Category Archives: Drug Regulation

Drug Regulation Others Patent

Reliance Life Sciences Scores Minor Victory in Continuing Litigation over Trastuzumab Biosimilars

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An appeals bench of the Delhi High Court finally heard and disposed, last month, an appeal filed by Reliance Life Sciences in 2016, against an order that Justice Manmohan Singh had delivered in a lawsuit filed by Genentech. Since this is a strange case, it is necessary to recap the origins of this lawsuit. Around 2013, Biocon, Mylan and Glenmark were circling around Genentech’s patents and pending patent applications over the biologic Trastuzumab, that is sold under the brand name…


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Drug Regulation Patent

Guest Post (Adarsh Ramanujan): Why Donald Trump’s Union Address Matters for Pharma Patents in India

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We’re pleased to bring to you a guest post by Adarsh Ramanujan. Adarsh is an advocate primarily assisting clients as a litigation attorney. He has recently started his own counsel practice with offices in Delhi and Chennai after having spent considerable time with Lakshmikumaran & Sridharan at their New Delhi and Geneva offices. He obtained his B.Sc. LL.B. (Hons.) degree (Gold Medalist) from National Law University, Jodhpur  and LL.M. degree from University of California, Berkeley. He is a qualified Patent Agent…


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Competition Law Drug Regulation Privacy

All You Need to Know About the New CCI Policy on Healthcare-Part II

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I had written a post few days ago covering the main highlights of the CCI’s press release on its Policy Note on healthcare. In my post, I had summarized and explained the main aspects of the Note (covered by the press release) and observed that though the Policy Note doesn’t really bring in many new recommendations, it does pay heed to the current shift from price control mechanisms to rationalisation of trade margins. With the recent release of the Policy…


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Competition Law Drug Regulation

All You Need to Know About the New CCI Policy on Healthcare-Part I

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It’s been around a week since the CCI released its press release on its policy note on ‘Making Markets Work for Affordable Healthcare’. In the past, the CCI has recognized the need to address issues in the healthcare industry on several occasions. For instance, it has observed in a past order that the lack of competitive forces in the pharmaceutical market has resulted in “innovative business practices, superior services, consumer choice, lower prices, etc.” taking a back seat. (In fact,…


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Drug Regulation

The Hindu Discovers That Indian Patients Have Not Been Informed of Bedaquiline’s Side-Effects

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For the last 6 months, we’ve seen The Hindu reporting on bedaquiline, Janssen’s new experimental TB drug from various angles. There was the first set of reportage by Vidya Krishnan, which was mostly incorrect and possibly fake news. Then there was the opinion editorial by R. Prasad, a correspondent at the paper, who while noting the pending Phase III trials for the drug, recommended ramping up access to the drug. I’m not sure whether it is regular for health reporters…


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Drug Regulation

The Ethics of Early Access to Experimental Drugs Like Bedaquiline That Have Not Yet Completed Phase III Trials

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Following my criticism of an opinion piece in the Hindu by R. Prasad for his recommendation to ramp up access to bedaquiline without tackling the ethical issues regarding the flawed informed consent form for bedaquiline, he published a news report in yesterday’s Hindu on the ethics of denying early access to bedaquiline. Titled ‘Unethical to withhold bedaquiline while waiting for Phase III results’, he cites Dr. Karin Weyer at the World Health Organisation (WHO) who claims that it would be…


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Drug Regulation

The Ministry of Health Is Yet to Communicate with J&J on the ASR Hip Implant Issue

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For the last few months, the Indian media has been doggedly tracking the J&J hip implant scandal. To briefly recap the main facts, the company sold its new ASR hip implants to around 4,700 patients between 2006 and 2010. Around 2010, J&J decided to withdraw the implants from the market because of quality issues with the product that threatened patient safety. One of the issues debated in the press is the need to compensate the patients. After unprecedented patient activism…


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Drug Regulation

Yet Another Journalist Pitches for Ramping Up Access to Bedaquiline before Phase III Trials, Without a Mention of the Flawed Consent Forms

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In a column published on September 4, 2018 the Hindu’s science editor R. Prasad has explained why India should ramp up access to bedaquiline to treat MDR-TB. Unlike most of the other cheerleaders for bedaquiline, Prasad thankfully points out that the drug demonstrated higher cardiotoxicity and that Phase IIb trials experienced more deaths and that the Phase III trials are yet to be completed. He however concludes that the recent revision of the WHO treatment guidelines on bedaquiline, that was…


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Drug Regulation Patent

IPO Grants Patent to Brodalumab

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Last week, our IPO granted a patent to Amgen covering the drug Broadlumab.  Brodalumab is a human monoclonal antibody designed for the treatment of inflammatory diseases including psoriasis  In the United States, Broadlumab is known as Siliq and in Europe it is Kyntheum. The application for Broadalumab was filed as a PCT application – PCT/US2007/021174 (click here to see the page on WIPO – Patentscope) and was accorded application number: 2350/CHENP/2007. One can see the entire file on this link – https://www.quickcompany.in/patents/il-17-receiptor-a-antigen-binding-proteins Sandeep Rathod –…


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Drug Regulation

The Bedaquiline Patient Consent Form in India & the Perils of Single Issue ‘Access to Medicine’ Activism

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‘Access to medicine’ activists at MSF are kicking off yet another campaign to increase access to Janssen’s new drug bedaquiline. Based on a new study and a new set of guidance from the WHO, the activists want the government to give all multi-drug resistant TB patients in India access to bedaquiline. A recent piece published on India Spend, with “support from MSF”, interviews the lead author of an earlier study of bedaquiline in light of a more recent study in the…


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