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.

New Bangla Patent Act?

Business Standard today carries this slightly unclear piece about a new Bangladeshi law that will increase “chances of technical partnerships in Bangladesh”. Apparently, Bangladesh has “changed its patent law in an attempt to become a hub for manufacturing cheap copies of patent-protected medicines. ” However, another statement in the same article casts some shadow on this assertion:

Nazmul Ahsan, general secretary, Bangladesh Association of Pharmaceutical Industry (BAPI):

“Our government is actively considering various provisions to incorporate the flexibilities of TRIPS (trade-related intellectual property rights) within the patent law. It will be in the form of annexes that make production of medicines having patent protection elsewhere legally possible. We will be able to supply it to other developing nations also,” he said.

The article contains the usual info about the TRIPs, parallel imports and developing countries as well as some useful info on how the Indian pharmaceutical industry operates:

India, under its new patent regime, cannot supply raw materials or bulk drugs of patented medicines. However, it can supply intermediates (which are one step down in the manufacturing cycle of bulk drugs) anywhere in the world.

If Indian companies can strengthen the technological capabilities of their Bangladesh partners, these intermediates can be further developed into bulk drugs and finished medicines in that country. While these medicines have an assured market in all poor countries, they can also reach nations like India on the basis of compulsory licences.

“Indian bulk drug companies are going to fetch good business as penultimate raw material suppliers to bulk drug firms in Bangladesh. It will be definitely attractive for all new products that cannot be made in India,” he said.

So.. we can’t directly infringe patents and manufacture drugs. So we will manufacture them cheaply till their last step. Export them over the border to Bangladesh where they are assembled. Then use compulsory licensing to re-import drugs back to India. A pirate alliance like no other! Everyone’s happy.

Bangladesh shouldn’t be happy with this arrangement. A couple of months ago, Padma Gehl-Sampath made a presentation at the Alternative Law Forum on the technical capacity of the Bangladesh pharmaceutical industry. According to her, although the industry has a fairly robust manufacturing base, it has a very thin research base due to inadequate investment in pharmaceutical education. So Bangladesh imports machinery to manufacture drugs, but does not itself possess enough skilled manpower to reverse engineer drugs. India’s pharmaceutical industry ‘miracle’ since the 70s has owed itself to the fact that we had a largish base of skilled pharmacologists who could re-engineer very quickly.

So, short term, as an Indian, this makes me very proud. Long term, I’d like to see more pirate drug producing nations.

Asli Nakli

There’s been a slew of interesting OriginalFake court rulings over the last few days:

• The Supreme Court has held that only licensed allopathic manufacturers can sell Viagra.. The accused were engaged in the manufacture of supposedly Ayurvedic Ozomen capsules and Ozomen forte which contained quantities of “sildenafil citrate” – one of the primary ingredients of Viagra. Section 18(a) (i) read with Section 17B(d) of the Drugs and Cosmetics Act prohibits manufacture and sale of certain drugs and cosmetics which are ‘misbranded, spurious and substituted wholly or in part by another drug or substance’.

The AP High Court had quashed the proceedings holding that the Drugs Inspector appointed under Section 21 of the Drugs and Cosmetics Act had no jurisdiction to launch prosecution under Section 32 of the Act (which deals with offences pertaining to Ayurvedic drugs).The Supreme Court held that this was not a case of an Ayurvedic drug, but clearly one involving an allopathic drug which was sought to be passed off as Ayurvedic.

• In M/S PARAKH FOODS LTD v. STATE OF A.P. & ANR, the Supreme Court held that a company cannot be blamed and found guilty of misbranding a food article if the picture on its label has nothing to do with the food article concerned. From the Indian Express news report:

The product in question was soyabean oil and the label, as noticed by the High Court, contained pictures of vegetables like cabbage, carrot, brinjal, capsicum, cauliflower, tomato and onions, which it found “are in no way connected with soyabean oil”.

While the High Court held that this was a case of misbranding, the Supreme Court took an opposite view

“In our opinion, the High Court has committed a serious error in arriving at a finding that the article of food (soyabean oil) was misbranded, since the picture contained on the label has nothing to do with the article of food in question, ignoring the fact that the article of food can be used for cooking the vegetables shown in the picture which cannot be said to be exaggerating the quality of the food in question.”

• The third case involves the advertisements of a pain balm called Volini manufactured by Ranbaxy which was accused of disparaging its rivals. Business Standard reports:
  

  The Supreme Court today directed Ranbaxy Laboratories to drop the word asli from its advertisement for Volini pain balm but allowed it to run the rest on television despite the protest of the manufacturers of a rival product, Moov.

  The Gujarat High Court had prevented Ranbaxy from running the advertisement which said that its product gives asli aaram while another product shown in purple is thrust away.
  Paras Pharmaceuticals, manufacturers of Moov, sued Ranbaxy for disparaging its product. The high court granted an injunction against Ranbaxy. Harish Salve, counsel for Ranbaxy, argued that hyperbole is allowed in a market which is not for the ‘faint-hearted’.

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.