Deputy Minister of Health Cao Minh Quang.

Switzerland’s La Roche AG has demanded a Vietnamese firm – HCM City City-based Nanogen Biopharmaceutical Ltd Company - stop making Pegnano based on allegations that the hepatitis drug uses a compound patented in Vietnam.

Pegnano is sourced from Peginterferon alfa 2a that the Swiss firm says is patented in Vietnam.

According to La Roche AG’s letter to Nanogen, interferon could not be made in Vietnam without their permission as the compound is protected under patent No. 2611. Granted in 2002 by the National Office of Intellectual Property of Vietnam, the patent is effective until 2017. Roche also demanded the drug to be deregistered at the offices of relevant authorities.

The Ministry of Health formed an ad-hoc team today to investigate the problem. Meanwhile, there are conflicting opinions on whether Pegnano should still be made considering the Vietnam-made drug is much cheaper and helps fight a possible monopoly of Roche products.

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 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 the chances of a monopoly and poor hepatitis patients, the deputy minister elaborated.

Nanogen’s director Ho Nhan said 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, the welfare of the people or badly affect other crucial national interests. Pegnano is a special product encouraged by the government, he said.

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 was able to make cheap drugs to cure malaria and did 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.

When 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 said.

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.

VNExpress talked with Deputy Minister Cao Minh Quang about this case:

Why did you grant registration number to Nanogen’s Pegnano while the chief of the Drug Administration of Vietnam protested?

As the Chair of the Drug Selection Council, I had two reasons to license this medicine.

Firstly, based on the current legal documents, the file meets criteria; it was evaluated by five groups of experts who are not employees of the Drug Administration of Vietnam; the producer committed to taking responsibility for intellectual property. Therefore, granting registration number for the medicine is legal.

Moreover, the producer was also able to prove the difference in the major chemical structure. So the two products are different.

Secondly, the Government and related ministries absolutely support the development of the local pharmaceutical industry. The price for locally-produced Pegnano is equivalent to one fourth of the imported product but its quality is just as good.

Do you think that Nanogen commits intellectual property violation?

During the licencing process, Roche has the right to protest. If it showed legal documents issued by the Intellectual Property Office or the court which proved Nanogen’s violation, the Ministry of Health would have considered the case and stopped licensing. But Roche has yet to prove Nanogen’s intellectual property violation.

Nanogen is a local firm, with foreign investment, which produces Pegnano medicine to treat hepatitis B and C.

Roche’s patent will be protected in Vietnam until 2017. On the other hand, what Roche doesn’t protect is important. There are many things being protected and for each of them and the producer has to pay a lot of money so Roche can’t protect everything.

Recently Roche lost a lawsuit, also with this drug, in Pakistan.

What do you think about the case in which a local company produces of one kind of medicine which is similar to an imported product?

The government’s policy is calling for foreign investment, especially investment in biology and specialized medicine production. In addition, realizing the Politburo’s Resolution, the Ministry of Health launched a campaign to call for Vietnamese people to use locally-produced medicines that meet international standards.

Therefore, the Health Ministry’s viewpoint is absolutely encouraging companies to produce medicine in Vietnam. They may be wholly foreign-owned, joint venture companies or even foreign individuals or organizations. However, the granting of registration numbers is based on the law and is done in a way that won’t “tie down our own legs”.

Though despite the disagreement from the Drug Administration of Vietnam, I still licensed three products of Nanogen.

In such disputes, how will state agencies deal with them?

Based on Article 14, Circular 22 on registration of medicines (issued on November 24 2009), businesses have to bear responsibility for intellectual property-related issues of their registered medicines and they have to make written commitment with relevant state agencies. In case disputes occur, the two sides have to cooperate with the Intellectual Property Office. The Ministry of Health is not responsible for dealing with intellectual property disputes.

Source: Tuoi Tre/VNE