First patent law in India came into being in 1852. This patent law was obviously aimed at giving preference to foreign
pharmaceutical
companies. After independence Indian Patent Act 1970 was enacted after deliberating on the issue for 15 years. This law was aimed at providing medicines at affordable prices to the masses, apart from giving encouragement to research and development and domestic competition while protecting interests of the patent holders. Provision was made only for the process patent and to ensure the availability of medicines at affordable prices to the public, provisions were made for compulsory licensing. Royalty to the patent holders was limited to 5 percent for use of patent by others and for patent to be effective, domestic production was the essential condition.
Then came TRIPS agreement under WTO. The government gave the commitment to amend Indian Patent Act in tune with TRIP’s agreement, which necessitated the inclusion of provisions in the Patent Act, which were undoubtedly not in the national interest in general and public health in particular. Indian Patent Act was amended which led to inclusion of Product Patent, limiting the scope for compulsory licensing, lengthening the period of patent to 20 years and patent protection, even in case there is no domestic production of that product and patent protection was provided even on the import.
Thanks to Indian Patent Act 1970, India emerged as an important production centre for medicines. Medicines are available in India at the cheapest prices. Our
pharmaceutical industry in comparison with the rest of the world served not only our own country; rather it emerged as one of the important exporters of medicines all over the world, especially to the developing countries. While Indian Patent Act was being amended by the government under the pressure from WTO appeals were coming from not only within India but even from other countries including WHO to safeguard public health. Under severe criticism from different quarters the government was forced to introduce amendments in Indian Patent Act (Amendment) Bill 2005. Under these amendments provisions were introduced so as to allow the existing domestic production of medicines to continue despite the Patent. Another provision was made to discourage continuation of Patent Right beyond the period of patent by preventing the grant of frivolous patents and ever-greening.
“Ever greening” is when patent owners attempt to extend the patent monopoly by seeking a new patent that “updates” the first one before its expiration. This is usually done by claiming things such as an “inventive” method for administering the pharmaceutical compound covered by the base patent. For pharmaceutical products, this means an extended monopoly that excludes generic drugs from the market.
Ever greening, in one common form, occurs when the brand-name manufacturer literally “stockpiles” patent protection by obtaining separate 20-year patents on multiple attributes of a single product. These patents can cover everything from aspects of the manufacturing process to tablet colour, or even a chemical produced by the body when the drug is ingested and metabolised by the patient.
EXPERIENCE OF EVER GREENING IN OTHER COUNTRIES
When ever-greening through patent strategies, the originator manufacturer simply keeps adding patents to the product (whether legitimate or not), essentially forcing the generic manufacturer to choose between waiting for all the patents to expire and applying for marketing authorisation anyway, running the risks of litigation and the associated costs and delays.
Drug patent
evergreening is the single most important strategy that multinational pharmaceutical companies have been using since 1983 in the US (and since 1993 in Canada) to retain profits from "blockbuster" (high sales volume) drugs for as long as possible.
When the original patent over the active compound of a brand-name drug is due to expire, these drug companies often claim large numbers of complex and often highly speculative patents. Laws in the US and Canada require manufacturers to notify the original brand-name patent holders of their intention to market copies at the expiry of the original patent. The original patent holders can then threaten these potential generic competitors with breaching their now "evergreened" patents and seek a court order preventing their marketing approval.
The ultimate consequence could be elderly and poor patients paying several times the present price for drugs.
The problem is a severe one in the US. In 2002, an extensive inquiry by the US Federal Trade Commission found that as many as 75 per cent of new drug applications by generic drug manufacturers were the subject of legal actions under patent laws by the original brand-name patent owner. These were driving up US drug costs by keeping the cheaper generic versions off the market.
In Canada, a similarly extensive investigation by the Competition Bureau revealed similar problems with drug patent evergreening. It found that the hundreds of legal actions involving evergreening claims were having a disastrous effect on drug prices.
The Generic Medicines Industry Association of Australia, in its submission to the Senate inquiry on the FTA, stated that this evergreening provision could lead to "long delays or generic equivalents not reaching the market".
If the big companies succeeded in delaying generic drug market entry for as little as 24 months, the federal cost for just the first few highest expenditure PBS drugs could be $1.5 billion between 2006 and 2009. Public hospital drug expenditures could increase by 12 per cent over the same period.