FOREWORD

Not the Tail Piece anyway!

According to a recent report from www.rediffmail.com, “Indians may be bagging patents the world over, but the story is very different at home. Even though the number of applications for patents filed during 2004-05 increased more than three-fold, from 5,330 to 17,462, Indian authorities issued just 1,843 patents during the period. Compared with 1,759 patents granted 10 years ago in 1994-95, this is hardly any improvement. Several thousand applications are gathering dust in the country's four patents offices in New Delhi, Kolkata, Mumbai and Chennai. On an average, an application stays well over four years with patents offices before a final verdict is handed out, against two-and-a-half years in the United States and the European Union. Companies and patents attorneys often complain of applications getting misplaced. The portents are ominous for India's scientific and industrial progress. Clearly, the patents infrastructure of the country is bursting at its seams. The patents offices in India have about 300 examiners, compared with 3,700 in the US, 4,000 in China and 6,000 in the EU, which operate through a centralized office. There is only one training centre for Indian patents examiners, while there are 12 in China. To address the problem, the Indian government has hired 200 examiners but it can turn out to be too little, too late. "The government has realized that the backlog needs to be cleared. But it is a slow process and will take time," said an official. Manpower shortage is just one of the problems. The patents offices do not have access to all the data bases of applications around the world. The "absolute novelty" clause in the Indian patents law requires that patents across the world be scanned. Since access to databases is limited, precious time is lost while studying applications. "Unlike its counterparts in the US, Japan and the EU, the Indian office has access only to free databases but not the paid ones," said H Subramanium, a practicing patents attorney. The lower efficiency levels of Indian patents offices has been attributed to a lack of information technology. As a result, companies often complain of applications getting lost in traffic. "The patents office has been losing applications. Since a project to modernize the process has not yet linked all the branches to the same network, the problem will persist for some time," said a prominent patents attorney. To address infrastructure issues, the government has launched a project to computerize the four patents offices with a total outlay of Rs 115 crore. While their physical infrastructure has been modernized, records have not yet been computerized”. Even if this is only half-true, one wonders whether the authorities are putting the cart before the horse even after a decade long interregnum in making the nation TRIPS-compatible!

Dear Sirs/Friend,

Sub: Foreword December 2005.

            1.By December end, patentmatics.org will be completing five years. It was started on January 1,2001 as a voluntary and educational effort as :

Over the years it has developed as a site championing the cause of a Campaign for an Affordable Patents Regime (CAPR) specifically for countries such as India and it is proposed that with effect from January 2006, patentmatics.org will be the website of CAPR. It is hoped that this step will be in the right direction. More of it in next month.

            2.Quite aptly enough, the December Issue is looking again in retrospect at the two major areas of crucial significance, namely, public health and agriculture under the newly heralded TRIPS-compliant regime. Through an article “”Bird Flu : Public Health Implications for India”, the well known expert in the field Dr T Jacob John (reproduced from Economic and Political weekly) summarizes the challenge very elegantly. He aptly calls upon the union government to use its Compulsory Licensing powers and see that the required drugs – oseltamivir of Roche and zanamivir of GSK – are made available to the people at affordable price through local manufacture. Why is the GOI fighting shy on the issue? Why did the GOI choose to place an order instead on Roche for one lakh dozes at $15 per treatment, that too when Roche has responded to supply only 10% of the quantity by April 2006? According to one IPR expert in the pharma sector, it is possible for GOI to go for CL for the following reasons:

                ‘The WHO has declared bird flu as global emergency. This is a good case to test the concern of the developed countries…The GoI is perhaps not even aware of the nine patent applications (four by Roche, three by Gilead and two by a Japanese company) pending with the Patent Office, leave alone the dates and claims of these applications. In the given situation, Sec 84 is not workable. GoI has to use Sec 92. The logic is explained below:

Option # 1: Section 84

a.       Section 84 of the Indian Patents Act, 1970, permits an
application for a compulsory license three years after the sealing of
the patent. The general principles embodied in the Act note that patents
are granted to encourage inventions and to make the benefit of patented
invention available at 'reasonably affordable prices to the public', to
secure that these are worked in India, and not to enable patentees to
enjoy monopoly power by importing. That the patent right is not abused
by the patentee and the patentee does not 'resort to practices which
unreasonably restrain trade or adversely affect the international
transfer of technology' (Section 83).

b.       An application for a compulsory license can be made under
Section 84 on the following grounds: that the 'reasonable requirements
of the public' have not been satisfied, or that the product is not
available at a 'reasonably affordable price', or that the patented
invention is 'not worked in the territory of India'. However, this is
constrained by the provision that it can be sought only after three
years from the sealing of the patent.

c.       Moreover, the wording of the grounds for granting compulsory
licenses in Section 84 is not amenable to easy interpretation and is not
operationally useful and the procedure specified is cumbrous. The
procedure is open-ended without any time limit imposed for the grant of
compulsory licenses. A copy of the application for compulsory license
will have to be advertised in the official gazette, though this is not
required under TRIPS Agreement. The patentee or any other person may
oppose the application and will have to be given adequate time for doing
so. The Controller will decide only after giving both the parties an
opportunity to be heard. A compulsory license granted by the Controller
can be opposed. Such appeals will be considered by an Appellate Board
before a compulsory license is ultimately permitted. The grounds of
'reasonable requirements of the public' or 'reasonably affordable price'
can easily be challenged by the patentees. The entire process is
excessively legalistic and provides the patentees the opportunity to buy
time through litigation. The huge legal expense involved in fighting the
MNC holding the patent may dissuade the local companies from applying
for a license in the first place.

d.       Hence, in the given situation, this option is ruled out.

Option # 2: Section 92

a.       Article 31 of the TRIPS Agreement, dealing with the compulsory
licensing, provides for special provisions 'in the case of a national
emergency or other circumstances of extreme emergency or in case of
public non-commercial use'.  For any such use, the government is not
required to negotiate with the patent owner. Nor is the latter provided
any injunctive relief. All that it can expect is payment of compensation
for the use.

b.       The government can notify that it is satisfied that in
circumstances of national emergency, extreme emergency, or public
non-commercial use, it is necessary to grant a compulsory license for
oseltamivir.  Anytime thereafter, an application for a compulsory
license be made by a local company under Section 92. The procedure
described herein above (Option # 1) is not mandatory for the 'public
health emergency' and thus provides an easy and workable solution.

c.       It is further suggested that instead of adopting a case by case
approach, the government may notify the list of medicines eligible for
compulsory licenses in public health crisis. It can thus find a solution
for imatinib mesylate (Glivec), also which is subject of dispute in
several courts.

d.       This is the best option in the given situation. It will enable
the country to protect, not only its citizens, but also help the poor of
the developing countries, as the Indian Patents Act incorporates
provision of Article 31(f) allowing export of 'non-predominant' part of
the production. 

e.        Last but not the least, the CL for Government Use is non-injunctive under Section 92 and the bird flu threat is certainly like an ‘emergency’, though anticipatory at present”. 

This issue will be taken up for further discussion and debate in the following months as well. Meanwhile, one has to await the decisions of the GOI – a meek surrender or a bold use of even its TRIPS-permitted powers! 

3. According to press reports, decks have been cleared for the implementation of the Protection of Plant Varieties and Farmers' Rights Act with the union Cabinet  approving the creation of the post of Registrar-General of the Authority set up under the Act. The Registrar-General shall be in the rank of Additional Secretary and appointed by the Authority on deputation or transfer or on contract basis. His term would be for five years or until he attained the age of 60, whichever is earlier. The Act was enacted in 2001 to fulfill India's obligation under the Agreement of Trade Related Aspects of Intellectual Property Rights of the World Trade Organization. The Act is meant to encourage investment in research and development of new plant varieties that will facilitate the growth of the seed industry and ensure the availability of high quality seeds to the farmers. This administrative step now provides for the establishment of an effective system for the protection of plant breeders' rights”. In other words, agriculture is from now onwards also is ipso facto brought under a TRIPS compliant regime. It is in this context that one has to look at the recent Indo-US Agreement for heralding what the Prime Minister called the Second Green Revolution, in which one expects a big role to be played by transgenic crops as well.

            Lest many has forgotten, Green Revolution could be implemented in late sixties under very specific milieu which also included non-patentability of plant varieties on the one hand and free transport of plant genes across the world without any hindrance from and Convention of Bio Diversity on the other. December Issue is reproducing an excellent article by Dharmapal Singh on “The Green Revolution and the evolution of agricultural education and research in India”, including the pioneering role played, as part of the Indo-US collaboration, by the Rockefeller Foundation and US Department of Agriculture. The issue is reproducing also a few more related ones to enable the interested reader to have a wider appreciation of many an issue involved in the success of the historic program. The Second Green Revolution will need a totally new strategy under the new TRIPS compliant regime, with the public funded ICAR being asked to withdraw steadily from varieties development programs and encouraging the private sector to develop new IP protected varieties. The seriousness of the situation can be understood straightaway with examples from the Transgenic Crops. The article “Global Status of Commercialized Biotech/GM Crops : 2004”, reproduced from ISAAA, summarizes the field as below:

a.     Estimated global biotech area is 200 million acres, grown by 8 million farmers in 17 countries.

b.     US accounts for 59%,, Argentina 20%, Canada 6%, Brazil 6%, China 5%, India 1% and so on.

c.      Major crops are cotton, maize, soybean and canola.

All these GM varieties are owned by the multi national companies. Under the New IPR Regime, the relevant IP protection measures are valid in India also under the Breeders’ Rights. With public funded agencies such as ICAR yet to open its account, GMC research continues to be in the exclusive domain of MNCs and their local partners. Even in the category of food crops, the GM technology is steadily consolidating. Patentmatics  has described in detail in earlier columns the field-level challenges of Indian farmers to use the fruits of the BT revolution as applied to Bt cotton varieties supplied by the private companies AND in absence of agencies such as ICAR coming to their technology input efforts. In other words, unlike in the West with large farm sizes and economically strong farmers, the Indian farmers cannot withstand the pressures and challenges in absence of adequate support from the union and state governments both for their ongoing activities, but also for going for new innovations essential for quantum leaps. In other words, if the GOI plans to implement a Second Green Revolution, which it must by all means, it should adopt a suitable strategy as well to suit the Indian milieu in terms of all factors which made possible the First Green Revolution a grand success. Simply accepting the WTO/AoA dictated policies could even “kill the goose who lays the golden egg”. The article “WTO Agreement on Agriculture: Govt.’s Tall Claims and Ground Realities” elaborates these challenges as applied to India. "Doha negotiations offer a unique opportunity to India to realise its trade and development goals. Benefits of trade liberalisation in all three areas (agriculture, industrial goods and services) can be high. According to some estimates, welfare benefits to the tune of 820 million dollar may flow into India from liberalisation of trade in agriculture," The former World Trade Organisation Director General and presently the UNCTAD Chief Supachai Panitchpakdi  said recently. Well, what else can the proponents of WTO/TRIPS advise? The nation seems to truly miss political leaders like late Mrs Indira Gandhi and C Subramaniam to lay down the right policies on the one hand and the total support by equally competent Agriculture Research and Extension Structures on the other to usher in a truly beneficial Second Green Revolution!

A very distinguished friend of mine wrote thus a few days ago: “As usual, the November 'tail piece ' or rather 'forward' makes very refreshing reading indeed. I have always been impressed with your analytical approach to IP related issues and your impressive dedication to publish them month after month”. Well such words of encouragement has kept the website going in its efforts to “Campaign for an Affordable Patents Regime” for our country. Hope that the Year 2006 will turn out to be more nation-friendly arising from similar efforts by many in the country longing for a better tomorrow.