Madhulika Vishwanathan

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

Chennai patent office revokes Pfizer’s patent on Detrol LA


In an interesting development the Chennai Patent Office recently revoked Pfizer’s patent on Detrol LA in response to a post grant opposition initiated by Ranbaxy. Detrol LA (extended release capsules of tolterodine) is used for symptomatic treatment of urinary incontinence/overactive bladder syndrome. The revocation order can be accessed here. Patent status of Detrol LA in India In India Detrol LA is protected by two patents IN211539 and IN229260 which cover its extended release capsule formulation. It is pertinent to note that there…


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Patent

Nitto Denko Corp v. Union of India: Backlog and shortage of staff at the IPO?


A civil writ petition was filed by Nitto Denko Corporation, questioning the delay in the issuance of FER and seeking directions regarding timeline of issuance of first examination report (FER) and expediting patent prosecution. Mr. Pravin Anand, one of the country’s leading IP counsels represented the petitioner in this case. The Delhi high court issued an order directing the Indian patent office to file an affidavit indicating the state of affairs in the patents office regarding issuance of FER and to…


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Patent

I-MAK files pre-grant opposition against Gilead’s antiviral drug Sofosbuvir


Non-profit group I-MAK (Initiative for medicines access and knowledge) filed a pre-grant opposition last week at the Indian patent office against Gilead’s  Sofosbuvir, potential blockbuster drug used to treat Hepatitis.Sofosbuvir has received an unprecedented  unanimous approval from the FDA advisory panel last month. Anticipating its launch in India, I-MAK filed a pre-grant opposition against the prodrug patent. Background and Factual matrix Sofosbuvir (PSI-7977), a nucleotide analogue was developed at Pharmasset Inc., which was subsequently acquired by Gilead Sciences. Sofusbuvir has been touted as a potential game changer in Hepatitis C…


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Innovation

The dark side of scientific publishing industry: Will the real slim shady please stand up?


As many of you might be aware, in a brilliant exposé titled “Who’s Afraid of Peer Review? ” Science mag’s John Bohannon unearthed the failings of the peer review process in the open-access publishing industry. Background: The sting operation John Bohannon’s ingenious plan involved creating a database of molecules, lichens, and cancer cell lines and using a computer program to generate hundreds of unique papers. A typical skeleton of the paper looked like this: Molecule “X” from lichen species “Y” inhibits the…


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Patent

The Dasatinib compulsory license conundrum


The anticancer meds “nibs” (including Imatinib, Sunitinib, and Dasatinib) have always been mired in controversy. Recently Dasatinib made news when the economic times reported that “The Indian Patent Office has rejected Mumbai-based BDR Pharmaceutical’s application for compulsory licence on cancer drug Dasatinib, according to an affidavit filed by Bristol Myers Squibb, the patent holder for the drug.” This post aims to explore whether the CL application has indeed been rejected. Image from here CL application by BDR u/s 84 –…


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Patent

IPAB revocation of Allergan’s Combigan patent: Viewing it through the lens of American patent doctrines


Recently Anubha had blogged about the IPAB decision revoking Allergan’s patent for Combigan. Combigan refers to a combination eye-drop product used for treating glaucoma comprising combination of Brimonidine tartarate and Timolol maleate. Media reports termed this decision as the latest in a series of intellectual property setbacks suffered by Western drugmakers. These skewed reports also portray this revocation decision as one of many tactics by India to remove an inconvenient patent out of the way to introduce affordable generic versions….


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Patent

DIPP refuses CL plea for Herceptin: Health ministry requests Govt to revoke patent in public interest.


  In a surprising move,DIPP has taken a decision to refuse grant of CL for anticancer biologic Trastuzumab/Herceptin as reported by Sidhartha of Times of India. Background: Earlier in Nov 2012 and again in March 2013 campaign for affordable trastuzumab (an association of patients and NGO’s) had urged the Govt to take appropriate measures to ensure affordability of Herceptin. Subsequently Trastuzumab was recommended for CL by the health ministry. Read our previous posts (here and here). However after several months…


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Others

IPO publishes draft guideines for examination of computer related inventions: A perspective


Last week the Indian patent office published draft guidelines for examination of computer related patent applications. The draft guidelines can be accessed here.Comments on the same are due by 19th July, 2013 and should be addressed to the deputy controller Mr. B.P.Singh ([email protected])   The proposed guidelines aim to foster consistency and uniformity in patent office practice for examination of computer related inventions. A very welcome development I would say, considering that past patent office practice has been marred with inconsistencies….


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Delhi High court grants ex-parte injunction order against Aprica Pharma


On 17th June, in a patent infringement suit initiated by Merck, the Delhi High Court passed an ex parte injunction order, preventing Aprica pharmaceuticals from launching generic versions of Januvia and Janumet. The high court order can be accessed here. Merck’s counsel argued that the drug (sitagliptin) has been patented in over 102 countries. Merck’s counsels also contended that the invention entailed huge investment and the sales of the medicine in India alone exceeded several crores and in case the…


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The Sunitinib Saga continues: Third time’s the charm?


The IPAB has set aside the revocation of Sunitinib patent due to procedural lapses again!!(IPAB order can be accessed here). As Sunny Deol would drawl “tariq pe tariq, tariq pe tariq…” (movie buffs you know what I’m talking about).Well Justice Prabha Sridevan also expressed a similar sentiment albeit in different way and stated that the Sunitinib litigation has been delayed endlessly owing to procedural lapses in the IPO and this is unfair to both the patentee and the challenger and also…


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