Tag Archives: Biologics

Drug Regulation

Roche & Biocon sue each other for contempt in Herceptin biosimilar case while Roche and Hetero squabble over judge in Avastin biosimilar case


The ongoing biosimilar litigation between Roche and Indian generic companies is becoming more contentious with every passing day. ET’s Prabha Raghavan reported on July 15 that both Roche and Biocon are now suing each other for contempt before the Delhi High Court. As Rahul had reported earlier over here, Justice Manmohan Singh had passed orders in an earlier litigation restraining Biocon and its partner Mylan from using the name Herceptin (or associated Indian trademarks) while marketing its drug although he…


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Events

SpicyIP Events: Colloquium on Selected IP Issues, NLU-D


NLU Delhi brings us news of an exciting event happening at their campus tomorrow evening – a panel discussion on “Early Market Entry of Biosimilars in India: Implications of the Roche/Mylan Dispute”. Please see the invite attached below: Colloquium on Selected IP Issues The NLU Delhi Colloquium on Selected Intellectual Property Issues is a panel/ speakers’ series launched with an aim to generate a nuanced dialogue and to promote free-thinking on emergent issues in IP law, policy and theory. The current…


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Patent

Herceptin’s biosimilar: off patent and still expensive. What now?


The access-to-medicines folks as well as Big Pharma backers will want to take note of the latest ‘issue’ arising in the pharmaeutical pricing arena. As we had reported earlier last year, Roche had decided to drop its pursuance of patents over breast cancer biologics drug Herceptin (Trastuzumab). However, if anyone thought this meant a cheaply available generic would soon be available, it turns out that they’d be mistaken. US-based Mylan along with partner Bangalore-based Biocon received regulatory approval a few…


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Patent

Guest Post: Examining the recently announced Compulsory Licenses on anticancer drugs


In light of the recent decision to issue compulsory licenses for three anti-cancer drugs, Madhulika Vishwanathan brings us her third submission for our SpicyIP Fellowship application. After looking into the possible legal provisions that could have been used in pursuing this decision, she examines how generics may follow up on this decision by noting the differences in approach that they will have to take regarding small molecule drugs and biologics. (Note: Much of the first half includes quoted provisions, so…


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Drug Regulation

Guest Post: The New India Guidelines on Similar Biologics


The Government of India has recently announced certain guidelines regulating the approval of ‘similar biologics’ also known as bio-similars. The bio-similar market is going to be a huge market opportunity for the generic drug industry. Given the complexity of the products themselves, the regulatory regime for bio-similars is also rather complex. Since none of us on the blog had a detailed understanding of the guidelines, we invited our frequent guest blogger Mr. Christopher Ohly to write us a guest post…


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Patent

KS Jayaraman on Biotech Patents and the Future of Compulsory Licensing


KS Jayaraman, one of India’s most well known science journalists (now with “Nature”), has written a very interesting piece on biotech patents and the prospects of compulsory licensing in developing countries such as India, Brazil and Thailand. Apart from two minor mistakes (he assumes that Tarceva is a biotech drug; and that “non emergency” compulsory licensing grounds in India came about only after 2005), the piece is a very good read. “Patent Threat in Emerging Economies Shifts to Biotech”“Recently revamped…


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