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.

Patent office rejects Tofacitinib patent application: An analysis [Part II]

/ By / Patent

Part I of this post examined whether the cited prior art actually qualifies as prior art for the purposes of prior claiming and also analyzed the patentability of an enantiomer over a racemic mixture. Part II of the post analyzes the Section 3(d) rejection and the potential influence it can have in future. Further Part II of the post also analyzes the extent of disclosure required for Section 8. [991/MUMNP/2003 DECISION]. In addition to prior claiming,the Controller also rejected the …

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Patent office rejects Tofacitinib patent application: An analysis [Part I]

/ By / Patent

On September 3, 2015, the Indian patent office rejected Pfizer’s Tofacitinib patent application 991/MUMNP/2003 second time around. The patent was rejected based on grounds of anticipation by prior claiming  and Section 3(d). I have divided this post into two parts to analyze the Controller’s decision. In part I, I analyze the anticipation ground and patentability of an enantiomer. Part II of the post examines the Section 3(d) rejection.[ 991/MUMNP/2003 DECISION] Image from here Background: Pfizer had filed a national phase …

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Evaluating the veracity of CSIR-TKDL claims

/ By / Patent, Traditional Knowledge

In the recent past, CSIR -TKDL (Traditional knowledge digital library) has gone on an overdrive touting several sensational claims. This post aims to evaluate the veracity of these claims and also examine whether the investment involved in the TKDL effort is actually worthwhile. In fact, our friends at IP Kat particularly Darren Smyth and Tufty the Cat got the debate started and have written a couple of posts regarding this. You can read these posts here and here. CSIR – …

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Users stranded after Indian patent office website shuts down for over 2 days

/ By / Others, Patent

Over the weekend, we received a few complaints that Indian patent office left users stranded – with its notification about scheduled website outage for over 2 days! The June 4,2015 notification stated “Due to Application and Data Migration from old to the New servers systems, the Online services of Patents, Designs, Trade Marks & Geographic Indications (including online filing and information services) shall not be available from Friday, 05th June 2015 (6:00 PM onwards) to Monday, 08th June 2015 (2:00 …

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Entecavir mystery reloaded: Cipla and BMS in talks over a potential settlement

/ By / Patent

Patent settlements are in the air! Reports indicate that Bristol-Myers Squibb and Cipla appear to be closing in on an agreement to settle a patent dispute relating to a pharmaceutical composition for once a day oral administration of Entecavir (a drug used to treat Hepatitis B). In 2010,  Cipla had filed a petition at the IPAB to revoke the composition patent. Readers may recall Natco and BMS had entered into a similar settlement over the Entecavir composition patent, after Natco …

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Onbrez patent infringement suit update: Cipla offers to pay Novartis reasonable royalty for patent

/ By / Patent

Recently, the Onbrez patent injunction appeal case came up for hearing. In an interesting twist, Cipla offered to pay Novartis a reasonable royalty fee, if it was allowed to continue selling generic version of Onbrez! Reportedly Novartis was not enthusiastic and flatly refused Cipla’s offer. As readers may remember in November 2014, Cipla had launched a low cost generic version of Novartis’ Onbrez (Indacetorol – a drug used to treat chronic obstructive pulmonary disease). Cipla had further petitioned to the …

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SpicyIP to charge readers a nominal fee for subscription in certain regions

/ By / Others

As we were busy crunching numbers on the financial year ending, we realized that we cannot afford to keep SpicyIP free anymore. As you all know, SpicyIP depends on a team of analysts who volunteer their time to analyze complex issues of IP and innovation law and policy free of cost to readers. However, in order to offset the heavy operating costs of maintaining our website and the technical support staff, a nominal fee will be charged from here onwards. We are introducing …

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SpicyIP Tidbit: Supreme court stays Delhi High court injunction restraining Glenmark

/ By / Patent

In a rather interesting turn of events the Supreme Court bench of Justices Ranjan Gogoi and          NV Ramana have stayed the Delhi High court order restraining Glenmark from selling Sitagliptin. We had analyzed the Delhi High court injunction order restraining Glenmark in detail over here. According to livemint, Merck, resisted the stay of the high court order. However the apex court said that since there had been no stay for a long time, a few more …

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Delhi High court grants interim injunction; restrains Glenmark from selling generic version of anti-diabetic drug Januvia (Sitagliptin)

/ By / Patent

On April 2013, Glenmark launched the generic version of Merck’s popular antidiabetic drug Januvia (Sitagliptin) and Janumet (combination of sitagliptin and Metformin). Subsequently Merck filed a suit against Glenmark seeking interim relief. The Delhi HC (Justice Rajiv Sahai Endlaw) denied interim relief to Merck. After denial of interim relief, Merck was also briefly engaged in mediation with Glenmark over the Januvia patent. Readers may recall that we had blogged about it here here and here. Aggrieved by the denial of …

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The Entecavir mystery: Natco and BMS enter into a hush-hush patent settlement in India

/ By / Patent

In a development with significant ramifications, Natco and Bristol Meyers Squibb entered into a settlement over a patent dispute involving Entecavir (Baraclude) a drug used in the treatment of hepatitis B infections. The patent which was disputed by NATCO pharma and settled at IPAB   relates to a pharmaceutical composition for once a day oral administration comprising upto 1% of Entecavir. Entecavir US Patent status: BMS and Teva Entecavir is protected by two patents in the US viz: US5206244– product patent …

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