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.

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.

Prices of life-saving medicines to come down

Last month, the chemicals and fertilisers ministry led by Ramvilas Paswan proposed a reduction of taxes on life-saving medicines on the assurance of drug makers that this benefit would be passed on to the consumers entirely.

The prices of about 20 life-saving medicines used in the treatment of diseases like cancer, diabetes and AIDS may go down in the coming months if the finance ministry considers the proposals for duty exemption on such drugs.

Multinational drug firms like Eli Lilly, Bristol Myers Squibb and Pfizer are likely to be the beneficiaries if the proposals find space in the forthcoming Union Budget.

According to sources, most of the imported medicines currently attract 10 per cent basic Customs duty and 16 per cent countervailing duty.

The recommended medicines are used in the treatment of diseases like diabetes, cancer, AIDS and asthma. A couple of preventive therapies like Hepatitis-B and pneumococcal vaccines also figure in the list.

Need to examine this some more. As usual this is a placeholder article.

.. more counterfeit drugs

Proving that all industry-wide bodies are alike in their megalomania, Assocham today disclosed estimates of “counterfeit drugs’ that are eerily similar to piracy scorecards the MPAA periodically puts out. Business Standard carries this article today with the heading “Fake drugs growing at 20-25%: Assocham”, and alleges that the fake and spurious drug market “has already exceeded the Rs 15,000-crore per annum mark nationally.”

The chamber also pointed out that the sale of spurious drugs in the National Capital Region (NCR) is to the extent of Rs 300 crore per annum, and according to the latest information available, it has gone up to 20-25 per cent of the total medicines sold in the region.

Intensification of the sale of spurious drugs in the region has not only severely impacted business of original drug manufacturers in the region by over 25 per cent but is also putting the life of patients on risk, the chamber said.

The concentration of fake drugs manufacturing facilities can be found in locations such as Bahadurgarh, Ghaziabad, Aligarh, Bhiwadi, Ballabhgarh, Sonepat, Hisar and parts of Punjab which are closed to the NCR, it added.

The shortage of drug inspectors and proper lab facilities for checking purity of drugs and inherent weakness in drug distribution system are the main reason for the spread of fake drugs in the NCR, the chamber pointed out.”

Only last month, the Orissa High Court had reportedly observed : “Orissa has become a dumping ground of fake medicines” and had directed the State Government to check entry of fake drugs into the State from outside.” The court made this observation in a case pertaining to the death of five persons, including two newborns at SCB Medical College and Hospital, seven years ago allegedly due to spurious saline administered on them.

More grist for the Indian Drug-Scene jigsaw that I’m trying to piece together.

Sui Generis protection for Traditional Medicine

I picked up an interesting snippet of information from the Business Standard yesterday.

“The government may take back its earlier plan to provide five-year data protection to traditional systems of medicine.”

Stop press! The Government had a plan to provide five-year data protection to traditional systems of medicine?! Who knew!

We’re informed of some of the history about this startling plan in the article:

The government’s plans for data protection began after a high-level inter-ministerial committee, set up by the Department of Chemicals and Petrochemicals in 2004, favoured such protection for traditional medicines and agro-chemicals.
After considering the Department of AYUSH’s submission, the committee, in its report submitted in May 2007, recommended that irrespective of the nature or the period of data protection granted to pharmaceuticals in general, a five-year data protection should be provided for traditional medicines. (See Satwant Reddy Report)

It also wanted the health ministry to make amendments to the Drugs and Cosmetics Rules, 1945, to effect the change.

But not anymore. Evidently someone at the Department of Ayurveda, Yoga, Unani, Siddha and Homoeopathy (AYUSH) decided that “such a protection will lead to similar demands from the allopathic segment” .. who are already beneficiaries of the stronger Patent system.. ahem.. one could possibly argue.

More:

While the government has been supporting the move to introduce data protection for traditional medicines, it has been reluctant to offer similar protection to the pharmaceutical sector in general due to the concerns of the domestic drug industry.

Domestic manufacturers say “data protection”, which results in “non-reliance” of data generated by the patent-holding company, will increase the cost of drug production and delay the entry of generic drugs into the domestic market.

“There are serious concerns relating to the ever-greening of patents under the guise of data protection and the need for providing affordable drugs to people,” it had reasoned.

Data protection to pharmaceuticals has been one of the most debated issues due to the strong reservations expressed by the domestic drug industry against such a move.

On the other hand, multinational drug majors have been saying that data protection is a prerequisite for foreign investments in drug research in India.

While the committee recommended a five-year data protection for traditional medicines, it refrained from making such a recommendation for other pharmaceutical products.

I fail to see how one has anything to do with the other, Data exclusivity for drug test results and data protection for traditional medicines. It’s like blocking the passage of the Copyright Act on grounds that artists could conceivably demand Patent type rights.

But I support the outcome.

From every angle that you approach it, a plan to gift monopolies over traditional medicine appears ill-conceived. Such a move is likely to discourage existing traditional practitioners and healers from experimentation and improvisation. Instead it sounds like it may benefit most the very pharmaceutical companies who are engaged in the sort of bio-piracy we witnessed with the turmeric cases. Pharmaceutical companies do not need further incentives to research traditional medicines.. it’s research that’s already been done for them over millennia.

While proper benefit sharing mechanisms need to be put in place to ensure that communities can receive their rightful share from commercial exploitations of their traditional knowledge, the answer cannot be an expansion of the already inflated IP System. The answer to the Question of the IP commons, does not lie in the creation of more property.