New PG Dip Course in IP and Technology Management in Agriculture, NAARM

There is a brand new specialised course in IP in India for graduate students of Agriculture, offering an in-depth understanding of Intellectual Property and Technology Management in Agriculture, and a cross-disciplinary study of agri-business, R&D, industry and law.

The National Academy of Agricultural Research Management (NAARM) has begun a one-year Post Graduate Diploma in Intellectual Property and Technology Management in Agriculture (IPTMA) , with a comprehensive curriculum designed in collaboration with leading experts from across the disciplinary spectrum - agri-business, industry, law schools, financial institutions, NGOs, R&D institutions and policymakers.

The course seeks to create a pool of "bridge professionals" who are equipped to develop IP assets in the agricultural sector by integrating agricultural research developments with industry needs, and strategically leveraging these assets for technology dissemination in the agri-food sector.

The first batch was enrolled this January, chosen from across India, after a rigorous selection process involving a written test, group discussion and interview. The course is an integral part of NAARM, and it promises to be of immense benefit to the agricultural and its allied sectors.

About the Course, From the Website

The course includes key modules on general management, intellectual property law and technology and innovation management covering topics on national and international policy as well as legal and administrative aspects including case studies. The course is also designed to provide an overall understanding of various stages of technology development and transfer in agriculture sector. Intricacies of IP management and innovation life cycle process towards entrepreneurship development would be explained through appropriate tools and techniques.

The faculty consists of experts in IP, law and technology management, strategic management and human resource planning and development. Experts have been drawn from within the NAARM as well as from other public and private sector organisations, law schools, statutory bodies and R&D consortia.

The PGD-IPTMA is a professional programme, with internships and placements forming a core part of the curricula. NAARM welcomes prospective employers from the private and public sector working in agriculture and allied areas to collaborate for internship and placement.

The NAARM is a premier institute of excellence under the Indian Council of Agricultural Research , and is nationally and globally acknowledged for for its expertise in agricultural education, research, extension and agri-business programmes.

For more information on the programme, and on the institute, please get in touch with Dr R Kalpana Sastry, Course Director, PGD-IPTMA, National Academy of Agricultural Research Management, Rajendranagar, Hyderabad - 500407; email: kalpana@naarm.ernet.in; Phone: +91-40-24581304; Fax: +91-40-24581452/3, 24015912.

Jurisdiction and Forum Non Conveniens: Part II - On IP and PIL

The interface between private international law and intellectual property raises some complex problems in legal policy. This post merely seeks to highlight a few issues in relation to this interface.

Over here, I had noted that the doctrine of forum non conveniens would apply even between two domestic Courts. The principles would be the same as the principles for the application of the doctrine in a private international law context. The position is summed up by Dicey and Morris on the Conflict of Laws, where the authors state that a Court has the power to order a stay of proceedings on the grounds of forum non conveniens if the “…defendant shows there to be another court with competent jurisdiction which is clearly and distinctly more appropriate… and (the stay of proceedings) is not unjust…”

It is interesting to examine how this doctrine will be applied specific to cases of intellectual property. A discussion on this aspect is found in James Fawcett and Paul Torremans, “Intellectual Property and Private International Law” (1998).

A case which highlights the problems posed in this area is Tyburn Productions v. Conan Doyle [1991] Ch 75. The plaintiff was a British company which wished to distribute a Sherlock Holmes movie in the United States. The defendant was the only surviving child of Sir Arthur Conan Doyle. The plaintiff was concerned that the defendant would make allegations that he was the sole copyright-holder in relation to Sherlock Holmes. Therefore, a declaration was sought from the British Courts that the defendant had no such copyright. It was held that the British Courts had no jurisdiction in the matter, as questions relating to the validity of intellectual property rights were local actions which could only be adjudicated in the place in respect of which the relief was sought.

A strong criticism against this decision was that it was based on several unfounded assumptions as to the territoriality of intellectual property rights. At the essence of this debate is the policy question of whether Courts should refuse to try a suit in respect of the infringement of a foreign intellectual property, despite having personal jurisdiction over the defendant in the matter. Suits of title to foreign land are typically not the concern of domestic Courts – should foreign intellectual property be treated on a different footing? (This issue was also discussed in a case between Satyam and Upaid, about which a post is found here.)

Fawcett and Torremans recommend the application of the doctrine of forum non conveniens in such instances. They say:

“The fact that the case concerns a foreign intellectual property right will be a powerful factor suggesting that the clearly appropriate forum is abroad… Nonetheless, there may still be circumstances where an English Court thinks it right not to decline jurisdiction, even though the case concerns the infringement of foreign intellectual property rights… one such case would be where one English company markets products in various countries and owns copyrights, designs and trademarks in respect of them. Another English company enters the same markets with products which infringe those rights. In essence one English company has harmed another and an English Court should try the case. This is the great virtue of the doctrine of forum non conveniens; it provides the flexibility to allow an action commenced in England to continue, which a blanket subject-matter limitation on jurisdiction does not…”

This provides one interesting area where the application of PIL rules in an IP context can give rise to legal controversy. Other such areas are documented in this WIPO note on “Private International Law and Intellectual Property”. Further, see this link for a discussion of the problems raised by the internet in relation to IP and PIL.

How do Indian Courts deal with such issues? How should they? The importance of answering these questions will only increase in the future…

IP COLLOQUIUM-Broadening IP Horizons in Pharma, Software and Entertainment Industries

It seems to be raining IP conferences in Mumbai. An IP Colloquium is being organized by NMIMS University -Institute of Intellectual Property Studies (India), Boult Wade Tennant (UK), Legasis Partners(India) on March 18th, 2009. The details of the conference can be accessed here. I've reproduced the contents of the link below: 

Location: Mayfair Banquets, Graviss Hospitality Ltd

Dr Annie Besant Rd
Mumbai, MAHARASHTRA IN

Entry fee: Rs. 1500 (Corporates), Rs. 650 (Students)

Who should attend: · Corporates from Pharma, IT-Telecom, Entertainment industries; specifically managers,· Entrepreneurs and managers of SMEs · Industry bodies and associations. involved in R&D & development of new products,· IP practitioners and students of law and tec

The colloquium has been designed to highlight and build consensus on the following: · General trends governing the protection of intellectual assets particularly in the area of pharmaceutical, software and the entertainment industries. · Development of brands in the context of international TM policies and market competition. · The preferred protection for software vis-à-vis patents or copyrights · Standards and new tests of patentability brought in through the Re Bilski case which may impact international standards in the protection of software. · Awareness with respect to best practices to be adopted generally for the protection of IPRs in particular the small & medium enterprises.

FICCI Conference on Pharma Innovation and Public Health

For an upcoming pharma conference in Mumbai (on 18th March) organised by FICCI, the Indian Ministry of Pharmaceuticals and the Observer Research Foundation (ORF), please see FICCI website. One of the sessions deals with Innovation and Public Health.

I've also extracted details of the conference from the FICCI website below.

Pharmaceuticals 2014: Will India Leap Forward
March 18, 2009, Hotel Taj Lands End, Mumbai


FICCI jointly with Dept. of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India and Observer Research Foundation (ORF) is organizing an International Conference on "Pharmaceuticals 2014: Will India Leap Forward" on March 18, 2009 at Hotel Taj Lands End, Mumbai.

Over the next decade the Indian pharmaceutical industry is clearly poised for a period of major changes and the most successful players in 2014 will be those whose strategies not only reflect these trends but also adapt to and take advantage of them. The objective of the conference is to highlight some of the major issues that will shape the Indian pharmaceutical industry in the next 5 years. Major topics being covered are:

Market Prognosis 2014 - Perspectives & Challenges
Dimensions of Quality
Biologics
Affordability & Access to Quality Medicines
Public Health, Innovation and IPR

Key presentations would be made by Mr. Graham Lewis, Sr. V P, IMS Health UK on "Global perspective" and McKinsey & Company Inc. on "Indian Perspective", Mr. Ashok Kumar, Secretary, Department of Pharmaceuticals, Govt. of India, Dr. A K Banerjee, Chairman, National Pharmaceuticals Pricing Authority (NPPA), Prof. Falguni Sen, Advisor (Healthcare), ORF and Professor of Management, Fordham University, USA and Drug Controller General of India, USFDA Officials along with senior industry CEOs and important NGOs.

Who should attend?
(Related to Pharma Industry)

Chief Executive Officers
Chief Information Officers
Marketing Professionals
Regulatory Affairs & Quality Managers
Directors-Corporate Strategy
Senior Management Officials
Policy Makers
Market Consultants
Consultants
Eminent Scientist from Industries and Research Institute
Contract Research Organization
About the Organizers:

FICCI-The Change Agent

Set up in 1927, FICCI is the largest and oldest apex business organization of Indian business. Its history is very closely interwoven with the freedom movement. FICCI is the rallying point for free enterprises in India. It has empowered Indian businesses, in the changing times, to shore up their competitiveness and enhance their global reach.

With a nationwide membership of 500 chambers of commerce and business associations, FICCI espouses the shared vision of Indian businesses. It has an expanding direct membership of enterprises drawn from large, medium, small and tiny segments of manufacturing, distributive trade and services. FICCI maintains the lead as the proactive business solution- provider through research, interactions at the highest political level and global networking.

The executive committee of FICCI consists of industry leaders who hold a place of pride in the business landscape of the country. Among them are some of the key innovators, wealth creators and employment providers. Their contributions to the national economy are immense and varied.

Intellectual Capital Highly qualified multidisciplinary Secretariat consisting of economists, MBAs, IT professionals, fiscal and financial analysts, lawyers etc., who can provide business solutions and guidance on industry issues like quality, market access, taxation, economic policies etc.

Department of Pharmaceuticals
(Ministry of Chemicals & Fertilizers)

The Department of Pharmaceuticals is formed recently and is a part of Ministry of Chemicals and Fertilizers. The Department is entrusted with the responsibility of policy, planning, development and regulation of Pharmaceuticals Industries. The some of the important functions of the Dept. are as follows:

Drugs and Pharmaceuticals, excluding those specifically allotted to other departments.
Promotion and co-ordination of basic, applied and other research in areas related to the pharmaceutical sector.
Development of infrastructure, manpower and skills for the pharmaceuticals sector and management related information.
Education and training including high end research and grant of fellowships in India and abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector.

Promotion of public - private-partnership in pharmaceutical related areas.
International co-operation in pharmaceutical research, including work related to international conferences in related areas in India and abroad.
Inter-sectoral coordination including coordination between organizations and institutes under the Central and State Governments in areas related to the subjects entrusted to the Department.
Technical support for dealing with national hazards in pharmaceutical sector.
All matters relating to National Pharmaceutical Pricing Authority including related functions of price control/monitoring.
All matters relating to National Institutes for Pharmacy Education and Research.
Planning, development and control of, and assistance to, all industries dealt with by the Department.
Bengal Chemicals and Pharmaceuticals Ltd. and other Pharmaceuticals PSUs.
Observer Research Foundation
Building Partnerships for a Global India

Observer Research Foundation (ORF) is a not-for-profit, multidisciplinary public policy think tank based in New Delhi with chapters in Mumbai, Chennai and Kolkata. ORF is engaged in developing and discussing policy alternatives on a wide range of issues of national and international significance.

Some of ORF's key areas of research include international relations, security affairs, politics & governance, and economy & development. The objective of ORF is to influence formulation of policies for building a strong and prosperous India in a globalised world.

ORF pursues this goal by providing informed and productive inputs, in-depth research and stimulating discussions. Set up in the early Nineties during the troubled period of India's transition from a protected economy to a new engagement with the international economic order, ORF examines critical problems facing the country and helps develop coherent policy responses in a rapidly changing global environment.

As an internationally well-known independent think tank, ORF develops and publishes informed and viable inputs for policymakers in the Government and for the political and business leadership of the country. It maintains a range of informal relationships with politicians, policymakers, policy influencers, civil servants and the media in India and abroad.

With the objective of Building Partnerships for a Global India, ORF has been associated with reputed international think tanks and research institutions like the Brookings Institution, USA; Pacific Council on International Policy, USA; Rosa Luxemburg Foundation, Germany; Polity Foundation, Russia; Institute of World Economics and Policy, Kazakhstan; and Bangladesh Enterprise Institute. ORF also has a partnership with the Federation of Indian Chambers of Commerce and Industry (FICCI).

ORF's key research divisions are: ORF Centre for International Relations, ORF Institute of Security Studies, ORF Centre for Economy and Development, ORF Centre for Resources Management, ORF Centre for Politics and Governance, and ORF India China Centre. The institutes are led by, among others, Mr. M.K. Rasgotra, former Foreign Secretary; Gen. V.P. Malik, former Chief of Army Staff; Mr. Surendra Singh, former Cabinet Secretary; Mr. Vikram Sood, former chief of R&AW; and Dr. Falguni Sen, Professor of Management, Fordham University (USA).

In nearly two decades of its existence, ORF has emerged as India's leading non-partisan public policy think tank. ORF events have drawn leaders from the entire political spectrum, like Dr. Manmohan Singh, Mr. Atal Behari Vajpayee, Mr. L. K. Advani, Mr. Pranab Mukherjee, Mr. Natwar Singh, Mr. Yashwant Sinha, Mr. Jaswant Singh, Mr. A.B. Bardhan, Mr. Sitaram Yechury, Mr. Omar Abdullah and Ms. Mehbooba Mufti. Business leaders like Dr JJ Irani, Mr.Nandan Nilekani, Mr. Naveen Jindal, Mr. Kiran Karnik, Mr. Kanwal Rekhi, Mr. Hari Bhartia, Ms. Anu Aga and Mr. Brooks Entwistle have also participated in our events.

(For more information about ORF, please visit our website www.orfonline.org)

For further details, please contact:

Mr. R K Bhatia, Head
Ranjita C Sood, Asst. Director
Chemicals & Pharmaceuticals Division
Federation of Indian Chambers of Commerce and Industry
Federation House, 1 Tansen Marg,
New Delhi-110 001
Tel: +91-11-2373 8760-70 (EXT 395/474)
+91-11-2331 6540 (Dir)/2335 7350 (Dir)
Fax: +91-11-2332 0714/ 2372 1504
E- Mail: rkbhatia@ficci.com/ranjita@ficci.com

Off-Topic: Screening “Smoking” Bans through a Constitutional Lens

Since I've lit up the cancer stick a great number of time till last year, all things relating to smoking interest me considerably. For those of you interested in a discussion on a recent Delhi High Court judgment on the constitutionality of "smoking" bans, see this post of mine at "Law and Other Things", perhaps India's leading blawg. This post draws on an editorial piece in the Mint, which I reproduce below:

The law, smoke and mirrors

"I often wonder about the hours when a man sits alone, watching the smoke of a cigarette, thinking. I wonder what great things have come from such hours. When a man thinks, there is a spot of fire alive in his mind— and it is proper that he should have the burning point of a cigarette as his one expression.”

Ayn Rands’ sentiments mouthed through one of her characters in the classic Atlas Shrugged may have spurred some of us to light up. But ought that be reason enough to prohibit the publication of this book in India? Although current legal norms weigh against such censorship of the printing press, it certainly sanctions it when “text” migrates to “screen”. The law vests our Central Board of Film Certification (CBFC) with the discretion to axe any scene that glamourizes or encourages smoking, notwithstanding the fact that such scene may be integral to the plot or to the character. And notwithstanding the fact that the law does not prohibit smoking, unless committed within public precincts.

It is in this context that the Delhi high court’s recent denunciation of a regulation banning the depiction of on-screen smoking is a very welcome one for those of us who zealously guard our free speech rights against an overtly paternalistic state. Justice Sanjay Kishen Kaul rightly notes that such regulation violates the right to free speech and expression guaranteed under Article 19(1)(a) of the Constitution of India.

However, the judgement is problematic in that it implicitly endorses CBFC’s right to interfere with artistic freedom, when the scene in question encourages smoking.

The case centres around a rule (promulgated under what is commonly referred to as the Cigarettes Act, 2003) which prohibited “characters” in films and television programmes from “displaying tobacco products or their use”. A writ petition challenging the constitutionality of this rule came up before justice Kaul. It is very difficult to take exception to justice Kaul’s staunch defence of the freedom of speech guaranteed under Article 19(1). However, his reasoning leaves much to be desired.

For one, he ducks the issue of whether or not certain exceptions articulated under different heads in Article 19(2) can save the governmental regulation in question, claiming that it is not germane to the controversy. Not only is it germane to the controversy, it is absolutely critical.

Article 19(2) permits the state to intrude upon the right to free speech when such intrusion is “reasonable” and is in the interest of any of the following: the sovereignty and integrity of India, the security of the state, friendly relations with foreign states, public order, decency or morality, or in relation to contempt of court, defamation or incitement to an offence.

It is difficult to see how the banning of on-screen smoking would fit within any of the above heads. Although one may qualify measures to discourage smoking as “public health” measures, this cannot tantamount to preserving “public order”.

As for “decency” and “morality”, the less said the better. The closest I ever came to witnessing such a nexus was when a student of mine categorically asserted that “civilized people do not smoke”.

Without dealing conclusively with whether or not the impugned ban fitted within any of the above heads, justice Kaul assumed that even if it did, it would still not amount to a “reasonable” restriction. Particularly since there already existed another guideline under the Cinematograph Act, 1952, that permitted CBFC to chop “glamourized” smoking scenes. In other words, an outright ban on “any” smoking scene was “unreasonable”, whereas a ban on only “glamourized” smoking scenes was perfectly constitutional. But this begs the question: Do such bans fall within the purview of the Article 19(2) categories at all? Unless they do so, one need not bother examining their reasonableness or otherwise.

Although the legality of the CBFC guidelines was not in issue, justice Kaul implicitly defends them. It is therefore imperative that film-makers take steps to challenge the constitutionality of these guidelines.

On a broader note, if our zealously paternalistic state is worried about the ill effects of smoking, it must take on the tobacco lobbies and ban smoking altogether (as to whether such a measure is likely to withstand a constitutional challenge is a moot issue). But until then, a film-maker must be offered the artistic freedom to depict the iconoclastic Hank Rearden lighting up his cancer stick in as swashbuckling a manner as possible. Even if this necessarily means more smoke-filled lungs and the encouragement of a habit described by James I as “loathsome to the eye, hateful to the nose, harmful to the brain...[and].. dangerous to the lungs...”

Jurisdiction and Forum Non Conveniens: Part I

A recent post had led to an interesting discussion on the appropriateness and applicability of the principle of ‘forum non conveniens’ in domestic law. Usually, the principle is applied in the context of private international law. Within a domestic system, the principle is applied in cases where the judicial structure is federal and not unified in structure. The debate assumes importance given the expansions in jurisdiction under certain legislations which allow the plaintiff a choice to file a suit in his place of residence, as opposed to the principle in the Code of Civil Procedure which requires filing of suits in the defendant’s place of residence. Now, if a Court does have the jurisdiction under either the CPC or under the specific provisions such as S. 62(2) Copyrights Act or S. 134(2) Trademarks Act, can it refuse to hear the case on the ground that a more alternative forum is available? Does the private international law principle of forum non conveniens extend to the jurisdiction of Courts within India in a solely domestic context? The Delhi High Court decision in St. Ives Laboratories v. Arif Perfumers, [CS (OS) No. 78/2009, decided by Justice S.N. Dhingra] suggests that it does.

The case involved allegations of trademark infringement. It was not the case of the plaintiff that it resided in Delhi. Thus, for the purposes of the case, the special jurisdictional sections were irrelevant. The question had to be decided in accordance with the rules of the Civil Procedure Code. In particular, the issue was whether part of the cause of action arose in Delhi, so that the Delhi Courts could assume jurisdiction.

There was a clear allegation in the plaint that the defendants were surreptitiously and clandestinely trading their goods under the impugned trademark and labels in Delhi and in other parts of the country. The trademark was registered in Delhi, and the plaintiff alleged that it was suffering losses in Delhi too. In deciding jurisdiction, a Court usually satisfies itself with the averments made in the plaint. In the facts of the case, those averments indicated that part of the cause of action did arise in Delhi. It was argued that in view of this, Delhi Courts would have jurisdiction under Section 20(c) of the CPC.

The Court held:

Looking at the entire plaint, it only seems that the plaintiff had filed this suit at Delhi only as a device of harassment calculated to force the defendant to come to Delhi, engage a Counsel at enormous expense and contest litigation. The plaintiff, who was resident of USA could have easily filed this suit at Courts at Bombay/Maharashtra and pursued the matter. Filing of suit in Delhi on the basis of vague allegations that the goods of defendants were being sold clandestinely throughout the country including Delhi makes no sense. No cause of action can be said to have arisen in Delhi. Such allegations of clandestine sale can be made against any person without any foundation and the plaintiff even during trial can always escape giving proof of such clandestine sale saying that he has stated in the plaint that the sale was clandestine and no bills were being issued. The Court cannot be used as a tool to put such a burden on the defendant that the defendant is unable to even defend the suit. The plaintiff cannot be given absolute liberty to choose the place of suing a defendant out of entire country on the basis of unfounded and vague allegations. In such a case CPC provisions regarding jurisdiction stand rendered useless.

(Emphasis added)

Now, it might well be possible to hold that the Court had concluded that no part of the cause of action arose in Delhi. There are at least three reasons, however, for believing that the Court was in fact applying the doctrine of forum non conveniens.

First, on the averments made in the plaint, it was not possible to say that no part of the cause of action arose in Delhi. The veracity of those averments cannot be gone into for the purposes of determining jurisdiction. Secondly, if indeed no part of the cause of action arose in Delhi, there was no reason to make observations concerning the hardship and burden faced by the defendant. Thirdly, in its reasoning, the Court referred to a Supreme Court decision – Kusum Ingots v. Union of India – holding that a Court is not bound to entertain a plaint if a small part of the cause of action arose within its jurisdiction. This indicates that the Court was holding that even though a part of the cause of action arose in Delhi, the Delhi Courts were not the most appropriate forum for adjudication.

The judgment in Kusum Ingots itself appears to accept the forum non conveniens principle. That case was concerned not with private law disputes but with the public law question regarding the appropriate High Court in cases of writ jurisdiction under Article 226 of the Constitution. Nonetheless, it was held that the CPC principles of jurisdiction were equally applicable to writ proceedings. The Supreme Court went on to say that “indisputably” even if a small fraction of the cause of action arises within the jurisdiction of a particular Court, that Court shall have jurisdiction in the matter. Yet, on appropriate cases, the Court could refuse to exercise that jurisdiction on the ground of forum non conveniens. Thus, the Court recognised the distinction between the existence of jurisdiction and the exercise of jurisdiction.

The principle of Kusum Ingots has been followed subsequently. In Jayaswals Neco, the decision was analysed in depth; and was held to be authority for the proposition that when a cause of action arises partly in one jurisdiction and partly in the other, it is ordinarily for the petitioner to choose his forum. Yet, “in appropriate cases” the Court concerned may refuse to hear the matter because of forum non conveniens. The Delhi High Court decision in St. Ives seems to now settle the issue that the doctrine would also apply outside writ jurisdiction to an ordinary civil suit between two private parties.

A question which arises in such a scenario is, “What are the principles which would determine the application of the doctrine of forum non conveniens?” A subsequent post will try to answer that question.

Customs Seizures in India: Patently Unconstitutional?

CH Unnikrishnan of the Mint breaks the news on a writ petition filed by Samsung challenging the constitutionality of India's customs regulations governing the import of IP goods. The matter came up today before Justice Vikramjit Sen of the Delhi High Court, but was adjourned for hearing to Tuesday (17th March). We'll bring you an update of this case on Tuesday.

It ought not to be lost on our readers that this is one of those rare cases where a multinational company is challenging the IPR regime in India as being too IP maximalist and overprotectionist and not vice versa. I've reproduced the news item in full and our comments on this story follow at the end:

"The Indian arm of Samsung Electronics is involved in a first-of-its-kind legal battle in the country, related to linking patents and import laws. The bone of contention: dual-SIM phones that the company has been barred from importing into India because a Madurai-based inventor has a patent on such technology.

Interestingly, India has objected to similar attempts to link intellectual property (IP) and import regulations by the Netherlands that had seized drugs shipments from the country.

Samsung India Electronics Pvt. Ltd, the Indian arm of Korean electronics giant Samsung Electronics Co. Ltd, has moved a writ petition in the Delhi high court challenging action by the Indian customs department to prevent its imports of dual-SIM-card mobile phones because this allegedly infringes a local patent.

The case challenges India’s Customs Act 1962 and the Intellectual Property Rights (imported goods) Enforcement Rules.

Dual-SIM phones are those that can hold more than one SIM (subscriber identification module) or phone card. This means the same phone can have two numbers—much like multiple lines being connected to one instrument in the case of landline phones.

The company’s petition says its imports have been detained at several ports in the country by the customs department on the basis of a patent granted to S. Ram Kumar, a Madurai-based scientist.

Ram Kumar was granted a patent in 2008 by the Chennai patent office for a technology “apparently similar to that is being imported by Samsung and several other mobile phone importers in the country, and Samsung has been now informed by the customs department that its products have been detained as it infringes this patent”, said the petition, which has been reviewed by Mint.

A person involved with Samsung’s import activities confirmed that the company’s imports have been detained by the customs authority in Mumbai and Chennai. This person, who is not authorized to talk to the media on behalf of the company, declined comment on the value of these shipments.

“The company cannot comment on this now as the matter is sub judice,” said Samsung’s spokesperson Ruchika Batra.

Ram Kumar could not be reached for comment because he wasn’t available at the address and number mentioned in his patent application filed at the Chennai patent office.

A senior official at Mumbai customs said, “If the patentholder has registered the patent rights under the Intellectual Property (imported goods) Enforcement Rules, the officials at the ports will be forced to detain the product imported by anyone else, unless they produce a valid licence from the registered owner of the patent.”

Experts, however, say that since the Trade Related Intellectual Property Rights (TRIPS) rule doesn’t cover patents, the customs department cannot decide such actions on its own.

“TRIPS does not mandate any border protection measures in so far as patents are concerned. The Indian customs rules are, therefore, clearly TRIPS-plus. Since they empower customs authorities to seize goods upon the mere complaint of a patent owner and treat them as ‘prohibited goods’ without even hearing the importer, they are likely to be struck down as unconstitutional,” said Shamnad Basheer, a patent expert and an IP law professor—appointed by the ministry of human resource development—at the National University of Juridical Sciences, Kolkata.

“Much like the DCGI (Drug Controller General of India), customs authorities do not have the expertise to decide complex patent disputes, where issues on invalidity and non-infringement are often raised. Under the Indian Patents Act, only courts have the exclusive jurisdiction to decide issues of infringement. Given that India is considering challenging EU (European Union) customs regulations in the wake of seizures of Indian drug consignments, it will have to set its own house in order by taking immediate steps to roll back customs regulations that vest undue powers in the hands of its customs authorities,” Basheer added.

Samsung’s petition in the Delhi high court said: “Ram Kumar was demanding payment of royalties due to him through various representatives at each port, and was issuing no-objection certificates to those parties who paid him the royalty.”

A person familiar with the matter, who did not want to be identified, said Kumar was demanding Rs35 a phone as royalty. This couldn’t be independently verified by Mint.

Last year, customs authorities in the Netherlands had detained shipments of Indian drug companies such as Dr Reddy’s Laboratories Ltd, Cipla Ltd, Aurobindo Pharma Ltd and Indswift Laboratories Ltd. These were on the way to Latin America and were seized after the EU issued a note to its members asking them to detain goods under patent rights protection law."

SpicyIP Comments

Anyone who has read the customs regulations (Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007) will appreciate that these regulations leave a lot to be desired. Firstly, it empowers a customs authority to determine the patent legality or otherwise of an import upon the mere representation of a patent owner, without even hearing the importer. It even goes to the extent of treating such goods as "prohibited" goods and consequently criminalising the import! It is very likely that a court will strike down these rules that violate principles of natural justice as unconstitutional.

Much like the DCGI issue, which we have blogged about in the context of the Bayer vs Cipla case, the issue is also one of institutional competence: Is the customs authority competent to decide a patent infringement case, which often involves complex issues of patent validity and claim scope?

In fact, in the case at hand, it would appear that the patent does not cover all "Dual SIM phones" (as Dual SIM technology itself has been around and is part of the prior art), but only those Dual SIM phones that also provide for more than one headphone/earphone jack, so that two people can be on two calls at the same time via the same handset. However, most of the goods seized by customs (consisting of both Samsung's products and a number of other imports belonging to several Indian importers) appear to be generic Dual SIM phones with just one headphone/earphone jack. In other words, the patentee is attempting to claim rights over technology that is part of the prior art and clearly outside the scope of his patent.

It is pertinent to note that TRIPS expressly mandates member countries to only provide border control measures in the context of "counterfeit" and "pirated" goods, in relation to which issues of infringement are much easier to assess.

In other words, TRIPS (Art 51) makes it clear that there is no border control obligation with respect to patented goods: rather this is left to member countries, who may wish to institute measures in this regard.

Therefore, even if India wishes to institute border control measures for patented goods, it ought to do so in a manner that is likely to provide a fairer and more equitable result. Let the onus be on the party claiming patent infringement to secure an order in this regard from a court of law. After all, section 104 makes very clear that it is only a court of law that can make an assessment of patent infringement.

And if the court finds in favour of patent infringement, this order could be acted upon by the customs authorities i.e. they could seize any "imports" that violate patent rights. One will appreciate that as per the current regulations, goods that allegedly infringe IP rights can be seized by the customs authorities without even hearing the importer and the onus is then on the importer to move the court and have it released. The better and more equitable policy option would be to flip this the other way around. Let the onus be on the patent owner to agitate this issue before a court and if the court decides in her favour, the customs authorities could then seize infringing goods.

Lastly, on a strategic note, given that India is planning to take on EC customs regulations, it may help if the government seriously examines its own customs regulations and waters them down to reach a fairer and more equitable result. No doubt, the Samsung case where the imports were meant for India cannot be directly equated with the Netherlands "in transit" seizure of drugs meant for another country, and India's chances of winning or losing the EU matter does not really depend on the fairness or otherwise of its own domestic regulations. However, in order to capture the moral high ground as well, the Indian government ought to re-examine what appears on the face of it to be an extremely overbroad and overbearing TRIPS plus customs regulation .

ps: Apparently, Ramkumar has also filed court cases (patent infringement actions) against parties that are locally manfuactuing Dual Sim phones in India. Once we confirm this news, we will bring you an update.

SpicyIP: What ails the Palakkad Rice Growers?

The Indian Grains seem to have a way of making news!!! If the Basmati saga hogged headlines in the last decade, it is the turn now of the Palakkad Matta and Navara rice from Kerala

Two endemic varieties of Palakkad variety, the Matta and the Navara rice that were awarded the G.I tag seem to be drawing media attention, albeit on a note that strikes a different chord.

Presenting a counterfactual to the ongoing G.I trend, this case study plays the devils advocate to the now popular “glory be to the G.I movement” tune that is fast acquiring an almost rhetoric lilt.
As reported in the Livemint a few weeks back, the Palakkad Paddy community admits ruefully to the non-effect of a G.I tag on the produce and quite to the contrary reports on dwindling production lines.

Both the Matta and the Navara are popular varieties with the Keralite expat population and therefore command a significant export potential. The Navara is popularly hailed for it medicinal value in the Ayurvedic system.

Reports in the Livemint state ‘

It’s 15 months since India got its first patent(hic!) for rice—for Kerala’s Palakkadan matta and the medicinal navara. The farmers can’t tell the difference. But M.A. Majeed, a matta farmer for the past 35 years, doesn’t even know that the rice he grows on his 3.5 acres at Vadakkencherry in Palakkad district, a rice hub, now has a premium tag. He barely earns enough and struggles to find labor for sowing and harvesting.
Worse, there is little awareness about the GI status and its benefits.” It wasn’t what the farmers—at least those who had campaigned for the status had hoped for.

Quite disappointing given the fact that the Palakkad Matta Farmers Co-operative ran a 3 year ardent campaign to earn the G.I tag. Posthumously on a weary note they conclude that a mere G.I award does little to improve the commercial worth of the produce.

Welfare dimension notwithstanding, economic benefit and commercial accruals to the producer/manufacturer lies at very the heart of the G.I ideology

Unlike in the case of other genre of IPRs, the holders of G.I more often than not come from economically underprivileged sections of the society with G.I products bearing rural origins.

Given that, it becomes increasingly important that the G.Is are applied in manner that makes commercial sense and accords equity to the G.I owners.

Observers of G.I will agree that we are past the G.I adolescent stage. With the onset of an adult awareness, the reality is that commercial accruals from G.I are not an automatic sequentially occurring outcome.

The path to commercial gains may have been a tad easier for the bestseller G.Is such as the Darjeeling, Pochampalli etc who already have attained a certain degree of visibility in the markets. In sharp contrast, it calls for examination of the number of G.I s that has seen no tangible benefit at all post a G.I registration. My guess is that the odds far outnumber the evens…and that’s just not broad conjecture.

A G.I tag, without adequate follow up and initiatives on the marketing, branding, awareness building direction would possibly render such registrations superfluous. The G.I is an effective marketing tool, one that can be effectively leveraged to bolster the popularity of the product subject to the fact that the ancillary brand building activities are undertaken with equal amount of vigor. Awareness campaigns, advertisement, adherence to supply chain integrity guidelines all account for a successful G.I that is fully realized in spirit and intent. Case studies from popular G.I models such as the Kota Doria and Pochamplli indicate a multi stake holder participation in the promotion of the product.

All of these factors seem to be sadly absent in the case of the Palakkad paddy varieties. The causative factors for the non –take off can quite clearly be attributed to a cumulative bunch of factors, pointing towards non-branding and the associated ones. The government has only been able to step in marginally to bail out the farmers by procuring the grain from the producers at a base rate, quite clearly insufficient to allow the producers to maintain production cost. The existing farmers are in a quandary and all willing to migrate to producing other cash rich crops. The Export ban affected by the government has done little to bail the farmers out of their plight.

Even as I analyze this case study, I am quite unwilling to write this off as a debacle or call it a post mortem on a ‘another one bites the death case’.

Minister Achuthandan may well take pride in the fact that it is yet another effort of the state government to protect farmers from the evils of globalization.Granted that, the deeper sense of purpose would be to tend to the grass root concerns that ails these producers and take it onwards to a path that charts for it a course which will carry it from the G.I tag to beyond.
We at SpicyIP take pride in lending viewpoints that help grow an objective well rounded debate. The Palakkad post is aimed thus, to project both sides of the picture and enhance the effectiveness of the ongoing G.I momentum.

SpicyIP Tidbits: India's Human Genome Bill

Each one of us in India with our multicultural backgrounds hold great genetic diversity that pharmaceutical companies believe could cure to several diseases. Not only will such a discovery be a breakthrough, but according to reports also have great financial benefit for those who supply the samples. Seemingly learning from their past mistakes, India has decided to forestall any biopiracy claims with respect to the Indian gene pool. The Outlook (in their issue dated March 9, 2009- p. 20) has reported that the Anthropological Survey of India (ASI) in consultation with “experts” has come out with a Human Genome Regulatory Bill which currently lies before the Ministry of Culture for approval this month.

Initial reports of the Bill state the following aims and objectives:
- To document human genetic samples;
- Control access of the samples for research purposes;
- Ensure commercial benefits derived from the research are shared especially with the community that lends the samples;
- Possible establishment of a repository for human genetic samples which allow for hospitals and laboratories affiliated with the programme to lend research samples.
- Also smaller tribes, especially those with unbroken genetic lines, can provide samples to the respoitory which will preserve the same as a Bank.

While SpicyIP does not currently have a copy of the Bill, we laud the Indian Government for acting quickly in formulating the same. We hope that a detailed analysis of the Bill, when the same is made available, proves to be well thought out, and a great asset to Indians after research efforts across the globe.

Microsoft being FAT headed?

Hot off the heels of Bilski, there's a new interesting, (though confusing) development in the software patent world. There has been a long-standing tension between the open source community and Microsoft, especially after Microsoft previously claimed the Linux and other open-source programmes violated more than 200 of its software patents. After years of threatening action over allegedly infringing elements of Linux, the open-source operating system, Microsoft has finally decided to approach U.S. District court in this regard.

Microsoft claims 8 patents were infringed by portable GPS device maker TomTom, which used Linux in its device. Five of these patents deal with in-car navigation technologies, while the three others which are allegedly violated by TomTom's linux kernel relate to FAT (file allocation table) file-management techniques. Gutierrez says that licensing agreements have been reached with the other in-car navigation vendors over the same patents. According to TechFlash,

The case, in U.S. District Court in Seattle and the International Trade Commission, is the third time Microsoft has brought such a suit, said Horacio Gutierrez, Microsoft corporate vice president and deputy general counsel for intellectual property. Both of the previous suits settled after they were filed. By comparison, Microsoft has struck more than 500 patent licensing deals in the past five years.


Microsoft claims that this isn't about taking on Linux or open-source, with Horacio Gutierrez, Microsoft's corporate vice president and deputy general counsel of intellectual property and licensing, saying that while "three of the infringed patents implicate open-source code ... open-source software is not the focal point of this action".

Microsoft is claiming that they are not targeting Linux itself, but rather that they are only targeting the TomTom specific implementation of Linux (which, according to some sites, is a meaningless statement, as there is nothing TomTom specific about its implementation of the kernel)


That apart, it's a little strange that Microsoft is choosing the FAT patent to defend in court for a variety of reasons. Firstly, there is the Bilski decision, due to which EndofPatents is calling the action a wet rag rather than a sword . Post-Bilski, the USPTO's Board of Patent Appeals and Interferences (BPAI) have started handing down some relevant patent rejections, including the rejection of one of IBM's database query patents because it wasn't a 'hardware patent', ie it was not tied down to a particular machine. Taken from one source :

“The BPAI goes on to justify the rejection by pointing out that the "system" on which the innovation operates is "not recited in terms of hardware or tangible structural elements", which is to say that the patent is rejected because the elements of the claim are "implemented solely in software or algorithms". Does the FAT patent about converting long filenames to short filenames sound like it would pass any of these tests?”

And putting their FAT patents up against this test seems a little more than risky, considering that these don't exactly seem to be 'tied down to hardware' in any manner. In fact, the site also seems to indicate that Microsoft has in fact stated that their technology is running on all sorts of devices.


Techdirt also points out an 'ITC Loophole' that Microsoft seem to be using. The 'ITC Loophole' essentially allows a party to take two bifurcated attempts at getting an injunction against the other party. Aside from proceeding in court, a party can also simultaneously approach the US International Trade Commission claiming that the goods in question were part of 'unfair trade practices' and that an injunction should be granted against importing them into the US. It should also be noted that the ITC is not bound by the Supreme rules either, thus giving any party two clear and separate shots for obtaining an injunction against the same good/product.

It's ironic that this action comes in the wake of Microsoft's recently proclaimed Free-Software Friendly approach. In fact, just recently, Microsoft had signed a partnership deal with RedHat. However, this development will send across a signal of insincerity to the open source society. Some are even going as far as saying that Microsoft's involvement with the Open-source community is a ploy in order to gain leverage for them to speak on behalf of the Open-source community in government circles.

Seeing the position which Microsoft seems to be approaching this, Steven Vaughan-Nichols from computerworldblogs puts up another theory. With the 'weak' patents it's protecting, the European anti-trust division back on the hunt for them; and broken start this provides to the initiative it had begun with the open source society recently, he doesn't see the sense in this approach by Microsoft. What he theorises is that perhaps instead of getting them to sign a patent-licensing agreement, Microsoft is actually trying to acquire them.

"Microsoft has long wanted to get into automobile embedded systems with their Windows Mobile operating system. Their attempts haven't gotten anywhere fast. The company would also like to get some traction into the suddenly hotter than hot location software business. Google, with its Latitude software, has shown that people are really interested in location-based programs.

Were Microsoft to acquire TomTom, they'd instantly solve those two problems. If they could get the merger done fast enough, they might even have a chance to drop the lawsuit and get open-source companies to forget that Microsoft is not now, never has been, and never will be, open-source's friend"


A look at some of the patents also reveal some interesting facts. Two of their patents filed in 1999, give monopoly rights to the simple (and innovative?) combination of a computer, a car and a wireless connection. Then, there is also the question of the validity of Microsoft's patents in the first place. With Bilski and KSR, the position of software patents have been substantially weakened. In addition to this, the Public Patent Foundation had earlier successfully approached the U.S. Patent Office for the invalidation of one of the FAT patents in question on grounds of prior art. However, the procedure that this was followed up with seems questionable, since on appeal the Public Patent Foundation wasn't given a chance to speak at the patent office proceedings. This means that the judge will now have the power to permanently invalidate that patent - if this case is allowed to proceed and is not settled.

For those interested in checking on them, the patents involved are 6,175,789(Vehicle computer system with open platform), 7,054,745 (Method and system for generating driving directions), 6,704,032 (Methods and Arrangements for Interacting with Controllable Objects within a Graphical User Interface Environment Using Various Input Mechanisms), 7,117,286 (Portable computing device-integrated appliance), 6,202,008 (Vehicle computer system with wireless internet), 5,579,517 (Common name space for long and short filenames), 5,758,352 (Common name space for long and short filenames, again), and 6,256,642 (Method and System for File System Management Using a Flash-Erasable, Programmable, Read-only Memory).

The complaints filed in the federal court and at the ITC have been made available by TechFlash here and here respectively.

SpicyIP Jobs: Senior Legal Manager

Job Opening for a Manager/ Senior Legal Manager in a Company into Cement Manufacturing

Location
Ambuja Nagar, Gujarat.

Profile and Specifications
• Should be well conversant with all labor laws, local laws, C.P.C, Cr. P.C, Evidence act etc.
• Should be able to independently handle legal cases for company in liaison with advocates.
• Should be able to deal with various departments in a factory and give legal advice independently to them on day to day affairs of the factory.
• Should have excellent communication skills in English and Gujarati (For Ambuja Nagar) - both spoken and written.

Qualifications and Experience
LLB or LLM
Experience: 10 Years out of which at least 7 Years in a factory, handling all legal matters in a senior position as Dy. Manager / Manager.

Advocate in practice having suitable industry experience will also be considered.
Indicative Salary 18 lakhs /p.a

Interested Candidates, please send in your C.V to Shamnad@gmail.com and/or ayshasaukat@gmail.com

Why did the Government of India oppose the 'counterfeit drug' definition proposed by IMPACT?

In July last year the ET reported that the Government, in a bid to boost the credibility of Indian generics in the international market, was proposing a new definition of what exactly constituted a counterfeit drug. This move may have been inspired by the efforts of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to come up with a new definition of counterfeit drugs. IMPACT is an agency setup by the World Health Organization (WHO). A senior Health Ministry official was quoted as saying “It is not only innovator companies that are troubled with counterfeit drugs; generic companies also face the problem as people are involved in distributing medicine packs that look same as the brand.”

By October the ET reported that the Indian Government had rejected the definition being proposed by IMPACT because it was concerned that the definition could be used to hinder the export of the genuine generic drugs from India. The DGCI was quoted, by the ET, as saying “The government is concerned about certain words being used in the new definition of counterfeits proposed by IMPACT. We are afraid developed countries may use such a definition to stifle the growth of our generic industry”. Civil society groups shared the Government's apprehensions since according to them the new definition would hamper the access to generic drugs.

By January the newspapers were reporting that the Indian Government scored a major victory at WHO meeting on counterfeit drugs because WHO had decided to shelf the new definition in face of opposition from developing countries spearheaded by India & Brazil. Ideally a debate on the definition of counterfeit drugs should have had public health concerns as its central focus. Interestingly the powers that are to be have articulated this debate in the language of trade barriers & survivability of export based generic drug industries. Even more interesting are the tactics used to influence this debate. Forget the definition, the very credibility of IMPACT as policy making institution itself was questioned by its critics. Allegedly the funding of IMPACT is under scrutiny since it is suspected that 8% of its funding is received from the 'industry' and it is also speculated that IMPACT's high degree of co-ordination with big pharma companies may actually be causing a conflict of interest. The text of one of WHO's resolutions makes a clear mention that 62% of IMPACT's funding comes from the EU, while another 30% of the funding comes from WHO. Oddly its silent on the remaining 8% funding. Personally I don't think the question of funding is such a big deal. As long as logic and reasoning are apparent in the definition it is irrelevant who paid for it. Allegations of irregularities in funding simply distract the focus from the main questions. If there is a problem with the definition it is possible to attack it with reason and logic. Another reason behind the allegations of conflict interest is the fact that IMPACT's chair on technology – Dr. Harvery Bale is also the Director General of the International Federation of Pharmaceutical Manufacturers & Association (IFPMA). Indian company Piramal, Ranbaxy's new owners Daiychi Sankyo & India based OPPI are all members of IFPMA which represents mainly innovator companies, all of whom are affected by counterfeit drugs. It is ridiculous to suggest that no member of IFPMA should have been involved with IMPACT. After all counterfeiting is as much their problem as the rest of the world’s and they are probably the most experienced.

Anyway enough of the conspiracy theories. It’s time to deal with the main issues. What is IMPACT? What were the issues it sought to discuss? & Why is its definition of counterfeit drugs so controversial?

What is IMPACT?

Back in 1999 a WHO report had warned that counterfeit drugs were posing an increasingly serious public health crisis. One of the most serious problems was that there was almost no global study as to the true magnitude of the problem. In 2006 the participants of theWHO International Conference on Counterfeit Drugs passed a resolution (The “Rome Resolution”) to initiate policy measures to co-ordinate action against counterfeit drugs on an international scale. One of the proposals of this resolution was to setup a dedicated body – IMPACT – consisting of governmental, non-governmental and international institutions to raise awareness about the counterfeiting menace and increase co-ordination and information sharing amongst different countries. For its part IMPACT defines itself as “a partnership comprised of all the major anti-counterfeiting players, including: international organizations, non-governmental organizations, enforcement agencies, pharmaceutical manufacturers associations and drug and regulatory authorities.” You can click over here to access IMPACT's website.

What was the definition that IMPACT proposed?

In pursuance to WHO Resolution No: WHA 41.16, an international conference on counterfeit drugs was held in 1992. The participants of that conference, which included a large number of member countries, Interpol, the World Customs Organizations, the International Organization of Consumer Unions adopted a definition jointly formulated by the World Health Organization (WHO) and IFPMA, which is as follows:

a medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.

In December 2008 the Secretariat of the World Health Organization introduced for the first time a new draft of a definition as proposed by IMPACT. The new definition is as follows:

The first limb of the definition, defines a counterfeit drug:

A medical product is counterfeit when there is a false representation¹ in relation to its identity² and/or source³. This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components⁴, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging.

The second limb of this definition, defines what is not a counterfeit drug:

Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit. Substandard batches or quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices in legitimate and medical products should not be confused with counterfeiting.

In addition, the first limb of the definition has four footnotes as shown above and expanded below:

1. Counterfeiting is done fraudulently and deliberately. The criminal intent and/or careless behaviour shall be considered during the legal procedures for the purposes of sanctions imposed.

2. This includes any misleading statement with respect to name, composition, strength or other elements.

3. This includes any misleading statement with respect to manufacturer, country of manufacturing, country of origin, marketing authorization holder or steps of distribution.

4. This refers to all components of a medical product.

(NOTE: There have also been some references to the use of the word 'history' along with 'identity' and 'source' but I have not been able to find a mention of that in any of the WHO resolutions and hence have not discussed it. Please do let me know if any of you find a mention of it anyway.)

What is so new in the new definition of a “counterfeit drug”?

1. The new definition uses the word ‘medical product’ instead of ‘medicine’. Some news reports have tried to point out that this is problematic because the initial WHA resolutions refer to only medicines. This however is not logical because a counterfeit condom can prove to be as dangerous, if not more, as a counterfeit drug.

2. Apart from that the new definition replaces the words ‘deliberately and fraudulently mislabelled’ with the words ‘false misrepresentation’. The new definition however also inserts a footnote after ‘false misrepresentation’ stating that “Counterfeiting is done fraudulently and deliberately. The criminal intent and/or careless behaviour shall be considered during the legal procedures for the purposes of sanctions imposed”. I'll deal with this in more detail later.

3. The third change in the new definition is this next sentence: “This applies to the product, its container or other packaging or labelling information.”

Apparently points 2& 3 turned out to be the most controversial part for the Indian government and generics. I’ll deal with this below.

The second limb of the definition: How the definition actually addressed the concerns of developing countries

1. A senior government official was quoted in this news report as saying “Calling trademark violations counterfeit may also mean that if a drug is not registered in a country then it becomes a counterfeit, which is completely wrong. The drug may not be registered because it may not suit that country’s environment. This does not make it a counterfeit.” Clearly these objections seem to have been taken into count because the final draft of the definition had this: “Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit.” This, I think, is a major concession for as EU backed (as alleged) committee to make especially given the weak regulatory architecture in some of the developing countries.

2. There have been some news items such as this one which (way back in May, 2008 before the final draft was ready) speculated that the new definition may club 'sub-standard' medicines with 'counterfeit' medicines. This view was echoed in several other reports. However the IMPACT definition puts to rest this apprehension. The new definition clarifies that “Substandard batches or quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices in legitimate and medical products should not be confused with counterfeiting.” This distinction has been criticised by many since it is widely thought that sub-standard drugs pose as much a problem as counterfeit drugs. Read one such critique here. In fact an expert committee constituted by the Government of India some years ago dealt with the problem of spurious/counterfeit drugs in the same breath because it reasoned that both were equally dangerous. Sub-standard drugs may in fact be even more dangerous because they may cause higher resistance levels to be triggered amongst some pathogens. In all probability IMPACT wanted to focus exclusively on counterfeiting issues without any distractions.

3. Some of you may have been following our recent posts on the secretive negotiations over the ACTA. One of the proposals of the ACTA was to classify all patent-infringing drugs as counterfeit. That is a dangerous proposal because while most patent statutes do not prescribe a criminal punishment for patent infringement almost every anti-counterfeiting statute will result in a jail term. Additionally, the EC when publishing its annual anti-counterfeiting reports was classifying even patent infringing goods as counterfeit as a result of which Switzerland accounted for 39.21% of all counterfeit drugs entering the E.U. The European Generic Association (EGA) which was involved in the IMPACT discussions came out with a brief paper stating its objections to the ACTA's proposal. (This paper can be accessed here). It looks like the EGA managed to impact the final draft because IMPACT's definition clearly states that “Violations or disputes concerning patents must not be confused with counterfeiting of medical products.” Imagine the victory that the developing countries could have ensured themselves if they had decided to adopt the IMPACT definition. Instead they have clearly stated their opposition to this definition thereby keeping the door wide open for the ACTA proposal.

   It is therefore quite obvious that IMPACT was listening to everybody unlike some sources which seem to hint at a biased streak within IMPACT.

What exactly was the biggest objection to IMPACT's definition?

The biggest objection to the new definition as has been reported in news report after news report after newsreport after newsreport (this report by Sriram Iyer was extremely balanced and objective) is the possibility that the new definition would cover even trademark violations i.e. even drugs with correct ingredients but violative trademarks will be classified as counterfeit drugs. As put in one news report “This had spread fear amongst the Indian industry that if deviations were found in packaging, container and labelling, their drugs would also be deemed counterfeit even if they contained the right chemical ingredient.” The fear thus was that developed countries would use this definition as a tool to hinder the export of generic medicines from countries like India. The Indian Pharmaceutical Alliance, the SME Pharma Industries Confederation (SPIC) and several other generic drug manufacturers associations along with several NGOs have opposed the new definition because they fear that the definition will deem even trademark violations to be counterfeits. According to the critics of the definition the fact that the new definition replaces ‘deliberately and fraudulently mislabelled’ with the words ‘false misrepresentation’ apart from inserting a new line - “This applies to the product, its container or other packaging or labelling information” greatly increases the possibility of trademark violations leading to drugs being deemed counterfeit. In addition 'identity' is interpreted to mean “misleading statement with respect to name, composition, strength or other elements.” In the words of one critic “in the new definition, false representation of identity and source applies not only to labelling but also to the "product, its container or other packaging"; thus false representation with regard to any of those elements would make the product a "counterfeit" within the scope of the definition.

This means that a product also may be classified as counterfeit for example when the shape or color schemes of a product is similar to the competing product irrespective correct labeling information and contents. This is particularly problematic since presently the scope of trademark protection covers not only traditional trademark like words, signs or combination of both but also non-traditional trademark taste, shape, color, touch and feel, smell, etc. Thus, in this case the definition is more about protection of IP elements.”

The above are basically the reasons for opposition to IMPACT's definition. In my opinion this is a wrong interpretation of the definition. However before proceeding any further it is first necessary to take a look at the relevant provisions in the Drugs & Cosmetic Act.

Section 17. Misbranded drugs.—For the purposes of this Chapter, a drug shall be deemed to be misbranded,—

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of betapeutic value than it really is; or

(b) if it is not labelled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.  

Section 17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be spurious,—

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug ; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

The highlighted portions of the above two provisions of law [Sec. 17(c) & Sec. 17B(e)] are very similar to the amendments proposed by IMPACT. If the new IMPACT definition can classify trademark violations as counterfeit drugs then so can the above two provisions. Both definitions use the word 'false' and 'misleading' in respect of the label or container. Additionally the S. 17 definition uses the words 'design' which is much more specific than the IMPACT definition. The language of Sec. 17B(e) could easily classify all drugs with trademark violations as 'spurious drugs'. Manufacturing or selling mis-branded or spurious drugs are criminal offences carrying prison terms for 3 years and 5 years respectively. There was a proposal a couple of years to amend the 5 year limit for spurious drugs and replace it with either the death sentence or life imprisonment.

The question therefore is why is the Indian Government objecting to IMPACT's definition when the amendments bear so many startling similarities with the definition found in our law? Is it because the Government of India does not implement its own laws or is it just a terrible case of mass hysteria? Everytime an intellectual property issue is brought up by an international organization in the context of public health we presume that there is an 'imperialist/blood thirsty East India type corporation' conspiring against India. The level of paronia is simply unbelievable. It is time India started acting like a responsible, confident nation before it decides to torpedo international negotiations. We could have used this opportunity to clarify certain points with the developing world before the USTR tries to spring any surprises through the ACTA. It would also be nice if the Government could start articulating its concerns in the language of public health and not in the language of the generic drug industry.

What is the actual impact of IMPACT's definition – should it exclude references to trademark law?

To begin with I dis-agree with the presumption that principles of trademark law should not be imported into the definition of counterfeit. The principle aim of trademark law is to prevent confusion amongst consumers since it effects consumers. Principles like dilution entered trademark jurisprudence at a much later stage. When trademark law provides us with a well developed, time-tested, sophisticated jurisprudence it makes sense to borrow from trademark law instead of attempting to create an entire new branch of law. In fact I think we would be hard-pressed to find a more appropriate law to fight this menace of counterfeit drug. Lets now try to understand how this new definition would work.

Contrary to several media reports the new definition does not delete the terms “fraudulent and deliberate” when it inserts the term “false representation”. It only shifts “fraudulent and deliberate” to the footnote stating that “criminal intent shall be considered during the legal procedures for the purpose of sanctions.” At first glance it may seem that the main definition is conflicting with the footnote. The impact of inserting the words 'false representation' is that it probably lowers the threshold to seize counterfeit drugs. Could this pose a barrier to legitimate trade. In all probability it will not. Once the drugs are seized the normal judicial procedures will kick in to determine whether the seizure was valid and whether the drugs were indeed counterfeit.

In my limited understanding, all that the new definition does is that it reverses the burden of proof i.e. any drug making any false representation or misrepresenting any information so as to mislead the consumer will be deemed to be counterfeit and the person manufacturing the drug will be deemed to be guilty until he can prove otherwise. The 'reversal of burden of proof' is not an uncommon proposition in Indian law. Although a majority of our criminal laws are based on the presumption of innocence there are a few special legislations like the anti-narcotic laws, dowry harrasment laws where it is presumed that the person is guilty until he can prove otherwise. The suspect therefore has to either prove that the counterfeit drug is not counterfeit or that they were not in his possession. Although such laws may seem unreasonable such low thresholds for determining guilt are usually a reflection of society's intolerance for particular criminal offences. It is however a moot point as to whether such an approach actually creates a greater deterrent against any possible violation of the law.

In case it is determined that the label, packaging is indeed confusing the quantum of punishment will most probably depend on whether the conclusion was reached on a question of fact, law or a mixed question of law and fact.

In conclusion I think India lost an important opportunity to clarify certain important definitions. As correctly noted by Sriram Iyer of Money Control we've only opened the door for greater uncertainity in the future. For those of you who have actually read till the end, my humble apologies for the length of this post.