Sunday, February 19, 2012

Revoking patents without ‘evidence’

In a decision dated the 24th of November, 2011 the Intellectual Property Appellate Board (IPAB) revoked patent number 193899 bearing title “Process for Preparation of Low Glycemic Sweets”. (This order can be accessed over here) As the title suggests the patent in question was for a process to prepare ‘low-sugar’ sweets for diabetic patients. The revocation petition was a part of a long-standing dispute between the famous Chennai based Adyar Bhavan and the inventors of the impugned patent. The first limb of this litigation was a suit for patent infringement filed before the Madras High Court by the inventors of the patent. At the interim stage the Madras High Court avoided examining questions of patent validity and proceeded to grant the plaintiffs an interim injunction. That order can be accessed over here. (Image from here

The patent in question was revoked by the IPAB due to the lack of ‘an inventive step’. The problem with the judgment of the IPAB is the fact that it has not based its decision on any evidence. The fault partially appears to lie with the petitioner. The normal practice in patent revocation petitions is to file the affidavits of expert witness as ‘evidence’ which would establish either obviousness or one of the other grounds for patent revocation. The expert witness in his or her affidavit usually leads the Court through documentary or other evidence and the veracity of the same may be tested by the opposite side through cross-examination. Surprisingly, in this case the petitioner does not seem to have filed any such expert witness affidavits or at least the judgment does not appear to refer to any such affidavits. In fact the judgment clearly mentions that the petitioner has failed to file any evidence. In pertinent part the IPAB’s order states that “ The respondents would like to state that the petitioner have never produced any documentary proof for substantiating his grounds of revocation, but only been repeatedly making bald statements, but failed to produce any convincing evidence or other documentary proofs. Similarly the petitioner has only relied on the arguments given in the pleadings, taking all the available grounds of revocation, but has not adduced any further documents or evidences to substantiate those grounds of revocation.” 

Despite the fact that there was no ‘evidence’ on record, as understood under the Evidence Act, 1872, the IPAB proceeded to knock-down the patent on the basis of alleged prior-art documents stated by the petitioner during the course of the arguments. In doing so the IPAB has failed to distinguish between ‘questions of law’ and ‘questions of fact’. ‘Questions of law’ can be argued by the petitioner’s counsel using judicial precedents and other statutory aids. ‘Questions of fact’ however need to be proved through evidence that is accepted under the Evidence Act, 1872. This would mean that the petitioner should have filed expert witness affidavits before the IPAB and those witnesses should have been put up for cross-examination by the opposing counsel. Issues such as ‘inventive-step’ are usually mixed questions of law and fact i.e. the prior art is a factual issue but the standard of obviousness is a legal issue. The prior art therefore has to be established through an expert witness and the subsequent standard of obviousness can be establish by counsel for the petitioner through judicial precedents which do not have to be proved. 

In the present case, the IPAB should have thrown out the revocation petition due to the lack of evidence, especially when the patentee made out an extremely strong case for such an action. Unfortunately, that did not happen. Instead the IPAB ignored the respondent’s argument on the lack of ‘evidence’ and proceeded to revoke the patent on the basis of prior art documents which do not qualify as evidence under the Evidence Act, 1872. 

A part of this problem can be traced to the lack of strong procedural rules before the IPAB. For example in civil litigation before the High Court, the Court under the Code of Civil Procedure, 1908 would have framed issues outlining the factual disputes and would have also placed the onus of proof on one particular party. Similarly documentary evidence would have been ‘admitted/denied’ by both parties before cross-examination. Although such procedure may appear tedious, it is absolutely essential to streamline litigation. Unfortunately, the trend in India is to view any kind of litigation before a tribunal as a summary proceeding where speed is favoured over substantive justice. Patent litigation is not ‘service law’ litigation before the administrative tribunals. The IP Bar needs to make a move to petition the IPAB to adopt substantial procedural rules. If necessary the IPAB can just lift the relevant provisions of the CPC and notify the same into rules of the IPAB.

Saturday, February 18, 2012

MNC's Trademark revoked for Non-Use on Indian User's Application

About a month back, an interesting case of trademark revocation had passed through the Delhi Circuit Bench of the Intellectual Property Appellate Board, to which the Spicy IP team wishes to turn the readers’ attention.

Name of the Case: M/s. Pops Food Products (P) Ltd. (Petitioner) vs. M/s. Kellogg Company (Respondent) [TRA/159/2004/TM/DEL]

Decided on: January 6, 2012.

Facts of the Case: Petitioner is the proprietor of the trademark POPS under Nos. 342674, 342675, 342676 in classes 30, 29 and 30 respectively for its goods viz. Chewing Gum, Bubble Gum, Dairy Products etc. and has acquired a goodwill for itself through usage and advertisement of such mark for a long period of time, so as to have created a general public perception of the mark being associated with its goods. Respondent had intimated the Petitioner of it being the proprietor of trademark POPS in relation to cereal derived breakfast food and of its intention to oppose the Petitioner’s registration, and possibilities of settlement provided the Petitioner restricted its goods to specified goods. The Petitioner in turn has sought rectification by removal of Respondent’s mark from the Register.

Petitioner’s contentions: Respondent has not made any use of the mark in India nor does it have bona fide intention to do so. Although the products for which the marks are used are not identical, yet they are all bought across the country through the same trade channel and by the same class of customers, who, especially children, would be inclined to buy POPS Cereals thinking that the mark belongs to the manufacturer of Bubble Gum and Chewing Gum with whom they are familiar. The Petitioner also submitted conclusive documentary evidence to prove that POPS Chewing Gum and Double Bubble Gum are sold across the country.

Respondent’s contentions: The Respondent argued that the Petitioner had not proven continuous use of the mark POPS, while the Respondent had adopted the mark (the marks CORN POPS-638273, COCO POPS-758864, SNAP, CRACKLE, POP-345988, POP-TARTS-516460) in 1941 internationally and gained subsequent good will by its use. Although Respondent is yet to use its mark in India, the latter has gained parallel reputation and trans-border goodwill owing to Indians travelling abroad and the Respondent intends to use the mark subsequently in India. Moreover, Petitioner’s use of the mark being limited to products like Chewing Gums and Bubble Gums only, the Petitioner cannot have any cause for grievance against the Respondent since there is no scope of mistaking the Respondent’s products for the Petitioner’s.

The Respondent also cited several cases such as:
Jupiter Infosys Limited vs. Infosys Technologies Limited (In TRA/25-27/2003/TM/CH) [stating that in case of proving non-use, in the present day world of commerce and industry a manufacturing industry can neither be commenced nor established over night];
Revlon vs. Rajendra Kumar Dhawan [the initial onus of proving non-user is to be established by applicant for rectification through cogent evidence];
Kamat Hotels (India) Limited vs. Royal Orchid Hotels Limited (In ORA 216-217/2008/TM/CH) [stating that law requires proof of both no bonafide intention to use and no bonafide use];
Osram Gesellschaft Mit Beschrankter Haftung Vs. Shyam Sunder & Ors. (2002 (25) PTC 198 (Del) (DB) [a registered trade mark holder cannot in law claim exclusive monopoly rights for its trade mark as extended to goods of all descriptions falling within the same class in which its sole and solitary product falls.];
Hardie Trading Limited and Anr. Vs. Addisons Paint and Chemicals Limited (2003 (27) PTC 241(SC)) [In cases of rectification on the grounds of non-use, there was no reason to limit the user to use on the goods or to sale of goods bearing the trademark].

Judgment: Reference was made to the Milment Oftho Industries case [2004 (28) PTC 585 (SC)], wherein the Supreme Court had held earlier that in case of conflict between usage of a mark by a company within India and off-shore use by another company, public interest must not be imperilled, although multinational corporations, who have no intention of coming to India or introducing their product in India should not be allowed to throttle an Indian Company by not permitting it to sell a product in India, if the Indian Company has genuinely adopted the mark and developed the product and is first in the market. Thus, the ultimate test should be who is first in the market. The judiciary also showed considerable insight in concluding that while the Respondent’s contention that business cannot be started overnight has merit and that the person who alleges non-user (in this case the Petitioner) should bear the burden of proof, yet in this case, given the Respondent’s admission of non-use till date, the Petitioner needs not submit additional proof of the same. Nor did the Court find any bona fide intention of use of the mark by the Respondent within India, given how no step had been taken towards the same within the 22 years since the date on which the Respondent had registered said marks.

Order: The Petitioner’s contentions for rectification are accepted and the Respondent’s marks are ordered to be removed from the Trademark Register.

Friday, February 17, 2012

No patent for Bristol's infant formula at the IPO: 4807/CHENP/2006

This post illustrates the current patent office view on claim amendments after national phase entry but before examination.  Claim amendments before the issuance of an office action/FER are not acceptable.  However, this view (claim amendments not acceptable before issuance of an office action/FER), in my opinion, is not correct because of two very specific reasons, both involving money.  1.  An applicant pays for, and gets claims to demarcate the metes and bounds of his rights.  In an infringement actions, it is the claims that matter. Claim amendment is therefore a right, and one that is limited to the disclosure originally made; (2) The applicant has an option of including claim language that complies with various  laws in the PCT application.  This choice may lead to an increase in the pages but the patent offices worldwide make a lot of money from those extra pages in the form of additional fees/page.  

The patent office may, therefore, reject an application because of no support in originally filed complete application, but it cannot reject an application merely because claims have been suitably amended to comply with jurisdictional norms.  Claim amendments that comply with jurisdictional norms must, in my view, be encouraged.  Warning: Long post follows:

Bristol-Myers Squibb ("Applicant") filed a national phase ("NP") application for, a "Therapeutically effective amount of Bb-12 and LGG in the preparation of a medicament for preventing or treating respiratory infections and acute otitis media in infants." This NP application was for an application number PCT/US2005/023330, filed July 1, 2005 and claimed prioirty to a US provisional application 60/584830, of July 1, 2004.  The Controller's decision can be accessed here.

Procedural History
At the time of filing the Indian application (NP), Swiss style claiming was used.  Claim 1 was:  Use of a therapeutically effective amount of Bb-12 and LGG in the preparation of a medicament for preventing or treating respiratory infections in an infant.

To contrast, the claim style in the PCT application was entirely different in the NP application. Claim 1 in the PCT application was: A method of preventing or treating respiratory infections in an infant, the method comprising administering to the infant a therapeutically effective amount of Bb-12 and LGG.
The Controller took objection to the change in the NP application and cited to the relevant provision in the Patent Cooperation Treaty (Article 19).  

The date of a NP application is reckoned from the date of international application filed in PCT. Therefore, the contents of the complete specification in PCT and the Indian National Phase application.  No amendment is allowed at the time of filing the application, but the same is allowed after filing the application. 
According to the Controller, applicant filed NP application with amended claims where there is no provision to do so.  An amendment to the specification is possible under the Indian patent laws and rules after the application has been filed in India (under section 57 and 59).

After the First Examination Report (FER), the applicant amended the claims again into composition claims.  Claim 1 after amendment read:
A nutritional formula, comprising an infant formula which comprises:
a lipid or fat;
a protein source selected from the group consisting of whey protein, casein, casein protein, non-fat milk, hydrolyzed protein, and combinations thereof;
one or more Bifidobacterium species which comprises Bifidobacterium lactis Bb-12; and
one or more bacterial species which comprises Lactobacillus rhamnosus GG.

At this stage, the Controller noted: [T]he applicant changed the entire scope of the initital 10 claims into 19 compositions to meet the objections of the FER. There was not a single composition claim at the time of filing the NP application, and hence application needed further examination, and a hearing was done.

After the hearing the applicant amended claims again.  This time the claim read:
An infant formula comprising:
3g to 7g of a lipid per 100kcal of infant formula;
1g to 5g of a protein source selected from the group of whey protein, casein, casein protein, non-fat milk, hydrolyzed protein, and combinations thereof per 100kcal of infant formula;
between 10^5 and 10^11 cfu of Bifidobacterium lactis Bb-12 and Lactobacillus rhamnosus GG.

The Controller then pointed to the the object of the invention and marked several statements from the complete specification.  For example, the Controller noted: "[A]ll the embodiments described in the description are related to method for preventing or treating respiratory infections and AOM in infants.  Interestingly, the claims at the international phase and NP entry are also related to the use of Bb-12 and LGG in the preparation of a medicament for preventing or treating respiratory infections in an infant by administering a therapeutically effective amount of Bifidobacterium lactis (Bb-12) and Lactobacillus rhamnosus GG (LGG), respectively.
...I wonder how different types of claims are possible for a single description which related to single invention in different jurisdictions.  Claims allowed in some countries are use/method (of treating and preventing) claims, but those are non-patentable in India.

Then the Controller discussed various prior art documents and their application to the claims and concluded that the subject matter of the claims did not involve an inventive step under section 2(1)(ja).

The Controller then cited to various tables in the complete specification and concluded: "Thus the present invention confidently related to a method of preventing or treating respiratory infections in an infant but the applicant amended from 'use' to 'infant formula' through method for preventing or treating respiratory infections in an infant claims.  Use or method of treating claims is not considered as an invention and/or non-patentable inventions under the provision of the Act in India.  Therefore the applicant willfully amended claims into infant formula to obtain a patent for a non-patentable subject matter.

...The infant formula as claimed in claim 1 of the present invention neither prepared so far nor imagined till receiving the FER in 2009.  The birth of claim 1 took place only after FER.  The applicant misleads patent administration by manipulating the information disclosed in the description in a different way to acquire patent for infant formula which was not at all prepared as a product.  ....Thus the claims of the present invention lack support in the description and not complied with the requirement under section 10(4) of the Act.

Therefore the Controller refused to allow the application.

More on the nationalization of GIs - Sarkar Raj - Power cannot be given - It has to be taken

Continuing from my earlier post on the ‘nationalization’ of G.I. which covered the G.I. applications from 100-200, I’ve now compiled some statistics for the first 100 G.I. applications to have been filed in India. Not surprisingly, 64% of these 100 applications have been filed and subsequently registered in the names of government agencies ranging from the Government of India to the State Government of Tamil Nadu. The entire list can be accessed over here

A total of 17 G.I.s for handicrafts have been registered by Development Commissioner (Handicrafts), Ministry of Textiles, Government of India. Amongst the various G.I. granted to this agency are the ‘Coconut Shell Crafts of Kerala’, ‘Temple Jewellery of Nagercoli’, ‘Kathputlis of Rajasthan’, ‘Leather Toys of Indore’ and ‘Bagh Prints of Madhya Pradesh’. The Development Commissioner sitting in Delhi has therefore registered G.I.s for handicrafts across the length and breadth of the country. The only way the Development Commissioner could have filed these applications is if he claimed to have been representing the interests of the producers of these handicrafts. I have no clue whether the Development Commissioner for Handicrafts was actually authorized under the law to represent the interests of the artisans who make these handicrafts. Image right: Madhubani Paintings - Image from here.

Other famous G.Is which have been registered by government agencies include the following: 

1. Madhubani Paintings: Director of Industries, Department of Industries (Govt. of Bihar); 

2. Kancheepuram Silk: Department of Handlooms & Textiles (Govt. of T.N.) Image right: Kanchipuram Silk Saree (from here
3. Kullu Shawl: H.P. Patent Information Centre, State Council of Science, Technology & Environment 

4. Darjeeling Tea: Tea Board, Ministry of Industries & Commerce 

5. Channapatna Toys & Dolls: Karnataka State Handicrafts Development Corporation Limited 

6. Mysore Sandal Soap: Karnataka Soaps & Detergents Limited, (A Government of Karnataka Enterprise) 

7. Coorg Oranges: Department of Horticulture, Govt. of Karnataka, Biotechnology Centre 

8. Muga Silk: Assam Science Technology and Environment Council

9. Bastar Wooden Craft: Chhattisgarh Hastshilp Vikas Board 

10.  Mysore Silk: Karnataka Silk Industries Corporation Ltd. 

Another interesting trend that caught my eye was the G.I. Application (No. 91) for ‘Nirmal Toys & Crafts’. This application was filed and subsequently registered in the name of Nirmal Toys & Arts Industrial Co-operative Society Ltd, Nirmal, Adilabad District. Two of the subsequent applications for ‘Nirmal Furniture’ & ‘Nirmal Paintings’ were filed by Andhra Pradesh Handicrafts Development Corporation Ltd. We therefore have an example where a private group of artisans and the government seem to be competing for similar G.Is. 

Apart from the general trend of nationalization of G.Is, I also noticed some rather odd G.I. registrations. For example Application No. 18 for ‘Mysore Agarbathi’ was filed and registered in the name of the All India Agarbathi Manufacturers Association. Why should an ‘All-India’ association be granted the registration for a product which is manufactured only in Mysore? 

The larger questions which I hope to be discussing in the future are the quality of examinations by the G.I. Registry especially since the rate of grant of G.I.s seem to be as high as 90%. 

Wednesday, February 15, 2012

‘NO’ to Monsanto: Indian NGO Complains Bio-piracy before the EPO over a Resistant Melon Variety

Indian scientist and environmentalist Dr. Vandana Shiva has joined hands with ‘No Patents on Seeds’ coalition in their opposition to a patent granted by the European Patent Office (EPO) in May last year to Monsanto Invest N.V. over ‘closterovirus-resistant melon plant’. The patent claims a new variety of melon which is resistant to Curcurbit Yellow Stunting Disorder Virus (CYSDV) bred using closterovirus-resistant trait identified in few melons of Indian origin. The Indian variety has long been registered in international seed banks (PI 313970) and the claim according to opponents uses conventional breeding methods of crossing and selection to create the new resistant varieties.

Image from here

The opponents seek complete revocation of the patent for lack of inventiveness and have pointed out that conventional breeding methods are beyond the scope of patentability under Article 53(b) of the European Patent Convention, 1973. Furthermore, they allege that the application does not sufficiently and clearly disclose information required to breed CYSDV resistant melons. More importantly, the opponents fear that the patent would deny ‘access to genetic resources necessary for further breeding’. In this regard, Dr. Shiva’s Navdanya argues that the claim is not patentable under Article 53(a) as it is against ordere public for violating provisions of the Indian Biological Diversity Act, 2002 enacted pursuant to Convention on Biological Diversity (CBD).

Bio-piracy of Indigenous Melons

Dr. Shiva’s Navdanya has deposed that Monsanto’s patent violates the following domestic biodiversity and plant variety legislations for not obtaining prior approval from the Indian Government:

(i) Biological Diversity Act, 2002: Section 6 of the Act mandates approval from the National Biodiversity Authority (NBA) for acquiring a patent right anywhere over an invention based on biological resources obtained from India. Given that Monsanto did not obtain any permission from the NBA and Indian melon varieties were used in creating the new variety, they can be prosecuted under the Act for bio-piracy.

(ii) Protection of Plant Varieties & Farmers’ Rights Act, 2001: The subject matter of the Act deals with granting and protecting rights of farmers and breeders of new plant varieties. The Act, however, nowhere imposes any obligation on breeders’ to seek permission from the Plant Varieties Authority before seeking an IP right over new varieties bred using indigenous biological resources. In fact, Section 30 permits all breeders to use any extant variety for creating new varieties without conflicting with other rights. Even otherwise, the Act is territorially limited to protection of new plant varieties domestically and it would not be sufficient to deny a patent abroad. Hence, I see no violation of sovereign rights under the Act.

What are they actually trying to oppose?

An underscore to this opposition is the violation of the Biodiversity Convention to which India is a signatory. Article 15 of the Convention recognizes sovereign rights of States over its biological resources. It allows the States to regulate access to their genetic resources and to enact legislations to mandate consent prior to obtaining access. As a fair and equitable bargain for providing access, the States can further require sharing of the ‘results of research and development and the benefits arising from commercial and other utilization of genetic resources’. Clearly, as the opponents rightly fear, breeders would be prevented from creating new varieties inheriting the resistant trait. This is nothing but misappropriation of Indian biodiversity and violates CBD which EU members have agreed to bind themselves.

Sunday, February 12, 2012

The ‘Nationalization’ of Geographical Indications in India

I spent the better part of this morning browsing through the registration details of 100 G.I applications (Applications nos. 100 to 200) at various stages of examination and registration before the G.I.Registry. Of these 100 G.I. Applications, a surprising total of 57 applications, i.e. 57% of the applications, were filed by either the Central Government or a State Government through different authorities, statutory and executive. The list of these applications can be accessed over here and here. I was always under the presumption that G.I. application would be filed by artisan or farming communities. Image from here.

As per the Geographical Indications Act, 1999Any association of persons or producers or any organization or authority established by or under any law for the time being in force representing the interest of the producers of the concerned goods” may file an application for registration of a GI. This is in keeping with the overall objective of the G.I. Act, which is to protect the identity of a particular good that has properties which are attributable to a particular region or which are manufactured in a particular region. In my opinion the G.I. Act was meant to help communities to protect the brand value of their goods or foodstuff which had acquired a reputation over several centuries. The G.I. Act was thus meant to empower communities across India, whether traditional or modern. It is thus surprising when you realize that 57% of all applications are being filed by the State and Central Governments. 

For instance the G.I. application for ‘basmati’ has been filed by the Agricultural & Processed Food Products Export Development Authority (APEDA) which is a government body and not an association of farmers or mill owners. Interestingly, APEDA has been authorized by an Act of Parliament (available over here) to protect the IP rights of ‘special products’ in India or outside India. The relevant provision of the legislation reads as follows: 

Without prejudice to any law for the time being in force, it shall be the duty of the Authority to undertake, by such measures as may be prescribed by the Central Government for registration and protection of the Intellectual Property rights in respect of Special products in India or outside India. Explanation.¯ For the purpose of this section “Intellectual Property” means any right to intangible property, namely, trademarks, designs, patents, geographical indications or any other similar intangible property, under any law for the time being in force.’ 

APEDA has invoked its powers under this provision to protect ‘Basmati’ in India and abroad. In essence, Parliament has ‘nationalized’ the ‘basmati’ mark which was otherwise the property of private farmers. I’m not sure of the terms of use that have been authorized by APEDA but I just hope that ‘basmati’ farmers, who are the real stakeholders, have adequate say in the manner in which APEDA controls the use of the word ‘basmati’. Image left: Basmati, from here.

Moving on to some of the other instances, I have to say that most of these registrations appear to be rather odd. For example the G.I. Application (No. 169) for the famous ‘Kolhapuri Chappals’ which is usually manufactured in the Kolhapur District of Maharashtra has been filed by the Central Leather Research Institute (a part of CSIR) located in Chennai i.e. at least a thousand kilometres from Maharashtra. The ‘Kolhapuri Chappals’ are really famous because of the efforts of traditional artisans over the years. Why then is CSIR filing a GI Application for this particular G.I.? Why aren’t the artisans of Kolhapur filing this application in the name of their own association? Image right: 'Kolhapuri Chappals' from here.

Similarly the Export Commissioner of the Uttar Pradesh Government has filed at least half a dozen G.I. applications for various GIs such as ‘Firozabad Glass’, Kannauj Perfume, Kanpur Saddlery, Moradabad Metal Craft, Varanasi Glass Beads, Khurja Pottery, Saharanpur Wood Craft. Again, why aren’t the artisans forming communities to register and control the use of their G.Is? 

Even stranger, are the instances of Universities filing G.I. Applications. For instance the Kerala Agricultural University has filed a G.I. application for ‘Central Travancore Jaggery’. The same was registered by the G.I. Registry. Similarly the Junagadh University in Gujarat has successfully managed to register the ‘Gir Kesar Mango’ as a G.I. Yet another example from Gujarat is ‘Bhalia Wheat’ which has been registered by the Anand Agricultural University. I can understand universities filing for patents but why are these universities filing for G.Is? Are they producing and marketing mangos and wheat? 

Another variety of registrations is joint registrations by a University and an association of farmers or artisans. The ‘Wayanad Jeerakasala Rice’ has been registered as a GI in a joint application by the Kerala Agricultural University and the Wayanad Jilla Sugandha Nellulpadaka Karshaka Samithi. Similarly the Tangaliya Shawl has been registered jointly by the Tangaliya Hastkala Association, the National Institute of Fashion Technology (NIFT) and the Ministry of Textiles. Why are artisan associations sharing their valuable IPRs with these universities and the government? It is not as if Universities can add value to the ‘brand-value’. At the most they can add to the yield or productivity of a certain product. 

Yet another oddity in these G.I. applications is when the Central Government starts registering G.I. for products across India. For instance the Development Commissioner (Handicrafts), Ministry of Textiles, Government of India sitting in New Delhi has been filing and granted registrations for the following G.I.s: Sankheda Furniture (Gujarat), Agates of Cambay (Gujarat), Datia and Tikamgarh Bell Metal Ware (Madhya Pradesh), Kutch Embroidery (Gujarat). Both Gujarat and Madhya Pradesh must be at least 700-1000 kilometres away from New Delhi. How do artisan groups in these states access the Development Commissioner sitting in New Delhi? 

The issue of State Governments registering G.Is in their own names seems to be quite wide-spread and includes states like Kerala, Tamil Nadu, Karnataka, Andhra Pradesh, Uttar Pradesh, Nagaland, West Bengal. Of the Central Government authorities it appears that the Ministry of Textiles, the Coffee Board and Spices Board both of which function under the Ministry of Industry and Commerce take the lead for the most number of G.I. applications filed in their own names. (Please note that the sample size was limited to 100). I’m sure that this post scratches only the surface of the issue. I hope that somebody is willing to fund some more serious research into the quality of G.I. registrations and whether the artists and farmers have been given their due by the Central and State Governments who seem to own a majority of the G.I.s.

Official Inquiry into mismanagement of IPRS given a quiet burial


In a reply to an RTI application, the Copyright Office has now informed us that the official inquiry into allegations of mismanagement of IPRS, has been given a quiet burial on account of the pending Copyright (Amendment) Bill, 2010 in the Indian Parliament. I don’t quite understand the link between the pending Bill and the inquiry but as long as the original complainants i.e. M/s Akhtar & Co. aren’t complaining, we can only presume that the matter has been amicably settled.  The reply can be read over here.

For a quick recap of the original inquiries by the Registrar of Copyrights, you can click over here and here. It has been almost a year since we had carried a series of stories on the inquiries by the Copyright Office into serious allegations of mismanagement at IPRS. This latest RTI Application basically asked for details on the events which followed the last document in our possession: a file-noting dated February 23, 2011. The file noting had detailed the possibility of a meeting between the complaints and IPRS along with the Government in a bid to sort out the matter. The RTI response has also clarified that there is no 'paper' following up on this particular file-noting. 


In hindsight, it seems to have been an awful waste of time to have been tracking these inquiries. I was expecting a more conclusive end to the inquiry.

Saturday, February 11, 2012

Controller's Decisions: Summary January 2012

This post provides a summary of the Controller's decisions issued in January 2012.  The general trend of more refusals than allowances continues. I would not take names but some controllers have not given a single allowance since a long time.  And only time would tell whether at least one applicant is able to convince them to take a contrary view and issue an allowance, rules and law permitting.  There are quite a few interesting decisions related to sections 3(k), divisional filings, and deemed withdrawals, and we will carry more detailed posts on a few of these decisions in separate posts.    

Some of you have written to me individually asking me about the upcoming exam (whenever it might be held) and it's preparation.  I generally mark these posts with an exam tag and my advise is: Prospective exam takers should read these decisions and see the application of the law/rules in action. For example, it is very helpful to see why one 3(k) decision is allowed and other refused.        
 
APPLICATION #
APPLICANT
DECISION
SECTION/RULE
CONTROLLER
BOEHRINGER
Refused
3(d), 2(1)(j)
N.R.Meena
CSIR
Deemed withdrawn
R11B
N.R.Meena
ENI .p.A.
Time extended
77(1)(g)
Shah Alam
BAXTER
Refused
2(1)(j/a); 10(4b)
Dr.Rajesh Dixit
BRISTOL-MYERS
Refused
10(4)
Dr Subramaniyan
I. N. S. E. R. M.
Refused
15
Shah Alam
TELECOM ITALIA 
Allowed
3(k)
B.P.Singh
TRIDENT SCIENCES 
Refused
15
Shah Alam
NETOMAT,INC.,
Refused
3(k)
B.P.Singh
LES LABORATOIRES
Refused
3(d), 3(e)
N.R.Meena
Dr. Reddy & Anr.
Refused
2(1)(j), 15
S Thangapandian
EMSENSE
Refused
11B(4)
Dr.K.S.Kardam
CARLOS, ALBERTO
Refused
11B(4)
Dr.K.S.Kardam
NAPO PHARMA
Refused
3(e), 15
Dr Subramaniyan

Thursday, February 09, 2012

SpicyIP Event: Global Pharma Regulatory Summit India 2012, Mumbai


This event comes specially for those of you interested in pharma regulation, from the same folks who organised the Pharma IPR Summit recently. The organisers send us the following details. Please don't forget to mention that you came via SpicyIP.



Event Name: Global Pharma Regulatory Summit India 2012

Dates: 28 Feb - 2 March 2012 [individually bookable days]

Venue: Holiday Inn Mumbai International Airport, Mumbai, India

URL: www.pharmaregulation-india.com

Contact Person: Ms Asan Bano

Contact Number: +91 (022) 4046 1466

Contact Email: conferences-india@ubm.com


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Global regulatory compliance is by far the biggest factor related to success, as pharmaceutical companies look to exploit the increasing demand of Indian generics in key export markets.

Join 120+ heads, executives, managers and team leaders of Regulatory Affairs, Quality Assurance, Quality Control and more at the Pharma Regulatory business conference and learn implementable strategies to support efficient approvals of your Indian generics in key export hot-spots.

Book for the day of your choice by registering online, or contacting Ms Asan Bano on +91 (022) 4046 1466 or conferences-india@ubm.com today!


Special offer for SPICY IP readers!

Our early bird discount packages that expired on 3 Feb, is now open only to SPICY IP subscribers!


Don’t miss – register quoting “SPICYIP” & take advantage of our special discounts valid until 24 Feb!

Region focused agenda:

(a) 29 Feb: US regulations - Learn practical insights to ensure flawless submissions for:

  • DMF and ANDA filing procedures
  • CTD and ECTD submissions
  • Variation handling process
  • Critical pharmacovigilance requirements
  • Approval of 505 (b)(2) applications
  • Dosage based deficiencies

(b) 1 March: EU regulations - Gain in-depth insights through live examples and comprehensive query handling sessions on:

  • Stability and impurity profiling requirements
  • Generic drug application filing procedure
  • Post approval supplements
  • Variation guidelines
  • Requirements for hybrid applications in the EU

(c) 2 March: India, Japan and ROW regulations - Understand and overcome complexities involved in gaining swift regulatory approvals for DMF and generic applications in:

  • India
  • Japan
  • Latin America
  • Australia
  • Russia
  • China
  • South Africa

To register and benefit from early bird discounts, please contact Ms Asan Bano on +91 (022) 4046 1466 or email conferences-india@ubm.com today!