
Saturday, February 13, 2010
Patents and Innovation

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Swaraj Paul Barooah
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Thursday, February 11, 2010
Indian "Bayh Dole" and Parliamentary Committee Hearings
"In the first instance of its kind in Indian legislative history, a panel appointed by Parliament to suggest changes to a controversial Bill has asked the government to review the proposed law before it completes its task."
Not too surprising, given that this law is fundamentally and conceptually flawed. More egregious than the bad drafting is the fact that this bill was kept a secret from the public and in fact, from most of its stakeholders (institutions/scientists) for over 3 years before it was introduced on the floor of the Rajya Sabha.
Now that scientists have wisened up and read the Bill, many of them are fuming over the rather harsh language in the Bill that insists that they disclose all IP to their respective institutions, which then has to disclose this to the government. One can only stare wide mouthed at the sheer transaction cost and waste of paper that this process entails! And if they dare disobey the law, they face rather harsh sanctions.
Some of us on this blog have been tracking this bill right from its nascent "secret" stage and documenting its various flaws, time and again. For all our Indian Bayh Dole related posts, see here.
The hope is that the government would now, in its wider review, consult with a wider group of stakeholders and arrive at a more evolved version. At this stage, the talk of "non exclusive" multiple licenses by the Secretary, DBT (Dept of Biotechnology), as documented by Unni in his article below is music to the ears. In this paper here, we've recommended that exclusive licenses be granted only after a mandatory advertisement and/or opposition phase, on much the same lines as the National Institute of Health (NIH) in the US.
Anyway, without much ado, I give you Unni's complete write up below:
"In the first instance of its kind in Indian legislative history, a panel appointed by Parliament to suggest changes to a controversial Bill has asked the government to review the proposed law before it completes its task.
The Bill in question is the Protection and Utilisation of Public Funded Intellectual Property Bill, 2008, which proposes to mandate scientific institutions and universities working on publicly funded research projects to patent their research output and licence it out on an exclusive basis.
“We have asked the concerned ministry to incorporate suggestions and guidance contributed by all stakeholders, including scientists, non-government agencies and scientific institutions in the Bill,” Subbarami Reddy, chairman of the panel appointed by Parliament, told Mint on Tuesday.
The panel will continue discussion on the legislation, known as the Innovation Bill, after the science and technology ministry’s review, he added. The date of the panel’s next hearing has not been decided yet.
The panel on Monday heard representatives from key scientific institutions, non-profit organizations and activists in New Delhi.
M.K. Bhan, secretary of the department of biotechnology in the ministry of science and technology, and one of the key proponents of the Bill, confirmed that the committee wants the ministry to review the Bill. He also said some of the changes the panel has been seeking have already been incorporated.
“We had interesting discussions with all parties concerned, and the changes will be mainly (relating to) the convergence of the views shared by scientific community,” he said.
According to him, the language of the Bill should be able to clearly communicate the interests of all stakeholders and promote innovation. “It should allow multiple licensing of such inventions, especially in case of agriculture technologies, as the government always intend to do,” he said.
The key changes anticipated in the Bill, introduced in the Rajya Sabha in January 2009, are removal of the clause for mandatory patenting of publicly funded inventions and exclusive licensing.
The local scientific community, non-profit organizations working in the area of healthcare and agriculture, economists and experts in intellectual property law have in several forums raised doubts on the relevance of the Bill, modelled on Bayh-Dole Act of the US of 1980.
The Bayh-Dole Act vests institutes with the right to acquire patents over inventions that result from publicly funded research and development. It also mandates that individual inventors be paid a minimum of 30% of any royalties that result from the licensing of patents by publicly funded institutes.
The Bill, introduced without any public debate, created a controversy and was put under scrutiny by the Reddy-led parliamentary panel.
After the review, it will be placed before the two houses of Parliament for final approval.
While the Bill presents an opportunity to regulate publicly funded research and patenting associated with such research for the first time, its critics say that there is a disconnect between its objectives and the efficacy of a Bayh-Dole structure in achieving them.
“The case for a full-fledged law in this regard is very weak,” said Shamnad Basheer, a professor of IP Law at the National University of Juridical Sciences in Kolkata.
According to him, if the government is keen on offering incentives for the registration of publicly funded research patents, it may be more sensible to attempt this through flexible policy measures evolved by the Scientific Advisory Council instead of attempting to do so through legislation. “It would be far easier to make changes to a policy by the science council and evolve as we go along but it is incredibly difficult to amend a law,” he said.
Leena Menghaney, India coordinator of Medecins Sans Frontieres, an independent humanitarian medical aid agency, said the country needed to identify priority areas of research by publicly funded institutions, such as drugs for malaria and other tropical diseases. “Exclusive licensing of technologies by these institutions will lead to abuse of such inventions,” she said.
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Wednesday, February 10, 2010
Second Annual Conference on Intellectual Property-hosted by Iona College
The keynote address will be presented by Dr. James Boyle and Nina Paley, writer and director of "Sita Sings the Blues" will be giving a special viewing of the film and talk.
500 words Papers/Panel abstracts or complete papers are to be submitted by February 25,2010 to Shannon Donlon at sdonlon@iona.edu. Questions can be directed to Dr. Amy Stackhouse at astackhouse@iona.edu.
For futher details,please see here .
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Shayonee Dasgupta
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Delhi HC: Pre-grant Patent Application Rejections Appealable before the IPAB- II
In the last post, I had discussed the Delhi HC’s decision on appealability of pre-grant patent rejections before the IPAB. The post discussed the effect and import of the 2005 amendment on Section 25, Section 116 and Section 117A of the Act. In this post, the combined interpretation of Section 15, Section 25(1) r/w Rule 55, 117A and 117G has been dwelt upon.
Section 15, Section 25(1), Section 117A and Section 117 G: Though it is clear that there must be an appeal provided for from a pre-grant rejection of a patent application, the question to be answered is, under which section would the order of rejection/refusal fall? Section 15 would be the obvious provision thanks to its broad phraseology. The reasons for the same are as follows:
The current Section 25(1) begins as follows:
“Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground…”
And concludes thus:
“but on no other ground, and the Controller shall, if requested by such person for being heard, hear him and dispose of such representation in such manner and within such period as may be prescribed.”
Section 25(1) speaks of disposal of representation in “such manner” and “such period as may be prescribed”. This again must refer to delegated legislation- Patent Rules, 2003. Rule 55 deals with the procedure for dealing with a pre-grant opposition representation. Sub-rule 6 states that acceptance of the representation would simultaneously translate to refusal of the patent application and vice versa.
Since Rule 55(6) speaks of refusal of the patent application and Section 15 also deals with the power of the Controller to refuse a patent application for any form of non-compliance with any requirement of the Act, the refusal of a patent application pursuant to a pre-grant opposition must fall within the ambit of Section 15.
The above conclusion is supported by a combined reading of Section 15, Section 117A, Section 117C and Section 117G. A provision of appeal from an order of refusal under Section 15 has been provided in Section 117A to provide the applicant with a forum which has the authority to reverse any unreasonable order of the Controller which violates principles of natural justice or which reflects non-application of mind by the Controller or which contravenes the provisions of the Act.
Also, if it cannot be denied that, in the absence of a pre-grant opposition, a “normal” order of refusal of a patent application would be one under Section 15, and is hence appealable before the IPAB under Section 117A(2) of the Act, why should the conclusion be any different merely because the rejection of the application is the consequence of a pre-grant opposition proceeding?
In other words, a pre-grant opposition does not in any manner alter the nature of examination of an application and consequently, ought not to be deemed as changing the nature of the Controller’s order of refusal of the patent application.
There is a relevant report of the Standing Committee on the Law of Patents of the World Intellectual Property Organization (WIPO) on this point, which none of the parties in the judgement seem to have relied upon (probably because they did not have an opportunity to). This report dated December 11, 2009 clearly states in paras 17, 18, 19, 22 and 23 that a pre-grant opposition is intended to merely aid the process of examination of a patent application. Further, the report also states that there must be an appeal from an order passed by the administrative forum (Controller) in a pre-grant opposition.
Moving on to Section 117G, it reads thus:
“All cases of appeals against any order or decision of the Controller and all cases pertaining to revocation of patent other than on a counter-claim in a suit for infringement and rectification of register pending before any High Court, shall be transferred to the Appellate Board from such date as may be notified by the Central Government in the Official Gazette and the Appellate Board may proceed with the matter either de novo or from the stage it was so transferred”
As I had stated earlier in a comment to a post by Mr.Basheer, Section 117G is the surest indication that an appeal would lie before the IPAB from an order of refusal of a patent application in a pre-grant opposition. Proof to this is the case of Novartis AG v. Union of India and Ors. (M.P. Nos 1 to 5/2007 in TA/1 to 5/2007/PT/CH).
In this case, Novartis, which was the patent applicant, filed Writ petitions before the Madras High Court from the order of the Controller under Section 25(1) read with Rule 55 pursuant to a pre-grant opposition. Upon coming into force of the provisions of the Patents Act relating to the IPAB, pending writ petitions such as the Novartis petition were transferred from Madras High Court to the IPAB.
This was pursuant to the transitional provision Section 117G of the Act; the effect of the transitional provision is of the essence here, since not only does it have the effect of transferring pending appeals from High Courts to the IPAB, but also empowers and stipulates that prospective appeals from any decision of the Controller, including rejection of patent applications in pre-grant proceedings, shall lie before the IPAB.
If prospective appeals are not meant to lie before the IPAB, it defeats the very purpose of the transfer of the pending proceedings, not to mention rendering nugatory the purpose of the constitution of the IPAB.
This is further supported by the concluding portion of Section 117G which permits the IPAB to start pending appeal proceedings de novo or afresh. If the IPAB can look into pending proceedings afresh, the only logical conclusion that one may arrive is that it is the sole authority before which fresh proceedings may lie.
This receives credence from Section 117C of the Act which speaks of bar on jurisdiction of Courts. Section 117C reads thus:
“No Court or other authority shall have or, be entitled to, exercise any jurisdiction, power or authority in relation to the matters referred to in sub-section (2) of Section 117(A) or Section 117(D).”
The consequence of Section 117C is that any order or decision from which an appeal lies before the IPAB, shall not be alternatively appealable before the High Court.
The decision of the Delhi HC is a welcome one and should hopefully reduce the woes of patent applicants.
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J. Sai Deepak
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Delhi HC: Pre-grant Patent Application Rejections Appealable before the IPAB- I
This post has been split in 2 parts for the convenience of readers.
To understand this post better, following is a reproduction of the relevant provisions of the Act:
Section 15: Power of Controller to refuse or require amended applications in certain cases (1) Where the Controller is satisfied that the application or any specification or any other document filed in pursuance thereof does not comply with the requirements of this Act or of any rules made thereunder, the controller may refuse the application or may require the application, specification or the other documents, as the case may be, to be amended to his satisfaction before he proceeds with the application and refuse the application on failure to do so.
Section 25(1) (Before 2005 amendment): “At any time within four months from the date of advertisement of the acceptance of a complete specification under this Act (or within such further period not exceeding one month in the aggregate as the Controller may allow on application made to him in the prescribed manner before the expiry of the four months aforesaid) any person interested may give notice to the Controller of opposition to the grant of the patent on any of the following grounds…”
Section 25(1) (After 2005 amendment): “Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground…”
Section 116 (Before 2005 amendment): Appeals:
(2) Save as otherwise expressly provided in sub-section (1), an appeal shall lie to a High Court from any decision, order or direction of the Controller under any of the following provisions, that is to say, section 15, section 16, section 17, section 18, section 19, section 20, section 25, section 27, section 28, section 51, section 54, section 57, section 60, section 61, section 63, sub-section (3) of section 69, section 78, section 84, section 86, section 88(3), section 89, section 93, section 96 and section 97.
Section 117A (After 2005 Amendment): Appeals to the Appellate Board:
(2) An appeal shall lie to the Appellate Board from any decision, order or direction of the Controller or the Central Government under section 15, section 16, section 17, section 18, section 19, section 20, sub-section (4) of section 25, section 27, section 28, section 51, section 54, section 57, section 60, section 61, section 63, Section 66, sub-section (3) of section 69, section 78, sub-section (1) to (5) of section 84, section 85, section 88, section 91, section 92 and section 94.
In a decision delivered on February 8th on a slew of writ petitions, the Delhi High Court has ruled that an appeal may lie under Section 117A(2) of the Patents Act from an order of rejection of a patent application in a pre-grant opposition proceeding under Section 25(1). Such orders are appealable since they are orders of refusal of a patent application given by the Controller under Section 15 of the Act for non-compliance with the requirements of the Act.
The decision was pronounced in view of 6 write petitions raising the same issue. The parties to these petitions were UCB Farchim, Cipla, ColorCon Inc, Ideal Cures Pvt Ltd, Yeda Research and Development, NATCO Pharma, Eli Lilly, Ajanta Pharma and Ranbaxy.
Though this decision settles the law (at least for now, unless the IPAB still takes a contra view), by and large, quite a few practitioners (including me) feel that what ought to have been an obvious interpretation of the Act and hence a non-issue, had become an issue because of IPAB’s view that such appeals were not maintainable (this I say from first-hand experience).
Stated otherwise, the IPAB was hitherto of the view that there did not lie an appeal before it from an order of rejection of a patent application in a pre-grant opposition proceeding. Thanks to this view, the usual recourse of the patent applicant was a writ petition before the appropriate High Court under Article 226 of the Constitution.
In ruling in favour of maintainability of the appeal under Section 117A(2), the High Court adopted the following line of logic:
Effect of 2005 Amendment on Sections 25(1) and 117A(2): The HC compared the version of S.25(1) prior to the 2005 amendment and post the amendment. This comparison also happens to be one of the primary underpinnings relied upon in Span Diagnostic v. Asst. Controller of Patents, to rule against maintainability of appeals before the IPAB.
The argument furthered in Span Diagnostics was that, prior to the 2005 Amendment, Section 25 found mention in Section 116(2) of the Act, whereas only Section 25(4) finds mention in Section 117A(2) after the amendment. However, a lot of us, including me, have consistently taken the view that this decision was based on an erroneous interpretation of the scheme of the Act and the nature of patent prosecution framework.
The reasons for the same are as follows:
Prior to the 2005 Amendment, Section 25(1) provided for opposition of a patent specification which was found to be in order for grant. Such opposition had to be instituted within four months of advertisement of such acceptance of the specification. Post the 2005 amendment, Section 25(1) provides for a representation of opposition of the patent application anytime after publication but before grant.
On comparison of these 2 versions of Section 25(1), strictly speaking, one could say that the pre-2005 provision was not in the nature of a pre-grant opposition in the sense we refer to it today. To put it simply, there was no pre-grant opposition provided for in the pre-2005 Act. In fact, the earlier version is closer in nature to a post-grant opposition, since under the earlier version the patent application was already found in order for grant by the Patent Office.
Such being the case, there was no need for a provision of appeal from a "pre-grant" opposition before 2005 amendment, because a "pre-grant" opposition was non-existent. However, since the 2005 amendment introduced the pre-grant opposition procedure, it was but natural that a provision for appeal too had to be made for in the Act.
Further, the 2005 amendment also brought with it the inception of IPAB for patent appeals. Consequently, it would only make sense to provide for an appeal before the IPAB under Section 117A(2) from an order of rejection of a patent application from a pre-grant opposition. It must be clarified that there exists an appeal before the IPAB from a rejection of a patent application only, but not from a rejection of the opposition application. This was clarified in the J.Mitra v. Asst. Controller by the Supreme Court.
The reason why there cannot or should not be an appeal from the rejection of an opposition representation is because the pre-grant opponent always has the option of post-grant opposition. Providing him with an appellate forum in the pre-grant stage would only serve to delay the examination of the patent application, and consequently its grant. (Precisely for this reason, the pre-grant opposition procedure was being phased out in several countries in the very year India introduced it).
Sometime back, Aditya Gupta, a student of NLU Jodhpur, raised this interesting question as to why the principle of res judicata would not apply to prevent a pre-grant opponent from raising the same grounds of opposition in a post-grant opposition. A tentative answer to his question is that a post-grant opposition proceeding, in a way, is a statutory exception to the principle of res judicata.
In the next post, I shall discuss the rest of the arguments to support maintainability of appeals before the IPAB.
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Nay Patent Linkages: Bayer v. UOI upheld by the Division Bench of Delhi HC
I had previously posted (click here for the post) on the judgment of the single judge of the Delhi High Court in relation to Bayer Corporation’s attempt to bring in patent linkages (click here for previous post on the same) through the back door. Bayer sought to prevent the granting of marketing approval under the Drugs and Cosmetics Act (DCA) to Cipla’s drug Soranib on the grounds that it violated its valid patent. The drug is used in the treatment of advanced renal cell carcinoma. On appeal, a Division Bench of the Delhi High court has concurred with the decision of the Single Judge.Bayer’s Contentions:
• The petitioners sought to read Section 48 of the Patents Act and Section 2 of the DCA together. Section 2 of the DCA provides that the DCA shall not be in derogation of any other law and thus the DCA cannot contravene the provisions of the Patent Act.
• Form 44 requires an indication of the ‘patent status’ of the drug. This inclusion was a conscious effort to bring in patent linkage.
• Section 156 of the Patents Act read with Section 48 mandates the Drugs Controller who is an officer of the Central Government to ensure non-infringement of patents.
• Judgment in Hoeschst Pharmaceuticals v. CVS Mani, ILR 1983 Delhi 548 is relied on. The judgment mandated adherence by the DCGI to the Trademarks Act.
Cipla’s contentions:
• The Parliament has never envisaged patent linkages in India and the scheme of the Patents Act and the DCA are entirely different. Patent linkages would also lead to a system wrought with uncertainties.
• The requirement of indication of patent status in Form 44 is only to indicate bio availability and bio equivalence protocol.
Cancer Patient Aid Association (The association impleaded itself in the writ petition)
• Patent linkages would adversely affect access of cancer patients to safe, effective and affordable medicines.
• “Patent linkages” is a TRIPS plus policy issue.
Drugs Controller General:
• The scheme, aim and objectives of the DCA and the Patents Act are entirely different.
• The Office of the Drugs Controller is not equipped to grapple with complicated patent disputes.
Indian Pharmaceutical Alliance: (intervener supporting Cipla’s stand):
• Accepting Bayer’s contentions would bring in penal consequences for the infringement of a patent through the DCA.
JUDGMENT:
Nay Patent Linkage:
The decision began by outlining the framework of the Patent Act and described the rights of patent holders as negative rights which can be protected only by resorting to the framework under the Patents Act. It was also noted that the purport of Section 156 was not to enable the Drugs Controller to uphold the patent but merely casts a negative obligation on the government and its officers not to infringe a patent.
The decisions referred to by Bayer; Hoechst Pharmaceuticals v. CVS Mani and Arvind Mills v. Associated Roadways were rendered in entirely different contexts. The judge makes an interesting analogy to the Companies Act. Section 20(2) of the Companies Act bars the registration of a company name which resembles a registered trademark. A similar protection can be found in Section 17 B (a) of the DCA. This however does not extend to refusal on the grounds of a valid patent.
The court accepted Cipla’s contentions with respect to Form 44 and the differing scheme of the DCA and the Patents Act. It also accepted the contentions of the DCGI that the Controller’s office is not equipped to grapple with complicated patent disputes.
The court noted that in the instance of a patent holder seeking only marketing approval and not manufacturing approval, the drug will be highly priced. And accepting Bayer’s contentions would effectively block generic manufacturers thus deterring the availability of affordable drugs.
The judges also pointed out that allowing or disallowing patent linkages is a policy decision that has to be taken by the Government and accepts the contention that patent linkage is a TRIPS plus concept.
Generic drugs are not spurious:
At the stage of application for permission to manufacture or market the drug, the only determination under Section 17 B (a) DCA that can be made is with respect to similarity in the brand names. The Section deems drugs to be spurious “if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive..”. Generics unlike spurious drugs use their own brand name and label. It was held that the words imitation and substitute have to read in conjunction with “in a manner likely to deceive”. Bayer’s interpretation would also lead to the back door entry of penal provisions with respect to infringement.
Conclusion:
Patent linkages are unlawful in the European Union and the European Union Competition Authority’s Report on the Inquiry into the Pharmaceutical Sector (click here for a detailed post on the same) categorically criticized patent linkages. Patent linkages cause huge costs to both the consumers and governments which sponsor healthcare. The DCA should serve only to prevent adulterated drugs from entering the market and cannot be used against generic drugs.
Reiterating from my previous post,
A system which permits patent linkage is detrimental to immediate generic entry and the interests of generic manufacturers for the following reasons:
(i) It effectively amounts to extension of the patent period of the drug as generic drug manufacturers can begin the proceedings to obtain license only after the expiry of the patent period.
(ii) It can lead to multiple proceedings against the generic manufacturer. This will to wasted time and resources in litigation.
(iii) The system breeds uncertainty with respect to the legal status of the drug.
(iv) Including ‘generic drugs’ under the definition of ‘spurious drugs’ will lead to bolstering the misinformation campaign of branded drug manufacturers against generic drugs.
Image form here.
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The BT Brinjal fiasco: Time to pass the National Biotechnology Regulatory Authority Bill?
The last few weeks have been witness to several very vocal, sometime violent, protests against the introduction of BT Brinjal into the Indian market. The Ministry of Environment under the stewardship of Jairam Ramesh has attempted to convince the Indian people that this latest innovation has been tested adequately as per the law of the country and that the same were safe both for the environment and for human consumption. The fiasco at the public hearings however is clearly indicative of the low levels of confidence that the Indian people have in the regulatory process for biotechnology products. Ultimately the Ministry has announced that it is withdrawing its proposal to introduce BT Brinjal in the Indian market.Image from here - photo credit - J.E.Fee
The lack of confidence in bio-tech products is obviously bad news for innovation in the bio-tech sector. If the people do not have confidence in the regulatory process it is but obvious that innovation in this sector will suffer. For example the face of modern medicine and the pharmaceutical industry may have been completely different if the thalidomide disaster of the 60's had affected the U.S. the same way it affected Europe.
This brings us to the inevitable question of what exactly is the regulatory mechanism for biotech products in India?
Currently the biotech sector is regulated by two separate committees and ministries – none of which seem to have a solid legislative basis. The two Ministries at the fore-front are the Ministry of Environment and the Department of Biotechnology which functions under the Ministry of Science and Technology.
These two Ministries have two further committees under them – The Genetic Engineering Approval Committee (GEAC) and the Review Committee on Genetic Manipulation (RCGM). While the latter is the apex body functioning under the Ministry of Environment, the latter functions under the Department of Biotechnology. The only legislation which is vaguely related to these Committees is the Environment Act, 1986. The Committees are mostly regulated by a complex web of rules and regulations drafted by the bureaucrats of these Ministries. More controversially however a non-specialist IAS Officer is heading the GEAC - a specialist body. The guidelines and notifications are partially a result of writ petitions filed before the Supreme Court of India. However to the credit of these Committees I must mention that their websites host a surprising amount of useful information.
The question therefore is why India lacks a credible statutory mechanism to regulate this very important sector?
The answer is absolute lethargy. The Department of Biotechnology had, ages ago, drafted a bill to setup an autonomous regulator – the National Biotechnology Regulatory Authority. We had blogged about it here. For some reason it has not yet been introduced in Parliament. The Financial Express has reported earlier this month that the Bill to setup the Biotechnology Regulatory Authority of India (BRAI) will be okayed by Cabinet later this month so that it can be introduced in Parliament in the budget session.
Hopefully this Bill will be thought through carefully and not rushed through Parliament like the rest of the legislations these days.
For a previous insightful guest post on the topic please click here.
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Prashant Reddy
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Sunday, February 07, 2010
Payyanur Ring GI: religious sentiment no bar to registration
The GI Registry recently issued an order on the Payyannur Pavithra Ring, a traditional adornment from north Kerala, stating that "the use of sentimental of religion does not bar for registration." Payyannur Pavithra Ring, Artisans & Devp versus K Balakrishnan [2009 (41) PTC 719 (GIG)] - unfortunately I cannot find an online copy of this order - has observations which would have been more interesting than they are at present had they been better phrased. [Image from here] FYI, for those not in the know, "pavithra" means 'pure' in Sanskrit and Malayalam, which will put some things in perspective below.
The Payyannur Pavithra Ring application was No. 6 in the history of GI applications in this country, and so fairly early to jump in the fray. Admittedly, it's also taken its own sweet time to proceed to registration, for various reasons. And this will take a bit of story-telling.
1. Applicants are entitled to registration
The first objection to the application was that the applicants, a registered society of ring artisans, were not representative of the producers of the GI and not entitled to registration. This was not sustained, but to my mind, the registry's reasons were not satisfactorily explained in the order.
The order explains, albeit vaguely, the applicant's defence for claiming rights to the application, i.e., that the artisans are special goldsmiths which have some special characteristics and have to observe discipline during the of the product, etc., but fails to place on record why the applicant's entitlement was challenged.
2. "Use of sentimental of religion does not bar registration"
Secondly, the opponents raised the issue that the ring was "a sentimental issue of the public and could not be considered a GI product". In content that seems to have been picked straight from the www.payyanur.com website (or vice versa - and thereby making my typist's life simpler!), the order goes on to state that the:
"Payyanur Pavithra Mothiram is a uniquely crafted ring shaped like a knot and considered being a sacred ornament. Usually Payyanur Pavithram is being made of Gold and Silver. The Pavithram is to be worn on the right ring finger by the person performing Vedic Karmas. It is believed that this ring will bring luck and grace to anyone who wears it with the deep devotion..." And it continues for a few paragraphs more about the ritualistic and religious associations of the ring, which you can read here. [Image from here]
The opponent "also manufacturing the Payyanur Pavithra Ring and before wearing by the concerned person some pooja to be performed before the temple which is represented by the society of the applicants and the part of the cost of the product is devoted to the temple [associated with the wearing of the ring]".
From this and preceding paragraphs, the order dismissing the opponent's challenge, concludes thus:
"It means the ring made of gold or silver in the region is the subject matter of the GI. This is regularly in use since the Year 1011. After going through the arguments ... the ring is the product available in the particular region and famous in the name of Payyanur Pavithra Ring having specific quality. The applicant has already submitted the certified Map in support of the Application. In view of that the product Ring is the goods of GI and use of sentimental of religion does not bar for registration."
This part of the Registry's order, which may set a precedent in other GI products with a tangential religious element, may strike a raw chord with those who have been arguing otherwise, e.g., in the case of the Tirupati laddu GI.
I offer a poorly thought out, quickly written, different, non-religious way of looking at the two grants - suppose we classify Tirupati Laddus as fast-moving consumer goods, which they are, and therefore in larger volumes, and have a larger number of manufacturers spread over larger territory, thereby diluting the identity of the "original" manufacturers and so on; versus the ring which is a durable product, therefore significantly lower volumes and fewer manufacturers, with less dilution; does such an explanation, applicable to any product which may have religious association, help defend the grant of a GI to the ring and object to the grant of the laddu? Your thoughts.
3. Ring not common to trade
The third objection raised was that the ring is common to the trade as it was in manufacture by several persons in the region, including the opponent. But the Tribunal was satisfied that "the manufacturing system of the rings are same having same quality and style in the region and to be used after performing a pooja in the temple and known in the name of Payyanur Pavithra Ring only and does not lose is originality and can't be considered as common to trade", thereby closing the doors on the opposition, and pushing the application for registration.
Having said all of this, I must also point you to this article from the Hindu in 2005 that I came across earlier, based on a study by the Centre for Heritage Studies in Kochi, which argues that "Ethnic ornaments, which were once restricted to certain social sections and religious groups, are now transcending the barriers of religion and caste." Specifically,"Pavithra Mothiram was traditionally worn by men of the Brahmin community in connection with some rituals that they performed....Gone are the days when the Brahmin community alone wore this ring, which was also the specialty of jewellers from Payyannur. The ring is now widely used by men of all caste and religion and available at almost all jewellers across the State."[Image: Payyanur and Kerala; from wikipedia]
In any event, I don't have much to say on this order, for the reason that I couldn't understand it. I don't know if it is the fault of the persons delivering the order, or the ones transcribing it, or even the copy editors of the PTC that eventually published it. But given the rarity of GI orders (which is logical, since there are hardly any GI applications in India at present), it would have been interesting to read a clear, crisp, and well-phrased document, if only from an academic point of view. Or perhaps I expect too much.
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Sumathi Chandrashekaran
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11:22 PM
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Labels: Geographical Indication
Bombay High Court declines to hear interim CL applications; shows the Appellant the way to the Copyright Board
The radio station Appellant had filed a CL application with the Copyright Board back in 2007 after several rounds of failed negotiations with the Respondent Copyright Society. Although the facts aren't exactly clear, it appears that the radio station appellant was frustrated with the Copyright Board not deciding on its application because of which it approached the district court for declaratory judgment stating that it was entitled to broadcast music pending adjudication of the dispute. The Appellants had even stated that they were ready to pay a fixed royalty to the Respondents for the time being. The Appellants had also prayed for an injunction restraining the Respondents from interfering with their business of broadcasting.
The main argument forwarded by the Appellant was that the Supreme Court in the landmark CL case – Entertainment Network of India Ltd. v. Super Cassette Industries Ltd. had recognized the right of broadcasters to broadcast copyrighted works under a compulsory licence. In pertinent part the Appellant depended on the following extract from the SC judgment:
This scheme shows that a copyright owner has complete freedom to enjoy the fruits of his labour by earning an agreed fee or royalty through the issuance of licenses. Hence, the owner of a copyright has full freedom to enjoy the fruits of his work by earning an agreed fee or royalty through the issue of licenses. But, this right, to repeat, is not absolute. It is subject to right of others to obtain compulsory license as also the terms on which such license can be granted…….
The Respondents however opposed the jurisdiction of an ordinary civil court to entertain such a suit since the same was barred by Section 9 of the Code of Civil Procedure. Section 9 of the CPC prohibits civil courts from entertaining any suit if the same has been prohibited either expressely or impliedly by any other statute. In this case since the Copyright Act expressely vested the adjudication of Compulsory Licensing disputes with the Copyright Board it could be argued convincingly that a Civil Court was impliedly barred from entertaining such a suit.
The Division Bench agreed with the Respondents contentions and stated that the Appellants could not attempt to short circuit the procedure established by the statute by approaching civil courts when only the Copyright Board is vested with the jurisdiction to entertain the same. The Division Bench however was careful to state that it was not making any comments on the powers of the Copyright Board to grant interim compulsory licences.
It would be interesting to see whether the radio station in question could approach the, now-functioning, Competition Commission and claim relief on the grounds that the Respondent has abused its dominant position.
Posted by
Prashant Reddy
at
3:22 PM
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Labels: Compulsory Licensing, Copyright, Copyright Societies
Friday, February 05, 2010
Buckuchurbu and (re) Hydrating Indian Traditional Knowledge
In an earlier post, I highlighted the alleged potential of Crofelemer, a drug to mitigate some of the sufferings in Haiti. This drug for tackling dehydration was based on ancient shamanic wisdom and is allegedly better than most rehydrating solutions known today.Closer home, a rare medicinal plant found in Arunachal Pradesh 3 years back is touted as having excellent re-hydration properties. An article notes the discovery of this plant, known interestingly as "Buckuchurbu" to the locals:
"Begonia Tessaricarpa, last seen in 1890, was found growing in the wild in Upper Subansiri and Namdapha National Park in Arunachal Pradesh by Kumar Ambrish and M Amadudin, scientists of the Botanical Survey India (BSI).
Known to local Adi and Tagin tribes as "Buckuchurbu" and "Rebe" respectively, the plant is used by them to treat stomach aches and dehydration.
....The plant is eaten raw and cooked by local tribes for its "delicious sour taste". The tribals make a chutney with its leaves and stem and consume it to treat stomach pain and dehydration.
The plant's juice is used as ward of leeches by the tribes. The flowers of the plant have four petals -- two large and two smaller -- that makes them look attractive."
Have any of our pharmaceutical companies explored the potential of this rare plant? Or given its rare status, is it better off hiding its traditional wisdom from corporate exploitation?
And lastly, as an aside, will the "hydration" possibilities offered by the Buckuchurbu lead to more evergreening in India?
Posted by
Shamnad Basheer
at
12:31 AM
1 comments
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Labels: Indian Pharma, Traditional Knowledge
Thursday, February 04, 2010
The Haitian Plight and Traditional Knowledge: A Promise Unfulfilled?
As we watch with horror at the plight of many in Haiti, the last thing on our minds is the nexus between traditional knowledge and the sad events that unfolded in the wake of a devastating earthquake almost a month back.According to this piece in the Huffington Post, there is indeed a significant nexus here. Apparently, the traditional medicinal wisdom of the Shamanic healers from the Amazonian forests was leveraged to create a drug, Crofelemer whose properties could be very effective for tackling dehydration--a rampant problem in Haiti (apparently only 47% of Haitians have accecss to clean drinking water) and one that was sharply exacerbated by the recent quake.
The article notes:
"A potential tool in the armament against the devastation of dehydration is crofelemer, a pharmaceutical product derived from the knowledge of shamans, or healers, in the South American rain forests.
The existing go-to formula, Oral Rehydration Solution (ORS), does indeed replenish depleted bodies and save lives, and should always be given to children and patients with severe disease in the case of dehydration. ORS does not slow or stop water loss. A complementary approach, crofelemer, according to data presented at scientific conferences, decreases fluid loss, and shortens the duration of diarrhea in both the mildest and most severe of cases, including cholera and chronic diarrhea in immuno-compromised patients."
Naturally, this drug would have been a boon to many Haitians suffering from a variety of ailments that trigger dehydration such as diarrhoea. However, this was not to be.
Apparently, owing to a number of financial bottlenecks involving the Gates Foundation and the organisation through which the funds had to be routed, the Institute of One World Health (iOWH), this drug is yet to make it to the market.
Important caveat: the piece is of written by Lisa Conte, the founder of Napo Pharmaceuticals, the company that created this drug in the first place. She ends her piece with:
"With great gifts comes great responsibility. No doubt, the Gates Foundation is a profound gift to global health, accounting for 80 percent of NGO funding these days. A Gates grantee recently told me that when, due to the recession, the foundation didn't increase its grant funding this past year, the effects were felt thunderously by the NGO community. In many arenas of global health, the foundation is the agenda.
The crisis in Haiti and the helplessness we all feel have moved me to write to the Gates Foundation again, yet perhaps this time in a way in which the message won't get submerged by those with personal agendas to protect at all costs, the most precious of which are the lives of children in places with little resources. Dear Mr. Gates, I hope you get this message."
Interestingly, for those of us interested in the link between TK and modern pharma, Conte's earlier article at the Huffington Post states thus:
"The drug discovery process at Napo is based on the knowledge of shamans -- traditional healers in the rain forest -- to identify plants, and ultimately compounds, that are more likely to be safe and effective in humans because they have been used in medicinal settings for thousands of years.
Posted by
Shamnad Basheer
at
10:55 PM
1 comments
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Labels: Pharma, Traditional Knowledge
IPR Summit 2010
- Patentable Subject Matter in Biotechnology and Pharma
- IP Issues in Life Science
- Enablement and Written Description Requirements in Patent Law
- Patent Litigation in India v. US
- IP Issues in Software and Electronics Industry
For registration and other information,please see here.
For further details,please contact :
Shilpi Jha,CII-shilpi.jha@cii.in [shilpi.jha [at] cii.in]
Posted by
Shayonee Dasgupta
at
9:57 PM
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Labels: SpicyIP Events
Indian "Bayh Dole" Problems: Some Resources
Some of you wrote to state that you had difficulties downloading it from the SpicyIP website. I have therefore now uploaded it to the SSRN website and you can access it by clicking on this link (and then proceeding to click the "download" button).
I've also come across some excellent writings and resources on this theme, as listed below:
1. Amit Ray and Sabyascahi Saha, Intellectual Bottlenecks, Financial Express
2. Latha Jishnu, "Perils of the US Model", Business Standard
3. Mrinalini Kochupillai, The PUFPIP Bill, Journal of IPR
4. Leena Menghaney, "A Bad Example from the US", Down to Earth
4. The CIS website: Collection of Resources on Indian Bayh Dole. See also here and this article by Pranesh Prakash here.
Given the hard hitting critiques in most of the pieces referred above, it will be a lamentable if the Bill goes through in the present form. One hopes that there will be some sensible refrains when it comes up for voting in Parliament.
Posted by
Shamnad Basheer
at
3:58 PM
1 comments
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Labels: Bayh Dole, Parliament, Patent, Scholarship
Tuesday, February 02, 2010
The National Biodiversity Authority invites comments on draft amendments
The National Biodiversity Authority (NBA), the statutory authority, under the Biological Diversity Act, 2002 has put out a delightfully public notice requesting public participation and comments on the following:(i)International Regime on Access and Benefit Sharing;
(ii)Evolving sui generis system for the protection of Traditional Knowledge; &
(iii)Amendments to the Biological Diversity Act, 2002 and Biological Diversity Rules, 2004.
The public notice along with the relevant reference material can be accessed here.
I use the words 'delightfully public notice' because in sharp contrast to the procedure followed by the Rajya Sabha Standing Committee on the Indian version of Bayh Dole Act, the NBA has not only published the public notice on its website it has also published advertisements in the newspapers inviting the public to send their comments before the 15th of February, 2010.
This move could not have come at a more opportune time especially since India seeks to take the lead in negotiating a new international protocol on Access and Benefit Sharing.
A quick look at 'The Protection, Conservation and Effective Management of Traditional Knowledge relating to Biological Diversity Rule, 2009' reveal an ambitious and equitable agenda. The Rules aim to establish an access and benefit sharing regime which will be based on the prinicples of prior-informed consent of the community holding the traditional knowledge in question.
Most interestingly the definition of 'traditional knowledge' in the rules is impressively broad - “Traditional Knowledge” means the collective knowledge of a traditional community including of a group of families, on a particular subject or a skill and passed down from generation to generation, either orally or in written form, relating to properties, uses and characteristics of plant and animal genetic resources; agricultural and healthcare practices, food preservation and processing techniques and devices developed from traditional materials; cultural expressions, products and practices such as weaving patterns, colors, dyes, pottery, painting, poetry, folklore, dance and music; and all other products or processes discovered through a community process including by a member of the community individually but for the common use of the community;”
I'm a little intrigued as to the inclusion of 'cultural expressions such as poetry, folkore, dance and music' into the rules of a legislation which aims to protect the biological diversity of the country.
Posted by
Prashant Reddy
at
2:27 AM
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Labels: Biological Diversity, Traditional Knowledge, Transparency
Monday, February 01, 2010
Abbott's "Humira" Patent Unilaterally Revoked by Indian Patent Office
In a rather bizarre incident, the Indian Patent Office (IPO) granted a patent to Abbott Laboratories relating to Humira, its best selling biologic meant to cure severe forms of arthritis. And then proceeded to revoke it a month later on its own accord!On receiving the rather pithy "cancellation" order from the IPO, a visibly shaken Abbott approached the Delhi High Court. Justice Muralidhar promptly stayed this unusual action by the IPO and issued a notice to it, returnable by the 27th of April. (the judges' order is dated 22nd Jan, 2009).
It turns out that a not so diligent Controller at the Delhi Patent Office had granted the patent without taking into consideration a pre-grant opposition filed by Glenmark. When this was pointed out by an upset Glenmark, the said Controller, in a bid to cover up her mistake, proceeded to take the law into her own hands and issued a "cancellation" order to Abbott.
Abbott's petition before the Delhi High court alleges that the patent office has no power under the Indian Patents Act to unilaterally revoke/cancel a granted patent. The only power of revocation vests with the IPAB and the High Court (as a counterclaim). Further, a Controller may review his/her own order, but this has to be done at the instance of a petition filed by an interested party.
Abbott then proceeded to argue that the only remedy in such an unusual situation is for Glenmark to file a post grant opposition. They cite the Supreme Court order in the Valcyte case which had ruled on similar lines, asking an aggrieved patient group that was denied the right to hearing at the pre-grant stage to take up their grievance as a post grant opposition.
From the facts, it would appear that there is no "foul" play here. Rather, the Controller appears to have taken this decision on her own accord without consulting her superiors. Her blatant ignorance of the law may perhaps make out a case for ramping up legal training at the IPO.
It might also make out a case for subjecting entry level patent examiners to the patent agent exam, in order to test their proficiency with basic legal principles.
Posted by
Shamnad Basheer
at
11:49 PM
10
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Labels: Indian patent litigation, Opposition, Patent Office, Pharma, revocation
Asked not to Dial : Just Dial Accuses Askme of Data Theft
For more on injunctions, please see here .
Posted by
Shayonee Dasgupta
at
4:13 PM
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