30.
Pegnano is sourced from Peginterferon alfa 2a that the Swiss firm says is
patented in Vietnam.
According to the letter, interferon could not be made in Vietnam without their
permission as the compound is enjoying protection under patent No. 2611.
Granted in 2002 by the National Office of Intellectual Property of Vietnam, the
patent is effective till 2017.
Roche also demanded the drug to be de-registered at relevant authorities.
Sources told Tuoi Tre the Ministry of Health is forming an ad-hoc team today to
look into the problem.
Meanwhile, there are conflicting opinions on whether Pegnano should still be
made considering the Vietnam-made drug is much cheaper, helping fight monopoly
from Roche.
Legal vs ethical
Last September, Truong Quoc Cuong, head of the Drug Administration of Vietnam
under the Ministry of Health turned down Nanogen’s request to register and sell
its Pegnano after Roche protested.
But Cuong’s boss – deputy health minister Cao Minh Quang authorized the
registration.
The drug was then registered and put on sale two weeks ago.
Explaining why he approved the drug despite legal issues, Quang said Pegnano was
much cheaper than Roche’s brand name product.
Pegnano is sold for VND1.5 million-1.9 million per 180mcg (from US$77) while
Roche’s Pegasys is priced at VND4.3 million.
This will reduce monopoly [Roche’s], helping poor hepatitis patients, the deputy
minister elaborated.
Nanogen’s director Ho Nhan even maintained his company did not violate
intellectual laws.
According to article 7 of the Vietnamese Intellectual Property Law as revised in
2009, the government can ban or limit the exercise of intellectual rights in
cases where such rights harm national defense, welfare of the people or badly
affect other crucial national interests.
Pegnano is a special product encouraged by the government, Nhan added.
Support
Doctor Tran Tinh Hien, deputy director of the Hospital for Tropical Disease in
Ho Chi Minh City supported Pegnano, saying producing cheap generic drugs is
highly welcomed.
He cited success stories where Vietnam is able to make cheap drugs to cure
malaria and does not have to rely on brand name medication any more.
But the country is still relying on trademarked and expensive hepatitis drugs
that many cannot afford, Hien said.
Asked whether Vietnam should violate the law to help the poor, Hien said it was
“a very sensitive matter but we all must obey domestic and international laws”.

But according to him, several countries are ready to violate intellectual
property rights to have cheap HIV medicine.
Hoang Huu Doan, former director of the state-run Central Pharmaceutical Factory
No. 1, also backed up Pegnano, saying it helps fight drug monopoly.
Many countries are producing generic drugs at lower prices to replace
trademarked products, he added.
Pegnano is indicated for the treatment of HBeAg-positive or
HBeAg-negative-chronic hepatitis B in adult patients with compensated liver
disease and evidence of viral replication, increased ALT and liver inflammation.

It is also indicated for the treatment of chronic hepatitis C in adult patients
who are positive for serum HCV-RNA, including patients with compensated
cirrhosis and/or co-infected with clinically stable HIV.
Source: Tuoi Tre