RANBAXY LOSES LIPITOR IN FINLAND

After the US and the UK, Ranbaxy suffers another patent defeat over multibillion dollar drug Lipitor in Finland. Like the US and the UK, it will appeal here as well. Thus far, its only victory has been in Austria.

The Financial Express states:

In another setback to India’s biggest drugmaker Ranbaxy Laboratories Ltd, a court in Finland has prohibited it from marketing its generic version of Pfizer’s cholesterol lowering drug Lipitor in the country.
The Helsinki court of appeal in Finland had granted a preliminary injunction against Ranbaxy Laboratories prohibiting it from marketing a generic version of Lipitor.

The ruling involves Pfizer’s patent that covers processes and intermediate compounds used to make atorvastain, the active ingredient in Lipitor

BIRD FLU HITS INDIA

One of the first posts on this blog related to Avian Flu. Little did I know that I would have to post again--as the notorious bird flu makes it way to India. As expected, it has brought with it the patent controvery as well. A news item states:

"The bird flu threat has become a litmus test for the government on how it would use the patent law flexibility to cope with a public health issue that could potentially be a national emergency.

Pharma companies like Cipla and Ranbaxy, willing to produce their versions of Roche’s influenza drug Tamiflu (oseltamivir), are at risk of liability suits because they don’t have the consent of the patent-holder.

Roche holds product patent on Tamiflu, the most-effective known drug for avian flu, in the western markets and process patents in India. The Swiss drugmaker had given the licence to manufacture and market the medicine to only one Indian company- Hyderabad-based Hetero Drugs. In case of a pandemic, it is uncertain whether Hetero will have the capacity to produce the medicine in sufficient quantities."

What troubles me is the following comment in the news report:

"Given that Roche has process patents in India, any company that produces/markets the the drug without authorisation by the patent-holder is liable to suits, an industry source argued".

Come on--don't all of us know the international reverse engineering reputation of Indian pharma manufacturers that can work around the most difficult of process patents. I have highlighted and this and other aspects in a recent article co-authored with a colleague, Tahir Amin. I reproduce the abstract and the conclusion below:

TAMING OF THE FLU: WORKING THROUGH THE TAMIFLU PATENTS IN INDIA

Shamnad Basheer* and Tahir Amin**


ABSTRACT


With an impending Avian influenza or bird flu pandemic, the issue of patents and public health has once again taken centre stage. Oseltamivir (known by its brand name ‘Tamiflu’), a patented antiviral pill, has emerged as the world's first line of defence against bird flu. A key priority for most nations is to create sufficient stockpiles of this pill that can then be easily distributed and administered during a pandemic. Keeping this end in mind, this paper explores the patent position in India and looks at ways to work around a patent, should one issue in future. The paper recommends various strategies for creating an optimal and affordable stockpile and calls on the government to take a more definite stand in the matter.CONCLUSION

As of the date of writing this article and from the information obtained thus far, CIPLA and other generics are free to manufacture Oseltamivir. However, should Gilead’s mailbox applications mature to patents and the claims amended to include the main Oseltamivir molecule, the Indian patent regime offers a comprehensive compulsory licensing/government use framework that would enable the continued production of Oseltamivir at affordable prices.

Unfortunately however, the government appears to be shying away from taking a stand in this matter, owing to perceived fears that this would send out the wrong signals to multinational pharmaceutical majors, from whom they expect significant investments in the post product patent era. In fact, it took a while for the government to even clarify the obvious point about Roche’s patent--i.e. that generics could manufacture at this stage, as there were no patents covering Tamiflu. A news item states:

The government, however, has no plans to intervene on the product’s patent-related issues. Although the government wants to be prepared for a crisis, it, apparently, does not want to signal to the world that it favours generic companies at a time when the scare does not pose an immediate threat.

This is ridiculous. No doubt, one cannot state with any certainty that the notorious avian flu would definitely mutate to a form easily transmissible among humans. However, the threat is a very real one and when it strikes, it will do so mercilessly without giving any advance warning. It is as ‘immediate’ as can possibly be and no government can afford to ‘fence sit’ in such a matter. Other governments appear to be more active in this regard. Illustratively, following a break down in talks with Roche and Gilead, the Taiwanese government granted a compulsory license to Taiwanese drug firms. This license, valid till 31 December 2007, enables them to manufacture Tamiflu for domestic use only, subject to the caveat that such manufacture can take place only when there is a shortage of supply from Roche.

As a first step, the government ought to fast track the examination of the Gilead’s mailbox applications. More importantly, the government ought to arrive at an optimal stockpile number and work towards ensuring that supplies matching such number are met. Amongst other things, it ought to evaluate whether the sub-licensing arrangement with Hetero is sufficient to ensure such supplies.

No doubt, patents incentivise innovation, particularly in the area of pharmaceuticals and some respect ought to be accorded to patent rights. However, given an impending public health disaster, the government can afford to accord a little less respect. After all, it must be borne in mind that even the worlds patent friendliest nation, the US had wilted on its pro patent stand in the face of the Anthrax crisis in 2003. As rightly stated by one commentator in the context of intellectual property rights and developing countries:

A mere 60 cases of one infectious disease moved these patent pillar nations to compromise business interests for public health. Developing countries house a sizable percentage of population with various diseases. Expecting developing countries to place business interests of developed nations ahead of the local public health issues is impractical.

The Indian government should therefore take a clear stand and devise an appropriate strategy/policy. We hope that this paper succeeds in giving some pointers in this direction.

Anyone who wishes to a full copy of the article, please write to me at shamnad@gmail.com. Meanwhile, as we continue debating the esoteric patent issues, more chickens are being culled in India.

CSIR and Ranbaxy among top PCT applicants

CSIR was always part of this list (taken from www.pharmabiz.com). Good to see that Ranbaxy features here too. It will be a while though before we catch up with South Korea which dominates here.


"India stands third in the list of international patent applications filed by developing countries in 2005, and the Council of Scientific and Industrial Research (CSIR) and Ranbaxy Laboratories are among the top ten users of the PCT from developing countries.

The top ten users of the PCT from developing countries are SamsungElectronics (Republic of Korea), LG Electronics (Republic of Korea), Huawei Technologies (China), Council of Scientific and Industrial Research (India), Ranbaxy Laboratories (India), LG Chem (Republic of Korea), Electronics and Telecommunications Research Institute (Republic of Korea), Agency for Science, Technology and Research (Singapore), ZTE Corporation (China) and NHN Corporation (Republic of Korea). According to Ranbaxy sources, the company has filed 57 patent applications in last quarter of 2005, bringing this figure to a total of 185 patent applications filed during 2005.


.The five top users of the international patent system are United States of America, Japan, Germany, France and the United Kingdom. In 2005, over 134,000 PCT applications were filed, representing a 9.4% increase over the previous year. The Republic of Korea is the 6th biggest user of Patent Cooperation Treaty (PCT) and China is the 10th largest PCT user."

More GI registrations in India

A spate of new GI registrations in India.

"The Geographical Indications Registry has granted GI certificate to Bidriware from Bidar, Channapatna toys and dolls, Nanjangud banana, Coorg orange, Mysore betel leaf, Mysore rosewood inlay, Mysore traditional paintings and Mysore agarbathi, thereby enabling producers and inventors to prevent others from exploiting their products without permission."

"We have accorded certificates to these items/products. The certificate owners will be the registered proprietors of the GI concerned," an official with the Geographical Indications Registry told The Hindu. The Controller General of Patents, Designs and Trade Marks attached to the Union Ministry of Commerce and Industry also acts as the Registrar of GI."


The increasing number of registrations seems to suggest that the registration mechanism is working well. However, international consensus on this is still a distance away. And unless things like Mysore agarbathi are protected abroad as well, one cannot prevent the sales of such agarbathi sticks by third parties abroad. It is hoped that working the system in India and ironing out the creases domestically would help when it comes to legislating internationally.

The GI registration system gives some cause for optimism that other controversial areas such as traditional knowledge (if indeed, we did come around to a registration system for traditional knowledge) would work well.

ps: couldn't help noticing that most GI registrations seem to be coming from the South-mysore silk, pochampalli saris and now all the products mentioned in the item above. Is the South richer in cultural and agri products??

INDIA LAGS IN NUMBER OF IT PATENTS

An interesting piece (titled "India lags in number of IT patents") on the low levels of software patents in India, despite India's global excellence

"India may be the world leader in information technology but it trails in a big way when it comes to patents in the IT sector.
While the top 10 patents holders across the world are IT companies, in India, no IT firm has patents. The list of top 10 patents holders in India comprises only pharmaceutical and bio-tech companies.
In India, 184 patents are held by the Council of Scientific and Industrial Research, followed by Ranbaxy (56) and Dr Reddy's Laboratories (19). Worldwide, though, the highest number of patents is held by IBM (3,248) followed by Matsushita Electric industrial company(1,934) and Canon (1,805).."

Another news item notes:

"Despite huge research and development facilities in the country, the five Indian information technology majors - Infosys, TCS, Wipro, Satyam and HCL Technologies - have together filed only 38 patent applications till mid-2005.

While IPR experts feel that the number is much higher than their US filings, these are negligible compared to the top five domestic drug companies that together have around 1,100 filings"

These articles cite the Indian patents act as the key reason underlying the low levels of patent filing:

"A major deterrent for these IT companies is the Indian patents law, which does not allow software per se to be patented."

I'm not entirely sure of the statistics presented in the news items---the Indian press does not score too highly on authentic statistics, particularly when it comes to IP. Be that as it may, these news items miss a very important point, that could perhaps explain the low levels of software patenting in India better.

No doubt, the fact that software per se is not patentable may account partially for this low level of patenting--however, it is but a minor reason. Any patent lawyer in India will tell you that scores of software patents have been granted in the past. Most such patents of course went to IBM, Microsoft and the like and not to WIPRO or Infosys. The underlying logic behind such patent grants in India resonated with that in the EU i.e. that it is only software per se that is not patentable. However, if such software is combined with hardware or has a technical effect of some sort, then it is patentable. This position may change slightly (though not drastically) with the new patent regime (since an Ordinance provision seeking to make explicit the practice of the Patent office in granting patents to software combined with hardware or showing a technical effect was shot down at the last stages and never made it to the final Act).

The 'software' per se exclusion cannot therefore be a key reason. IMHO, the software 'services' oriented model followed by the IT biggies in India is the chief cause. Despite India’s supposed global excellence in software, we have largely restricted ourselves to a ‘services’ model--where the products that are created are done for and on behalf of others. Consequently, the IP is owned by such "others". The services model banks a lot on the cheaper cost of labour in India and is relatively risk free--as revenues are more or less guaranteed. Compare this with conceptualising and designing your own software product. It may or may not click in the market. If it clicks, the returns are colossal--but the risk of market failure is high too.

An article rightly notes:

"The common point is that we don't have enough product and technology innovation, taking place in India. This is true. Except in pockets, the IT industry has focused mainly on process innovation. A unique Indian problem is that IT services companies have sucked out the oxygen from product companies. Their success has not only drained away talent, but has created an instruction-led and risk-averse mindset. They have turned our smart guys into mental coolies. .....In a product company one has to be at the cutting edge of technology. Product and technology innovation is the currency that you bring to the market. It requires risk-taking, a market focus as opposed to a customer focus. ....It's time for software product companies in India to break free from the IT Services ecosystem."