A major boost to cancer patients- Indian SC rules against swiss Novartis AG

[Mech]

Landmark verdict gives big boost to cancer patients
J. VENKATESAN

Supreme Court rejects Novartis’ plea for patent; green signal for cheaper generic drugs

In a ruling that will help patients continue to buy several life-saving medicines as generic drugs, the Supreme Court on Monday held that the modification of a well known cancer-fighting drug is not a patentable new invention.

The judgment allows suppliers to continue making generic copies of Swiss firm Novartis’ Glivec or Gleevec, which has been shown to fight chronic blood cancer effectively. While the Novartis drug costs more than Rs 1 lakh per month, with doctors often advising patients to take it lifelong, the generic equivalents cost less than one-tenth. The ruling would be a relief to some 300,000 patients in India currently taking the drug.

Observers say that the Court’s judgment sets a precedent against the practice of “evergreening” — a strategy through which drug manufacturers introduce modifications of drugs to extend the five-year patents on them. They say that other “evergreening” patent applications could be rejected citing this judgment, helping to keep many life-saving drugs out of the patent regime and pushing down costs.

Glivec is the brand name of Imatinib. Novartis had applied for a patent for a modification of this drug, a “beta crystalline” salt form of Imatinib Mesylate or IM, which it said could be better absorbed by the body – by up to 30% more. After its patent application was rejected by the Patent office, Novartis moved the Intellectual Property Board, Chennai. The Board rejected the claim, but gave certain findings favourable to the company. Instead of filing an appeal before the Madras High Court, Novartis moved the Supreme Court.

A Bench of Supreme Court Justices Aftab Alam and Ranjana Desai said: “We firmly reject the appellant’s case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann [original] patent.”

The Bench said that the patent application contains a “clear and unambiguous averment” that all the therapeutic qualities of the modified form, for which the patent was applied, “are possessed” by the original version.

The court held that patents can be granted only for medicines that are truly new and innovative. For new forms and new uses of existing medicines, patent applicants should prove improved efficacy.

The court said that the Patents (Amendment) Act, 2005 established that the “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not an invention — for the purpose of patenting. The Bench also dismissed the argument that the modified form had better “solubility”, saying the “efficacy” of this property over its predecessor chemical is not established.

Landmark verdict gives big boost to cancer patients - The Hindu

 

[Markus]

This move will benefit millions of poor Indians requiring cancer treatment.

 

[sms]

It'a real boost. I suppourt it!!

e.g. tablate/ capsule with Imatinib sold in range of USD350~550 per bottle wheres as Indian companies can do it < 50$.
Most patient need 4~6 bottles a month. It wil be unaffordable for most people in India or south asia.

We must not let these companies loot and play with innocent people's lives

 

[Mech]

End of R&D

&#8216;Ecosystem to encourage innovation does not exist here'

Novartis will not invest in research and development (R&D) in India as the ecosystem to encourage innovation does not exist here, the company has said.

The pharma major, which was denied a patent for its anti-cancer drug Glivec by the Supreme Court on Monday, said that while it would continue to invest in R&D globally, it hoped to get the right environment to do so here.

&#8220;No global player has invested in R&D here, and, it is unlikely to happen given the atmosphere here,&#8221; Ranjit Shahani, Vice Chairman and Managing Director of Novartis India told reporters here.

&#8220;India is a developing country and needs to encourage innovation. The verdict is not very encouraging and shows that the ecosystem to encourage innovation does not exist here. If investments have to flow into R&D, the ecosystem has to be right,&#8221; Mr. Shahani said adding that the ruling was a setback to patients and would hinder medical progress.

Patented products constitute a very small percentage of drugs sold in India and Indian companies such as Cipla and Natco Pharma make generic versions of Glivec and sell it at a fraction of the price sold by Novartis.


&#8220;We brought this case because we strongly believe that patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. We have to test the system all the time. The issue is not about Glivec. We will not stop the supply of medicines to India. More than 9 out of 10 patients currently taking Glivec in India will continue to get the drug free through Novartis Oncology Access programmes. There are 1,200 oncologists in India in cities mainly and they know about the access programme,&#8221; he said. :

Novartis&#8217; shares on the Bombay Stock Exchange opened at Rs. 599 and moved to a high of Rs. 604.8. However, after the news of the judgement came in, the stock moved to a 14-month low of Rs. 558.1 before recovering smartly to close at Rs. 587.95.

End of R&D - The Hindu

 

[INDIAISM]

This move will benefit millions of poor Indians requiring cancer treatment.

Forget about Poor Indian this will help upper middle class Indian as well....Gleevec Drug cost upto $70,000{around 37 Lacs in INR}
and Indian Genetic version cost around $2500 {around 1.25 Lacs in INR}..

This move will benefit millions of poor Indians requiring cancer treatment.

Forget about Poor Indian this will help upper middle class Indian as well....Gleevec Drug cost upto $70,000{around 37 Lacs in INR}
and Indian Genetic version cost around $2500 {around 1.25 Lacs in INR}..

 

[Mech]

Forget about Poor Indian this will help upper middle class Indian as well....Gleevec Drug cost upto $70,000{around 37 Lacs in INR}
and Indian Genetic version cost around $2500 {around 1.25 Lacs in INR}..


Forget about Poor Indian this will help upper middle class Indian as well....Gleevec Drug cost upto $70,000{around 37 Lacs in INR}
and Indian Genetic version cost around $2500 {around 1.25 Lacs in INR}..

Indian version costs INR10,000 Novartis version costs around 1.2 lakh INR

 

[Abu Zolfiqar]

Actually it is a good move and it will benefit society as a whole

R&D is through the Roof with these pharmaceutical companies but at the same time they make a hell of a profit so it's good that affordable generic drugs can be provided by other companies to the public. Important they are set apart from the nefarious fake pharmaceutical industry which plagues the region

 

[sms]

“We brought this case because we strongly believe that patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. We have to test the system all the time. The issue is not about Glivec. We will not stop the supply of medicines to India. More than 9 out of 10 patients currently taking Glivec in India will continue to get the drug free through Novartis Oncology Access programmes. There are 1,200 oncologists in India in cities mainly and they know about the access programme,” he said.

If they are distributing 90% of there production free of cost. Why do they need patent to not allowing others to make and deliver it at low cost?

It's simple, saying that ain't making them saint. Another Wolf in sheeps skin. First block other from producing drug and then sell at your own conditions/ price/ control availability blah blah... also, these center are used to test new drugs and patient visiting there are mere ginipigs.

 

[Desi Guy]

There is Nothing Magical about Indian Generic versionor about the Generic companies .Those generic Companies Just copied the drug chemistry and They do not have any Research and developmental funding put in the drug that they need to recover. and The Indians are somehow now boasting about how they are selling it at a low price. Novartis is absolutely with in bounds when they said the culture of innovation does not exist in India.Frankly One of reasons why I went abroad.

 

[Desi Guy]

Indian version costs INR10,000 Novartis version costs around 1.2 lakh INR

Cost of making the drug is the same .Novartis sells it at a higher price Because They need to recover the money they put in and to fund Future innovations in Pharmaceuticals. Indians generics do not have to do the same.

 

[sms]

Cost of making the drug is the same .Novartis sells it at a higher price Because They need to recover the money they put in and to fund Future innovations in Pharmaceuticals. Indians generics do not have to do the same.

They are can sell it every wher in world at higher price not in India. Additinally it's an existing salt nothing new!!

 

[Infinity]

Cost of making the drug is the same .Novartis sells it at a higher price Because They need to recover the money they put in and to fund Future innovations in Pharmaceuticals. Indians generics do not have to do the same.

Dude i repeat the question.................Why do Novartis sell some of their Patent Expired Products cheaper than there generic version in India...................

There is Nothing Magical about Indian Generic versionor about the Generic companies .Those generic Companies Just copied the drug chemistry and They do not have any Research and developmental funding put in the drug that they need to recover. and The Indians are somehow now boasting about how they are selling it at a low price. Novartis is absolutely with in bounds when they said the culture of innovation does not exist in India.Frankly One of reasons why I went abroad.

I think at present Brain Drain is almost Zero.................

 

[Desi Guy]

Dude i repeat the question.................Why do Novartis sell some of their Patent Expired Products cheaper than there generic version in India...................

I am sorry, I could not Understand your query. Generic drugs can be produced without patent infringement when the patent has expired. " Patent expired = Any Company can manufacture the drug with a license" and "Generic version = Version made by any company without a label" . Can you rephrase ?

 

[Infinity]

I am sorry, I could not Understand your query. Generic drugs can be produced without patent infringement when the patent has expired. " Patent expired = Any Company can manufacture the drug with a license" and "Generic version = Version made by any company without a label" . Can you rephrase ?

I am asking about Pricing...............How could Novartis price there product below Generic Version of a molecule in India..............That means they still have margin..............

 

[Beerbal]

This move will benefit millions of poor Indians requiring cancer treatment.

Not only Indian dude, Entire Human race .. India is major exporter of generic medicines. UN buy less costly medicines from India and distribute it world wide.