Author name: Ritvik M Kulkarni

Ritvik Kulkarni is a final year student at ILS Law College, Pune. He is the Student Coordinator of the ILS Intellectual Property Rights Cell and Student Editor at the ILS Abhivyakti Law Journal since 2014-15. Ritvik first learnt of IP while preparing for his first moot; and has been regularly taking his weekly IP fix ever since. Additionally, he takes interest in learning the law and practice of domestic and international dispute settlement. Speaking of disputes, he's an ardent follower and jabra fan of Game of Thrones. You can get in touch with him at [email protected]; and dont worry he loves F.R.I.E.N.D.S too.

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

/ By / Drug Regulation, Patent

(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 […]

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UNDP Releases Guidelines for Pharma Patent Examination from a Public Health Perspective

/ By / Patent

The United Nations Development Programme (UNDP) has published a new set of guidelines for patent examination with a primary view to sieve poor and weak pharmaceutical applications out of the patent pool.  In writing the foreword, Director of HIV, Health and Development, UNDP Mandeep Dhaliwal rightly observes that an appropriate balance should be maintained between protecting the rights of inventors and incentivizing innovation, on the one hand, and promoting accessibility and affordability of treatments, on the other. These guidelines have

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

/ By / Drug Regulation, Patent

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

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Hep C Drug Pricing: New Study finds Sofosbuvir globally unaffordable

/ By / Drug Regulation, Innovation, Patent

Imagine waking up on the wrong side of the bed. Your skin looks yellow and you start feeling blue. Abdominal pains make you cringe, despite never having binged. The family doctor rules out jaundice and draws a blank. Your hospital-next-door churns out the blood report and you anxiously gaze into the diagnosis: “Tested positive for Hepatitis C”. You become the latest addition to a pool of around 130 million people across the globe. Initially drained of every modicum of hope,

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Reflecting on the US Special 301 Report 2016: Patently Insignificant(?)

/ By / Drug Regulation, Innovation, Patent

The United States Trade Representative (USTR) on 12th April released its 2016 version of the annual Special 301 Report on IP protection and enforcement. I understand that many of our readers may already be aware of this development. Therefore, albeit a bit belated, I have tried to analyze this Review and its impact that on India. Unsurprisingly, India has been featured in the Priority Watch List. India has had the honor of being featured on this list since 1974. In

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SpicyIP Weekly Review (May 15 to 22)

/ By / Others

This week’s highlight is undoubtedly Prof. Basheer’s hard-hitting critique of the recently released National IPR Policy (Final Policy). He points out that the so-called innovation-oriented Final Policy itself lacks an innovative spirit. He states that the powerful IP rights-centric Final Policy in its present form is resultant of successful US pressure. Prof. Basheer also identifies a few key positives, such as expedited patent examination, open IP exchange and the infusion of CSR funds into open innovation. Nevertheless, he tears through

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Patent Rules Amendment 2016: Tatkal Patents, Benefits for Startups and US Victory.

/ By / Patent

The Office of the CGPDTM has on 14th May 2016 issued a public notice on the publication of amended Patent Rules, 2003. Accordingly, the Patent (Amendment) Rules, 2016 (Amended Rules) were published (and came into force) on 16th May 2016. Earlier, the government had released the Draft Patent (Amendment) Rules, 2015 (Draft Rules) for public comment and consideration. There are quite a few positive changes to the patent rules. Among these, I will be dealing mainly with the inclusion of startups,

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(SpicyIP Tidbit) India signs Landmark Collaboration Agreement with WHO to promote Traditional Medicine Systems

/ By / Innovation

In a press release dated 14th May 2016, the Ministry of AYUSH has declared that it has inked a major collaboration agreement with the World Health Organization “for cooperation on promoting the quality, safety and effectiveness of service provision in traditional and complementary medicine (T&CM)”. This historic Project Collaboration Agreement (PCA) will operate between 2016 and 2020. It will be seminal in the creation of the first ever WHO benchmark document for training in Yoga and similar WHO benchmark documents

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Breaking News: IPO Official forced out for rejecting Sovaldi patent application? 

/ By / Patent

Gilead Sciences has been engulfed with controversy ever since it filed for a patent in India for its notoriously expensive blockbuster drug Sofosbuvir (Sovaldi) for Hepatitis C. Now, in a shocking development, Mandakini Gahlot and Vidya Krishnan have reported in their piece for The Caravan that patent-examiner Hardev Karar may have been compelled to withdraw from the Sovaldi case after he rejected Gilead’s patent application in January 2015. Background While the Sovaldi application was initially rejected by the Indian Patent

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SpicyIP TidBit: NHRC asks Govt for clarification on (anti?)CL stance

/ By / Drug Regulation, Patent

The National Human Rights Commission (NHRC) has on April 1, 2016 issued a press release expressing its apprehension over the India’s alleged promise to the US to refrain from issuing compulsory licenses in pharmaceutical drugs for commercial purposes. The Commission is particularly skeptical about the fact that “at least two applications for compulsory licenses to produce, domestically, generic versions of drugs patented in America were rejected last year.” These two applications (concerning ‘Saxagliptin’ and ‘Dasatnib’) have been examined on SpicyIP

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