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Bayer loses patent in India test case

Germany’s pharmaceutical giant Bayer has made history by being the first firm ordered to give up control of a patented drug after an Indian court said its cancer drug Nexavar was too expensive.

Bayer loses patent in India test case
Photo: DPA

The drug, used to treat liver and kidney cancers, is currently sold at more than €4,000 (284,428 Rupees) for a month’s supply of 120 tablets – well beyond the financial reach of most Indian patients.

Generic drugs company Natco took Bayer through the Indian courts to win a license to produce cut-price copies of the drug. It said in a statement it would sell the drug at less than €134 (8880 Rupees) a month.

The Indian Patents Act rules that drugs unavailable at affordable prices must be compulsorily licensed after three years of patent approval, the Times of India newspaper reported on Tuesday.

Under the agreement, Natco will pay Bayer six percent royalties on sales, but Bayer is determined to continue fighting the decision if possible.

This was decided on Monday, a spokeswoman for Bayer confirmed to The Local. “We are very disappointed and will be checking out legal options,” she said.

Indian Patent Controller PH Kurian said Bayer had priced the drug “exorbitantly,” making it “out of reach” of most Indian patents.

The case will be watched carefully by other pharmaceutical firms keen to protect their patented drugs and the high prices they can demand for them.

Under the World Trade Organization’s TRIPS Agreement, which governs trade and intellectual property rules, compulsory licences are a legally recognised means to overcome barriers in accessing affordable medicines.

The decision was welcomed by Medecins Sans Frontieres (Doctors Without Borders), whose policy director Michelle Childs said it, “serves as a warning that when drug companies are price gouging and limiting availability, there is a consequence.”

The Local/AFP/hc

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INDIA

Travel: Spain imposes mandatory quarantine on arrivals from India over virus strain fears

Spain will make all travellers arriving from India undergo a 10-day quarantine to prevent the potential spread of the Asian country’s coronavirus variant within the Spanish territory.

Travel: Spain imposes mandatory quarantine on arrivals from India over virus strain fears
Photo: JACK GUEZ/AFP

Spanish government spokesperson María Jesús Montero made the announcement on Tuesday, explaining that as there are no direct flights between Spain and India, it isn’t possible for Spain to adopt measures such as banning arrivals outright as other European countries have done.

The quarantine requirement for travellers arriving to Spain from India starts on May 1st 2021.

India joins a number of South American and African nations that are already on Spain’s quarantine list to stem the spread of the Brazilian and South African variants. 

According to the Spanish government’s website, those “coming from the Federative Republic of Brazil, the Republic of South Africa, Republic of Botswana, Union of Comoros, Republic of Ghana, Republic of Kenya, Republic of Mozambique, United Republic of Tanzania, Republic of Zambia, Republic of Zimbabwe, Republic of Peru and Republic of Colombia, must remain in quarantine for 10 days after their arrival in Spain, or for the duration of their stay if it is shorter than that. This period may end earlier, if on the seventh day the person is tested for acute infection with negative results.”

India is currently battling a record-breaking rise in Covid-19 infections that has overwhelmed hospitals and led to severe bed and oxygen shortages.

A key question is whether a new variant with potentially worrying mutations – B.1.617 – is behind what is currently the world’s fastest-growing outbreak, setting four records in a row for the highest daily coronavirus infections by one country, the latest on Sunday with 349,691 new cases.

The country has also been recording around 3,000 deaths per day from Covid-19. 

Germany, France, the United Kingdom, Switzerland, the Czech Republic, Italy and the Netherlands have all imposed restrictions or travel bans on arrivals from India in recent days.

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“No cases of the Indian variant have been detected to date to my knowledge,” Spain’s Emergencies Coordinator Chief Fernando Simón told journalists on Monday. 

“The intel does not indicate that we have to worry about it,” he added, given that the UK variant now makes up 94 percent of all infections in Spain. 

“We cannot rule out that a case (of the Indian variant) may be detected”, Simón admitted, but “so far it is not a variant of concern, it is a variant of interest”.

Patients breath with the help of oxygen masks inside a banquet hall temporarily converted into a Covid-19 coronavirus ward in New Delhi on April 27th, 2021. (Photo by Money SHARMA / AFP)

That is not a view shared by Amós José García Rojas , president of the Spanish Association of Vaccinations (AEV), who argues “we have to worry a lot” about the “chaos” that this new variant is leaving in the Asian country and why it could affect the spread of this strain of the virus.

“This new variant is fundamentally worrying because of what it is causing in India,” Rojas told medical publication Redacción Médica. 

“It shows that as there are territories where people are largely not vaccinated, there’s many people who are susceptible to the virus and it creates a breeding ground for the development of new variants”.

“We cannot vaccinate comprehensively in some countries and forget about other countries at the mercy of God.

“We have to worry about everyone because there is a risk that situations like the one seen in India will happen again. 

So far, the B.1.617 variant has been categorised by the World Health Organisation as a “variant of interest”.

Other variants detected in Brazil, South Africa and the UK have been categorised as “of concern”, because they are more transmissible, virulent or might reduce antibody efficacy.

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