Category Archives: Drug Regulation

Domino Effect: Teva withdraws patent application in India after USPTO invalidates its patent in blockbuster drug COPAXONE

by Ritvik M Kulkarni September 20, 2016

In a groundbreaking development, Israeli behemoth Teva Pharmaceutical Industries Ltd. (Teva) has suffered a third consecutive blow after the US Patent Office (USPTO) invalidated its third patent [U.S. Patent No. 8,969,302] for COPAXONE (Glatiramer Acetate) on September 1, 2016. According to The Financial Express, the USPTO upheld a Mylan’s challenge in an Inter-partes Review (IPR) and found that all claims in the said COPAXONE patent were un-patentable. The 40mg version of COPAXONE is a $4 billion blockbuster injectable drug used…

Drug Regulation

The Naked Truth: An Expose on Big Pharma

by Inika Charles September 16, 2016

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Medecins Sans Frontiers (‘MSF’) new must-watch short film, The Naked Truth is hilarious, strongly worded, and to the point. In the video, MSF challenges Big Pharma’s age old claim of their medicines being necessarily priced as high as they are. Using metaphors that are nothing but apt, MSF strips away at Big Pharma’s supposedly continued expenses on drug research, demanding a revelation of their actual costs. MSF uses the medicines for Hepatitis C as an example, noting their $1000 per…

Drug Regulation

The Sub-Standard Drug Problem: A Report Explaining the Failures of India’s Drug Regulatory System

by Prashant Reddy September 4, 2016

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Although this blog concentrates mainly on IP issues, we occasionally do cover drug regulatory issues. The state of drug regulation in India, as most of you will know, is quite alarming. Plant after plant is being banned by foreign regulators, while CRO outfits like the GVK Bio stand accused of serious fraud. Clearly, the present Drug Controller General of India (DCGI) G. N. Singh is presiding over a system which is failing at every level. He admitted as much when…

Drug Regulation

Parliamentary Committee slams the Department of Pharmaceuticals over Drug Prices

by Vasundhara Majithia August 29, 2016

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Amidst claims of the NDA Government to have brought more generic drugs under pricing control, the Parliamentary Committee on Government Assurances (PCGA) submitted its report on 11th August this year regarding the pending assurances to control the prices of patented drugs, and it turns out; the Ministry doesn’t believe in keeping its promises. The PCGA was instituted in 1953 and its primary function is to scrutinize the assurances, promises and undertakings given by Ministers on the floor of the House…

Drug Regulation Traditional Knowledge

Innovation and Regulation of Ayurvedic medicine: CSIR’s BGR-34, nimensulide in Ayurvedic medicine and other such stories

by Prashant Reddy August 6, 2016

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A few years ago, Open magazine published an excellent cover story “Ayurveda: Hoax or Science?” by Priyanka Pulla, one of India’s best science journalists. (She’s written for us on a couple of occasions over here and here). That cover story discussed several issues surrounding Ayurvedic drugs and how despite having a Rs. 8,000 crore market in India there is still not enough evidence for modern medicine to prescribe any Ayurvedic medication. In her story Priyanka asks “Why hasn’t the dazzling…

Drug Regulation

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

by Prashant Reddy July 21, 2016

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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…

Drug Regulation Patent

UN Human Rights Council Adopts Landmark Resolution for promoting Access to Medicine in Developing Countries

by Ritvik M Kulkarni July 5, 2016

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(This post has been co-authored by Swaraj Barooah) It appears that 30th June 2016 was quite a good day for access! Aside from the developments with the Marrakesh Treaty that Vasundhara recently posted on here, the United National Human Rights Council (UNHRC), in its 32nd Session, adopted the much awaited Resolution on “Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” (the Resolution). The Resolution…

Drug Regulation Trademark

India contemplates WTO action over EU Trademark Law

by Vasundhara Majithia June 30, 2016

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A few years ago, a series of in-transit drug seizures led to an outcry in the developing world. We have posted about this several times here. New developments have brought this issue into light once again. A quick recap In 2008, 17 seizures of generic drugs took place in EU on grounds of patent infringement as per EC Regulation 1383/2003. These drugs were in transit to and from developing countries. In 2010, India and Brazil started proceedings against the EU…

Drug Regulation Others Patent

Government relaxes FDI norms in Pharma

by Shan Kohli June 24, 2016

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The government has recently allowed up to 74% Foreign Direct Investment (“FDI”) in existing pharmaceutical companies (brownfield investment) through the automatic route. 100% FDI is already permitted under the existing policy for brownfield investments after obtaining approval of the Foreign Investment Promotion Board (“FIPB”). The press release is available here. From a plain reading these changes should lead to an increase in deals in the pharma sector. The only difference between the recent change and the existing policy is a…

Drug Regulation Patent

Pinocchio d’Pharma: False claims about Tarceva cost Genentech and OSI Pharma $67 Million

by Ritvik M Kulkarni June 20, 2016

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Pharmaceutical giants Genentech Inc. and OSI Pharmaceuticals LLC have coughed up $67 million to finally settle allegations against them under the US False Claims Act of 1863 (FCA). The United States Department of Justice (DOJ) stated in a public release that “Genentech and OSI Pharmaceuticals made misleading representations to physicians and other health care providers about the effectiveness of Tarceva to treat certain patients with non-small cell lung cancer, when there was little evidence to show that Tarceva was effective…

Jaideep { I have 2 additional perspectives on the above topic: a. What about the right as a performer or Ms. Chopra? Could an argument be raised under section 38A... }
B S Chauhan { very relevant in present scenario. The humanitarian aspect in emergencies like the Covid-19 should be taken care in all such laws. well researched article. kudos to Pankuri Agrarwal. }
Ramu { Brazen, political rant sought to be passed off as academic commentary. And the sensationalist headline did not quite carry through. Sounds quite vapid, really. Try harder next time,... }
Mahabaleshwar Pandit { Who is paying royalty for Covaxin? In any case India is demanding global waiver. This appears to be an attempt on the part of misleading club of international... }
Sadly, No! { This is bizarre since it has been widely recognised now, even in the most capitalist countries such as the US, that pharmaceutical companies and their market-oriented incentives will... }