The Supreme Court on Monday firmly rejected Swiss drugmaker Novartis AGs demand for exclusive patent rights on cancer drug Glivec,ruling that the drug had failed in both the tests of invention and patentability under Indian law.
The verdict in the case that was seen as a battle between research and innovation on one side and public health and affordability on the other boosts the prospect of producing cheaper generic versions of lifesaving drugs in the country.
A bench led by Justice Aftab Alam held that Novartis had failed to establish either that the compound Imatinib Mesylate was a new product invented beyond the existing Zimmermann patent,or that its beta crystalline form enhanced therapeutic efficacy.
We hold and find that Imatinib Mesylate is a known substance from the Zimmermann patent itself. Not only is Imatinib Mesylate known as a substance in the Zimmermann patent,but its pharmacological properties are also known in the Zimmermann patent and in the article published in the Cancer Research journal, the court said while dismissing Novartiss appeal with cost.
Mentioning that the law of patent in India was in its infancy, the bench said that it could not help the law develop along lines in which there was a vast gap between protection and disclosure under a patent.
The court also disapproved of situations where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers,and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.
In an official release,Novartis said that the denial of patent clarifies limited intellectual property protection and discourages future innovation in India.
However,domestic drug manufacturer associations,including Indian Pharmaceutical Alliance and Indian Drug Manufacturers Association,hailed the judgment that helps poor patients. Glivec costs Rs 1.2 lakh for a months dose; generic drugs manufactured by Indian companies are priced between Rs 8,000 and 12,000 for the same dose.
Novartis had exclusive rights over the Zimmermann patent,which also used Imatinib Messilate,and it sold the cancer drug Gleevec with this patent. However,it sought a fresh patent for Glivec for India,saying that this drug used a beta crystalline form of Imatinib Mesylate,which was an invented product created through innovative processes not known for the previous patent.
After the Intellectual Property Rights Board refused to allow a patent on Glivec on the ground that the new version was only an amended version of the known compound Imatinib Mesylate,the pharma giant moved the apex court.
Natco Pharma and Cancer Patients Aid Association participated in the proceedings,and raised serious objections against Novartiss claims of innovation and enhanced efficacy for procuring the patent.
The bench,after detailed consideration of the development of patent laws in India and the journey of Novartis from the time of getting the Zimmermann patent until it moved the patent application for getting exclusive marketing rights of Glivec,held that for grant of patent,a subject must satisfy the twin tests of invention and patentability.
It termed as unacceptable a contention that a test of enhanced efficacy was not required when the product was prima facie established to be an invention.
The amended portion of section 3(d) (of the Indian Patents Act) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but,at the same time,to check any attempt at repetitive patenting or extension of the patent term on spurious grounds, the court held,adding that Novartis had failed on both counts on Glivec.
It also referred to Novartiss patent application,in which the company makes a clear and unambiguous admission that all therapeutic qualities of the beta crystalline form of Imatinib Messilate are also possessed by Imatinib in free base form.
Now,when all the pharmacological properties of beta crystalline form of Imatinib Mesylate are equally possessed by Imatinib in free base form or its salt,where is the question of the subject product having any enhanced efficacy over the known substance of which it is a new form? the court said.
In this case,there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that the beta crystalline form of Imatinib Mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with Imatinib free base in vivo animal model, the court said.
It added that even the patent application appeared to be a loosely assembled,cut-and-paste job,drawing heavily upon the Zimmermann patent.