Articles by : Usharani



ELISA for diagnosis of Crohn’s disease: Serological detection of IL-23 Receptor variants

ELISA for diagnosis of Crohn’s disease: Serological detection of IL-23 Receptor variants

Interleukins are cytokines that act as immunomodulatory agents and are implicated in a variety of autoimmune inflammatory diseases. Interleukin-23 (IL-23), considered to be involved in the differentiation of T helper type 17 cells, is a principal molecule in autoimmunity and is an important drug target molecule for the treatment of many auto immune inflammatory diseases.

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Nobel Prize winning patents?!…Er…not exactly!

Usharani

Nobel Prize winning patents?!…Er…not exactly!

Come October and the scientific community will be geared up for the announcement of Nobel Prizes. In the same vein or rather the other way around, is another event that scientists, especially those with a sense of humor, look forward to. It is the Ig Nobel Prize ceremony, which is a kind of spoof on Nobel Prizes.

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Gene patents: First-of its-kind agreement in Canada for non-commercial public use

Usharani

Gene patents: First-of its-kind agreement in Canada for non-commercial public use

In a scenario where the Indian Government is in a hot seat over its so-called “private assurances” to the US authorities on not issuing any more compulsory licenses, the first-of-its-kind agreement between a Canadian Public Hospital and an American Biotechnology Company allowing “not-for-profit” fair use of gene patents benefitting the public is a welcome news.

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Google’s new patent application covers technology for use in the field of Optogenetics

Usharani

Google’s new patent application covers technology for use in the field of Optogenetics

Google has filed a patent application with USPTO for microelectrode arrays that have applications in the field of Optogenetics. Optogenetics combines the use of optics and genetics to control and monitor well-defined events within living cells. It involves the use of light to stimulate light responsive proteins that are expressed in specific cells. Optogenetics was hailed as the “method of the year” …

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Delhi HC issues notice to Indian Govt in a PIL filed on working of Patents

Usharani

The Delhi high court issued notice to the Government of India on Sep 1st 2015, in response to a public interest litigation (PIL) on working of patents filed by eminent IP professional, Shamnad Basheer and the matter is now listed for November 17th.

The PIL was filed based on the outcome of a survey undertaken by the petitioner and his research group and information gathered by the petitioner through RTI applications. The PIL claims that the statutory requirements on working of patents are either not fulfilled/ inadequately fulfilled by most of the patentees and that the respondents (government authorities) are complacent in this regard. The petitioner contends that the working of patents lies at the very heart of the Indian patenting system and that the grant of exclusionary ‘rights’ to the

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Third compulsory license application in India: Controller decides against the applicant – Lee Pharma Ltd.

Usharani

India’s compulsory licensing policy, though TRIPS compliant, has come under scathing attack from many quarters of developed countries, mainly attributed to the pressure from big pharma lobbies based in those countries. India granted its first compulsory license in Mar 2012 to NATCO Pharma Ltd., a generic drug manufacturer, to produce Nexaver, an anticancer drug patented by Bayer and the license is valid till 2020. An attempt by another generic drug maker, BDR Pharma to get a compulsory license for another anticancer drug – Dasatinib was however unsuccessful with the Indian patent office rejecting it on the basis of failure of the applicant to make a prima facie case.

The third compulsory license (CL) application was filed by Lee Pharma Ltd., a Hyderabad based company on 29th June 2015 for manufacturing and

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Chennai Patent office revokes Roche’s patent for valganciclovir

Usharani

Patient organizations gained a victory in their fight for access to medicines as Roche’s patent on Valganciclovir, an antiviral medication was revoked by the Chennai Patent Office. But this long drawn fight is not a clear victory since the patent term expired almost simultaneously.

Background:
Roche filed a patent application (959/MAS/1995) with the Indian Patent Office on 27 July 1995, covering Valganciclovir and its salts as well as a process for preparing the same. Valganciclovir is an oral prodrug of Ganciclovir that is used in the treatment of cytomegalovirus infections, primarily in immunocompromised patients such as HIV/AIDS patients or patients who have undergone organ transplants. The drug is prohibitively expensive costing around 2.7 lakhs for one course of treatment of a patient.

A pre-grant opposition was filed in Dec 2006 by patient

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Symed V. Glenmark: Glenmark process does not infringe Symed’s process Patent for Linezolid manufacture

Usharani

The Delhi High Court in its interim order dated 17th July 2015, disposed off the appeal filed by Glenmark against the interim injunction awarded by a single judge of the Delhi High Court on 19th Jan 2015. The 19th Jan 2015 interim injunction restrained Glenmark from making linezolid on the ground that it violated Symed’s patented process. On an appeal by Glenmark, a Division Bench of the Delhi High Court vacated the interim injunction in an interim order dated 5th Feb 2015. As per the recent order dated 17th july 2015, Symed had agreed that the Glenmark process for preparing linezolid is distinct from the patented process and Glenmark is now free to use its process for manufacturing linezolid.

Symed, a Hyderabad based company that manufactures Active Pharmaceutical Ingredients (API) and

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Life Sciences embrace exigent technology in global innovation as per patent statistics

Usharani

As per Thomson Reuter’s analysis of global patents, the life sciences industry is attaining increasing succession over technology-based sectors in terms of driving global innovation.

The year 2014 has been full of patents application and successful grants than any other year in the history. This reflects the ingenious nature of civilization with relevance to few examples like designing driverless cars, discovering new drugs for cancer or building bionic limbs.
Nevertheless, a slow growth in innovation has been observed with worldwide patent volume up 3% last year, the smallest annual rise since the end of the global recession in 2009. Whereas, previously, nearly double-digit percentage increase has been recorded. One plausible reason for such a behavior could be tighter patenting rules in the US.

A significant drop in patents for semiconductors to 5%

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IPAB Sets aside Patent office order refusing Patent to Pfizer’s Anti-Psychotic drug

Usharani

In a case reflecting the sorry state of affairs with respect to patent prosecution in India, the Intellectual Property Appellate Board (IPAB) had set aside the order passed by the Delhi Patent Office refusing patent to Pfizer’s anti-psychotic drug. Pfizer’s patent application (No. 1154/DEL/1997) was directed to Ziprasidone mesylate trihydrate for treatment of psychotic disorders. The First Examination Report (FER) on the application was issued on Apr 2006 for which Pfizer filed a response in Mar 2007. Subsequently, an office action was issued objecting to the claims under section 3(d) & (e) of the Patents Act. Notwithstanding the response filed by Pfizer furnishing necessary data, the Assistant Controller had then refused grant of patent under section 3 (d) & (e) in the order dated Mar 2010 leading to Pfizer filing

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Johnson & Johnson’s expanded policy to include India for improved access to pediatric HIV drugs

Usharani

Janssen Pharmaceuticals, a pharmaceutical company of Johnson & Johnson, has announced an expanded policy on improved accessibility of medicines in which the geographic scope of its earlier 2012 policy of waiving enforcement of patent rights for pediatric formulations of Darunavir, is expanded. This expansion includes many low and middle income countries including India, Pakistan and Sri Lanka. The company has further committed itself to providing technical expertise to Pediatric HIV Treatment Initiative (PHTI) on developing a fixed-dose combination of Darunavir boosted with ritonavir (DRV/r).

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Pharma and Healthcare summits at Hyderabad

Usharani

Indus Foundation, a registered non-profit trust for promoting healthcare in India is organizing three summits viz. Indo-Global Pharma Expo and Summit 2015, Indo-Global Medical Expo and Summit 2015 and Indo-Global Healthcare Expo and Summit 2015, from July 23 to July 26, 2015 at Hyderabad. Indus Foundation is organizing this summit in association with Federation of Telangana and Andhra Pradesh Chambers of Commerce and Industry and OMICS group. The summits would serve as a platform for bringing together various stakeholders in the Pharma and Healthcare industry.

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Suven Life enhances its patent portfolio with two new patents

Usharani

Suven Life Sciences Ltd., from Hyderabad, specializing in research on new drug candidates for central nervous system (CNS) disorders had procured two new product patents – one from the European patent office (EPO) and another from Hongkong. Both the patents claim drug compounds (New Chemical Entities- NCEs) targeting a serotonin receptor that modulates the release of different neurotransmitters. These new drug compounds will be further developed for treatment of various neurobehavioral and neurodegenerative disorders like Attention Deficit Hyperactive Disorder (ADHD), Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and schizophrenia. These new drugs have a huge market potential globally and Suven Life might out-license these drugs.

The Hong Kong patent (numbered 1173140) claims 1,2-Dihydro-2-Oxoquinoline compounds as 5-Hydroxy tryptamine (a serotonin) receptor 4 modulators. Suven Life has already been granted patents for the drug

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Pre-Grant opposition: Wyeth loses to Fresenius Kabi

Usharani

The Indian Patent Office has refused patent to Wyeth, a group company of Pfizer Inc., in response to representation for Pre-grant opposition filed by Fresenius Kabi (formerly Dabur Pharma Ltd.). The pre-grant opposition is against a divisional patent application filed by Wyeth (1155/KOLNP/2007) claiming stable parenteral formulations having a rapamycin hydroxyester (CCI-779).

The grounds for the opposition were that: the invention has been published already [Sec25(1)(b)]; the invention was publicly known in India [Sec25(1)(d)]; the invention is obvious and does not involve any inventive step [Sec25(1)(e)]; the invention is not an invention and not patentable as per the Indian Patent Act [Sec25(1)(f)]; the description of the invention is insufficient and diffuse [Sec25(1)(g)] and the information under section 8 was not furnished by the applicant [Sec25(1)(h)].

In the hearing during opposition proceedings, Fresenius

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Govt. responds to USTR Report placing India in the “Priority Watch List”

In response to clubbing India with other countries in the “Priority watch list” of special 301 report released by USTR, the Commerce and Industry Minister, Nirmala Sitharaman stated that India will keep its national interest in mind while framing the new IPR policy and will not respond to outside pressure. She also stated that the US had given its suggestions for the drafting of the new IPR policy mainly with regard to section 3(d) of the Indian Patents Act. This statement is of significance given the concern of many Indian IP experts about the way in which the new IPR policy is being drafted and the Prime minister’s statement implying India needs to improve its IPR regime.

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EMA’S harsh recommendations against GVK: India contemplates WTO action

Usharani

GVK Biosciences, a contract research organization that conducts clinical trials for many reputed generic manufacturers in India and foreign countries is facing rough weather following the harsh recommendations made by the European Medicines Agency (EMA).

The trouble started for GVK last May when ANSM, the French drug regulatory agency alleged data manipulation of “check-out ECGs” during its inspection at the Hyderabad center of GVK. It further alleged systematic falsification of the data over a period of about five years. GVK countered the allegations by submitting necessary evidence with the EMA to establish good clinical practices followed by the company. In spite of that, by December, four European countries including France, Germany, Belgium and Luxembourg had suspended marketing authorization of about 25 generic drugs that were tested in GVK. In January

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China grants Patent to an Indian company for its Flagship technology in Stem Cell research

Usharani

Stempeutics Research, a stem cell research company having facilities in India as well as in Malaysia has obtained a Chinese patent (Chinese Application No. CN 201080053627) for its lead product-Stempeucel. The company has obtained patent rights in US as well (US 8956862) for the same technology. Stempeutics Research is the first company in the world to be granted a US process patent for a stem cell medicine based on pooling technology.

The technology pertains mainly to large scale culturing of mesenchymal stem cells for various clinical applications. The mesenchymal stem cells are derived from the bone marrow of multiple donors and are cryopreserved in a unique cryopreservation solution.

Stempeucel is prepared from allogenic bone marrow cells by passing through various cell bank generations. First, a “Master Cell Bank” (MCB) of mesenchymal

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