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.

Drug authority may require patent for approval of biosimilar drugs

The Hind Business Line reports that the Drug Regulatory Authority in India is “considering a proposal wherein generic versions of bio drugs, called biosimilars, may be mandated to apply for patents.”

Biopharmaceutical drugs are medicines produced using a living system or genetically modified organism. Compared to traditional chemical medicines, even a minor change in the conditions, formulation or the processes can change the final product drastically.

Biosimilar medicines are supposed to be replicate versions of original biopharmaceutical medicines designed to treat the same diseases as the innovator’s product. However, compared to generic versions of chemistry based medicines, biosimilar medicines are extremely complex.

The report quotes the Director General of the pressure group ‘Organisation of Pharmaceutical Producers of India’ (which counts among its members several “Big” pharma companies like Pfizer, Eli Lily, Roche and GSK, significantly excluding generic biggies like Cipla and DRL) as approving this idea because of “the complexities involved,”

The very nature of a biologic means it is practically impossible for two different manufacturers to produce two identical biopharmaceuticals if identical host expression systems, processes and equivalent technologies are not used. This has to be demonstrated in an extensive comparability programme. Therefore, a generic biopharmaceutical cannot exist.”

A “Government source” however said that a final view is yet to be taken.

According to Mr. Ray only such stringent measures can facilitate the growth of the biogeneric business.

Ha.

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.

RTI and clinical trials

Sarah Hiddleton has a useful note today in the Hindu about the Right to Information and Clinical trials in which she discusses how disclosure of test data is in the public interest. This is against the backdrop of the Mahyco/Greenpeace fight over Bt Brinjal test data currently being fought in the Delhi High Court. Some useful international comparisons in the article which make it a compelling read.

The question therefore is this: when does public interest in trial data outweigh commercial interest?

If the researchers had not gone to such lengths to obtain full data from the U.S. Food and Drug Administration (FDA) under the freedom of information act, we would never have known that published data available to the scientific community had not included significant information from unfavourable trials (nine of these were refused by the FDA, data from four of them were obtained from a company website). We would have also been ignorant of the fact that the FDA had not spotted data manipulations from which conclusions were drawn and approved the drug on that basis. Nor would we have known that the companies involved had breached the trust of those who underwent the trials, the doctors who prescribed the medicines, and the patients who took them. Nor that these companies have made massive profits for something that has not stood up in the trials.

What if a product was found not just to be ineffective, but harmful? Just 10 days after Kirsch’s results were published, GlaxoSmithKline was found to have withheld clinical trial data from the United Kingdom regulator, the Medicines and Healthcare Regulatory Authority (MHRA), that showed that its anti depressant increased the risk of suicide among teenagers, and that it had known this since 1998.

Does putting such data in the public domain affect a company’s commercial interest: Yes. But does the public interest outweigh this? Yes, because if the product is useless or harmful, there should be no commerce in it in the first place.

Companies claiming that this might affect their intellectual property would do well to remember that this is at the core of the a defined set of criteria through which society gives up its fundamental immediate right to health to grant a right to property. A patent, which gives a company a monopoly in recognition of the risks it undertakes in product development, is awarded if a product is new, involves an inventive step, and has an industrial application – in other words if it is useful.

A very long time ago, I wrote this article on Data Protection that has since been quoted somewhat widely. Has some useful information on clinical trials, although my position is opposite to what is stated in the article.

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.

Monsanto Vs. Greenpeace in the Delhi High Court

Some news today about Mahyco’s (Monsanto’s Indian partner) suit in the Delhi High Court challenging the Central Information Commission’s November 2007 order which required the Department of Biotechnology to disclose information pertaining to Bt Brinjal.

The Maharashtra State Information Commission had previously denied this request on the ground that it “would affect the competitive position of a third party” (Sec. 8 ) – in this case Monsanto. The CIC had overruled this decision holding that notwithstanding the existence of such a ground of withholding of information, where public interest lay in the disclosure of information, such information could not be denied. The Delhi High Court passed an interim order in December 2007 staying the order till the next hearing of the case on April 23.

More details in this Business Standard article.

Greenpeace has obtained similar data on Monsanto’s genetically modified insect resistant maize in Europe through a court order. The Monsanto data, when independently evaluated, had given rise to conclusions that were contradictory to Monsanto’s observations.

Armed with the new data, the international NGO had launched a campaign, though not with much success, to see that the marketing approval given to the particular maize variety (MON 863) in Europe was withdrawn. Greenpeace is looking at the possibilities of a similar review of the data generated by Mahyco for its brinjal variety..

What’s startling about this suit is that Mahyco’s argument that in disclosing this information, India is violating our TRIPs data protection obligations. This is the Novartis case all over again. The Delhi High Court is notoriously more narrow-minded with patent suits and I hope this isn’t a strategy to arrive at data protection by other means.

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.

A new bill on publicly funded research

Suddenly all sorts of news on a Bill on publicly funded research.

A quasi-editorial piece by P.T. Jyothi Datta in the Business Line today reports some talk about a bill on the lines of the Bayh-Dole Act in the US.

Mumbai, March 16 Scientists may not be the best negotiators, when it comes to converting their inventions into commercial products. But the Centre is set to change this through a research and intellectual property-related (IP) Bill that seeks to empower Government-funded institutions to commercialise their research, besides ensuring some of that revenue flows back to the scientist.

A draft Bill to protect and commercialise public-funded research has been circulated among different ministries and is with the Cabinet for comments and approval, Dr K.K. Tripathi, Adviser to the Department of Biotechnology, told Business Line. The Cabinet will decide whether to take the Bill to Parliament or seek further public debate, he said.

But, with the draft Bill being cloaked in secrecy, IP experts are concerned whether the proposed legislation will succeed in side-stepping the draw-backs of a similar Act in the US that had sought to IP-empower US universities in 1980.

On similar lines as the US’ Bayh-Dole Act, the draft Indian Bill encourages public-funded institutes to patent inventions and explores avenues for commercialisation. It also proposes that the inventor gets 30 per cent of the revenue from commercialising the patent, while 10 per cent is ear-marked for the institute’s IP Management Cell, Dr Tripathi explained. Rights to the product remain with the institute, while assignment rights are jointly held between the scientist, institute and the Government. Commercialisation plans require consent from all the three, he added.

There has been a substantial increase in the product filings by the Government-funded institutes, post the product-patent regime in 2005, he said, without giving details.

But can a US legislation that addressed specific issues with some success be ‘imported’ into the Indian context, questions Mr Shamnad Basheer, Research Associate with the IP Research Centre that is part of the Oxford University. Unhappy with the ‘non-transparent’ manner in which the Bill is being introduced, he seeks clarity on issues such as whether an inventor would have the discretion to decide to leave his/her invention in public domain. In some critical areas of science, it may make sense to encourage more ‘open science’ as opposed to a proprietary model, he observes.

Mr Mark Pohl, with US-based Pharmaceutical Patent Attorneys, agrees that the US legislation concerned did support some significant success stories such as blood-thinner Warfarin, for example, that came from a University patent.

However, universities have not benefited in revenue-terms, he says, citing an economic analysis by the US government that found that every dollar invested by universities in patents and licensing created approximately $0.30 in revenue. The missing link, he said, is universities’ lack a sense of what is commercially valuable. They tend to patent work that is scientifically creative or unusual, without knowing much about whether or not that innovation will make a profitable product.

Patent expert, Dr Gopakumar Nair, adds that over-negotiation by scientists, evaluation of the benefits of technology-sharing etc. will unravel as the proposed norms get implemented. The Bill should be flexible and there should be a head-room for change, if it has to succeed, he observed.

Kalpana Pathak in an article ‘Varsities may soon own patent rights’ in the Business Standard reports the same thing.

The Union government is likely to enact a law to create uniform legal framework for government-funded research and give universities and research institutions ownership and patent rights for their innovations.

The matter is before the Cabinet and will shortly be moved to Parliament for approval, according to a source close to the development.

The move was initiated by National Knowledge Commission (NKC) Chairman Sam Pitroda as an incentive to encourage innovation, collaboration, licensing and commercialisation in Indian institutes.

The law will be on the lines of the 1980 Bayh-Dole Act of America, which played a part in multiplying the number of patents filed by and granted to universities, the number of universities involved in patenting and licensing of inventions and in the number of new companies that were set up on the basis of new inventions licensed by universities.

Before the Bayh-Dole Act was enacted, America’s federal agencies owned about 28,000 patents, out of which only 5 per cent were licensed to industry for development of commercial products.

The proposed legislation will also help universities and research institutions file patents in their own name and forge commercialisation processes with the industry.

It may also allow the balance of any royalties or income earned after payment of expenses, to be ploughed back into institutes for scientific research and education.

“Giving ownership rights to universities and linking such ownership with the patent system and the market, will make research a much more attractive option,” said a professor working with NKC.

According to the proposal, the government could have ‘march-in rights’ to protect certain public good(s) or matters pertaining to national security.

The government could also be given the right to own an invention where the party decides not to retain title or fails to file the requisite patent application.

Business schools also need to incorporate IPR dimensions in their curricula. “There is also an urgent need to set up IPR cells in major scientific and educational institutions in the country with trained staff, competent in the law and technical aspects of relevant disciplines,” added the professor.

Indian institutes have realised the importance of patenting their innovations and have even begun formulating their own IPR policies.

A professor from IIT-Bombay said: “If this legislation is passed, it will be a good move. In general, institutes in India have not been proactive on this. Academics have to publish their research articles which one should get patented. This move will motivate them to patent their items and get it published.”