Madhulika Vishwanathan

Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

Patent

Delhi high court grants temporary injunction against Cipla in Onbrez case; Cipla challenges order.


After Novartis sued Cipla alleging infringement of its Onbrez patents, in the latest salvo the Delhi high court has granted temp.injunction restraining  Cipla. The judgement can be accessed here.Earlier in November 2014, Cipla had launched a low cost generic version of Onbrez and petitioned to DIPP requesting them to revoke Novartis ‘patents. Cipla argued that chronic obstructive pulmonary disease has reached “epidemic” proportions and the Central Govt should exercise its powers under Section 92(3) (compulsory license under special circumstances of national emergency, extreme urgency)…


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Patent Trademark

Novartis sues Cipla over infringement of Onbrez patents: HC reserves judgement


Close on the heels of the health ministry’s statement regarding patent revocation, Novartis has sued Cipla for infringing patents covering Onbrez (Indacaterol-drug used to treat chronic obstructive pulmonary disease) and sought damages. Onbrez is protected by 5 patents in India – IN222346 (product patent- expiring in 2020); IN214320 (composition patent- expiring in 2021); IN230049, IN210047 and IN230312 (process patents- expiring in 2024). Earlier last month Cipla had launched a low cost generic version of Onbrez and petitioned to DIPP requesting…


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Patent

Govt refuses to entertain Cipla’s request for revocation of Novartis Onbrez patents


In a crucial turn of events, according to TOI, the health ministry stated that Cipla’s petition does not make a compelling case for revocation of Novartis’ Onbrez patents. As readers may remember last month Cipla had launched a low cost generic version of Novartis’ Indacetorol marketed under brand name Onbrez, a drug used to treat chronic obstructive pulmonary disease. Cipla had further petitioned to the DIPP and argued that chronic obstructive pulmonary disease has reached “epidemic” proportions and the Central…


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Patent

Roche -Cipla agree to disagree: Erlotinib patent dispute mediation fails


Looks like Cipla is the news again, this time around in the mediation arena! In an interesting development reported by TOI, Roche and Cipla have failed to reach an agreement over the Erlotinib patent dispute. Earlier around April this year, the Delhi High court had ordered Roche and Cipla to engage in mediation. The mediator submitted the failure report after discussions between the two parties failed to fructify. Even when the court ordered mediation, many were skeptical about the possibility…


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Others Patent

Spicy IP Halloween trivia :patents and the spirits


In the “spirit” of Halloween, SPICY IP brings to you – a post about the Ouija board and its patent history. Read on for an interesting anecdote about a skeptical US patent examiner asking the inventor to provide a “working model”. As a method of supposed communication with the spirit world, the Ouija board has both terrified and spooked a number of children and has been flogged to death as a plot vehicle in countless Hollywood horror flicks. Here’s where…


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Govt withdraws NPPA powers to cap prices of non-essential medicines in public interest


In a momentous development, earlier this week  the Government withdrew guidelines that enabled the National Pharmaceutical Pricing Authority (NPPA) exercise its powers to fix the prices of drugs that are not on the essential medicines list. It is pertinent to note that this withdrawal is prospective not retrospective; that is to say that this move will not reverse the price caps already placed. Brief recap of events: Last year around, May 2013 the Department of Pharmaceuticals (DOP) intervened and released…


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Patent

Quia timet injunction storm: Delhi HC grants injunction against Ranbaxy in Galvus (Vildagliptin) case


As the mint reports; in response to a quia timet suit filed by Novartis, the Delhi high court issued an order Restraining Ranbaxy from manufacturing and selling a generic version of Vildagliptin (Galvus). Interestingly the court observed the fact that Ranbaxy had applied for revocation of Novartis’ patent shows that the defendant (Ranbaxy) wants to launch the compound patented. Novartis was represented by senior advocate and former Solicitor General Gopal Subramanium and Ranbaxy was represented by senior advocate and former…


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Others

Guest Post: A tribute to Chris Ohly


As many of you may know by now, Chris Ohly passed away earlier last week. Shamnad has penned a touching obituary which can be accessed here. Chris Ohly was a fine lawyer and a leading IP litigator. His expertise on the Hatch Waxman act and Biologic Price Competition act was unparalleled. His contribution to IP will be deeply missed! As readers may recall Chris Ohly has authored several posts for Spicy IP some of which include US patent reform (AIA)…


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Patent

IPO issues revised draft guidelines for examination of pharmaceutical patents: A perspective


After finalizing guidelines for examining computer related, biotechnological and traditional knowledge patent applications, the Indian patent office released guidelines for examination of pharmaceutical patent applications. The pharmaceutical sector has always enjoyed an unusual prominence in debates about IP policy, and has always been the subject of national and international controversies. The original pharma patent examination guidelines (which can be accessed here) was open for public comments. Stakeholders met and discussed the guidelines extensively. Here stakeholders refer to a person interested…


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Drug Regulation

Delhi High court refuses to allow pharma industry’s plea seeking stay on NPPA price cap decision.


As readers would recall, earlier this month National Pharmaceutical Pricing Authority had capped the prices of 108 anti-diabetic and cardiovascular formulations, sending the pharma industry into a tizzy. I had blogged about it here. It was noted that the inter-brand price differentials for some drugs was as high as ₹360. Even after accounting for quality differences,huge inter-brand price variation is indicative of a severe market failure. The NPPA invoked powers vested with it under paragraph 19 of DPCO, 2013 according to which the…


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