Economic Times, July 21, 2007
The Indian Patent Appellate Board (IPAB) has dismissed Novartis objection to the appointment of S Chandrasekaran, former Patent Controller General India, to hear its appeal for Glivec.Novartis had filed a petition with IPAB last month, insisting that the newly appointed technical member to the board had in a different capacity refused its patent for anti-cancer drug Glivec.The dismissal of the Swiss giants protests could make Novartis take its case to the courts, triggering a fresh legal wrangle.
According to legal sources, IPAB has argued that Mr Chandrasekaran was serving in a different capacity with the Indian Patent Office and, therefore, though it was under his tenure that the patent for Glivec was rejected, he was not directly involved in the decision on Glivecs patent. Besides, the technical member to IPAB needs to have work experience of five years with the Indian Patent Office, which makes it difficult to appoint a new person to hear Glivecs case.
Click to read on…
No Comments »
Business line Wednesday, Jan 31, 2007
New Delhi Jan. 30 Health organisations from across the world have came forth in support of the Indian Government in its ongoing legal case against drug manufacturer Novartis and urged the Swiss company to drop its patent case in India.
Novartis had filed an application for patenting its cancer drug Gleevac, used for treating Leukaemia, which the Indian Government had turned down. The company filed a case with the Madras High Court challenging the decision.
“The treatment with Gleevac costs Rs 1,20,000 per month for a patient as compared to Rs 8,000 per month with its generics. If Novartis wins the legal battle, it will set a wrong precedent for other patent cases and have widespread implication on provision of other life saving drugs,” said Dr Amit Sengupta of People’s Health Movement, a health organisation working for the poor people.
Click to read on…
No Comments »
Economic times, July3, 2007
The Indian Patent Appellate Board (IPAB) on Monday heard a case that will decide whether S Chandrasekaran, former controller general of patents, will be allowed to hear Novartis appeal for Glivec, or if a new person will be appointed for the case.
The Swiss drug major had earlier objected to the appointment of Mr Chandrasekaran to hear its appeal, arguing that he was responsible for the rejection of Glivecs patent application in the first place. Novartis has launched two suits after India refused to grant a patent for Glivec, an anti-cancer medicine. Novartis is challenging not just the Glivec decision, but also a section of the Indian patent law designed to promote cheaper generic medicines for poor patients who cannot afford patented medicines.
Click to read on…
No Comments »
Times of India, June 19, 2007
The much-awaited appeal proceedings in a cancer drug patent case could not begin on Monday as Swiss major Novartis AG, turning the tables on the government, raised a conflict-of-interest objection to the composition of the two-member bench of the Intellectual Property Appellate Board (IPAB).
How can an officer who swore an affidavit on behalf of the government turn into a judge in the same matter?
Novartis objected to S Chadrasekharan, former controller general of the Indian Patent Office, being the technical member on the bench that will decide its appeal against a decision taken last year by his then subordinate, rejecting its patent application for cancer drug Glivec.
Click to read on…
No Comments »
Financial Express, June 20, 2007
The Intellectual Property Appellate Board (IPAB), which has been formed to give a verdict on various patent cases across the country, may reject Novartis objection on the presence of S Chandrasekharan, the former patent controller, on IPAB.
Novartis had objected to Chandrasekharans presence on the board saying he was responsible for Glivec being denied product patent in 2006, when he was the controller general of patents.Experts close to the development say that IPAB will consider the fact that Chandrasekharan was actually not responsible for the decision on Glivecs patent application. IPAB will consider Novartis objection on July 2.
Click to read on…
No Comments »
The case filed by the big pharmaceutical company Novartis has attracted global attention. “Doctors Without Borders” winner of the Nobel Prize for best medical relief in 1999, has requested people all over the world to write to the company to drop the case. Over two lakh people have written to Novartis. Why is this case so important?
Novartis, the Swiss Multinational pharmaceutical company, has filed a case in the Chennai High Court against the order of the Chennai Patent office rejecting the patent application filed by them for getting a patent on imatinib mesylate, a medicine useful in the treatment of chronic myeloid leukemia (CML) – a form of blood cancer. Currently it is being produced in its generic form by NATCO, Cipla, Ranbaxy and Hetero as well as by Novartis under the brand name Gleevec. Treatment with Gleevec, the Novartis brand costs Rs 1.2 lakh per month, whereas the Indian generic versions cost about Rs 8000 ($175)! If product patent is granted to Novartis, the Indian generic versions will be forced to go out of the market, while the treatment of the CML would cost Rupees 1.2 lakh per month and this would go out of the reach of 99 per cent of the patients of CML. There is no explanation as to why Novartis is not offering different prices depending on the circumstances in a country like India.
Click to read on…
No Comments »
THE HINDU, May 01, 2007
Norwegian Minister of International Development Erik Solheim has urged Novartis to withdraw its case against India, challenging a clause of the Indian Patent (Amendment) Act, which does not grant patents to medicines that are new forms of an existing drug or “ever-greened” rather than innovations.
Last year, Doctors Without Borders (Mdecins Sans Frontires or MSF) had made a similar appeal to the Swiss company as its legal challenge could restrict access to affordable medicines in the developing world. HIV/AIDS advocacy groups and the pharma company’s shareholders have also called on the company to withdraw the case filed before the Madras High Court.
No Comments »
In a rather predictable move, Novartis, the swiss multinational company which holds patent for a many medicines used for treating camcer, leukemia, malaria and many others including the the anti retro-viral AIDS medicine has challenged the contentious Section 3(d) introduced via the 2005 Amendments to India’s Patent Act.
This unique section which has been specifically been introduced into the Indian Patent Acrt provides a part that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance is not patentable. While this clause has no precedent in any other patent laws in the world it was specifically drafted so as not to misuse the rediscovery of an already known item and patent it. The section then states (via an explanation to the section) that salts, esters, esthers, polymorphs, metabolites etc shall be considered as the same substance, unless they differ significantly in properties with regard to efficacy.
Click to read on…
No Comments »
In 1997, Novartis AG filed a patent application in the Chennai ( Madras) Patent Controller’s office for the beta-crystalline of Imatinib Mesylate, brand name Glivec (Gleevec) on the ground that they invented the beta crystalline salt form (imatinib mesylate) of the free base, imatinib. In 2003, it was granted Exclusive Marketing Rights (EMR) for marketing Gleevec in the Indian market. On the basis of the EMR, Novartis AG obtained orders preventing some of the generic manufacturers from generic equivalents of Gleevec.
Novartis was selling Gleevec at USD 2666 per patient per year. Generic companies were selling their generic versions at USD 177 to 266 per patient per month.In 2005, the CPAA and the other generic companies filed a pre-grant opposition against Novartis’ patent application for imatinib mesylate, claiming, among other things, that Novartis’ alleged “invention” lacked novelty, was obvious to a person skilled in the art, and that it was merely a “new form” of a “known substance” that did not enhance the substance’s efficacy, and was thus not patentable under section 3(d) of the Patents Act. These arguments were based on the fact that Novartis had already been granted a patent in 1993 for the active molecule, imatinib, and that the present application only concerned a specific crystalline form of the salt form of that compound.The CPAA and the generic companies contended that the 1993 patent effectively disclosed both the free base, imatinib, and the acid-addition salt, imatinib mesylate. Further, the CPAA and generic companies argued that different crystalline forms of imatinib mesylate did not differ in properties with respect to efficacy, and thus the various forms of imatinib mesylate must be considered the “same substance” under section 3(d) of the Patents Act.
In January 2006, the Patent Controller in Chennai, in a landmark decision, refused to grant Novartis a patent, agreeing with the contentions of the CPAA and generic companies that the subject application lacked novelty, was obvious, and was unpatentable under section 3(d) of the Act.The patent rejection meant that generic companies could manufacture and market their drug, both in India and abroad, who make available the generic imatinib mesylate priced at less than one-tenth the price that Novartis was charging (USD 166 to 266 instead of 2666 per person per month).
No Comments »
Medical Patent News , March 8, 2007
A court in Chennai, India, last month heard arguments in the case regarding Novartis claims to Gleevec Patents in India. Some HIV/AIDS advocacy groups are calling on Novartis to drop its legal challenge, saying that if the company wins the case it could restrict access to antiretroviral drugs for millions of people worldwide.
Novartis brought a civil lawsuit against the Indian government after the country in January 2006 rejected the company’s attempt to patent a new version of its leukemia drug Gleevec on the basis that the drug is a new formulation of an existing drug. India’s patent law, which went into effect in January 2005, allows patents for products that are new inventions developed after 1995, when India joined the World Trade Organization, or for an updated drug that exhibits improved efficacy.
Click to read on…
No Comments »
