Tuesday, May 30, 2006

A Journey called TRIPS Compliance

April 1994 Indian signs the Marrakesh Agreement. Join the World Trade Organization (WTO) as a founding member. December 1994 The President of India on 31 December 1994 promulgated the Patents (Amendment) Ordinance, 1994. Feature initiated: Mailbox mechanism – pharma or agro-chemical products under article 70.8 (a) of TRIPS Agreement. January 1995 The WTO comes into force. March 1995 Ordinance 1994 lapsed on March 26, 1995. During this period 125 product patent applications filed. Amendment Bill 1995 introduced in the Loksabha. May 1996 Bill 1995 referred to a Select committee of the House for examination and report. The Patent (Amendment) Bill 1995 lapses with the dissolution of the 10th Loksabha on 10 May 1996. April 1997 Cases against India (for non-compliance of TRIPS) at the WTO initiated by the US and EC. March 1999 Bill 1999 passed on March 26, 1999 with retrospective effect from January 1, 1995. May 2002 Patent (Second Amendment) Act, 2002 comes into force on May 20, 2003. December 2003 Patent (Third Amendment) Bill, 2003 introduced in Rajya Sabha. January 2005 Third Amendment Ordinance came into force on January 01, 2005. March 2005 On March 23, 2005 Rajya Sabha passes the Patent (Amendment) Bill, 2005 April 2005 On April 5, 2005 President of India gave assent to Patents (Amendment) Bill, 2005. May 2006 Government of India on May 11, 2006 notified Patents (Amendment) Rules, 2006.
Compiled by Seema Singh, Patent Attorney working with Mumbai-based Pharmaceutical Company. (Email ID: seemasingh_27@yahoo.com)

Monday, May 29, 2006

Medicinal Product SPCs Holders (1991 - 2003)

The figure above represents the number of SPCs sorted by holders. Source: European Generics Medicines Associations

1991 - 2003 Medicinal Product SPCs

The figure above represents the number of SPCs sorted by country. For each country, is shown the number of SPCs, which were still in force, which were expired or lapsed, and which were withdrawn or rejected on January 1st 2004.

Thursday, May 25, 2006

What is Indian Pharma’s Next Move?

Indian pharmaceutical industry received 1/1/2005 with mixed feelings. While, domestic and foreign markets were expanding, 1/1/2005 had ushered in the new era of product patents. The game board was the same, but the game had changed from ‘Checkers’ to ‘Chess.’ Indian pharma had thrived on process patents till 1/1/05, but now will have to contend with product patents. Some industry analysts were predicting that this ‘1/1’ will be a kind of a ‘9/11’ for Indian pharma. So, how are we doing so far? What is on Indian pharma’s health chart? Is the pulse sinking? Was the product patent regime just a bitter medicine or a deadly poison? Indian Pharma: Medical History The Indian Patent Act, 1970, permitted the Indian pharmaceutical companies to reverse-engineer (manufacture through a different process) the patented molecules and sell them in the domestic and certain foreign markets. Most of the pharma companies in the Indian pharmaceutical industry were able to register significant growth until 2005 because of a system of ‘process patents’ as against the Western countries, which were following the ‘product patent’ system. The process patent regime has enabled India to become a global and respected player in the pharmaceuticals industry. However, when the Indian Parliament passed the Patents (Amendment) Bill, 2005, on March 22, with retroactive effect to 1/1/2005, all of that changed. Indian Pharma: Diagnosis The highly organized Indian pharma industry is in the forefront of scientific industries, with a wide range of capabilities in the technological and drug manufacturing fields. The Indian pharma industry is estimated to be worth about $10 billion, with an 8-9% annual growth rate. It is one of the leading industries among the Third World countries, and is highly respected for its quality, technology, and range of drugs manufactured and supplied at competitive prices. The growth of the Indian pharma industry is primarily propelled by export markets. India exports its drugs to more than 65 countries. According to McKinsey, Indian pharma exports contribute US $3.2 billion out of the annual turnover of $5 billion, with the industry further assured to grow at $25 billion by 2010. Indian pharma industry’s share in value terms in the global market is estimated to be at 1% (13th rank), while in volume terms, it is 8% (4th rank). India also has the largest number (74) of US Food & Drug Administration (USFDA) approved drug manufacturing facilities outside the US. There were 126 Drug Master Files (DMFs) filed by Indian companies, which was higher than the combined DMFs of China, Italy, Spain and Israel. Indian companies, on an average, account for 35% of all DMF applications in the US. The Indian companies’ share in the domestic market has witnessed continuous growth from nearly 20% in 1970 to 70% in 2005. In terms of revenue, Ranbaxy Laboratories leads the Indian pharma companies, while Cipla and Dr. Reddy’s Laboratories stand second and third respectively. With the size and foothold of the big Indian pharmaceuticals industry, some analysts feel that the impact of the new product patent regime will not be earth-shattering. As, Dr. Anji Reddy, Chairman, DRL, said, "We [in India] have brilliant people who are as good as or even better than anyone anywhere else in the world. We're ready for 2005." Big companies such as Dr. Reddy’s Labs, Cipla, and Ranbaxy are following a two-pronged strategy in the new product patent regime. In the domestic market, these companies are manufacturing generic drugs, or are using a different ‘process patent’ to boost their growth. In the global pharmaceuticals market they are targeting the US generics market, where $40 billion worth of drugs are about to go off patent in 2005 and another $70 billion drugs by 2008. Drugs with combined global annual sales of $80 billion will go off patent before 2012. The global generic market, growing at 10% annually, is expected to expand from $36 billion now to $50-55 billion by 2008, in which India will capture a significant share of the market. This will enable Indian companies to continue to grow at healthy rates. Opportunities under the new patent regime are immense for India as even the new MNCs such as Pfizer and GlaxoSmithKline are expanding their R&D bases in India. Mr. Uday Saxena, the Chief Scientific Officer of DRL, felt that opportunities in drug discovery were huge in India due to its low cost of R&D and clinical trials contrasted with burgeoning R&D costs in the US. According to Syngene, India’s highly successful contract research firm for pharmaceuticals, the cost of doing R&D in India is five times lower than the cost involved in new drug discovery in a developed country. The launch of a new molecule in India costs only about $100-200 million. Compare this to the US, where it is estimated that the average cost to develop a successful new drug is nearly $500-900 million, and the development period ranges between 10 and 12 years. Studies also reveal that patient recruitment and medical personnel costs constitute about 70% of the clinical trial costs expected in introducing a drug into the market. In 2001, the global pharmaceuticals industry spent $30.4 billion on R&D. Obviously, the R&D costs will be recovered from the sale of those patented drugs. It is also true that the monopolistic conditions created by a patent influence the drug manufacturer’s pricing decisions. 3TC (Lamivudine), marketed by Glaxo, is priced in the US at $ 3,271 per patient per annum, while Indian generic producers such as Cipla and Hetero Drugs offer their generic versions at $190 and $98 per annum respectively. Similarly, Bristol Myers Squibb’s US price for Zerit (Stavudine) is $3,589 per patient per annum, as against Cipla’s $70 and Hetero Drugs’ $47 respectively. The price charged for Viramune (Nevirapine) by Boehringer Ingelheim in the US is $3,508 compared with Cipla and Hetero Drugs’ prices of $340 and $202 respectively. Cipla offered to supply a three-in-one combination of the aforementioned drugs for $350-600 per annum compared to US price of $10,000-15,000 for the patented drugs. Prescription A ‘product patent’ regime does not really un-plug the ventilator of any country’s pharmaceutical industry. Actually, the pharmaceuticals industry thrives in countries where ‘product patents’ are strictly enforced. What then, is Indian pharmaceutical industry’s specific medical condition? Indian pharmaceutical industry is now undergoing a change. It needs to take certain actions to get in step with the joggers in the big-money park. Some Indian pharmaceuticals companies could seriously consider consolidation efforts with other companies to increase their R&D capabilities. Indian pharmaceuticals companies can also enter into licensing agreements and earn good revenues from licensed pharmaceuticals. In 2003, licensing deals contributed to 20% of total sales to pharmaceuticals companies, and this figure is set to increase to 40% by 2009. They can also obtain more contract manufacturing opportunities. There is also a huge global market for generic drugs, which the Indian companies are well poised to exploit. According to the research study by London-based researcher, Global Insight, India’s global share in the generic market, which is 4% now, will increase to 33% by 2007. These strategic steps can enable Indian companies to become much bigger global players. However, the giant leap will be to emerge as the R&D leader. India can use its cost advantage to develop new drugs at a cheaper rate and a faster pace. In this manner, India will soon have its own, patented new drugs to dominate the global markets. Expressing his views on the new product patent regime, Homi Bhabha, Director, Organization of Pharmaceutical Producers of India (OPPI), said, “This is a big opportunity for Indian pharmaceutical industry, and should not be treated as a threat. The process patent regime which we had till January 2005 has really helped Indian industry to grow by leaps and bounds to become very cost effective producer of bulk drugs and medicines. The time has now come for the Indian industry to establish a global foot print by taking advantage of the Intellectual Property Rights (IPR) regime.” Indian pharmaceuticals industry has already embarked on the journey to benefit from the product patents. As opposed to earlier, when Indian companies invested only around 1% on R&D, they are now investing huge amounts on R&D. In 2003-04, the top 10 Indian pharma companies spent about $400 million on R&D. In 2004, Ranbaxy invested 7% of its $ 1 billion sales on R&D, while Dr. Reddy’s Laboratories (DRL) spent 14% of its sales of $ 446 million on R&D. As Dr.Reddy, Chairman DRL, says, “Excelling in the basic business operations will be necessary, but not sufficient. To maintain a long-term presence in the global pharmaceuticals markets and to grow profitably will require companies to be even more focused on R&D and creation of successful IPRs [Intellectual Property Rights].” Second Opinion As the medical care persons acknowledge, everyone has a right to seek a second opinion. Let us review some other courses of action. Some companies invest heavily in R&D, with the strategy to create direct revenues from the patents through licensing. Andrx corporation, which has approximately 100 US patents and 135 international patents pending in 2005, earned $11.9 million in 2005, and $12.5 million in 2004 in just one quarter through licensing. Isis Pharma has a portfolio of 1,500 patents, covering antisense and RNA-based drug discovery and development. Isis is the owner of largest antisense and RNA patent portfolio in the pharma industry. It holds key patents covering antisense mechanisms, biology, chemistry, inhibitors of gene expression, and production of antisense drugs. Isis successfully capitalized on its IP portfolio and generated about $70 million from licensing its patents. Isis exploited its IP by entering into strategic collaborations with other companies that leveraged its revenues and enabled it to offer new and useful products to patients. Isis Pharma’s broad patent portfolio enables them to grow into other areas of their core therapeutic focus, leading to increase in the number of antisense drugs under development, contributing to their commercial success of multiple drugs.
There is another popular opinion. Indian pharmaceuticals companies are also making strides in contract manufacturing and out-sourced research. Many small and medium-sized pharma companies in India can serve as research centres for MNCs abroad because of the low cost of research and large pool of talent in India. It is estimated that the global contract research accounts for $30 billion, of which a significant share can be captured by India. Moreover, India is now being widely looked upon by the world as the most preferred destination for clinical trials. Reinforcing India’s position in the new product patent regime, Habil Khorakiwala, Managing Director, Wockhardt, said, “India will be a research base for new drug discoveries and a hub for clinical trials. In the long term extensive research and clinical trials for new drugs will be conducted, considering the large population.” Global companies such as Astra Zeneca, Chiron, Bayer, Eli Lilly, Merck, GlaxoSmithKline, Novartis, Pfizer, Aventis, and Rosch have chosen India as a regional centre for conducting clinical trials and research. It is estimated that pharma companies globally spend $ 8-10 billion per annum on clinical research. According to some estimates, India gets $20 million worth of outsourced operations, which is further expected to increase to $2 billion over the next decade. Alternate Medicine The global herbal market, estimated to be worth US$ 62 billion, offers a plethora of opportunities for the Indian pharma companies. India’s current share in the global herbal market is just $1 billion and a huge opportunity awaits the ingenious Indian pharmaceuticals, to be availed through innovation, patents, and trademarks. According to the World Bank, the global market for medicinal plants and products includes the potential sectors of pharmaceuticals, nutraceuticals, cosmetics, and agro-chemicals. India has enormous resources of medicinal and herbal plants. The pre-historic knowledge of Ayurveda and its applications to cure illnesses effectively hasn’t been explored fully by India. If this happens successfully, India could gain a very significant competitive edge in the global market, especially in the pharma, beauty care, and healthcare segments. Since this traditional knowledge of Ayurveda is not available to other countries, India could dominate in this sector. Reinforcing this idea, Dr. SPS Khannuja, Director, Central Institute of Medicinal and Aromatic Plants (CIMAP), Lucknow, said, “There is a lot of scope for India to achieve global leadership through export of quality produce and products from medicinal and aromatic plants.” But India seems to be lagging behind, and is ranked third in the herbal medicine category, with less than 2% of global market share, while China occupies nearly 30% of the market. According to an Ayurveda expert, Chinese herbal medicines, which rarely contain 10% scientific base when compared with the Indian Ayurvedic System, are doing better than India by fifty-fold. India has the necessary resources and the ability both to cater to the ever-increasing demand for natural and herbal products in various segments such as perfumery, food, pharma, cosmetics, haircare, healthcare, etc. To give an idea of the kind of resources at the disposal of India, it has 10 bio-geographic regions and 25 biotic territories. India is also a haven for 8000 medicinal plants, of which 2200 possess therapeutic properties. Dr. BR Rajeswara Rao, Deputy Director of CIMAP, Hyderabad, echoed the thoughts of Khannuja and said that traditional knowledge, with a judicious mix of modern biotechnological and chemical tools, has the potential to leverage new drug discovery, resulting in the fusion of traditional and modern medicine. We have seen examples of successful companies, such as Himalaya Drug Company (HDC), Emami, Aswini, Ayur, Dabur, Cholayil Pharma, etc., who have patented their herbal/ayurvedic products in India and abroad. HDC patented its ‘Herbal Laxative’ preparation for treatment of constipation in February 2001 in the US. HDC’s products have been endorsed by more than 250,000 doctors worldwide, and the company exports its products to more than 60 countries. Today, HDC is the only phytopharmaceutical company whose ayurvedic products are registered as a ‘pharmaceutical specialty’ in Switzerland. Emami has also filed a patent in India. Between 1995 and 2003, Dabur India Ltd., applied for 96 patents in India. Dabur, which owns 29 patents in the US, is amongst the leaders in healthcare. It became one of the only two companies in the world to introduce an anti-cancer drug, Intaxel (Paclitaxel). Dabur Research Foundation developed a unique eco-friendly process for extracting the drug from its plant source. Other countries, such as China and Malaysia, are also recognizing the importance of natural/herbal products. The traditional medicine business in Malaysia is estimated to be US $ 1.19 billion (or Ringgit 4.5 billion) annually. In the last 5-10 years, most of the traditional health products originated from either China or India, but now, even Malaysia has entered the race. This proves that there is tremendous potential for natural/herbal products, whose formulations can be patented. It is no exaggeration to say that an ‘Herbal Revolution’ by India is just waiting to happen. India could truly become a global leader in the herbal medicine category by inventing and patenting medicines for several ailments by using a combination or mixture of herbal formulations. Winning Formula In the present situation, Indian pharmaceuticals may have weathered the storm because of many factors. The ‘product patents’ of foreign companies may have expired, or may have a corresponding ‘process patent’ in India, or may not have been registered as patents in India. In all these situations, there is no cause for alarm. Indian pharmaceutical industry is still in good health, as seen by the results declared by the leading pharmaceutical companies (pharma sector sales up by about 20% year-on-year). However, prevention is better than cure. This is the best time to perform patent analysis, assess the situation of your patents and others’ patents, explore the possibilities of patent extensions, and licensing, and to understand the impact of product patents when new drugs will be introduced in future. This is the opportunity to create market advantage by patenting robust drug formulations and to create effective brands (trademarks) that can outlast patents. Now, more than ever, there is a need to define a growth-focused Intellectual Property Rights (IPR) strategy. Because, winning without a strategy is only possible in a lottery.
Today's post comes from M.Qaiser & P. Mohan Chandran with iPrex Solutions, Hyderabad. This article was first published with US-based Online Portal IPFrontline on October 29, 2005. Copyright © 2006 iPrex Solutions.

Tuesday, May 23, 2006

Viread: The Next ‘Pre-grant Opposition’ Target

After infamous anti-influenza drug Tamiflu (Oseltamivir Phosphate), Gilead Sciences is again back in news but this time with its antiretroviral drug Viread. Like Tamiflu pre-grant opposition, Viread patent application is also facing pre-grant opposition. Lawyers, from Bangalore-based Alternate Law Forum, have filed a pre-grant opposition against the Viread patent application on the behalf of two NGOs --- Delhi Network of Positive People and Indian Network for People Living with H.I.V./AIDS --- contending that Viread is not a new drug but a modified version of earlier known compound, and therefore not eligible for patent protection under post-product patent regime. In addition, there is widespread apprehension among the public that if patent is granted against this pending application the prices for this antiretroviral drug may shot up up as Indian companies would be required to pay royalties Gilead Sciences to legally continue their generic copies as per new Patent Amendment Act. Presently, Cipla and Ranbaxy are manufacturing and marketing generic versions of Viread in India. Under section 25 (1) of the Patents Act 1970 any person can file an opposition against the grant of patent on the specified eleven ‘ mutually exclusive’ grounds. Nowhere mere public apprehension is considered to be valid ground to oppose patent application. Following the Gleevac case, here again section 3 (d) of the Patents Act 1970 is likely to play a critical part in the pre-grant opposition, questioning the patentability of Viread under newly amended section 3(d). Not a Drug but a Prodrug Before debating the patentability issue of Viread under the Patents Act 1970 it is important to explain what Viread exactly is and how it is similar or dissimilar to earlier known compound. Viread is an antiretroviral drug belonging to the class of acyclic nucleoside phosphonate analogs having anti-human immunodeficiency virus activity. Generically known as Tenofovir Disoproxil Fumarate (TDF) --- Viread is, in fact, prodrug of Tenofovir which is disclosed in U.S. Patent No. 5,922,695 assigned to Gilead Sciences Inc. and was developed to encounter the bioavailability problems associated with tenofovir.

Tenofovir which was disclosed in U.S. Patent No. 4,808,716 exhibits ionic nature at physiological pH and low cellular permeability and thereby demonstrated low oral bioavailability during preclinical trials. After more than 10 years of discovering Tenofovir, Gilead Sciences revealed a lipophilic oral prodrug of tenofovir --- Tenofovir Disoproxil, a bis (isopropyloxycarbonyloxymethyl) ester of Tenofovir --- having better oral bioavailability as compared to Tenofovir. TDF when orally administered metabolized by diester hydrolysis to tenofovir in the systemic circulation, which is subsequently metabolized by phosphorylation to form pharmacologically active metabolite tenofovir diphosphate responsible for antiretroviral activity. Pre-1995 compound Gilead Sciences disclosed Tenofovir Disoproxil Fumarate in U.S. Provisional Application Serial No. 60/022,708 filed July 26, 1996 against which U.S. Patent Nos. 5,922,695 (genus patent) and 5,977,089 (species patent) were issued on July 13, 1999 and November 02, 1999 respectively. Even though TDF is a new form of a known compound, Tenofovir, it was disclosed after 1995 and thereby making Viread eligible for patent protection in India. Now, the critical question is whether Viread has sufficient merit to overcome the barrier of section 3 (d). The Word is ‘Efficacy’ According to section 3 (d), the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance will not be considered as a patentable invention. Further, in the explanation part it is specifically mentioned that salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance will be considered to be same substance, unless they differ significantly in properties with regard to efficacy. Considering section 3 (d) along with its explanation, it is clear that a new form of a known compound with improved efficacy would be enough to overcome barrier of section 3(d) and thereby sufficient to stand the requirement of inventive-step under section 2 (1) (ja). As it is technically clear that TDF has significantly better oral bioavailability as compared to earlier known tenofovir, the likelihood of Viread to overcome the ‘efficacy’ barrier of section 3(d) is apparent. Generics 'Dilemma' Tenofovir Disoproxil Fumarate tablet was given marketing approval in India on August 17, 2005. So, the next critical question would be whether generic companies infringes Gilead’s patent if granted by the Patent Office. Answer is Yes! According to section 11A of the Patents Act, 1970 all patent applications will be publish after completion of 18 months, after which application will be open for pre-grant opposition. Further section 11A (7) states that an applicant, on and from the date of publication of the application for patent and until the date of grant of a patent in respect of such application, will have the like privileges and rights as if a patent for the invention had been granted on the date of publication of the application with a proviso that the applicant will not be entitled to institute any proceedings for infringement until the patent has been granted with a further proviso thatthe rights of a patentee in respect of applications made under section 5 (2) before the 1st day of January, 2005 shall accrue from the date of grant of the patent with yet another proviso that after a patent is granted in respect of applications made under 5 (2), the patent-holder will only be entitled to receive reasonable royalty from such enterprises which have made significant investment and were producing and marketing the concerned product prior to the 1.1.2005 and which continue to manufacture the product covered by the patent on the date of grant of the patent and no infringement proceedings will be instituted against such enterprises. Proviso of section 11A (7) of the Patents Act, 1970 clearly states that a patent-holder cannot a bring an infringement suit against generic manufactures which have made significant investment and were producing and marketing the concerned product prior to the 1.1.2005 and will continue to manufacture the product covered by the patent on the date of grant of the patent by paying reasonable royalty to the patentee. Proviso clearly emphasizes that generics should be producing and marketing the patented product prior to 1.1.2005 which is, in fact, not the case with Viread. Generic companies got marketing approval form the Drug Controller General of India (DCGI) on August 17, 2005 and started marketing their generic versions after 1.1.2005. Under newly amended patent act, it is apparent that in case of patent issuance against the pending patent application for Viread, Gilead is not bond by the proviso of section 11A and can institute patent infringement lawsuit against generic manufactures, if they continue to market their generic versions after patent is granted. Irrational Apprehension Opposing Viread patent application on the grounds of apprehension that it would make antiretroviral drug dearer is completely irrational. Presently, a strip of 30 tablets of generic Viread costs around Rs. 4000 in India which itself is expensive for Indian public. Even if patent is granted and Gilead launches Viread at higher cost then Government can curtail its price under Drug Prices Control Order, 1995 which can further be monitored and revised time to time by National Pharmaceutical Pricing Authority. Government also have the option to invoke compulsory license is case of adverse situations. But presently, it seems to be that only generics want to have the whole cake.

Tuesday, May 16, 2006

Patent holder deserves the Monopolistic Rights

Picture this: A man sits on an ergonomically designed chair that reduces fatigue, and clicks away on a key-pad technologically enhanced to ‘sense’ the touch of his fingers enough to type the letter just once (not twice) on his laptop screen, which has the right resolution of horizontal and vertical lines to perfect the illumination on his screen so that his eyes are better protected. He finishes typing, checks his spelling and grammar on a word processing software, which has a thousand features, and saves his document on his miniscule thumb-drive, using a high-speed USB port through a giga-powered processor. He e-mails it to his publisher, who will soon use the full power of the available technology to get the article to the readers with the shortest elapsed time and best quality print or even a web-cast. He sits back and sips his drink, which has sugar-free ‘Equal,’ non-dairy creamer, and de-caffeinated coffee. He has just written an article criticizing Intellectual Property Rights, (IPRs), patents and innovations – ironically, the key drivers which made all of the above possible. He says patent holders are profiteers. He says R&D creates more wealth for the wealthy. He says as long as there are patents and Intellectual Property Rights, the poor will suffer. He takes his tablets for blood pressure and diabetes. He looks at his screen once again. Somehow, his criticism lacks conviction. He seems to be biting the hand that feeds him. Next time he wants to criticize innovation, inventions, and patent rights, he should go back to his cave and engrave it on the walls of his cave.
Punish the Good Guys?
Whether our critic is working on the laptop, or travelling in his car with turbo power (>20 patents), and fuel injection (>50 patents), protected by airbags (>50 patents), or sitting in his office with air-conditioning having plasma cluster (>26 patents), or using his Canon (31,388 patents) photo copier, or watching Hitachi (32,834 patents) TV, we are increasingly becoming aware that inventions, innovations and patent rights improve quality of life. Good! So, we support patent rights, for computers, photocopiers, automobiles, air conditioners, and many more industries, except……except? Except pharmaceuticals! Really? Why is it that all companies that spend money on R&D can recover their investments except pharmaceutical companies? It appears that we discriminating against pharmaceutical companies who discover new drugs. Pharma companies are investing in R&D to save lives and reduce human suffering. So, what if they are trying to make some money from it? The company which invented TV Plasma screen made money from it, and no one created a scene. The company which invented quieter air-conditioners made money from it, and no one made a big noise about it. Should we reward entertainers and punish life-savers? Besides, if pharmaceutical companies don’t benefit from their investments in a drug, they will neither have the incentive nor the resources to invest in the R&D for the next life-saving drug.
R&D is the lifeline of a company. New products are the company’s differentiators. Without innovation, invention and discovery, a company will not be able to stay ahead of competition. Leading companies recognize the value of R&D, and invest heavily in R&D. Specifically, in pharmaceutical industry, it takes about $500 million to $900 million to develop a successful new drug. Obviously, the pharmaceutical company invests this amount to make a profit, not to give away its invention to its competition. It will be silly for Pfizer to give away its block-buster drug to Merck for free after spending a billion on R&D. Then, why do we think Pfizer should give it away to a company in India? Competition is competition, be it in USA or in Antarctica. Actually, no company in India has asked Pfizer to give away its block bluster drug without any licensing arrangement. But then, re-engineering the drug, and manufacturing and selling it without license amounts to the same, if not worse.
Business or Charity?
I will meet the CEO of Pfizer. I invite any interested company in India or any other country to join hands with me. I will personally convince Mr. Henry McKinnell, and I hope that he will agree. The deal will be this: Pfizer will allow unrestricted use of its patent without royalties or license or any payment of any kind by the Indian pharmaceutical company. In return, the Indian company will manufacture and sell the drug in their home country to the patients “at cost.” There will be no profit for Pfizer, and no profit for the Indian company. Deal?
If we are concerned about patient’s lives and well-being, then let us work for their cause. Let all the pharmaceutical companies of the world come together and form one big charitable organization. Red Cross can eat its heart out. Generic medicines will be distributed free, because there are no patents involved anyway. Marketing managers’ incentive compensation will be based on lives saved, not on sales booked. Okay, we can all wake up now. In reality, businesses do serve charitable causes, but their philanthropy department is very far from their R&D department, and its going to be that way until their R&D managers prove accurately that the end of the world is nigh.
There are many ways to skin a cat!
We need not target the pharmaceutical companies. There can be other ways to make drugs cheaper for patients.
Government Can Fund R&D
If government sponsors R&D of a drug which targets a certain disease, the equation will change completely. The government, in association with private companies who have the required expertise, can jointly pursue a drug which can cure a life-threatening disease. If the government is very vocal about public health, this is one good way to put their money where their mouth is.
Government Can Subsidize the Cost
Another way the government can help is by subsidizing the cost of life-saving drugs. If the government can subsidize the price of rice, petrol, etc., it can also subsidize the cost of life-saving drugs. But, may be there are not enough dying patients to form a ‘vote bank,’ or may be, the cost of drug subsidy versus number of vote generation does not seem to be a viable proposition.
NPPA Should be More Aggressive
National Pharmaceutical Pricing Authority (NPPA) should aggressively follow the agenda of lowering price of life-saving drugs through participation in technology transfer or licensing arrangements. India is a big market, and foreign pharma companies will definitely fall in line when new drug pricing is seen to be connected with the purchasing arrangements on the generics.
Compulsory Licensing Should be Invoked
A serious approach to compulsory licensing with a sincere resolve can be a good deterrent to over-pricing of drugs. The government should force licensing whenever it sees a foreign company unwilling to consider Third World pricing.
Government Can Acquire the Patents
The central government can acquire a patent/invention for a public purpose, paying a suitable negotiated compensation. What is needed for this is a conclusive argument that a certain drug is essential for life-saving and the suffering is of certain magnitude.
India Can Develop its Own New Drugs
India can use its cost advantage to develop new drugs at a cheaper rate and a faster pace. In this manner, India will soon have its own, patented new drugs to dominate the global markets in research and new drug discoveries, too. According to Syngene, India’s highly successful contract research firm for pharmaceuticals, the cost of doing R&D in India is five times lower than the cost involved in new drug discovery in a developed country. The launch of a new molecule in India costs only about $100-200 million as against the US, where it is estimated that the average cost to develop a successful new drug is nearly $500-900 million (sometimes close to $1 billion). New drugs developed by India can be priced lower for Indian consumption.
Indian pharmaceutical industry has already embarked on the journey to benefit from the product patents. As opposed to earlier, when Indian companies invested only around 1% on R&D, they are now investing huge amounts on R&D. In 2003-04, the top 10 Indian pharma companies spent about $400 million on R&D. The shift in the patent regime from process patents to product patents will prove to be a blessing in disguise for India in the long run, as it will encourage more Indian pharma companies to focus on R&D and compete with their global counterparts. As Dr. Reddy, Chairman DRL, says, “Excelling in the basic business operations will be necessary, but not sufficient. To maintain a long-term presence in the global pharmaceuticals markets and to grow profitably will require companies to be even more focused on R&D and creation of successful IPRs [Intellectual Property Rights]."
Contrary to popular belief, especially in the pharmaceutical industry, no harm was done to India in the Patents (Third Amendment) Act of 2005. The Act neither says that pharmaceutical patents will only be granted to foreign companies, nor does it say that Indian companies will be disallowed to conduct R&D, or that there will be any discrimination against India. On the contrary, it said that India will have equal rights and equal opportunities – equal to USA, and equal to all countries of the world. India can invest in R&D, and the actual spending in India will be lower than that of USA. India can sell their new drugs in the whole world and have patent protection in most countries. India will have full legal protection of its rights which are now equal to USA and all other countries. So, why this hue and cry? Since when has equality become such a cruel punishment and a dreadful nightmare? Why is India trying to show equality as unjust or unfair? Or, is India unsure of its quality in equality? I would have thought that India deserved to be equal. In fact, the ‘equal’ position is always the start of a race. And, if India does it right, it can win this race!
Today’s post comes from M. Qaiser & P. Mohan Chandran with iPrex Solutions, Hyderabad. This article was earlier published with globally leading U.S. based online portal --- IPfrontline in February 2006. Copyright © 2006 iPrex Solutions


SOCIAL PATENTS Not everybody is interested in money (Did you read the word ‘not?’). There are some people who have different motivations. Here is an example. Hidden from the world, working secretly and steadily for a long time, just last week, Jim Brown discovered a medicine that completely cures cancer. Because of the advancement of science and technology, he was quite sure that there would be other persons (and companies) very close to the same discovery. He did not want this new drug to be a block-buster, money-spinner drug for a mega-bucks multi-national company. He did not like the idea that someone would patent such a drug and deprive the society of easy access to the medicine. He was in an anti-patent state of mind for this particular drug. It may sound paradoxical, but on Monday morning, he intends to file for a patent. Anti-climax? A patent acquired to stop others from patenting the invention with the intention to serve social cause is termed as ‘social patenting.’ The idea is catching on because several big companies want to take visible actions that showcase their social responsibility. In fact, a company which obtains several patents to make profits, would also acquire “social patents” to win over (or at least, confuse) the anti-patent lobby. The process to obtain such patents is almost the same, but the implementation phase is different. As for Mr. Jim Brown, that’s not his real name and he is not even a real person. However, we hope there are several Jim Browns working on their inventions on this day and at this hour, so that society would benefit sooner or later. In fact, everyone should patent their inventions. Because inventions are inventions, regardless of the intentions. COPYLEFT A copyleft is to copyright, what a social patent is to a patent. If you apply the principles and motivations of the social patents to a copyright, it will be termed as copyleft. In other words, the copyright material is developed and used for social benefit, but the rules of copyrights are used against profiteers. This can also be used by companies to highlight their actions on social responsibility. The process for obtaining a copyright is the same, but the different implementation will make it a copyleft. Again, everyone’s creative output, and fruit of labour must be protected by a copyright, regardless of the ‘direction’ he would choose to go subsequently.
Today's post comes from M. Qaiser & P. Mohan Chandran with iPrex Solutions, Hyderabad. This article was earlier published with globally leading U.S. based online portal --- IPfrontine dated April 08, 2006.
Copyright © 2006, iPrex Solutions.

Monday, May 15, 2006

Patent Insurance: Teflon Coating on Armour?

Thankfully, there is always some insurance protection available against all the dreadful calamities that can befall the human race: accident, fire, earthquake, floods, death, and now, patent infringement. But wait! Patent insurance sounds like re-fried beans. A patent itself is a kind of insurance. A patent, by definition, is an exclusive right granted by the government to make, use or sell the patented products. In other words, no one other than the patent-holder can manufacture or market the patented products. This appears to be a sort of insurance. What then, is a patent insurance? Patent insurance is a protection against infringement of patents and the costs associated with it. Patent insurance is of two types: Patent Liability Insurance and Patent Pursuance Insurance. Patent Liability Insurance is a defensive instrument, which helps the insured fight an infringement lawsuit filed by a rival company. It is also called ‘Patent Infringement Defense Insurance’. In this case, the insurance company pays a part of the legal expenses incurred and/or the damages to be paid. Patent Pursuance Insurance on the other hand, is an offensive instrument, which aids the insured fight against a patent infringing company. This is also called the ‘Patent Enforcement Insurance’ or ‘Offensive Patent Insurance’. In this case, the insurer pays a portion of the legal expenses incurred by the insured company. Though it is neither well known, nor widely subscribed, patent insurance has been around for almost a decade on the international scene. With more and more firms entering the knowledge-based business and fighting hard to safeguard their interests and achieve their business objectives, insuring one’s intellectual assets have now become an imperative and vital strategic business decision. Most companies, including well-established ones, may not want to use their stacked-up profits to fight any IP litigations that may arise during the course of their business. SMEs, that have comparatively weaker balance sheets, dread the idea of patent litigations. This, in turn, has an impact on their organic and inorganic growth, as well as on research and development, and hence on their revenues. Effective management of intellectual property basically involves creating, maintaining, and safeguarding its patent portfolio, apart from strategic planning of risk management. This requires constant vigilance for any infringement by competitors. The company also needs to be cautious in its research and development work while expanding its portfolio, so that it does not infringe on others’ patents. Filing or fighting a legal suit is an extremely expensive affair (with a median range of $0.5 million to $0.5 billion), as most of the firms involved in these legal battles have learnt. Sun Microsystems parted with US $92 million in October 2004, in an out-of-court settlement, after Kodak filed a patent infringement lawsuit. More examples of penalties: Polaroid Vs Kodak – US$873 million; Cordis Vs Boston Scientific – US$324 million; 3M Vs Johnson & Johnson – US$107 million. Bitter experiences. Expensive litigations. Moments of truth. According to American Intellectual Property Law Association, the average cost of a patent litigation is $0.5 million to $5 million for each of the warring firms, depending on the amount of infringement in question. In some cases, the costs could also go as high as even $500 million. For small and medium enterprises and firms entering a new business, it might be a question of life and death as a single infringement case might impair their entire portfolio of products and services. The invisible costs may include the stress on the employees involved and also loss of many man-hours as they go about fighting an infringement or an allegation of infringement. The company’s business and its image may also take a beating as customers and investors lose their confidence when a lawsuit is filed. DEFENSIVE INSURANCE “Whether or not a patent is truly infringed, it costs $3 million dollars on average to defend a patent lawsuit,” says patent attorney Dan Ravicher, and that is only the attorney’s fees and associated expenses, not the jury award. The damages can sometimes wipe out the assets side of the balance sheet. In today’s business scenario, risk management is a key focus area, and Patent Liability insurance is the only effective protection available for a product portfolio. This insurance can be the best shield in the hands of all those companies – big, medium, small, or start-ups – that have to fight the infringement lawsuits. Though these insurance policies have been in the international market since 1995, it is only in the recent times that more and more companies are opting for them with an increase in the number of patent lawsuits being filed. The number of patent infringement lawsuits filed annually in the U.S. increased by a whopping 111 % between 1999 and 2000. Most insurance companies offer policies that cover a part of the legal expenses as well as the damages awarded in infringement lawsuits.
The following issues are generally covered by a patent infringement insurance:
  • Defence expenses, including legal attorney fee, declaratory statements, injunctions and appeals.
  • Damages covered, including judgments and settlements; previous lost royalties and previous profits, interest and costs; attorney fees assessed by the court.
  • The policy covers directors, officers, employees, company, its subsidiaries, all products, and all patents – utility, process, and design.
  • Coverage of new acquisitions, previous acts, arbitration, and dispute resolution procedure.

ENFORCEMENT INSURANCE Some companies do not apply for patents because of the misconception that there is huge cost and time involved in obtaining and protecting the patents. On the contrary, the cost of applying and securing a patent is only a fraction of the cost of developing the new product. If the invention has financial viability, then it makes good sense to apply for a patent. And once the patent is granted, insuring the patent would be the next logical step as it reduces the financial burden of fighting any legal suits. An insured patent also discourages probable infringement, as the infringing firms would fear the financial strength of the patent holder (due to the muscle power of the insurance company) in fighting any legal battle. INSURANCE PREMIUMS Premiums for patent insurance depend on the patent and/or the product being protected. They usually range between 2-5% of the insured amount. Damages of up to $1 billion are covered under the insurance, while $20-30 million are common. Insurance limits up to $15 million coverage per patent are available. Deductibles start around $50,000-$100,000 and include a co-insurance percentage after the deductible. The co-payment can vary from 15% to 25%. Defense expenses such as legal fees, declaratory statements, injunctions, and appeals are usually covered by the policies. The insurance coverage premiums for a $1 million patent starts at $25,000. The factors that determine the premium rates are the past records of the firm, the care taken in patent research to prevent infringement and the firm’s own research and development work. However, before providing the insurance coverage, insurance companies carefully consider the following aspects of the insured company:

  • Past attempts at handling and enforcing patents
  • Licensing programmes
  • Detailed patent claims of the insured’s patented product
  • Steps taken by the company to protect and monitor conflicting patents
  • Existing and potential competitors in related markets
  • Sales and market share of top five companies in the market
  • The known patents and patent-holders in a particular field
  • The availability of capital resources for marketing a competitive/patented product.

WHO SHOULD OBTAIN PATENT INSURANCE? Every company which manufactures or markets new products must cover its risk by obtaining patent insurance. The key words here are “new products.” If new technology, new design or new functionalities are available or embedded in the products that are manufactured or marketed by a company, it is recommended that the company must obtain patent insurance. Also, several aspects of a business have inherent intellectual property material which may not even be known to the business. For instance, a business may have websites that need to be protected. Websites are publications, and as a publisher, the company may be liable to infringement claims. If the new technology is patented by the company, they will benefit from the patent pursuance insurance or enforcement insurance. If the patents are not held by the company, it is possible that some other company holds the patents, and therefore the company must have the patent litigation insurance, to mitigate the risk of possible infringement suits against the company. Patent insurance of both kinds (defense and offence) should be obtained by companies of all sizes – small, medium and large. Because, patents are size-neutral, and so is its insurance. In fact, the smaller companies must try to get more patents and more Enforcement Insurance to benefit from licensing to bigger companies. The bigger companies, on the other hand, must obtain Liability Insurance to protect against lawsuits brought against them by smaller companies. Of course, the bigger companies must also strive to have their own patents and the Enforcement Insurance on those patents. In short, if you have your own patents, you must have Patent Enforcement Insurance. If you don’t have patents on your product line, you must have Patent Liability Insurance. In addition to everything stated above, every company must perform infringement analysis to ensure that their products do not infringe on anyone’s patents. On the other hand, they must also establish market vigilance procedures to ensure that their competitors are not infringing on their patents. EVERYBODY HATES INSURANCE! A patent is the armour on the products. A patent insurance is the Teflon coating on the armour, which ensures that no infringement will stick. Having said that, it is also fair to mention that patent insurance is not the main highlight of a business plan. Of course, there is always the option to “do nothing.” It is the first course of (in)action; it is the path of least resistance; it is a procrastinator’s quick decision, and it is a no-premium but high-risk option. Yes, it is a simple decision to be without insurance. However, the people who do not obtain insurance, knowingly or unknowingly, still have, what is termed as ‘self-insurance.’ They are just not paying premiums. In a self-insurance scenario, you don’t pay premiums, but you might, one day, pay a heavy price.

And, if and when, that day comes, and an infringement occurs, against your patents, or against your products, and if it finds you without a Patent Liability Insurance or Patent Enforcement Insurance, and then, and there, you find the competitor to be aggressive and fierce, and you feel a sense of loss; and, for that day and hour, if you want to save this article, to be read and reviewed – yes, by all means, save it now; and, on that day, read it again; and then, surely you will read it in a different light.

Today’s post comes from M. Qaiser and P. Mohan Chandran with iPrex Solutions, Hyderabad, India. This article was earlier published with globally leading US-based online portal --- IP Frontline. Copyright © 2005, iPrex Solutions.

Thursday, May 11, 2006

Patent Applications filed in India

Number of Patent application filed in India from 1992-93 to 2001-02.
The above patent map refers to number of applications for patents filed during last five years from 1997-98 to 2001-02 under various technical fields of inventions. Total number of patent applications filed from 1997-98 to 2001-02 for - Chemical – 6649 Drugs – 5798 Food – 565 Electrical – 6571 Mechanical – 7352 General – 5309 However, the number of patent applications filed from 1997-98 to 2001-02 is constantly on decline, particularly, applications for chemical and electrical patents have seen a major declination over the past five years (1997-98 to 2001-02).
Source: Indian Patent Office (Annual Report)

Monday, May 08, 2006

Sunitinib Malate - New Drug Approved by US FDA

International Non-Proprietary Name: Sunitinib Malate Chemical Name: N-[2-(diethylamino) ethyl]-5-[(Z)-(5-fluoro-2-oxo-1, 2-dihydro-3H-indol-3-ylidene) methyl]-2, 4-dimethyl-1H-pyyrole-3-carboxamide (2S)-2-hydroxybutanedioate Molecular Formula: C22H27FN4O2 . C4H6O5 Chemical Structure:

CAS Number: 341031-54-7 Brand Name: Sutent Dosage Form: Capsule (12.5mg, 25mg, 50mg) Applicant: Pfizer U.S. Patent No. 6,573,293 U.S. Patent Expiry: February 15, 2021 Data Exclusivity Expiry: January 26, 2011 Therapeutic Indication: Treatment of Cancer

Wednesday, May 03, 2006

Ranbaxy & Teva --- the last laugh

On April 30, 2006 Judge Richard W. Roberts of U.S. District Court for the District of Columbia, in his memorandum opinion, has ruled in the favor of Ranbaxy & Ivax (acquired by Teva) by granting them summary judgment and contending that the FDA has acted contrary to the clear intent of Congress in its decision to deny Ranbaxy and Ivax’s citizen petitions. This ruling means that Ranbaxy and Ivax are likely to be the sole generic competitors to sell generic version of Merck’s Zocor after the basic patent (U.S. Patent No. 4,444,784) covering simvastatin get expired on June 23, 2006. Delisting Orange Book Patents Earlier, at the time when Ranbaxy and Ivax submitted their abbreviated new drug applications (ANDAs) with US FDA, Merck had three listed patents for simvastatin in the Orange Book -- U.S. Patent No. 4,444,784 (‘784 patent’), U.S. Patent No. RE36481 (‘481 patent’), and U.S. Patent No. RE36520 (‘520 patent’). However, Ranbaxy and Ivax filed Para III certifications with respect to ‘784 patent but both filed Para IV certifications in respect of other two listed patents contending that the ‘481 and ‘520 patents were invalid or unenforceable, or that their drugs would not infringe those patents. Following the submission of Para IV certifications by Ranbaxy & Ivax, Merck, instead of suing them within 45 days, submitted a letter to the FDA requesting that the ‘481 and ‘520 patents to be delisted from the Orange Book. Learning that FDA has delisted the ‘481 and ‘520 patents from the Orange Book, both Ranbaxy and Ivax submitted citizen petitions, requesting FDA to confirm that it would not approve subsequent ANDAs until after the 180-day period and to relist the patents in the Orange Book. On October 24, 2005 FDA denied both the petitions deciding that it would not relist the disputed patents, that no applicant will be entitled for 180-day exclusivity for delisted patents, and that it will approve all subsequent ANDAs for simvastatin. As a result, Ranbaxy and Ivax separately sued the FDA under 5 USC § 706 claiming that the FDA improperly nullified Ranbaxy and Ivax’s rights to a 180-day period of exclusive marketing of generic Zocor. These civil actions were consolidated and all three parties moved for summary judgment, contending that there are no genuine issues of material fact and that each is entitled to judgment as a matter of law. The last laugh
The District Court Judge in his opinion ruled that the FDA should have granted the petition by Ranbaxy & Ivax and also that the FDA’s decision “contravened the plain and undisputed intent of Congress.” The issue is now sent back to the FDA by the District Court for a decision, giving Ranbaxy & Teva the last laugh. However, FDA may file an appeal against the ruling in the U.S. Court of Appeals for the District Court of Columbia Circuit, which may delay the sale of a generic Zocor beyond June 23, 2006.

Tuesday, May 02, 2006

India retained on US ‘Special 301’ watch list

Despite India’s adoption of the product patents regime in early 2005, the United States has retained India among the most severe category of countries accused of not providing an adequate level of Intellectual Property Rights (IPR) protection. Washington has, however, taken Pakistan off the priority watch list of countries providing inadequate IPR protection after Islamabad improved its patent laws and enforcement machinery. The annual Special 301 Report by the office of US Trade Representative (USTR) has included India among the 48 countries that have been retained in the priority watch list 2006. “India made some improvements to its IPR regime during the past year but IPR protection concerns remain due to inadequate laws and ineffective enforcement,” the USTR said in the report. “The United States urges India to improve its IPR regime by providing stronger protection for copyrights, trademarks, and patents as well as protection against unfair commercial use of undisclosed test and other data submitted by pharmaceutical companies seeking marketing approval for their products,” it said even while calling on New Delhi to join and implement the World Intellectual Property Organization (WIPO) treaties. WIPO has been spearheading a global campaign to harmonise patent examination, search and grant standards in countries around the world. India is already a member of the WIPO but faces opposition domestically to implement all its treaties. Additionally, the US government, under pressure from its pharma industry lobbies, has been arguing with New Delhi for data exclusivity on new drugs introduced in India. “India improved its patent protection regime when it passed legislation in early 2005 to provide for product patents for pharmaceuticals and agricultural chemicals. While this was a positive step, the new legislation has important omissions that detract from India’s patent regime. Additionally India’s copyright laws and enforcement system are weak,” the USTR said in its report. It noted that although New Delhi had pledged to improve the trademark regime, foreign trademark owners experience difficulties “due to procedural barriers and delay”. What has been pointed out also is that India’s criminal enforcement of IPR is weak, the deficiencies in a number of areas including border enforcement, judicial dispositions and imposition of deterrent sentences. “The United States urges India to address these issues during the coming year and thereby strengthen its ipr regime,” it said. Source: Financial Express

Cipla opposes patent application on bird-flu drug

Cipla has opposed the patent application on Oseltamivir, a drug that became popular at the peak of the bird-flu epidemic. The pre-grant opposition was filed at the Patent Office in New Delhi earlier this month. Oseltamivir was developed by Gilead Sciences and is sold globally by Roche under the Tamiflu brand name. It is much sought after by Governments across the world as they stockpile the drug in the event of bird-flu jumping species from birds to humans. Cipla's Joint Managing Director, Mr Amar Lulla, told Business Line that the pre-grant application had been "filed on the grounds of known prior-art, invalid claim, lack of novelty and inventive step”. Prior-art is when knowledge on the drug already exists before the cut-off date — of 1995, in this case — and, hence, a patent cannot be claimed, explained an expert on Intellectual Property (IP). There is already another pre-grant opposition on Oseltamivir, filed by Meditab Specialities. A pre-grant opposition allows people to contest a patent application filed by a company at the Patent Office. On hearing the patent-holder and the opposition, the Patent Office eventually grants or rejects the drug firm's application for a patent. The Indian Patent Office had rejected Novartis' claim for a patent on imatinib mesylate, its cancer drug sold under the brand name Gleevec. Source: Business Line

Number of Patent Applications up on new IPR norms

With laws protecting intellectual property rights (IPRs) getting streamlined, the government has received nearly 23,000 patent applications during '05-06. In comparison, the number of applications received during the previous financial year was 17,466. With product patents now in place, the government expects the number of applications to touch a record high during '06-07. The situation is undergoing a sea change, considering that the government received only 5,000 patent applications in '00-01. More applications are expected now since the new rules proposed by the government would allow the grant of applications as early as three months. The minimum period prescribed for the grant of patents is six months, according to existing rules. According to the proposed rules, patents have to be issued within three years from the time of applications. Existing rules allow the government up to six years to take a decision on patent applications. Mailbox applications have been opened up and they are being processed now, officials said. Implementation of the new rules would also lead to streamlining of patent guidelines, they added. The proposed rules are significant, since the industry is in favour of updated IPR laws. This will help India in getting out of the Super 301 'watchlist' of the US, said Dr Dhawan, president of the National Intellectual Property Organization (NIPO). Speaking at a seminar on data protection laws here on Wednesday, he said no country can lag behind in updating their intellectual property rights laws in line with the new global order. The discussions at the meet focused on the proposed new legislation on data protection and amendments to the Information Technology Act. Industry representatives cautioned that the updated guidelines should be transparent and it should not result in undue protection for multinational companies. NIPO director Akash Taneja said the current perception is that existing provisions in the Indian copyright law and IT Act are insufficient to protect the interests of database owners. The final decision on the issue would depend on the recommendations of the inter-ministerial committee set up by the government to study the necessary changes. Source: Economictimes. Indiatimes.com