What do you mean by evergreening of patents?
When innovators ,through various means try to increase the lifespan of the patents to have monopoly in the respective market. Evergreening of patent is a social practice rather then legal principle practiced by patent owners . Evergreening of patent can also be described as a business strategy to elongate the patent period .The patents are granted for a period of 20years in India by paying of annuilty fees. Once the tenure of patent period of invention is over it goes to public domain where it becomes available to company ,firm or individual are to manufacture, sell or import .However ,sometimes the patentees (mostly pharma companies) try to extend their monopoly right beyond the patented invention period and file new patent so that no other company gets the right to manufacture or sell that invention. This is known as Evergreening of patents.
Generics medicines comes into frame once the patent period gets expired which much cheaper drugs. An entire cycle of discovery, clinical trials ,marketing and distribution takes alot of risk and vast collection of drug do not makeup to the market. So the innovating company’s look for an alternative as to extend the patent as long as possible. Innovating company’s carry out Evergreening of patent by changing minor variant of parent compound called secondary patent. This practice of Evergreening allows leads to extension of the Patent period due to which Generics cannot come into picture which leads to monopoly of innovators. Evergreening of patent came into limelight when recent ruling India’s supreme court when they refused to grant patent to Swiss pharmaceutical company Novartis a Patent to its new version of Cancer drug Gleevec. Novartis’s claimed that their new version of drug was more absorptive in blood and was more reactive in fighting with leukemia and they wanted warrant patent protection on that ground which was rejected by India ‘s Patent law does not allow such Evergreening.
What is patent?
A patent is a form of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of years in exchange for publishing an enabling public disclosure of the invention. In most countries, Patent rights fall under private law and the patent holder must sue someone infringing the patent in order to enforce his or her rights. In some industries patents are an essential form of competitive advantage; in others they are irrelevant.
Patent law in India
By replacing the existing Indian patents and Design Act 1911 ,the Patent Act 1970 along with the Patent Rules 1972 came into existence on 20th April 1972.A committee Report headed by Justice R.N.Rajagopala highly recommend the Patent act 1972.Allowing of only process Patents in regards with invention of food,medicine,drug and chemical was the recommendation of the Patent Act 1972.0n 7th December 1998 India became signatory of the Paris
Convention and the Patent Co-operation Treaty and thereafter on 17th December 2001 signed the Budapest Treaty .In 2005 India altered it Patent law to accept the TRIPS obligation .
Do Evergreening really makes a difference!!
According to Mr.Jim Keon, president of Canadian Generic Pharmaceutical Association the modified drug don’t offer enough of advantage over generic version of the original molecule . So the Evergreening of patents is merely done to earn more profits .The reason which company’s give for the Evergreening of patent is that they need finance to do R&D .But is this type of R& D really useful?? Just tweaking the original version of product in name of R&D dose only justify the monopoly of the innovating company without improving medication in reality.
Mr.Patrick Kieran’s ,the global head of pharmaceuticals and lifescience for Norton Rose says that if the change in parent molecule is bringing efficient in bringing the necessary improvement in medical science then only they are eligible for Evergreening of patent.
Patent registration is the first step of protecting your invention.
Evergreening a global practice
This problem is faced all over the globe by local generics and is also a hot topic for global debate as Evergreening of patents by unfair or incompatible means is leading to delay the entry of local generics. The concern here is to what extent new chemical entities(NCE) could be relied upon to argument the flow of medicine and whether we can allow combination of known substances to fill in till a fresh NCE is developed. According to a study only 433 new chemical entities entered the world market but the number of patents provided was far far more.According to Dr Mashelkar Committee this issue is quiet big as there are loop holes in the rules and regulations. One of the solution as recommended by Dr Mashelkar committee was to provide patent only to ‘new chemical entity’.
Overview of cases of Evergreening of patent
The Australian parliament in 2004 passes a legislation which discourages the improper legal action of pharmaceutical companies to delay generic entry.
The European court of justice (EJC) proposed a regulation stating that if any new substance is added or major parent molecule is changed then only new SPC will be formed
In 2004The Canadian Competition Refused to pursue complaint on the practice of Evergreening of patent saying they have enough of law designed to protect the interest of generic manufacturers.
Patent search is also a necessary step before patent registration.
Evergreening of Patent does not leads to therapeutic advantage but it’s done for company’s economic advantage.
Extension of Evergreening of patents shouldn’t be granted unless and until the new version provides the necessary improvement, which is also stated in section 3(d) of the Patent Act 1970.
Blocking the Evergreening of patent will bring a big relief to poor people and poor patents who are dependent on life saving drugs.
Evergreening of patent law should be taking positively to benefit people and medical science rather than using it as a shield against competitive market
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