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Archives for : Intellectual property

Drug Patent Rights India Wins First Round Novartis Full Text of Judgement

 

The instances of Multinationals stealing indigenous medicines is well-known.

So are the capricious overpricing of life saving Drugs, like Cancer Drugs.

The Intellectual Property Appellate Board rejected the German drug maker’s appeal of the 2012 ruling on Monday. It also ruled that under the license Natco must pay 7 per cent in royalties on net sales to Bayer.

Bayer sells a one month supply of the drug for about $5,600. Natco’s version would cost Indian patients $175 a month, less than 1/30th as much.

Western pharmaceutical companies have been pushing for stronger patent protections inIndia to regulate the country’s $26 billion US generics industry, which they say frequently flouts intellectual property rights. However, health activists and aid groups counter that Indian generics are a lifesaver for patients in poor countries who cannot afford Western prices to treat diseases such as cancer, malaria and HIV.’

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

India drew first blood in a Patent case in The Supreme Court .

DOWNLOAD FULL JUDGEMENT

‘People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while…

Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court.

Cost of Glivec used for targeted therapy in CML patients: 1 lakh per month (approx)

Cost of its generic versions : 8,000 -10 ,000 per month

No. of cancer centres in India: 450 approx (half are in the private sector)


The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.

Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, which is made by Novartis. It is spelled Glivec in Europe and elsewhere. The drug provides such effective treatment for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time. The ruling will also help India maintain its role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against deadly diseases. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.

The ruling comes at a challenging time for the pharmaceutical industry, which is increasingly looking to emerging markets to compensate for lackluster drug sales in the United States and Europe. At the same time, it is facing other challenges to its patent protections in countries like Argentina, the Philippines, Thailand and Brazil.

“I think other countries will now be looking at India and saying, ‘Well, hold on a minute — India stuck to its guns,’ ” said Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group based in New York that works on patent cases to foster access to drugs.

In trade agreements — including one being negotiated between the United States and countries in the Pacific Rim — the drug industry has lobbied for stricter patent restrictions that would more closely resemble protections in the United States.

 

  • #India- SC rejects Novartis’s patent plea for cancer drug Glivec #goodnews (kractivist.wordpress.com)

 

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Delhi HC judgement -Super Cassettes v. MySpace #copyright

The Delhi High Court’s judgment in Super Cassettes v. MySpace last July is worrying for a number of reasons. The court failed to appreciate the working of intermediaries online and disregard all pragmatic considerations involved. The consequences for free expression and particularly for file sharing by users of services online are especially unfavourable.

The judgment[*]is extremely worrying since it holds MySpace liable for copyright infringement, despite it having shown that it did not know, and could not have known, about each instance of infringement; that it removed each instance of alleged infringement upon mere complaint; that it asked Super Cassettes to submit their songs to their song identification database and Super Cassettes didn’t.

This, in essence, means, that all ‘social media services’ in which there is even a potential for copyright infringement (such as YouTube, Facebook, Twitter, etc.) are now faced with a choice of either braving lawsuits for activities of their users that they have no control over — they can at best respond to takedown requests after the infringing material has already been put up — or to wind down their operations in India.

The Facts

Aside from social networking, MySpace facilitates the sharing of content between its users. This case concerns content (whose copyright vested in T-Series) was uploaded by users to MySpace’s website. It appears that tensions between MySpace and T-Series arose in 2007, when T-Series entered into talks with MySpace to grant it licenses in its copyrighted content, while MySpace asked instead that T-Series register with its rights management programme. Neither the license nor the registration came about, and the infringing material continued to be available on the MySpace website.

Specifically, T-Series alleged that cases for primary infringement under section 51(a)(i) of the Copyright Act as well as secondary infringement under section 51 (a) (ii) could be made out. Alleging that MySpace had infringed its copyrights and so affected its earnings in royalties, T-Series approached the Delhi High Court and filed a suit seeking injunctive relief and damages. In proceedings for interim relief while the suit was pending, the court granted an injunction, but, in an appeal by MySpace, added the qualification that the content would have to be taken down only on receipt of a specific catalogue of infringing works available on MySpace, rather than a general list of works in which T-Series held a copyright.

The Defence

While other arguments such as one around the jurisdiction of the court were also raised, the central issues are listed below:

  1. Non-Specificity of Prayer
    T-Series’ claim in the suit is for a blanket injunction on copyrighted content on the MySpace website. This imposes a clearly untenable, even impossible, burden for intermediaries to comply with.
  2. Knowledge
    MySpace argued that no liability could accrue to it on two counts. The first was that it had no actual or direct knowledge or role in the selection of the content, while the second was that no control was exercised, or was exercisable over the uploading of the content. Additionally, there was no possible means by which it could have identified the offending content and segregated it from lawful content, or monitored all of the content that it serves as a platform for.
  3. Intermediary status and Safe Harbour Protection
    In relation to its status as an intermediary, MySpace raised several arguments. First, it argued that it had immunity under section 79 of the IT Act and under the US Digital Millennium Copyright Act (US DMCA). Another argument restated what is arguably the most basic tenet of intermediary liability that merely providing the platform by which infringement could occur cannot amount to infringement. In other words, the mere act of facilitating expression over internet does not amount to infringement. It then made reference to its terms of use and its institution of safeguards (in the form of a hash filter, a rights management tool and a system of take-down–stay-down), which it argued clearly reflect an intention to discourage or else address cases of infringement as they arise. MySpace also emphasized that a US DMCA compliant procedure was in place, although T-Series countered that the notice and take down system would not mitigate the infringement.
  4. Relationship between MySpace and its Users
    Taking from previous arguments about a lack of control and its status as an intermediary, MySpace argued that it was simply a licensee of users who uploaded content. The license is limited, in that MySpace is only allowed to alter user-generated content so as to make it viewable.

Outcomes

  1. Infringement by Facilitation
    The court concluded that infringement in terms of section 51 (a) (ii) had occurred in this case, since web space is a “place” in the terms required by the section and there were monetary gains in the form of ad revenue. The argument as to a lack of knowledge of infringement was also rejected on the ground that MySpace’s provision for safeguards against infringement clearly established a reason to believe that infringement will occur. Also referenced as evidence of knowledge, or at least a reason to believe infringement would occur, is the fact that MySpace modifies the format of the content before making it available on its website. It also tested for infringement by authorization in terms of section 14 read with section 51 (a) (i), but concluded that this did not arise here.
  2. Reading away section 79?
    The court accepted the argument made by T-Series to the effect that sections 79 and 81 of the IT Act must be read together. Since section 79 would be overridden by section 81’s non-obstante, the effect would be that rights holders’ interests under the Copyright Act will erode intermediaries’ immunity under section 79.
  3. Due Diligence
    The court rejected the argument that the provision of due diligence or curative measures post-infringement would be sufficient. Specifically, the contention that the quantum of content being uploaded precludes close scrutiny, given the amount of labour that would be involved, was rejected. Content should not immediately be made available but must be subject to enquiries as to its title or to authentication of its proprietor before it is made available. In fact, it holds that, “there is no reason to axiomatically make each and every work available to the public solely because user has supplied them unless the defendants are so sure that it is not infringement.” (Paragraph 88).

There is also an attempt to distinguish the Indian framework from the DMCA. While that law calls for post-infringement measures, it is argued that in India, on reading section 51 with section 55, the focus is on preventing infringement at the threshold. In response to the case that it would be impossible to do so, the court held that since the process here requires MySpace to modify the format of content uploaded to it to make it viewable, it will have a reasonable opportunity to test for infringement.

Analysis

Accounting for the Medium of Communication

The court’s analysis of the issues begins with a predictable emphasis on how the law of copyright would operate in the context of what is termed “internet computing”, peppered with trite statements about “the virtual world of internet” creating “complexit[ies]” for copyright law. The court appears to have entered into this discussion to establish that the notion of place in section 51 (a) (ii) should extend to “web space” but the statements made here only serve to contrast starkly against its subsequent failure to account for the peculiarities of form and function of intermediaries online. Had this line of argument been taken to its logical conclusion, after the character of the medium had been appreciated, the court’s final conclusion, that MySpace is liable for copyright infringement, would have been an impossible one to arrive at.

And What of Free Speech?

As it had argued before the court, intermediaries such as MySpace have no means by which to determine whether content is illegal (whether by reason of amounting to a violation of copyright, or otherwise) until content is uploaded. In other words, there is no existing mechanism by which this determination can be made at the threshold, before posting.

The court does not engage with the larger consequences for such a scheme of penalizing intermediaries. Censoring patent illegalities at the threshold, even if that were possible is one thing. The precedent that the court creates here is quite another. Given the general difficulty in conclusively establishing whether there is an infringement at all due to the complexities in applying the exceptions contained under section 52, it should not be for ordinary private or commercial interests such as intermediaries to sit in judgment over whether content is or is not published at all. In order to minimize its own liability, the likelihood of legitimate content being censored by the intermediary prior to posting is high.

The consequences for civil liberties, and free speech and expression online in particular, appear to have been completely ignored in favour of rights holders’ commercial interests.

Consequences for Intermediary Liability and Safe Harbour Protection

Even if every instance in question did amount to an infringement of copyright and a mechanism did exist allowing for removal of content, the effect of this judgment is to create a strict liability regime for intermediaries.

In other words, the court’s ruling will have the effect that courts’ determination of intermediaries’ liability will become detached from whether or not any fault can be attributed to them. MySpace did make this argument, even going as far as to suggest that doing so would impose strict liability on intermediaries. This would lead to an unprecedented and entirely unjustifiable result. In spite the fact that a given intermediary did apply all available means to prevent the publication of potentially infringing content, it would remain potentially liable for any illegality in the content, even though the illegality could not have been detected or addressed.

What is perhaps even more worrying is that MySpace’s attempt at proactively and in good faith preventing copyright infringement through its terms of use and in addressing them through its post-infringement measures was explicitly cited as evidence of  knowledge of and control over the uploading of copyrighted material, at the threshold rather than ex post. This creates perverse incentives for the intermediary to ignore infringement, to the detriment of rights holders, rather than act proactively to minimize its incidence.

A final observation is that the court’s use, while pronouncing on relief, of the fact that MySpace makes a “copy” of the uploaded content by converting it into a format that could subsequently be hosted on the site and made accessible to show evidence of infringement and impose liability upon MySpace in itself is a glaring instance of the disingenuous reasoning the court employs throughout the case. There is another problem with the amended section 79, which waives immunity where the intermediary “modifies” material. That term is vague and overreaches, as it does here: altering formats to make content compatible with a given platform is not comparable to choices as to the content of speech or expression, but the reading is tenable under section 79 as it stands.

The result of all of this is to dislodge the section 79 immunity that accrues to intermediaries and replace that with a presumption that they are liable, rather than not, for any illegality in the content that they passively host.

Effect of the Copyright (Amendment) Act, 2012

Since the judgment in the MySpace case, the Copyright Act has been amended to include some provisions that would bear on online service providers and on intermediaries’ liability for hosting infringing content, in particular. Section 52 (1) (b) of the amended Act provides that “transient or incidental storage of a work or performance purely in the technical process of electronic transmission or communication to the public” would not infringe copyright. The other material provision is section 52 (1) (c) which provides that “transient or incidental storage of a work or performance for the purpose of providing electronic links, access or integration, where such links, access or integration has not been expressly prohibited by the right holder, unless the person responsible is aware or has reasonable grounds for believing that such storage is of an infringing copy” will not constitute an infringement of copyright. The latter provision appears to institute a rather rudimentary, and very arguably incomplete, system of notice and takedown by way of a proviso. This requires intermediaries to takedown content on written complaint from copyright owners for a period of 21 days or until a competent rules on the matter whichever is sooner, and restore access to the content once that time period lapses, if there is no court order to sustain it beyond that period.

This post does not account for the effect that these provisions could have had on the case, but it is already clear, from the sloppy drafting of section 52 (1) (c) and its proviso that they are not entirely salutary even at the outset. At any rate, there appears to be nothing that *determinatively* affects intermediaries’ secondary liability, i.e., their liability for users’ infringing acts.


Disclosure: CIS is now a party to these proceedings at the Delhi High Court. This is a purely academic critique, and should not be seen to have any prejudice to the arguments we will make there.


[*]. Super Cassettes Industries Ltd. v. MySpace Inc. and Another, on 29 July, 2011, Indian Kanoon – Search engine for Indian Law. See http://bit.ly/quj6JW, last accessed on October 31, 201

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Immediate Release- Patients succeed in overturning first ever product patent on medicine in India #goodnews

Hope for hep-C patients:

Context and Background 

Today, the Bench of Intellectual Property Appellate Board, comprising Justice Prabha Sridevan (Chairperson) and Mr DPS Parmar (Technical Member), set aside the first ever product patent on a medicine granted in India to Roche for Pegasys (a medicine used to treat Hepatitis C) on an appeal filed by a patients’ group. 

In 2005, to comply with its international trade obligations, India re-introduced a system of granting product patents on medicines. In 1970, it had changed its patent law to disallow such patents precisely because they had resulted in high prices of medicines in India. This was the first product patent granted under the amended 2005 patent law.

As you know, a product patent on a medicine allows the patentee to prevent others from making or selling the medicine. This means that the patentee is able to set monopolistic prices. In the case of Pegasys, Roche charges approximately INR 4,36,000 for a course of six-months’ treatment. There may also be a relapse in which case the treatment course will have to repeated.

The Indian patent law provides for several tiers of protection to ensure that only genuine inventions are protected by patents. For instance, it allows “any person” to file an opposition challenging its grant. This could prevent a patent from being wrongfully granted in the first place. If a patent is granted, it can still be challenged by a “person interested” in a post-grant opposition or in a revocation proceeding. 

The order delivered by Justice Prabha Sridevan is important for several reasons. 

Sankalp, a patients’ group, had filed a post-grant opposition, which was rejected by the Patent Office. In the appeal filed by Sankalp before the IPAB, Roche sought to place a narrow interpretation on who a “person interested” could be. It argued that Sankalp is not a “person interested” because it was not a business competitor or a researcher. This issue probably arose for the first time before the IPAB. Rejecting Roche’s contentions, the IPAB held that a patients’ group that is a “person interested” in whether a patent is revoked or not. Justice Sridevan noted that the revocation of a patent could bring down the costs of the medicine as well as increase supply. She also held that public interest is persistently present in intellectual property law. 

On the merits, the IPAB revoked the patent on the ground that Roche’s claim of combining interferon (a protein known to treat Hepatitis C) with an inert PEG structure using conventional methods to obtain predictable results was obvious to a person skilled in the art. The IPAB also held that Roche did not show that this pegylated interferon showed enhanced efficacy over other known pegylated interferons —  a requirement under section 3(d) of India’s patent law.

By setting aside the patent , this order now paves the way for Indian companies that may decide to launch biosimilars of this medicine in India.

 

PRESS RELEASE

2 November 2012, New Delhi.

 

In a landmark victory for patients’ groups fighting against patents to ensure access to medicines, the bench of the Intellectual Property Appellate Board (IPAB) comprising Justice Prabha Sridevan (Chairperson) and Mr. D. P. S. Parmar (Technical Member), has revoked a patent granted in India to F. Hoffmann-La Roche AG (Roche) for pegylated interferon alfa-2a (Pegasys, a medicine used to treat Hepatitis C) as well as held that a patients’ group can challenge the validity of granted patents.

 

Mr. Eldred Tellis, Director of Sankalp Rehabilitation Trust, who had challenged the patent, said, “We hope that the absence of patent barrier will spur generic competition to bring down the price of this much-needed drug for those suffering from Hepatitis C. We also hope that the Government will now take concrete steps to start providing access to this medicine. It is unacceptable that people are dying due to Hepatitis C because they cannot afford to buy the medicine.”

 

As may be recalled, this patent granted to Roche in 2006 was the first product patent on a medicine in India under the new TRIPS-mandated product patent regime for medicines. The patent granted a monopoly to Roche to market pegylated interferon alfa2a. Patients with chronic Hepatitis C, who need a six-month course of treatment of Roche’s pegylated interferon alfa2a, have to purchase it at a cost of approximately INR 4,36,000 [USD 8,752.38] (available at a discounted price of INR 3,14,496 or USD 6,313.28). Again, it has to be taken in combination with ribavarin, which alone costs INR 47,160 [USD 946.70].

 

Concerned about the impact of this patent on access to medicines, Sankalp—an organisation that provides treatment and rehabilitation support for injecting drug users—filed a post-grant opposition challenging the grant of the patent with technical and legal aid from Lawyers Collective HIV/AIDS Unit.

 

Mr Anand Grover, senior counsel and Director of Lawyers Collective HIV/AIDS Unit, who appeared for Sankalp in this matter, said, “This victory will facilitate early entry of generics which is likely to lower the prices. If this happens, millions suffering from Hepatitis C, both in India and globally, will benefit. It is also historic because this was the first ever product patent granted on a medicine in India since 1970.”

 

Hepatitis C represents a huge public health problem in India and globally. An estimated 10–12 million people in India, including 50% of IDUs nationally and 90% of IDUs in the northeast, are infected with the Hepatitis C virus (HCV). Left untreated, Hepatitis C can lead to liver cirrhosis, liver cancer or liver failure. Hepatitis C is especially of concern for those co-infected with HIV, as several studies have shown that HIV-HCV co-infection leads to increased rates of disease progression. Injecting drug users are especially vulnerable to HIV-HCV co-infection with HIV-HCV co-infection rates as high as 93% among IDUs in Manipur. However, unlike both first- and second-line HIV treatment, which is available to all people living with HIV who need it,   Hepatitis C treatment is not available in government hospitals largely due to its high cost and treatment programmes do not even bother to screen patients for HCV due to the unavailability of treatment.

 

Despite Sankalp’s case that Roche’s clams did not satisfy the patentability requirements under Indian law, in 2009, the Patent Office rejected the post-grant oppositions filed by Sankalp and an Indian company and upheld the validity of Roche’s patent. Sankalp then filed an appeal before the IPAB challenging this decision.

 

Before the IPAB, Roche also challenged Sankalp’s standing to file the post-grant opposition as well as the appeal. Roche argued that because Sankalp was not a business competitor or a researcher in the sector, it could not have challenged its patent at all. Sankalp argued that its members were directly affected by Hepatitis C as well as that it represented a community of drug users who are particularly at risk to Hepatitis C. The IPAB observed that “public interest is a persistent presence in intellectual property law” and also held that it was against public interest to “allow unworthy patents to be on the Register”. Holding that “the appellant who works for the community which needs the medicine, is definitely ‘a person interested’”, the IPAB noted that a successful challenge would “break the monopoly” and “bring the drug within reach of the community for whom it works, not only by reduction in cost, but also because of increase in supply”.

 

Mr. Grover said, “We are happy that the IPAB has recognised the element of public interest in setting aside undeserving patents and held that patients’ groups, who are directly impacted by patents on medicines, can challenge granted patents. This will be of import as concerned patients’ groups will now have better clarity in challenging patents on medicines for HIV, cancer and other diseases.”

 

Setting aside the patent, the IPAB held that Roche’s pegylated interferon was obvious to a person skilled in the art. It also found that Roche has not provided any evidence, in the specification or even otherwise, to prove that pegylated interferon has enhanced efficacy. The IPAB, however, held that Roche’s claims were novel.

 

Welcoming the findings on obviousness and section 3(d), Mr. Grover said, “The IPAB has rightly observed that the patentee used conventional methods to pegylate interferon and obtained predictable results, thereby rendering it obvious to a person skilled in the art. It also correctly held that the patentee has failed to satisfy the requirement of section 3(d) of showing enhanced efficacy. We hope that the Patent Offices too follow these standards while deciding pre- and post-grant oppositions.”

 

The text of the order can be accessed at the website of the IPAB.  We will upload a copy of the official certified copy on our website as soon as we receive it.

 

Lawyers Collective HIV/AIDS Unit and Sankalp Rehabilitation Trust

 

For further information, contact
Anand Grover: +91.9820184788, Eldred Tellis: +91.9820194363
Prathibha Sivasubramanian / Julie George: +91.11.46805506; +91.9968050357

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FAQ -Copyright Amendment Act and impact on print Impaired persons

English: A collection of pictograms. Three of ...

English: A collection of pictograms. Three of them used by the United States National Park Service. A package containing those three and all NPS symbols is available at the Open Icon Library (Photo credit: Wikipedia)

Some Frequently Asked Questions to the Amendment to the Copyright Act of India, 1957 and its Impact on Print Impaired Persons


1. Who benefits?

All print impaired persons be they totally blind, low vision, learning disabled or orthopedically challenged in certain ways are covered by this clause.

2. What can be done now that was not possible earlier?

Print impaired individuals, or authorized service providers / organizations can suitably modify a work under Copyright so as to make it accessible to meet the specific needs of the print impaired person concerned. This means that a standard printed book, for example may be converted to an alternate format (not necessarily a special format) including Braille, large font, text readable by screen reader, audio (be it synthetic audio or human voice recording) without seeking the permission of the rights holder.

3. How is this different?

In the past, any alternate format creation could have been defined as an infringement unless it was backed up by prior written permission from the rights holder. One had to seek the permission if one had to be on the right side of the law. Now thankfully we do not need permissions.

4.  Are there any restrictions?

Yes, there are reasonable restrictions such as
– conversion should be a not for profit activity. In case it is a for profit activity, there is a separate clause under which a special license can be obtained.
– the beneficiaries has to be a bonafide print impaired person or organizations that serve them.
– reasonable precaution need to be taken by all that the accessible copy is not misused commercially.

5. Does this mean that the publisher has to give soft copy?

No. The copyright law does not cover the delivery of books which is the purview of another department and another law. We are planning to take it up as well. For the present, these exemptions allow an existing work which is not accessible to be made accessible without permission.

6. Can accessible copy be shared?

Effectively yes, as long as it is not misused for commercial purposes and is available to print impaired persons only.

7. What is the wording of the clause?

It runs as follows.

Section 52 (1)The following act shall not be an infringement of copyright, namely:
(zb) the adaptation, reproduction, issue of copies or communication to the public of any work in any accessible format, by —
(i) any person to facilitate persons with disability to access to works including sharing with any person with disability of such accessible format for private or personal use, educational purpose or research; or
(ii) any organization working for the benefit of the persons with disabilities in case the normal format prevents the enjoyment of such works by such persons:
Provided that the copies of the works in such accessible format are made available to the persons with disabilities on a nonprofit basis but to recover only the cost of production:
Provided further that the organization shall ensure that the copies of works in such accessible format are used by persons with disabilities and takes reasonable steps to prevent its entry into ordinary channels of business.
Explanation. For the purposes of the sub-clause, “any organization” includes an organization registered under section 12A of the Income Tax Act, 1961 and working for the benefit of persons with disability or recognized under Chapter X of the Persons with Disabilities (Equal Opportunities Protection of Rights and Full Participation) Act, 1995 or receiving grants from the Government for facilitating access to persons with disabilities or an educational institution or library or archives recognized by the Government.

8. What provisions affect the creation of accessible cop[ies when it is undertaken as a not for profit activity?

The following new section involving a compulsory license would be applicable

³31B. (1) Any person working for the benefit of persons with disability on a profit basis or for business may apply to the Copyright Board, in such form and manner and accompanied by such fee as may be prescribed, for a compulsory license to publish any work in which copyright subsists for the benefit of such persons, in a case to which clause (zb) of sub-section (1) of section 52 does not apply and the Copyright Board shall dispose of such application as expeditiously as possible and endeavor shall be made to dispose of such application within a period of two months from the date of receipt of the application.

(2) The Copyright Board may, on receipt of an application under sub-section (1), inquire, or direct such inquiry as it considers necessary to establish the credentials of the applicant and satisfy itself that the application has been made in good faith.

(3) If the Copyright Board is satisfied, after giving to the owners of rights in the work a reasonable opportunity of being heard and after holding such inquiry as it may deem necessary, that a compulsory license needs to be issued to make the work available to the disabled, it may direct the Registrar of Copyrights to grant to the applicant such a license to publish the work.

(4) Every compulsory license issued under this section shall specify the means and format of publication, the period during which the compulsory license may be exercised and, in the case of issue of copies, the number of copies that may be issued including the rate or royalty:
Provided that where the Copyright Board has issued such a compulsory license it may, on a further application and after giving reasonable opportunity to the owners of rights, extend the period of such compulsory license and allow the issue of more copies as it may deem fit.

 

Compiled By:

The Xavier’s Resource Centre for the Visually Challenged (XRCVC)
Dr. Sam Taraporevala
St. Xavier’s College, 5 Mahapalika Marg, Mumbai 400001
#+91-22-22623298/22626329

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The Seed Emergency: The Threat to Food and Democracy

Vandana Shiva

Patenting seeds has led to a farming and food crisis – and huge profits for US biotechnology corporations.

The seed is the first link in the food chain – and seed sovereignty is the foundation of food sovereignty. If farmers do not have their own seeds or access to open pollinated varieties that they can save, improve and exchange, they have no seed sovereignty – and consequently no food sovereignty.

The deepening agrarian and food crisis has its roots in changes in the seed supply system, and the erosion of seed diversity and seed sovereignty.

Seed sovereignty includes the farmer’s rights to save, breed and exchange seeds, to have access to diverse open source seeds which can be saved – and which are not patented, genetically modified, owned or controlled by emerging seed giants. It is based on reclaiming seeds and biodiversity as commons and public good.

The past twenty years have seen a very rapid erosion of seed diversity and seed sovereignty, and the concentration of the control over seeds by a very small number of giant corporations. In 1995, when the UN organised the Plant Genetic Resources Conference in Leipzig, it was reported that 75 per cent of all agricultural biodiversity had disappeared because of the introduction of “modern” varieties, which are always cultivated as monocultures. Since then, the erosion has accelerated.

The introduction of the Trade Related Intellectual Property Rights Agreement of the World Trade Organisation has accelerated the spread of genetically engineered seeds – which can be patented – and for which royalties can be collected. Navdanya was started in response to the introduction of these patents on seeds in the General Agreement on Tariffs and Trade – a forerunner to the WTO – about which a Monsanto representative later stated: “In drafting these agreements, we were the patient, diagnostician [and] physician all in one.” Corporations defined a problem – and for them the problem was farmers saving seeds. They offered a solution, and the solution was to make it illegal for farmers to save seed – by introducing patents and intellectual property rights [PDF] on those very seeds. As a result, acreage under GM corn, soya, canola, cotton has increased dramatically.

Threats to seed sovereignty

Besides displacing and destroying diversity, patented GMO seeds are also undermining seed sovereignty. Across the world, new seed laws are being introduced which enforce compulsory registration of seeds, thus making it impossible for small farmers to grow their own diversity, and forcing them into dependency on giant seed corporations. Corporations are also patenting climate resilient seeds evolved by farmers – thus robbing farmers of using their own seeds and knowledge for climate adaptation.

Another threat to seed sovereignty is genetic contamination. India has lost its cotton seeds because of contamination from Bt Cotton – a strain engineered to contain the pesticide Bacillus thuringiensis bacterium. Canada has lost its canola seed because of contamination from Roundup Ready canola. And Mexico has lost its corn due to contamination from Bt Cotton.

After contamination, biotech seed corporations sue farmers with patent infringement cases, as happened in the case of Percy Schmeiser. That is why more than 80 groups came together and filed a case to prevent Monsanto from suing farmers whose seed had been contaminated.

As a farmer’s seed supply is eroded, and farmers become dependent on patented GMO seed, the result is debt. India, the home of cotton, has lost its cotton seed diversity and cotton seed sovereignty. Some 95 per cent of the country’s cotton seed is now controlled by Monsanto – and the debt trap created by being forced to buy seed every year – with royalty payments – has pushed hundreds of thousands of farmers to suicide; of the 250,000 farmer suicides, the majority are in the cotton belt.

Seeding control

Even as the disappearance of biodiversity and seed sovereignty creates a major crisis for agriculture and food security, corporations are pushing governments to use public money to destroy the public seed supply and replace it with unreliable non-renewable, patented seed – which must be bought each and every year.

In Europe, the 1994 regulation for protection of plant varieties forces farmers to make a “compulsory voluntary contribution” to seed companies. The terms themselves are contradictory. What is compulsory cannot be voluntary.

In France, a law was passed in November 2011, which makes royalty payments compulsory. As Agriculture Minister Bruna Le Marie stated: “Seeds can be longer be royalty free, as is currently the case.” Of the 5,000 or so cultivated plant varieties, 600 are protected by certificate in France, and these account for 99 per cent of the varieties grown by farmers.

The “compulsory voluntary contribution”, in other words a royalty, is justified on grounds that “a fee is paid to certificate holders [seed companies] to sustain funding of research and efforts to improve genetic resources”.

Monsanto pirates biodiversity and genetic resources from farming communities, as it did in the case of a wheat biopiracy case fought by Navdanya with Greenpeace, and climate resilient crops and brinjal (also known as aubergine or eggplant) varieties for Bt Brinjal. As Monsanto states, “it draws from a collection of germ-plasm that is unparalleled in history” and “mines the diversity in this genetic library to develop elite seeds faster than ever before”.

In effect, what is taking place is the enclosure of the genetic commons of our biodiversity and the intellectual commons of public breeding by farming communities and public institutions. And the GMO seeds Monsanto is offering are failing. This is not “improvement” of genetic resources, but degradation. This is not innovation but piracy.

For example, the Alliance for a Green Revolution in Africa (AGRA) – being pushed by the Gates Foundation – is a major assault on Africa’s seed sovereignty.

Agribusiness

The 2009 US Global Food Security Act [PDF] also called the Lugar-Casey Act [PDF], “A bill to authorise appropriations for fiscal years 2010 through 2014 to provide assistance to foreign countries to promote food security, to stimulate rural economies, and to improve emergency response to food crisis, to amend the Foreign Assistance Act of 1961 and for other purposes”.

The amendment to the Foreign Assistance Act would “include research on bio-technological advances appropriate to local ecological conditions, including genetically modified technology”. The $ 7.7bn that goes with the bill would go to benefit Monsanto to push GM seeds.

An article in Forbes, titled “Why Uncle Sam Supports Franken Foods”, shows how agribusiness is the only sector in which US has a positive trade balance. Hence the push for GMOs – because they bring royalties to the US. However, royalties for Monsanto are based on debt, suicidal farmers and the disappearance of biodiversity worldwide.

Under the US Global Food Security Act, Nepal signed an agreement with USAID and Monsanto. This led to massive protests across the country. India was forced to allow patents on seeds through the first dispute brought by the US against India in the WTO. Since 2004, India has also been trying to introduce a Seed Act which would require farmers to register their own seeds and take licenses. This in effect would force farmers from using their indigenous seed varieties. By creating a Seed Satyagraha – a non-cooperation movement in Gandhi’s footsteps, handing over hundreds of thousands of signatures to the prime minister, and working with parliament – we have so far prevented the Seed Law from being introduced.

India has signed a US-India Knowledge Initiative in Agriculture, with Monsanto on the Board. Individual states are also being pressured to sign agreements with Monsanto. One example is the Monsanto-Rajasthan Memorandum of Understanding, under which Monsanto would get intellectual property rights to all genetic resources, and to carry out research on indigenous seeds. It took a campaign by Navdanya and a “Monsanto Quit India” Bija Yatra [“seed pilgrimage”] to force the government of Rajasthan to cancel the MOU.

This asymmetric pressure of Monsanto on the US government, and the joint pressure of both on the governments across the world, is a major threat to the future of seeds, the future of food and the future of democracy.
TRANSCEND Member Prof. Vandana Shiva is a physicist, ecofeminist, philosopher, activist, and author of more than 20 books and 500 papers. She is the founder of the Research Foundation for Science, Technology and Ecology, and has campaigned for biodiversity, conservation and farmers’ rights, winning the Right Livelihood Award [Alternative Nobel Prize] in 1993. She is executive director of the Navdanya Trust

Source: TRANSCEND Media Service, Sunday, February 12, 2012

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Free Medicines in Rajasthan, India

India is known as the pharmacy of the world but 65% of Indians have no access to essential medicines. Watch this video to see how the State of Rajasthan in India is tackling the problem by promoting generic medicines and providing these free of charge in the public sector.

This week negotiations continue on the EU-India Free Trade Agreement. Worldwide there are serious concerns that the deal will include stricter intellectual property rules than necessary and result in a deadly escalation in medicine prices for developing countries. Such a deal would also threaten innovative and progressive schemes like this one in India itself.

 

Watch the Video here 

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A Victory for the Internet: SOPA Act Dropped After Mass Protest

 

The blockage last week of SOPA, the Stop Online Piracy Act of 2012, is a tentative victory not only for net neutrality and changing definitions of intellectual property, but also an impressive display of new online organizing.

SOPA is the first of what will likely be several attempts to censor the Internet, under the logic of media’s intellectual property law. Nominally, the act would have shut down offshore torrenting sites, a move which the FBI already took in part on Jan. 19, when massive file share sites Megaupload and Megavideo were shut down. Actually, the law would have the capacity to shut down or censor some of the most trafficked sites, including Facebook, Twitter and Google, as well as numerous smaller sites with much less clout and bargaining influence.

SOPA is not the last we’ve seen of the push to censor the Internet. As our modes of information access have shifted from newspapers and libraries to the vast universe of the web, law, especially intellectual property law, has struggled to keep up. It’s no secret that record sales, newspaper sales, movie attendance and other hallmarks of our media-saturated era have plunged in recent years, and the industries have scrambled to save their bottom lines. SOPA and its ilk will not go without a fight.

The most interesting outcome, then, of the SOPA debacle is the massive backlash from the general public. Goaded in part by blackouts of popular sites such as Wikipedia and Reddit, millions of angry consumers signed petitions large and small to “save the Internet!” The sites in blackout, and even those that weren’t, linked viewers to a place where they could look up their representative and send an email in protest, as well as sign a petition.

People’s activist fervor, at least as exhibited through Facebook and Twitter, was overwhelming. Seasoned organizers might argue that anything done in front of a computer screen is not activism but “slacktivism”; yet behold, the architects of the bill have backed down and vowed to go back to the drawing board.

How SOPA is critical, is determined by the means we had to use to protest it, indicating ever more clearly the Internet’s omnipotence and almost crippling power in our lives. A censorship of the Internet would be a censorship of the people’s power, through the means we in the developed world now use to express it.

The anti-SOPA petitions are a heartening harbinger of the massive quantities of fervor and activism, even via the Internet, waiting to be tapped. This was a large-scale version of the rapid-fire Change.org petitions that stunned corporations, such as Molly Katchpole’s Change.org petition against Bank of America‘s proposed $5 fee for debit card usage. Katchpole, a 22-year-old nanny (and full disclosure, a former coworker of mine), collected 300,000 signatures through an online petition and the bank relented. Several months later, SOPA protests ignited the same kind of public fervor, just on a larger scale. Both protests indicate the ubiquity and power of online organizing, and both capture public distress at a time when banks and governments are overstepping their limits more than ever.

Attempts to legislate the Internet will not go away. The Internet is a relatively young place and as such is inevitably going to be reined in as the boundaries of authority shift with the meaning of intellectual property. Fortunately, the medium shapes the message, and the millions of signatures, calls and emails to our representatives indicate how the general online public can organize not just for net neutrality, but for anything.

Source- Sophian

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