FOREWORD

Sub: Foreword, patentmatics.org August,2005

The following is the text of Indo-US Joint Statement issued after the delegation-level meeting between the Prime Minister, Dr. Manmohan Singh and the US President Mr. George W. Bush, in Washington DC on July 18, 2005. (Only items of relevance to nuclear and space technologies included).

"Prime Minister Manmohan Singh and President Bush today declare their resolve to transform the relationship between their countries and establish a global partnership. As leaders of nations committed to the values of human freedom, democracy and rule of law, the new relationship between India and the United States will promote stability, democracy, prosperity and peace throughout the world. It will enhance our ability to work together to provide global leadership in areas of mutual concern and interest.

Building on their common values and interests, the two leaders resolve:

· Strengthen energy security and promote the development of stable and efficient energy markets in India with a view to ensuring adequate, affordable energy supplies and conscious of the need for sustainable development. These issues will be addressed through the U.S.-India Energy Dialogue.

· Agree on the need to promote the imperatives of development and safeguarding the environment, commit to developing and deploying cleaner, more efficient, affordable, and diversified energy technologies.

mobilizes private sector and government resources, knowledge, and expertise.

· Express satisfaction at the New Framework for the U.S.-India Defense Relationship as a basis for future cooperation, including in the field of defense technology.

· Commit to play a leading role in international efforts to prevent the proliferation of Weapons of Mass Destruction. The U.S. welcomed the adoption by India of legislation on WMD (Prevention of Unlawful Activities Bill).

· Launch a new U.S.-India Disaster Relief Initiative that builds on the experience of the Tsunami Core Group, to strengthen cooperation to prepare for and conduct disaster relief operations.

· Sign a Science and Technology Framework Agreement, building on the U.S.-India High-Technology Cooperation Group (HTCG), to provide for joint research and training, and the establishment of public-private partnerships.

· Build closer ties in space exploration, satellite navigation and launch, and in the commercial space arena through mechanisms such as the U.S.-India Working Group on Civil Space Cooperation.

· Building on the strengthened non-proliferation commitments undertaken in the NSSP, to remove certain Indian organizations from the Department of Commerce's Entity List.

Recognizing the significance of civilian nuclear energy for meeting growing global energy demands in a cleaner and more efficient manner, the two leaders discussed India's plans to develop its civilian nuclear energy program.

President Bush conveyed his appreciation to the Prime Minister over India's strong commitment to preventing WMD proliferation and stated that as a responsible state with advanced nuclear technology, India should acquire the same benefits and advantages as other such states. The President told the Prime Minister that he will work to achieve full civil nuclear energy cooperation with India as it realizes its goals of promoting nuclear power and achieving energy security. The President would also seek agreement from Congress to adjust U.S. laws and policies, and the United States will work with friends and allies to adjust international regimes to enable full civil nuclear energy cooperation and trade with India, including but not limited to expeditious consideration of fuel supplies for safeguarded nuclear reactors at Tarapur. In the meantime, the United States will encourage its partners to also consider this request expeditiously. India has expressed its interest in ITER and a willingness to contribute. The United States will consult with its partners considering India's participation. The United States will consult with the other participants in the Generation IV International Forum with a view toward India's inclusion.

The Prime Minister conveyed that for his part, India would reciprocally agree that it would be ready to assume the same responsibilities and practices and acquire the same benefits and advantages as other leading countries with advanced nuclear technology, such as the United States. These responsibilities and practices consist of identifying and separating civilian and military nuclear facilities and programs in a phased manner and filing a declaration regarding its civilians facilities with the International Atomic Energy Agency (IAEA); taking a decision to place voluntarily its civilian nuclear facilities under IAEA safeguards; signing and adhering to an Additional Protocol with respect to civilian nuclear facilities; continuing India's unilateral moratorium on nuclear testing; working with the United States for the conclusion of a multilateral Fissile Material Cut Off Treaty; refraining from transfer of enrichment and reprocessing technologies to states that do not have them and supporting international efforts to limit their spread; and ensuring that the necessary steps have been taken to secure nuclear materials and technology through comprehensive export control legislation and through harmonization and adherence to Missile Technology Control Regime (MTCR) and Nuclear Suppliers Group (NSG) guidelines.

The President welcomed the Prime Minister's assurance. The two leaders agreed to establish a working group to undertake on a phased basis in the months ahead the necessary actions mentioned above to fulfill these commitments. The President and Prime Minister also agreed that they would review this progress when the President visits India in 2006.

The two leaders also reiterated their commitment that their countries would play a leading role in international efforts to prevent the proliferation of weapons of mass destruction, including nuclear, chemical, biological and radiological weapons.

Prime Minister Manmohan Singh thanks President Bush for the warmth of his reception and the generosity of his hospitality. He extends an invitation to President Bush to visit India at his convenience and the President accepts that invitation."

Much has been spoken and written about this historic bilateral Agreement – some describing it as if India has come out at long last from her “Nuclear Winter”, others as a “sell-off” and many including a former AEC Chairman opining that “one has to wait and see if and when these promises are implemented."

. Patentmatics August Issue has reproduced a large number of articles and editorial comments in full from the prominent news papers, essentially to provide a more or less consolidated historical summary of the sort of policy issues raised through them for study and future guidance of seriously  interested readers and of potential researchers.

A quick recource to the history is perhaps not irrelevant. The first Atomic Energy Act was passed in April 1948 – vesting the GOI with exclusive authority for all activities relating to the development of atomic energy in the country. The first Atomic Energy Commission was constituted on Aug 10,1948 as the apex policy making body for the programme. And a separate Department of Atomic Energy was created on August 3,1954 in the direct charge of the Prime Minister in order to ensure complete autonomy for the Department in matters of staff, construction, supplies and finance without reference to agencies such as UPSC, CPWD, DGSD, etc. And most appropriately enough, Dr Homi Bhabha became the first to head  the program in toto, reporting to the then Prime Minister Jawaharlal Nehru. Inaugurating the Trombay Research Establishment and the first experimental swimmimg Pool Reactor PURNIMA on January 20,1957, he said:

“I should like to say on behalf of my government, I think I can say with some assurance of any future government in India, that whatever might happen, whatever the circumstances we shall never use this atomic energy for evil purposes”.

During the past five decades, it has been a great saga of persistence against odds and ingenuity in the absence of help from abroad – thanks to the most vociferous embargo conditionalities. And yet the DAE has grown to a veritable premier agency and the great saga has been exquisitely brought out in “Atomic Energy in India – 50 Years” by C V sundaram, LV Krishnan and TS Iyengar. “The maturity of an organisation is revealed from the way it rides over crisis situations”, to quote Vikram Sarabhai, who took over the reigns after the demise of Bhabha in a plane crash, and DAE has fulfilled it superbly indeed! Through its dozen power reactors operating under  optimum conditions of safety and plant load factors and providing the nation with a “credible nuclear deterrent capability” guided through her own self-imposed “never the first to use doctrine”, DAE is the priced jewel of India’s self reliance in this area of advanced technology. Hopefully the DAE will emerge victorious from the current “crisis situation” as well through its hard-earned maturity.

Undoubtedly the new India-US Agreement is of tremendous significance and matching consequences. Are there alternate options, including opting to sign the NPT to make purchase of raw material uranium possible through import from friendly supplier nations? It is somewhat amazing that suddenly GOI wants to install a 20 -30,000 MWe nuclear power. This is certainly not that easy or even practicable, if not impossible, by any considerations, including massive supplies of systems by the foreigners. It is fairly known for sure that one of the reasons for nuclear power to be attractive in our country is due to the attractively low cost of indigenous fuel even at international costs of raw material uranium concentrate. One has very serious doubts whether this will be true if the fuel is imported. Afterall, even for Tarapur, DAE has been importing ONLY the raw material as uranium hexafluoride, not the final fuel. The same is certainly true of all other zirconium components in the fuel assembly.

Any import of nuclear technology will ipso facto bring in issues connected with IPRs, as emphasised again in the next para. In other words, the Indian Atomic Energy Act 1962 will have to be modified, strictly speaking by the parliament. IPR implications on recurring requirements of spares and replacements could be very far reaching. Even the Russians have NOW started raising these IPR related issues on strategic items including space items, saying that "Russia is not Soviet Union" ! Last but not the least, will it in any way affect the nations’s independence in this crucial and strategic sector, one seriously wonders unless the issues are discussed through a parliamentary committee in which experts from outside also could contribute.DAE is our most precious jewel on the indigenous S&T horizon, with ISRO coming a close next. We must preserve it.

Coming back to  the IPR related implications, if the IUSA is to be implemented faithfully. The need to give special status for inventions related to atomic energy was taken care of even in the Atomic Energy Act,1948, essentially on the lines of those covered under the defence category. Eventually they were made non-patentable under the revised Atomic Enery Act,1962, and which was incorporated into the 1970 Act itself. It is well known to one and all with IP expertise that, alike the fields of chemicals/drugs/materials and  but for such an umbrella provision, DAE would not have been able to achieve its present level of capabilities in the field, more so under the embargo. The amended 2005 Act also has retained these provisions to meet such exigencies. In other words, items covered under the 1962 Atomic Energy Act are nonpatentable even in the post TRIPS regime. Will the foreign suppliers allow these provisions to continue? If not, will India have to depend upon continued import of those IP protected items under ‘dictated’  prices? What could the implications be in terms of economic viability of such imports? Or does it mean that the IUSA would be subject to only accepting TRIPS conditionalities for this sector also? Hopefully these issues would be clear in due cource.

No issue of patentmatics can ignore the implications of the new IP regime as applied to drugs. Continuing the theme focus, the August issue reproduces a publication of National Cancer Institute of an anticancer drug case study on FLUDARA. Complimentary to this is the third in the series on “…Challenges Summarised” as applied to New Molecule Discovery. The anticancer drug Fludara was invented and patented the same  by Montgomery et al of National Cancer Institute in 1978. National Cancer Institute initiates clinical testing in 1983. Once the clinical activity was established and FDA approval pending, NCI obtained permission from FDA to distribute the drug to patients with B-Cell Chronic Lymphocytic Leukemis (CLL) who had exhausted all other treatment options (“compassionate use”). Concurrently  a license was signed coexclusively with two drug companies, but only Berlex Laboratories was able to develop the drug. Pivotal Phase II clinical trials were carried out during 1984-88, additional toxicity studies during 1988-89, data analysis during 88-89 and FDA approval in 1991. First commercial sales took place only in December 1991.Once successful the same company was given exclusive rights for five years after the first commercial sale. Berlex license expired when the last NIH patent expired, in February 2003.

In summary, it took nearly 13 years after the invention for the drug to have the first commercial sale. In turn the licensee got five years exclusive right for the invention and an additional seven years as non-exclusive licensee to recover its expenditure and in turn also a reasonable commercial benefits, now of cource only as a generic product. In other words, invention and commercialisation of a new drug molecule demand enormous multilevel-multidisciplinary capabilities – high level R&D and innovation, adequately rigorous IP protection, clearcut and state-of-art clinical trials and approval procedures and competent corporate level T/T and commercialisation and marketing strategies.

Now that the TRIPS compliant regime is in force, the MNCs have started bringing in their new IP protected drugs to Indian market - Swiss pharma major Roche has decided to launch its new colo rectal cancer drug Avastin in India, just four months after the drug’s launch in Europe this March, the US-based pharmaceutical major Merck & Co, with two drugs, Zienam (a beta-lactam anti-biotic) and Aggrastat (a cardiovascular drug) and  four more products undergoing registration studies, including Invanz, an anti-biotic, Cancidas, an anti-fungal and two vaccines, Pneumovax (anti-pneumonia) and Varivax (anti-chicken pox)  and with no immediate plans to set up manufacturing unit in the near future, Novartis, the EMR holder of the anticancer drug Glivec, launching a couple of products for cadio-vascular,respiratory, oncology and the only other worry for all being "The uncertainty over price control is the biggest challenge for pharma companies." In other words, THE GOLD RUSH has already started in the sensitive national health sector.

What is the state of Indian R&D in drugs? Unfortunately there is hardly any official report on the situation. Even though there are the usual claims that Indian R&D is “second to none”, objectively speaking there are hardly any proven examples yet, thanks to the decade-long neglect in R*D in this vital field by both government and industry sectors. In other words, inventing new molecules never became a priority area among the national R&D community for reasons known to itself, save a few encouraging ones such as the CDRI/CSIR invention of Saheli. The other worthwhile examples from the industries sector are the ANDA type ‘patent greened’ products, e.g. the nimulid transgel. Now that the 2005 Act does not allow patentability for such ‘greened’ modifications, new molecules-based IP protected drug molecules will remain as the de facto monopoly of MNCs themselves. India does not have even a rudimentary FDA like agency to regulate and clear new drugs, leave alone adequate number of qualified laboratories to conduct state-of-art evaluation tests, if reports are to be believed.

In other words, the nation does not have even a bonafide and effective clearance system itself for this vital sector, leave alone the more sophisticated and advanced  proven ability for New Drugs Invention or even the relatively much easier IPR e-infrastructure. And yet, the necessary  TRIPS dictated Amendments were pushed through the parliaments with TRIPS-dictated speed and efficiency. A Faustian Challenge indeed for years to come.

The article on Law and Public Health and the NBER research publication on drugs, patents, etc. are other related ones dealing with important issues connected with this vital sector.

 Last but not the least, “NEW economies, inventions and technologies will dictate a major shift in the trends of legislation globally”, according to the Chief Justice of India, Mr Justice R.C. Lahoti. Continuing he said “Already, national territories were being obliterated for international trade and commerce, he said in his convocation address at the NALSAR, University of Law, Hyderabad. Multi-level governance with regulated markets and various public-private partnerships would also require new institutional architecture for law. Courts and court-inspired reforms would be important and law schools would have to play a role, he said.Urging the legal fraternity, including the judiciary, to keep pace with developments in science and technology”. Chief Justice said “a Science-Law interface was necessary to develop appropriate legal regimes. DNA techniques, development in forensic science, patent regime, stem-cell research and cloning had opened up areas yet uncharted by the legal fraternity. The `Logic of Science' and the `Logic of Law' needed”. Very valuable forebodings indeed, if our jurisprudence has to deliver the dictates of the New IPR Regime for the welfare of our citizenry!

Too many such thoughts and forebodings when in a few days time the nation will celebrate her 58^th Independence Day, with the historic Tryst With Destiny Speech of late Jawaharlal Nehru still reverberating in the ears of the many in the country!

Kindly keep sending your suggestions and contributions.

Thanking all friends and patrons in anticipation,

Yours truly,

A D Damodaran.