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
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).