Category Archives: Drug Regulation

Drug Regulation Patent

USTR Special 301 Review (2020) Submissions – Continued


Special 301

As readers may know, the Special 301 Review is an effort by the US Trade Representative (USTR) to identify countries whose IP regimes are not conducive to US persons’ IP interests, with the stated goal of increasing bilateral attention on ‘problem areas’. This has most frequently been done through the threat of unilateral sanctions (see our posts on earlier editions of the Special 301 review here). This year’s report has come out as well – with India once again being…


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Drug Regulation Patent

Delhi HC Allows Genentech’s Internal Expert to Inspect Reliance’s Documents in Trastuzumab Suit: Dilution of Confidentiality Club?


On 2nd March, a Single Judge of the Delhi High Court in the case of Genentech Inc. and Ors. v. Drugs Controller General of India and Ors. passed an order, which effectively allowed Genentech’s in-house employee/expert to inspect the documents placed on record under a Confidentiality Club. This is the Trastuzumab litigation involving Reliance. This litigation saga has been covered on several occasions including here, here, here, here, here and here. When I first heard of this order, I was…


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Copyright Drug Regulation Patent

An Overview of the Lobbying against Indian IP Law before the USTR


Every year, the United States Trade Representative (USTR) conducts hearings for its ‘Special 301’ report. The report which draws its name from Section 301 of the Trade Act, 1974 is meant to name and shame America’s trading partners based on their efforts to protect American intellectual property. This report then feeds into other reports by the USTR, such as the National Trade Estimate on Foreign Trade Barriers which forms the basis of the American President’s trade policy. In almost all…


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Drug Regulation Patent

Trastuzumab Biosimilar Litigation Saga: A New Order from the Delhi High Court


Last week, the Delhi High Court issued yet another order in the Trastuzumab litigation saga. This time, it is common order in two suits bearing CS (COMM) 1119/2016 (Roche v. Cadila, DCGI and DoB) and CS (COMM) 540/2016 (Roche v. DCGI, DoB and Hetero Drugs Ltd.). This litigation saga has previously been covered here, here, here, here and here. Suffice to say that broadly, the prayers in these suits are similar to the ones in the other suits against Biocon/Mylan and…


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Drug Regulation Patent

Delhi HC Issues Notice on Petition Challenging Price Control Exemptions for Newly Patented Drugs


The Delhi High Court recently issued notice on a petition by All India Drug Action Network (AIDAN) that challenged the Drug (Prices Control) Order 2013 and Drug (Prices Control) Amendment Order, 2019. The specific averments were concerning Paragraph 32, which is the list of exemptions, of DPCO 2013 and the amendment to it by the 2019 Order. Para. 32 of DPCO 2013 creates an exemption from price control for new drugs patented under the India Patents Act, 1970, thereby creating…


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Drug Regulation Others Patent

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


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


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


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


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


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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