High Court stays Novartis appeal

THE HINDU, 13 August 2007

All further proceedings on the statutory appeals filed by Novartis, challenging the rejection of its patent application, pending before the Intellectual Property Appellate Board (IPAB) were stayed by the Madras High Court on Thursday.

The First Bench comprising Chief Justice A.P. Shah and Justice P. Jyothimani granted the interim relief on a writ petition filed by Novartis AG stating that the IPAB had erred in dismissing its plea to exclude its Technical Member S. Chandrasekaran from hearing its statutory appeals.

The Bench has posted the matter to September 10 for further proceedings.

Novartis application to patent the beta crystalline form of imatinib mesylate was rejected by Chennai Patent Office in January 25, 2006. In April 2007, the High Court transferred the statutory appeals to the IPAB after a Technical Member was appointed and the Board became functional.

When the IPAB took up the appeal for hearing, Novartis sought to exclude Mr. Chandrasekaran from the Bench, on the ground that he had filed a counter-affidavit in support of the Union of India and the Controller-General of Patents and Designs and hence he would be biased against Novartis. In July 2007, the IPAB rejected the objections. The present writ petition challenges the rejection of its objections.

Describing the timing of appointment of Mr. Chandrasekaran as significant, the company said the IPAB had erred in rejecting its plea to request the Centre to appoint another member in lieu of Mr. Chandrasekaran.

The January 25, 2006 order rejecting Novartis patent application was passed by the Assistant Controller under the aegis of the erstwhile Controller-General Chandrasekaran, the petitioner said, adding that he had deposed an affidavit against Novartis in High Court before becoming a Technical Member of the IPAB. It said he would suffer from a prejudiced mindset and would not be able to apply his mind in an independent fashion. It said, It is well nigh impossible to expect that a person with an indelible mindset will be able to serve as an unbiased Technical Member (Patent).

It sought to quash the IPAB order and consequently direct the Board to remove Mr. Chandrasekaran from acting as a Technical Member (Patent) to hear the appeal and direct the Centre to appoint another Technical Member in his place.

Swiss govt not to take Novartis case to WTO

BS Reporter / New Delhi August 8, 2007

The government of Switzerland will not be taking up the allegation by Novartis that Indian patent law is incompatible with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement at the dispute settlement board of the World Trade Organization (WTO).

“We accept any case settled in India. It is normal litigation, in which one party happens to be a company and another is a country,” said Doris Leuthard, federal councilor, department of economic affairs of the Swiss Confederation, here today.

Leuthard was in Delhi to sign a memorandum on cooperation in international property rights with India.Leuthard was responding to the Madras High Court verdict on Monday rejecting a Novartis petition that questioned the constitutional validity of Section 3(D) of the Indian Patents Act, which restricts patenting of minor improvements of known molecules.

In its judgment, the court had advised Novartis to approach the dispute settlement forum of the WTO on TRIPS compliance, for which the Swiss company would have had to approach its government (only countries, and not companies, can approach the WTO on matters of trade
policy). “We must have a reliable TRIPS system and the one in India is good enough,” said Leuthard, adding, “The Swiss government never gets involved in any judicial pronouncements of other countries.

However, Leuthard also said the impact of the verdict on prospective Swiss investors in India remained to be seen. “I do not know how Swiss companies will react to it. Maybe they will have a closer look at the verdict. Some of them may find thatinvesting in India may not be attractive,” she said.

Commerce Minister Kamal Nath said the Indian Patents Law was compatible with TRIPS. “It has been two years since the Indian Patents Act has been passed and no country has filed any complaint in the WTO yet. This Act is compliant with TRIPS,” said Nath, who was present on the occasion.

Madras High Court dismisses Novartis’ challenge to the Indian patent law

A division bench of the Madras High Court today dismissed a challenge to section 3(d) of the Indian Patents Act, 1970 filed by Swiss pharmaceutical multinational Novartis AG and its Indian subsidiary, Novartis India . These petitions challenged the validity of a key provision in the Indian law, which seeks to prevent ever greening and which provided one of several grounds on which the Patent Controller rejected Novartis AG’s patent application for the beta-crystalline of Imatinib Mesylate, brand name Glivec (Gleevec).

In March 2005, with retrospective effect from 1 January 2005, the Indian Parliament amended its patent law to protect product patent protection. A significant and important provision was introduced to prevent every greening and granting of frivolous patents, section 3(d). Continue reading

Novartis moves Madras HC on Glivec judge

Daily News & Analysis, August 02 ,2007

Novartis has moved the Madras High Court on Wednesday against the Intellectual Property Appellate Boards (IPAB) decision in the Glivec case, in which the company is fighting the case to obtain a patent on its anti-cancer drug.

On July 20, IPAB shot down Novartis appeal to drop former controller general of the Indian Patent Office, S Chandrasekaran, as IPABs technical member for the Glivec case.As Chandrasekaran was responsible for the original rejection of the Glivec patent, Novartis believes that Chandrasekaran cannot act as an impartial member of the appellate board.

Novartis is optimistic about its appeal in the high court thanks to a recent Delhi High Courts decision against Chandrasekaran. In the case involving Magotteaux International, Delhi High Court said that Chandrasekaran cannot be a technical member on IPAB as he has earlier dealt with the matter under appeal.

Apart from this Glivec case, Novartis is also awaiting the final judgement from the Madras High Court for its second case. In the second case, the Swiss company has challenged constitution of Indian Patent Act.

Novartis not to plead Glivec case

The Economic Times 2 August 2, 2007

Triggering a fresh legal wrangle, Swiss drug major Novartis on Wednesday filed a writ petition with the Madras High Court contesting the Intellectual Property Appellate Board (IPAB)s decision to let former Patent Controller General S Chandrasekaran hear its appeal for Glivec.

Novartis had filed a petition with the IPAB last month insisting that the newly appointed technical member to the board had refused its patent for anti-cancer drug Glivec in the first place, and should therefore not hear its appeal. However, the IPAB dismissed Novartis objection.

The Madras Patent Office rejected Novartis patent application for Glivec in January 2006, arguing that the Basel-based drug makers innovation was obvious and did not meet the requirements of section 3(d) a legal clause specific to the Indian patent law, which stipulates that modifications of already-known medicines cannot be patented unless they make the drug significantly more effective.

While Glivec is a new medicine, patented in over 40 countries around the world, Novartis is seeking patent protection in India for a crystalline form of the drug, as the original molecule was invented prior to 1995, and is therefore not eligible for a patent in India.

Novartis has last year filed a petition with the Madras High Court challenging the constitutionality of Section 3(d).

Setback for Novartis as Chandrasekaran stays

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. Continue reading

Health organisations urge Novartis to drop patent case

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. Continue reading

IPAB hears Novartis objection against S Chandrasekaran

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. Continue reading

Cancer drug patent case takes new turn

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. Continue reading

Novartis may suffer jolt in Glivec case

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. Continue reading