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.

NPPA asks Cipla to refund `overcharges`

WHAT?!
I need to look at this Supreme Court order now.

The National Pharmaceutical Pricing Authority (NPPA) has asked leading drug-maker Cipla to pay Rs 62.85 crore as interest on alleged unpaid overcharged amounts in respect of drugs Ciprofloxacin, Norfloxacin, Salbutamol and Theophylline.

The NPPA also made a fresh demand of Rs 4.12 crore as alleged overcharged amounts inclusive of interest in respect of Doxycycline and additional packs of Norfloxacin.Cipla, informing the Bombay Stock Exchange today, said the demand was contrary to the orders of the Supreme Court and the company had received legal advice that entire amount demanded by the government was not tenable and sustainable.

Patents and Prices

A few follow on articles in todays news on the theme of patenting and drug prices.

Joe Matthew reports in the Business Standard today that 358 of 413 drug patent applications for cancer in India are from top multinationals like Novartis, Aventis, Bristol Myers Squibb, Pfizer, Boehringer, Roche and Abbot.

The rush for patents on cancer medicine can be explained by the potential of the Rs 1,200 crore Indian market.

With nearly 2.5 million patients, cancer is one of the ten leading causes of death in India. Data sources from the National Cancer Registry Programme show that over 700,000 new cases and 300,000 deaths occur annually due to cancer.

However, not all 413 applications will pass muster with the patent office, a patent expert warned. India does not give patents on drugs patented elsewhere before 1995.

The other article, also from the Business Standard titled “Patent Crusader” is a company profile of Cipla.

in 2000, his son stunned the pharmaceutical world by offering to sell anti-retroviral drugs for the treatment of HIV/AIDS at a fraction of existing prices. In an event that gained huge publicity at that time, he told a European Commission meeting that he could sell a three-drug anti-retroviral combination for around $800 per patient, while multinational pharmaceutical companies were selling it for over $12,000.

The next year, he brought his price further down to $300 and finally to $140. This opened the floodgates for Indian drug makers. Soon, countries facing the HIV/AIDS epidemic started placing large orders with them.

The Erlontinib case was the next logical step. In 2005, India switched to a regime of product patents. Companies could no longer produce clones of patented medicine. Knowing very well that Roche had got the patent for Tarceva in July 2007, Cipla went ahead and launched Erlontinib in January this year.

The Delhi High Court has opened the debate one more time for life-saving drugs — should patients be deprived of cheap medicine if it is patented?

Cipla has also challenged the Roche patent on Tarceva, arguing that the original invention data does not justify the patent claims. It has said that the “invention claimed is obvious and does not involve any inventive step and cannot be patented in India.”

This was not the only incident when Hamied showed that he has a mind of his own. In the last decade or so, most large Indian pharmaceutical companies have expanded overseas, especially in the US, which accounts for about half of the world market.

But Cipla kept its focus steady on India and developing countries. Though the company was called conservative by many, it reaped the benefits when the US market for generic drugs, the forte of Indian companies, crashed a couple of years ago. Soon, it had become India’s most valuable pharmaceutical company.

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”.