Section 3 (K)haos: IPAB on Patenting Mathematical Methods

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The IPAB recently upheld the Controller’s decision in a mathematical method application (here). In this case the petitioners claimed that they had invented “A Chaos Theoretical Exponent Value Calculation System” which was denied patent protection on the ground that since it was inherently a mathematical method it was excluded from protection under Section 3(k). 

The invention involved a system which used a mathematical formula that could calculate a chaos theoretical exponent value at high speed and on a real time basis. This method could even calculate time series signals of noise including speech which are not stable dynamics (stable physical disposition and length) but are temporarily changing dynamics (changing physical disposition and length. Eg. Different sounds have different lengths and the shape of the throat and mouth changes with each sound). Previously, such temporarily changing dynamics could not be calculated on a real time basis. 

The IPAB quoted the Yahoo decision “When the patentee explains that there is an inventive step which is a technical advance compared to the existing knowledge (state-of the-art) or that it has economic significance that would not give him the right to a patent as such. The ‘inventive step’ must be a feature which is not an excluded subject itself. Otherwise, the patentee by citing economic significance or technical advance in relation to any of the excluded subjects can insist upon grant of patent thereto. Therefore, this technical advance comparison, should be done with the subject matter of invention and it should be found it is not related to any of the excluded subjects”. It was held that in the present case since the invention was itself a mathematical method, even if there was technical advance, the subject matter being excluded under Section 3(k) could not be patented.

Rajiv has blogged about the Yahoo business method patent decision here. Madhulika recently wrote about the draft guidelines on computer programs and S. 3(k). For more on S 3 (k) and business methods see here, here and here.

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IPAB on Descriptive Trademarks

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The present case is Overseas Pvt. Ltd. v KRBL Ltd and Anr. The applicants sought to remove the respondent’s registered trade mark ‘BEMISAL’ (868081/class 30). The said mark has been registered in respect of rice as a “proposed to be used” trade mark. A prayer for stay under S. 95 from giving effect to the mark was also asked for. The IPAB denied removal and held in favour of the respondent’s descriptive mark. 

The applicant contended:

• The word ‘Bemisal’ which means ‘matchless’ is a description of quality of goods hence cannot be trademarked as per S. 9 (2) of the Trademark Act. Section 9 lays down various categories of words that cannot be trademarked e.g. words that a devoid of distinct character, which designate kind, quality, values, geographical origins etc. 

• The applicant has been using the name ‘Bemisal’ since 1993 in respect of its rice trade, even before the Respondent adopted the mark in 1999. Hence registration is contrary to S. 11 and the respondent wrongly claimed to be the proprietor of the mark under S. 18 (1). 

The respondents contended: 

• They have honestly, continuously, openly and commercially been using the trade mark ‘Bemisal’ for the sale of their products including rice since 1999. The respondents have built goodwill throughout the world with respect to their rice trade. Also, apart from the impugned mark the respondents are also the proprietors of two other pending marks Bemisal under nos. 1120954 and 1482415. 

• It was contended that even though the mark was descriptive on the date of its adoption, it has acquired distinctiveness on the date of rectification and adjudication. This being the case, the objections raised under S. 9 fails as the mark is now protected by virtue of S. 32. S. 32 creates an exception whereby any mark which has been registered in breach of S. 9 will not be invalid if it has acquired distinctiveness after registration and before legal proceedings challenging its validity are initiated. 

• Further, the respondents did not know that the applicant existed in the market until 2010. In June 2010 it came to the knowledge of the respondents that the applicant who was engaged in the same trade was also conducting business under the name ‘Bemisal’. Being aggrieved by the activities of the applicant the respondent filed a civil suit C.S (OS)946/2010 for the infringement and passing off of their trade mark by the applicant before the District Court, Saket, New Delhi. The Court granted ex parte interim injunction against the applicant on 6th July, 2010 restraining the applicant from the using the trade mark Bemisal. 

• It was also contended that the documents produced by the applicants stating use since `1993 were forged and manipulated and the instant petition was initiated so that the applicant could wriggle out of the restraint order. 

IPAB 

The balance of convenience, according to the IPAB, was in favour of the respondents. The documents produced by them showing rice export to several countries including: Kuwait; Baharain; New Zealand; Saudi Arabia; Canada and the value of its aggregated domestic sale figure (over Rs. 69 crores) convinced the Board of its extensive sale in and outside India.

More importantly, these figures also helped the IPAB establish that the respondent’s mark had acquired secondary significance. Holding that the test under S. 9 has been relaxed as it is the market that determines a good trademark, it can be inferred that descriptive marks can be registered provided they acquire distinctiveness before legal proceedings are initiated. To quote “The old theory that some trademarks are incapable of distinguishing the goods/services and can never serve as a badge of origin has been now relaxed under the current Act. It is the market place that determines what is good trade mark subject only to the limitation that the name of goods or services can never be regarded as a trade mark – example apple for apple (goods) or hotel for hotel (services). The threshold test under Section 9 is very minimal indeed.”

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APAA succeeds in getting IPAB a new home in Delhi; also objects to Patent Office fee hike

The Asian Patent Attorney Association (Indian Group), represented by its Secretary, Prathiba Singh has succeeded in getting the Intellectual Property Appellate Board (IPAB) a new residence for its hearings in Delhi. This latest victory for APAA, is a part of a long running litigation which APAA initiated before the Delhi High Court back in 2011. This was the same litigation which led to the appointment of Justice Prabha Sridevan as the Chairperson of the IPAB in 2011. The latest order passed by Justice Bhat of the Delhi High Court, on 18 July, mentions that the Delhi bench of the IPAB may now be located at the new Intellectual Property Office building coming up at Dwaraka in New Delhi. 

APAA has been quite regular in taking the government to court over the lack of resources provided to IP institutions. Apart from the IPAB, APAA has also sued the government for the lack of resources with the Copyright Board. We had blogged about that petition over here. 

In other news from APAA, the organization has written to the Controller General of the Patent Office objecting to the proposed fee hike at the Patent Office. We had earlier blogged about the fee hike over here. The communications to the Controller General can be accessed over here and here. In pertinent part, APAA points out how patent applications filing in India have registered much slower growth than in other jurisdictions such as China and Malaysia and cautions that a hike in fees may lead to even those numbers falling. On the e-filing point, the organization informs the Controller General of the American experience with making the switch to the e-filing forms and cautions the IPO about the complexity of making the switch from a physical to electronic format. Another interesting proposition by APAA, is to reduce fees for patent applications filed by research organizations such as CSIR and for all universities. I think that is a great suggestion because as we explained earlier CSIR has been spending a pretty penny on just filing and maintaining its patents without really earning much. It would help if the Government could cut such costs. 

We don’t know of the feedback given by other organizations since the IPO has not made the feedback to the proposed rules public. Hopefully they will do so in the near future.

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London High Court awards damages against an Indian law firm for professional negligence in patent prosecution

In a recent development, first reported by Kian Ganz of Legally India, the London High Court has reportedly entered a default judgment of £100,000 against Fox Mandal in a lawsuit filed by one of its former clients, Lawrence Karat, alleging professional negligence in a patent prosecution being handled by the law firm. The Legally India story can be read over here. 

According to the Legally India report: 

Karat claimed that Fox could not retrieve his case files and a power of attorney was misplaced. A new power of attorney was executed by Karat but was allegedly notarised by Fox in India without Karat physically present, which in his view was illegal.

Furthermore, a “proof of right” deadline was missed in the Mumbai patent office, which could lead to a dismissal of the patent, according to Karat. 

Apparently Fox Mandal did not put in an appearance before the London court, as a result of which the court entered a default judgement. 

It doesn’t give us any pleasure in having to carry this news on the blog but the truth of the matter is that we’ve heard of several cases of missed deadlines in other patent prosecutions and unless IP law firms adopt better docket management techniques we will be hearing of more such law suits.

The case also raises the issue of professional standards and a regulatory body for patent agents in India. Currently there is no procedure to complain against patent agents for possible malpractice. Perhaps the government should propose a mechanism to regulate patent agents. 

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3(d)-ed by IPAB, Monsanto denied patent on method of producing climate-resistant plants

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On July 5, 2013, the IPAB upheld the decision of the Controller against grant of patent to Monsanto Inc. for a method of producing plants which can withstand harsh environmental conditions. Monsanto filed the application in India (2407/DELNP/2006) on May 1, 2006 (priority date of Sept. 29, 2003) for a ‘recombinant DNA molecule for enhancing stress tolerance in plants, recombinant plants and methods thereof’. As is evident from the title, the application initially claimed (a) recombinant DNA (rDNA) molecule encoding a specific cold shock protein (CSP) (b) steps for inserting the rDNA into plant cells and (c) transgenic plants expressing CSP. Later, Monsanto restricted the scope of the application to ‘a method of producing a transgenic plant with increased heat tolerance, salt tolerance, or drug tolerance’. The claims on proteins of the ‘cold shock domain’ responsible for the cold tolerant properties and the resultant stress resistant plants were excluded. 

Nonetheless, the Controller refused registration for lack of inventive step and that the subject matter is ineligible in terms of Sections 3(d) and 3(j). The IPAB concurred with the Controller’s findings on all counts except Section 3(j). 

Summary of the IPAB Order

Although, Monsanto’s claims were limited to the method of producing stress-resistant plants, the IPAB held that the true construct of the application seeks to cover the ‘use’ of cold shock protein for expression of heat, salt and drug tolerant traits. Since the cold tolerant properties of CSPs is known from the prior art, the Board concluded that the patent lacked the inventive step and was ineligible in terms of Section 3(d). Below is the gist of IPAB’s findings: 

(i) Lack of inventive step: The Controller held that the structure and function of cold shock protein responsible for climate resistant is a ‘known’ and hence rejected the claim as obvious. Monsanto argued that that the application of single bacterial gene (i.e. CSP) in developing climate resistant variety was unclear and results were ‘unpredictable’ at the time of the filing (i.e. prior art). Furthermore, the prior art suggested that environmental tolerance ‘is a quantitative trait under the control of many genes’ and hence the invention claimed ‘teaches away’ from the existing science.

The IPAB, however, refused Monsanto’s arguments relying on prior art which demonstrated reasonable degree of predictability in employing CSPs in developing stress-resistant varieties. The Board reaffirmed the Controller findings that: 

the claimed invention is related to production of transgenic plant by transformation with admittedly known cold shock protein. Claims do not define any invention under section 2(1)(ja) of the Patents Act, 1970 as structure and function of cold shock protein was already known in cited prior art and it is obvious to person skilled in plant to make transgenic plant.

(ii) Section 3(d): Monsanto argued that the invention does not claim any ‘new’ use of known substance (i.e. CSP) instead, it submitted that the invention relates to a ‘method’ of producing a ‘new product’ (i.e. stress resistant plants). Further, it adduced post filing data which demonstrate ‘superiority’ of transgenic plants produced using the claimed method vis-à-vis wild plants. 

The Board again rejected the arguments reiterating that the cold tolerant properties of CSPs are already known. The Board rightly concluded that the application in essence claims ‘new use’ of specific proteins from ‘cold shock domain’ for producing desired traits and therefore ineligible under Section 3(d). 

(iii) Section 3(j): Monsanto argued that the production of transgenic variety involves ‘substantial human intervention’ in inserting the rDNA molecule into the plant cell and transforming the cell into climate resistant plant. The Controller, however, rejected the claim on the ground that the invention relates to essential biological process of regeneration and selection and hence ineligible as per Section 3(j). The IPAB agreed with Monsanto’s submission that the plant cell is transformed as a result human intervention in the manner claimed in the application. To this extent, the Controller’s findings were set aside. 

Exaggerated political overtones

Expectedly, the decision attracted reactions from environmental activists who viewed the decision as an end to Monsanto’s monopoly on climate resistant varieties. Some were quick to draw parallels with the Novartis decision of the Supreme Court applauding the IPAB for ‘standing up to corporate greed and domination of the world food supply’. Dr. Vandana Shiva of Navadanya stated that ‘what the Novartis case is to Right to Health, the Monsanto case is to the Right to Food and Farmers Rights to Seed and Livelihoods’. These views in my opinion are a tad bit far-fetched and misleading. 

The IPAB decision on Section 3(d) relies on same reasons that found lack of inventive step. This again raises the issue of whether Section 3(d) is a patentability or patent-eligibility standard, a question which the Supreme Court dodged to provide a categorical answer in the Novartis decision. Be that as it maybe, the IPAB did not look into the patentability of genetically modified organisms (GMOs) that demonstrate improved climatic resistance. Hence, drawing huge conclusions on India's patent regime based on the decision with little clarity on Section 3(d) is far-fetched. Therefore, Monsanto could still obtain a patent on such plant varieties.

Furthermore, the Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPV&FR Act) could offer an alternative to patent protection in this regard. The legislation provides for a sui generis model of protection for ‘extant’ varieties among others. Unlike new and farmer varieties, protection of extant verities need not fulfill the criteria of ‘novelty’ [Sec. 15(1)]. Under the Act, the right holder obtains exclusivity to sell, market, distribute, import and export the registered variety for a limited period.

[Jul. 31, 2013: An error in the earlier draft has been corrected based on Mrinalini Kochupillai's comment. Relevant portion appears as struck-out]

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DIPP refuses CL plea for Herceptin: Health ministry requests Govt to revoke patent in public interest.

In a surprising move,DIPP has taken a decision to refuse grant of CL for anticancer biologic Trastuzumab/Herceptin as reported by Sidhartha of Times of India.

Background:

Earlier in Nov 2012 and again in March 2013 campaign for affordable trastuzumab (an association of patients and NGO’s) had urged the Govt to take appropriate measures to ensure affordability of Herceptin. Subsequently Trastuzumab was recommended for CL by the health ministry. Read our previous posts (here and here).

However after several months of deliberation and debates, the DIPP has refused a plea for CL for Trastuzumab. India, in the recent past has attracted strong criticism from several quarters for taking a pro-patient stand in its patent disputes involving Pharma MNC’s. International scrutiny on India’s IP policies, heightened when India granted its first ever CL against Bayer’s anti-cancer drug Nexavar (read Shamnad’s post here). Ergo, I believe the DIPP must have decided to take it easy with grant of compulsory license.

Prashant makes a very interesting point here; does the DIPP have the right to turn down the recommendations of the health ministry? If the DIPP and health ministry disagree on the grant of CL for Herceptin, the matter should ideally have been directed to the Prime Minister’s office or Cabinet.

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Herceptin patent status:

Apart from platform technology patents, Herceptin is protected by three patents in the US viz. US6339142, US6407213 and US7074404, all of which expire in 2019. In India however, I am aware of only one granted patent relevant to Herceptin IN205534. This patent broadly covers a method of purification where a product molecule must be separated from a very closely related contaminant molecule (acidic variant). I have covered this in detail in this post here.

What next?

Now after refusal of plea for CL, the health ministry has suggested that the government use powers vested with it under section 66 of the Indian Patents Act to revoke the patent in public interest.

Revocation of patent in public interest: Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.

History of Section 66 shows that it has been used only a couple of times to revoke patents. The first instance was when a process patent was granted to Agracetus, a U.S. company, for genetically engineered cotton cell lines. Around the year 1997, this patent was revoked in public interest because it was viewed as being prejudicial to farmers’ rights. The Govt was of the view that Cotton is an important crop essential to national economy and should not be the subject matter of patents.

The other instance was when Indian patent 252093 was granted to Avesthagen for “synergistic ayurvedic/functional food bioactive composition”. The patent covered the composition consisting of jamun, lavangpatti and chandan to be used for treatment of diabetes, which is in effect traditional knowledge (section 3(p) of Indian patent act precludes patenting of traditional knowledge). Thus the patent was revoked as it was deemed to be generally prejudicial to public. Prashant has covered this development extensively in his blog posts here, here and here.

In both instances the patents were revoked either because their working was detrimental to public interest or because they contravened provisions of the Indian patent act. As I see it, Section 66 is a safeguard against patents (detrimental to public interest), which have been inadvertently granted by the patent office. However in this case, the fact that Trastuzumab/Herceptin is exorbitantly priced; can it be construed as being generally prejudicial to public?

CL u/s 92 versus Patent revocation in public interest

Provisions relating to grant of CL u/s 92 require that an interested person should make an application after weighing the benefits conferred by the CL against other costs like payment of reasonable royalties to the patentee, manufacturing costs etc. However these factors need not be considered by a potential biosimilar manufacturer if a patent is revoked u/s 66.

I believe that high price of Herceptin alone is not reason enough for the Govt. to invoke Section 66. It would be unfair to the patentee. Compulsory license would have been a better option in my opinion. Also if DIPP has refused a plea for CL; we wonder whether it will accept a plea for revocation of patent in public interest. It remains to be seen, what stance will be adopted by DIPP regarding this. Interesting times ahead!

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Are Song Titles entitled to IP protection?

Making movie titles from popular song tracks seems to be the latest trend in Bollywood. Off late many movie makers are using super hit song titles to boost a movie’s popularity before its release ( Ye Jawaani hai Diwaani, Ramaiya Vastavaiya, etc.). Clearly, lyricists are not thrilled about this new fad. According to them, movie dialogues and songs in India become a part of the language of the people and sometimes a few lines acquire a huge reputation and strike an instant connect. The popularity of their creation cannot be up for free for the rest of the world to cash on, and the writer community is entitled to credit and royalty from the industry. The problem gets compounded when titles are used liberally on merchandise products which result in huge revenue losses to the producers.

Presently, any producer may register a title with various film associations which function as registered societies. There is no rule mandating the originality of a film title. While lyricists seem to think that stricter copyright enforcement is a solution, the claim to lawful ownership of song titles hardly lies in copyright law. Copyright laws governing cinema in India only extend to songs, movies and books, and the owner can’t claim copyright of the title unless the title is a ‘substantial’ part of the work itself. Use of a song title often creates an association of the title with the original work(song). Therefore, a title may be registered as a trademark. Movie titles have been registered in India since long as trademarks, the cult movie Sholay enjoys trademark protection with respect to its title, brought into the spotlight by this dispute. Quite some time ago, Shamnad Basheer in this post had brought to us an analysis by Manisha Singh of LexOrbis on the issue of copyrightability of film titles with respect to a Delhi HC decision. The Court had held that title of a copyrighted work ( in this case a movie ) cannot enjoy protection under the Copyright Act. It observed that in case of a single copyrighted work, the title must have acquired a secondary meaning to qualify as registrable trademark; and titles of series of films enjoy standard trademark protection.

A trademark registration for a song title in India is unprecedented, however in 2011, Sony Music Entertainment India Pvt. Ltd applied for the registration of the title of its hugely popular song Why This Kolaveri Di ( Application No. 2246257). Sony plans to launch products such as CDs, cassettes and SD cards as well as film and non-film entertainment content and talent discovery programmes branded Why this Kolaveri Di and, more importantly restrict others from using it.

There are some legal issues that would likely apply to trademark protection of song titles: Who would be entitled to the registration of the title (owner of the copyright in the song, or the first person to file for registration of the title). In the case of Why This Kolaveri Di, Sony, the owner of the copyrighted song applied for registration. The application is pending with the Registrar and hopefully we’ll have some clarity on this issue soon. 

Further, a trademark registration lapses if the mark remains unused for five years. Thus, if the applicant has registered the title with the sole purpose of restricting others from using it, and is not interested in using it commercially, the registration may be deemed unfair under the Trade Marks Act, 1999. This INTA article  authored by Jatin Y Trivedi ( IP Attorney at Y J Trivedi and Co.) suggests that it might be appropriate to relax this particular condition for registration in the case of song titles, in order to protect the intellectual property of the song creator. Also, if a title is generic in nature, in theory if it is distinctive or has acquired a secondary meaning in the course of its use as a part of a work, it may be registered as to protect the brand identity. Then, there is also the issue of popular songs sharing a title. For example, Vande Mataram has several popular versions; a trademark registration of the title would preclude artists from giving the song a different creative spin. 

However, trademark registration has been granted to advertisement punch lines, quotations and television commercial jingles. Nike has registered its well known punchline Just do it. The issue of registrability of song titles remains blurry. The practice of using song titles is gaining traction, and there ought to be clarity on the kind of protection that Indian law can offer to remedy infringement of these works.

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Special Report: The Curious case of the "A" Files: Is the truth out there?

The recent $500 million dollar fine against Ranbaxy by the U.S. Government has finally sparked some scrutiny of the Indian drug regulatory process and its highly understaffed drug regulator. This comes close on the heels of two damning Parliamentary committee reports indicting our drug regulatory body for cosying upto industry and neglecting the cause of public health... a cause for which they were allegedly set up in the first place.

Unfortunately for us, the Indian Government continues to be in denial. Both the Commerce Ministry and the Health Ministry, talk of vested interests out to malign India and the need to refrain from knee-jerk reactions against Ranbaxy.  While there may be some truth to this, the government must also make clear that conspiracy theories notwithstanding, they will never compromise on drug regulation. Sadly, no such clear message appears to be forthcoming, leaving one to wonder whether they are serious about drug regulation at all. 

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As we noted on this blog several years ago, tis a tad bit unfortunate that while there is a significant amount of attention paid to “patents” and their impact on public health, there is hardly any attention paid to drug regulation itself. Very surprising, considering that drug regulation has more of a direct nexus to public health than patents. Or perhaps, not so surprising at all, given that drug regulation is one area, where MNCs and generics cosy up to each other. After all, as Chanakya rightly suggests, the enemy of an enemy is a friend (the enemy here being stringent drug regulatory norms, and perhaps price control as well). While patent issues routinely pit MNC’s against generics, drug regulation is less contested between these two behemoths, barring special cases such as the one we bring you below.

This case study is part of a new initiative by SpicyIP to throw more light on India’s drug regulatory framework. In particular, we intend investigating cases that raise serious issues about drug regulation. As always, an advocacy for greater “transparency” will be a large part of this campaign…and as the Learned Judge Brandeis one remarked: Sunshine is the best disinfectant! From a policy perspective, we intend to use these case studies to advocate for effective reform in the drug regulatory space. We sincerely hope that many of our readers will join us in this campaign. We also encourage those of you with inside knowledge to share leads with us, so that we can investigate further. We promise to respect your anonymity. 

The Curious Case of Albupax

Our first case study revolves around Albupax, a biosimilar for treating breast cancer, manufactured by NATCO. About 4 years ago, mainstream media carried several stories about how Abraxis, the US company which manufactured the originator drug – Abraxane, complained to the DCGI about serious safety and efficacy problems with NATCO’s Albupax. Here are links to some of the stories: ToI, ET and Mint. It should also be mentioned that Natco had also won a pre-grant opposition against Abraxane and the same is under appeal before the IPAB.

 The DCGI investigated the issue and tested the samples more than once at CDL (Central Drug Laboratory), Kolkata. Upon finding that the Albupax samples contained excessively high amounts of endotoxins and chloroform, the DCGI suspended NATCO’s manufacturing licence. The DCGI also gave the green signal to the CDSCO (Central Drugs Standard Control Organisation) for initiating criminal proceedings against NATCO for these lethal lapses in drug safety.  For those not in in the know, the CDSCO is a curious organsiation born after recommendations in the Mashelkar committee report, but without any specific statutory basis or parentage. For the moment, suffice it to note that it is an organisation that largely oversees drug regulation and works out more specific norms that could help the DCGI who plays a more direct role in the drug approval process.

Not too surprisingly, Natco appealed the DCGI decision to the Health Minister, Ghulam Nabi Azad. In less than 45 days, the Ministry over-ruled the DCGI’s expert opinion by issuing an interim stay and permitting Natco to market the drug. The entire case is shocking to say the least, because a politician has effectively overturned the reasoned decision of the DCGI, a technical expert to suspend the manufacturing license for a potentially dangerous drug, on what would appear to be flimsy procedural infirmities. What is most surprising is that despite the efflux of 3 years from the date that the Minister gave them a clean chit, Natco has refused to introduce the drug in the market? Why so?

Strangely, mainstream media reported this issue only in bits and pieces and never investigated the issue thoroughly, missing several key aspects, including the investigation of Natco’s manufacturing plant by the CDSCO.

We managed to unearth this murky case history in full, thanks to the power of the RTI.  We’ve narrated this sordid tale in a rather comprehensive report that can be accessed over here,along with links to all relevant case files and reports. We would urge you to wade through this story in full and appreciate for yourself how serious (or otherwise) the government is about drug regulation and protecting public health. 

For those in a rush, here are some salient points that we wish you to mull over.

The Role of Vimta Laboratories?

The CDL tests found that Natco’s product contained high levels of endotoxin and was therefore unsafe. Upon Natco’s insistence CDL tests again and comes up with the same finding. Natco then gets the same samples tested by a certain “Vimta Laboratories”. Not too surprisingly, Vimta finds that Natco’s drug is perfectly safe. Interesting thing about Vimta, is that its name pops up even in the Ranbaxy scandal. Katherine Eban’s, now famous ‘Dirty Medicine’ article in CNN, mentions Vimta Labs’ role as below:

“Back in his office, Kumar handed him a letter from the World Health Organization. It summarized the results of an inspection that WHO had done at Vimta Laboratories, an Indian company that Ranbaxy hired to administer clinical tests of its AIDS medicine. The inspection had focused on anti-retroviral (ARV) drugs that Ranbaxy was selling to the South African government to save the lives of its AIDS-ravaged population. As Thakur read, his jaw dropped. The WHO had uncovered what seemed to the two men to be astonishing fraud. The Vimta tests appeared to be fabricated. Test results from separate patients, which normally would have differed from one another, were identical, as if xeroxed.”

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NATCO Appeal:

Based on the CDL tests (done more than once at Natcos insistence), the DCGI suspends Natco’s manufacturing licence and gives the A.P. CDSCO the green light to prosecute Natco. Natco then appeals to thethe Health Minister Ghulam Nabi Azad who immediately issues a temporary stay of the DCGI’s order on the grounds of alleged procedural irregularities i.e. that NATCO was not given a chance to be heard and also because questions were raised at the authenticity of CDL tests. He also recommends that new samples be tested. The stay was to operate until the appeal was decided.

It is surprising that the Health Minister thought it necessary to even issue a temporary stay, despite the severity of the allegations against NATCO. Why not wait until the samples could be retested – what was the hurry to allow NATCO to re-enter the market? Even more surprising, is NATCO’s ‘thank you’ letter to the DCGI for “revoking the suspension order” and announcing its intention to release the product into the market by March 2010. It is still a mystery as to how the CEO of NATCO interpreted a ‘stay’ as a final disposal instead of a temporary measure pending disposal of the appeal. You can read their letter over here.

In order to decide the final appeal, the Under-Secretary to the Health Ministry wrote to several medical experts to get a better understanding of the issues at hand. One such opinion from an AIIMS doctor clearly warned the Government on the dangers of high endotoxin levels stating that it could cause even death! It can be accessed over here.

At the same time, the Health Ministry also asked the DCGI/CDSCO and the CDL to submit a report on why NATCO was not given a chance to respond before its licence was suspended.

(i) The CDL Response: In a strongly worded response, the Director of the CDL informed the Health Ministry that the lab stood by its tests on NATCO’s product and submitted a unanimous report signed by senior scientists at CDL. This letter can be accessed over here.

(ii) The DCGI Response: In its long reply to the Ministry, dated 6^th January, 2010 and signed by all its members, the CDSCO/DCGI refuted all allegations made by NATCO and informed the Ministry that NATCO was given an opportunity to present its defence at every stage of the process and that the company had simply failed to give any cogent reason for its samples failing the endotoxin test multiple times.

The reply also makes it a point to refer to the inspection report of NATCO’s facilities and it informs the Ministry that NATCO was in “gross non-compliance” of GMPs standards. Apparently, according to guidelines (Guidelines for taking action on samples of Drugs declared spurious or Not of Standard Quality) laid down by the Drugs Consultative Committee, a statutory body under the D&C Act, NATCO’s product would have to be classified as a “Grossly sub-standard drug” and as per these guidelines a prosecution had to be launched in such cases.  The entire DCGI/CDSCO reply can be accessed over here.

The final order: Given that both the DCGI and the CDL defended their orders/tests vigorously and also made clear that NATCO was given an opportunity to present its case, one wonders as to how the Helath Minister could have brazenly overturned the DCGI order of suspending Natco’s licence. Particularly since the drug in question is a very important cancer drug, and any potential toxicity could cause severe health issues including death.

Regardless of the strong defence by the DCGI and CDL, the Health Ministry over-ruled the regulators on the ground that both the initial round and secondary round of testing took place at the same laboratory – CDL, Kolkata; instead of testing the samples at two different laboratories. This is a strange line of reasoning, to put it mildly. The CDL tests were conducted more than once, at Natco’s behest. It is ridiculous to insist on some kind of an alleged “appellate” level testing, when the statutory framework does not provide for such mechanism.  In fact, Sections 25(3) and (4) of the Drugs and Cosmetics Act, 1945 provides for such an appellate framework only in cases where the matter is before a court of law. And even in those cases, it clearly provides that when the first test is done at a Central level lab like CDL, then there is no need to retest at any other lab. The Central lab report would be treated as “final” and there is no need for an “appellate” testing!

It also bears noting that there is no evidence on record that the CDL tests were inherently flawed (in legal parlance, there was no gross error on the face of the record to warrant suspicion). As the CDSCO response more than amply demonstrates, the testing kits and other modes of measurement were in line with the prescribed standards.

The aftermath: Eventually, Natco’s product cleared a third round of testing at CDL. The CDL test reports dated January, 2011 can be accessed over here. After this clean chit from the CDL, the A.P. Office of the CDSCO sought to drop the prosecution against Natco and the Health Ministry gave the decision its stamp of approval. The relevant correspondence can be accessed over here. Thus ended Natco’s legal woes.

Unanswered Questions: Will the Truth Out Itself?

This controversy raises several unanswered questions:

1. Firstly, despite a clean chit by the Health Minister in 2010, why has Natco chosen to keep the drug away from the market? Is this indicative of the fact that Natco is wary of not being able to comply with safety standards? Is this fear of releasing new batches an alleged admission that the earlier batches of Albupax were not “safe”? Or does this have to do with other business considerations? Natco’s representatives have told Mint’s C.H. Unni, in an article published in today's Mint, available over here, that they did not release their version of the drug because of market conditions, which now has three generic players for the very same drug. Natco has claimed that all regulatory issues have been resolved. 

Please do read Unni's article where he questions Natco on why it has dropped its plans to launch Albupax despite winning a patent dispute against Abraxis and getting a clean chit from the government on the regulatory front.

2. Secondly, in Abraxis’s complaint, it listed not 1 but 5 serious defects in Natco’s product. We’ve outlined all 5 defects above – why is it that the DCGI and CDL analysed only endotoxin levels without examining any of the other issues raised by Abraxis. What about the elevated Chloroform levels, deficiency in Albumin levels etc. Why didn’t the DCGI look into any of these issues? The CDL claims that it does not have “recommended instrumental facility” to test for chloroform? Given that this is the premier testing lab, does not cast serious doubts on the infrastructural readiness of India to enable safe drugs in the market for its citizens?

3. Thirdly, how could the Health Ministry (and the Minister directly at that) contravene the statute so blatantly and overrule a decision of the regulator? Especially when the drug is a cancer drug and the biosimlar version allegedly contains high level of toxicities.

4. And lastly, the larger question is how and why the DCGI failed to detect these defects before the complaint from Abraxis? Should there not be effective post marketing surveillance and a push to mandatory comply with this requirement? Further, if this is a new drug, how was NATCO given permission to market in 2008, barely a year after the innovator company was granted permission? And on what basis was the biosimilar approved? What were the norms then? Did the DCGI merely look at bio-equivalence or did it insist on something more, as it is commonly acknowledged that mere bio-equivalence confirmation does not work for biosimilars in order to guarantee their safety and efficacy.

If the truth is out there, one hopes that it will certainly out in the days to come. If not, this will be yet another sad burial, as have most other drug regulatory lapses in the past.

Conclusion

This case study highlights the cavalier manner in which the government deals with drug regulation. In any other jurisdiction, it would be unthinkable for a politician to overrule a reasoned decision of the regulator in blatant violation of the statutory framework.

The governments’ message to drug companies seems to be thus: we’re perfectly okay if you play around with public health by releasing highly toxic drugs in the market. We’ll simply ask you to recall existing batches. You can then manufacture fresh batches without the toxic impurity and release them on the market, and we’ll forget it ever happened. No liability will ever attach to you despite the fact that your drug cost the lives of Indian citizens!

Fear of Free Speech

In the interests of full disclosure, it must be stated that Shamnad was sued for defamation by NATCO in the past for pointing out that Natco lied to a court of law in the famous Dasatinib case. For those interested, here is a Legally India article that links to the pleadings including Shamnad's defence to this high handed corporate bullying. Given Natco’s intolerance to free speech, one might expect them to hit us with another SLAPP suit  here as well. Only time will tell! 

By Prashant Reddy, Shamnad Basheer and Sai Vinod

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IPAB directs removal of AYUR from the Registry

The IPAB, disposing four miscellaneous petitions in M/s. ITC Ltd v. M/s. Three-N Products Pvt Ltd (dated 28 June 2013) concerning goods in the classes 29 - 32, ordered for the removal of the mark “AYUR” from the Registry. Coming down heavily on the Registrar, the Order noted as follows: “18. It is indeed unfortunate that the Registrar who registered the first mark AYUR for the respondent, had not endorsed that the respondent will not have an exclusive right to AYUR. If he had done that, the respondent may have come up with modifications. Further, with such a registration, the respondent would not have ventured to launch an attack on anyone who ‘dared’ to use AYUR anywhere in their marks. If the respondent had not attacked others and had dealt with the mark as a label mark, claiming no exclusive right to the letters A, Y, U & R perhaps this mark would not have been challenged. The Registrars who are vested with the important duty of deciding which marks are registrable should make their decision wisely and correctly. We doubt if anyone in India can plead ignorance of the meaning of the words Ayu or Ayur. It is very unfortunate that by casually granting this registration, the Registrar has generated unwarranted litigation.” 

Facts and Arguments 

The applicant obtained registration for the marks "AYURVIBHA", "AYURUVAR" and "AYURBHO". In May 2004, the respondent instituted C.S. No. 124/2004 in the Hon'ble Calcutta High Court for restraining the applicant from using the above marks “or any other marks with the word "AYUR" as a prefix or suffix.” On 10th June, 2004, ex parte injunction was granted against the applicant. On knowing that the respondent had obtained registration for the trade mark "AYUR" in class 29, 30, 31 and 32 in Nos. 536257B to 536260B respectively, the applicant filed the petitions for rectification. 

The applicant contended that “AYUR” per se is generic. It is neither distinctive nor inherently capable of distinguishing the respondent’s goods. Further, the mark “AYUR” is not a well-known mark. It was submitted that the claim to a well-known mark must be proved by the production of evidence to satisfy the Court that the mark is a well-known mark 

The respondent filed his counter statement claiming that they had been engaged in the manufacture of cosmetic products, ayurvedic formulas, body case and health care products since 1984 under the trade mark "AYUR". According to the respondent, the trade mark "AYUR" is an invented word as there was no other mark "AYUR" when the respondent adopted the mark. Further, it was contended that the mark is a well-known mark. 

Order ("Instant Order") 

IPAB considered the High Court judgments which held that "AYU" and "AYUR" cannot be said to be invented words. [We blogged on the Calcutta High Court judgment in Three-N Products v. Emami Ltd here.] IPAB also considered its earlier Order (TRA/138/2004/TM/DEL - IPAB Order No. 117 of 2012) in Hindustan Unilever Ltd v. M/s. Three – N Products (P) Ltd and Anr concerning Classes 3 and 5. IPAB noted that “We had held there that Ayur is a generic word and in public interest, it cannot be monopolized by anyone. We had held in that case that in public interest the respondent cannot be allowed to monopolise the words Ayu and Ayur. Ayush, in fact, is a Department of the Government under the Ministry of Health, exclusively devoted to alternative medicine and systems (Ayurveda, Unani, Sidha and Homeopathy). The words Ayu or Ayur cannot claim to have acquired secondary significance when there are so many traditional connotations signifying healthy long life, etc." IPAB re-affirmed the aforesaid position in the Instant Order. 

IPAB made some significant remarks regarding well-known marks. In the context of Section 11(8) of Trade Marks Act, 1999 ("Where a trade mark has been determined to be well-known in at least one relevant section of the public in India by any Court or Registrar, the Registrar shall consider that trade mark as a well-known trade mark for registration under this Act."), it was held that a reference or an observation in an interlocutory application by a Court will not amount to a determination under S. 11(8). Further, “the well known label cannot be granted for the asking. There must be strong evidence to prove the case of the person claiming that his mark is a well-known mark….Therefore, the determination that the mark is well known will be arrived at only on strong and unimpeachable evidence that the mark is in fact a well known mark.” 

The respondent offered to modify the impugned mark. Terming the aforesaid gesture as a late concession, the IPAB rejected it. The rectification petitions were, therefore, allowed. 

Comments 

I had earlier blogged on IPAB order in M/s. Three-N-Products Pvt. Ltd v. M/s. Alex Resorts and Hotels Pvt. Ltd. In the aforesaid Order, IPAB affirmed the removal of the mark “AYUR” while deciding on an appeal against the impugned Order of the Registry granting registration for the trademark “AYURTHEERAM” in favour of the respondent for the services “Ayurveda Hospital and Resorts” (included in Class 42) subject to confining the services in the States of Kerala and Karnataka. 

I agree with the position laid down by IPAB. In fact, the conclusion arrived at the Instant Order in M/s. ITC Ltd v. M/s. Three-N Products Pvt Ltd could have been predicted in the aftermath of IPAB order in M/s. Three-N-Products Pvt. Ltd v. M/s. Alex Resorts and Hotels Pvt. Ltd (dated 18 May 2012). As I had earlier stated in my post on Ayur, the Sanskrit word “AYUR” means ‘giving life’ or ‘giving longevity’. It is well-settled that a dictionary word cannot be registered as a trade mark unless it has acquired a distinctive character. The generic name of a product cannot function as a trademark. An acronym of a generic name, which still conveys the original generic connotation of the abbreviated name, is generic. Even misspelt generic name is generic if it does not change the generic significance to the buyer [Mc.Carthy on Trade Marks and Unfair Competition (Third Edn. Vol 2) cited by Delhi HC in S.B.L Ltd v. Himalaya Drug Co. AIR 1998 Del 126]. Considering this legal position, the mark "AYUR" in case of other classes of goods may also face a similar fate (if challenged). 

The Instant Order also serves as a stern warning to the Registry. In fact, the Instant Order went to the extent of saying that the casual grant of registration by the Registry resulted in an unwarranted litigation. Hopefully, this stern warning will preclude any further mindless grant of registrations.

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Reason should underpin stronger India-US ties and not rhetoric: Mr. Chidambaram at the USIBC leadership summit

In the past week, Union Finance Minister P. Chidambaram addressed corporate leaders, officials and senior leadership from the American Government at the 38th US-India Business Council Leadership Summit. Mr. Chidambaram particularly addressed the allegations of American companies that a strong protectionist regime exists in India especially in the arena of patent protection. The Union Finance Minister attributed these allegations to the "growing challenge" posed by Indian companies to US businesses in these areas. While recognizing that business interests of firms in both countries may occasionally collide, Mr. Chidambaram stressed on the importance of avoiding a confusion between rhetoric and reason and stated that the difference in business interests must not be made into a political issue. 

Mr. Chidambaram also clarified the reasons for the allegations of American companies being largely rhetoric. The Union Finance Minister pointed out how only one compulsory license has been granted in India as of now while other countries including the US itself had licensed one or more drugs. In such a situation, he argued that it was unreasonable for the Indian patent protection to be singled out especially since the compulsory licensing was upheld on judicial review on the three required grounds: non-availability of the drug in sufficient quantities in India, non-affordability of the drug and the non-workability of the patent in India. In any event, Mr. Chidambaram noted that the WTO was a forum that the American Government could approach if they had qualms about the Indian Government's decision and that it was a better method than "needlessly heating up the rhetoric." He also clarified that the Indian Government had little control over patent infringements that happen in India and in the event of such infringement, the judicial system could be approached where the observed trend is largely in favour of granting injunctions.

Indian officials are of the view that some degree of understanding is present between the attendees on both sides. However, it must be noted that only five of the 180 lawmakers who authored the letter to US President Obama criticizing the Indian IP regime attended the Summit. This letter and the testimony, which among other factors that led to this letter has been analysed in detail  by Swaraj here and here. Readers can also look out for Swaraj's next post in which he promises to expose more empty rhetoric from the US!

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Ghost Post: Performance under Copyright Act restricted to live performance?

A practising lawyer sent me this very interesting ghost post on a possible conflict, in the scope of performance rights, between the Copyright (Amendment) Act, 2012 and the Copyright Rules, 2013. The lawyer in question has preferred to remain anonymous. I think the post raises some interesting issues for debate. I don't think the issue has been raised in any of the constitutional challenges but I'm guessing it should crop up soon enough. 

Performance under Copyright Act restricted to live performance?

While the infirmities in the amendment to the Copyright Act and Rules continue to be debated and challenged, the amendments with respect to the performer’s rights seem to have attracted relatively less attention.

It would be interesting to highlight few inconsistencies in the amendments pertaining to performer’s rights.

Section 2 (q) of the Copyright Act defines "performance” in relation to performer's right to mean any visual or acoustic presentation made live by one or more performers;

Section 38 A (2) categorically provides that once a performer has, by written agreement, consented to the incorporation of his performance in a cinematograph film he shall not be entitled to object to the enjoyment by the producer of the film, including his performance in the same film.  However, the proviso to Section 38 A (2) provides that the performers’ entitlement to receive royalties is only in case of the performances being made for commercial use.

Interestingly, while the Copyright Act fails to clarify what construes to be “commercial use”, the explanations to Rule 68 of the Copyright Rules, 2013 clarify three things:

1)  The royalty collected from enjoyment of the performer’s right in (i) to (v) of clause (a) of sub section (1) and proviso to sub.-section (2) of Section 38 A, shall be shared equally between the performer and other owner of copyright

2) Commercial use as mentioned in proviso to sub-section (2) of Section 38 A, means the exploitation of the performers right by way of reproduction , issue of copies or distribution, communication to public including broadcasting and commercial rental of the cinematograph film.

3)  Performance includes recording of visual or acoustic presentation of a performer in the sound and visual records in the studio or otherwise.”

It can thus be seen that Explanation 3 to Rule 68 has not only expanded the scope of the term “performance” but is clearly inconsistent with the definition of performance provided under Section 2 (q) of Copyright Act. While the Act limited the definition to “live performances” i.e. performances which are not pre-recorded, the Rules have gone ahead and included within its scope pre-recorded performances. What constitutes “live performance” has been a debatable issue which was briefly addressed in the case of Neha Bhasin vs Anand Raj Anand [2006 (32) PTC 779 Del] wherein the Delhi High Court observed that “Every performance has to be live in the first instance whether it is before an audience or in a studio. If this performance is recorded and thereafter exploited without the permission of the performer then the performer's right is infringed.”  In that sense, Explanation 3 to Rule 68 could be in conformity with Delhi HC’s interpretation of live performance, but clearly ultra vires its parent Act.

Impact:On a harmonious reading of Section 39 A, Section 18 and 19 of the Copyright Amendment Act, 2012, one could conclude that the performers are entitled to non assignable rights to receive royalties for every performance for commercial use. If the exclusive rights granted to the performers are not restricted to merely live performances, then by virtue of Explanation 2 to Rule 68, every time a performance is reproduced, distributed, communicated to the public or commercially rented, it would attract royalties for the performers. In effect, every time a movie is telecast, a song played (as a whole or in parts), the performers which would include an actor, singer, musician, dancer, acrobat, juggler, conjurer, snake charmer, a person delivering a lecture or any other person who makes a performance (except extras i.e. a person whose performance is casual or incidental in nature), would be entitled to non assignable royalties.

It would be interesting to see the implementation of these amendments and the disbursement of royalties to the performers.

Another practising lawyer writes in with the following comments: 

I've read your blog on performer's rights with interest.  There is indeed ambiguity about the meaning of a "live" as distinct from a "studio" performance. 

However, the short point I want to make is that Section 39A can't apply to  the third  proviso to Section 18 which is specifically limited to literary and musical works.  If they had extended to all copyrighted works, then there would have been a case to apply Section 39A.  But Section 18 does not even apply to all copyrighted works that may be included in a film, like dramatic works—screenplay and choreography—and artistic works, including photography which is so basic to the film, and set design. Therefore Section 39A simply cannot apply here, being specifically excluded along with many copyrighted works.

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Composers & Lyricists hold a ‘flop’ of a news-conference: Crying wolf, once too often?

The composers and lyricists of Bollywood held a press-conference last week, complaining once again about music companies trying to cheat them of their dues and of the attempts being made to circumvent the copyright amendments. (You can see the conference over here) This was the same story before the amendments and frankly, it is getting a little tiring to hear the same old complaints from Akhtar & Co. a whole year after Akhtar promised Parliament that they were enacting a law that would correct a historic injustice against the composers and lyricists of the Indian music industry. If things continue at this rate, the composers and lyricists runs the risk of being perceived as the ‘boy who cried wolf’ once too often.

I specifically use the word ‘flop’ because the news-conference was not covered by anybody from the mainstream media and almost nobody from the trade magazines.

'The boy who cried wolf'. Image from here

A part of the reason for this flop performance was the super-technical narration of events by Sanjay Tandon & Javed Akhtar, without providing any worthwhile information. After a life-time in Bollywood, you would expect Akhtar & Tandon to have learnt the basics of a good story: first you need a villain & second in this age of scams galore, you need to give journalists a figure of the money involved. Although Sony does get a brief mention in the context of the post amendment negotiations, there isn’t a squeak from anybody in the news conference about the main players in the fiasco that is IPRS. As for the exact amount of money involved in the scam, Akhtar was specifically asked by a journalist of an estimate of the unpaid royalties, to which Akhtar replied saying that he didn’t know the sum involved since he had no idea how much IPRS was earning. But the earnings of IPRS, PPL and Select Media are public knowledge. With such little information being put into the public domain, it is no surprise that Milind Shrivastav’s resignation from IPRS got more coverage than the press-conference by Akhtar & Co.  

In the circumstances, I would advise the composers and lyricists to recruit themselves a PR agency.

Throughout his conference, Akhtar makes the occasional plea to the government to enforce the new law – surely he knows that it is up to the Courts and not the government to enforce this law – composers and lyricists have to start litigating their rights – case law has to be created – precedents have to be set – that is the way our judicial system works. The angels of the law aren’t going to waltz into Mumbai and change the minds of the fat cats running the music industry. As for the affairs at IPRS, the composers and lyricists should know that if the Central Government has not intervened in the last 9 years to rectify the situation – they are not about to step in now to set things rights. There is also the question of what the composers and lyricists have done to set things right at IPRS – as things exist today, the music labels, have on paper, taken over IPRS, as per the law and none of their acts have been challenged in court by the composers or lyricists. If a majority of composers and lyricists are being screwed over by IPRS, why have they not filed a petition for oppression and mis-management before the Company Law Board (CLB)? If I’m not mistaken, the law in India requires a one/fifth of the entire membership of a company, without share capital, to sign on to such a petition. Even presuming that the numbers weren’t available, what is preventing the composers and lyricists from filing a shareholder derivative suit, much the way that Saregama did before the Barasat Civil Court? If Akhtar & Co. haven’t got royalties from IPRS, why have they not filed civil suits for a breach of contract?

This refusal to exercise their rights before the judiciary gives rise to suspicions of whether there are in fact any rights which can be enforced before the judiciary. Instead Akhtar makes an open appeal, in the news-conference, for the government to intervene. It is necessary to understand that IPRS is first and foremost a company under the Companies Act, 1956 – if the Board of IPRS so wishes it can pass a resolution seeking to annul its effort to be registered as a copyright society – what is the Government going to do then, under the Copyright Act? The answer is nothing.

Like god, the law helps only those who help themselves – its time the composers and lyricists woke up and smelt the coffee. Things are the same one year down the line after the amendments and nothing has changed.

Why is that so?

Ask the right questions to get the right answers.

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SpicyIP Announcement: 4th IUCIPRS Annual National Workshop on Rethinking Intellectual Property Rights (2014)

The Inter University Centre for IPR Studies in association with MHRD Chair on IPR at Cochin University of Science and Technology (CUSAT) has announced the fourth edition of its annual national workshop for law students, 'Rethinking Intellectual Property'. The workshop will focus on 'Copyright Issues in the Entertainment Industry' and will be held from January 16 to 18, 2014. The workshop is open to all undergraduate and post-graduate students of law keen on developing a research paper on any of the workshop's sub-themes (see below). Interested students have to submit an abstract (of max. 350 words) on any of the sub-themes by July 31, 2013 and final papers by October 5, 2013. For more about the workshop and registration process, see the announcement below or visit here: 

Objectives of the Annual Workshop: Rethinking IP is an annual national level workshop for law students organized by the IUCIPRS in association with the MHRD Chair on IPR, CUSAT to initiate critical thinking regarding the role of Intellectual Property Rights in a social context. The pedagogical practice existing among the Law Schools in India predominantly approaches IP from a commercial angle, often ignoring the social implications of IP. The main objective of Intellectual Property law is to maintain a correct balance between protection of IP and providing access to the public to the modern technology and its benefits. The western approach of looking at IP as a catalyst for development is being followed by our law schools without being interrogated. Our experience with the western approach signifies that it stifles innovation and research and creates barriers in the enjoyment of benefits by the public. The question therefore is should India imitate the western practices, both statutory and judicial, or whether we should evolve our own jurisprudence of IP reflecting wider questions of national development and the welfare of people.  

About theme of 2014: The advent of digital technology and the consequent explosion in the information and communication technology has brought out sweeping changes in the access and distribution of copyrighted content. For copyright owners, it exposed new avenues of exploitation of copyrighted works and at the same time it brought in serious challenges in enforcing the copyright. Interests of different stakeholders belonging to the diverse sectors of entertainment industry such as film, broadcast and music industries are being drastically affected by the emergence of new technologies. Today’s copyright domain is featured with the copyright owners resorting to extension of the scope of copyright to the technological measures protecting the content from unauthorised access. Owners of copyright and related right holders, especially in the entertainment industry, demand for greater protection of their rights in the digital context. The challenges faced by different sectors of entertainment industry, authors, performers and other related right holders, along with the issue of access to copyrighted materials in the more beneficial environment created by the digital technology are the serious issues faced by the copyright law in the digital era. In this changed environment, India had amended its copyright law in 2012 to provide solutions to the troubled copyright platform. The theme of 2014 addresses the copyright issues in the entertainment industry in the wake of new technologies, and the solutions offered by the Indian copyright law to such challenges, meticulously attempting not to compromise access right to users. 

The programme includes lectures, invited talks, case studies, corner discussions, students’ presentations, exercises, scenario analysis, role play, field exposure etc. 

The sub-themes are

1. Challenges faced by the film and music industries in the digital era. 
2. Entertainment industry and the triangular relation among author, owner and user
3. Role of collecting societies in ensuring a balanced copyright system 
4. Enforcement issues in the entertainment industry.
5. Digitization and challenges to legitimate access to copyrighted contents to the public
6. Internet file sharing and challenges to entertainment industry

Registration: Law students (undergraduate and post graduate only) willing to prepare a paper on any of the subthemes could apply. The sessions of the workshop are designed in a manner reflecting the concerns of the entertainment industry as well as the public. So students are urged to prepare papers accordingly so that each session will comprise of two student presentations representing the conflicting interests. Each student is allowed to register by sending an abstract (maximum 350 words) on one or two themes on or before 31st July 2013. Based on the title and abstracts submitted by the students as approved by IUCIPRS, the subthemes will be allocated to the students. We encourage original single author papers, though joint submissions with a maximum of two authors are also permissible.  

Selection: After the allocation of subthemes, each student is required to submit the full paper on or before 5th October 2013. Selection to the workshop shall be based on the quality of the paper submitted. To ensure quality, students on each theme will be linked to the resource person of the concerned theme; and based on his/her suggestions, each student has to revise the full paper. Last date for submission of revised full paper shall be 3rd November 2013. Two best papers on each theme representing conflicting views will be selected for student presentations and the announcement of final selection will be made on 15th November 2013. Total number of participants is limited to 40. All selected students will have to take an active role in the workshop by way of exercises such as mock moots, role plays, parliamentary debates etc. Exercises form an important part of the workshop where critical issues in the subthemes get highlighted. Exercises on each subtheme with the names of the allotted students will be posted in the website during the month of December 2013. The participants are required to do the exercises during the concerned sessions.  

Awards/ Certificates: Two best papers will be published in the Journal of WIPO/ Journal of Intellectual Property Rights/ Cochin University Law Review. The best two participants who perform well in the exercise will be given the opportunity to do their one month internship with the IUCIPRS. 

For registration and more details, visit http://ciprs.cusat.ac.in

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