The Madras High Court in the southern Indian state of Tamil Nadu a few days ago delivered a historic judgement by rejecting Novarti's patent plea. Perhaps, the court has saved millions of poor and middle class families with one of its members suffering from chronic myeloid leukemia (CML), a rare form of cancer, not just in India but around the world, says Sapru, founder chairman of the Cancer Patients Aid Association (CPAA).
Novartis seeking patent for its product Glivec, a life-saving drug to be taken by CML patients lifelong. First the Indian patent authorities shot down Novartis' patent application. Then the Swiss pharmaceutical giant went to court challenging the rejection and also the Indian patent laws under which its application was rejected.
The Madras High Court ruled that the company go back to the appellate board set up for the purpose of reviewing appeals against rejection of patent applications. That was a couple of months ago. Then came the second part of the judgement in which the court has upheld the constitutional validity of the Indian laws.
So long as Glivec remains unpatented, a months consumption of generic equivalents would cost a patient between Rs 8,000 to 10,000 per month. But once patented the same quantity could cost a whopping Rs 1.25 lakh per month. That is the price Novartis charging worldwide.
Novartis, claiming innovation, wants patent. Novartis also claims that the company was selling it free for 99 percent of the patients prescribed Glivec in India. Patenting could prevent generic drug manufacturers from making copycats, it argues.
India's generics exports comprise about 60 to 65 percent of pharma revenue, estimated at $5 billion. 'It is a significant judgement,' says Sapru. By confirming that Section 3(d) was an essential part of the Indian Patent Act, the court has restricted the monopoly sought by pharmaceutical giants, he contends. 'It is not about Glivec. There are 7,000 drugs, with minor variants, awaiting patent.
Only Section 3(d) has kept them at bay. If 3(d) is removed, all these drugs, most of them life saving, will become unaffordable for the vast majority. It will be very, very expensive,' says Sapru.
Section 3(d) states: 'For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.' Clause 3(d) is very specific and precise with respect to pharmaceutical and biotechnology industry.
In March 2005, the Indian Parliament amended its patent law to protect product patent protection. Section 3(d), a significant and important provision, was introduced to prevent evegreening and granting of frivolous patents. Novartis AG (and Novartis India) had challenged the validity of Section 3(d).
The issue has also opened the debate on 'incremental innovation' against 'evergreening'. Incremental innovation is the way through which majority of the advances in medical or health sciences occur. Evergreening is a term used for activities wherein companies seek to extend the market exclusivity of a pharmaceutical product by introducing small changes just before patent expiry. It occurs when a company stockpiles patent protection by obtaining patents on multiple attributes of a single product.
Glivec is indeed a miracle drug. The first in a class of medicines to fight cancer without harming the healthy cells. 'Glivec is being tested for tumours and sub-trials are on for treatment of breast cancer as well,' says Shanta, chairperson, Chennai Cancer Institute. Results of clinical trials have showed that the wonder drug could restore healthy blood cells in 90 percent of the patients with CML.
Predictably the Indian pharma companies started manufacturing the generic version of Glivec. First, Natco Pharmaceutical, a Hyderabad based generic drug manufacturer, manufactured and started selling generic Glivec branded Veenat. Cipla followed. In all nine companies pitched in.
In 1997, Novartis AG filed a patent application in the Chennai Patent Controller's office for the b-crystalline of Imatinib Mesylate, brand name Glivec) claiming that the company has invtented the beta crystalline salt form of the free base, imatinib. In 2003, the company got Exclusive Marketing Rights for India.
Six out of the nine generic manufacturers had to stop production and the other three could not cover the entire country. As Novartis was priced 10 to 15 times higher than the generic versions, the cancer support groups and associations could no more fund their programmes.
As it happened there was a glitch in the Novartis schedule. The base compound of Glivec was invented in 1993. It was only two years later that India joined the World Trade Organisation (WTO).
India said that over the next 10 years, as it moved towards a patents regime, it would consider fresh patent applications of inventions that did not exist before 1995. So the original base compound of Glivec did not qualify, but Novartis filed for patent for a slight variation, a beta crystal form.
When the Indian Patent Law came into effect in 2005, with the incorporation of 3(d) meant, it became clear that in effect patent claims on beta crystalline would not hold water. Novartis first lost its exclusive rights and the Indian generics who were debarred from making copies rose again.
The CPAA and other generic companies also filed a pre-grant opposition against the patent application of the Novartis charging that the 'invention' lacked novelty. They argued that Novartis had already been granted a patent in 1993 for the active molecule, imatinib, and the present patent was only for a crystalline form of the salt from the compound.
In a landmark decision in January 2006, the Patent Controller in Chennai refused to grant Novartis a patent. It was obvious that subject applicant lacked novelty, he said. The decision also meant the generic companies could market their versions worldwide.
The High Court has refused to intervene in the decision and also upheld the Indian patent laws.
'There are 5 to 7 million people in the third world whose lives depend on life saving drugs like Glivec. The Chennai High Court judgement is truly historic,' Sapru said. The Glivec case in India has given a bad name to Novartis worldwide. Already under criticism for Glivec's global programme, for which it chose an unknown charity foundation, Max Foundation, as partner as major international aid agencies rejected the proposal, Novartis has been accused of stopping the free supply of Glivec and then asking pateints, who can't live without the drug, to buy the drug for the rest of their life.
That was the reason Novartis got the Public Eye Swiss Award 2007 for irresponsible corporate behaviour on the opening day of the World Economic Forum in Davos, Switzerland. (The Berne Declaration and Pro Natura, Switzerland, are giving this negative award for the past three years).
Not everyone hates Novartis though. 'For five years now, Novartis is giving Glivec free for our patients,' says Dr P Guhan, director, Sri Ramakrisha Institute of Oncology and Research, Sri Ramarishna Research Hospital, Coimbatore. 'Initially, we were also apprehensive of the intentions of Novartis when it said Glivec will be given free. We also felt that it will stop the free programme midway. I should tell the truth. There are patients receiving the drug free of cost for the fifth and sixth year now.' All his patients have been adapted by Novartis. In Chennai Cancer Institute, Glivec is supplied free to patients in the general ward but not to those in the special ward.
Glivec supplied by Novartis was definitely superior than the generics, Guhan said pointing out that the manufacturers of generics were not giving it free to patients even for a few months. 'Spending Rs 10,000 for the generic varieity is not possible for everyone,' he says adding that most of his patients were poor who would not be able to afford to buy generics life long. That is the crux of the issue.
But then MNC pharma companies like Novartis, are not out there for charity. They are actually fighting to patent their inventions and looking to invest more in research only because they want to rake in billions in return.
Incidentally, fifty percent of the Glivec research funding came from the US government, 30% from a US NGO and 10% from the Oregon Health and Science Institute. Only 10% came from Novartis, CPAA claims. But Novartis itself would not comment.
Since millions of dollars are at stake, the multi-national is unlikely to give in. Already it is challenging the presence of an official who had rejected its patent application in the appellate board too. Activists are promising to fight every inch of their way, WTO or not.