Author name: Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

NPPA caps prices of non-essential medicines:A policy appraisal

/ By / Drug Regulation

In a momentous development the National Pharmaceutical Pricing Authority has capped the prices of 108 anti-diabetic and cardiovascular formulations, which has left the pharma industry fuming! Last year around, May 2013 the Department of Pharmaceuticals (DOP) intervened and  released drug price control order (DPCO),which expanded the list of medicines which fall under the essential medicines category.We had blogged about it in detail over here. NPPA cap: how does it work? While considering the price cap of non-essential medicines, the NPPA …

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Merck – Glenmark to mediate in Januvia (Sitagliptin) patent infringement case

/ By / Competition Law, Patent

As reported by the TOI, in an interesting turn of events Merck has sought a settlement with Glenmark in the Januvia (Sitagliptin) patent dispute. Earlier this month, Merck applied in court to refer the Sitagliptin patent case to the mediation centre. Since the defendant Glenmark had no objection and was agreeable to engage in mediation, Justice AK Pathak allowed Merck’s application. According to TOI reports the matter is to be listed before the Delhi high court mediation and conciliation centre …

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Tesla motors open source initiative and the Future of Intellectual Property

/ By / Innovation, Patent

Recently in a welcome development Tesla motors made an announcement that it will not initiate lawsuits against anyone who in good faith wants to make use of their patented electric car technology. Nikola Tesla would have been proud!  To use the inimitable phraseology of the legendary Nikola tesla    “I don’t care that they stole my idea; I care that they don’t have any of their own” The majority cheered Tesla’s open source initiative; however some cynics maintained that the patent pledge uses …

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Delhi High court orders Roche and Cipla to mediate in Erlotinib (Tarceva) patent case

/ By / Patent

After fighting a long drawn out patent battle over Erlotinib (Tarceva), in an interesting development the Delhi High court has ordered Roche and Cipla to engage in mediation. The Erlotinib patent case is unique in many ways because it was India’s first post-trial pharma patent ruling in a post TRIPS world and also it was the first of its kind at-risk infringement case. A brief recap of the Erlotinib patent saga: As readers may recall Roche had sued Cipla over …

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CSIR-URDIP announces admission for PG Diploma in Patinformatics(Patent Informatics)

/ By / Event, Sponsored

CSIR-URDIP has been working in the field of Patinformatics for more than a decade. Patinformatics is fast emerging as a science of analyzing patent information which supports decision making in research, technology and business planning.   CSIR – URDIP is now launching for the first time in the country a one year full time post-graduate diploma course in the field of Patinformatics. The course has been designed to train the candidates in the art of patent searching, reading and analysis …

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European patent office to include Indian patents in their search database.

/ By / Patent

An invention can be the subject of a number of patent applications worldwide, in a variety of languages. Patent equivalents are a list of similar patent documents; with the same priority dates from throughout the world (for example see here). Searching for Indian patent equivalents is a herculean task! I’ve always wondered why Indian patents never featured in free online databases like WIPO’s Patentscope or EPO’s Espacenet. Thankfully that’s going to change. As reported by Business standard, Indian patents will …

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It’s raining injunctions: Novartis granted injunctions against four other generic makers over Galvus.

/ By / Drug Regulation, Patent

It seems like Novartis is jealously safeguarding anti-diabetic drug Galvus against competition. In an interesting turn of events Novartis filed quia timet suits against against four other pharmaceutical generics: Glenmark generics, Bajaj healthcare, Cadila healthcare and Alembic pharmaceuticals over alleged patent infringement of Galvus (Vildagliptin). In the Bajaj healthcare case and Alembic pharmaceutical case the court  granted ex-parte ad-interim injunctions and observed that that plaintiff (Novartis) has made out a strong prima facie case for grant of ad-interim injunction. The balance …

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Novartis sues Biocon over anti-diabetes drug vildagliptin: Bitter pill?

/ By / Drug Regulation, Patent

A year after the Glivec saga and looks like Novartis is leaving no stone unturned to protect its blockbuster anti-diabetic vildagliptin. According to news reports, Novartis filed a suit seeking an injunction against Biocon Ltd. at the Delhi High Court for infringement of the vildagliptin product patent. During the hearing on March 28, 2014, the court recorded a statement according to which Biocon will not manufacture, sell or export Vildagliptin for commercial purposes till the next court hearing. Details of …

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Roche sues Biocon and Mylan over biosimilar version of Herceptin;Delhi HC grants injunction

/ By / Drug Regulation, Patent, Trademark

Trastuzumab/Herceptin has been controversy’s child (please read my previous posts on Herceptin here and here.) Initially it was considered for Compulsory license u/s 92 and then last year in a very surprising development Roche decided not to pursue Herceptin patents in India. In a SPICY IP exclusive Prashant had blogged about this development over here.  Shortly thereafter, after regulatory approval a “biosimilar” version developed jointly by Biocon and Mylan was launched in India under the brand names CANMAb™ and   Hertraz™ respectively. Swaraj had blogged about the pricing issues …

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IPAB sets aside patent office order refusing crystalline form patent of Vorapaxar

/ By / Patent

Ever filed a patent application and have a rejection issued without any explanations? With the recent IPAB order, hopefully we won’t be having more of that anymore. In this case the patentee/appellant (Plough Schering now Merck) had filed a patent application claiming a particular crystalline form of a thrombin receptor antagonist, Vorapaxar. In 2009, the patent office passed an order rejecting the patent application under Section 15 citing lack of inventive step and lack of proof regarding therapeutic efficacy of the …

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