For the half-year to 31 December 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Rebecca Gulbul, Lucas Michels and Marie-Andrée Weiss.

Regular round-ups of the previous week's blogposts are kindly compiled by Alberto Bellan.

Thursday, 9 May 2013

The IPKat in despair - What is to be done when senior courts don't understand novelty?


One of the privileges of being a blogger is the ability, from time to time, to rant.  This moggy doesn’t do this very often, and indeed tends to eschew the polemical most of his time.  If you want to know why, you will have to ask his therapist (psycatatrist, corrects Merpel).  But occasionally something happens that makes this Kat really rather annoyed, and today is one of those days.  “What”, feline ears hear readers cry “can it be that has disturbed the serenity of the usually irenic IPKat?  Well, it is the Indian Supreme Court Glivec decision, refusing the patent application directed to imatinib mesylate in beta crystalline form.

Since this decision was excellently reported by fellow feline Stefano Barazza, your humble servant did not look at the original decision until just now.  Previously his attention, and that of most commentators, focused on the Section 3(d) issues – that unique part of Indian patent law that declares:

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 or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

This Kat hates this section in its current form, as it is laden with conclusory terms such as “mere discovery” and “known efficacy”, but he is not opposed to the principle that inventive step in the case of derivatives of compounds known in the art should be rigorously examined.

But the section of the judgment that this Kat had previously overlooked and now has his blood boiling is that relating to novelty.

Imatinib per se was known from an earlier US patent number 5,521,184 (“Zimmermann”), which disclosed the compound and made it in free base form in example 21.  Zimmermann stated that the compounds claimed therein included their respective salts, and stated:
“Salt-forming groups in a compound of formula I are groups or radicals having basic or acidic properties. Compounds having at least one basic group or at least one basic radical, for example a free amino group, a pyrazinyl radical or a pyridyl radical, may form acid addition salts, for example with inorganic acids, such as hydrochloric acid, sulfuric acid or a phosphoric acid, or with suitable organic carboxylic or sulfonic acids…”
The claims to the compounds ended with the customary wording “or a pharmaceutically acceptable salt thereof.”

Now, the Supreme Court could have said that the effective list of available salts is limited and that therefore the mesylate is implicitly disclosed, even though not explicitly recited.  Instead, it went on to observe the following:
“It is, however, interesting to note that Gleevec, the drug was launched much earlier in the market, on the basis of the Zimmermann patent itself".
“In the patent information furnished in connection with the NDA as required under (US Code) 21 C.F.R. § 314.53, the active ingredient of the drug was stated as Imatinib Mesylate. The Drug Substance (active ingredient), Drug Product (composition/formulation) and method of use were declared to be covered by US Patent No. 5,521,184 (i.e. the Zimmermann patent). It was further declared that the United States Patent No. 5,521,184 covered the composition, formulation, and/or method of use of Imatinib Mesylate (STI571).” 
“After the grant of drug approval for Gleevec, on July 3, 2001, the appellant made a Patent Term Extension Application for the Zimmermann patent (US Patent No. 5,521,184) under 35 USC § 156(g)(1)(B), for extending the term of the patent for the time taken in the regulatory review for Gleevec. This application leaves no room for doubt that Imatinib Mesylate, marketed under the name Gleevec, was submitted for drug approval as covered by the Zimmermann patent.”

It was further noted that the corresponding European patent had been asserted against NATCO Pharma Ltd in relation to sales of “VEENAT 100 capsules, the active pharmaceutical ingredient of which was Imatinib Mesylate as claimed in the Zimmermann patent.”

After considering some further points, the Supreme Court concluded:
“In the face of the materials referred to above, we are completely unable to see how Imatinib Mesylate can be said to be a new product, having come into being through an “invention” that has a feature that involves technical advance over the existing knowledge and that would make the invention not obvious to a person skilled in the art. Imatinib Mesylate is all there in the Zimmermann patent. It is a known substance from the Zimmermann patent.”
It is completely unforgivable to conflate the issues of infringement and anticipation.  This Kat is appalled that a senior court has done this.  Understanding the difference between the two tests is fundamental to any grasp of patent law.

Not that counsel for Novartis did not do their best. 
“Mr. Andhyarujina and Mr. Gopal Subramanium, learned Senior Advocates appearing for the appellant, strenuously argued that the patent information furnished by the appellant before the US FDA, or its Patent Term Extension Application, or the legal notice given at its behest to NATCO Pharma Ltd. should not be construed to mean that Imatinib Mesylate was anticipated in the Zimmermann patent.”
They patiently explained (no doubt crying inwardly with frustration):
“The learned counsel further submitted that there was a difference between that which is covered and that which is disclosed. Imatinib Mesylate is covered by the Zimmermann patent but not disclosed therein.”
Quite right.  But the Supreme Court was having none of it.  On reading the following sections, the IPKat wanted to stab himself [claw himself?]:
“The submissions of Mr. Andhyarujina and Mr. Subramanium are based on making a distinction between the coverage or claim in a patent and the disclosure made therein. The submissions on behalf of the appellant can be summed up by saying that the boundary laid out by the claim for coverage is permissible to be much wider than the disclosure / enablement / teaching in a patent.” [no, they are based on applying the test for anticipation which is separate from and independent of the question of whether the claims of the prior patent might be infringed] 
“The dichotomy that is sought to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private individual in exchange of the invention being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents.” [no, it recognises that a patent is infringed if the features of the claim are reproduced.  The patent needs to teach those features.  It does not need to teach each and every unclaimed feature for every possible context in which the claimed invention might be put into practice.  Still less does it disclose all of those contexts for the purposes of assessing the novelty of later patent application.] 
“However, …. , we would like to say that in this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on 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.” [At this point the IPKat gives up.  It is nothing to do with “artful drafting of its claims by skilful lawyers” it is the basic operation of the concepts of disclosure and claimed subject matter.]
It is inevitable that senior courts are more generalist and less specialised in technical areas of the law such as patent law.  But how is one supposed to give deference to a decision that contains so many elementary howlers in the fundamental precepts of patent law?  This decision does no credit to the court that issued it.

The IPKat is not particularly quibbling with the conclusion of lack of patentability - this is not the issue, it is the reasoning used.  It would have been perfectly possible for the Supreme Court to deny the novelty of imatinib mesylate based on Zimmermann and its disclosure of "suitable organic ... sulfonic acids", perhaps coupled with the observation that mesylate is arguably a rather conventional pharmaceutical salt.  The issue of the patentability of the beta crystalline form could then have been analysed starting from a sound foundation. If the Supreme Court had done that, and not looked at irrelevant issues relating to the subsequent conduct of the applicant, then the judgment would have been many pages shorter and vastly more credible.  Then one may have disagreed with the conclusion, but it would have been hard to argue that it was a conclusion that a Court was entitled to reach.

Those who cautioned against drafting of the legislation for the European Unitary Patent and Unified Patents Court in a way that would render fundamental precepts of patent law open to review by the (non-specialist) CJEU will see in this decision what can happen when senior courts have insufficient fundamental experience of the field.  US commentators seeing the US Supreme Court conflate novelty and patent-ineligible subject matter, as in the Prometheus case last year, may feel that the US is not immune to judicial misunderstanding at high level either.  Observers of the oral argument in the Myriad case may have formed the same conclusion.  Surely the highest level courts of major jurisdictions can do better.

34 comments:

Anonymous said...

A little late to the party on this one. This is old news to us pharma attorneys. The Supreme Court just confirming the 'long-standing' (long being a relative term) interpretation of the law which was clearly laid out from the beginning.

Anonymous said...

I really enjoyed this article from Darreb and Im not sure what anonymous above is getting at.

The Section 3(d) issues were clearly laid out from the beginning but this is the first time I've come across the idea that India complete rejects the UK's Gernal Tire "Planting the flag" approach to novelty and believes that a granted patent claim automatically anticipates anything within its scope.

I agree with Darren that it makes no sense whatsoever- a broad patent in a new field would seemingly prevent patents for any future improvements.

Anonymous said...

Why on earth should India follow a UK case on anything?

Anonymous said...

Section 3(d) is a novelty provision as far as pharmaceutical inventions are concerned. Need to read more than the section of the act.

Rahul said...

great post, Darren ! Finally, I got to read a reasoned argument against the verdict. Here, in India, the decision has been peddled as "in the benefit of public" or "the novartis drug was costly, now more access". And I am pretty much sure, the access is going to remain same, patent or no patent.

Anyhow, you provided a clinical analysis hitherto missing from the landscape. And I also fear that US SC will reject patentability of genes without giving any sound arguments.

Anonymous said...

Not that unusual really. Just today I've responded to an EPO office action where the Examiner argued that a feature was implicitly disclosed in prior art and therefore novelty destroying.

In my view, the purpose of s3(d) of the Indian Patent Act is precisely to qualify such implicit disclosures.

HM

Darren Smyth said...

Several comments above, particularly Anonymous 1, 4 and 6, do not seem to have appreciated that what my post sought to criticize is the novelty analysis BEFORE the Section 3(d) analysis was carried out. The comments that I refer to have nothing to do with Section 3(d). If this is not sufficiently clear from the post, I would like to emphasize the point now.

Anonymous said...

I think it is fair to say that the court took a holistic approach to the assessment of patentability. We cannot deny them this right simply because we have developed our novelty provisions so far down the road that it becomes counter-intuitive to many. As the court says:
"To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents.” A desire not to allow their law to develop where this gap is huge is reasonable in my view.

If a patent discloses (for example) a list of specific compounds (say 10) and a statement that they may be in the form of a salt. Preferred salts being selected from a list (say 10), then who is to say that a patentability analysis must come under the novelty provision as opposed to obviousness?

The real issue here is the 3(d) point.

Anonymous said...

Concerning HM's post, I have no problems with implicit disclosures being potentially novelty destroying. If the following of the teaching of a prior art document automatically leads to the creation of the claimed product, even if this is not explicitly mentioned in the description of the prior art, the claim lacks novelty in my opinion. It is similar to the "Russian beer bottle" case where a claim to a bootle shape having a particular mathmatical formula was granted because the formula was not in the prior art but bottles complying with the formula were well known.

In the Indian case, if the evidence was that the skilled person would understand "pharmaceutically acceptable salt" to be in fact a reference to the Mesylate, then I would agree on a lack of novelty. Whether that is what the evidence showed is another matter.

Anonymous said...

I was taught that novelty is a yes/no question: is the subject matter disclosed in the document or not?

As soon as you start bringing in anything else then you're in the realm of inventive step.

Am I wrong?

Anonymous said...

Darren,

That distinction is clear from your post.

What I've tried to say that the issues are perhaps not as unconnected. Although s3(d) relates to patent-eligibility, it's purpose is to essentially qualifies novelty for 'known substance' in 'new form'. Therefore it is not entirely divorced from novelty.

Refusals based on implicit disclosures are not that uncommon and are often made by the specialist examiners at the EPO. They are very annoying and are at best inventive step objections in disguise.

I agree that the Indian Supreme Court is confusing 'enabling disclose' and 'disclosure as prior art'.

Anonymous Six
(AKA HM)

Darren Smyth said...

As I said in my post "the Supreme Court could have said that the effective list of available salts is limited and that therefore the mesylate is implicitly disclosed, even though not explicitly recited". Then I would not have had a problem. instead, it said "because you said that your patent would be infringed by the mesylate, therefore the patent discloses the mesylate". So what is being confused is infringement of the patent and disclosure of the patent document. And Novartis explained this very well, but this was dismissed in the judgment with some apparent contempt. This is where I have a problem.

Rahul said...

HM said - "Although s3(d) relates to patent-eligibility, it's purpose is to essentially qualifies novelty for 'known substance' in 'new form'. Therefore it is not entirely divorced from novelty"

IPAB,in their decision to this patent app, disagreed. They found that Section 3d evaluates "inventive step" requirement and not novelty. IMHO, Supreme Court has, in fact, combined both (novelty and inventive step) while interpreting Section 3d.

Was the compound "explicitly" disclosed in Zimmerman?
Was it obvious to make it from reading the spec?

The above two questions, as Darrell pointed out, have been answered largely on basis of the "conduct" of the applicant with regards to regulatory filing. The court has strayed from applying legal principles and has, in fact, used irrelevant events as "incriminating" evidence. Moreover, have SC seen the quality data of the drug that was submitted to US FDA? Did they first submit quality data for Imatinib and later on submitted for Imatinib Mesylate (on finding better response from this salt)? I do not think so. So, the court even erred in applying this "evidence" properly, they concluded that since the patent was cited in a regulatory filing, the regulatory filing only contained the data pertaining to that application. Please note that though Hatch Waxman requires innovators to submit patent data to FDA, it does not allow FDA to evaluate whether the patents submitted to them under an NDA actually claims the molecule. It is for courts to decide. FDA has no jurisdiction. Indian Supreme Court has therefore, "heavily" erred in concluding this particular event as a supporting evidence.

Rahul said...

Also consider this argument by SC in their judgment -

NATCO was served legal notice by Novartis in the UK citing this zimmerman patent againt the sale of VEENAT. It was settled out of court.

Now, if i look at this para objectively - I would conclude either of two things

1. that Novartis "believed" Veenat infringed Zimmerman Patent
2. Since it was settled out of court amicably, NATCO too "believed" so.

Indian SC only took first thought into consideration and neglected the second one.

And in my opinion, both thoughts are trash. Since, this was "believed" by both the parties, not proven as a matter of fact by any court in the UK.

So, the SC even erred while establishing this as evidence that zimmerman patent anticipated Mesylate.

A wholesome look to judgment will tell you how it has erred by upholding "beliefs" while completely undermining facts.

mahi said...

Main issue/objection in decision was section 3d and efficacy..if you understand the whole matter behind this case. Section 3(d) of the Act is nothing but a requirement of higher standard of inventive step in the law particularly for the drug/pharmaceutical substances. It is an additional layer of protection above inventive step to prevent frivolous/trival inventions to get patented in India.

And the whole issue revolved around section 3d, IPAB has already admitted that concern invention satisfies the novelty and inventive step criteria. But Appelant didnot overcome the 3d objection. They have not shown any "efficacy" data of "New form" ie. Beta form of imatinib mesylate against "known form" ie imatinib mesyalte, which was already known, not necessarily only from Zimmermann patent but also from other publications!!

Simply if your New form of known substance in not efficacious then why should you get the patent for the trival/frivolous invention, at least in India.....leave the other things that also in some extent influenced this decision.

Anonymous from India said...

Agreed with Rahul on certain points. The court did look at quality data, Rahul, but you are right on the fact that FDA doesn't evaluate whether a submitted patent actually covers the investigational molecules. It wd be decided by a court, when a generic player files Para 4 application and a litigation ensues.

And yeah, the UK settlement too does not "prove" that zimmerman patent covered mesylate.

I have one more observation. How good or better etc. it is to use regulatory filings by a company as anticipating document? May be SC has used it to prove the "belief" of Novartis but looking at it, turns out that regulatory filings have been used as sort of "prosecution history estoppel". Can regulatory filing history be used in courts to establish claim boundaries? India, waives off, submission under regulatory filing as anticipating reference.

Many inconsistencies indeed in the judgment. Thanks for the writing post !

Anonymous said...

It still all comes back to section 3(d). It is the Act which confuses novelty with obviousness in order to make many pharmaceutical inventions patentable. I presume everyone has read statement:

"“Explanation:- For the purposes of this clause, salts, esters,
ethers, polymorphs, metabolites, pure form, particle size,
isomers, mixtures of isomers, complexes, combinations and
other derivatives of known substance shall be considered to
be the same substance, unless they differ significantly in
properties with regard to efficacy”."

Anonymous said...

...or rather, I should have said 'unpatentable'.

rahul said...

Thanks for correcting me, Anonymous from India.

B Prashant Kumar said...

Dear Derren,

I disagree with you as far as your stand on disclosure vs. coverage.

Logically speaking, if the Claims cover the salts but do not teach, clearly means that eitehr those salts are known in the market or can be made or cause to be known in by the 'experts' or the 'person skilled in such art'. If such salt (as n instant case) is not possible to be made, or couldn't be foreseen, it should not have been claimed at all.

The Hon'ble Supreme Court of India was correct in its observation that its not the 'expertise/skill of lawyers drafting the claims' so as to provide 'broadest possible protection', rather the possible teaching or enablement should be checked on the anvil of 'obviousness'.

So lets leave the Business and Capitalism out of this Judgment and welcome it, atleast with the perspective of India, and applaud it for still being within the bounds of TRIPS, for not creating any violations of any International Obligation.

Regards,
Prashant!

Darren Smyth said...

Dear Prashant,

Thank you very much for commenting, but I am afraid that I cannot agree with you. What you say "logically speaking" simply does not follow. As a matter of logic is is absolutely not the case that everything that infringes the claims is taught by the patent, or otherwise the claim is invalid.

And now you have muddied the water even further by conflating into the mix the question of enablement. The imatinib patent could, for example, have been infringed by a complex controlled-release formulation of imatinib that the patent did not remotely enable (or teach), and it need not have been well known by experts. There is no requirement that a patent enable (or teach) every feature of its infringement. What it has to enable is its invention, which in this case is the "imatinib". As soon as you conflate different aspects of patent law things begin to go very wrong.

So I am sorry but I maintain my position.

Anonymous said...

Prashant, I'd rather congratulate India for being such a successful parasite that contributes nothing to the advancement of science, healthcare or peace, while proving that capitalism can be more profitable for the few who falsely espouse a desire to care for the weak and the poor. Such hypocrisy cannot possibly be surpassed.

B Prashant Kumar said...

Dear Derren,

I agree when you say that everything that infringes the claims can not be taught by the patent, but then comes the need of evaluating the circumstantial evidences to check whether 'it was the drafting skills which led to the wordings of the claim' and that
was the salt (imatinib) actually known to the proprietors and thus should be anticipated in light of claims and the other documents, which I think the Hon'ble Supreme Court did correctly.

I agree that every feature of its infringement cannot be enabled by by the Patent but with respect to Claims, if it doesnt cover all the possible features of infringement, it would obviously be of no use. And also, as far as my understangin goes, when in the Claim, one writes a possible salt which can be made, and try to broaded his/her scope, he/she invariably hints or informs the users/readers that such salt can be either made or there are high chances that he/she knows that it exists, which can be and which should be checked by looking the circumstantial evidences and if not for infringement, but can definitely by used for ascertaining novelty of later products. At the end, its the evergreening of patents that Section 3(d) wants to prevent and I think, this strategy works perfectly to do so.

In any case, you agree that the Court could have rather said 'mesylate is arguably a rather conventional pharmaceutical salt' and if it would have been observed in this lines, probably the outcome would have been the same.

So lets settle the discussion, kudoing the decision, especially for its contribution in giving a rest to the controversy towards the scope and effect of Section 3(d) atleast to some extent. I may not be completely correct in my understanding of the difference between coverage and disclosure, but I am sure that the mesylate salt of imanitib was not novel in light of Zimmerman patent any which way.

I sincerly admire your analysis and its free world, so everyone is allowed to take his stand.

Regards,
Prashant!

B Prashant Kumar said...

On a much separate note to @Anon-20.38:

Let's better not go into the socialist-capitalist dichtomy or I would have to remind you that more than the number of call centers are there in India catering your capitalist greeds, are the number of Scientists, Doctors and Engineers leading the way in you top research institutes and your best of companies. And please dont even bother to raise the topic of Peace because that is something which we would never be able to achieve, Yes I say that, TILL the day your capitalist economies stop injecting funds into elements to breed the real parasites, behaving like the Queen Bee.. Whether its the protests against Nuclear Plants in India, or the Naxals armed with sophisticated weapons. Saying your two-faced capitalist 'peace loving' countries have nothing to do with these things is as hard to believe as saying Pyramids of Egypt was made by just Human Beings. The fear of a internally stable India, taking bolder and powerful strides in the International Arena is the last thing your capitalist economies would want.
Go and contribute to world peace.. Don't you small oil rich poor nations to conquer!!

Anonymous said...

Prashent,
you misunderstand greatly. I have no problem with India being a selfish, capitalist, war-mongering, self-centred, egotistical, racist, discriminatory, un-innovative, copying country. It's just the Indian hypocrisy that gets my goat.

As for Indian call-centres, they are world class at fobbing people off with nonsense and lies and having absolutely no respect for customer information, which they happily sell to their criminal cousins for a few Rupees.

Hope I've cleared up that little misunderstanding.

As for your skills in analysis of patent law it is fair to say that it is of the quality I expect.

B Prashant Kumar said...

@Anon-17.45:

Thanks for your 'kind' words (which though looks like honest admission about yourself, sic!) and for making me realize 'again' that its waste of time to even talk to people who do not even have guts to speak without even identifying him/herself.

And yes, lets not talk about privacy or deception here.. specially when you know (yet avoid) facts like this!

Have a Good Anonymous Life!

Pushp said...

being Anonymous and blaming culture that annon dont understand is easy.. You should use words which suits to intellectual person.

Anonymous said...

I can only know facts like 'this' if 'this' actually meant anything. Maybe you could cut and paste the content from the link - or to to put it in words the Indian Supreme Court would understand - "copy it directly but deny the originality in what you copy".

The 'anonymous commenter' criticisms are always a sign of a failed argument on IPkat, and unsurprisingly, for one who lauds the decisions of the Indian patent courts, wholly unoriginal.

An old Indian friend of mine shares this conundrum every now and then: "Did Xerox invent the copier or was it an Indian? If it was an Indian, then who did they copy it from?"

Anonymous said...

Who does more to provide access to medicine: The generic company from India who charge $1 per dose per day to someone who earns $1 per day (Congo average) or the evil Western multinational pharma company who charges $10 to someone who earns $120 per day (USA average)?

Answers on a postcard please.

Anon (blue chip pharma employee who is too ashamed to admit he works for an evil regime that develops drugs to treat the sick when his non-anonymous friends are busy making an honest living developing more cancerous tobacco products or mugging little old ladies)

Anonymous said...

"PushP" link = "Profile not available". Ahhhh the sweet smell of hypocrisy.

Anonymous said...

India: The future? I sincerley hope not.


http://features.blogs.fortune.cnn.com/2013/05/15/ranbaxy-fraud-lipitor/

Rahul said...

" but I am sure that the mesylate salt of imanitib was not novel in light of Zimmerman patent any which way" said Prashant

That is a conclusive statement, it is not an argument. Further, you have already said you may not understand coverage and disclosure, so your conclusion has no merit. But yeah free world, lets hold onto our respective opinions. And it will not be wholly false to say that SC may well have been driven by socialist landscape and backdrop of India in giving the judgment.

And as to "perspective of India", have reasons to believe that accessibility of drugs to patients in our country will always be questionable, patents or no patents. In pre-TRIPS era, when there were no product patents, I would like to see how many Indians has access to drugs. I am confident that access was much lower than today. The pre=product patent era, only helped some cronies of India's socialist government and helped them to make huge profits. In that, I totally agree with the Anonymous - that the hypocrisy of India- does piss me off.

Rahul

Anonymous said...

I'm sure Rahul doesn't agree with all of my anonymous comments but on the pharma and patent front we may be on the same side. As with all attacks, my anti-Indian comments are targeted at a specific minority. I know there are many who are unimpressed by their country's IP laws. I also know there are many many millions of ordinary Indians living in absolute poverty and many who work extremely hard to make a living.

The problem is obviously the usual controlling majority.

Rahul said...

To Anonymous

Being an Indian, I cannot be as acerbic as you are in criticising Indian policies lest I run the risk of being told to get out of India by the "peace-loving" Indians. But I do share the sentiment that India as a nation has been let down by hypocrisy of her own people,who refuse to answer difficult questions, who refuse to give stage to acerbic criticism, who sweep harsh criticism under the carpet, who strangulate free speech, who refuse to interpret laws in purely legal spirit, where court judgments are so driven by controls from outside. And therefore, India is neither a socialist state which has universal healthcare nor it is capitalist where everyone has private health insurance. It is a crony capitalist state, those who can game the system, those who can tweak laws and those who can successfully relate their shameless activities of copying innovations to their ""cause of helping poor, while minting millions of dollars" - More than 50% revenue of top Indian pharma companies is from the US.


As with regards to patent laws, Indian patent law are heavily interpreted in a very different landscape. Every challenge to every patent has at least one argument, this one - it is excessively priced, it gives monopoly to the applicant. But courts do not put such arguments in trash bins and say that "patents are meant to give monopolies only,how can you challenge that basis only?" But no - we will go round and round and round, make million excuses, write long judgments, conflate infringement with novelty, want infringing patent to be infringing only is it discloses to enable the infringing party come up with infringement. No Indian company would have EVERY thought of Imatinib mesylate, let alone its beta crystalline form, if there were no Imatinib known to them. This is the depths we have plumbed to - shamelessly projecting our feats of copying innovations as "invented by us". And if Indian pharma companies are to loathe to patents, why do they themselves file patents? They should altogether discard patent system, put their processes, systems, methods, best modes out in the public for all to benefit. But they will not do so. And we all know why. They too want to secure their little incremental advances but want to game the system for breaking monopolies of path breaking inventions.

In current case too, initially I was of the opinion that the Indian SC has given a great judgment, totally in spirit of the laws, avoiding pitfalls like too expensive for public/monopoly etc; but reading between the lines of the certain paragraphs of the judgment, are fading these initial impressions.

Rahul

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