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Bayer fights for cancer drug patent in India

The Local · 5 Mar 2013, 07:18

Published: 05 Mar 2013 07:18 GMT+01:00

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India's Intellectual Property Appellate Board has rejected an appeal by Bayer against the decision by a local patent authority to grant a license to generics manufacturer Natco Pharma, allowing it to copy Nexavar.

The patent authority allowed Natco to make copies of Nexavar on the grounds that Bayer's drug is too expensive for most people in India.

The license allows Natco to sell generic versions of the drug at a fraction of Bayer's price.

But Bayer said in a statement that it "strongly disagrees with the conclusions of the Intellectual Property Appellate Board."

"Bayer is committed to protecting its patents for Nexavar – and will rigorously continue to defend our intellectual property rights within the Indian legal system," said a company spokesman in an emailed statement.

"We will pursue the case in front of high court in Mumbai with a writ petition."

The challenges faced by the Indian healthcare system had "little or nothing to do with patents on pharmaceutical products as all products on India's essential drug list are not patented," Bayer said.

One of the main barriers to access to medicines in developing countries such as India was the lack of adequate healthcare services and infrastructure ensuring that drugs would effectively bring treatment to those who need it.

"The order of the Intellectual Property Appellate Board weakens the international patent system and endangers pharmaceutical research," Bayer argued.

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The limited period of marketing exclusivity made possible by patents ensures that the costs associated with the research and development of innovative medicines can be recovered, it said.

Bayer said it has a patient access programme in place in India for Nexavar, which "significantly reduces the cost of the monthly treatment."


The Local (news@thelocal.de)

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Your comments about this article

11:43 March 5, 2013 by wood artist
I'm not often a fan of drug companies. I understand the high costs of developing new medicines, and the potential liability involved, but sometimes their actions seem less than ethical, especially in the way they pressure doctors to prescribe their product line (within the US at least).

However, I'm really struggling with this decision, mainly because patent law shouldn't be held hostage to whether or not somebody thinks the resulting product is over-priced. India hardly has a health care system to brag about, with millions unable to access even the most basic care. That's also true in the US, but for very different reasons. I have no problem with them wanting to bargain with Bayer, just as health care providers do in other countries, but to simply decide they will ignore patent law because they happen to think the drug is too expensive seems a very shaky legal precedent, and it's likely to make other manufacturers thing twice about trying to do business in the country.

13:04 March 5, 2013 by vkfra
@wa: reg your comment abt patent law being held hostage & that this decision seems a shaky legal precedent - far from the truth, the Indian government has invoked a clause within the WTO rules (called Compulsory Licensing) related to life saving drugs. If these drugs are so overpriced as to be out of reach of the common man, then the government can force the patent holder to license the drug to generic manufacturers for a reasonable fee.

So it isn't the case where the patents are being ignored; instead, Bayer has repeatedly refused to lower the drug and is now forced to license it out to generic manufacturers in return for a fee (6% royalty). Bayer isn't getting totally shafted, they just won't make billions off the dying!
13:21 March 5, 2013 by ichbines
Three fourths of the world does not suffer from cancer because they eat a diet consisting of plant based whole foods. Drugs are not needed to cure cancer. It starts going away as soon as the victim stops eating (or seriously limits) whats causing it, that is meat and dairy. We do not even need cancer drugs. The China Study proved this beyond any doubt whatsoever.
14:01 March 5, 2013 by venkyfra
@ichbines, True. Greater percentage of cancer is due to bad diet. Sadly junk food is very popular in India. Value of nutrition is not known.

Also environmental toxin is on the rise. Almost all the water sources is polluted. Water scarcity is very high in many states. Air is also polluted. Hence food has very low nutritional value and they are treated with lot of chemicals.

Thanks to Monsanto soon India will have GMO seeds for almost every vegetable. Clinical trials of drugs on humans is on the rise. Last year 211 people died in first six months due to that. Poor dont have a clue what disease they are getting. Public healthcare is a joke.

So early death in India is not avoidable. Cancer will rise. It has risen at unbelievable percentage in last years.

Regarding Nexvar it costs 3974EUR. Only super rich in India can afford it. Dont know how many people need it. If Bayer wins the case those who need that medicine for survival will certainly die.
17:25 March 5, 2013 by hmmmmmm
Indian lawyer here, just sharing some perspective to everyone crying foul:

1) Indian patent law did not even permit product patents (as opposed to process patents) for drugs and pharmaceuticals until 2005. If you can manufacture the same medicine in a substantially different way, you could do it.

2) The reasoning being that when it comes essential commodities like medicine, the immediate public need for a country like India was to ensure that the general public has easy access to medicines and not to ensure that the inventor of the medicine was able to exploit (term exploit being used objectively and without value judgement) his invention sufficiently. Yes, innovation would be stifled but there is an immediate public need in India and this is not some patent for a car or computer or smartphone but one for medicine.

3) Its only in 2005 that product patents were permitted subject certain conditions one of which was compulsory licensing (Section 92A of the Patents Act, 1970). This was invoked in exceptional circumstances where the drug becomes absolutely unavailable to the general public due to exorbitant over-pricing.

4) The Novartis case mentioned in the article - their new application just got rejected for evergreening (industry practice of companies extending their patent monopolies by making fractionally different modifications of known compounds), which is prohibited in India. A new form of a known medicine can only be patented if it shows significantly improved therapeutic efficacy over existing compounds and the onus is on the patent applicant to demonstrate the improved therapeutic efficacy (Section 3(d) of the same Act).
18:18 March 5, 2013 by michael4096
I haven't looked at the numbers in this case, but in previous cases it has been clear that the 6% they get multiplied by the many millions more doses created means that it is even more profitable for the drugs company this way. They still fight the cases on principle - they don't want everybody dictating their own price. Which is a reasonable position until you take the many millions of suffering people into account.
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