Ranbaxy, Glaxo join hands for R&D

P.T. Jyothi Datta , Business Line,

New Delhi , Oct. 22

PHARMA majors GlaxoSmithKline (GSK) and Ranbaxy may fight turf wars in the US pharmaceutical market, but they have decided to come together for the discovery and development of new drugs in the urology, anti-diabetic, anti-bacterial, asthma and anti-fungal segments.

Taking one large leap in terms of converting itself into an "engineering company compared to a re-engineering company", homespun Ranbaxy Laboratories on Wednesday inked the dotted line with global drug major GSK Plc, with whom it has sparred several times over issues of intellectual property.

"It is the maturity of GSK that has made the alliance happen. What happens on the generic front is a different issue. The companies have seen that there is an opportunity to benefit from collaborating for New Chemical Entities (NCE). GSK has the maturity not to combine the two issues," pointed out Dr Rashmi Barbhaiya, Ranbaxy's President (Research and Development), responding to a query from Business Line.

Call it "maturity" or "business sense", the agreement envisages that Ranbaxy will be responsible for optimisation of a lead discovery to the generation of a candidate that could be developed into a drug. The company would be involved with the pre-clinical trials and early clinical trials as well, he told mediapersons in a conference call from the US.

GSK top brass on a visit to India earlier this year scouting for local partners had told this correspondent that the company would keep the clinical trials of a drug within its jurisdiction. Dr Barbhaiya said, "At the point of candidate selection, GSK and Ranbaxy would take a decision on who would take the process further up to commercialisation of the drug."

The agreement was for a finite period of five years. However, this would not limit any drug development process that either company was undertaking as a follow-through from the alliance.

Meanwhile, the companies would also set up an executive steering committee that would oversee the operation of the alliance.

GSK will hold exclusive commercialisation responsibilities worldwide, while Ranbaxy will have the controls for India, the Ranbaxy R&D chief said. Further, he pointed out that the revenue-sharing pattern and intellectual property-related issues, such as who would hold the patents for the drugs, had been discussed. He was unwilling to disclose details. However, he said in the event of disputes, there were `dispute resolution provisions' incorporated in the agreement.

Mr Sanjiv D. Kaul, Vice-President (Global Licensing), said the agreement was a milestone in pharmaceutical research in the country, not just for the companies involved, but also for other pharma companies in the future.

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DuPont-led Scientists Unveil Key Nanotechnology Discovery with Use of DNA
Sorting Carbon Nanotubes Provides Significant Step in Advancing Nano-Electronics Applications

WILMINGTON, Del.,  December 2, 2003  —  A collaborative group of DuPont-led scientists have discovered an innovative way to advance electronics applications through the use of DNA that sorts carbon nanotubes.

This research in the emerging field of nanotechnology appears in the current issue of the journal Science, which is published by the AAAS – the world's largest general scientific organization. The research paper is titled " Structure-Based Carbon Nanotube Sorting by Sequence-Dependent DNA Assembly."

Carbon nanotubes possess excellent electrical properties that make them potential building blocks in a broad range of nanotechnology-related electronic applications, including highly sensitive medical diagnostic devices and mini-transistors more than 100 times tinier than those found in today's microchips. When they are fabricated, however, carbon nanotubes of different electronic types randomly clump together, deterring consistent conductivity. The ability to sort and assemble carbon nanotubes allows for uniform conductivity – enabling the applications to be realized.

Initially, DuPont Central Research & Development scientists found that single-stranded DNA strongly interacts with carbon nanotubes to form a stable DNA-carbon nanotube hybrid that effectively disperses carbon nanotubes in an aqueous solution.

As a follow-up to that initial work, a multidisciplinary team of scientists from DuPont, the Massachusetts Institute for Technology (MIT) and the University of Illinois worked together to discover a new method for separating carbon nanotubes using single stranded DNA and anion-exchange chromatography. By screening a library of oligonucleotides, the team found that a particular sequence of single stranded DNA self-assembles into a helical structure around individual carbon nanotubes. Since carbon nanotube-DNA hybrids have different electrostatic properties that depend on the nanotubes' diameter and electronic properties, they can be separated and sorted using anion exchange chromatography. The technique can be used to separate metallic carbon nanotubes from semiconducting carbon nanotubes, both which are created during nanotube production. The technique also can sort semiconducting carbon nanotubes by diameters, an important element in nanoelectronic applications. The collaborative work is further detailed in the current edition of Science.

"Wrapping of carbon nanotubes by single-stranded DNA was found to be sequence-dependent," said DuPont Central Research & Development scientist Ming Zheng. "This outstanding collaborative effort is a good example how researchers from both industry and academic institutions can work together in a multidisciplinary approach to further advance this emerging technology."

DuPont Central Research & Development scientists who contributed to the research were Ming Zheng, Anand Jagota, Bruce A. Diner, Robert S. McLean, G. Bibiana Onoa, Ellen D. Semke and Dennis J. Walls. University of Illinois contributors were Michael S. Strano, Paul Barone, and Monica Usrey. MIT contributors were Adelina P. Santos, Grace Chou, Mildred S. Dresselhaus, and Georgii G. Samsonidze.

DuPont is a science company. Founded in 1802, DuPont puts science to work by solving problems and creating solutions that make people's lives better, safer and easier. Operating in more than 70 countries, the company offers a wide range of products and services to markets including agriculture, nutrition, electronics, communications, safety and protection, home and construction, transportation and apparel.

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Indian Drug Manufacturers Association – Press Release on the EMR for the  anti cancer drug “Glivac”.

Patents (Amendment) Bill introduced

Business Line,New Delhi , Dec. 22

IN the run-up to meet the deadline of ushering in the product patent regime from January 1, 2005, the Government today introduced the crucial Patents (Amendment) Bill, 2003, providing for introduction of product patent protection in all fields of technology as per the provisions of the trade-related intellectual property rights (TRIPs) Agreement of the WTO.

Though the Bill was not scheduled for the day, the Union Minister of Law and Justice and Commerce and Industry, Mr Arun Jaitley, introduced the Bill in the Lok Sabha on the penultimate day of the winter session of Parliament.

Some of the salient features of the Bill include introduction of product patent protection in all fields of technology as per Article 27 of the TRIPs agreement, deletion of the provisions pertaining to exclusive marketing rights and introduction of a transitional provision for safeguarding exclusive marketing rights (EMRs) already granted, besides amending and strengthening the provisions pertaining to national security.

Besides the Patent (Amendment) Bill 2003 seeks to amend the provisions relating to Appellate Board with a view to extending its jurisdiction to revocation of patents also, to amend the provisions relating to opposition procedures, to amend certain provisions with a view to harmonising them with the Patent Co-operation Treaty to which India is a signatory.

The Bill also seeks to introduce a provision for enabling grant of compulsory licence for export of medicines to countries, which have insufficient, or no manufacturing capacity to meet emergent public health situations. This provision is in accordance with the agreement reached on August 30, for implementation of Para 6 of the Doha Declaration on TRIPs and Public Health.

The Bill also provides for amending certain provisions pertaining to time lines for different activities with a view to introducing flexibility and reducing the processing time for patent application, besides amending the provisions of the Act with a view to simplifying and rationalising the procedure aimed at benefiting the users.

Mr Jaitley said in the statement of objects and reasons for the Bill that given the importance of the issues, the Government undertook broadbased and extensive consultations involving different interest groups on aspects critical to the changes, which might be necessary in the Patent Act, 1970.

He said that while considering amendments to the Act, efforts have been made to make the law not only TRIPs-compliant but also to simplify and rationalise the procedures governing grant of patents so as to make the system more user-friendly.

It may be noted that law relating to patents is contained in the Patents Act 1970 which came into force on April 20, 1972. This Act was subsequently amended in March 1999 and June 2002 to meet India's obligations under the Agreement on TRIPs, which forms part of the agreement establishing the WTO. The amendments primarily focussed on the obligations which came into force from January 1, 1995 (in respect of amendments made in March 1999) and obligations, which came into from January 1, 2000 (in respect of amendments notified in June 2002). While making the latter amendments, opportunity was also utilised to provide necessary and adequate safeguards for protection of public interest, national security, biodiversity, traditional knowledge etc., and also to simplify certain procedural aspects.

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Novartis gets EMR approval for Glivec

The Hindu,MUMBAI NOV. 12. Novartis India said today it has become the first pharmaceutical company in the country to be granted exclusive marketing rights (EMR) for Glivec, a drug used in treatment of cancer, by the Controller General of Patents and Trademarks of India.

"This is a positive sign to the international community that India is progressing towards meeting all its obligations under TRIPS,'' Novartis India Vice-Chairman and Managing Director, Ranjit Shahani, told newspersons here today.

Glivec is one of the oncology drugs that validate rational drug design based on an understanding of how some cancer cells work. — PTI

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Natco to challenge grant of exclusive rights to Novartis cancer drug

Business Line,Hyderabad , Nov. 12

NATCO Pharma Ltd has decided to challenge the decision of the Controller-General of Patents and Trademarks of India granting exclusive marketing rights to Novartis India for its anti-cancer drug in the country.

Novartis India is the first company to get exclusive rights for a drug in the country under the product patent regime. The Indian subsidiary of the multinational company was reportedly given exclusive rights to market its drug - Glivec - for five years or until a product patent supersedes the rights in the country.

In a press release here on Wednesday, the Natco Pharma Vice-President, Business Development, Mr Rajeev Nannapaneni, announced the company's decision to challenge the grant of rights to Novartis.

Natco had launched early this year Imatinib Mesylate, a drug for the treatment of chronic myeloid leukaemia. The company was also granted National Award for R&D efforts on this drug by the Department of Science and Industrial Research recently.

Natco made the medicine, under the brand `Veenat', available at one-tenth of the cost of Novartis' Glivec.

According to Mr Nannapaneni, the company's therapy costs $2,700 per annum, against Novartis' $27,000. The company had also undertaken a drug donation programme under which it was helping over 250 patients suffering from chronic myeloid leukaemia with free supply of Veenat.

According to Mr Nannapaneni, under the provisions of the Indian Patent Act and Rules, exclusive rights can be granted only in respect of patents and applications filed in a convention country after January 1, 1995. "According to the information available, the applications for patents with respect to Imatinib Mesylate were filed (by Novartis) prior to 1995. In this backdrop Natco feels that grant of rights is not correct, and therefore, feels that it has a strong case for revocation of the exclusive rights," he said.

He saidthe concerned authorities should look beyond commercial and legal considerations.

"Granting of exclusive rights to a costly therapy, which prohibits the availability of an equally good medicine at a fraction of the cost, is against humanitarian principles. In effect, implementation of the exclusive rights would make the drug out of reach for thousands of patients who are already on Veenat and consequently, this would mean a death sentence to ill-affordable patients."

Further, Mr Rajeev Nannapaneni said: "The policy needs to be reviewed at least in respect of non-lifestyle, critical and life-saving medicines."

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Pickering wants foreign equity norms relaxed further

Business Line,Bangalore , Nov. 19

MR Thomas Pickering, former US Ambassador to India and Senior Vice-President of Boeing Company, asked India to further relax norms for foreign equity participation to enable both the countries to develop and produce next generation technologies.

He told a meeting of the India-US high technology cooperation group that the regulations restricting foreign participation in joint ventures to 26 per cent of equity should be re-examined. Technology export controls in India as well as export compliance practices by Indian end users, will need to be strengthened to give private parties and the US Government comfort that leading edge technologies co-developed in India are appropriately used.

Mr Pickering said the US export licensing needs to be further reviewed, more on a case-to-case basis to permit the growth of the Defence R&D nexus and increase manufacturing capabilities in India. He said US companies should identify areas of technology that they are prepared to develop even at the risk of a dilution of ownership and control.

He said the US companies bear the burden of being unreliable suppliers largely because of dynamic relationship between the two countries. As the global technology leaders, the R&D and production costs tend to be higher than many of our competitors, Mr Pickering said.

He said India has several qualities that make it a `desirable' partner for the US defence industry. Some of these are a large and growing national market or buying capacity, world class engineering and R&D capabilities at a scale that cannot be replicated and an ability to produce advanced technologies at substantially reduced costs.  

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Indian units of U.S. firms file more than 1,000 patents

The Hindu,BANGALORE DEC. 16. In clusters of modern low and high-rise office buildings set amid acres of lush greenery here, thousands of engineers are hard at work, writing software for the latest telephones, designing next-generation microprocessors and developing wireless broadband technology.

The work of these engineers is generating significant amounts of intellectual property for U.S. companies such as Cisco Systems, General Electric, IBM, Intel, Motorola and Texas Instruments — whose various Indian units have filed more than 1,000 patent applications with the U.S. Patent and Trademark Office. Some applications, with patents already granted, date to the early 1990s. But most applications from India have been filed in the last two years and still await decisions by the patent examiners in Washington.

For U.S. technology companies, under pressure to generate quick breakthroughs and develop products while curbing costs, India's big draw is its low-cost, deep pool of well-educated technical talent. The Indian research centres of Cisco and Motorola, for example, are now those companies' largest outside the U.S.

While outsourcing lower-level technical tasks to India has been a practice of U.S. industry for years, the U.S. technology titans' increasing reliance on Indianresearch- and- develop ment operations is a relatively new and growing trend.

"In the process of getting low-end work done in India, multinationals discovered that there are not too many locations where they can find this abundance of superior talent at these kinds of costs,'' said Chandra Srinivasan, Chairman of the Indian unit of the consulting firm A.T. Kearney.

Thousands of engineers in disciplines as different as textile engineering and aeronautics graduate each year from India's engineering schools. Top-notch graduates can be hired at salaries beginning at $10,000 a year, even as their peers in the U.S. earn six times that amount or more. In all, personnel experts estimate that in the next 18 months, the Indian centres of multinational technology companies will double their head counts from 40,000 today.

Intel plans to move into a $41 million, 42-acre Bangalore campus next year and more than double its number of employees in India to 3,000. "It would easily cost twice as much to set up a similar operation in the U.S.,'' Ketan Sampat, President of Intel Technology India, said.

Texas Instruments, with 1,000 employees in India, said it expected to expand to 2,500 and would move to a new high-rise building by 2005, with Motorola as its neighbour. A decade ago, Motorola set up its research and development operations in India with six employees who did small jobs for its two-way radios. Today, Motorola's software, integrated circuits and semiconductor divisions in Bangalore and Delhi have 1,200 employees.

``Thirty per cent of all software for Motorola's latest phones is written in India,'' said Sammy Sana, Managing Director of Motorola India Electronics. In a Bangalore plant for Intel, the world's largest chip maker, Ajith Prasad and 20 other engineers are designing and developing chips that they hope will power new types of high-speed broadband wireless technology within the radius of a home or an office in the next few years. Mr. Prasad's team has filed six of the 60 U.S. patent applications from Intel's India unit in the last 22 months. (Because patents can often take four or more years between the filing and the granting, no Intel India patents have yet been awarded.)

As the export of technology jobs from the U.S. continues, the rise of development centres in India can be a politically delicate topic in U.S. circles. But Indian executives take pride in their nation's growing status as a preferred offshore location for high-level work. — New York Times

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