Patent office rejects Abbott’s application on HIV drug


The Indian Patent office has rejected Abbott’s patent application on its heat-stable version of Lopinavir/Ritonavir drug ( sold under the brand name “Kaletra” ) on grounds including failure to satisfy inventive step. The rejection was in response to pre- grant oppositions filed by I-Mak , Cipla, Okasa Ltd and Matrix Lab Ltd.

The decision paves the way for access to life-saving medication for patients across the world, noted Tahir Amin, director of initiative for Medicines, Access & Knowledge (I-MAK), one of those who initiated legal action against the US company. The development sets an important precedent to stop pharmaceutical companies from gaming the patent system, I-MAK note added. A generic version of Lopinavir/Ritonavir is currently being produced in India for domestic consumption and exportation. As Abbott’s patent application has been denied, generic manufacturers can continue producing them.

Lopinavir/Ritonavir is one of the medications recommended by World Health Organization for second-line treatment in HIV-positive patients whose first set of medications can no longer keep them healthy. I-MAK points out that the medication is the subject of the greatest abuse of the patent system around the globe. Since 1992, when Abbott was awarded its first patent related to Ritonavir in the U.S., the company has sought at least 75 new patents on essentially the same set of drugs in Lopinavir/Ritonavir. Abbott has continued making minor modifications over the last two decades and cement its monopoly on these products. In a continuation of that strategy, Abbott tried to seek a new patent in India on the basis of a modification which adds no clinical benefit.

There are over 33 million people living with HIV today. Of these, nearly 15 million require access to HIV drugs, the note said. Further, it adds, cost-savings generated over a three-year period by introducing generic Lopinavir/Ritonavir to 43 low- and middle-income countries will be sufficient to cover 130,000 new patients on HIV treatment who currently lack access. In other words, 130,000 lives can be saved from opening up the market for this drug alone. 
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Mathews P. George

Mathews P. George

Mathews is a graduate of National University of Juridical Sciences, Kolkata. His interest in intellectual property was kindled when he bagged the second position in his very second year in the prestigious Nani Palkhiwala Essay Competition on Intellectual Property. Winner of almost a dozen essay competitions in his law school days, he was involved in various research and policy initiatives relating to intellectual property. His stint as a student of Prof. Shamnad Basheer further accentuated his interest in intellectual property.

30 comments.

  1. AvatarAnonymous

    I am very surprized with such a post on this blog. Most comments of the post look rather “anti-patent” and pro-generic. If patents were not available, generics would likely not exist as well, because no innovative company would invest the huge development costs of a new medicine, and there would be no regulatory file for such medicines which generic companies could rely upon.
    Making this comment, I am also not against generic companies and against cheap access to medicines, but most medicines, especially the important ones like for treating HIV, would just not exist if MNCs would not identify and develop them and therefore if patents would not be available. And patents are not always there to protect only breakthrough inventions, but also more minor inventions providing moderate improvements. Generic companies could also invest in research for finding such minor improvements, but they are just not doing it, waiting for the MNCs to do it for them. I do not know the details of this case, and if truely the Abbott invention did not have any additional effect over the prior art, then it should indeed not be awarded a patent. But that should not mean that patents are just a break to the development of medicines.

    Reply
  2. AvatarRajiv Kr. Choudhry

    Anonymous,

    The patent has been ruled to be invalid because it was not novel and was already known in the prior art. All applicants have to clear the hurdles of patentability and novelty and that includes the applications from MNCs.
    This blog is not anti-patent or pro-patent-it is about the development of Intellectual property law in India.

    Reply
  3. AvatarAnonymous

    Dear Anonymous,

    Please remember that comments come from readers, not Blog authors.

    As Rajiv noted, the aim of the blog is spreading information.

    Coming to your observation- there are readers from both- Innovator and generic side reading this blog and posting comments. I have had my share of comment ‘wars’ with other readers- but that cannot be imputed to the Blog Author.

    Finally, do read the decision. In any case, the real juice to note is that Abbott already has a child divisional filed from current (rejected) Application and also as has been noted elsewhere, Abbott will appeal this decision. This is not the end of the war for either sides… merely winning one stage/ battle.

    Freq. Anon.

    Reply
  4. AvatarAnonymous

    Dear SpicyIP Contributors,
    Thank you for your further comments. As a European Patent Attorney, I must say that I very much appreciate this blog for its contributions to the diffusion of Indian IP law developments. And this is precisely the reason why I felt the need to make this comment, because my impression is that this particular post was not really diffusing IP information but rather partisan view.
    Regards,
    Anonymous EPA

    Reply
  5. AvatarAnonymous

    This is a vvery positive step in the right direction,
    @ anonymous — May be Sir, You need to look over the fact the millions of lives in Africa can be saved now….

    which is invaluable and can not be measured by profit-loss statement of any company.

    Also, the patent was not rejected arbitrarily.

    Though, I would love to have Shamnaad’s feedback on the issue,

    Reply
  6. AvatarShamnad Basheer

    Dear All:

    As to whether or not this blog article is biased cannot be argued in the air, but must be penned down to specific decision and its analysis. May I please request the anonymous commentators who made this rabid allegation to stop being lazy, read the decision and then argue on the merits.

    If the IPO’s decn is a tenable one jurisprudentially, and all that the blog did was to endorse it, then anyone who labels the post as biased should take a crash course in English or if their time and finances do not permit, buy a dictionary at the very least.

    Now lets look very carefully at the central claim. It reads:

    “A pharmaceutical composition which comprises a solid dispersion of ritonavir and lopinavir in one or morepharmaceutically acceptable water-soluble polymers and one or
    more pharmaceutically acceptable surfactants, and said one or more pharmaceutically acceptable water-soluble polymers have a Tg of at least about 50oC, and iaid composition comprises from about 50 to about 85 % by weight of the total composition of said one or
    more pharmaceutically acceptable
    water-soluble polymers, and at least one of said one or more pharmaceutically acceptable surfactants has an HLB value of from about 4 to 10.”

    To crystallise the claim even further, it essentially comprises the comprises “a solid dispersion of ritonavir and lopinavir in one or more pharmaceutically acceptable water-soluble polymers AND one or
    more pharmaceutically acceptable surfactants”,where said “pharmaceutically acceptable surfactants has an HLB value of from about 4 to 10”.

    The former part of the claim (solid dispersion of R + L in water soluble polymer) is already comprised in the prior art (the ‘119 patent) and the IPO clearly recognises this. It is the latter part (the surfactant) which allegedly results in the “inventive” addition.

    The IPO rightly notes:

    “Thus the main difference of the instant invention from the prior art lies in the selection of
    surfactants with HLB value from 4-10. In view of above, the alleged invention resides in the selection
    of a suitable surfactant.

    Now for determining the inventive step, the question to be answered
    is whether the selection of surfactants of HLB values
    from 4-10, with ritonavir,
    lopinavir and 50-85% water soluble
    polymer in a solid dispersion
    is obvious to a person skilled in the art in view of the disclosures
    and teachings in cited prior art.

    The IPO then goes on to note the existence of US patent ‘528 which effectively discloses “the importance of selection of surfactant for preparation of solid formulations of protease inhibitors for oral use based on HLB value…from 2 to 18.”

    The combination of ‘119 (which anticipates first part of Abbot’s claim) and ‘528 (which anticipates the second part) is therefore obvious. I personally think this line of reasoning is not just tenable, but jurisprudentially quite sound. Of course, I have assumed the IPO’s evaluation of the prior art and what it comprises as accurate. If this is not so, then somebody with better knowledge of the prior art ought to argue that the IPO mischaracterised the prior art and its content. But that would be a far more nuanced debate, which some of our anon friends who claim bias are just too lazy to examine and argue on!

    Reply
  7. AvatarAnonymous

    Dear Mr. Basheer and all,
    I am sorry if I have hurted the sensibility of the Blog contributors, that was not my purpose. As indicated earlier, my purpose was to highlight the fact that, as regular reader of this blog, I would have been interested in the technical details of the case rather by partisan statements. Now, it seems that the partisan statements of the post may not be the ones of the author, but the ones of parties to the proceedings. The absence of quoting marks may have misled me to think that it may have been the authors comments. Anyhow, a balanced post (i.e. not partisan) would have also quoted Abbott’s comments of the decision, which they apparently made.
    Clearly, the post on this topic would, in my reader’s view, have been much more interesting if based on the legal analysis made by Mr. Basheer just above.
    As to my alleged laziness, I do not feel lazy at all, I am just too busy to read the details of this case, and this is why I so much appreciate this blog when it delivers analytical and critical posts of Indian decisions, as it does most of the time.
    My intention was just to possibly contribute to the high standard of this blog, which this post seemed to me deviating from. By the way, I appreciate that my comments have been accepted for publication, which illustrates the openness of the blog authors for criticism. I only wished this criticism to be constructive. You seem not to have percieved it that way. Be it.
    I wish a long life to SpicyIP and I am looking forward to read the next posts. I know that this is not an easy task, and I am grateful that certain people like the authors of this blog dedicate their time for this. please continue.

    Reply
  8. AvatarShamnad Basheer

    Dear Anon:

    I greatly appreciate the tenor of your response and for appreciating the pains that we put into blog posts. Thanks for taking the time out to comment—we naturally very much value critiques that help us improve our standards and be of more use to readers like you. Mathews is a very conscientious blog writer who devotes a lot of time to his posts: and I am glad you appreciate it. I very much look forward to your continued interaction…and please feel free to let us know when we slip up and to help us improve. Thanks.

    Reply
  9. AvatarFormulator

    Dear Shamnad,

    My message was getting a little long, so here is my summary:
    —————
    As a matter of fact, the IPO severely misunderstands the formulation art, and ignores what actually happens to formulation patents in other countries such as the US.

    The purpose of IP is to allow companies to make investments they otherwise could not make, the effect of these types of decisions and what India considers to be patentable severely limits Indian pharmaceutical R&D investment as a result. To think India correctly identifies these types of inventions as unpatentable is to ignore the immense amount of R&D (Abbott in this case) for a so called “Non-Inventive/Obvious” invention and to also ignore other countries such as Singapore that have pro-patent/business policies and have greater Pharma R&D investment than India.
    ————————

    I respectfully disagree with your and the IPO’s conclusion. Do you believe that if you invested immense resources and found a way to formulate the most difficult, complex API in the world, that the IPO would grant/validate the patent?

    I would really love to see an example if you have one of a formulation patent that held up. I’m not an expert in Indian Patent Law so I’m prepared to be wrong, but my understanding is that the IPO/Indian courts believe nothing inventive can possibly happen after the chemical structure is discovered. (They also failed section 3(d)) Frankly, this position is absurd when most of the work/resources in drug development come after the API is discovered and there is significant research activities to advance new molecules and the skill in the art. This work is sometimes not obvious and not easy, although it can be if the compound is stable and BCS 1 (that wasn’t the case in this decision I would add)

    When you read the decision, to believe that the surfactant is the only differentiation factor from the prior art severely misunderstands the art of formulation and you would have to ignore an immense amount of R&D that the company did despite the decision saying it was “Non-Inventive/Obvious”.

    If you believe that conclusion, then its important to remember that the patent didn’t claim the chemical structure, only a single formulation approach and if its that obvious to formulate, it would be very easy to design around. This is actually what almost always happens in the US, formulation patents are granted, but can usually be designed around to not infringe the formulation patents.

    Frankly, this approach to pharmaceutical patent law is good in the short run for India because it allows them to free load off other’s R&D investment, but before you agree with this view of patent law, I would advise you to take a look at other countries with Pro-Pharmaceutical Patent Laws, Singapore is one of the best examples. As a result of Singapore’s pro Patent and business growth policies, you see much more investment in Pharmaceutical R&D compared to India.

    If you still believe that India’s pharmaceutical patent policy is the right approach, then you should take a look at the discovery projects in Indian Pharmaceutical Companys. Having the patent laws that it does, India severely limits the ROI on any new molecule that targets regional diseases and even Indian companies won’t invest in those programs as a result.

    Thats the purpose of IP, allow companies to make investments they otherwise could not make, the effect of what India considers to be patentable severely limits Indian pharmaceutical R&D investment as a result.

    Reply
  10. AvatarAnonymous

    Dear Mr. Formulator,

    Without going into your tangent on Singapore, my request to you is “please read the decision”.

    Once you read the same, you will realise that there are a lot more angles/ nuances than merely stating that India does NOT give enough importance to formulation inventions. FYI… please read the recent SpicyIP post from Rajiv on the post grant opposition where the generic company was heavily criticised and the patent UPHELD.

    Coming back to the present case, here are some points that do not come up readily in this decision:
    a) Take time out and read the prior art cited by the Opponents on your own – as a formulator.
    b) IF this ‘invention’ was so critical, why did Abbott abandon this file in its home country – USA (do a PAIR search for the parent).
    c) Also, while the IPO has disagreed with the Opponents on 3(d) – so you should be happy here (unlike your comment above), I have my own take on the 3d angle here. FYI, this ‘break through’ development needs to be assessed in context of Abbott’s prior formulation – the soft gelatine capsule. For all the talk of patient benefit, its my humble submission that 3d should have been upheld here. Reason – the new ‘tablet’ dose form while reducing number of pills to be taken in a 24 hr period does NOT reduce the amount of Lopinavir or ritonavir to be given to the patient. So, prima facie, this is NOT enhanced efficacy – the tablet merely reduces the number of pills to be taken from 8 capsules per day to 6 tablets per day (or may be I am wrong here – 4 tablets now against 6 capsules earlier). BUT point to be noted – in pure drug terms, the absolute quantity of Lopinavir/ Ritonavir administered is SAME.

    I would love to have an off line debate with you on the merits of the decision in view of prior art. So, please do read the key prior art cited, the rationale of the decision and lets touch base again, soon.

    Regards,
    Freq. Anon.

    Reply
  11. AvatarAnonymous

    Dear Mr. Formulator,

    While I wait for the oppurtunity to discuss this case with you, off line, I wanted to clarify one point from my comment of yesterday:

    “please read the recent SpicyIP post from Rajiv on the post grant opposition where the generic company was heavily criticised and the patent ON THE TOLTERIDON FORMULATION WAS UPHELD.

    Freq. Anon.

    Reply
  12. AvatarAny Person

    Dear Formulator

    You raise two key points in your post.

    1. That in the case of the decision relating to Abbott’s patent, it would be a misunderstanding that the surfactants with an HLB value of 4-10 is the only difference from the prior art and that it is difficult to formulate BSC Class IV compounds.”

    2. That the purpose of patents is to allow companies to make investments in R&D and formulations take considerable R&D investment and enhance the skill in the art

    Given the length of my response Im going to reply in three different post.

    Point 1.

    a) The techniques for creating solid dispersions using water-soluble polymers, surfactants through melt extrusion techniques i.e spray drying, single screw extruders and twin screw extruders have been known for at least 30-40 years. Numerous examples exist in the field (too many to mention here) which show solid dispersions for BCS Class II and IV compounds using water-soluble polymers like polyvinylpyrrolidone (PVP) and/or polyehthyleneglycol (PEG) alongside surfactants and other excipients.

    Indeed, as suggested by the last poster Freq, Anon, there is a host of prior art that shows how to use PVPs, surfactants to create a matrix within which to disperse a poorly water soluble compound, (which ritonavir is). Indeed, there are around 4/5 Abbott patents pre-dating the current one that was showing the use of PVP and/or PEG to form a matrix and then to use surfactants. In fact there is literature from 1996 showing that Abbott had created a solid dispersion of ritonavir using PVP and surfactants in different ranges. This literature alone would be enough to show a case of obviousness.

    But as is the craft of patent attorneys, Abbott’s attorneys have carefully worded some of their earlier patents so that they can file follow on patents on closely related formulations or they simply have confused examiners with their arguments distinguishing one patent from the next. If you read the prior art WO 01/34119 you will see all that Abbott has done differently in this current patent that was refused is to remove the PEG element. The PVP used in the 119 patent achieves the same objective as in the current patent – to create an amorphous matrix. As mentioned in Shamnad’s post, the 528 patent (also Abbott) sets out the HLB values for surfactants to be used for solid dispersions in relation to protease inhibitors (like ritonavir/lopinavir). Abbott can also consider itself somewhat lucky that the Controller even required such specific art re HLB values considering that the use of different surfactants with HLB values in formulation techniques (including solid dispersions) is basic level formulation science taught in first year PharmD courses.

    Reply
  13. AvatarAny Person

    Continuing on point 1:

    There is another interesting tale to this case that has not been picked up on.

    The main problem Abbott was having in trying to get the solid dispersion for ritonavir and ritonavir/lopinavir has very little to do with the issue of which PVP or surfactant etc as claimed in the patent. General common knowledge in the field and Abbott’s own prior art shows that. What Abbott needed was a modern melt extrusion technology to do this (the older techniques not working so well). They found this technology through Knoll AG (one of BASF’s divisions, now called Soliq’s) called Meltrex – which Abbott bought in 2001/2. Meltrex is a an already patented technology and as described by BASF’s own literature and by one of the inventors in the current patent, Meltrex is able to ‘predict with a high level of confidence the probability of being able to produce a stable solid dispersion of an active ingredient in a polymer matrix’. In fact Abbott itself has stated in its own literature that it was the Meltrex technology that overcame the problem for making a solid dispersion of ritonavir and the co-formulation. Moreover, the promotional literature of Soliq’s says ‘meltrex is a technology that provides opportunities for patent protection and life cycle management’. This is bearing out as one can already see the next formulation strategies Abbott has planned for ritonavir/lopinavir with the patents they are filing.

    So in a nutshell, the whole issue of PVP selection, surfactants with a particular HLB – this all known. The question was the process, but this was not the claim of the patent and nor could it be as Meltrex is already patented. As Meltrex was already patented and known to solve the issues Abbott wanted to – where is the invention? And I don’t buy the argument that it was combining the meltrex with the PVP etc – BASF has hosts of literature telling you how to do this using meltrex with various PVPs and surfactants.

    Reply
  14. AvatarAny Person

    And on the 2nd point of R&D.

    I think your main gripe is that companies spend money on formulation R&D (though it is important to state that formulation stage R&D costs are not even close to that of finding new compounds or other upstream R&D) but don’t get patents for them in India. Not true, many formulation patents have been granted in India – albeit they may have been incorrectly granted, but I wont address that here.

    I sympathise and agree with the need that companies investing resources expect some reward for that investment. After all companies (including generics) need that reassurance to operate. But your argument of equating R&D spend with something being an invention and deserving a patent is flawed. Yes the common law justification for patents is built on an economic justification – but also one of invention. S3d aside (because this patent was not rejected on that ground) the patententability criteria, as is, requires that the claimed invention in a patent be new/have inventive step (non-obvious). These two principles are at conflict today as newer technologies (which are probably inventive and patentable in their own right) enable those in the art to easily predict properties of compounds, screen the most stable crystalline forms easily or as in the case here, create solid dispersion or other formulations using known and tried excipients like PVP, surfactants.

    The late Hugh Laddie (former Justice sitting on the Patents Court of the High Court in England ) raised this issue in a short essay ‘Patents – what’s invention got to do with it?’ As someone who heard many patent cases, he states that in many cases most things are obvious as per the current obviousness tests. So I think as someone who decries how unfairly the patent system (especially India’s) treat formulation patents, you should be asking yourself, isn’t it time the patent system was reformed? Isn’t it time we ask ourselves, perhaps the patent system no longer serves the incentive system companies need to make the investments because a number of patents are vulnerable to being found obvious or gamed. Isn’t it time the patent system caught up with the technologies that make the art of formulations and other genetic/drug screening disciplines more and more obvious? Perhaps the solution is to have an incentive system that says, look we know it’s not inventive, but we spent money and we need to have some reassurance for that. The problem is the pharmaceutical industry and the political economy can’t/won’t admit this. India has with s3d to some degree for now. Politicians and businesses run on the ticket of ‘innovation/inventions’ – just look at the new green patent economy talk. Until they do realise this there is always going to be this friction.

    Reply
  15. AvatarAny Person

    Point 2 and R&D:

    Point 2

    I think your main gripe is that companies spend money on formulation R&D (though it is important to state that formulation stage R&D costs are not even close to that of finding new compounds or tother upstream R&D) but don’t get patents for them in India. Not true, many formulation patents have been granted in India – albeit they may have been incorrectly granted, but I wont address that here.

    I sympathise and agree with the need that companies investing resources expect some reward for that investment. After all companies (including generics) need that reassurance to operate. But your argument of equating R&D spend with something being an invention and deserving a patent is flawed. Yes the common law justification for patents is built on an economic justification – but also one of invention. The patententability criteria, as is, requires that the claimed invention in a patent be new/have inventive step (non-obvious). These two principles are at conflict today as newer technologies (which are probably inventive and patented in their own right) enable those in the art to easily predict properties of compounds, screen the most stable crystalline forms easily or as in the case here, create solid dispersion or other formulations using known and tried excipients like PVP, surfactants.

    The late Hugh Laddie (former Justice sitting on the Patents Court of the High Court in England ) said it best in his short essay ‘Patents – what’s invention got to do with it?’ As someone who heard many patent cases, he states that in many cases most things are obvious as per the current obviousness tests. So I think as someone who decries how unfairly the patent system (especially India’s) treat formulation patents, you should be asking yourself, isn’t it time the patent system was reformed? Isn’t it time we ask ourselves, perhaps the patent system no longer serves the incentive system companies need to make the investments because a number of patents are vulnerable to being found obvious or gamed. Isn’t it time the patent system caught up with the technologies that make the art of formulations and other genetic/drug screening disciplines more and more obvious? Perhaps the solution is to have an incentive system that says, look we known it’s not inventive, but we spent money and we need to have some reassurance for that. The problem is the pharmaceutical industry and the political economy can’t/won’t admit this. India has with s3d to some degree for now. Politicians and businesses run on the ticket of ‘innovation/inventions’ – just look at the new green patent economy talk. Until they do realise this there is always going to be this friction.

    Reply
  16. AvatarAnonymous

    @any person: always easy to say anything obvious once it is well described and read from the literature. Despite continuous claims that polymorphs and formulations are obvious Indian companies themselves not able to even devise such obvious inventions and for that also rely on copying from others.

    Reply
  17. AvatarAny Person

    @ Anonymous:

    There’s a lot of ‘Anonymous” in here, but to Anonymous of the last post.

    “always easy to say anything obvious once it is well described and read from the literature”.

    Im afraid that’s how patent law (and human development generally) works under the current patentability tests. If the information is out there and lays out the path to a skilled person then it’s obvious. The so called originators benefit from the research and pathways created by others (making a lot of their work also obvious – you should perhaps look at the beginning of the life of new compounds to see that they all come from some other compound etc so a number of inventions even at that stage are incremental), as do generics. So you see it’s the nature of the beast and where we are at technologically today.

    As I said, maybe the pro-patent folk like yourself should look hard in the mirror and the very system you prop up and admit some things need to be changed. Things is its hard to admit as you have to confess things are not ‘inventive’, but you deserve a monopoly because you spent the money. It messes with the cosy profits and gaming of companies and lawyers, but it is what it is.

    And on your point of Indian companies not being able to formulate the ‘obvious inventions, but relying on copying. There’s a number of reasons for that, from budgets to personnel, education etc. Its all part of the development process just like the east asia tiger economies who now do things better than the so
    call ed originators at the time.

    But one of the key reasons is that ‘originators’ that hold/have rights to the upstream patent practice a ‘scorched earth policy’ – patenting every form and use so as to prevent competitors. So it becomes a bit like threading a needle for any other actor to come in or devise something that’s not infringing. In that sense patents hold back science. Yet despite that and originators often saying generics couldnt formulate a drug because it is too complex e.g heat stable kaletra, tamiflu to name a few – they time in time out do it. I’d have a bit more faith in the Indian generic’s if I were you as this is part of a development process that requires the right framework. The only copying India (China etc) should not be doing at this moment is copying the broken patent laws of the west.

    Reply
  18. Avataralso anonymous

    A fundamental point here, as “Any person” puts it, is that dedicating lots of resources (human, financial, etc) does not necessarily equate with “inventing.” The patent system is supposed to reward inventions. There are other mechanisms to compensate actors for their investments and expenses.

    Reply
  19. AvatarAnonymous

    @Any anonymous: Would be interested to know what are other mechanisms to compensate investments and expenses made in drug discovery and new drug development (importantly that must cover failures too)?

    Also, can’t understand why innovators stupidly focus around developing and bringing new drugs irrespective how effective or less effective they are to already known drugs. If they really mean bottom line then why not to focus generic business…generic businesses are blossoming like anything…be it in the United States or any least developing countries. I bet if they majorily focus on generics not only they will make astonishing bucks that also without risky investments 🙂 (learn from Teva) but also would be considered pro-patients companies 🙂

    It sound stupid to spend time, resource and money to bring second-line, third-line or effective drug agents when 99% of world pharma companies are not bothered solving ailments but focus to make money in the name of affordability and selling drugs whatever available in market (whether it can save life or not). Life and disease is not in your hand, God is there to take care. So MNCs stop crying and join the generic wagon.

    Reply
  20. AvatarShamnad Basheer

    if the interest in bio-generics is anything to go by, it would seem that even big pharma is looking at riding the generic bandwagon. also the mergers (ranbaxy daichi) would seem to indicate a good future generics strategy. the worlds that earlier collided have met now: and soon there will be collusion…resulting in fewer patent challenges…making it all the more imperative for the public to ward off bad pharma patents!

    Reply
  21. AvatarAnonymous

    @Shamnad: Bio-generics are different ball game…for that they do not need much generic hand because of various regulatory and technical hurdles. My comment is more focus to bioequivalents…once big innovators too join the bandwagon there would be nothing much left on patent side…because no innovation, no investment and no patent. It is pretty obvious innovators will never develop generics themselves and will surely contract manufacture to Indian generics (something similar what Pfizer did with Aurobindo, Claris, Strides). In short, once innovators join the generic bandwagon the argument of innovators not pro-patient will end and with that possibly investment in eradicating ailments too will end. Even big innovators are now realizing this fact better to invest in generics than in R&D. That is what we called BUSINESS.

    Reply
  22. AvatarShamnad Basheer

    you really think so? even after the US (under a very evolved Obama administration) decided to dole out 12 years of exclusivity to biologics? and even after witnessing all the potential high rents and monopoly profits the likes of amgen have commanded from single biologics? do you really think that big pharma will give up on this potential big fat heifer of an opportunity? i doubt it. and if they perchance do, i think it might do the world a lot of good. as it will then prevent us from relying on a reductionist health framework where the old adage “prevention is better than cure” is all but forgotten. when no drugs are available, people will perhaps turn to yoga, meditation and importantly try and prevent the disease itself. certainly a better state of affairs according to me. but we’re talking of the future. and crystal ball gazing is never an accurate art, barring for a lucky few such as an eight limbed Paul!

    Reply
  23. AvatarAnonymous

    Well said Shamnad! Then let us learn this way only! As far as biologics/follow-on is concerned I mean to say MNCs do not need Indian generic hand.

    Oh yes I do miss Paul baba!

    Reply
  24. AvatarAnonymous

    This issue has been on air for the past few months..I agree to the fact that patents should not be granted to the minor changes brought about in the existing applications or inventions. Mostly such issues arise because of lack of knowledge regarding patentability. Inventors should be well aware of the conditions and terms to be met in order to obtain a patent grant for their product. Recently i happened to come across an article titled “Request for Examination of a patent application – a mandatory requirement in India” which describes in detail about the need of request for examination of a patent application in India. Have a look at the mentioned article at “http://www.sinapseblog.com/2011/01/request-for-examination-of-patent.html”.

    Reply
  25. AvatarABBEY

    If you still believe that the policy of pharmaceutical patents in India is the right approach, then you should take a look at discovery projects in India Companys pharmaceuticals. Having patent laws it does, India is severely constrained the profitability of any new molecule that targets diseases in the region and even companies in India will not invest in the programs as a result.

    people searches

    Reply
  26. AvatarElectric fireplace inserts

    As European patent attorney I must say that I very much appreciate this blog for their contribution to the dissemination of the development of the law for the Indian IP. And this is exactly the reason why I felt the need to make this comment.

    Reply

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