Wednesday, December 17, 2008

Mint Baseless Reporting Continues

In last few days I received fair number of phone calls and emails from my readers and friends including couple of concerned Indian patent examiners commenting about Mint latest news that India has granted at least 10 patents in the past 12 months for what would appear to be mere modifications or new forms of known drugs and further cementing with inconsistency and lack of transparency in the functioning of Indian patent offices. Even some readers strongly pointed out that list of selective patents used by Mint is obtained from Patent Circle (see here and here) and more sadly accused Patent Circle for putting posts on granted patents in past and giving newspaper media ground for baseless reporting. I do accept that there had been instances where our posts are been negatively used by newspaper media but as an author I would like to clarify that our intention for carrying such posts was to send a constructive and positive message to our readers, particularly overseas readers which include foreign patent attorneys and pharmaceutical in-house counsels about Indian patent system and to remove misapprehension that Indian patent law do not merit incremental innovation. There are many newspaper journalists who not only used our post constructively but also doing a great job in building patent awareness.

In past Patent Circle exclusively brought in notice couple of patents issued to Cipla for new forms of known drugs, namely, esomeprazole and alendronate and accused Cipla of practicing double standards on patenting so-called trivial improvements. Our basis of raising fingers on such patents was our years of understanding and expertise in technical domain and Indian patent practice. Now coming back to Mint news, the reporter has accused the Indian Patent Office of oversighting Section 3 (d) of the Patents Act, 1970 and issuing patents for mere modifications or new forms of known drugs. The reporter’s allegation is based on selective 10 patents which include Cipla’s esomeprazole inclusion complex (IN219034) and alendronate monohydrate (IN219022) patents. The other patents are –

1. IN204325 titled “An eletriptan hydrobromide monohydrate and a process for the preparation of the same”

2. IN204343 titled “Polymorph of (2R, 3S, 4R, 5R, 8R,10R, 11R, 12S, 13S,14R)- 13- [[2,6-dideoxy-3-cmethyl-3-0-methyl-4-(-[(propylamino)methyl]-a-l- ribohexopryanosyl] -2-ethyl-3,4,10- trihydroxy-3,5,8,10,12,14 -hexamethyl -11- [[3,4,6-trideoxy-3-(dimethylamino)-b-D-xylohexopyranosyl] oxa]-1-oxa-6-azacycopentadecan-15-one diphosphate”

3. IN204126 titled “4-(Diarylmethyl)-1-piperazinyl derivatives”

4. IN204151 titled “Substituted oxazoles and thiazoles derivatives as HPPAR ALPHA Activators”

5. IN204158 titled “Imidazo Pyridine Derivatives which inhibit Gastric Acid Secretion”

6. IN202128 titled “Stable crystalline polymorph Form I of (-)-4-[4-[4-[4-[[(2R-cis)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-tri azol-1-ylmethyl)furan-3-yl]methoxy]phenyl]-1-piperazinyl]phenyl-2,4-dihydro -2-[(S)-1-ethyl-2(S)-hydroxylpropyl]-3H-1,2,4-triazol-3-one”

7. IN201649 titled “Novel succinate salt of O-desmethyl-venlafaxine”

8. IN201140 titled “Novel crystalline forms of a macrolide antibiotic CP-472,295”

Apart from four patents - IN219034 (esomeprazole inclusion complex), IN219022 (alendronate monosodium salt), IN204325 (eletriptan hydrobromide monohydrate) and IN201649 (Desvenlafaxine succinate salt) – which fortunately have drug substance generic name included in the title, the reporter seems to be not sure about what drug substances are covered by remaining six patents. In fact, the reporter seems to be not even sure whether such patents are related to human drugs or they relate to agro-chemicals/veterinary drugs. To identify such information one need to be more than an average organic chemist or patent specialist in chemistry (what the reporter referred to be so-called patent agent). For instance, IN201140 and IN204343 both issued to Pfizer are covering crystalline forms of anti-bacterial veterinary drug Tulathromycin marketed as Draxxin for the treatment of bovine respiratory disease (BRD) in cattle and swine respiratory disease in pigs. Obviously the reporter seems to be not aware of this fact because these two patent was not mentioned anywhere in public domain except one of them reported by Sandeep’s blog. I personally believe that efficacy requirement in Section 3(d) of the Patents Act, 1970 is restricted to efficacy intended for human subject not for pig, dog, cow and other animals. I hope the reporter is not weighing interests of human and pigs in same basket.

IN202128 covers polymorphic form of antifungal drug posaconazole. Remaining three patents – IN204126 issued to Sun Pharmaceutical industries Ltd. covers 4-(diarylmethyl)-1-piperazinyl derivatives having base structure similar to cetirizine, IN204151 issued to Glaxo covers substituted oxazoles and thiazoles derivatives, and IN204158 issued to AstraZeneca covers imidazo pyridine derivatives having base structure similar to structure disclosed in the US4920129 – are related to novel compounds. Obviously it is well known to a person skilled in the art that most of the new compound or group of compounds synthesized in a laboratory are chemically derived from some known chemical structure (basic chemistry concept) and by mere reading term ‘derivative’ in title or abstract of a patent no one (not even veteran chemist) would have concluded that these patents are mere derivative or modification of known substances. I am completely perplexed how a newspaper journalist came to such a conclusion, which even for me is a challenging task, and requires high-end research (not to forget complex structure search).

6 comments:

  1. Anonymous1:29 PM

    Dear Varun
    I am not agree with yu\our comments against Reporter. although I agree that he reported some news without any basic knowledge.I come to your own post in which you previously mentioned that how come Indian patent office grant such polymorph related patent . infact here you take double standard in view of polymorph patent/applications. efficcay is nowwhere related to human according to section 3 9d) of Indian patent act. if it is related to human they have to mentioned specificallly in act.

    Right now in IPAB efficacy is still in question and argument is going for same.

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  2. Dear Anonymous,

    I am unable to find where I have shown my biasness regarding polymorph patents. In fact, my post is against the reporter’s allegation that patents issued for mere modification or new forms of known drugs that also without knowing what exactly patents are covering and how they are been examined and finally issued by the Indian Patent Office. Making baseless allegation is very simple.

    As far as efficacy is concerned, you may be correct that it may not be restricted to human and may include pigs and dogs. But as far as my limited understanding is concerned regarding legislature history of section 3(d) and inclusion of term ‘efficacy’, it was included to safeguard public health policy and avoid ever-greening of drug patents. At least for me, public health does not extend to pigs and dogs.

    Regards,

    VC | Patent Circle

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  3. Patent Agent3:02 PM

    May be the next point Anonymous would like to make is section 3 (d) also includes pesticides which need to show efficacy in pests.

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  4. Patent Agent2:58 PM

    Anonymous - I do have some disagreement with Varun arguments but I strongly support his reasoning on efficacy. Whatever Mint reported cannot be excused, in fact they blatantly pointed fingers on functioning of the Indian patent office and that also without any valid ground.

    If Varun would haven’t written this post probably most would have relied on Mint reporting. Reporter should understand that online news media has no borders and is widely read in other countries. Such baseless news will only tarnish image and creditability of the Indian Patent Office and patent practitioners around the globe.

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  5. Hey Varun,

    I appriciate your efforts in disseminating your knowledge attained through time consuming researches and educating people like us.

    I suggest professionals to use this oppurtunity to learn and have constructive debates and not be a complete critic.

    Though, criticism is the DNA for every successful project, there has to be a level maintained, else all projects would have been just blue prints and no actions would have been taken.

    Of course in case of minor errors or uncomplete information, readers are always welcome to share their views and Varun will appreciate this I suppose. Am I correct Varun?

    Thanks

    Krishna

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  6. Thanks Krishna for your comments. Obviously Patent Circle managed to come this far due to constructive debates and constant comments from the readers. As you rightly suggested that our posts are efforts of experience and knowledge acquired by us over the years. We always appreciate our readers’ response to our posts and will always be grateful for their support to Patent Circle.

    ReplyDelete