A news report recently states that Indian legislators plan on including criminal penalties under the Indian Bayh Dole Bill. Already the centre of much controversy, this inclusion could have more people up in arms about the passing of the Bill, and create further hurdles in India having it's first ever Bayh Dole styled legislation.
What is the Indian Bayh Dole Bill?
For our newer readers and a quick recall for our older readership, the Public Funded R&D (Protection, Utilisation and Regulation of Intellectual Property) Bill of 2007- more commonly called the Indian Bayh Dole Bill- is a bill styled on the American Bayh Dole Act that hopes to allow researchers sposored by the Government to patent and commercialise their work.
What is the latest Spicy development?
As we have reported time and again, the Bill has been shrouded in secrecy and there has been no real report from the Government confirming the nuances of the Bill that will in fact be passed in the end. SpicyIP and various other scholars have pieced together several news reports to help keep the public more informed and create room for discussion, where the Government (for some reason) seeks to have none. The latest in the line of these reports is one published on the 28th of August in the Economic Times that states that the Law Ministry is keen on including penal provisions in the proposed legislation.
What are the problems with such a proposal?
SpicyIp has covered the Indian Bayh Dole Bill carefully over the many months since its conception, and it comes as no surprise that this new piece of information suffers from the same defects as all other information about the Bill- lack of clarity and transparency.
While the report states that the penal provisions are hoped to make the Bill more sound and act as a "deterrent for scientists from infringing their rights to reap profits out of their inventions", it is still unclear what exactly will be subject to criminal penalties since the report at different points talks of the penalties for infringement and misuse by scientists. As we are all aware, the Indian Patent Act, 1970 has in Chapter XX certain penal provisions prescribed for various offences including, imprisonment and fines. However, unless criminalising provisions that have a wide reaching impact are mooted and debated, SpicyIP believes it imprudent to include such provisions as part of the already controversial India Bayh Dole Bill.
This report of the ET is an apt example of what SpicyIP has aimed to do: increase transparency in IP Institutions in India and ensure fair, objective as well as lucid reporting of IP News in India. We hope that if there are in fact provisions such as this to be included in the new Indian Bayh Dole Bill, not only will the Indian Government be more open to discussion over such provisions but also will the media provide more clarity when reporting matters of such import.
(SpicyIP would like to thank Mr. Nihas Basheer of Wadia Gandhy for pointing us toward this news report).
Sunday, August 31, 2008
A news report recently states that Indian legislators plan on including criminal penalties under the Indian Bayh Dole Bill. Already the centre of much controversy, this inclusion could have more people up in arms about the passing of the Bill, and create further hurdles in India having it's first ever Bayh Dole styled legislation.
Thursday, August 28, 2008
An update on the Hari Puttar story we reported on recently: Our primary sources for that report were news stories that appeared on various websites, Indian and international. These reports, considering that they contained practically the same quotes from the parties to the case, were presumably based on a press release or a press conference.
SpicyIP has since acquired information that suggests that these reports might in fact be incorrect. The applicants, i.e., Warner Bros. (WB), have been tight-lipped on the case, leaving us little room to investigate. However, one glaring error has been made in the preceding reports: the suit has been filed in the Delhi High Court, and NOT the Bombay High Court, as suggested earlier. It is strange that every news report running this story should have written otherwise, unless someone has deliberately led them astray.
Hari Puttar vs Harry Potter: Deceptive similarity
Further, SpicyIP has researched and unearthed a number of news clippings on the web dating back a few years that refer to Hari Puttar as an alternate handle for Harry Potter. E.g., take this Subhash K Jha article in TOI of 2005, where the reference is made abundantly obvious. Even though any association with the Rowling series is denied, a hat-tip to the namesake is made– by the filmmaker himself, here.
Mirchi Movies, the defendant moviehouse, is incidentally the movie arm of the Times Group. It amuses me that the film house, on its own site, should put up for view press coverage such as this, which is titled “India’s reply to Harry Potter”. Would it be too much to surmise that the filmmaker and/or the production house, by linking to such articles, is trying to indirectly cash in on the Harry Potter trademark? I.e., in acknowledging that Hari Puttar is indeed a “reply” to Harry Potter, surely there is more to the tale than meets the eye.
What concerns one immediately is the large number of articles pre-dating this suit that presume the film, or at least the title, is a spoof on Harry Potter, and/or that it hopes to attract an audience riding the HP wave: such as this rediff article, and this TV18 piece. Further, reports such as this quote Shamita Shetty, who performs briefly in the movie, who initially had the impression that the film was an Indian take on Harry Potter. Similar observations were allegedly made by the lead actor, Zain Khan. That the producers/filmmakers made no attempt to deny such reports could swing the matter against them.
Curious about the linguistic debate that this has spurred, I did a search for the official translations of the books into Indian languages. I found that the Devanagari spelling was the closest to the original English, but there were variants in the other languages: in Malayalam, for example, the name is transliterated as “Haari Poater”. But while the “authorised” translations retain the original proper noun, the colloquial reference to the series may vary, as appears to be the case in this story.
The Hari Puttar moniker (as the Hindi/Punjabi version of Harry Potter) was bandied about several years ago, when translations of the books were being discussed. I found this editorial and this blogpost (on the mother-of-all NRI blogs, Sepia Mutiny) which refer to HP as "Hari Puttar". This would say something about the similarity between the two, and may dent the defence's case about the name being mere coincidence.
There is also the concern that some images from the movie are evocative of the Harry Potter series. Two screen grabs from the promo trailer running on the film’s official website have been added to this post, which I thought could spell trouble for the defendants: a palatial house, very castle-like; and an old fashioned steam engine, presumably for effect, but does the Hogwarts Express spring to mind?
What happened when
To give you a run-through of sequence of events in the case: UK-based entrepreneur Lucky Kohli, and others, began filming/production in 2005 on location in the United Kingdom. Indeed, at the time of filming itself, in November 2005, a UK-based regional daily tabloid had reported that the movie would likely run into trouble because of its title. Foresight. Hmm.
In 2006, there was reportedly some exchange of letters on the subject between Warner and the producers but the picture is unclear as to how the talks concluded and why the title stayed. Circa March 2008, WB became aware of the filmmaker’s tie-up with Mirchi Movies for marketing and distribution, and decided to go litigious. The suit was filed on 14 August 2008, and it came up for hearing on 19 August, before Justice Reva Khetrapal of the Delhi High Court. WB were denied an ex parte injunction, and instead the defendants were issued notice, to which they had to give a written response within a week. However, it did not get argued on 25 August as per scheduled, and has been adjourned for hearing to 2 September, when the tragicomedy (or as you will) continues.
As an aside, Justice Khetrapal, who is hearing this case, has passed some quality IP judgements in the recent past, most notably on a jurisdictional matter involving Kensoft Infotech Limited, and another involving fashion designer Tarun Tahiliani. We naturally look forward to her observations in this matter.
What happens next?
You may recall from the earlier post that I was curious about the timing of the suit, which was, like in the Durga Puja pandal case, very close to D-day (in that case, it was the puja; here, it is the film release, which SpicyIP has learnt is scheduled for October 19, and not as reported earlier). If the decision is in favour of Warner Bros, will the court pass an order similar to the one in the Durga Puja pandal case?, where the pandal was allowed to stand despite an observation that there had been a violation.
The striking difference in this case is that the Indian movie house will find it difficult to demonstrate absence of commercial interest, I suspect. Additionally, there is the question of intent of the defendant filmmakers: consider the images of the film, the argument that they attempted to sell the rights to Warner Bros., the film’s uncanny (and acknowledged) similarity to Home Alone… It is very likely that the objectives of the filmmaker may come under scrutiny, and play a pivotal role in deciding the case.
SpicyIP congratulates its “colonial cousin”, IPKat, on this happy occasion and wishes it the very best for the future. This is another feather in its cap; in July 2005, Managing Intellectual Property magazine named IPKat as one of the 50 most influential people in the IP world.
The list of the top 10 nominees for the IT Law Blog Award is available here.
Wednesday, August 27, 2008
Make that Bargain Equitable
The recent World Trade Organization (WTO) talks came a cropper: Despite intense negotiations over weeks, member states could not agree on critical “agricultural” issues. Under the circumstances, a number of member states are likely to resort to the WTO dispute settlement mechanism to extract more concessions out of scofflaw states. Brazil is one such country—it had won a WTO case against the US on illegal cotton subsidies several years back. But, despite a panel and appellate ruling in its favour, the US had refused to comply and had dangled hopes of further concessions at future WTO talks. As most of us know, those talks came and went, but Brazil’s farmers continue to suffer. So, Brazil is now seriously considering “retaliating” against the US in order to secure compliance with the WTO ruling.
What is unique about the Brazilian strategy is that, consistent with existing WTO norms, it wishes to “cross-retaliate” by suspending the intellectual property (IP) rights of US corporations. In other words, a Brazilian generic company could “legally” make copies of Pfizer’s patented drug. Contrast this with a “traditional” retaliation approach under which Brazil would have merely imposed tariffs on US goods imported into Brazil. The WTO framework has a number of agreements, and one of those—Trade-Related Aspects of Intellectual Property Rights (TRIPS) —obliges member states to guarantee a minimum level of IP rights protection. Since Brazil’s proposed retaliation is not under the same agreement that is under dispute (i.e., agreement on subsidies), it is popularly referred to as “cross-retaliation”.
The desire to cross-retaliate is easy to understand: Given the highly disparate value of trade between Brazil and the US and the relatively “lower” value that the US places on its exports to Brazil, “traditional” retaliation through tariffs, etc., would not hit the US hard enough. Besides, given the much “higher” relative value that Brazil places on US goods, such a retaliation may be tantamount to Brazil shooting itself in the foot.
The story is the same for a number of developing countries including India, which find that traditional retaliation is more a bane than a boon. The Byrd Amendment case at WTO is an excellent example— where a group of 11 WTO members jointly filed an action against a US law that granted illegal subsidies to US companies. While eight of these countries sought and were granted the right to retaliate, the only countries that exercised this right by imposing duties were the “developed” ones i.e., the EU, Canada and Japan. Barring Mexico, developing countries, including India, Brazil and Chile, shied away from exercising their right to retaliate. One can hazard a guess that part of the reason must have been their lack of confidence in the traditional “retaliation” machinery.
Cross-retaliation is “legal” under the WTO framework and DSB (Dispute Settlement Body) has already sanctioned it in three cases: the Ecuador bananas case; the Brazil cotton subsidies case and, most recently, the Antigua gambling case. But this remedy is not automatic and has to be pleaded for in every separate case: It is more the exception than the norm. Importantly, despite such authorizations from WTO, countries have never exercised this right, not least because of the uncertainty involved in implementation. So, there is no clarity how a country could suspend the IP rights of foreign corporations and still recover only what is due to it (as a result of the scofflaw state maintaining WTO-inconsistent measures) and no more.
Leaders of the less developed bloc such as India and Brazil need to urgently work out an effective cross-retaliation model that can be translated into domestic legislation. Much like section 3(d) of Indian’s Patents Act, a unique provision brought in to rein in “evergreening” of pharmaceutical patents, that is now being copied by other developing countries, India should take the lead here as well. One such model has been proposed by the author in a recent paper. It includes the following elements:
1. In the event of a WTO ruling permitting India to cross-retaliate by suspending TRIPS obligations against any member state, all categories of IP rights belonging to such member state shall stand suspended.
2. Any new rights that are subsequently registered stand suspended from the date of registration till the date of removal of the WTO-inconsistent laws or till the parties settle. Such determination of dates shall be made exclusively by a designated government office/person.
3. Subsequent to a WTO ruling granting India the right to cross-retaliate, any domestic entity can register with a designated government office and declare its intention of working the suspended IP rights. Such entities would then have to file statements each month or quarter of how they have used the “suspended” IP and the profits earned from the sales of goods/services made using the “suspended” IP. A government office/person shall be entitled to audit accounts, etc., of the said entities to ensure their filings are accurate. One could then use such “profits” of Indian entities as a proxy for the amount of losses that accrue to the US by such IP suspension. Or one could impute a hypothetical royalty that might have been paid, had the IP right been in force, and use such royalties as a proxy for those losses.
“Cross-retaliation” does not suggest blatant disregard for IP rights: Rather, given the strong IP lobbies in the developed world, it serves as an effective threat and is likely to induce compliance by scofflaw states. In many cases, if the threat is strong enough, countries may not even need to work their cross-retaliatory models.
Importantly, such a remedy is likely to make the WTO framework more meaningful to a large number of developing countries that continue to see it as representing an inequitable bargain. The WTO bargain effectively represents a give and take between the developed and developing country blocs—where the former offered to open their markets to the latter’s goods such as textiles and agriculture, and the latter promised to implement minimum standards in IP so that developed country “knowledge” goods could be sold unimpeded in international markets. It is therefore only fair that TRIPS obligations be suspended by developing countries when developed countries fail to live up to their commitment to open up their markets.
All this rests on developing countries providing for this possibility within their domestic regimes.
Indian blog threatened
By Bala Shah
First there was the world of mainstream media where a few business houses-owned newspapers told us what was happening in the world. Then PM Rao, Finance Minister Manmohan Singh started the liberation of our energies and economy. The BJP continued this push towards a market economy and handed the baton back to PM Singh. All this has resulted in more newspapers, magazines and TV stations which are good for a healthy democracy.
And then came the blogs in India which were a quantum leap towards a free flow of ideas as well. Some of the best analysis in our country is done by bloggers.
One of the best legal blogs in India is Spicy IP. So good that in May, 2008, Lexis Nexis listed it as a top IP blog. The US Library of Congress describes Spicy IP as a useful online IP resource. And there are many more experts in India and overseas for whom Spicy IP is mandatory reading.
Spicy IP says it aims to increase transparency in Indian intellectual property policy/institutions. They also stand for fair, objective and accurate reporting of intellectual property and innovation policy news from India.
As you can imagine such an honest voice has ruffled the egos of a few people. Spicy IP reports about some legal strategies and a few policies of drug giant Roche in India have resulted in the blog being threatened by someone claiming to be a Roche representative. The thug had the audacity to ring the aunt of the writer in Kerala and warned her that such “anti Roche’ articles would result in the blogger “paying for it dearly”.
Unfortunately for Roche, the blogger Shamnad Basheer happens to be a lawyer who has impeccable qualifications. After graduating from Bangalore, he did his post graduate studies from Oxford. Later, he taught at a number of respected institutions including the George Washington University Law School. Spicy IP has a many such eminent Indian bloggers. Coupled with such legal credentials, they have the moral courage to stand by what they feel is in the best interests of the Indian consumers.
Even a technology gossip website like techgoss recognizes that in this world of greys, there are some issues which are black and white. Contacting and threatening the aunt of a blogger is criminal and a new low in trying to intimidate bloggers.
Shame on you Roche India. You may not realize it but an attack on one Indian blogger is an attack on the entire Indian blogging community.
Roche India, the best medicine for you is an unqualified apology to the blog.
As a forerunner in all aspects of IPR, the State of Kerala plans to introduce IPR as a core subject in its curriculum both at the school and university level.
Readers may recall our earlier post where we had mentioned that Kerala is approaching its IPR initiatives in a systematic bottom up approach.Introducing policy initiatives, gearing up the IP- admin infrastructure and inculcating awareness and educating the young, the State is on a robust IPR mission.
Unnikrishnan of Livemint reports:
The government has already directed universities to include IPR law and implementation in the syllabus at the degree level from the next academic year. The move is aimed at motivating students to take up a career in patents and their protection.
“The state will initially start five or six centres of excellence to provide degree-level classes to students in all five universities, and faculty will be provided in the universities and its affiliated institutions over a period of time,” said a senior official in the state education ministry who declined to be named because he is not authorised to speak to the media.
“The Kerala government’s move to include IPR in general education will also help overcome the severe shortage of professionals in the field of intellectual property rights and related areas in the country,” says R.S. Praveen Raj, a scientist at the Intellectual Property Management and Technology Transfer office, National Institute for Interdisciplinary Science and Technology, who played a key role in drafting the state policy.
Tuesday, August 26, 2008
Readers may recollect our earlier post, where I had queried an uncle of mine (a cancer specialist at RCC, Trivandrum and married to the "aunt" above) on the price of "Tarceva". In that post, I noted:
"In several earlier posts, we pointed out inconsistencies in Roche’s argument on the Tarceva price. While they claimed in court (before Bhat J) as well as in the press that the tablet costs only Rs 3200, the packaging in the market (which Cipla produced in court) speaks otherwise i.e. Rs 4800 per tablet (which coverts to about Rs 1.4 lakh per month for a patient). Justice Bhat naturally preferred the hard evidence produced by Cipla (i.e. the packaging) to the word of Roche.
Since I've been perplexed about this pricing issue, I spoke with an uncle of mine, a cancer specialist at the RCC (Regional Cancer Center), Trivandrum. He’s treated several patients with Tarceva in the past. He informs me that although the open market price for Tarceva is Rs 4800 per tablet, RCC was able to negotiate a lower price of Rs 3200 from Roche. In other words, a powerful institution such as the RCC could strike a good bargain with Roche. But he cautions, this price is strictly for RCC patients only and Roche has left strict instructions to ensure that this cannot be traded in the open market (sort of the way military canteen goods in India are subjected to arbitrage)."
I just can't fathom how anyone could stoop to such a level, sneakily procure personal details (telephone numbers etc-so much for privacy in this country!) and threaten family members.
More importantly, I'm not entirely sure what part of the above statement peeved this alleged representative of Roche. Or whether his angst was against previous posts that pointed to critical flaws in Roche's legal strategy. Anyway, if he thinks that his highly reprehensible act of issuing threats to family members is going to shut us up and derail our efforts to further "transparency", he is sadly mistaken.
Monday, August 25, 2008
Close on the heels of SpicyIP's new logo, there's spicy news that a Mumbai banner - Mirchi Movies (and I shan't make things more obvious) - has been sued for IPR violations by Warner Brothers over the choice of title of its children's film, Hari Puttar -- A Comedy of Terrors, for being too similar to its "Harry Potter" franchise.
The case was listed for hearing today in the Bombay High Court, while the film is scheduled for release in India on September 12. As initial reports begin to stream in about this case, the lawsuit is being berated as over-zealousness on the part of WB in its attempt to "value and protect" its IPR.
The Mumbai studio is particularly concerned over why WB should have chosen to sue a fortnight before the release, when the title Hari Puttar had been registered way back in 2005.
Some of you may recall the Durga Puja drama about the Hogwarts Castle-pandal from last year, where although the injunction was in Warner Bros' favour, the pandal was allowed to keep standing. In that case, the structure was an acknowledged reproduction of the imaginary castle, and therefore a challenge was more understandable. in this Hari Puttar lawsuit, there is little to defend apart from a syllabic similarity. The Indian film's characters apparently bears no resemblance to Rowling's creations. In fact, there are suggestions that the film looks more like an Indian-ised version of Macaulay Culkin's Home Alone films.
The time period of filing the suit was also similar - just a few days/weeks before the Puja celebrations (in this case, a few weeks before the film release). It is possible that this is strategising on WB's part ensure that ownership over the franchise is made abundantly clear, and a signal to show that vigilance continues. Otherwise, the suit itself appears to be weak, particularly when considering the cultural prevalence of both "Hari" (a popular given name) and "puttar" (a colloquial north-Indian term for "child") in the country. Unless, of course, they are suing for something deeper than that... which a Harry Potter non-fan such as self (yes, our ilk does exist!) wouldn't understand anyway.
The much anticipated first of several meetings discussing the Draft Patent Manual was chaired by NN Prasad in
However, already the meetings have run into controversy by creating more of a flutter and garnering criticism from all sources.
Our readers will remember our Spicy recommendation to the interpretation of Section 3(d) as well our interpretation of the draft in light of the Novartis litigation as well as our report on the Software Patent Vigil conducted in
Managing IP carries this interesting comprehensive piece on the meeting held thus far as well as the various comments received. We reproduce the same for our readers below:
"Patent manual causes debate in
A draft of
IP India is holding a series of consultations on the manual. NN Prasad, joint secretary of the Department of Industrial Policy and Promotion at the Ministry of Commerce, chaired the first meeting in
If approved, the Manual of Patent Practice and Procedure would not have the force of law, but would act as a guide for examiners. It contains a section that explains to examiners how to interpret the controversial section 3(d) of
The manual states that, to calculate increased efficacy the examiner should compare “the known substance and the new form of known substance. In case the new form is further converted into another new form, the comparison is made between the already existing form and another new form but not between the base compound and another new form”.
“This appears to be a clear attempt to prejudge the Novartis case,” said Shamnad Basheer, academic and founder of the blog Spicy IP. The case, which is still before the Intellectual Property Apellate Board, concerns Novartis’ application for a patent for imatinib mesylate, which is sold by Novartis under the brand name Glivec. The Chennai Patent Office rejected the patent application citing section 3(d). Deciding what is the known substance against which imatinib mesylate should be compared is crucial to deciding if it is patentable in
According to Basheer, the way the manual is phrased assumes that a new salt that emerges during an invention will be a “known substance”, which will make it harder to prove increased efficacy.
The Federation of Indian Chambers of Commerce and Industry has criticised the phrasing in the draft manual, stating: “This section does not cover guidelines about those inventions in which one crystalline form is converted into another crystalline form.”
Campaigners for open source software are also worried that the manual will open the way for software patents in
But Red Hat
Section 4.11.6 seeks to draw a distinction between “software per se” and “software having its technical application in the industry”.
On August 23, the Free and Open Source Software group held a candlelit vigil in
We at SpicyIP certainly hope that the participation in these meetings will result in significant changes to the problematic portions of the policy, and the policy ultimately ends up well reasoned and balancing all sides as best possible.
Sunday, August 24, 2008
The net result of sections 68 and 69 is that unless a license/assignment or any other interest in a patent (mortgage etc) is "in writing" and "registered" in the register maintained by the Controller of Patents, it is not valid. Section 69 (5) however provides that in some cases, the court/controller may (after giving its reasons in writing) admit a "non recorded" patent license/assignment.
So how does this impact the Roche vs Cipla case?
The patent in suit is jointly owned by OSI Pharma Inc and Pfizer Products Inc. It is licensed for use/sale etc to Roche (the main defendant in the case). What if this license agreement is not recorded under section 69? Clearly, unless the court otherwise directs, Roche's interest in the patent is not valid and it cannot bring the law suit against Cipla. Rather the suit will have to be taken over by OSI/Pfizer Products. I'm guessing that the license was duly recorded under section 69--else Cipla's counsel would have certainly raised this issue.
We once again wish to thank our wonderful readers for helping us come this far. Your support and encouragement means a lot to us. Please let us know what you think of this logo. Spicy enough?
It bears noting that Jaitley did touch upon "pricing" issue briefly, while reiterating before the appellate court that the price of Tarceva (as printed on its box) was Rs 4800 per pill. Interestingly, he also pointed out something that was first raised by SpicyIP many months back i.e that NICE (a UK government authority) had rejected Tarceva as too expensive! He even relied on the very same Dow Jones report that SpicyIP had quoted from! I quote from our earlier post in this regard:
Jason Douglas of Dow Jones reports that:
" The U.K's National Institute for Health and Clinical Excellence said Thursday that Roche Holding AG's (RHHBY) drug Tarceva has been turned down as a treatment for non-small cell lung cancer because it's too expensive.
NICE said Tarceva could not be considered a cost-effective use of the U.K.'s state-run National Health Service's resources compared to Sanofi-Aventis's (SNY) Taxotere.
NICE, which determines whether drugs should be available on the NHS in England and Wales on the basis of their effectiveness and value for money, said the cost of Tarceva was considerably higher than acceptable. It found Tarceva was GBP 2,100 more expensive to buy per patient than Taxotere and said it was not persuaded that Roche had proved its drug, known generically as erlotinib, had an equivalent survival benefit to Taxotere, or docetaxel."
However, I am given to understand that the above decision by NICE has been succesfully appealed against by Roche and overturned. In other words, the NICE decision rejecting Tarceva as too expensive is not valid anymore. I am yet to confirm this, but should any of our readers have more information on this, please do let us know. Or we'll have to wait and see what Roche's attorneys have to say about this when the matter comes up for rebuttal on Monday.
So How Much Does Tarceva Really Cost?
In several earlier posts, we pointed out inconsistencies in Roche’s argument on the Tarceva price. While they claimed in court (before Bhat J) as well as in the press that the tablet costs only Rs 3200, the packaging in the market (which Cipla produced in court) speaks otherwise i.e. Rs 4800 per tablet (which coverts to about Rs 1.4 lakh per month for a patient). Justice Bhat naturally preferred the hard evidence produced by Cipla (i.e. the packaging) to the word of Roche. Jaitley produced this packaging in court on Thursday and insisted once again that the price was Rs 4800. I wonder how Abhishek Singhvi (counsel for Roche) is likely to react to this. Since Justice Bhat (the trial judge) found in favour of Cipla on this count, it is very unlikely that the appellate would disturb this "factual" finding, unless there was a clear/manifest error.
Since I've been perplexed about this pricing issue, I spoke with an uncle of mine, Dr Mirza Hussain, a cancer specialist at the RCC (Regional Cancer Center), Trivandrum. He’s treated several patients with Tarceva in the past. He informs me that although the open market price for Tarceva is Rs 4800 per tablet, RCC was able to negotiate a lower price of Rs 3200 from Roche. In other words, a powerful institution such as the RCC could strike a good bargain with Roche. But he cautions, this price is strictly for RCC patients only and Roche has left strict instructions to ensure that this cannot be traded in the open market (sort of the way military canteen goods in India are subjected to arbitrage).
When I asked him about whether or not all his patients could afford the Rs 3200 tab, he shrugged his shoulders and said “Of course not”. I asked: “Could they afford Cipla’s tablets at Rs 1600? And he shot back: Well if it's a poor labourer who earns Rs 100 a day, then whether it is Roche’s Rs 3200 or Cipla’s 1600, it does not make a jack of a difference to them. And then I asked: So how should we help them? Do we let them die? Should the government step in? Has the government stepped in? He balked: The government!! And gave the most pitiful look that I’ve seen come from him in all these years. I got the message and moved on to other more pleasant topics.
ps: On the "pricing" issue in relation to life saving drugs, check out this wonderful piece by CH Unni in the Mint, where he states that:
"Patients on a regimen of high-value cancer drugs imported into the country continue to pay up to 35% more than the international prices—the result of import duties that are yet to be removed or reduced despite the government having exempted life-saving cancer drugs from all import duties in early 2007.
The delay seems to be a result of inter-ministerial red tape. “We have our limitations in judging the priority of these life-saving drugs. So, we are awaiting timely recommendation from the health ministry for notifying these drugs on the list,” said an official with the finance ministry who did not wish to be identified."
Moving on to other Bollywood news: Shah Rukh Khan's blockbuster Om Shanti Om is facing its own problems regarding accusations of script-lifting also known as copyright infringement. Anshika Misra of DNA India reports that:
Ajay Monga, who has written the scripts of films like Corporate and the forthcoming Fashion, has filed a suit in Bombay High Court, alleging that OSO is a copy of a script he wrote. Alleging copyright infringement, Monga’s suit states that he had wanted Shah Rukh to play the lead role in the film, and gave a copy of the script to his company — Red Chillies Entertainment — in December 2005, but got no response. Monga’s action may seem belated given that OSO was released in November. However, he has stated that he filed complaint with the Script Writers’ Association in December itself. He decided to file a suit in the HC on August 2 after learning that the film is slated for a worldwide television release on August 10.
Apparently the Script Writer's Association had already dismissed the complaint as having no basis. Mongia has reportedly filed a suit against King Khan's Red Chilli Entertainment alleging copyright infringement. It should still be interesting to note how the Bombay High Court would deal with this case.
This news is a bit stale but still, its news: The ET had reported a month ago that two entertainment majors Percept Picture Company & UTV have entered into a major copyright dispute regarding UTV's new movie ShoeBite (consequently renamed Johnny Mastana). Initially Percept had engaged Director Shookit Sircar for UTV on the basis of the same script. The Delhi High Court granted a stay in favour of Percept restraining UTV from releasing the movie. Hopefully both companies enter into some agreement since it doesn't make sense to can a movie, the shooting for which has already been completed.
Thats all for now folks!
Saturday, August 23, 2008
The 'Olympic' Copyright Dispute - DD sues news channels for broadcasting footage of the Beijing Olympic Games
It is rather (pleasantly) surprising to see a government organization enforcing its rights so aggressively. The news channels for their part can argue the fair dealing exception under Section 52(b) which allows for the use of copyrighted material “for the purpose of reporting current events”. However I doubt whether this provision will be interpreted to read as a blanket exemption and it is more likely that a court of law will read this exemption in light of DD’s own broadcast guidelines for news channels. It is most likely that the news channels will get away with breaching the guidelines, while broadcasting more than 10 seconds of the medal winning matches, by citing public interest, however, there will still be hell to pay for broadcasting the spectacular (partially doctored) opening ceremony which was one of the most viewed events in the world. The same stands true if any news channel was broadcasting entire events.
Friday, August 22, 2008
Published annually by NALSAR University of Law, Hyderabad under the patronage of its Vice Chancellor Dr. Veer Singh and Mr. Justice UC Banerjee (Former Judge, Supreme Court of India), the journal invites contributions from students, academicians and practitioners for its next issue.
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Thursday, August 21, 2008
Readers may recall the various posts that SpicyIP has written on the status of Software Patents in India and abroad. The draft Patent manual, which has created scares of creating a backdoor entry for allowing Software patents is currently undergoing public consultation in the various metros. The Bangalore round of discussions is tentatively scheduled for the 27th of August and civil groups are preparing to protest the 'sneaking in' of the clause allowing software patents by means of a candlelight vigil and preparing a document for a written appeal against the same. See more details below.
Free Software User Group is organising candle light vigil to say no to software patents on 23rd Saturday.
Software patents are rejected by Indian Parliament in 2005 (Patent Amendment bill 2005). But Indian Government is now trying to push it through back door by bringing a Patent manual. Public consultations on this draft manual is going on in various metros in India. Bangalore. Consultation is scheduled for the last week of August.
The Candle light vigil to "Say No To Software Patents" is a occasion to raise civil society voice against this back door trojan to Indian patent system. Software Patents kills innovation & competition. Patents turn software publishing into the privilege of a few. Software is a key technology that is important to every company, every public administration, and every household. Therefore, everything that makes the software industry ill has effects on the entire organism, on all aspects of the economy and society.More details here http://upcoming.yahoo.com/event/1022228
Posted by Swaraj Paul Barooah at 8:48 PM
TK(traditional knowledge) has been quite an attention grabber the last few months-from hotch potch state legislations that threaten to reawaken the bygone era of the License Raj, to high voltage discussions at the Green room in Geneva, TKs’ assumed centre stage.
Making inroads into the mountainous terrains of the Hindu Kush, The International Centre for Integrated Mountain Development(ICMOD) has launched a project to implement and facilitate an equitable ABS(Access and Benefit Sharing) mechanism in the Eastern Himalayan countries of India, Nepal, Bangladesh and Bhutan.
The Hindu Kush-Himalayan (HKH) region, and more specifically the Eastern Himalayas, is one of the 34 global biodiversity hotspots and a treasure house of genetic resources and traditional knowledge. The region also has great linguistic and biocultural diversity. These resources provide the basis for the livelihood security of mountain communities.
For a more socially inclusive notion of biodiversity conservation and usage, it is important to facilitate the implementation of the CBD in letter and spirit in all the major biodiversity hotspots in the HKH region. Towards this, the ICIMOD launched a regional programme on Access and Benefit Sharing (ABS) from Genetic Resources and Associated Traditional Knowledge (TK) in Eastern Himalayas, with support from the German Agency for Technical Cooperation (GTZ). The overall objective of the programme is to facilitate the development and implementation of the CBD’s ABS regime in these regions.
More on the project can be accessed here
The international momentum and thrust on protecting Indigenous produce that merit G.I protection is fast catching up
Extension of equal protection to all goods (and not merely wines and spirits as stipulated in the TRIPS articles) and the demand for a multilateral register for G.Is’ was largely bruited upon at the recently held Doha round of talks at Geneva , albeit inconclusively.
Interesting international developments indicate that producers are fast waking up to the importance of acquiring a domestic G.I registration, but also seem to be moving towards getting a transborder G.I cover
Scotsman reports the Scotch Whisky Manufactures’ G.I victory in China
SCOTLAND'S whisky industry received a significant boost yesterday when it was given official legal protection in China.
The trade mark office in the country, which is expected to become the fourth-largest blended whisky market in the world, ruled that the phrase "Scotch whisky" would now be defined in law.
The deal to register a "collective trade mark" and protect Scotch whisky as a geographical identification followed an application by the Scotch Whisky Association (SWA).
The SWA said the protection – the highest granted by the Chinese state – would cover the words "Scottish whisky" and its Chinese translation.
This positive decision to grant stronger 'collective trademark' protection to Scotch is an important advance and will help to ensure Chinese consumers and Scottish distillers are protected from fake products."
Would the SWA look towards India as the next jurisdiction to obtain a G.I mark for the malt?
Hail the Glenfiddich!
For those of you not familiar with the Novartis patent litigation (given the 100 odd posts that we've done so far on this big ticket patent litigation in India, its highly unlikely that our readers may not have come across this till now), here is a brief gist, from a recent paper of ours that was published a few days back in Script-ed, a publication from the Univ of Edinburgh. (A copy of this paper, as published, is available on SSRN: once you access the link, click on "chose download location", a tab which appears right on top of the webpage and then click button titled "SSRN (New York, USA)").
“Like all drug sagas, the story of Gleevec begins with two outstanding scientists, who rarely figure in the “patent” narratives that are doing the rounds today.
In 1960, Peter C Nowell, then a junior faculty member at the University of Pennsylvania School of Medicine, together with a graduate student, David Hungerford, discovered a genetic mutation in patients with chronic myelogenous leukemia (CML), a debilitating form of cancer. The discovery of this abnormality, designated the Philadelphia chromosome after the city in which it was discovered, broke fresh ground and spurred the search for a potential cure for CML. In the 1980’s, researchers determined that the chromosomal abnormality produced a cancer-causing kinase enzyme.
With this enzyme as a target, Novartis researchers (led by Drs. Zimmermann and Buchdunger) in close collaboration with a prominent scientist, Brian Drucker created and tested 400 molecules to find one that would target this enzyme, without disrupting any of the hundreds of other similar enzymes in a healthy cell. Pioneering the concept of rational drug discovery, they closed in on a promising candidate, “Imatinib,” a free base. In 1993, Novartis filed a patent covering this free base and all pharmaceutically acceptable salts.
Imatinib was then further researched upon and improved – first, by converting it to a particular salt form, namely imatinib mesylate. From this salt, Novartis found that the most stable version was a particular polymorphic form, namely the beta crystalline form. Novartis then formulated the beta crystalline form of imatinib mesylate into a pharmaceutically useful drug, Glivec. After its approval by the FDA in 2001, Glivec has proven effective for innumerable patients and has been hailed as nothing short of a wonder drug.
The Novartis (Glivec Patent Dispute)
The patent dispute centres around the beta crystalline form of imatinib mesylate referred to above. To date, 40 patents covering this polymorph have been granted to Novartis in various countries. However, owing to the unavailability of drug patents in India until 1 January 2005, Novartis claimed this polymorph in a “mailbox” application.
Pursuant to the 2005 amendment to India’s patent regime, which introduced product patents for pharmaceuticals, the mailbox application by Novartis, as above mentioned, was opened and examined. The grant of a patent was opposed by several generic drug companies (and an NGO, the Cancer Patients Aid Association (CPAA)) on several grounds including:
i) lack of novelty/anticipation;
ii) lack of significantly enhanced “efficacy” under section 3(d);
iii) obviousness, and;
iv) wrongful priority.
Agreeing with the above arguments, the Assistant Controller of Patents rejected the patent application.
Aggrieved by this rejection, Novartis AG, along with its Indian subsidiary, Novartis India, filed two writ petitions in the Madras High Court. These petitions not only sought a reversal of the Assistant Controller’s order, but also a declaration that Section 3(d) was unconstitutional and in violation of India’s obligations under TRIPS. The Madras High Court ruled against Novartis on both counts.
Pursuant to a government notification, the High Court transferred the first petition to the Intellectual Property Appellate Board (IPAB) – a specialist tribunal set up to deal with appeals from the various intellectual property offices across the country. As of today, the matter is still pending before the IPAB.
Section 3 of the Indian Patents Act is the key section on “patent eligibility” and lists out what are not “inventions” under the Indian Patents Act. Section 3 (d) lists out one such non-eligible patentable subject matter:
d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such process results in a new product or employs at least one new reactant.
Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
In essence, section 3(d) aims to prevent a phenomenon commonly referred to as “ever-greening” by providing that only those pharmaceutical derivatives that demonstrate significantly enhanced “efficacy” are patentable.”
The Patent Office Manual and Section 3(d):
Now, coming to the patent office manual, in relation to section 3(d), para 4.5.3 of the Manual states: “The examiner makes comparison with regard to properties or enhancement of efficacy between the known substance and the new form of known substance. In case the new form is further converted into another new form, the comparison is made between the already existing form and another new form but not between the base compound and another new form.”
This appears a clear attempt to prejudge the Novartis case. The various steps in the alleged inventive process that went into the making of Glivec are as below (again, I’ve reproduced this verbatim from our paper):
i) Synthesizing imatinib as its free base, a compound that was patented in the US, EU and several other countries. However, this could not be patented in India, owing to the fact that in 1993, India did not provide product patents for pharmaceutical substances.
ii) Converting the free base to a particular salt form, imatinib mesylate, by adding methanesulfonic acid.
iii) Crystallising the imatinib mesylate to obtain the beta crystalline form, which is allegedly the most stable polymorphic form of the salt. A patent application was filed for this and it is this application that is the subject matter of dispute.
iv) Formulating the beta crystalline form of imatinib mesylate into a pharmaceutically useful drug, Glivec.
In short, the base compound (“Imatinib Free Base”) is converted to a salt (Imatinib Mesylate) which is then further crystallized to another new form” (Beta Crystal form of Imatinib Mesylate). One might also contend that prior to the discovery of the beta crystalline form, there existed an alpha crystalline form of Imatinib Mesylate.
Unfortunately, the patent office decision rejecting the application for Glivec is quite sketchy on this point. It is "non speaking" to the extent that it does not answer a critical question: What is the “earlier known substance” against which the beta crystalline form was compared for "increased efficacy" under section 3(d)?
The “known” substance for the purposes of section 3(d) could either be the salt (Imatinib Mesylate) or the polymorphic form (alpha crystalline form). However, such substances can be taken to be "known" substances, only if they were, in fact, "known" as on the date of filing the patent application covering Glivec (the beta crystal form). If the salt (imatinib mesylate) or the polymorphic form (alpha) is not “known” (i.e still novel) as on the date of filing the patent application for beta crystalline version, then such substances cannot be used as the basis for comparison under section 3(d).
In short, as to whether a substance is "known" or not is an issue that has to be determined on a case by case basis and one cannot assume that in every case, a new salt or a new form emerging during the course of an alleged invention will always be a “known” substance. Unfortunately, from a reading of the patent office manual, this is the kind of "prejudged" result that one gets.
Does Novartis' earlier application anticipate Imatinib Mesylate?
Having said all of the above, we wish to draw your attention to one of our earlier posts ,where we opine that, from the available evidence, the earlier 1993 application covering the imatinib free base "in fact" appears to anticipate "imatinb mesylate". However, it does not anticipate the "alpha cystal" form or the beta crystal form. I noted in that post as follows:
"Novartis claims that Glivec (beta crystalline form of imatinib mesylate) is more effective than the Imatinib free base, since it displays better bio-availability properties i.e. it is absorbed more easily into the blood.
Novartis claims all acceptable pharmaceutical salt forms in its main 1993 patent (step (i) above). This would ordinarily include Imatinib Mesylate as well. The question however is: does the 1993 patent "enable" the making of imatinib mesylate? I personally think it does--but am happy to be corrected. If it does not, then imatinib mesylate cannot form part of the claims. It also cannot taken to be a "known" substance. Section 3(d) requires that the new form demonstrate increased efficacy over the "known" substance. If Imatinib Mesylate is not a "known" substance, then the comparison under section 3(d) cannot be with Imatinib Mesylate. And to this extent, the case against Novartis on section 3(d) becomes a weak one.
However, as I said earlier, I personally think the patent enables the making of Imatinib Mesylate and the case on section 3(d) therefore still remains a strong one."
I’ve now found an international (PCT) prelim examination report which buttresses our point by clearly stating that the application for the beta crystal form of imatinib mesylate (Glivec) was "novel", as on the date of filing. However, the salt (imatinib mesylate) itself was anticipated by the first application filed in 1993 covering the imatinib free base. We quote this PCT examination report finding in our paper as below:
“Methanesulfonic acid addition salts of the present compound….are disclosed in D1(D1: US Patent Application)….However, no mention is made of a particular crystalline form of the monomethanesulfonic acid addition salt of said compound. The novelty of the present claim can therefore be acknowledged.” (edited)”
This point also seems to be endorsed by an EPO ruling, which Tahir Amin drew my attention to in a comment to our post:
"when the EPO was examining the B-crystalline patent, the examination report held that the '184 patent disclosed the methanesulfonic acid additional salts for formula (I) - but the application was considered novel because the '184 patent did not disclose the b-crystalline form. "
Given that the patent office will hold another 2 hearings or so on the patent office manual, we hope that some of our readers who attend these hearings will raise this issue (if they are convinced, of course, that a manual ought not to blatantly prejudge a case, but decide the "known substance" issue on a case by case basis).
Patent Office Does Not Have Force of Law: So Why Worry?
Lastly, it bears reiteration that the patent manual does not have the force of law And indeed, the manual itself acnowledges this by stating so in the preface. However, as many of you who practice before the patent office are aware, the manual pretty mush assumes a sacrosanct /biblical position with patent examiners. Therefore, any proposition included in the manual is likely to be religiously adhered to--unless challenged and struck down by a court of law. And therein lies the danger. (interestingly, the patent office has had a history of "secret internal circulars" that were religiously adhered to as well. Such circulars were famously used for rejecting biotech applications containing living subject matter and documented in this paper).
We'd be very interesting in hearing what our readers think of the draft manual in general. Better than the last one? Good bed time reading? More of a paper tiger--and in the language of the bard: "full of sound and fury, signifying nothing" (paper tiger has such a nice homely ring to it, given that we're speaking of India…doesn't it?)
According to a news report in the Economic Times, "Supachai Panitchpakdi, Secretary-General of the UNCTAD personally visited the handlooms at Varanasi earlier known as Banaras, and saw for himself the labour being put in by the artisans in weaving the traditional brocade silk sarees." Aparantly moved by the artisans' hard work, he was reported as having said that "We would like to support the effort to have a formal geographical indication, of course, at national level. There would be a subsequent international recognition of this product of 'Banarsi silk sarees' and brocades and other products that should be gaining in terms of more value outside India as well..."
The report goes on to state that "The UNCTAD plans to produce a systematic information network that would be disseminated around in a way that markets abroad will be well informed of the products from Varanasi. They would also try to create brand recognition along with the geographical indication of the products."
Readers will recall our earlier posts on GIs where we discussed the need to have an Article 23.2 level of protection for GIs that do not relate to wines and spirits. As Felix Ador told our very own Aysha in a SPICY IP Interview, Articles 22-24 of the TRIps Agreement envisage two different levels of protection for GIs:
"Section 22 applies to GIs for all products and protects them against all uses that are misleading to the public or which constitute an act of unfair competition. Section 23.2 provides an additional level of protection to wines and spirits, where regardless of the risk of the public being misled , GIs in wines and spirits get an additional cushion of protection. This is violative of the non-discriminatory principle envisaged by TRIPS and calls for rectification.
Regrettably the protection of GIs at the international level is far from being adequate. Except for wines and spirits it is all too easy to misuse GIs. Although a number of countries have developed effective legislation to protect GIs for all products, national regulations which only apply in one country are not sufficient in the global economy. Products often travel beyond national borders, which is why satisfactory protection of GI across all categories must be granted at the international level without further delay."
Stories of dying arts and starving artisans are neither new nor uncommon in India. Machine made cloth lead to India's economic dependence on the British during the colonial era. As a consequence, Ghandhi Ji's Charkha became a symbol of India's economic self sufficiency and independence. The popular use of the Charkha to spin one's own cloth rather than buying machine made cloth imported from Britain, is considered to be one of the effective "non-violent" means adopted by India to gain independence.
More than 60 years after independence, it is still a challenge for the handloom industry and small time artisans and weavers in India to preserve their art and their livelihood. Machine made cloth is much cheaper and often the industries that produce the cloth have greater resources to spend on advertising and marketing. Borrowing a term my father uses often, I have to say that the art as well as the artisans are being "priced out of existence." This is true for artisans not only in Banaras or in other parts of India, but all around the globe. The Indian government should take advantage of Mr. Panitchpakdi's visit and his interest to push for stronger (Article 23.2 style) GI protection for all categories of goods.
Posted by Mrinalini Kochupillai at 12:05 AM
Wednesday, August 20, 2008
Sarai in collaboration with ALF, Bangalore are working on a three-year project focussing on non-traditionally dealt with aspects of piracy such as cultural needs and practices in developing countries and in connection with this, they are looking for researchers. Please check below for further details. We would also like to request you to mention where you've found out about the position (i.e., SpicyIP) while contacting the email address given below. Thanks in advance.
The Cultural and Material life of Media Piracy is a three year project carried out by the Sarai programme of the CSDS in collaboration with the Alternative Law Forum, Bangalore. We begin with the premise that piracy is widespread in places where a media-saturated modernity meets severe inequalities of purchasing power for books, software, recordings, videos and other knowledge products. One of the key aims of this research project will be to understand this media environment as it unfolds itself in diverse contexts. The main research node is in India with comparative work in China and Pakistan. The Sarai-ALF teams of researchers work in tandem with an international project on media piracy with fellow researchers in Brazil, South Africa and Russia. The larger study is coordinated by the SSRC (New York).
The project seeks to open different debates on piracy other than simply that of enforcement and criminality. Through research, we hope to generate discussions of cultural needs, community practices of sharing and circulation in societies of high inequality. We will also look at media industry approaches to piracy and enforcement strategies. In addition, there will be ethnographic and quantitative work on media use in neighbourhoods. The study of piracy offers a unique vantage point to study the media environment, through the sites of media and its movement across limits set by law, the complexity of user-bases, and the diversity of cultural delivery platforms.
We are looking for bright, energetic and qualified researchers who can work in collaboration with a regional and international team.
Applicants must demonstrate abilities to research and write on the subject. A familiarity with the debate on piracy and the creative commons is preferable. Social science and Humanities applicants should have completed post graduate degrees and law students a four year programme.
Researcher One: Delhi
The researcher will be looking at fieldwork material on media piracy in the Sarai archive, as well as conduct neighbourhood surveys slate to begin in 2009. Work will include research papers presentations and collaborative work with the team.
The researcher will be looking at the range of piracy strategies pursued by media industries in the film and music sectors. Research will span the larger media companies as well as the smaller companies.
Work will include research papers presentations and collaborative work with the team. Applicants from outside Mumbai are also welcome to apply for this position, although Mumbai based work will be significant.
Applications without a written research sample will not be entertained.
SSRC piracy project: http://programs.ssrc.org/ccit/ip/ Sarai, CSDS :
Again, like we requested earlier, when you are writing to the concerned people (whose email address is given above), please mention that you are coming via Spicy IP. Thanks
Also, as an aside, if you're generally interested in the above mentioned topic or the below mentioned topic for that matter , you also might want to check out this one hour documentary "Good Copy, Bad Copy" (freely available for download)