Category Archives: Drug Regulation

Copyright Drug Regulation Others Patent Trademark

SpicyIP Weekly Review (July 6 – 12)


Topical Highlight Telegram Copyright Infringement Case: India’s Chance to Seek Inspiration from Foreign Principles In a guest post, Abhishek Iyer discussed the issue of intermediary liability in light of the Telegram copyright infringement case. The post first discusses the burden of knowledge with respect to e-notices to understand Telegram’s liability given the requirement of ‘specific and actual knowledge’ of intermediaries with respect to infringement of copyrighted material. The doctrine of inducement used in US Courts is discussed to determine Telegram’s…


Read More »
Drug Regulation Patent

DPCO’s Para 32 Conundrum Continues: Price Control Exemptions for Newly Patented Drugs


Earlier in February, I had written about a petition filed by AIDAN challenging Paragraph 32 of the Drug (Prices Control) Order 2013 (DPCO) and the Drug (Prices Control) Amendment Order, 2019. Para. 32 of the DPCO creates a provision for the exemption of certain drugs from price control. One of the exemptions under Para. 32, brought in through the 2019 amendment, is for ‘new drugs’ patented under the Indian Patents Act, 1970. The latest provision, after the amendment, reads –…


Read More »
COVID-19 Drug Regulation Patent

Nationalism, Drugs and Public Interest – Remdesivir and Beyond


A few days ago, the US Department of Health and Human Services (HHS) announced that their President has struck an ‘amazing deal’ with Gilead, that ensured nearly all of Gilead’s projected production of Remdesivir for the next three months are secured by the US. “Nearly all” in this case, refers to 100% of Gilead’s projected production of Remdesivir for July, and 90% of the projected production for August and September. This is after US has already kept about 60% (940,000)…


Read More »
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…


Read More »
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…


Read More »
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…


Read More »
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…


Read More »
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…


Read More »
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…


Read More »
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…


Read More »