
India Supreme Court rejects Novartis' right to patent new version of cancer drug - bonchibuji
http://www.foxnews.com/health/2013/04/01/india-supreme-court-rejects-novartis-right-to-patent-new-version-cancer-drug/
======
lawnchair_larry
Important context, and if you didn't RTFA:

India recognizes patents just like anywhere else. What they don't recognize is
when drug makers trivially re-formulate their drug upon patent expiration in
such a way that the old medicine cannot be made generically without also
infringing on the new patent. India called BS on that, and rightfully so. Now
millions of people in India don't have to die because even though a drug
company made several multiples on their investment already, billions in
exclusive profits per year still isn't enough.

Edited to add: This is informally called "Evergreening". I'm not an expert in
that field but you can read more at
<http://en.wikipedia.org/wiki/Evergreening> and linked sources.

In this case, they wanted to charge Indians $2600/month, and the generic is
$175/month. If you have this condition and do not take this drug, you die.

~~~
jkimmel
As an aside, the evergreening process has taken on frightening new faces in
recent years. Drugs have been repatented with the same formula for 'new'
purposes. Case in point is BiDil, an active ingredient repatented for race-
specific use in African-Americans without alteration to a previously patented
drug formula (the case of repatenting is in and of itself an interesting
study, many in the field contest the trials that validated the repatenting as
well as the concept of a race-specific drug, as there is no drug-relavent
biological basis for race.)

[1] -
[http://en.wikipedia.org/wiki/Isosorbide_dinitrate/hydralazin...](http://en.wikipedia.org/wiki/Isosorbide_dinitrate/hydralazine)
(BiDil)

[2] - <http://www.nejm.org/doi/full/10.1056/NEJMoa042934>

~~~
sseveran
If they paid for the clinical trial then there should be some sort of
protection for the person who paid. Otherwise it will be impossible to expand
what a drug is used for after the patent expires.

~~~
zosima
Doctors may just use the drug off-label. If the patient responds then they use
the drug, otherwise they try something else. A formal trial really helps very
little in these cases.

If a bunch of clinicians find that the drug is effective against the
condition, they can (as has happened so many times) make their own study to
popularize the usage.

Remember: The safety of the drug is not in question, just the efficiacy.

~~~
refurb
But how do physicians know it works if trials aren't run? You can't go by
anecdotal evidence.

Hell, look at the huge niacin trial that Merck ran. Doctors have been
prescribing it for 30 years and you know what? It doesn't help. Unless a
massive clinical trial was run, you'd never know whether it was worth
prescribing.

------
zaidf
Thank you, India.

Let me tell your my story. I am on a pill called Colchicine that I have to
take 3 times a day for life. The pill's formula is hundreds of years old and
would cost me pennies. That was until a company convinced FDA to ban the
generics and only allow its own brand. The same pill that used to cost 10
_cents_ now costs $5/pill to me here in the US. Meanwhile in India, it still
costs pennies.

I wish US would take a page from India.

~~~
MichaelGG
Interesting about Colchinine[1]. Apparently the FDA does 3-year exclusive
agreements with companies in exchange for conducting new clinical trials.

The idiotic thing here is that by raising the prices, it cost Medicare $49M
more a year for apparently a ~$100M investment into research.

I don't know why the government wouldn't fund it directly in this case. Or in
general, why they don't add a tax onto the drug in question and do the
research themselves. It seems like an odd, public-damaging way to go about
things.

[http://en.wikipedia.org/wiki/Colchicine#Marketing_exclusivit...](http://en.wikipedia.org/wiki/Colchicine#Marketing_exclusivity_in_the_United_States)

------
shabda
If a private company has the duty to maximise profits, shouldn't a sovereign
state have the duty to maximise the benefits to its citizens while fulfilling
its minimum international treaty obligations.

The cost of gleevec/year is $36,000. The average per capita income is
$1219[1]. If patented about 99% of people who need this drug can not afford
it. Why should any state keep 99% of its people away from a life saving drug,
if it doesn't have a legal obligation to do so.

Property rights are a means to an end. Even if all of Asia and Africa refused
to recognize Novartis patents, they would still have enough incentive to
continue developing cancer drugs.

1\. <http://en.wikipedia.org/wiki/Income_in_India>

~~~
kvb
Do you have a citation for that drug price (for Indians)? Another post cited a
price more than an order of magnitude lower.

~~~
bostonpete
The article says it costs about $2,600/month. Cheaper than $36,000/yr but not
by an order of magnitude.

~~~
mani27
This drug is expensive at $2600/month. A fresher software engineer salary in
IT company is about $500/month. Average Indian income is way low than that
possibly less then $100/month.

------
anuraj
To put this in perspective, Novartis Glivec is the beta crystalline form of
'imatinib mesylate' - an already known compound which went out of patent.
Novartis failed to establish that the new form has demonstrable efficacy over
non-crystalline form. As per section 3 (d) of Indian Patent Law designed to
prevent Evergreening - inventions that are mere "discovery" of a "new form" of
a "known substance" and do not result in increased efficacy of that substance
are not patentable. Indian patent law follows guidelines set forth by WTO
under TRIPS agreement. So Novartis has exhausted all their legal defences.
Novartis did not get even one favourable verdict in the entire legal battle
which played out in 3 different courts of law.

~~~
jostmey
Would the crystalline form even be a viable drug? Don't drugs have to be
soluble in order to circulate in the blood stream?

Is the beta cystalline form the same chemical formula as the soluble form?

~~~
anuraj
Beta crystalline form has the same chemical formula as the non-crystalline
form and is soluble.

------
refurb
Why drugs cost so much isn't really that hard to figure out.

Drugs cost a lot of money to develop. On average it costs somewhere between
$250M (for an orphan disease) to $1B (for a primary care drug). The problem is
that most drugs fail during development and when you take that into
consideration, it's typically over $1B to develop a drug.

Where does that money come from? Just like money for anything else, it comes
from the marketplace. People (not unlike readers of HN) take their money and
put it into investments that get them an optimal return. If you eliminate
patents, you eliminate the mechanism to get a return on R&D dollars invested.
No patent (or at least a mechanism to get a return on an R&D investment) and
you have no drug.

~~~
ascendantlogic
The issue here isn't getting a patent to cover the R&D costs, it's a case of
the patent expiring, the drug company reformulating the drug slightly and then
applying for a "new" patent on what amounts to a slightly modified version of
the previous drug.

~~~
refurb
No, that's not the issue here.

In India, the only patent you can get is the initial "composition of matter"
patent. These patents are typically obtained very early in the R&D process
(right after the drug is discovered).

For most drugs you can't just give the drug to a patient, it has to converted
to a salt (this is why most drugs have "hydrochloride" or "sulfate" after
their name). The right salt to use is usually determined a few years after the
drug is discovered. The company typically gets a patent on this as well.

Since India doesn't recognize patents other than novel "composition of matter"
patents, Bayer can't rely on their formulation patent to extend their market
exclusivity. The patent in question is NOT a new formulation, it's the
original formulation. The patent in question would only extend their market
exclusivity for a few years.

~~~
MichaelGG
I looked up the drug in question and apparently it was patented in 1993.
That's 20 years. Even if the second patent was filed in 2007 it's still quite
more than "a few years".

------
neya
Seriously? You want to start a company under the pretext of making humans'
lives better, but only worsen it for them?

I will justify my sentiments:

By worsening, I mean, nothing is terrible in life than knowing there is a
solution/cure to your problem, but you have to die just because you can't
afford it.

India is a developing country, even something as moderate as $100 is actually
a luxury for many people - Remember, we are talking about a country where
millions slog their lives to death for $0.01 to $0.5 per hour (even in call
centers, etc) and anything between $100-200 is NO JOKE for them.

Just don't put barriers to such things - Everybody has the same blood inside
them and has a right to live on this planet irrespective of having enough
money or not. You want money? Don't charge the peasants - Charge the R&D
departments of the billion dollar companies that want to sponsor you and
compete for fame. These peasants are already selling their blood (literally)
to make their both ends meet, and this should be the last thing they should
die to pay for - Their very own life.

~~~
alan_cx
Diet is a huge factor in quality and longevity in life. "Good" food is a lot
more expensive than processed horse muck. So even there a financial divide
exists. Unless we want to lean over to a more socialist way, that sort of
divide will always exist. Poor people will usually die before richer people,
mostly its down to food and water and sanitation, even fitness. I'd rather get
those things right first, then worry about funky cancer drugs. Might need less
cancer drugs if these things were addressed. Might need less drugs in general.

~~~
amalag
Not much money to be made in healthy foods, much more money to be made in
processed foods and cancer drugs. I don't think there is some grand conspiracy
and huge collusion. I just think the profit factor is so huge in giving people
crap foods. Then there is tons of money to be made selling them exotic drugs.
Healthy foods means someone cooks fresh vegetables a few minutes before you
eat it, can't store that in a warehouse.

~~~
rmc
There are many profitable businesses going after the healthy / natural food
market. You just need to change your business and marketing to go after that
segment.

Additionally it's not as simple as "you can't store that in a warehouse". If
you do the have the time to buy fresh vegetables (y'know every day or 2)and if
you don't have the time to make them, then you can't eat that form of diet.

------
slaxman
I believe this is where India has got it's patent system right. I am not a
lawyer, but as I understand it, the Patent Office (Controller General of
Patents Designs and Trademarks) rejects patents that are obvious and not a
genuine invention.

Furthermore, you can only patent a __process __not an idea or a product. This
was the key reason that you have so many generic alternatives for otherwise
patented medicines. The process encourages competition and its the consumer
who wins.

Perhaps this is something that US can learn from.

~~~
saurabhnanda
Didn't India introduce product patents quite some time back?

~~~
slaxman
They did. But I believe it's still somewhat a gray area. They are more in the
form of Geographical Patents (such as Darjeeling Tea)
[http://en.wikipedia.org/wiki/Indian_Patent_Office#Geographic...](http://en.wikipedia.org/wiki/Indian_Patent_Office#Geographical_Indications_tags)

------
nova
And this is why medical research should be directly funded by goverments,
exactly like they fund military research, the cost shared among the developed
nations, and directly throw away the patent system.

~~~
lake99
Throw the baby out with the bathwater? I speak from an Indian perspective.
Almost everything the government touches leads to crippling corruption.
Including the police force. I have colleagues from government-run research
centers, and I've heard enough stories from them to never wish to deal with
one.

~~~
nova
No. Research would still be done by private companies. But we would pay them
directly with money, instead of with an artificial monopoly. It's not free
market anyway.

These companies could focus on pure research, and leave manufacturing to
others. Their income would be more predictable too.

Cost could be shared among countries, proportional to their wealth. Research
is very expensive, but it's a fixed cost. No reason to reinvent the wheel
twice.

No more "convincing" doctors with "gifts" to use their products. No more money
wasted on publicity. No more fake studies to boost sales.

Effort could be aimed towards deadly, rare or specially awful diseases,
instead of profitable ones.

I guess patent lawyers would lose.

This system is far from perfect, as we know there is a lot of corruption in
getting government contracts. But I still think it would be an improvement on
what we have today. Medical research is already very difficult. No reason to
make things worse with an outdated, inefficient and sometimes just outright
evil funding mechanism.

------
hmottestad
Question remains, if they had gotten a new patent. Wouldn't the old version
still be open for the public?

~~~
div
I'm not a patent lawyer, but I fail to see why this would be the case.

If the old version was held by someone else, would it then also be open for
the public ?

As far as I can tell, patents pretty much stand on their own.

~~~
hmottestad
They were wanting a new patent for a slightly improved version of their drug.
They held the patent for the previous version which expired.

Since they were fighting so hard for a new patent, I was wondering if such a
patent would affect a generic drug made from the pervious version.

------
rajksarkar
“We certainly do not wish the law of patent… to develop on the lines where
there may be a vast gap between the coverage and the disclosure under the
patent; where the scope of the patent is determined not on the intrinsic worth
of the invention but by the artful drafting of its claims by skilful lawyers;
and where patents are traded as a commodity not for production and marketing
of the patented products but to search for someone who may be sued for
infringement of the patent.” said by Bench of Justices Aftab Alam and Ranjana
Desai.

Well! This says it all

------
samyak_bhuta
An hypothetical question is : Would Brian Drucker apply at
<https://www.microryza.com> ?

As I understand, all hue and cry from Novartis is - they have invested big in
R&D and yet not reaped reasonable returns. Also, they claim that this dents
their effort to come with better drugs in future as profitability is at stack
and such judgements are demotivating for any actual R&D to take place. Just
wondering with crowdfunding gaining acceptance would this be a relevant
argument ? What are real chances of getting a life saving drug as good as
Imatinib seeing light of the day. What are practical challenges ?

------
joonix
It might be worth mentioning that India has a large generic pharmaceutical
manufacturing industry. Many generics sold in the US and around the world are
manufactured in India.

------
ChuckMcM
I would love such a provision in US law for patents if it does not yet exist.
I'd hate to see someone patent linked lists where the "previous" node pointers
are at the top of the data structure and the "next" node pointers are at the
end. Or some other silly re-structuring.

------
salilpa
Bravo india Bravo. hope USA learn something from you

------
imran
Why would you patent a cancer drug?

~~~
InclinedPlane
Why haven't you, personally, dedicated your life to making cancer drugs?

The people that do so would rather like to be compensated for it. You may
think it's an imperfect system but until you personally start making cancer
drugs for the world for free maybe you should think a little deeper on the
subject.

~~~
dhimes
I only regret that I have but one vote to give for bringing this comment out
of the gray (apologies to Nathan Hale).

And, I would add: talent, on average, goes where the money is. We've seen it
in sports, and it's true in academic pursuits.

Plus, it takes a helluva lot of money to get these drugs to market. Nobody
gives that money to a company without a fair shot of getting it back. Hence,
for the time being anyway, patents are a requirement in that field.

~~~
ctoth
I would like to discuss this claim that it takes a lot of money to bring a
drug to market, and this is why drugs are currently so expensive.

This seems to be common wisdom in this thread, but I note an extreme lack of
actually cited sources, so I decided to go dig some up.

I remember reading a book in 2004 discussing what percentage of medical
industry profits went towards research and development, verses what percentage
went towards marketing. While I cannot recall the title (I have read thousands
of books since then), the idea did stick with me, and a bit of quick Googling
produced some results:

First, and perhaps most shocking: <http://www.bmj.com/content/345/bmj.e4348>

Here is a copy of this research without the paywall:
[http://www.pharmamyths.net/files/BMJ-
Innova_ARTICLE_8-11-12....](http://www.pharmamyths.net/files/BMJ-
Innova_ARTICLE_8-11-12.pdf)

According to the pop-sci summary of this article in the HufPo, what these
numbers translate to is that Pharma companies spend 19 times as much on self-
promotion as they do basic research:
[http://www.huffingtonpost.com/2012/08/09/pharmaceutical-
comp...](http://www.huffingtonpost.com/2012/08/09/pharmaceutical-companies-
marketing_n_1760380.html)

If you assert that drugs are so expensive because of the cost to develop them,
and yet I have demonstrated that the R&D budget is a small percentage of the
money which the drug companies are spending, do you withdraw your assertion?
Given the aforementioned lack of sources in this thread I somehow doubt it.

Ah: I found a review/summary of the book which originally sparked this
comment. It's The Truth About the Drug Companies, and is by Marcia Angell, the
first female editor of the New England Journal of Medicine. The review is
available at: [http://www.nybooks.com/articles/archives/2004/jul/15/the-
tru...](http://www.nybooks.com/articles/archives/2004/jul/15/the-truth-about-
the-drug-companies/?pagination=false)

More:
[http://www.slate.com/articles/business/the_customer/2011/03/...](http://www.slate.com/articles/business/the_customer/2011/03/the_makebelieve_billion.html)

~~~
refurb
The author of the article you posted, Donald Light, has done a pretty poor job
of supporting the numbers he has come up with.

If you want to see what drugs cost to develop, just ask the scientists who
develop them:
[http://pipeline.corante.com/archives/2012/08/09/getting_drug...](http://pipeline.corante.com/archives/2012/08/09/getting_drug_research_really_really_wrong.php)

His numbers don't even pass the sniff test. If you want to find out how much
it costs to develop a new drug, there is nothing stopping you from calling a
CRO and asking how much they charge for phase III trials (they are all in
competition, so they'll freely give you a quote).

The average cost for a phase III trial is approximately $15,000/pt/yr. 1000
patients is a pretty average size trial, so now you are at $15M for one trial
and the FDA requires at least two phase III trials.

And that's just the cost of phase III trials which doesn't include: phase I,
phase II, manufacturing, regulatory costs, etc. Donald Light's claim that
drugs cost $45M to develop is laughable and the could only come from someone
with no understanding of drug development.

~~~
ctoth
I am somewhat confused by the term "article you posted" in your comment. I had
believed that I had posted a variety of different articles from several
different sources, one of which was written by Marcia Angell, former editor of
the New England Journal of Medicine and presumably someone who knows how much
a drug costs to develop.

~~~
refurb
The article I was referring to was the BJM article.

Oh yes, I know all about Marcia Angell. She has been rallying against the
pharma industry for over a decade. The link I posted also goes into some of
the outrageous things she has said that are completely unsupportable.

Here is another article talking about Marcia:

[http://www.forbes.com/sites/johnlamattina/2012/12/14/marcia-...](http://www.forbes.com/sites/johnlamattina/2012/12/14/marcia-
angells-attacks-on-pharma-have-lost-all-credibility/)

Does pharma do bad things? Yes! But claiming there is a pharma conspiracy to
drive down "target" cholesterol levels so they can sell more drugs is
laughable. It ignores all the scientific evidence (most of it NOT from pharma
companies), much of it published in her the journal she works for.

------
bonchibuji
What's the legality (in US) for a Kickstarter model R&D and clinical trials
for new drugs?

------
aaron695
I you find this stuff interesting I found Bad Pharma an interesting read
(Random Review: <http://boingboing.net/2012/11/06/bad-pharma-account-o.html> )

They talk about tricks like mirror versions of a drug can then be patented
after the first drug expires. Then the company can push them over the
original, which is not necessarily bad, mirror versions can be better or
sometimes worse.

------
Daniel_Newby
I do not understand the hoopla. When the patent on the old version expires,
anybody can make it for pennies a day. An expensive new formulation hurts no
one, since they are free to huy the cheap one.

~~~
MichaelGG
First, sometimes they try to get a new patent that will cover some aspect of
the old process, too.

Secondly, a lot of effort goes into getting people on the newer formulation.
Look at Concerta versus Ritalin. Both are methylphenidate, but I've met
several people that think Concerta is a totally new drug and that "Ritalin
didn't work for me". I've even talked to doctors that thought they were
different chemicals. Not the drug company's fault, but it still "hurts
someone".

~~~
Daniel_Newby
Hurts? Immediate release methylphenidate has a half-life of 2-4 hours, while
Concerta has a duration of effect of 12 hours. Given the narrow therapeutic
window of methylphenidate and the harsh wthdrawal syndrome, they _are_
different drugs.

------
pinaceae
this is India playing with fire. and it is not about securing access to
important drugs to Indian patients - it is about boosting the native Indian
generic pharma industry. while India itself does not provide any significant
output in R&D spending in pharma.

so yeah, big pharma is evil and greedy, however no one else takes 1bn$ to try
out a new product and have it fail in front of the FDA - which is the usual
scenario, as most(!) new products get denied.

how many other industries out there need to PROVE that their products are not
only safe but also have an actual benefit? as this is HN, let's see all those
fancy task/email/collab/social apps _prove_ their usefulness in scientific
trials - and get denied if they fail to be better than notepad.

so yeah, awesome, let's kill pharma's business model without any alternative
in sight.

how about having generic makers pay a fixed % of their revenue into a R&D
fund? without it they are just leeching off.

~~~
product50
Read about evergreening first. The issue is not that India is denying some
novel invention - but a slightly modified version of an already expired
patent.

~~~
pinaceae
see, and this is why nerd-news is so frustrating. one article, plus one cool
term 'evergreening'. super, let's hit wikipedia and whoa i can spout internal
sounding knowledge.

problem being that here we have a larger pattern in india's behavior which is
not neatly laid out in a few linked articles. so no way to quickly read up on
it, you need to be in the industry or closely following it.

so yeah, evergreening, awesome. same with roche, bayer?

and in novartis case: you know that the original molecule was never patented
in india? india only started recognizing patents issued after the early 90s.
you know that novartis already gave away 95% of this particular product for
free in india? right?

this new item is a trainwreck, just like the pycon thing. problem that far
fewer people here will recognize that.

~~~
oneandoneis2
Oh, well, if your problem is that people are on India's side without the due
knowledge to make an informed opinion, how's this: I have a degree with
honours in Biochemistry, and I worked for Novartis for eight years in clinical
safety.Glivec was one of the drugs we handled all the reports for. I have no
axe to grind with Novartis, it's a good place to work and it'll be a long time
before I'm as well-off as a programmer as I was when I was working for them.

I'm of the opinion that India got it absolutely right.

~~~
jacquesm
Almost on par with:

<https://news.ycombinator.com/item?id=35079>

