Articles
Mantras for success: FDCs and NDDS
(Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates,20-Dec-2017,Express Pharma)
“Every cloud has a silver lining”, it is said, “There is always light at the end of the tunnel”. Be it adages, maxims, proverbs and axioms or soothsayers’ predictions, crystal ball readings, priceless priestess Pythia’s Oracle at Apollo- statements, in current scenario of devastating confusions, FDC conundrums and Supreme Court hearings and pronouncements, they all become relevant for Indian pharmaceutical industry. More...
Technology Transfer during Outsourcing
(Dr.Gopakumar G Nair,19-Sep-2017,PharmaBio World)
With outsourcing and contract manufacturing well-established in the commercialization strategies of most pharmaceutical and biopharmaceutical companies, technology transfer becomes an enabling asset. Outsourcing and technology transfer provide firms with the platform for developing capability to achieve superior performance in the marketplace. More...
Evolution of Indian Pharma Regulatory Framework
(EP News Bureau ,5-Aug-2017,Express Pharma)
Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, gives insights on the transformational journey of India’s pharma industry coming to par with the global standards, since independence More...
Price Control of patented drugs in India
(Dr Gopakumar G Nair,27-Apr-2017,Pharmabiz)
Balancing of rights and obligations - rights of IP owners with obligation to honour needs of IP users has always been a hotspot on the IP system. More...
Techniques to enhance IP valuations
(Dr Gopakumar G Nair,20-Apr-2017,Express Pharma)
‘Jallikattu’ controversy can wait, IPR appears to be the new arena for the “bulls and bears.” Intellectual property right (IPR) has come a long way since Paris Convention and other early treaties and conventions. More...
New IPR policy to benefit MSMEs pharma sector with innovation: Dr Gopakumar Nair
(Laxmi Yadav,30-Jul-2016,Pharmabiz)
Medium and small scale pharma units in India need to update themselves to survive in changing regulatory and intellectual property environment. The government through the new IPR policy and amendment to the Rules (2016) is sending out clear signals that patents will be enforced in India to protect the patentee's rights, according to Dr. Gopakumar G Nair, CEO, Gopakumar Nair Associates. More...
Maharashtra FDA begins probe into sale of counterfeit version of cancer drug BiCNU by Taj Pharma
(Laxmi Yadav,4-Jun-2016,Pharmabiz)
The Maharashtra FDA in coordination with the DCGI office has initiated investigation into the alleged sale of counterfeit version of Emcure Pharmaceuticals' chemotherapy agent BiCNU (Carmustine for injection) by Mumbai based Taj Pharmaceuticals violating Drugs & Cosmetics Act, 1940 and Rules made thereunder. The probe was launched by the FDA following complaints by IPR committee of IDMA in this regard. Emcure had approached IDMA IPR committee seeking assistance to take action against Taj Pharma for selling counterfeit version of cancer and brain tumour drug Carmustine in global market thereby jeopardizing public health, informed Dr Gopakumar Nair, chairperson of IDMA IPR committee. More...
Experts urge India to join PIC/S to enhance recognition & sustain India’s global leadership in pharma generics
(Laxmi Yadav,2-Jun-2016,Pharmabiz)
In its efforts to enhance recognition as provider of quality drugs and boost drug exports, a leading generics player like India needs to step up efforts to join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) that currently has 48 medicine importing countries including US and European Union, said noted patent expert Dr Gopakumar G Nair. More...
India & Brazil: a comparative table
( Antonio Abrantes ,24-Aug-2015,http://patentescomentarios.blogspot.in)
The patent offices of India released in August 2015 re-examination manual for computer-implemented inventions program. The possibility of granting this area are enlarged compared to 2013. In 2013 Manual the method implemented by software on general-purpose computer was not considered invention: "The question Therefore, is Whether the computer program loaded on a general purpose computer known or related devices can be held patentable. Keeping in view the spirit of law the answer is in the negative. In an application for patent for a new hardware system, The Possibility of a computer program forming part of the claims is not ruled out. The examiner is to carefully handsome to the how is the novel integrated hardware with the computer program. The computer program Which may work on any general purpose computer known does not meet the requirements of the law. " More...
Forecast 2015
(Dr Gopakumar Nair,7-Jan-2015,Express Pharma)
Is Indian pharma under seige?
Is Indian pharmaceutical industry under siege? whom? USTR & Big Pharma? US FDA? NPPA? CDSCO? Other regulatory agencies? NGOs? Indian pharma is facing more challenges than opportunities at current times. As the year 2014 is exiting and a New Year is dawning, the Indian generic pharma industry needs to lay down strategies for the future. More...
The ‘Counterfeit’ conundrum in pharma industry – Is it time for concerted action?
(Dr Gopakumar G Nair,22-Dec-2014,Express Pharma)
SSFFC — ‘the latest World Health Organisation (WHO) initiative on Substandard/Spurious/Falsely-labelled/ Falsified/ Counterfeit medical products’ has been making slow but steady progress through meetings in 2012, 2013 and the latest on October 29-31, 2014. A technically strong delegation comprising four seniormost drug regulators from (DCSO/DCGI) office represented India. More...
Wake up call for Indian pharma
(Dr Gopakumar G Nair,25-Nov-2014,Express Pharma)
It is time for Indian pharma industries to wake up and take note of the emerging patent litigation scenario in India. Patent litigations in India in past five years or more have taken India closer to US in ex-parte injunctions and duration of individual patent cases pending in High Courts even though India can be proud (?) that we have longest pendencies of patent suits in India. More...
Indian generic pharma and global regulatory challenges
(Dr Gopakumar G Nair,1-Oct-2014,Express Pharma)
Indian generic pharma has come a long way since the 70’s and 80’s. The then Executive Director of IDMA (Indian Drug Manufacturer’s Association) Dr Venkat Narayan who was earlier Joint Secretary in Ministry of Chemicals including Pharmaceuticals stated in 1987, “If we have atleast 10 to 20 Indian pharma manufactures having more than Rs 100-crore turnover, we can be confident that the Indian pharmaceutical industry has found its place in the global map.” More...
India's options for improving affordable access to lifesaving patented medicines
(Dr. Gopakumar G. Nair, Karthika Nair and Andreya Fernandes,01-May-2014,Journal of Intellectual Property Rights, Vol 19(3), May 2014.)
India may need to have a relook at the flexibilities available under TRIPs and “Doha” to wriggle out of the stranglehold of endless adjournments without ‘cause of action’ and irrationally claimed injunctions against imaginary infringements and validly granted Compulsory Licences. Such an analysis is possible by starting to look at available options under Patents Act, 1970, as amended; to date, which are dealt with in this article. More...
Landmark Pharma Patent Jurisprudence in India
(Dr.Gopakumar G. Nair, Andreya Fernandes and Karthika Nair.,07-Apr-2014,Journal of Intellectual Property Rights, Vol 19(2), March 2014.)
In a short span of less than 10 years after the new WTO/TRIPS based product patent regime came into effect, there have been many landmark judgments from Indian Courts on interpretation of various provisions of the exhaustive (Indian) Patents Act, 1970, as amended. Even though very large number of product patents has been granted during this period, patent challenges and infringement suits are limited to a few blockbuster molecules. Currently, litigations are in progress, including in appeals as well as on matters remanded back to patent office. The landmark cases of recent times and additional areas, which may require judicial intervention arising out of the ambiguities in the Act and Rules are briefly dealt with in this Article. More...
Patent Policies and Provisions relating to Pharmaceuticals in India.
(Gopakumar G. Nair and Andreya Fernandes,Jan-2014,Journal of Intellectual Property Rights)
Indian generic pharma industry has established a “pride of place” as the largest generic manufacturer and supplier of essential and life-saving medicines to UNICEF, WHO, MSF and others. India has been acclaimed as the “Pharmacy of the World” with largest number of manufacturing facilities approved by the USFDA and EDRM, etc. More...
India should provide leadership to the initiative.
(Dr.Gopakumar G. Nair,1-Jan-2014,Express Pharma)
India, Brazil, China, Russia,Indonesia & South Africa should take initiative in pushing forward the agenda for an alternate patent system. India will not be isolated More...
Pharma sector seeks most number of patents in India
(Kalyan Ray,New Delhi,14-Dec-2013,Deccan herald)
New-age economic sectors like pharmaceuticals and computer technology pioneer innovation in India, leaving behind agriculture and heavy engineering that was the bedrock of the Indian economy for decades, a new analysis suggests. More...
MNCs lead in patenting of both product and processes in India after change in patent law: Origiin IP
(Nandita Vijay,Bengaluru,14-Dec-2013,Pharmabiz.com)
Origiin IP Solutions LLP has observed that there is an impressive number of foreign multinational pharmaceutical companies which have taken a lead in patenting activities in India. An analysis of the patent granted to pharmaceutical firm’s by Indian Patent Office (IPO) for period January 1, 2011 to September 25, 2013, revealed that, foreign MNC’s are keen in patenting their inventions at IPO with F. Hoffamann-La Roche AG leading the patent portfolio during period of study followed by Sanofi-Aventis. Indian origin MNC, Dr Reddy’s Lab occupies the third position, stated Bindu Sharma, patent attorney and CEO, Origiin IP Solutions LLP. More...
Not having data exclusivity is a boon for biosimilar or biobetter prospecting in India
(Dr Gopakumar G Nair,20-Nov-2013,Express Pharma)
Comparing the evolution of the global biotech/ biopharma industry and in India, what are the steps for India to reach to the next level of maturity? Identifying, evaluating and mapping Indian biotech proficiency, both within the country as well as overseas (NRIs), is the most urgent priority for moving towards the next level of maturity. India needs to attract biotech talents and nurture them. In the fields of biotech education and training research, regulatory bodies and industry, India needs practically qualified human resources. More...
India needs to adopt bold strategies
(Dr. Gopakumar G. Nair and Karthika Nair,01-Nov-2013,Express Pharma)
India needs to adopt bold strategies to provide affordable access to meet Cancer Care and Healthcare needs. More...
Indian regulatory scenario is far from rosy at these times
(Dr Gopakumar G Nair,1-Sep-2014,Express Pharma)
I have been a firm believer and a positive thinker on Indian pharma industry and its capabilities and strengths to scale the global technological and turnover tables and stables since the 1970s. In tandem with the strategies of the Indian government in the 70's and 80's, the Indian pharma industry picked up the gauntlet, stood up to the challenges and proved their might beyond doubt with the excellent growth, both in quality standards and in global generic pharma dominance, which commenced in early 1970s' and is continuing in the post-2005 product-patent era. More...
Legal Battles Patents vs. Generics: Who will rule?
(Dr Gopakumar G Nair,1-Jul-2013,Modern Pharma)
Dr. Gopakumar G. Nair,CEO, Gopakumar Nair Associates,opines," Generics are here to stay and will continue to be in the pink of health in 2020 too. By 2020, the early challenges to patented molecules viz. New chemical entity(NCE) will substantially diminish" More...
Aftermath of Drug Price Control Order, 2013.
(1-Jul-2013,Pharma Bio World - Chemtech Foundation)
Pharma Bio World in an exclusive interview with Dr. Gopakumar G. Nair, Founder, Gopakumar Nair Associates, explores the two sides of the new Drugs (Prices Control) Order,2013. More...
GNA Patent Gurukul submits revisions to norms for processing of patent applications relating to TK
(Nandita Vijay, Bengaluru,8-Mar-2013,Pharmabiz)
GNA Patent Gurukul has submitted the required revisions to the guidelines for processing of Patent Application relating to Traditional Knowledge to the Controller General of Patents: Design and Trademarks (CGPDTM). More...
Herbal sector object to draft norms for patenting of traditional knowledge
(Our Bureau, Bengaluru,23-Feb-2013,Pharmabiz)
Scientists representing herbal sector have strongly objected to the draft guidelines for patenting traditional knowledge and biological material issued by the Controller General of Patents Designs and Trademarks (CGPDTM) for which comments are solicited before March 15, 2013. More...
Needed – An innovation policy & roadmap for India
(Dr. Gopakumar G. Nair ,6-Dec-2012,Pharmabiz)
It is time we initiate a new road map for “globalization” with specific strategies to encourage innovation. More...
What keeps Indian Pharma going, growing ?
(Dr. Gopakumar G. Nair,22-Nov-2012,Pharmabiz)
Entrepreneurial resilience nothing else, assisted in part or occasionally by well-meaning government officials and confusingly compounded Indian pharma policies, apparently drafted in National interest, keeps the Indian Pharma going, growing. More...
Loopholes in the QA & QC system: Need to clear the ambiguities
(Nikunj Sharma,20-Nov-2012,Modern Pharma)
Dr.Gopakumar G.Nair, Patent Attorney and CEO,Gopakumar Nair Associates,says,“In regulatory fields, India is unique in many ways. India is the only country, till now, having multiple patent offices in all metros, which leads to non-uniform patent practices and poor centralized controls. Similarly in pharmaceutical regulations, India is unique" More...
Discourages the art of ever-greening
(Dr Gopakumar G Nair,1-Nov-2012,Express Pharma)
The Indian Patent Law-the Patents Act, 1970 and Rules thereunder truly encourages innovation. More...
Quo Vadis, Indian API - Bulk drug Industry?
(Dr.Gopakumar G. Nair,1-Oct-2012,Pharma Bio World)
In this article, Dr.Nair argues about the decline of bulk drug manufacturing and dominance of import lobbies in the country. More...
Post-TRIPS thrust triggers for Indian Pharmaceuticals in the IP Context.
(Gopakumar G. Nair, Andreya Fernandes and Kavita Rao Parmar.,1-Jul-2012,Journal of Intellectual Property Rights)
The impact of the transition of Indian patent regime from pre-TRIPS to post-TRIPS and the post 2005 product patent regime is discussed sequentially with evaluation thereof. Contrary to general perceptions and negative expectations, India appears to have driven through the anticipated 'rough weather', most successfully and creditably, largely thanks to the lawmakers making best use of the flexibilities permitted in TRIPS. More...
Govt use of compulsory licence - Sovereign immunity
(Gopakumar G. Nair and Andreya Fernandes,27-Jun-2012,Pharmabiz)
The US Patent Law 35 U.S.C while being silent on Compulsory Licence has a separate code for granting of CL outside the provisions of the US Patent Law. More...
Stale news: Universities for research and innovation Bill 2012
(J.Sai Deepak,27-May-2012,The Demanding Mistress (Google Groups))
On May 21 2012 the Universities for Research and Innovation Bill 2012 was introduced in the Lok Sabha. From the Statement of Objects and Reasons of the Bill it appears that although innovation is recognised as one of the key drivers of the economy the position that has been adopted is that public expenditure alone is not sufficient.
Acknowledgment - Thanks to Mr. J.Sai Deepak of The Demanding Mistress (Google Groups) for drawing attention to this case. More...
Patent controller to meet stakeholders today at his office
(Suja Nair Shirodkar,3-Apr-2012,Pharmabiz.com)
With a view to understand the demands of the industry, the patents office has organised a high profile meeting with the stakeholders in Mumbai on April 3. This will be the first meeting held under the leadership of the new CG, Chaitanya Prasad with an aim to develop better understanding between the stakeholders and the patents office for better delivery of services in the future. More...
DHC brings down the viva-voce cut off marks for patent agent exam
(Rajiv Kr. Choudhry,15-Mar-2012,SpicyIp)
In a recent decision Ms. Anvita Singh v. Union of India and Another the Delhi High Court has directed the Patent Office to register a candidate as a patent agent who had passed the the written portion but failed in the viva voce.
Acknowledgment - Thanks to Rajiv Kr. Choudhry of SpicyIP for drawing attention to this case. More...
Compulsory licensing Patients vs Patents?
(Viveka Roychowdhury ,12-Mar-2012,Express Pharma)
The recent grant of Indias first compulsory license has once again brought the patients vs patents debate to the fore. More...
POSER OVER MEDICINE SUPPLIES
(Martin Khor,9-Jan-2012,The Star (Malaysia) )
Patients worldwide suffering from various ailments have benefited from cheap generic Indian drugs.
Acknowledgment - Thanks to Mr. Gopa Kumar of Third World Network for drawing attention to this case More...
Chennai HC rejects Roche's patent suit against Matrix in light of lack of jurisdiction
(Our Bureau, Mumbai,17-Dec-2011,Pharmabiz)
Dr Gopakumar G Nair intellectual property and patent and trade mark attorney pointed out that under the recent judgement the HC held that Matrix by approaching the IPA Board Chennai did not give rise to a cause of action from Roche against Matrix as mere filing of an application for revocation in IPA Board Chennai cannot give rise to a cause of action especially since IPA Board has its headquarters at Chennai. More...
For a “Pretty Picture” in Indian pharma industry
(Dr. Gopakumar G. Nair,15-Dec-2011,Pharmabiz)
The latest decision of the Court of Justice of the European Union equivalent to the Supreme Court is a welcome relief for all generic exporters. More...
MNC patent monopoly and takeover of generics in India
(K. M. Gopakumar,21-Dec-2011,SUNS and TWN )
A new study reveals that multinational pharmaceutical companies are exploiting their product monopoly to charge high prices under Indias product patent law as well as gradually taking over the domestic generic sector. More...
DIPP amends FDI policy on options in equity instruments by deleting Clause 3.3.2.1
(Suja Nair Shirodkar,7-Nov-2011,Pharmabiz.com)
According to Dr.Gopakumar G. Nair, Intellectual property and Patent and Trademark Attorney, the real strength of India over the years have been a strong autonomous and non-corrupt RBI. RBI having objected to the inclusion of such bar on options as in the Clause 3.3.2.1, thus the DIPP is justified in deleting this clause. More...
Strong policy support, incentives are better option to pharma sector than FDI cap: Dr G G Nair
(Suja Nair Shirodkar, Mumbai,5-Nov-2011,Pharmabiz)
Pharma industry wants the government to give more incentives to this sector so that it would not be forced to look at the foreign direct investment route for growth. More...
AIA Ho! - US Patents Act Amendments
(Dr Gopakumar G Nair,5-Oct-2011,Pharmabiz)
Something long overdue in the patent regime of the USA the America Invents Act has been passed by the US Congress amending the 35USC American Patents Act and Procedures thereof. More...
Bionic Bacteria May Help Make New Drugs, Biofuels: Artificially Enhanced Bacteria Capable of Producing New Kinds of Synthetic Chemicals
(Science News,22-Sep-2011,ScienceDaily )
For the first time the scientists were able to create bacteria capable of effectively incorporating unnatural amino acids artificial additions to the 20 naturally occurring amino acids used as biological building blocks into proteins at multiple sites. More...
Cipla wins pre-grant opposition against Novartis for dispersible tabs containing deferacirox
(Suja Nair Shirodkar,30-Jun-2011,Pharmabiz.com)
The Chennai patent office has granted a pre-grant opposition in favour of Cipla for dispersible tablets containing 'deferacirox'. Out of the four grounds under which Cipla had filed for the pre grant opposition, the Patent office upheld two of it. More...
New drug discovery - need for introspection!
(Dr. Gopakumar G. Nair ,15-Jun-2011,Pharmabiz)
Trend of annual NCE approvals have been alarmingly coming down from average of about 50 prior to the nineties to almost an average of below 30 in the recent times. More...
Patent office yet to upload information on working patents in India
(Suja Nair Shirodkar,15-Jun-2011,Pharmabiz.com)
The patent office is yet to upload the information it has collected from the companies on their patents that are being worked in India, on its website for public use. According to the Controller General of Patents, Designs & Trade Marks, the data collected through this was supposed to be accessible to the public on its website by June 1, 2011. However, as of now there have been no updates on the same. More...
India asks firms to provide data on working of patents
(By Anju Ghangurde,20-Jan-2010,Scrip World Pharmaceutical News)
India has asked all patentees and licensees to provide information on the working of patents in the country before March 31st 2010. More...
People who will save the world
(Yusuf K. Hamied ,8-Jan-2010,FORBES INDIA)
For someone who calls himself a man of science Yusuf K. Hamied has a patent dis like for intellectual property rights. More...
Genesis of Pregrant Oppositions & its current status
(Dr Gopakumar G Nair,10-Dec-2009,Pharmabiz)
The Patents Act 1970 as amended in 2005 with active participation from the lawmakers in the floor of the House introduced the provision for Pregrant Opposition for the first time in India. More...
Blocked in transit
(Dr Gopakumar Nair ,D G Shah,30-Nov-2009,Express Pharma)
As per TRIPS provision under Section 255 cross border measures really do not include patents and in transit materials because a majority of issues of counterfeit are related to quality and misbranding wrong branding informs Dr Gopakumar Nair Patent Attorney and CEO Gopakumar Nair Associates. More...
Latest Situations and Developments of Trademark Applications and Examinations in China
(Mr Hung-Pang Bian ,21-Aug-2009,World Patent & Trademark Law Office)
According to a recent mass media report Fu Shuangjian who is currently deputy chief of Administration Bureau of Chinese Industry and Commerce paid a visit to Taiwan on June 15 2009 during which he gave a comprehensive presentation and outline on the latest situations and developments of Trademark applications and examinations in China. More...
Mr D G Shah presentation to Secretary, DoP
(21-Jul-2009,IDMA)
Reproduced with due permission from Mr. D G Shah and IDMA. More...
Ready for Round 2
(Dr Gopakumar G Nair,Dr M Venkateswarlu,Tapan Ray,A S Krishna,Ranga Iyer,A S Krishna,16-May-2009,Express Pharma)
Legally speaking a patent is an exclusionary right given by the government or the authorised authority to its inventor for a particular duration in respect of his invention. More...
Blocked in transit
(D G Shah,Dr. Gopakumar Nair,10-Apr-2009,Express Pharma)
As aggressive IP enforcement continues at the hands of EU ports should goods in transit be protected when they are without a doubt intended for markets where their use is legitimate. More...
Form No. 44 Entry relating to Patent Status is redundant and unnecessary
(Shri Dedashish Panda ,07-Apr-2009,IDMA BULLETIN)
In the recent controversy on Marketing Approval the entry Patent Status in Form No. 44 came up for discussion rather prominently. More...
More than just a rubber stamp?
(Dr Gopakumar G Nair,Dr Ajit Dangi,Dr Venkateswarlu,15-Mar-2009,Express Pharma)
It is unfair to blame the MNCs for everything. The MNCs themselves are the most frequent targets of USFDA. More...
Impact of TRIPS on Indian Pharmaceutical Industry
(Dr.Gopakumar G. Nair,1-Sep-2008,Journal of Intellectual Property Rights)
After India became a founder member of WTO and acceded to the TRIPS Agreement, the product patent regime was reintroduced in India after a gap of 35 years. The significance of the new IP regime on pharmaceutical industry in India, the amendment to the Patents Act 1970, in fulfillment of the obligations to comply with TRIPS, related developments in other fields of IP as well as enforcement of new IP/Patent regime on the pharmaceutical industry are comprehensively discussed in this Article. More...
A tug of war
(Dr Gopakumar Nair, Dilip G Shah, Tapan Ray, Dr Ajit Dangi, Priyank Gupta,28-May-2008,Express Pharma)
India's nasacent patent regime is under the scanner and the industry is grappling with questions like - What is the long term solution to balance patent protection with patient needs, in developing countries like India and especially with life threatening conditions like India and especially with life threatening conditions like cancer and AIDS? What is the situation in other countries on such issues? More...
Why is the DCGI trying to implement a 'patent-registeration' linkage system in India?
(Prashant Reddy,09-May-2008,Spicy IP)
The Drug Controller General of India - Dr. Surinder Singh - has made a public statement that he intends to link up regulatory approval for drugs to the patenting system i.e. he has gone on to record to state that the DCGI will not grant regulatory approval for generic drugs if in case the innovator drug still has a valid patent covering it. More...
IP education -The Indian reality
(Dr Gopakumar G. Nair,Chronicle,13-Dec-2007,PharmaBiz)
The emergence of intellectual property (IP) through WTO & TRIPs to the forefront of international trade had taken India by surprise in the early 90's. More...
Opposing before granting
(Ashwini Sandu & Raju Kumar,Chronicle,13-Dec-2007,PharmaBiz)
The emergence of Pre-grant opposition is a newly emerging hot topic of discussion on the international scenario too. More...
Notices regarding Claims And Continuations Rules
(5-Nov-2007,USPTO)
Recent USPTO Announcement of postponing the implementation of proposed revision in the rules of practice in USPTO.The report is reproduced . More...
Ranbaxy gets favourable decision from German court against Pfizer
(Our Bureau, Mumbai,31-Oct-2007,PharmaBiz)
Ranbaxy Laboratories Limited (RLL) has announced that the Federal Patent Court of Germany located in Munich, handed down a favourable decision for Ranbaxy in its case against (Pfizer) Warner-Lambert's European Patent 409 281 (281) More...
USPTO Publishes Examination Guidelines for Determining Obviousness in Light of the Supreme Court's KSR v Teleflex Decision
(10-Oct-2007,USPTO)
The Department of Commerce's United States Patent and Trademark Office (USPTO) has published Examination Guidelines (Guidelines) to help USPTO examiners make appropriate decisions regarding the obviousness of claimed inventions in light of the Supreme Court's decision in KSR International Co. v. Teleflex Inc., 550 U.S., 82 USPQ2d 1385 (2007) (KSR). More...
The Examination Guidelines can be found at
More...
Patenting: The Indian way
(27-Sep-2007,PharmaBiz)
India's entry into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) compliant product patent regime has stirred hornet's nest in the global IP scenario. More...
For a fool proof patent
(22-Sep-2007,Express Pharma)
Pharma companies employ various strategies while drafting patent claims. More...
USPTO Publishes Measures to Improve Patent Quality
(20-Aug-2007,USPTO)
USPTO moving forward to improve patent quality -Federal Register publishes new draft rules will become effective 1st November 2007.For details go to More...
Verdict On Glivec
(9-Aug-2007,CHRONICLE PHARMABIZ)
The controversial patent litigation over Glivec has come to almost to an end on last Monday with the Madras High Court rejecting Novartis' petition challenging More...
Indian Pharma Industry: The Road Ahead
(Feb-Mar-2007,Modern Pharmaceuticals)
In this article, Dr. Nair takes a look at the Indian Pharma Industry and the future trends in the industry. More...
Time to "bridge the gulf"
(25-Jan-2007,PharmaBiz)
In this article, Dr. Nair takes a look at the potential for growth for the Indian Pharma sector in the Gulf countries. More...
The Mashelkar Committee Report.
More...
Invitation from the Department of Science and Technology for Research Proposals
Invitation from the Department of Science and Technology for Research Proposals from Academic Institutions/National Laboratories and Industries in Drugs and Pharma Sector under the Drugs and Pharmaceutical Research Programme (DPRP). More...
Indian Patent Act and its impact on Pharma Industry.
(2006,Pharmexcil)
In this article, Dr. Nair takes an in-depth look at the Indian Patent Act and its impact on the Indian Pharma Industry. More...
Incremental innovations in drug research
(30-Nov-2006,PharmaBiz)
This article takes a look at the rising importance of "Incremental Innovations" for pharma companies and also takes a look at the Indian scenario for the same. More...
People Assets - Are we on track.
(1-Nov-2006,Express Pharma)
In this article, Dr. Gopakumar Nair opines that a road block to the Indian pharma success story could be diminishing human resources. More...
Towards greater IPR protection
(19-Oct-2006,PharmaBiz)
This article takes a look at the current IPR scenario in the Middle East countries, giving UAE as a specific example. More...
Data exclusivity - a practical model for India
(28-Sep-2006,PharmaBiz)
This article gives the significance of data exclusivity for the Indian pharma industry and a practical model for implementing the same. More...
TRIPs & Patents
(Aug-2006,Modern Pharmaceuticals)
This is the first draft of the article which appeared in Modern Pharmaceuticals, August-September 2006 and describes the impact of TRIPS on the Indian Pharmaceutical industry. More...
The decision of the Indian Patent Office
The decision of the Indian Patent Office (IPO) regarding the opposition filed by M/s Cipla Ltd to the patent application no. 1602/MAS/1998 filed by M/s Novartis AG for Gleevec (Imatinib Mesylate). More...
IP Protection post-2004: A Review
(1-Dec-2005,PharmaBiz)
This article gives the scenario of IP protection in India, after 2004. More...
Is latest US Appeal Court's En Banc judgment anti-"evergreening"?
(22-Oct-2005)
This article takes a look at the anti-evergreening steps taken by the Indian Parliament and a case study regarding a recent US judgment concerned with evergreening. More...
Harmonised Patent Law installed at WIPO
(23-Jun-2005,PharmaBiz)
This article gives an overview of the problems faced by SPLT (Substantive Patent Law Treaty) at the June meeting of the SCP (Standing Committee on the Law of Patents). More...
Additional features of the new Patent Ordinance
(15-Jan-2005,PharmaBiz)
This article draws attention to certain aspects of the new patent amendment that needs closer attention. More...
Ordinance 2004 (Patent tsunami or parting gift)
(29-Dec-2004,Pharma Pulse)
This article mentions a few salient features of the 2004 Ordinance to the Patent Act, 1970. More...
Product patents and transition status
(23-Dec-2004,PharmaBiz)
This article discusses the 3rd Amendment to The Patent Act, 1970. More...
Discovery of India The El-"CRO"rado (CRO - Contract Research Organisations)
(28-Jun-2004,Pharma Pulse)
This article cries out for a re-discovery of India for its technological treasures. More...
Emergency Encounter and other Reminiscences
(31-May-2004,Pharma Pulse)
This article takes a look at a few meetings Dr. Gopakumar Nair attended in Delhi, during the Emergency. More...
IP in India: A Hobson's Choice
(25-Dec-2003,PharmaBiz)
This article discusses the limited options facing India regarding IP. More...
Agriculture: Great Expectations from Cancun? for the day after syndrome
(3-Sep-2003,PharmaBiz)
This article discusses the problems faced on the road from Doha to Cancun. More...
Patent Rules 2003 Ushers in the Patent (Amendment) Act, 2002
(9-July-2003,PharmaBiz)
This article discusses the changes brought about by the Patent (Amendment) Act, 2002. More...
Balancing benefits and downsides of Intellectual Property
(18-Jun-2003,PharmaBiz)
This article discusses the balancing act to be performed by various countries with regards to IP. More...
Indian Patent Law and Pharma Industry
(29-May-2003,PharmaBiz)
This article discusses the Indian Patent Law w.r.t. the Pharma Industry. More...
Critical commentary on changes in Patent Law effective 20th May 2003
(23-May-2003)
This article is a critical commentary on the changes in the Patent Law. More...
Hathi mere Sathi
(17-May-2003,Pharma Pulse)
This article starting with an anecdote, takes a brief look at the Hathi Commission Report. More...
Pharma Technology Upgradation
(30-Jan-2003)
This article states the need for technology upgradation in the Indian Pharma sector. More...
A problem of mindset
(23-July-2002,PharmaBiz)
This article details the changes in mindset that have to be made in the Indian Pharma industry to meet the strong global demand. More...
Indian Pharmaceutical Industry - Some myths and few facts
(29-May-2002,Pharmabiz)
This article states some myths and a few facts regarding the Indian Pharmaceutical Industry. More...
An ode to the budget (& the FM)
(29-Jan-2002,PharmaBiz)
This article, in the form of an ode, requests the FM to do away with regulatory pricing in the Pharma industry. More...
Point-Counterpoint: Doha Ministerial meet
(11-Dec-2001,PharmaBiz)
This article discusses the Doha Ministerial meet. More...
