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.

Articles on GIs and creativity

Some interesting articles in the papers this last week.

Latha Jishnu’s written a characteristically insightful and analytical piece about GI registration in India. Excerpts:

In recent months there has been practically a stampede for GI registration in India. Unlike the developed countries which use it primarily for food products (Champagne, of course, and things like Parma Ham), India has extended GI protection to products across the spectrum, from handicrafts to flowers and spices. Thus the Aranmula mirror, along with assorted silks, saris, textiles and embroidery styles, joins soaps, incense, different varieties of jasmines, several strains of rice, tea, betel leaf, pepper and chillies to get the GI tag.

The GI Registry at Chennai, where right-holders can register their products, is getting inundated. The question, however, is how much of a protection a GI offers. For one, other WTO members are not obliged to ensure the same kind of protection to all Indian GIs because there is a problem of hierarchy. Although TRIPS has a single definition for all GIs, it has authorised a two-level system of protection: one, a general protection under Article 22, and the other, a higher level under Article 23 that is applicable only to wines and spirits.

According to some experts, Article 22 is not good enough. It is simply a law against unfair trade practices and for consumer protection and is not really for IPR protection. A producer not belonging to a specific geographical region could still use the GI as long as the product’s true origin is indicated on the label. In other words, an Aranmula mirror could be turned out from, say, Houston in Texas, thus allowing an American producer to free ride on the reputation and market goodwill created by Keralite artisans over two centuries. Tellicherry pepper and Udupi jasmine thus far are not in the same class as wine from Champagne.

Lawrence Liang’s article in the Indian Express covers the recent Rakesh Roshan V Ram Sampath row in the Bombay High Court and makes some poignant comments on creativity, copying and copyright.

The language of the case and the reportage around it rely very heavily on the language of theft, property and damages for infringement of copyright and plagiarism in music. This rather hasty leap of faith to stricter enforcement of music copyright does not seem to find too much support in the history of music itself. While there was surely a violation of propriety in the Ram Sampath case, the important question that emerges is the impact of thinking of creativity only in terms of property. The history of copying, appropriation and plagiarism is in fact central to the history of various forms of cultural production, including music. We should therefore be a little cautious when we celebrate this case for the quick remedy it provided to an act of copying.

The act of copying has been central to the ways in which culture has flowed through various parts of the world, transcending the limitations set by space and time. Thus a Polish folk song, “Szla dzieweczka do gajeczka”, becomes a part of Indian popular consciousness through its adaptation as Salil Chaudhury’s “Dil Tadap Tadap Ke” from Madhumati. Secondly, the creation of music has always relied on adaptations, influences and inspirations, whether conscious or unconscious. It would be unfortunate if as a result of aggressive copyright suits, we reach a situation like the United States where even subconscious copying is held to be infringement. In a case brought by a band, The Chiffons, against former Beatle George Harrison, the court held that Harrison’s “My Sweet Lord” was in infringement of The Chiffons’ “He’s so fine”, even though the judge believed that Harrison did not intentionally copy the song and had only been inspired by it subconsciously.

In our enthusiasm to protect the creator and ensure that he gets his just rewards, let’s not forget that the sense of touch is not limited to the hand, but extends to our eyes and ears. It is only natural that when we create something, it will be influenced by things we have read, heard or seen, even if they are not our property. Walter Benjamin describes this form of mimicry as a form of learning as a “sensuous similarity”, a right to copy, which should be as jealously guarded as copyright.

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’.

Karnataka HC to decide whether free software is stifling competition

In a case that has potentially far reaching implications (always wanted to use that phrase – far reaching implications),”some software companies” have filed a petition before the Karnataka High Court challenging its use of the Nudi software font for egovernance purposes. The Government claims that the software is free and the ” best among the softwares available.”. The Companies on the other hand allege that there is no “scientific basis for the State to prefer Nudi over other compatible softwares” and insist that the Government “prescribe uniform standards for bilingual fonts for developing software in Kannada”.

Is there a scientific basis to prefer free software over proprietary alternatives? Hm.

After some scouting around the web, I’ve stumbled upon some history of the dispute. All is not well, it seems, in the Karnataka Font Development industry. I’m going to use internet sources to try to piece together this sordid saga of hope, suspicion, treachery and betrayal that is the Kannada Font.

Two websites are going to be my primary sources: The Government of Karnataka and some vitriol on a site called Ella Kannadaabhimanigala Antharrashtriya Vedike In (Ekavi)

So it turns out, the Karnataka Government mandates the use of a font called ‘Nudi’ for use in all e-governance projects. The Karnataka Government asserts that this is freeware:

The Karnataka Government owned Kannada Script enabling software NUDI, developed by Kannada Ganaka Parishat, is a freeware. Most of the fonts with NUDI can be used for dynamic font embedding purposes. Since the fonts and the software are available free, these can be used in the no font-embedding situation as well. Regarding R&D, it is a continuing activity to move with the changing technological conditions, mainly so with NUDI. As per the requirements, new features will get implemented in NUDI, of course maintaining compatibility with earlier versions. Futher, it is to be noted that enthusiatic and innovative font developers can develop any number of fonts for NUDI engine using standard software like Fontographer, Fontlab, Font creator etc.

Turns out, Nudi was created by copying a software called Baraha – which it turns out, was a rehashed, pirated – murder most foul! – version of a font called Akruthi. According to this rambling invective on Ekavi, this sinister design was apparently executed by an evil genius/tyrant called ‘VASU of BARAHA’ who is ‘PRIMARILY responsible for all the problems KANNADA SOFTWARE DEVELOPMENT is facing TODAY’.

VASU has allowed Srinatha Shastry, Narasimha Murthy and Dr. Panditharadhya of Kannada Ganaka Parishat “KGP” to COPY BARAHA Fonts and name it NUDI Fonts and sell NUDI Fonts to Govt. of Karnataka “GoK”. So GoK is using STOLEN PROPERTY and forcing all Departments to use NUDI FONTS. This made other KANNADA SOFTWARE DEVELOPERS to GO OUT of BUSINESS.

Who knew.

NEXT question, we all need to think is,
If BARAHA and NUDI Fonts are being offered FREE like this to KANNADIGAS,
Why BARAHA and NUDI fonts are not in OPEN SOURCE PLATFORM ??? WHY ? WHY ? WHY ? WHY ? WHY ? WHY ?

Oh dear.

Copyright in fonts is untested in India and needs a closer look.In the US, in 1998, a federal district court held in Adobe Systems, Inc. v. Southern Software, Inc that copyright law protects “software programs” that create fonts that are distinct typefaces. But the question of originality can still be raised in the Indian context.The artwork involved in fonts is language itself – not something elaborately conceived independently by the developer. ‘Sweat of brow’ alone is not a determinant of copyrightability in India.

More on this later.

Karnataka – Bangalore

Nudi software: court asks Government if uniform standards can be applied

Staff Reporter

BANGALORE: The Karnataka High Court on Wednesday sought to know from the State Government why it could not prescribe uniform standards for bilingual fonts for developing software in Kannada.

The court was dealing with a petition by some software companies that had questioned the rationale of the Government going in for Nudi software for e-governance.

They claimed that Nudi is creating a monopoly and stifling competition. They said there is no scientific basis for the State to prefer Nudi over other compatible softwares.

The Government argued that Nudi was a free software and that it was essentially being used by Government departments. It said it was the best among the softwares available.

An official of the Department of e-governance, who was present in the court, said more developed and sophisticated tools are now available. Justice A.S. Bopanna, who is hearing the petition, asked why it could not formulate a uniform bilingual font. He asked the State to look into the suggestion.

© Copyright 2000 – 2008 The Hindu

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.

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.

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.

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”.

What’s on TV? Less surrogate adverts, More Golden Temple Live, more responsible content

So there are three significant broadcast related news items today.
#1) The Punjab and Haryana High Court has directed TRAI to regulate the prices at which channels can offer feeds to DTH player. This, after a complaint from TataSky that the channel ETC Punjabi, which telecast live Gurbani from the Golden Temple (oh joy!), offered their feed to TataSky at more than double the rate offered to CAS providers.

#2) The Union Government has reverted to its original ban of surrogate advertisement in all forms through an amendment to the Cable Television Networks Rules (CTNR), 1994. In 2006 a mild relaxation of the ban was introduced which permitted ‘advertisements of products which shared a brand name or logo with any tobacco or liquor product’. See The Hindu report and also in The Indian Express

#3) Union Information and Broadcasting Minister Priyaranjan Dasmunsi on Monday informed the Lok Sabha that a Content Code — acceptable to all television channels — would be in place without much delay. (See the Hindu report) The minister has made such noises in the past. (See ALF Comments on the Broadcasting Bill and Content Code)

.. 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.