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India Revokes Gsk Cancer Drug Patent In Latest Big Pharma Blow

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http://uk.reuters.com/article/2013/08/02/uk-india-gsk-idUKBRE9710BC20130802

India has revoked a patent granted to GlaxoSmithKline Plc (GSK.L) for its breast cancer drug Tykerb, a decision that follows a landmark India court ruling disallowing patents for incremental innovations that was a blow to global pharmaceutical giants.

However, India's Intellectual Property Appellate Board (IPAB) upheld a patent granted on the original compound, or active pharmaceutical ingredient, lapatinib, citing innovative merit. Tykerb is the salt form of lapatinib sold in India.

India's Supreme Court in April rejected a patent for Novartis AG's (NOVN.VX) cancer drug Glivec, saying it was an amended version of a known molecule called imatinib, setting the precedent for more such cases in the country.

India's latest move is a blow for GSK, which had cut prices of Tykerb by a third in the country as part of a flexible pricing programme designed to make key drugs more affordable in certain emerging markets.

As incremental innovations are part of big pharma business plans to keep the profits rolling in what next?

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As incremental innovations are part of big pharma business plans to keep the profits rolling in what next?

Things aren't quite that simple.

In both cases, the active molecule was discovered a number of years ago and patented. However, that compound was not itself useful as a drug.

For example, pure imatinib, , the active ingredient in glivec is not soluble so you can't get it into the body in a sensible way. It took several years of work to find a soluble crystal form (a particular salt of the imatinib amine) that would be absorbed into the body if taken as a pill.

The ruling in India is that salts of existing compounds are not patentable. The issue for Novartis is that their original imatinib patent has now expired.

This is a difficult decision and I don't know if it is the right one. However, I don't shed a tear for Novartis whose pricing policy for glivec was outrageous.

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Things aren't quite that simple.

In both cases, the active molecule was discovered a number of years ago and patented. However, that compound was not itself useful as a drug.

For example, pure imatinib, , the active ingredient in glivec is not soluble so you can't get it into the body in a sensible way. It took several years of work to find a soluble crystal form (a particular salt of the imatinib amine) that would be absorbed into the body if taken as a pill.

The ruling in India is that salts of existing compounds are not patentable. The issue for Novartis is that their original imatinib patent has now expired.

This is a difficult decision and I don't know if it is the right one. However, I don't shed a tear for Novartis whose pricing policy for glivec was outrageous.

Bottom line here is that if there are other molecules that could be turned into useful drugs in the same way no one is going to invest the time and effort in doing so (apart from the original patent holder) if they can't get the reward.

Edited by Gigantic Purple Slug

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Things aren't quite that simple.

In both cases, the active molecule was discovered a number of years ago and patented. However, that compound was not itself useful as a drug.

For example, pure imatinib, , the active ingredient in glivec is not soluble so you can't get it into the body in a sensible way. It took several years of work to find a soluble crystal form (a particular salt of the imatinib amine) that would be absorbed into the body if taken as a pill.

The ruling in India is that salts of existing compounds are not patentable. The issue for Novartis is that their original imatinib patent has now expired.

This is a difficult decision and I don't know if it is the right one. However, I don't shed a tear for Novartis whose pricing policy for glivec was outrageous.

Hmmm to increase solubility its really an absolute no brainer to convert to an amine or carboyxlate salt. So typically such a conversion is a very very small incremental advance, to the extent I would not give it the term innovation.

Unless there is something special about what they did?

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Bottom line here is that if there are other molecules that could be turned into useful drugs in the same way no one is going to invest the time and effort in doing so (apart from the original patent holder) if they can't get the reward.

The problem is is that big pharma is using this as a way to extend patents beyond all reasonableness. They make absolutely tiny changes that are obvious and not really innovative to known compounds, then patent to gain another two decades of exclusivity.

Patents need to be looked at on an individual basis but the ease with which they are handed out for the obvious needs to be reigned in.

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The problem is is that big pharma is using this as a way to extend patents beyond all reasonableness. They make absolutely tiny changes that are obvious and not really innovative to known compounds, then patent to gain another two decades of exclusivity.

Patents need to be looked at on an individual basis but the ease with which they are handed out for the obvious needs to be reigned in.

I used to work for the NHS in the early 1980`s...........

In those days the NHS told pharma company's what they would pay for drugs - they still made a profit

today pharma tells the NHS what they must pay - they make a HUGE profit

It really is time we went back to the 80`s otherwise soon some greedy pharma company will patent "sex"

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I recall a discussion with a generally erudite friend who argued, similar to what had happened to seemingly 'superior' Western industries (e.g IT and computer programming), that the presumed superiority and dominance of Western pharma companies would also in the not too distant future come under threat.

The main thrust of his argument was that, at present, high tech pharma is one of the areas of economic dominance the west holds over asia(?). But.....

The masses of asian science/technology students we have been educating here in the west and 'sharing' with them cutting edge science (let alone the vast masses of 'home grown' scientists!) will be the university professors of tomorrow. It's only a matter of time before we see a Chinese version of GSK, AstraZeneca, etc.

They will be able to develop cutting edge drugs as effiently and more cheaply than we can in the West - and still meet all the stringent Western safety standards.

It was this latter point he stated would likely be used for as long as possible to argue that Asian drugs arent as safe as Western drugs, etc - to justify protection of western business interests.

Bottom line: he wasn't convinced that buying shares in Western pharmas to be a 'safe' portion of ones portfolio was quite so assured longer term.

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Hmmm to increase solubility its really an absolute no brainer to convert to an amine or carboyxlate salt. So typically such a conversion is a very very small incremental advance, to the extent I would not give it the term innovation.

Unless there is something special about what they did?

Apparently, this was a big problem in this case. The only bioavailable form they found was a quasi-stable rhombic crystal form of a methanesulfonic acid salt. The stable crystal form of the same salt was apparently not absorbable (I don't know why) or absorbable only at a substantially greater dose.

Edited by ChumpusRex

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The problem is is that big pharma is using this as a way to extend patents beyond all reasonableness. They make absolutely tiny changes that are obvious and not really innovative to known compounds, then patent to gain another two decades of exclusivity.

Patents need to be looked at on an individual basis but the ease with which they are handed out for the obvious needs to be reigned in.

If it was so easy then the original discoverer of the molecule would have done it. Chumpus Rex gives the explanation.

My guess is (no evidence) that this new compound would have had to be run through trials of some significant expense and cost, not to mention the effort involved in producing and optimising the manufacturing process for the modifications.

Simple changes from a chemical perspective can be major changes from a pharmaceutical one. Pharmacy and chemistry are not the same.

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Apparently, this was a big problem in this case. The only bioavailable form they found was a quasi-stable rhombic crystal form of a methanesulfonic acid salt. The stable crystal form of the same salt was apparently not absorbable (I don't know why) or absorbable only at a substantially greater dose.

Hmm that doesn't make sense to me. When in solution the solid-phase crystal morphology won't matter. Unless it was somehow being transported as a solid???

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Hmm that doesn't make sense to me. When in solution the solid-phase crystal morphology won't matter. Unless it was somehow being transported as a solid???

Makes very little sense to me, but maybe it's related to being degraded in the stomach or intestine.

However, it's telling that none of the generic manufacturers have come up with an alternative preparation that works; with Novartis charging upwards of US$30 per tablet, and huge sales, there is a huge financial incentive to be able to sell a generic. The only generic formulations available are the same salt/crystal structure and they are only available in India for reasons of the patent.

Edited by ChumpusRex

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It's not necessarily a simple process to know what salt form or similarly co crystal is going to be your target when you start developing an Active Pharmaceutical Ingredient

Issues effecting the choice are stability of the molecule, bioavailability and drug delivery method.

If you are making an non injectable formulation, when you swallow the tablet you generally don't want extremely quick dissolution and high availability of the drug in your system but only for a short period of time. Many drugs only work in safe doses if you get a sustained therapeutic dose.

There are cancer therapies in development that are designed to be targeted, so the drug travels around your body but is only released in controlled areas of the body.

This is not an easy business and development is very costly. We have very good therapies that are cheap for a huge range of conditions now. Pharma companies need incentive to go for the serious illnesses where the total patient population is small.

Otherwise we are not going to get the range of cancer treatments and other gene therapies we need.

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