Category Archives: Data Exclusivity

COVID-19 Data Exclusivity Innovation Patent

Patents for Pharmaceutical Innovation – Basic Concerns


Comparison of BRICS countries Public Health spending. Please contact author if you want breakdown of details

Covid 19 seems to have done what public health activists have been crying hoarse about for years – that is, shine a bright spotlight on the various inadequacies of the public health systems around the world, and its related issues. With several public calls for letting patent rights on pharmaceuticals take a back seat vis-a-vis this pandemic, this bright spotlight has also shone on those who’ve been lobbying for ever-restrictive patent rights on pharmaceuticals. For example, as KEI has pointed…


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COVID-19 Data Exclusivity Patent

CoViD-19 Pandemic Spurs Calls for ‘Openness’ in IP


Corona covid 19

The CoViD-19 pandemic may well be humanity’s biggest collective challenge in a post-globalisation era. In the midst of this global emergency, the artificial scarcity produced by international and domestic intellectual property laws and norms is revealing itself to be a scourge to public health systems around the world – from restraining drug research and development to denying access to medical devices. The responses of various stakeholders will certainly have an immediate impact on CoViD-19 related public health responses, but its…


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Copyright COVID-19 Data Exclusivity Innovation Others Patent

Corona and IP – Looking for the Right(s) Answers


Corona covid 19

The Covid 19 pandemic has now changed the way most of us are going about our day to day lives. In India, we are now on day 2 of our 21 day nation wide lock-down. In the midst of all that is going on now, Intellectual Property enthusiasts with a keen eye, would have noticed several IP related issues that have been cropping up, even if relatively under-discussed. For this current post, I thought I would do a round-up of…


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COVID-19 Data Exclusivity Patent

Patent Politics in the Time of Corona


3D medical depiction of coronavirus

The new coronavirus threat/scare seems to be increasing with every passing day. At the time of writing this, it is reported that there are 138,941 cases (of which 80,815 are in China), of which 70,727 have recovered, 57,317 in mild condition, 5,786 are serious, and 5,111 have died. India has 81 cases of which 4 have recovered and 1 person has died. The new Coronavirus, or COVID 19 as it is technically known is, is now the 7th known coronavirus (other…


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Competition Law Data Exclusivity Overlaps in IP Patent

Shogun Organics: Burden of Proof and Follow On Registrations


Shogun Organics Limited v. Gauri Hari and Others is a curious case concerning burden of proof and an apparent conflict between the Patents Act, 1970 and the Insecticides Act, 1968. Facts Shogun Organics Limited (plaintiff) filed a suit seeking a permanent injunction to restrain the defendants from infringing its process patent. The patent relates to the manufacturing of d-trans Allethrin (an active ingredient in mosquito repellants). Shogun had also obtained an ‘original’ registration for the manufacture of this product under the…


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Data Exclusivity Drug Regulation

Killing Me Softly: Of Data Exclusivity and Deadly Drugs!


In a recent post, Prashant took issue with the IPA’s contention that the Indian governments’ latest move to extend the moratorium for state drug regulatory approvals from 4 years to 10 years results in a long and damaging data exclusivity. Who is right? And who is wrong? Once one begins to trudge down this rabbit hole in search of answers, one realises that the alleged data exclusivity norm is the least of our worries. We have a far more deadly…


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Data Exclusivity Drug Regulation Patent

IPA Alleges that New Rule Change will Bring in a Data Exclusivity Regime – Here’s Why I Think it Does no Such Thing


In a report published yesterday in the Bombay edition of the Times of India it has been alleged that the government is proposing a rule change to the Drugs & Cosmetics Rules, 1945 to introduce:  “a form of ‘data exclusivity’, a provision which will potentially give protection to Big Pharma, thereby delaying generic competition and hence impacting access and affordability of drugs.” The source of this information as per the news report is D.G. Shah, the spokesperson of the Indian Pharmaceutical…


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Copyright Data Exclusivity Others Patent Trademark

Judging Judges: Reviewing Justice Singh’s IP Jurisprudence


In this guest post, Prashant Reddy reflects on the major decisions by Justice Manmohan Singh of the Delhi High Court in the field of intellectual property law and on the larger question of criteria for appointment of persons to the position of Chairperson of the Intellectual Property Appellate Board. Warning: Very long post ahead. Title: A review of Justice Manmohan Singh’s judgments Author: Prashant Reddy As reported by Shamnad recently, the grapevine has it that Justice Manmohan Singh of the…


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Data Exclusivity Drug Regulation Patent

Delhi HC Imposes Strict Conditions on the Sale of Biomedicines: Part 2/2


In part 1 of my analysis, I offered a brief summary of the Delhi High Court’s judgment imposing strict conditions on the sale of the biosimilar version of Roche’s breast cancer drug, Trastuzumab, by Biocon and Mylan. Before I delve into the findings of the single judge, I should point out that, as one of the commenters to my previous article noted, the decision has been stayed by a Division Bench and the matter is listed to be next heard…


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Data Exclusivity Drug Regulation Patent

Delhi HC Imposes Strict Conditions on the Sale of Biomedicines: Part 1/2


In an order that is likely to have wide-ranging ramifications on the biomedicine industry, the Delhi High Court on Monday (25th April) imposed some conditions on the sale of the biosimilar version of Roche’s breast cancer drug, Trastuzumab, by Biocon and Mylan. The decision, clocking in at 227 pages, discusses a number of profoundly important issues such as data exclusivity, patent linkage, norms to be followed for patient safety and the rights of patentees after the expiry of their patent….


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