Friday, July 29, 2011

Border Enforcement Of Intellectual Property In The EU And Indian Goods

European Union (EU) has been actively working in the direction of improving Innovation and protection of Intellectual Property Rights (IPRs). EU has recently released a new IPR Strategy. Under this new IPR Strategy, EU proposes an ambitious programme until the end of 2012 that foresees actions in all the main IPRs. These include IPRs like Patents, Trademarks, Copyright and Related Rights and Geographical Indications.

Similarly, EU has also published a Green Paper on the Online Distribution of Audiovisual Works. In the framework of the IPR Strategy (Commission's communication "A Single Market for Intellectual Property Rights"), this paper aims to contribute to the development of a digital single market by launching a consultation on the opportunities and challenges of the online distribution of audiovisual works. All stakeholders are invited to participate in this consultation, which is open until November 2011.

Now EU is streamlining its border enforcement of IPRs, especially those pertaining to Indian goods meant for third countries destinations. In this regard, EU India expressed their desire to sign a Letter of Understanding (LOU) to fairly deal with Off Patent Generic Drug Consignments. Now a LOU has been signed between EU India in this regard.

According to the Understanding, so long as the EU and its Member States adhere to the principles contained in the Understanding with respect to generic drugs in transit through the EU, India has assured the EU that India will not request the establishment of a Dispute Settlement Panel at the WTO. With the exchange of these letters, India and the EU have reached, for the present, an informal settlement of this dispute. This would also result in a better border enforcement of IPRs in the EU.

In addition, EU agreed to India’s request for adoption of guidelines which would confirm the principles agreed to in the Understanding with a view to give greater and immediate legal certainty for producers and traders. EU also agreed to reflect the principles contained in the Understanding in its proposal for a new Regulation to replace Regulation 1383/2003.

India has taken note of the commitments offered by the EU. India has reiterated the core principle of the Understanding that the mere fact that medicines are in transit through EU territory, and that there is a patent title applicable to such medicines in the EU territory, does not in itself constitute enough grounds for customs authorities in any Member State to suspect that the medicines at stake infringe patent rights. However, a situation in which medicines are in transit through EU territory and there is adequate evidence that satisfies the customs authorities that there is a substantial likelihood of diversion of such medicines on to the EU market may constitute enough grounds for customs authorities to suspect that the medicines at stake infringe patent rights in the EU.

India initiated dispute settlement consultations on 11 May 2010 at the WTO with the EU on the issue of detention of Indian generic medicines while in transit through the EU. The dispute was triggered by the repeated instances of detentions/seizure at EU ports, particularly in the Netherlands, of Indian generic drugs destined for export to Latin American and other countries. The detentions were made by invoking the EC’s Regulation 1383/2003 which contains customs procedures for taking action against goods suspected of infringing IPRs. These detentions were made during the period October – December 2008 at Schiphol airport, Netherlands. The consignments were initially detained and later, either destroyed or returned to India or allowed to proceed to the destination.

The detentions by the customs authorities of these generic medicine consignments were in violation of the obligations of the EU and the Netherlands under Article V of GATT which enshrines freedom of transit of goods through the territory of each contracting party of GATT via the routes most convenient for international transit. The detentions were also inconsistent with the EU and its Member States’ obligations under Articles 41 and 42 of the TRIPS Agreement as these detentions created barriers to legitimate trade, led to abuse of the rights conferred on the owner of a patent, were unfair and inequitable, unnecessarily burdensome and complicated and created unwarranted delays.

Moreover, these detentions were inconsistent with certain fundamental obligations of the EU under Article 31 of the TRIPS Agreement read together with the provisions of the Decision of the General Council of August 30, 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the Trips Agreement and Public Health to ensure access to medicines for members of the WTO (“Members”) with insufficient or no capacity in the pharmaceutical sector to enable them to address their public health problems.

India was joined by Brazil in this dispute; Brazil also filed a similar complaint against the EU before the Dispute Settlement Body of the WTO. India and Brazil jointly held two rounds of consultations with the EU on 7-8 July 2010 and 13-14 September 2010 in Geneva. During these consultations, EU acknowledged that some provisions of the EC Regulation 1383 were misinterpreted by the customs authorities while detaining the Indian generic drugs. EU showed willingness to resolve this dispute without resorting to the WTO dispute panel.

Now that has been done, it is time to proceed further towards the conclusion of EU India Foreign Trade Agreement.

Thursday, July 28, 2011

India Abandons The Demand For Establishment Of Dispute Settlement Panel At WTO

European Union (EU) and India have confronted each other on the issue of Generic Drugs shipments in the past. Indian Generic Drug consignments have been confiscated by some European Countries customs authorities in the past for violation of Intellectual Property Rights (IPRs).

Reacting sharply, India and Brazil filed a case against the EU in the World Trade Organisation (WTO) protesting the action. India contented that such seizures were against the provisions of multilateral Trade Related Intellectual Property Rights Agreement (TRIPS Agreement), as the medicines were off-patent both in India and the country where they were being exported.

Even some unpleasant speculations like removal of India from Generalised Systems of Preferences (GSP) Scheme of EU, disagreements over TRIPS Plus provisions vis-à-vis IPRs, issues of Data Exclusivity, etc also surfaced. However, all these issues were amicable settled between India and EU.

The best shot came when EU India expressed their desire to sign a Letter of Understanding (LOU) to fairly deal with Off Patent Generic Drug Consignments. Now a LOU has been signed between EU India in this regard.

According to the Understanding, so long as the EU and its Member States adhere to the principles contained in the Understanding with respect to generic drugs in transit through the EU, India has assured the EU that India will not request the establishment of a Dispute Settlement Panel at the WTO. With the exchange of these letters, India and the EU have reached, for the present, an informal settlement of this dispute.

India would watch with interest EU’s further steps in implementing its commitments. India’s options to revive the dispute remain intact in case the EU does not abide by the core principles agreed to in the Understanding.

To Whom Radio Stations Must Pay Music Royalty?

Radio stations around the globe are using songs for their broadcasts and are willing to pay reasonable royalties in this regard. But the crucial question is when radio stations play copyrighted songs in India, to whom they are liable to pay royalties?

Is it the music company, the music composers and lyricists, Indian Performing Right Society Limited (IPRS) or Phonographic Performances Limited? This question recently came for determination before the Bombay High Court.

The Bombay High Court upheld the right of the music companies over a song recording. The order by Justice S J Vazifdar is a welcome relief for the radio stations, hotels and discotheques, etc of India that are playing copyrighted songs. Music composers and lyricists were demanding a separate royalty every time their music was played by these entities.

The Bombay High Court also ruled that IPRS is not entitled to claim or demand royalty or licence fees from a private FM channel for the recorded song and music it plays on its radio station. This means that the FM stations would now have to only deal with Phonographic Performances Limited for obtaining a licence to play the music.

The judge, however, clarified that the owners of the copyright-composers and lyricists-do not lose all their rights when they allow it to be recorded. "It does not prevent the owners of the copyright in the underlying musical and literary works from making any other sound recording embodying the same underlying work," said Justice Vazifdar.

The HC has stayed the judgment till October 31, 2011 and an appeal against the decision is very likely.

Wednesday, July 27, 2011

Patents Registrations In India Are Declining

Patent law of India has been in existence for a considerable long period of time. It has also been amended from time to time to incorporate the requirements of contemporary times, technology and international treaties.

While patent law of India is well established, India is lagging behind in the field of innovation and administrative efficiencies. This is resulting in a declining numbers of patents applications in India.

As per the latest annual report 2009-10 of the intellectual property office India, the number of patents applications filed has decreased as compared to previous years’ applications. India has also slipped to the 62nd position in the global innovation index. Further, although India is a member of patent cooperation treaty (PCT) yet it has still not been able to utilise it to maximum possible extent.

Some other issues that have to be taken care of by Indian patent office (IPO) pertains to software patents, challenges from software patents trolls, working of pharmaceuticals patents, regulation of patents trolls, etc.

On the positive side, India is planning to confer utility models protection to Indian innovators. Similarly, the efforts to digitalise the patent documents by IPO, recognition of the IPO as an International Search Authority (ISA) and International Preliminary Examining Authority (IPEA), etc are also positive developments.

Let us see how Indian patent regime would proceed from this juncture.

Software Patents In India And Their Registrability

Patent Law of India is well established. For a considerable long period of time it was primarily based upon Indian Socio Economic conditions. With the signing of Trade Related Intellectual Property Rights (TRIPS) Agreement, Indian Patent Act, 1970 was also amended accordingly. One major change was allowing Product Patents for Patentable Pharmaceuticals in India.

After India signed the TRIPS Agreement, an Ordinance to bring necessary changes in the Patent Law of India was passed. The Ordinance also incorporated a provision that allowed granting of Software related Patents. In fact, on the basis of such Ordinance, many Software related Patents were granted by the Patent Office of India.

While the Patents Ordinance had allowed such Patenting, the final Patent Amendment Bill passed in Parliament of India in this regard dropped the clause that allowed Patenting of Software-related inventions. So as on date, granting of Patent for Software per se is not allowed in India.

However, this has not deterred the Software patent Trolls in India from claiming Patent Rights in the same. This is happening because there is a general lack of awareness about Patent Trolls and their Regulations in India. Thankfully, the mainstream press is turning against such Software Patents and their Trolling exercises.

India is not granting any Software Patent per se as per its Laws and any person or institution claming the same is not entitled to any such protection in India. Any Software Patent infringement claim must be thoroughly analysed and fiercely fought against at all appropriate forums in India.

Tuesday, July 26, 2011

European Commission’s Green Paper On Online Distribution Of Audiovisual Works

European Commission’s stress upon intellectual property rights (IPRs) is well founded as IPRs bring innovation and prosperity to any nation. These days, IPRs of media, film industry, audio visual works, etc have assumed great importance.

Recently EU declared the new IPR policy for European economy. Under this new strategy, the Commission proposes an ambitious programme until the end of 2012 that foresees actions in all the main IPR, in particular patents, trade marks, copyright and related rights and geographical indications.

EU has also published a Green Paper on the online distribution of audiovisual works. In the framework of the IPR Strategy (Commission's communication "A Single Market for Intellectual Property Rights"), this paper aims to contribute to the development of a digital single market by launching a consultation on the opportunities and challenges of the online distribution of audiovisual works. All stakeholders are invited to participate in this consultation, which is open until November 2011.

This Green Paper is focused on the copyright licensing framework, but it also looks at the remuneration of authors and performers for the online use of their works.

New IPR Strategy Of European Union Declared

European Union (EU) has been stressing upon increase in innovation and protection of intellectual property rights (IPRs). In order to achieve this task, EU has been declaring various initiatives and policies from time to time.

The latest to add to this effort of EU is the declaration of new IPR strategy for the EU economy. Last week, EU published a communication titled “a Single Market for Intellectual Property Rights: Boosting creativity and innovation to provide economic growth, high quality jobs and first class products and services in Europe”. In this document, the Commission sets out its new IPR strategy intended to foster innovation, as well as the growth and competitiveness of the EU economy.

Under this new strategy, the Commission proposes an ambitious programme until the end of 2012 that foresees actions in all the main IPR, in particular patents, trade marks, copyright and related rights and geographical indications.

In the field of enforcement, it is foreseen the expansion of the responsibilities of the European Observatory on Counterfeiting and Piracy, the revision of the IPR Enforcement Directive (Directive 2004/48/EC), the support of further voluntary measures between stakeholders in the context of the internet and the adoption of a new Customs Regulation.

The Commission also prepared a booklet and frequently asked questions with the purpose to explain the IPR strategy, its goals and main actions foreseen.

Monday, July 25, 2011

Patent Cooperation Treaty (PCT) 1970 And Indian Response

Patent Cooperation Treaty (PCT) is one of the most significant Treaties of our times. It covers issues pertaining to grant of Patents at both National and International levels. The PCT was concluded in 1970 and it was subsequently amended in 1979, and modified in 1984 and 2001.

Any States party to the Paris Convention for the Protection of Industrial Property (1883) can become a member of PCT. Once accepted, the instruments of Ratification or Accession must be deposited with the Director General of WIPO.

PCT has a distinctive advantage of seeking Patent protection for an invention simultaneously in each of a large number of countries by filing an "International Patent Application”. Such an Application may be filed by anyone who is a National or Resident of a Contracting State. It may generally be filed with the National Patent Office of the Contracting State of which the applicant is a National or Resident or, at the applicant's option, with the International Bureau of WIPO in Geneva.

If the applicant is a National or Resident of a Contracting State which is party to the European Patent Convention, the Harare Protocol on Patents and Industrial Designs (Harare Protocol), the revised Bangui Agreement Relating to the Creation of an African Intellectual Property Organization or the Eurasian Patent Convention, the International Application may also be filed with the European Patent Office (EPO), the African Regional Industrial Property Organization (ARIPO), the African Intellectual Property Organization (OAPI) or the Eurasian Patent Office (EAPO), respectively.

The International Application is then subjected to what is called an "International Search." That search is carried out by one of the major Patent Offices appointed by the PCT Assembly as an International Searching Authority (ISA). The said search results in an "International Search Report," that is, a listing of the citations of such published documents that might affect the Patentability of the Invention claimed in the International Application. At the same time, the ISA prepares a written “Opinion on Patentability”.

The International Search Report and the written opinion are communicated by the ISA to the applicant who may decide to withdraw his application, in particular where the said report or opinion makes the granting of Patents unlikely.

If the International Application is not withdrawn, it is, together with the International Search Report, published by the International Bureau. The written opinion is not published.

The procedure under the PCT has great advantages for the Applicant, the Patent Offices and the general public:

(i) The Applicant has up to 18 months more than he has in a procedure outside the PCT to reflect on the desirability of seeking protection in Foreign Countries, to appoint local patent agents in each foreign country, to prepare the necessary translations and to pay the national fees; he is assured that, if his International Application is in the form prescribed by the PCT, it cannot be rejected on “Formal Grounds” by any designated Office during the National Phase of the processing of the application; on the basis of the International Search Report or the written opinion, he can evaluate with reasonable probability the chances of his invention being patented; and the applicant has the possibility during the International Preliminary Examination to amend the International Application to put it in order before processing by the Designated Offices;

(ii) The search and examination work of Patent Offices can be considerably reduced or virtually eliminated thanks to the International Search Report, the written opinion and, where applicable, the International Preliminary Examination report that accompany the International Application;

(iii) Since each International Application is published together with an International Search Report, third parties are in a better position to formulate a well-founded opinion about the patentability of the claimed invention.

India approved the PCT and the Ministry of Minister for Foreign Affairs deposited the required instrument with the Director General of WIPO on September 7, 1998. The said instrument of accession also contained the declaration that the Government of India declares that pursuant to paragraph (5) of Article 64 of the Patent Cooperation Treaty (PCT) of 1970, it does not consider itself bound by the provisions of Article 59 of the said Treaty. PCT became “Applicable” to India from December 7, 1998.

Saturday, July 23, 2011

Patent Trolls And Their Regulation In India

Patent Trolls are increasingly becoming a nuisance world over. Patent Troll is a negative term that is used in the context of a person or company that enforces its Patents against one or more alleged infringers in a manner considered unduly aggressive or opportunistic.

Patent Trolls usually have no intention to manufacture or market the patented invention and their sole purpose is to make some quick money through cease and desist orders and Patents infringement litigations. Now even in India this practice has begun to surface.

Patent Trolls frequently explore Information and Communication Technology (ICT) related fields though other fields are also covered. This is the main reason why many Software Developers have decided to leave US unless the US Patent Laws are modified suitably to immune them from Patent Trolls.

Patent Trolls are flourishing due to “Very Liberal Patent Regimes” like the US Patents System. These Patent Systems grant Patents in a very “Wide and Liberal Manner” that gives lot of leverage to Patent Trolls to harass others. Since legal fees for litigation is reasonably high, most of the Companies or Individuals prefer to settle the case out of the Court.

Many activists have been raising their voices against the granting of Patent for Software that is the main reason for flourishing of “Software Patent Trolls”. The way Software Patents are allowed in the “Most Liberal Manner”, it is also hindering “Innovation” in this regard.

The Indian Patents Act, 1970 does not grant a Patent for Software Per Se but India extends a Copyright Protection to Software under the Indian Copyright Act, 1957. So the nuisance of Patent Trolls in the field of Software is not troublesome as even if a cease and desist order or litigation is started in India, not much benefit would be derived out of the same.

Similarly, Indian Patents Act 1970 “Prohibits” Unfair Trade Practices of Hoarding a Patent by not using the same and hindering its availability to general public. If a cease and desist order is issued in respect of such a “Hoarded Patent”, the very grant of Patent can be challenged. This is sufficient “Deterrent” for Patent Trolls operating in India.

It seems Indian Patent Law is better formulated for Software Developers and those harassed by Patent Trolls. If you are a Software developer or an SME Innovator, it is a better idea to shift your work to India to get maximum commercial benefits.

Wednesday, July 20, 2011

Effective Brand Enforcement Policy Is Needed In India

Recently I was engaged in a very informative discussion about brand protection laws in India and brand enforcement laws in India at a networking group. The discussion focused on the nature, scope, brand enforcement policy, brand risk management strategy and legal framework of brand protection and enforcement in India.

Brand protection and enforcement is generally managed by the intellectual property (IP) laws of India, especially Trademarks law of India. However, there is a difference between Trademark and Brand. Though in general practice, Trademark and Brand are often used as interchangeable terms but technically, the term brand is much wider than Trademark. Trademark is one of the pivotal and crucial components of Brand. The other components of Brand vary from country to country and industry to industry.

Trademark registration is one of the steps in creation of brand but such registration in itself is not capable of creating Brand since a registration can be sought and obtained in respect of Trademark proposed to be used in future. Further, one can even develop a brand without getting their Trademark registered.

The Brand signifies existence of some sort of goodwill or reputation between particular goods/services and the owner/entity manufacturing/trading/rendering them. Such goodwill, apart from Trademark can even be associated with any / more of following –

(a) Company slogan,

(b) Products/services themselves,

(c) Unique feature(s) of the Products/services, such as the manufacturing process or the way they are made available to consumer/client, e.g. particular ambience created or a particular dish served by a particular hospitality player in their hotels/restaurants,

(d) Market positioning of the product / services.

The above stated are the features that are taken as a base for determining the financial value of any brand.

Further, a Trademark can be changed/discontinued at any point of time without affecting the brand of particular product/service or of corporate houses as whole. It is one of widely used risk mitigation strategy to check infringement and piracy of goods.

In Brand, it is the goods/services themselves which assume a personality. Thus, through effective Brand Enforcement Policy, the Corporates needs to protect the personality and goodwill of their goods/services, not the trademark (which in most of the cases is just a name or graphical representation) under which they are sold/served.

Saturday, July 16, 2011

India-US Strategic Dialogue For Trade And Economic Development

India and United States are going to discuss trade and economic cooperation and development relates issues in New Delhi very soon. This is a significant event as it would covers areas of great importance to both the countries.

Issues like cooperation on counter terrorism, improving homeland security of both countries, the contentious Part 810 authorisation, technology transfer issues, civil aviation and cyber security, etc would be discussed.

Cooperation on the economy, defense, environment, trade and other issues are also expected to be discussed. In march this year senior officials from both the countries have already shared existing threat assessments and reviewed ongoing cooperation in combating terror including intelligence sharing and capacity building.

The present dialogue is a continuation of these collaborative efforts between India and US. India is also engaging in trade and economic development cooperation with other countries as well.

For instance, European Union and India are planning to engage in foreign trade agreement that would cover many crucial issues like intellectual property rights (IPRs), technology transfers, barrier free market access, etc.

We would update on these agreements the moment they are finalised.

Thursday, July 14, 2011

EU India Would Sign LOU To Protect Off Patent Generic Drug Consignments

Indian off-patent generic drug consignments have been confiscated by some European countries customs authorities in the past for violation of intellectual property rights (IPRs).

Interestingly, these consignments were never intended to be delivered in any of the European country. Rather they were using Europe as a transit alone and the final destination was some other non European country.

Now it has been agreed that European Union (EU) members will not seize Indian medicines passing through Europe on the ground of violation of IPRs. EU has sent a final draft in this regard to India and India has agreed to the changes in their rules. EU has also accepted India's stand and within two weeks, both the sides will exchange a formal “Letter of Understanding” (LOU) regarding this.

As per the understanding, none of the customs authorities in the 27-nation EU bloc will confiscate any drug dispatch meant for third country destinations like Latin America or Africa. Some of the EU customs authorities, mainly the Netherlands and France, had confiscated several Indian off-patent generic drug consignments going to Brazil via European ports and airports over alleged infringement of EU IPRs. Reacting to confiscation, India and Brazil had filed a case against the EU in the World Trade Organisation (WTO) protesting the action.

India had argued that such seizures were against the multilateral Trade Related Intellectual Property Rights Agreement (TRIPS Agreement), as the medicines were off-patent both in India and the country where they were being exported.

This LOU would bring positive development for IPRs cooperation between EU and India that had been strained in the past. Now EU India trade and IPRs cooperation is improving and this step endorses the same.

UNECE Held IP Stakeholders Meeting

The United Nations Economic Commission for Europe (UNECE) has recently held a two day meeting to increase intellectual property rights (IPRs) awareness throughout the Europe.

The meeting was attended by wide variety of IPRs experts from various fields. However, public interest representatives were missing from the meeting. IPRs cannot be effectively utilised if they cannot be reconciled with public interest demands of the society.

UNECE maintains that an effective and balanced intellectual property (IP) regime increases national wealth and benefits consumers by stimulating research and investment into new technologies and innovative products, and by enabling the transfer of technology, including between countries at different stages of economic development.

UNECE believes that the problem in the UNECE region is that smaller companies are not aware of the benefits of IP, university researchers do not realise that research results need IP protection to be commercialised, and “consumers do not fully understand how, by buying counterfeit products, they are undermining innovative businesses.

This is an important regional development that can assist in the strengthening of IPR regime at the international level. However, in order to develop a global partnership for IP development the United Nations must work in cooperation and coordination with the private sector to make available the benefits of new technologies.

Technology sharing and technology transfer can also help in IP research and innovation throughout the world.

Wednesday, July 13, 2011

Data Exclusivity Laws In India

Data exclusivity is a protection that has been demanded by pharmaceutical companies for long. If data exclusivity protection is extended, others cannot use the data submitted by pharmaceutical companies for manufacturing generic version of the corresponding medicine.

The generic drug manufacturers can do their own research and development and generate their own approved data. However, it can take substantial amount of research, expenditure and time.

Allaying fears against conferring data exclusivity in India through bilateral trade agreements, the Commerce and Industry Minister of India has recently given assurances that India will reject any efforts to include "data exclusivity" clauses in bilateral trade agreements.

India’s insistence upon not extending data exclusivity protection may make the foreign trade agreements like EU India FTA tough and difficult to negotiate. However, despite various differences, including intellectual property rights difference and generalised system of preferences (GSP) scheme differences, positive development between EU and India is expected.

There are also talks in progress to extend utility models protection in India. Further, although we have no data protection laws in India yet India is gearing itself for the same. Further, we have no trade secret laws in India as well and the growing incidences of theft of trade secrets through cyber crimes are a cause of concern world over.

Overall the call to allow or disallow data exclusivity legal framework in India is a tough one and Indian government must consider all the aspects before taking a decision in this regard.

Regulatory Framework For Data Exclusivity In India

Praveen Dalal

This is the updated version of my previous article on similar issue. India Patent regime has witnessed many important developments since the original article has been written. Some of these developments include willingness to recognise “Utility Models” in India, suggesting the draft Patents 3rd Amendment Rules 2010 in the Indian Patents Act 1970, etc.

However, till now the tussle between Pharmaceutical Companies and India Government regarding recognition of “Data Exclusivity” is still going on. Although some changes may have taken place since the time this article was originally written yet by and large the legal position and regulatory framework has remained the same. For latest changes we would come up with a new article very soon.

The grant or refusal of Data Exclusivity protection has to be considered keeping in mind the Nation's interest and provisions of Doha Declaration and TRIPS Agreement, more particularly Article 39.3 of the TRIPS Agreement.

Data exclusivity refers to a practice whereby, for a fixed period of time, drug regulatory authorities do not allow the registration files of an originator to be used to register a therapeutically equivalent generic version of that medicine. Data exclusivity is completely separate from patents but its practical effect is to confer an additional protection to patented invention.

In fact, the strongest impact may be felt in a country where there is no patent for a medicine - if data exclusivity is granted this will provide a monopoly for a set period. Data exclusivity is one of the most controversial issues in the current discussion on pharmaceutical intellectual property policy-making globally. It is aimed at protecting and safeguarding pharmaceutical registration files, i.e. the data submitted by pharmaceutical companies to drug regulatory authorities (DRA) for the purpose of obtaining marketing approval for new drugs.

The underlying logic of data exclusivity suggests that it is an expression of trade-secrets, and that as such, data exclusivity should be independent of patents. Compared with patents, the market power of data exclusivity is, in theory, less restrictive, mainly because it does not legally prevent other companies from generating their own registration data. However, in practice, the vast financial resources and extended time required for gathering and generating pharmaceutical registration data for a new drug create a market barrier that is too high for generic-based companies.

The data included in the registration file of a pharmaceutical product is disclosed to the health regulatory authorities. Without this data a drug cannot be approved for market use. This in turn means that the term unfair commercial use is linked to the responsibility of the Government for protecting this data. In what form such data has to be protected by the Government is a different issue. It may be protected in the form of administrative guidelines or it may be protected in the form of a separate law. The larger question that remains to be answered is whether India is at all required to protect the same in the form of a "statute"? This question directly relates to the Public International Law obligations of India as India is a signatory to the TRIPS Agreement. India is not required to provide any protection beyond the scope of TRIPS Agreement and any demand over and above that will be TRIPS plus option and not a TRIPS related obligation.

Article 39.1 of TRIPS establishes that in order to prevent unfair competition, as defined in Article 10bis of the Paris Convention, members shall protect undisclosed information and data submitted to governments and governmental agencies. Pursuant to Article 39.2, WTO members shall allow natural or legal persons to prevent information lawfully within their control from being disclosed, obtained, or used, without their consent, in a manner contrary to honest commercial practices. In order to be protected, undisclosed information must fulfill three criteria:

(1) It must be secret in the sense that it is not generally known or accessible to persons who normally deal with this kind of information (Art. 39.2a);
(2) It must have commercial value because it is secret (Art. 39.2b);
(3) Reasonable steps were taken by the owner of that information to keep it secret (Art. 39.2c).

As to pharmaceutical registration files, Article 39.3 states that "Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use".

The rationale is that where substantial cost has been incurred by the researcher, it would be unjust to deprive him of the legitimate and reasonable profits by allowing the other persons adopt its unfair commercial use. Developed countries pushed very hard during the TRIPS negotiations to have data exclusivity included in the TRIPS Agreement as a new kind of IPR. They succeeded in part, as test data are mentioned in Section 7 of the TRIPS Agreement, but not entirely, as TRIPS does not talk about "exclusivity" as such.

The conferment of data exclusivity has serious implications for domestic enterprises engaged in the fields of pharmaceutical and agro-chemical products. If data exclusivity is approved domestic enterprises would be prevented from taking marketing approvals on the basis of the data submitted by the first enterprise who had generated the data and submitted the same for taking marketing approval.

The World Health Organisation has recommended that developing countries must keep the systems of Intellectual Property Rights and drug regulation separate and reject efforts to make connections between the two. Recently, International Aid Agency Medecins Sans Frontieres (MSF) - Doctors Without Borders - said in its letter to the Prime Minister of India that the Drugs and Cosmetics Act was a legislation related to health and improving access to drugs.

An amendment to implement an intellectual property agreement in the Drugs and Cosmetics Act can have a serious impact on the approval and availability of generic versions of essential drugs. If the Indian Government starts providing exclusive rights over test data, this will delay generic competition from Indian pharmaceutical companies even in cases where the medicines are not patent protected.

Opponents of data exclusivity provisions argue that the TRIPS provisions speak only about the protection of test data against unfair use and nothing on data exclusivity. It is also pointed out that data exclusivity might restrict access to drugs, especially generics, which helps keep down prices. Other arguments focus on unwarranted extension of patent rights and obstacles to compulsory licensing, which helps poor countries to avert emergencies. In order to delay competition from generic manufacturers, multinational companies have been pushing hard to obtain exclusive rights over their test data. The biggest impact of data exclusivity is on medicines that are not patented in some countries, as a result of pre-TRIPS patent laws excluding pharmaceutical patents. This is the case of most antiretroviral medicines in Guatemala for instance, where generic manufacturers will now have to wait five years from the date of approval of the original medicine in Guatemala before obtaining registration of their own version of the medicine.

In other words, even when a medicine is not protected by any patent, multinational pharmaceutical companies are assured a minimum period of monopoly in countries that provide data exclusivity. This is clearly going beyond the TRIPS Agreement. In other situations, where a medicine is protected by patents, data exclusivity may constitute a barrier to the use of compulsory licenses. If a generic manufacturer is granted a compulsory license to overcome the patent, it will not be able to make effective use of the license if it has to wait for the expiry of data exclusivity before it can get its generic version approved by DRA and put on the market. Therefore, countries will need to ensure that the uses of compulsory licences are not restricted by data exclusivity. Data exclusivity is a means of impeding generic competition, and maintaining artificially high prices, thereby restricting access to medicines.

In simple words, what TRIPS says is that WTO Members should protect "undisclosed test or other data" against "unfair commercial use" and "disclosure". Nowhere does TRIPS state that countries should provide exclusive rights to the originator of the data for a given period. Since the wording of Article 39.3 is very general, Members maintain substantial flexibility when determining how submitted test data should be protected. WTO Members do not have an obligation under Article 39.3 to confer exclusive rights to test data, whether it is for three years, five years, or 10 years, as pointed out by many experts. This is because Article 39.3 allows considerable discretion as to what member states must do. It does not specify a minimum term of protection.

More importantly, it is not clear whether the phrase "unfair commercial use" includes use of the originator's data by the regulatory agency to assess applications by generic competitors. This has been argued not to amount to "unfair commercial use" so long as the regulatory agency does not disclose the data to the generic competitor. Under this interpretation, Article 39.3 does not require data exclusivity. On the other hand, the research-based pharmaceutical industry, the United States Trade Representative and others have argued strenuously that Article 39.3 does require data exclusivity. Thus, data exclusivity is no more than "TRIPS-plus" and is designed to delay the introduction of generic competition, creating a barrier to access of medicines, in particular where there are no patent barriers. The countries that are members of the WTO do not have to grant data exclusivity, as specified under TRIPS Article 39.3. However, if they agree to grant data exclusivity in a trade agreement signed after the TRIPS Agreement, they are bound by the later agreement, in accordance with the rules of international law, and will have to implement this obligation at national level.

Unlike US and European Union, India's stand and interpretation of Article 39.3 does not include market exclusivity to the innovator and does not create market protection. India is of the view that the said article only talks about the protection of test data against unfair use and nothing about data exclusivity, which is further interpreted to be same as market exclusivity.

It is viewed that Data Protection is very different from data exclusivity. EU and US are of the opinion that article 39.3 also covers data exclusivity, wherein they have adopted similar legislation to provide data exclusivity to innovator, the duration of which may exceed up to ten years in EU and five years in US.

The decision of India of not allowing data exclusivity is not only TRIPS compliant but also in nation's interest. It must be appreciated that we need not to follow precedents set by developed countries that are primarily based on a different societal set up and is guided by commercial exigencies. The larger interest of India requires us to stick to the obligations of TRIPS Agreement and not to venture into the arena of TRIPS plus terrains. The TRIPS Agreement nowhere stipulates and obligates India to confer data exclusivity and the only requirement is to prevent an unfair commercial use of the data submitted.

The concept of prevention is negative in nature whereas the conferment of data exclusivity is positive and pro-active in nature. It is strange that Government has not appreciated this simple fact. The Government must inculcate confidence in the mind of these pharmaceutical companies that their interest and data will not be misused as stipulated in the TRIPS Agreement and beyond that it need not to enter into the controversy of data exclusivity. The solution lies in administrative reforms and not in invoking the legislative machinery of India. This is more so when the TRIPS Agreement itself has left that provision flexible. Thus, India should not confer data exclusivity as that is not only against the TRIPS Agreement but also against nation's interest. The ideals of Doha Declaration must not be forgotten and India must consider the interest of nation first rather than succumbing to the pressure created by big multinational companies manufacturing pharmaceuticals.

Wednesday, July 6, 2011

Trade Mark Registrations In India-A Practical Guide

Trade Mark registrations in India form an integral component of any Corporate Brand Development and Management Policy. The same becomes more crucial in case of Multinational Companies, Overseas Investors and Foreign Entrepreneurs that desire to use Indian soil for establishing and/or expanding their business presence in Asian region.

Generally speaking, the procedure of Trademark Registration in India confirms to the international standards and India is a party to prominent International Conventions and Treaties related thereto, except Madrid Protocol. However there are certain allied technical aspects which if taken care off in professional manner and under customised guidance of proper IP Law Firm / expert Trade Mark Attorney would help brand owners to save their money and time invested in getting their trademarks registered in India and, further help them to curtail consequent infringement / passing off claims.

These facets have further got relevance in view of various technological initiatives of Indian Trademark Office such as facility of Free and portal based Trademark Search, E-filing of applications and responses, Online Application status and other similar facilities.


Governing Law – (Indian) Trademarks Act, 1999 read with Trademarks Rules, 2002

What Constitutes Trademark / Brand under Indian Law – Any word / symbol derived from signature, name, device, label, numerals or combination of colors or even sound recording capable of graphic representation, used to create distinctiveness in respect of goods / services of the trademark owner.

Who can be Applicant for Trademark Registration – Any person claiming to be the proprietor of a trade mark used or proposed to be used in India can apply for its registration with Indian Trademark Office. Thus even foreign national / company can hold valid Trademark in India.

Classification System – India follows NICE / International Classification system. And various goods and services can be registered in appropriate class(s) out of the total 45 (Forty Five) classes provided under schedule IV of the Trade Marks Act, 1999. These classes earlier 42 (Forty Two) in No. give an indicative summary of such goods and services and final authority regarding determination of the appropriate class(s) in respect of the goods or services in question lies with Registrar of Trademarks.

Benefits of registering a trade mark in India?

The registration of a trade mark under Trademarks Act, 1999 confers upon the owner / registrant following benefits –

1. Exclusive right to the use / grant the license to use the registered trade mark in Indian Territory or specified part thereof;
2. Create new market for its products;
3. Generate authenticity and trust amongst its consumers regarding origin and quality of its goods or services;
4. Create goodwill and thereby enhance financial worth of registrant entity;
5. Right to expanded legal remedies against infringer.

Details and Documents Required for Trademark Registration process –

Soft copy of the Mark to be Registered in India;
First Use date of the Mark, (required in case, Mark is already in use);
Description of related Goods and Services;
Complete details of Applicant

In case of Applicant being an Artificial Entity –

– Name of the entity / Company,
– Communication Address,
– Name and designation authorised to sign required documents.

In case of Applicant being a Natural Person –

– Name of the Applicant,
– Father’s / Husband’s Name,
– Communication Address.

Execution of Board Resolution (if applicant is an Artificial Entity) and Power of Attorney which shall further be required to be notarized and consularised in the home country.

Registration Stages –

The involved procedure of Trademark Registration in India requires an Attorney to possess practical knowledge of the involved steps so that the Applicant does not waste their valuable money and time in proceedings that might be unwarranted in view of its specific trademark or related goods and services. These registration steps are as follows –

1. Filing of Trademark Registration Application in requisite manner,
2. Issuance of acknowledgment by the Trademark Registry with Application No.,
3. Issuance of Examiner’s Report by the Trademark Registry,
4. Filing of Reply to Examiner’s Report on behalf of Applicant,
5. Arranging publication of Trademark in official Trademark Journal, either as Accepted or as Advertised before Acceptance,
6. Replying to third party objections in case any received in a particular case,
7. Attending personal hearing at Trademark Registry for explain applicant’s case,
8. Dispatch of Trademark registration Certificate,
9. Advising Registrant with Renewal Date and related formalities,
10. Ensuring exclusive Trademark exploitation by Registrant through Trademark watch services.

Registration Time Frame – The effective time taken by Indian Trademark office varies between 24 to 48 months, depending upon presence of objections or third party opposition in a particular case. In case of straight forward application or through proper professional handling of registration process, this time frame can be reduced to 18 to 24 months.

Friday, July 1, 2011

India Ranked 62nd In The Global Innovation Index 2011

As per the recent Global Innovation Index 2011, India got an overall ranking of 62nd place out of 125 economies. Switzerland ranked first among 125 economies surveyed for their innovation capabilities.

This shows that India is still not concentrating upon innovative capabilities and there are not sufficient incentives and infrastructures to nurture and encourage innovation in India.

To start with India must improve its educational system that more academic than professional and vocational. With academic knowledge, innovation cannot be achieved. Take the example of legal education of India. Till now we have no innovation university on law in India, though suggestions in this regard have been long given.

Similarly, India also needs to develop innovative capabilities in the fields like cyber security, cyber forensics, cyber warfare, anti cyber terrorism initiatives, etc.

Even the outsourcing industry of India needs to be innovative. LPO and KPO in India need to be innovative as new fields are emerging that are beyond the expertise of traditional LPOs and KPOs.

We at Perry4Law and Perry4Law Techno Legal Base (PTLB) believe that India must formulate suitable policies and schemes so that innovation can be encouraged. Utility models protection in India can be a starting point. Further, sharing of intellectual property rights (IPRs) with the innovator using governmental facilities can also be a good option. But these are only starting points and India needs to do much more than that.