"When is it right for a government to grab a company's patent rights  in the interest of public health? Scared by the anthrax outbreaks south of the border, Canada's health ministry decided that public 
health comes first. It commissioned a generic drug company to make a million doses of ciprofloxacin (Cipro), a drug used to treat one of nastier forms of the disease, for the national stockpile. But the 
patent to Copra belongs to Bayer, a German drug giant. Bayer protested that it could supply Canada's needs and that, by turning to a generic rival, the ministry had broken the law.

Canada's hasty actions had little justification. There have been no anthrax outbreak there and no evidence of spores travelling through the post. Several other antibiotics, aside from Bayer's drug, are 
effective against the most common form of the disease; their patents have already expired. The government did not even take the politically sensible -- if unjustified -- step of declaring a national emergency, in which case `compulsory licensing' (as such patent expropriation is known) is legally permitted with compensation to the patent-holder.

Canada's Cipro saga ended this week: Bayer donated hundred of thousands of tablets now and promised to deliver a million later in case of an emergency. But the issue will remain. American 
officials too threatened to follow Canada's example in order to ensure a steady supply of drugs.

There is an irony here. Other countries want to bend patent rules in the interests of public health; indeed, this is what Brazil, South Africa and other poor countries battling with AIDS have been trying 
to. And yet, these countries have come under attack from the developed world, particularly America, for subverting international intellectual-property rules. But surely millions of victims of HIV in 
Kenya are as much of a national emergency as a dozen cases of anthrax in America.

This contrast will doubtless come up at next month's meeting in Doha of the World Trade Organization (WTO). Deals there will probably include a ministerial declaration of the impact on public health of TRIPS, the international ground rules on intellectual-property rights that all members of the WTO are bound to observe sooner or later. Many poor countries, among them India and Brazil, are calling for change.

Some of their proposals should be resisted, as they are aimed mainly at boosting their domestic drug industries. But others should go ahead. For instance, it would be reasonable to extend the definition 
of compulsory licensing to allow poor countries, which, unlike Canada, lack the domestic industrial capacity to produce the drugs they need, to import them from elsewhere. Most important is attitude: 
TRIPS in its existing form is flexible enough to allow poor countries to satisfy their public-health goals, as long as other member states do not complain when they legitimately exploit flexibility in the agreement. One of those loopholes is the right to allow compulsory licensing to handle a national emergency.

Patent protection is, of course, only one reason why poor people cannot get their hands on life-saving medicines. And patents exist for good reasons. Developing new drugs is a costly and time-consuming 
exercise; it is only fair that pharmaceutical firms have an opportunity to recoup that investment, and an incentive to design better medicines. But this is a good time for America and its 
industrialized allies to soften their hard line on patent enforcement around the world. The attacks of September 11th have shown America to be as vulnerable as other countries; it would do well to extend the same goodwill as it may one day need in return."

In fact the so-called " Green Room" tactics were reportedly used by the developed countries at Doha also to isolate and corner the vocal developing countries ( alas ! India had fallen an easy  victim to this strategy during the earlier GATT negotiations leading to her signing on the dot for the WTO), but perhaps the post-Anthrax confusion in the West and the newly found global support and self confidence would have enabled India and other developing countries to put up a stiff fight .

2.          Bayer Aktiengesselschaft, Leverkusen  has been holding a patent for " Topically applicable formulations of gyrase inhibitors in combination with cortisesteroids " vide US Patent No 4,844,902 issued on July 4, 1989 - a very comprehensive 44 page document with the following abstract:
 "Typically applicable formulations comprising known ciprofloxacin-type antibacterials of the formula ##STR1## in which A is N or C-R.sup.9 , and cortisteroids are especially effective in therapy, particularly in oral cavity. The formulations can be used in the form of plasters, gels, suspensions, emulsions and solutions".  

This has been followed by the other related patents, 5,023,257; 5,152,986; 5,639,886; 5,843,930; 5,965,549, and 6,066,292 issued on May 23,2000. The continued business interests of Bayer is more than obvious.

3.          Thanks to the Anthrax scare in the developed countries, Bayer is under serious pressure to produce in assured and adequate quantities of the drug at acceptable costs; and a country such as Canada decided to violate the patent and order one of its native companies to manufacture and supply in the generic form. Indian companies, on the other hand , offer the generic form at very low prices making use of the provisions of 1970 Indian Patents Act. Even USA has reportedly been contemplating of using its emergency compulsory licensing powers to meet its need for supplying adequate quantity anti-anthrax drug at acceptable costs to her citizens !

4.           It is in this context that one should read the recent Geneva Agencies  report "Novartis warns against patent, price pressure"  in Business Line November 20,2001.

 " The pressure to lower prices of medicines is threatening the pharmaceutical industry, the chief of the Swiss pharmaceutical giant Novartis said. Mr Daniel Vasella acknowledged in an interview with the Swiss-French newspaper Le Temps that the pressure on German drug firm Bayer over its patented anthrax treatment had been huge.' The pressure exerted on Bayer has been enormous. I did not envy them. That shows that the pressure on prices constitutes today a major risk for all pharmaceutical companies, the Novartis Chief Executive Officer told the paper. Bayer last month agreed to supply the US government with the anti-Anthrax drug Cipro at a discounted price to help the country face its recent Anthrax scare. US Health and Human Services Secretary, Mr Tommy Thomson, had warned that in the absence of a price agreement the US might waive Bayer's patent on Cipro to allow cheaper generic versions into the market. " To use the threat of expropriating a firm by breaking the patents is an unfortunate and dangerous tactic, Mr Vasella said".

5.          In other words, the effects of  the TRIPS compliant IPR regime on human healthcare - the "patents versus patients"  issue- will continue to be a matter of serious political-economic-ethical debate in all international gatherings including those under the WTO, thanks to the great courage of the "original sinner", South Africa ! Three cheers to that great country !

6.          It is in this connection that the Second Amendment Bill currently before the Parliament needs to be given once again a critical examination. The following minimum level 'protection' clauses at least should be included :

a.          The term "government use" must include indigenous manufacture and production of ESSENTIAL DRUGS , FOOD ARTICLES  INCLUDING CONCERNED PLANT MATERIALS and STRATEGIC MATERIALS & SYSTEMS ; and for these items, GOI must retain unilateral powers for enforcement through willing indigenous  agencies. To meet the essence of the  WTO conditionalities , the GOI may even work out an appropriate compensation scheme for  the IP related rights of the assignees. Items to be covered under the above categories may be decided as and when required through a standing high level committee of experts .

b.           Linking up of Compulsory Licensing with 'emergency' requirement is a mistaken concept when considered from the above items and accordingly such references should be deleted. After all in times of a real emergency like war or war-like internal situations as approved by the administrative-parliamentary bodies, all governments make use of emergency powers as a matter of course.

c.           IPR protection must get automatically invalid if those items are under embargo under any pretext.

In a way the Anthrax based conflicts of interests ( even between the developed nations ! ) have come as a "blessing in disguise" to the developing countries and we must fully utilize the resultant opportunities to protect our national interests .