Madras HC orders review of Roche’s AIDS drug patent

Another important victory for the Lawyer’s Collective and the access to medicine campaign. The Business Standard reports today that the Madras High Court has ordered a review of Roche’s valganciclovir marketed under the name Valcyte in India. This is described as “a critical drug needed for patients suffering with life threatening illnesses such as AIDS to prevent them from infections.” Excerpts from the BS report (also see the Lawyer’s Collective report):

The court’s decision is in response to a petition filed by the Indian Network of Positive People and the Tamil Nadu Network of People with HIV/AIDS against the Chennai patent office’ decision to grant patent for Valgancyclovir without hearing their pre-grant opposition.
The patent was granted for Roche in June 2007, without hearing the opposition filed by the groups alleging that the drug lacks novelty and hence non-patentable. The patient groups has maintained that the drug was first patented in the US in 1994 and as Indian laws provide product patent protection only to those drugs that are patented after 1995, and hence, cannot be considered patentable.

“Valgancyclovir is an important drug for HIV/AIDS patients and a product patent allows monopolistic situation in India, where the drug is sold at very high price. We are happy about the court decision,” said Loon Gangte, president of Delhi Network of Positive People (DNP).

Meanwhile, industry observers said the Madras High Court decision could impact another case being heard by the Bombay High Court between Roche and Indian generic drug maker Cipla on the same drug.

Roche had filed patent infringement case against Cipla seeking an order to stop the generic drug maker from selling its version of Valcyte, which was launched in January, this year.

From the Lawyer’s Collective report

At the centre of the dispute is the drug called valganciclovir, which is a prodrug of an already known drug ganciclovir. This drug is crucial for treatment of cytomegalovirus (CMV) retinitis, an opportunistic infection that affects persons living with HIV, and to prevent CMV infection in patients who have received organ transplants. At Roche’s maximum retail price of over Rs. 1000 (approx USD 20; 1 USD = approx Rs. 50) per tablet, a patient who has to take a treatment course of approximately four months for CMV retinitis would have to pay about Rs. 250,000 (approx USD 5000). This puts the treatment out of reach for those who need them.

In July 2006, INP+ and TNNP+ filed a pre-grant opposition before the Patent Office at Chennai objecting to the grant of a patent to Roche for valganciclovir and requested the Patent Office for a hearing. Under the Indian law, if an Opponent requests a hearing, the Patent Office is required to hear the Opponent. The Patent Office sent the pre-grant opposition to Roche and received a reply from Roche. Satisfied that the objections raised by INP+ and TNNP+ had been met by Roche, the Patent Office went ahead and granted a patent without hearing INP+ and TNNP+. The grant of the patent was published in June 2007. After correspondence with the Patent Office failed to yield any result, INP+ and TNNP+ filed a petition in the Madras High Court in October 2008. They alleged that failure to grant them a hearing amounted to violation of the mandatory requirements of the patent and also a violation of the principles of natural justice. The Assistant Controller, who had granted the patent, filed a reply justifying the grant. Roche objected to the petition on the ground that INP+ and TNNP+ could take recourse to mechanisms such as post-grant opposition or revocation available under the patent law to challenge the grant of the patent.

Delhi High Court passes interim order allowing Cipla to market generic lung cancer treatment drug

The Delhi High Court passed an interim order yesterday permitting Cipla to market its version of a lung cancer treatment drug for which Swiss multinational Roche Scientific holds the Indian patent. The next hearing is scheduled for August 6.

The Business Standard article today has an excellent timeline of this suit.

# March 13, 1996: Roche files patent application in India
# July 13, 2005: DCGI gives approval to Roche for marketing Tarceva in India
# July 13, 2007: Patent granted for Tarceva in India
# January 2008: Cipla launches generic version of Tarceva
# January 19, 2008: Roche files infringement lawsuit at Delhi High Court
# March 19, 2008: HC allows Cipla to sell version of Roche drug

Yesterday Latha Jishnu wrote in the BS about Natco’s compulsory license for the same drug.(See my earlier post here)

More snippets from today’s news piece:

The interim order was passed by the court today on a plea filed by Roche Scientific on January 19 this year. The generic name of the drug is Erlotnib, which Roche markets as Tarceva and Cipla as Erlocip.

Ahead of the next hearing, the court has asked Cipla to maintain records of sales of Erlocip.

The case, which is being keenly watched by global and Indian drug firms and consumer interest groups, is the first test case of India’s new patent regime.

Days before Roche sought legal redress, Cipla started marketing the drug for Rs 1,600 a tablet, one-third the price Roche charges (Rs 4,800 a tablet). Roche has been selling Erlotinib under the brand name Tarceva in India since 2006.

The crux of Roche’s argument is that the product patent right it has for Tarceva prevents competition from manufacturing a copy-cat version of the drug.

In response, Cipla has claimed that the Indian patent is not valid and argued that it was well within its rights to manufacture and market the medicine in the country.

The counsel for Cipla said the high court’s order today made special mention of the life-threatening nature of cancer and the life-saving properties of this drug.

“Given the price difference, the court did not want patients to be deprived of a low-cost alternative by staying sales of the generic product,” the counsel claimed.

Today’s decision will ensure uninterrupted supply of a low-cost medicine for treating lung cancer. Nearly 160,000 people in the country are estimated to be suffering from the disease, which has a high fatality rate.

Welcoming the interim verdict, the Cancer Patients Aid Association (CPAI) Chairman Y K Sapru said he was glad to note “the judiciary has given preference to the right of a human being to live over all other rights enshrined under the Constitution of India”.

Natco files for Compulsory License in life-saving cancer drug

! Update – Read Chan Park’s (Lawyer’s Collective) excellent minutes of the Compulsory License proceedings.

In an excellent article today, Latha Jishnu of the Business Standard reports on a Compulsory License case initiated by generic manufacturer Natco to obtain permission to sell its cancer “life-saving” drugs in Nepal (Roche’s erlotinib (brand name Tarceva) and Pfizer’s Sunitinib (sold as Sutent)). Snippets from the full article:

For example, Natco is offering its version of erlotinib at just Rs 1,000 per tablet in Nepal against Rs 4,800 a tablet that Roche charges for Tarceva in India. It’s not so difficult to calculate the implications of this across the spectrum.
..

Natco’s is the first CL application in India and only the second in the world to be made under the Doha Declaration on public health that was incorporated in the TRIPS agreement. This allows developing countries to use CLs to make cheaper versions of patented drugs in special circumstances, each country being free to use the flexibilities within the TRIPS agreement to formulate its own rules. The first time the CL was invoked, and granted, under the Doha Declaration was in Canada on GSK’s AIDS drug, TriAvir, for export to Rwanda. A CL allows a drug company to manufacture a patented drug without the consent of the patent owner by paying what is deemed a reasonable royalty.

Although the application was made in September, 2007, the Controller General of Patents has yet to take a decision on this. Instead, it had convened a meeting of Natco with the two drug majors last month to which the Hyderabad company had objected, saying that the law (Section 92 A of the Indian Patent Act, 2005) did not warrant that the patentee should be given a hearing. Natco has offered a 5 per cent royalty to the two drug majors in its CL application, a rate that is in keeping with the guidelines suggested by the WHO and other international organisations like UNDP.

What the law does state is that the CL can be made available for manufacture and export “to any country having insufficient or no manufacturing capacity for the concerned product to address public
health problems”. For this, Natco needs to have either a licence or a notification from the Nepal government for the contracted amount. So far, there has been no confirmation on this score from either Natco or the authorities in Kathmandu.

In Canada, royalty is capped at 4 per cent of the price of the generic product, the rate being adjusted downwards depending on the importing country’s rank on the UNDP Human Development Index. In the tiered royalty system proposed by UNDP, the base royalty is set at 4 per cent of the price of a product in high-income markets. This rate is adjusted taking into account the relative capacity of a country to pay, based either on the relative per capita income or the national income.