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Acta and its impact on India

One of the long lasting problem encountered by all nations is trademark counterfeiting. Several countries especially those developed countries, therefore, would like to strengthen the rule and regulation in order to suppress the widespread of this phenomena. Accordingly, the new agreement has been introduced, Anti-Counterfeiting Trade Agreement (ACTA) writes Pooja Tripathi.
 
 
I. INTRODUCTION

While one of the most controversial issues arisen directly related to the intellectual property division in all nations is the accession and implementation of Anti-Counterfeiting Trade Agreement (ACTA) which definitely brings the new face mechanism especially at cross border. These upcoming features and changes will virtually bring the attention from all authorities to discuss and provide the opinion in order to be able to draw further conclusion. The born of ACTA is due to the vulnerability to suppress the expansion of counterfeiting. ACTA was born under an intense circumstance and discussion especially by the developed countries. Most of developed countries view that the current agreement; Trade Related Aspects of Intellectual Property Rights Agreement (TRIPs) is not adequate to combat against trademark counterfeiting and piracy matters. Therefore, the other measures have been sought in order to strengthen the widespread of this phenomena accordingly. Nirmalya explained that the ACTA negotiations were launched jointly by the USA, EU, Japan and Switzerland in 2007. Australia, the Republic of Korea, New Zealand, Mexico, Morocco, Singapore, and Canada also joined the negotiations. The first round of negotiations was held in Geneva in June 2008. Nine rounds of negotiations have been held till June 2010. In the WTO Council for TRIPS (‘TRIPS Council’), Brazil, India and China have consistently blocked the inclusion of enforcement as a permanent agenda item. However, the access through such draft of ACTA is restricted to public in general. On the

1. Syam Nirmalya,"IP Enforcement through Anti-Counterfeit Laws: The ACTA Negotiations and Their Implications", the South Centre.
2. Anselm Kamperman Sanders, DalindyeboBafanaShabalala, et al,"The Anti-counterfeiting Trade Agreement (ACTA): An Assessment", available at http://www.laquadrature.net/files/INTA%20-%20ACTA%20assessment.pdf last visited on 05/02/2014.
other hand, the industrial groups have been given access to the technical details of the negotiations on a confidential basis. The fact that the draft text has been released very close to the conclusion of the negotiations suggests that the text is rather mature and there is very limited possibility of substantial revision of the text in consideration of public interest objectives. Hence, the provisions in the draft ACTA text, which have been drawn up in a confidential manner without consulting public interest groups, require thorough examination with regard to their implications for developing countries and least developed countries altogether.

As stated by the former US Trade Representative Susan Schwab, the goal of ACTA is to"establish, among nations committed to strong IPR protection, a common standard for IPR enforcement to combat global infringements of IPR particularly in the context of counterfeiting and piracy that addresses today’s challenges, in terms of increasing international cooperation, strengthening the framework of practices that contribute to effective enforcement of IPRs and strengthening relevant IPR enforcement measures themselves." Thus ACTA seeks to establish new global standards for IPR enforcement and provide for increased cooperation. On the other hand, India complained that ACTA completely bypasses the existing multilateral processes provided, in particular, by the WTO and the World Intellectual Property Organization (WIPO), and that it also scales up the minimum enforcement level enshrined in the TRIPS agreement.

2. ACTA AND ITS IMPACTS ON INDIA

Though the purpose of ACTA is to address the issues on the trademark counterfeiting which currently has been widespread across the globe, it is unforgettable to mention that this agreement will certainly has its effect on the manufacture and circulation of generic medicines. There are many countries around the world especially developing countries and least developed countries which neither manufacture the medicines for the people in their nations nor be able to afford the patented medicines which costs very expensive. Definitely, India, as one of the biggest generic drugs manufacturers, might be affected as the generic drugs might be seized and detained which will definitely devastate the aim to distribute the generic drugs to other countries especially least developed countries for public health.The confusion of this agreement starts from the Footnote 2

3. A Party may exclude patents and protection of undisclosed information from the scope of this Section
of Section 2 that ACTA the member countries ‘may’ exclude patents and undisclosed information from the scope of the civil enforcement section, the term that a country"may exclude" suggests that such exclusion should be the exception rather than the rule. It is possible that the countries shall absorb and include the patent and data exclusivity into the scope of civil enforcement as well. Simultaneously, some member countries may harmonise such scope whereas some may not and this might lead to the contradiction and confusion subsequently. Moreover, it is worrisome if there is an inclusion of patent as this might harm the legitimate trade of generic medicine.

The ongoing problem of this agreement also includes the subject matter at the cross border as stated under Article 13, Footnote 6 . Though ACTA indicates not to apply the patent into the scope, it still contains a dramatic expansion of border measures requirements to all intellectual property rights in TRIPS and expands the border measure beyond"counterfeit trademark or pirated copyright goods" to include the seizures of suspected"confusingly similar"trademarks. The inclusion of civil trademark claims in ACTA’s border measures creates risks for access to medicines similar to those raised by patents. Theargument over allegations of similar sounding names or packaging are common in the medicines field as similar names and packaging are often even desirable to demonstrate medical equivalency, but they do not mean that the medicines are unsafe. If India distributes the generic medicine to other countries, another concern is the seizure at the trans-border on the ground of trademark infringement rather than on the patent infringement basis. The issue on the seizure on the confusing similar trademark has been strongly highlighted when the medicines were detained in Germany based on the wrong assumption that a generic medicine, using the required international non-proprietary name (INN) 'amoxicillin' to describe the contents, infringed GlaxoSmithKline's trademark on the brand name Amoxil. At the core of this detention was an expansive EU customs regulation designed to expand the enforcement of IP rights that led to many other detentions of medicines in transit between developing countries which were not IP-protected in the source or destination
4. The Parties agree that patents and protection of undisclosed information do not fall within the scope of this Section
5. Medicine Sans Frontier,"The Secret Treaty Anti-Counterfeiting Trade Agreement (ACTA) and Its Impact on Access to Medicines", available at http://infojustice.org/download/acta-a2m/other/101006%20ACTA%20Impact%20on%20Access%20to%20Medicines%20-%20FINAL-%20v2.pdf last visited on 12/08/2014.
countries. It is also possible that the custom authority, who do not actually have the thorough information on the identification of the mark whether it is counterfeit or confusingly similar, is empowered to decide whether to detain or even destroy the allegedly infringing good without any court oversight or even notification to the right holder or the generic company alleged to have violated the trademark but merely on the ground of the customs official's own view on whether the goods in question infringe a commercial trademark.For instance, civil trademark infringement requires surprisingly complex legal analysis, often including multi-factor tests and market-specific knowledge, and is frequently the subject of lengthy and considered litigation at court. This might be become the measure for the right holder to delay or destroy the competitor’s goods be claiming the infringement until the court decides whether there is a valid ground.

Comparing to the clause specifying in TRIPs under Article 46"in considering such request, the need for proportionality between the seriousness of the infringement and the remedies ordered as well as the interests of third parties shall be taken into account" and the term revealed under ACTA that,"except in exceptional circumstances," all infringing goods be"disposed of outside the channels of commerce.", this phrase can be considered to differ from the safeguard as stated in TRIPs. ACTA could be interpreted to require that, for example, absent"exceptional circumstances," a medicine found to have a minor trademark infringement on a label be destroyed rather than re-labelled and re-sold. Besides ACTA disappears to mention the right of the defendant to seek the review by the judicial authority in connection with the dispose of infringing goods as mentioned under Article 59 of TRIPs. As stated in the ACTA, the generic medicine producer might face not only the destruction of the products which can destroy the generic medicine business but also the harsh punishment as stipulated under civil and criminal provisions may also increase the risk and harm to the business. The criminal penalties must also

6. Health Action International,"Another Seizure of Generic Medicines", 5th June, 2009, available at http://www.haiweb.org/19062009/5%20Jun%202009%20Press%20
release%20Seizure%20of%20generic%20medicines%20in%20Frankfurt.pdf
last visited on 10/06/2014.
7. Article 59 of TRIPs: Other Remedies
Without prejudice to other rights of action open to the right holder and subject to the right ofthe defendant to seek review by a judicial authority, competent authorities shall have the authority to order the destruction or disposal of infringing goods in accordance with the principles set out in Article 46. In regard to counterfeit trademark goods, the authorities shall not allow the re-exportation of the infringing goods in an unaltered state or subject them to a different customs procedure, other than in exceptional circumstances.
be available in cases of label and packaging offenses. Aiding and abetting infringement must also be subject to criminal liability. All offenses must be punishable with imprisonment and monetary fines (unlike TRIPs which mandates the penalty either imprisonment or fines). Moreover, the questions also arises in the case of intention to commit the crime which is considered to be one of the factors to punish the offender. However, under the provision of ACTA regarding the wilful importation seems to contrast to the required mensrea factor. The importer who brings the goods with the trademark counterfeiting to the country regardless of whether the importer knows that the goods are affixed with the trademark counterfeiting, he shall be considered to be liable for the offense.

Another inevitable concern is thepower to inspect, seize and detain is expanded to cover the export and in transit, , which seems contrast to the requirement prescribed under TRIPS. One incident on the seizure of generic medicine which created several debates and arguments is the seizure of the generic drugs so-called ‘losartan potassium’, which was produced by Dr. Reddy’s Laboratories in India. However, this drug was patented for the EU territory by DuPont and Merck Sharp &Dohme. The detention was taken by the Dutch custom authority when the medicines were in transit to Brazil. The consignment was eventually sent back to India due to threat of destruction by the right holder. Another incident of detention happened again when the

8. Article 16 of ACTA - Border Measures

1. Each Party shall adopt or maintain procedures with respect to import and export shipments under which:
a) its customs authorities may act upon their own initiative to suspend the release of suspect goods; and
(b) where appropriate, a right holder may request its competent authorities to suspend the release of suspect goods.
2. A Party may adopt or maintain procedures with respect to suspect in-transit goods or in other situations where the goods are under customs control under which:
(a) its customs authorities may act upon their own initiative to suspend the release of, or to detain, suspect goods; and
(b) where appropriate, a right holder may request its competent authorities to suspend the release of, or to detain, suspect goods.

9. This version defines"in-transit" goods as those under"customs transit", defined as the"procedure under which goods are transported under customs control from one customs office to another," or"transshipment," defined as the"procedure under which goods are transferred from the importing means of transport to the exporting means of transport within the area of one customs office which is the office of both importation and exportation." See Article 5(f), (i), (n).
medicines funded by UNITAID comprising forty-nine kilograms of ‘abacavir’ sulfate tablets was confiscated byDutch customs authorities on the ground that the drugs were counterfeit. Themedicines, manufactured by the Indian company Aurobindo, are used in second-linetreatment of HIV/AIDS in Nigeria for a programme implemented by the ClintonFoundation on behalf of UNITAID. UNITAID protested sharply insisting that the shipment does not involve any counterfeit drugs or any other infringement of IP rights. Instead, the medication had been prequalified by the World Health Organisationand had received tentative approval by the United States Food and Drug Administration.

These incidents would by somehow led to the introduction of EC Regulation 608/2013 which has been applied and repealed the EC Regulation 1383/2003from January 1, 2014 onwards as the old regulation is considered to be vulnerable to address the increase and widespread of trademark counterfeiting especially at cross border. At certain point, it is also pertinent to note that harmonisation of ACTA is appeared in this new regulation as well. The power of custom has been highlighted as the authority is empowered to intercept and destroy the counterfeit goods entering or in transit through the European Union Territory. The custom authority can, without an intervention from a judiciary, seize and destroy the goods under certain condition"without there being any need to examine whether it infringes the intellectual property right under the law of Member State where the goods are found. Further, the procedure allows destruction with reference to implied consent provided that the importer has not notified his opposition to destruction of the goods within 10 working days pursuant to Article 23. The detention and seizure authorities extend to cover the small consignments defining as: ‘postal or express courier consignments, which either contain three units or less or have a gross weight of less than two kilograms’. The consent from the right holder is not required. Instead, Customs will notify the declarant/holder of the goods of their intention to destroy the goods and if either agrees (including by implied consent), the goods may be destroyed. Nevertheless, it is pertinent to note that the procedure only applies if the IP rights holder requests and mentions in the application.

10. Henning Grosse Ruse-Khan,"A Trade Agreement Creating Barrier to International Trade? ACTA Border Measures and Goods in Transit", available at http://infojustice.org/download/acta-2m/scholarly/2011%20Henning%20Grosse%20Ruse-Khan,%20A%20Trade%20Agreement%20Creating%
20Barriers%20to%20International%20Trade%20AU%20ILR.pdf
last visited on 12/08/2014.

In Blomq vist v. Rolex SA, theCourt of Justice of the European Union (CJEU) ruled that EU customs officials could seize and destroy non-EU originating counterfeit goods in the EU that were purchased by EU citizens for personal use. The rights holder does not have to prove that a non-EU seller was directly trying to sell or advertise counterfeit goods for personal use in the EU in order for EU customs officials to seize imports of the counterfeit goods. This is different from the Council Regulation No. 1383/2003 which the trademark owner would have to prove that the counterfeit seller was directly trying to market the counterfeit goods to EU consumer in order for the personal purchase to be subject to infringement and seizure.

4. CONCLUSION

All nations would certainly like to strengthen the provision of law as well as the enforcement mechanism to combat the trademark counterfeiting including other types of infringement. It is, nevertheless, important to note that the promotion of intellectual property rights at the same time shall not hamper or increase any burden on any other legitimate trade. International agreements are considered to be the instruments where all countries shall mutually and jointly agree to absorb and harmonise within their internal legislations. Therefore, like the other agreements, the states should collectively be convened to discuss on ACTA in order to increase the possibility of harmonisation of the same.The call for discussion in order to finalise the certain mechanism is significant because certain provisions are still considered to be unclear and might also lead to the confusion and argument in future. Certain word such as"may" will virtually bring the different implementation by each country and accordingly creates various interpretations. In addition, notingone of the objectives of ACTA to address the hurdle of trademark counterfeiting which affects not only the trademark owner but also several bodies, the primary aim which all nations shall take into a serious consideration is to promote and allow the access of medicines and enhance the public health of the fellowmen. Accordingly, any agreement shall not become the barrier for the movement of legitimate trade specifically the generic drugs which are

11. Blomq vist v. Rolex SA (C 98/13).
manufactured and circulated in order to correspond with the objective as set out in the Doha Declaration.
 
POOJA TRIPATHI is a Ph.d student at the National Law School of India University, Bangalore. She may be reached at tripathi.pj@gmail.com.
 
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