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Background
With the increasing harmonisation of intellectual property regimes worldwide and the gradual erosion of TRIPS flexibilities through a variety of bilateral agreements, there is a dire need for developing countries to adapt their basic interpretations of concepts such as novelty, inventive step and industrial application to the needs of their public health system. The lack of information concerning the flexibilities that a country may exercise in defining their patentability criteria and the corresponding inability of patent examiners to effectively analyse applications has led to a steep rise in the number of patents that contribute nothing to innovation but block further scientific progress in a certain area. One area in which the impact of these developments may be felt most acutely is pharmaceutical research and development, with patent monopolies on pharmaceuticals being extended indefinitely through a variety of methods of strategic patent application. The results of this extended ever-greening of vital pharmaceutical products may be of great consequence to public health in the long term, unless steps are taken to check the grant of such 'strategic' patents.
Professor Carlos Correa of the University of Buenos Aires, Argentina, had prepared a list of draft guidelines outlining some of the common forms of claims utilised in 'strategic' pharmaceutical patent applications, along with recommendations on patent examination and procedures to check the spread of such strategic patents. As part of the process of refining and fine-tuning these recommendations, Prof. Correa participated in a series of discussions. The consultation was held to facilitate a detailed discourse on patent law and policy that would include scientists, policy-makers, academics, patent practitioners, civil society and participants concerned about public health. The conference was held in New Delhi on the December 13-14, 2007. It enabled people to share perspectives on the technical and legal aspects of patent prosecution and drug development and discovery in India. Parties from Nepal, Bhutan, Sri Lanka, Thailand and Indonesia also took part in the discussion.
Day 1
Session 1: Opening Addresses
Chairperson:
. Mr. B.K. Keayla, Convenor, National Working Group on Patent Laws
Panelists:
. Mr. German Velasquez, World Health Organisation (WHO)
. Ms. Aradhana Johri, Joint Secretary, Department of Health
. Ms. Gina Vea, Programme Officer, Intellectual Property and Technology, International Centre for Trade and Sustainable Development (ICTSD)
. Mr. D.P.S Parmar, Deputy Controller of Patents & Designs, Department of Industrial Policy and Promotion
. Prof. Carlos Correa, Professor, University of Buenos Aires, Argentina
1. Chairman's Statement: Mr. B. K. Keayla
The session began with an introductory statement by Mr. B. K. Keayla, the Convenor of the National Working Group on Patents. Mr. Keayla noted that there was still a standing debate on the TRIPS Agreement despite its ratification in 1995. During this time, the UK Commission on IPR and the WHO Commission on IPR had been formulated to investigate the TRIPS Agreement. India had also formed a non-official commission to examine the TRIPS Agreement. The Doha Declaration was another landmark for providing member countries with flexibilities in adopting the TRIPS Agreement. It has been found, especially from the perspectives of India, that these flexibilities have been adopted. Patents are important from the perspective of health. India is a country with 80 million cardiac patients and 60 million diabetes patients. There are also serious cases of TB, HIV etc. The patent system of India needs to be viewed from the perspective of the health system of each country. In India, two important issues are - firstly, the scope of patentability and patenting of pharmaceuticals, and secondly, the patenting of micro-organisms.
2. Statement by Mr. German Velasquez, WHO
Mr. German Velasquez of the World Health Organisation (WHO) spoke about the document created by Prof. Correa, pointing out that at the stage of discussion it was still in draft format. In the international context, Mr. Velasquez highlighted the fact that of 10 million people dying every five years, at least 8 million die with no access to medicine. Six million people are in need of Antiretroviral Treatments, but only one million people have access to such treatments. A concern voiced by many countries has been the high prices of new drugs, reduction in local pharmaceutical companies and the rise of bilateral agreements. At one point, there were only two actors in the access to medicines arena: the WHO and the Ministry of Health. Today, there are a number of ministries and organisations, and the role of the WHO is no longer as clear as it used to be. One of the needs is to define that role.
One problem is that all of the new actors are contributing billions of dollars towards issues around three diseases. The new mandate of the WHO should be to use TRIPS flexibilities to protect access to medicine, and to promote the Inter-Governmental Working Group (IGWG) as the future of the WHO.
Within the context of trips flexibilities, India has managed to use Articles 7 and 8, on objectives and principles of the TRIPS Agreement, to interpret the concepts of inventive step, novelty and industrial application. As Prof. Correa said earlier, cases in which real novelty exist are few. Though the number of patents filed is rising steadily, the discovery of new drugs is falling. The Indian Patent said in August that no more than 30-50 new drugs were being patented, but that more than 2,000 new patents had been granted.
3. Statement by Ms. Gina Vea, ICTSD
Ms. Gina Vea, the Programme Officer for Intellectual Property and Technology at the International Centre for Trade and Sustainable Development (ICTSD), spoke of ICTSD's work towards the creation of public policy professionals. She said while Intellectual Property protection was originally a tool to reward innovators and to give access to new technologies, there is a concern that today, IP does not strike this balance. Though the guidelines issued to patent examiners provide crucial methods for the examination of patents, there needs to be additional layers of review, within the provisions of national law for pre- and post- grant opposition.
4. Statement by Mr. D.P.S. Parmar, Indian Patent Office
Mr. D.P.S Parmar, of the Indian Patent Office provided a detailed account of the offices of the Indian Patent Offices and of the developments in the Indian Patent system.
5. Statement by Prof. Carlos Correa
Prof. Correa noted that the review of the working paper was an important challenge for him. The paper had been developed in consultation with experts from developed and developing countries through a process of face-to-face consultations with patent examiners, non-governmental organisations, research organisations etc. While Prof. Correa noted that the document was not a collective work, he emphasised that it was based on the collective knowledge of many people. The purpose of the document is to guide the evaluation of pharmaceutical patent applications. The reason for this is that when patents are granted for pharmaceutical products or processes, the implications affect people directly. A patent creates exclusive rights, essentially a monopoly. The owner of such a patent is free to charge such prices as can be taken by the market. When a patent is granted, the owner has control over the market and prices in the market.
The problem is that today, the number of patents granted has risen dramatically, to 2030 applications in a year, from 80-90 earlier. The majority of these applications are for me-too drugs, second indications of original compounds. Prof. Correa noted the strong need to examine the reasons for such a paradoxical situation to have arisen. While some part of the profits from these drugs would go to marketing, some part should also be going to research and development. However, the number of patent applications made does not correspond to the number of innovations, because the applications are for variations of existing drugs. Prof. Correa noted the major proliferation in patent grants. The reason for this proliferation is that even though such granted patents cover very little development, they may be used effectively to prevent competition and to obtain an injunction from a judge. Therefore, such very weak patents are used to exclude competition.
Prof. Correa noted that in the upcoming discussion, they would examine specific subject matter and to what extent it is possible to identify such patents as were discussed above. He saw the objective of the discussion as being to obtain views on the suggestions put forward by the document, and also to see if other examples, policies and variations may be introduced.
6. The Scope of Patentability - Mr. D P S Parmar, Indian Patent Office
Mr. Parmar provided the first presentation on the scope of patentability provisions under the Indian Patents Act. He examined the norms of patentability covered by the sections of the Act. Some of the important provisions he covered were: Section 2(1)(j), defining inventions; Sections 3 and 4, providing exclusions from patentability and covering the norms of novelty, inventive step and industrial application.
7. Presentation by Mr. Gopakumar and Prof. Biswajit Dhar
After an introduction by Mr. B. K. Keayla, Mr. Gopakumar of CENTAD and Prof. Biswajit Dhar of the Centre for WTO Studies gave a presentation on the current status of mailbox applications in the Indian Patent Office. The presentation highlighted the current status of applications that had been submitted through the mailbox route prior to the introduction of the product patent regime. The presentation showed a country-wise break-up of applications, as well as highlighting some of the major pharmaceutical companies that had submitted applications. It also showed the number of applications that may be affected by Section 3(d), such as salts, esters, polymorphs, compositions and formulations, selected on the basis of the titles of the patents. The number of applications for tuberculosis treatment and cancer treatment were also highlighted, and the fact that 14 of the anti-cancer drugs applied for were not currently available was also pointed out. A key concern was that a number of the mailbox applications contained patents that may not be grantable, a fact that indicated the extent to which the patent office's intervention would be necessary in the coming years. The need for a re-examination of the patent guidelines was emphasised. The need to rethink the patent system outside the boundaries of the TRIPS Agreement was also highlighted by Prof. Dhar.
Discussion:
The discussions subsequent to these presentations highlighted a number of concerns about the ability to utilise the machinery of the patent office. The primary concerns highlighted in this area were:
. The lack of online search facilities and a copy of patent abstracts, obstructing the process of conducting effective searches and pre-grant oppositions.
. An insufficient number of patent examiners.
. The lack of interconnectivity between different patent offices, requiring people to go to a specific regional office to refer a patent that had been filed there
. The lack of cooperation from examiners concerning disclosure of patent application information
Session 2: Technical Session
Introduction
Professor Correa opened the technical session by mentioning the TRIPS flexibilities allowed to each country in interpreting the core patentability criteria of inventive step, novelty and industrial application. He said countries had the option to opt for utility as a criterion for patentability, thus allowing for business method patents. He pointed out that though each country was allowed to frame its own policies on patentability, the advice given to these countries concerning their implementation would lead to a specific type of patent regime, in the form of the patent examiner's policy. The guidelines mentioned in this paper would be crucial for policy formation.
1. Formulations and Compositions
The discussion began with a description of the use of formulations and compositions in patent drafting. Prof. Correa said most patent applications consist of formulations or composition claims, with a corresponding decrease in New Chemical Entities. The usual practice in creating such applications is to play with a reformulation of an existing compound and then submit an application. The majority of examiners are unable to distinguish a genuine claim from such reformulations. When an application for a chemical compound is filed, the scope of the formulation is not known even to the applicant. However, given time and sufficient research, it is possible to return and file for further formulations of the compound. Formulation claims can often be so broad as to block access to the original drug even if it has completed its term of patent protection. It is also possible to mislead the courts into believing that a case of infringement would exist. The use of formulation claims as a commercial tool to strategically block competition, therefore, cannot be ignored.
Prof. Suchart Chongprasert added that knowledge of how to make further formulations or compositions comprising the original compound may not be a part of existing literature, but it may still be known to persons skilled in the art. The examiner should be made aware of the extent of knowledge a person already in the field has.
Discussion:
A number of questions and observations were raised following the presentation on formulations and compositions. Some of the important points raised are:
. It was suggested that the term of patent protection for a formulation or composition incorporating a particular compound should be linked to the term of the patent over the original compound. Any technical advances should be eligible for the grant of process patents alone.
. All formulations cannot be ignored as unpatentable, as a number of formulations grant the ability to deliver the drug to the target site more effectively. The problem lies in the grant of broad claims.
. The provisions of Section 3(d), especially with the introduction of the requirement of efficacy as interpreted in the Novartis judgment (i.e. having a therapeutic effect) actually provide a stricter limitation on the use of formulations and compositions as compared to the guidelines. However, it is also possible that the Court could interpret the ambiguous phrase "therapeutic effect" in the context of side effects at a later point.
. The concept of efficacy as applied in the European Patent Office (from which the phrase is derived) is based on a problem-solution approach. If there is a problem, and if a solution to the problem is presented, then it would obtain patent protection. However, this sort of approach would only apply to the EPO. Within the Indian Patent Office, such an approach is not adopted.
2. Combinations
Dr. Correa described combinations as being basically the same as compositions, except that they consisted of a combination of two or more compounds. According to Correa, combinations should only be patentable when the combination of compounds produces a synergistic effect that should be non-obvious and new. Even a mere synergistic effect would not be eligible for patent protection.
Discussion:
The discussion concerning this issue raised a number of questions, primarily about evidence of synergistic effect. The points raised in the course of discussion were:
. The term composition is differentiated from a combination in that, while the term composition is more general in nature, the term combination refers to a combination of 2 or more active ingredients. The issue whether such a combination represents a technical advance or is a mere admixture depends on the situation.
. The question of the level of disclosure required to demonstrate a synergistic effect elicited much debate. While some participants felt that a disclosure made on the part of the applicant was sufficient, others felt the need to show evidence of such synergistic effect, demonstrated in the form of biological testing or some form of clinical trial. It was also noted that such a requirement would impose an additional burden on patentability that was not within the TRIPS requirements. Another point raised in this discussion highlighted the inability of the patent office to verify claims of synergistic effect and efficacy through clinical trials. The patent office would only be able to rely on the data presented to them.
3. Dosages
Claims on a certain dosage of a drug were described as essentially a claim on a method of treatment of that drug. One example is the difference between the drug Aspirin and the child-safe version of Aspirin, Baby Aspirin, which is merely the same drug in a smaller dosage. Claims on dosage quantities should fail the test of industrial applicability as the effect of a different dose of a drug is merely the effect of the drug on the body.
Discussion:
Discussion on the subject of dosages pointed out that Indian patent law already deals with the subject of dosages, though in some cases, methods of treatments may be patentable.
4. Salts and Esters
Salts and esters of a compound were described by Dr. Correa and Prof. Chongprasert as derivatives of the compound itself. While they were pharmacologically new chemical entities, they would not satisfy the criteria of novelty. Prof. Correa noted that while the rules regarding lack of patentability for salts and esters are already known, it was important to highlight the exceptions to these rules.
Discussion:
The discussion on the subject of salts and esters highlighted the following points:
. Uncovering a salt or an ester of a known substance is a common practice in pharmaceutical research and relatively obvious to perform.
. There may be situations where certain pharmaceutical substances are first introduced in their ester or salt form. In such situations, the usefulness of the drug remains, though the inventiveness may be in question.
. It is possible that salts may never be sufficiently inventive. Even if the creation of a salt of a compound discloses "unexpected effects", there is no requirement to grant a patent for such a product if the creation of such a salt was already obvious.
. A salt cannot be patented as a new property of a known substance as such patentability is already prohibited under Indian Patent law.
5. Polymorphs
Prof. Correa and Prof. Chongprasert explained that some chemical entities exist in different physical structures, and that the physical structure in which a certain compound resided could not be determined. The only solution would be to play with the structure of the compound until one arrived at a suitable alternative. However, such a structure could not be said to be created by human efforts, but would merely have been arranged by nature. The variations in these physical structures are called polymorphs. While there is no difference between a chemical compound and the polymorph of that compound, there is a difference in their structural properties. The impact of such polymorphs is felt in the area of antiretroviral drugs, where there is a trend in the pharmaceutical industry to extend patent protection for such drugs through polymorphism. It was pointed out that polymorphism is not so much an invention as a discovery, as it was not possible to determine a polymorph. Rather, a suitable polymorph would only appear.
Discussion:
The discussion on polymorphism covered the patentability of polymorphs as well as the question of their inventiveness. The following points were raised:
. There was a point when polymorphism was considered to be an inventive step. This is evidenced by a US Federal Circuit judgment acknowledging the inventiveness of polymorphs. However, today it is a common procedure similar to crystallisation.
. The statement that no human intervention is required for creating a polymorph is debatable, as a chemist may face considerable problems in creating a polymorph. Such a polymorph, once created, may have significantly different properties with regard to absorption. However, the polymorph itself should not be granted a patent. A process for the creation of such a polymorph may be patentable.
. The usage of the term "amorphous" in patent claims was also highlighted, such as the claim for astorvastatin, as being one more form of a substance. An amorphous form of a substance is basically still a polymorph. However, an amorphous form of a substance shifts form constantly, and therefore, a patent for an amorphous form would block any other applicant from claiming a patent on any other form of the substance.
Day 2
Day 2 saw the conclusion of the technical discussions and the discussion on steps to be taken for the improvement of patent examination and prosecution.
Session 2 Continued
6. Markush Claims
Prof. Correa described Markush claims as part of United States patent practice, where large numbers of compounds are covered in a claim on the basis of equivalence. Sometimes, the number of compounds covered under a single claim could number in the millions. The patentability of Markush claims should not be questioned on the basis of inventive step, but of disclosure. Prof. Chongprasert elaborated by pointing out that even if a Markush claim has been presented for patenting, the applicant would have only tested a few of the compounds in the claims. Though Markush claims are accepted in the US, they present major problems with the examination of novelty under such claims. It is impossible to predict with full certainty the exact properties of all the compounds within a certain range of equivalence.
Due to the similarity in issues concerning Markush claims and Selection Patents, the discussions concerning these two areas were combined.
7. Selection Patents
Selection patents are usually granted for a subgroup of patents with specific properties within a group of patents claimed in a Markush claim. Selection patents raise questions of novelty, as they have already been disclosed in the Markush claims on a patent.
Discussion:
The discussion around Markush claims and Selection Patents covered the following points:
. One instance of the positive effects of Markush claims was highlighted in a case where a corporation filed an application incorporating millions of claims with a number of options, essentially a Markush claim. However, this resulted in these vast quantities of claims being opened up to the public domain once the term of patent protection had expired.
. It is up to the policy of a country to determine whether or not it would allow for the patenting of Markush claims. It is up to each country's individual patent policy to allow for selection patents.
. The Indian Patent Office usually rejects Markush claims on the ground of lack of inventiveness and insufficiency of description.
. An interesting question was raised concerning the creation of Markush claims covering therapeutic effects of a range of compounds. If one of the compounds within this range was discovered to have carcinogenic properties, would the claim for the range of compounds be invalidated? Similarly, the question was raised as to if a Markush claim, covering certain properties contained a particular selection within that claim that was found not to have such properties, could become the subject of opposition or revocation of patent. In response, it was stated the practice of the Indian Patent Office was that if a certain selection within a Markush claim did not have the properties claimed within the Markush claim, then that selection would be removed from the claim.
8. Analogy Processes
Prof. Correa described analogy processes as non-inventive processes that create a novel or inventive compound. Analogy processes are patentable in certain jurisdiction, while non-patentable in others. In this case, the patent is granted not for the novel product, but for the already known process, thereby transferring novelty to the process. Analogy processes essentially operate as a fiction, and therefore should not be allowed irrespective of the novelty or inventiveness of the product.
Discussion:
The discussion around analogy patents covered the patentability of analogy patents under Indian law and the cases in which analogy processes are used. Some of the relevant points covered were:
. It was pointed out that under Indian Patent Law a "mere use of a known process" which results in a new product or reactant is patentable. Therefore, the Indian Patent Office grants protection to analogy processes. This point was responded to with the observation that analogy processes are only allowed in applications where the product and the process are both claimed. This raised a further question as to whether it was necessary to give an analogy patent at all in such a case, and as to whether it was not better to give a straight product patent.
. It was observed that the majority of analogy processes were granted for inventions in the field of biotechnology. This was supplemented by an observation that US legislation prohibited analogy process patents except in the case of obvious biotechnological process claims involving new and non-obvious results.
. It was agreed that the provisions concerning analogy processes should be examined, especially to draw the analogy with regard to such claims very clearly. If a process was obvious, there would be no justification in granting it a process patent if a product patent could be granted for the new and non-obvious product.
9. Enantiomers
The presentation on enantiomers began with an explanation from Prof. Chongprasert on the nature of enantiomers. Enantiomers were described as isomers of a compound that behaved as a mirror image to the original compound. Claims are usually made for a "racemic mixture" of the two enantiomers, with a later claim being made for more active of the two enantiomers. In this manner, protection for a racemic mixture of a compound can be extended by later claiming the more active of the two enantiomers forming that mixture.
Discussion:
The discussion looked into issues of obviousness concerning enantiomers and their constituent compounds.
. A question was raised concerning whether a person skilled in the art would find it obvious, having created a racemic mixture, to look for a more efficacious compound within that mixture. The question was answered with the statement that if it was known that one of the two forms of the enantiomer was more active, then it would be a natural step to try to isolate it.
. Another question was raised regarding the patentability of an enantiomer arising from a racemic mixture when the racemic mixture had already obtained patent protection and was therefore known. Such a patent would lack patentability under Indian law as a new use of an already known substance. To this, it was responded that it may be possible to argue the existence of an inventive step for an isomer resulting from this racemic mixture or for the process of its creation.
10. Active Metabolites and Prodrugs
Prof. Chongprasert described an active metabolite as a compound created within the body as a result of the action of another compound's metabolism in the body. He distinguished active metabolites from prodrugs by explaining that prodrugs were inactive compounds that, when introduced into the body, would produce a therapeutically active ingredient. Prof. Correa argued that active metabolites which produced a compound within the body that was already under patent protection or had completed its term of patent protection should not be granted patent protection. Then Prof. Chongprasert said with regard to prodrugs, especially where, if a patent for a compound is granted, the applicant may, at the end of the term of the patent, file a new application claiming the prodrugs to that compound.
Discussion:
The discussion around prodrugs and active metabolites yielded the following points:
. Patents for prodrugs and metabolites are usually not granted in India for products, but for processes. A patent for a new and inventive process of producing such a drug would obviously be eligible for patent protection.
. It is possible that the patent for a prodrug or active metabolite of an already patented compound may face revocation under Indian law on the grounds of its secret use in India.
. The argument concerning prodrugs is grounded in public health policy. When a compound has already been granted a patent, it would be a definite public health issue to extend protection over the compound by granting protection to the prodrug of that compound.
11. Method of Treatment
Prof. Correa did not expand on the topic of methods of treatment as the guidelines as formulated are for the benefit of countries with no existing method of treatment clauses. However, discussion on the topic did highlight the practice of disguising method of treatment claims within patent claims to a particular substance or product.
12. Use Claims and Second Indications
Prof. Correa opened the last technical presentation by highlighting the clear tendency among pharmaceutical companies to find new uses for existing products. Some jurisdictions accept the patenting of second indications. He mentioned an EPO decision in 1994 which stated that while the grant of patents for second indications was against the patent law, it was good for the development of pharmaceutical industry. The US also provides some protection for new uses. Second indications are merely secondary methods of administration or treatment of a compound. In countries where industrial applicability is a standard for patentability, second indications cannot be granted patent protection. Second indication claims are also referred to as "Swiss claims" and have been accepted by the EPO on the ground that they have "novelty of purpose".
Discussion:
During the discussion on second indications, it was pointed out that the recommendation as highlighted in the guidelines only covered second indications of known pharmaceutical products, and not of known substances. Accordingly, it was suggested that the recommendations be changed to incorporate new uses of a known substance as well.
Session 3: Mechanisms to Enhance the Examination of Pharmaceutical Patents
Prof. Correa introduced the final session as an effort to introduce ideas for mechanisms that would enhance the examination of pharmaceutical patents. Prof. Correa highlighted two mechanisms that he believed would improve this process.
Firstly, he dealt with the opposition process and its relevance in checking patents that should be granted. He mentioned the practical problems involved in the filing of an opposition, such as the need for skilled practitioners to mount a satisfactory opposition, the high costs involved in the filing of oppositions in light of the fact that benefits accrued as a result of a victory go to the competitors of the filing party as well. Prof. Correa noted that very often, as a result of these problems, even parties with a strong case to file for oppositions preferred instead to settle for a license with the owner to utilise the patent. Prof. Correa noted that this problem was being effectively tackled in a number of countries through the intervention of Non-Governmental Organisations (NGOs), especially in terms of post grant oppositions to Antiretroviral vaccines. Until recently, NGOs would only deal with political issues as well as compulsory licenses. Today, however, an increasing number of them were stepping forward to filing oppositions to the grant of patents over vital medications. Prof. Correa noted that these oppositions are beneficial from the public health perspective because they are not conditioned by commercial interest.
The second mechanism highlighted by Prof. Correa was a system being adopted in some countries, of direct intervention in the patent grant process by a country's Ministry of Health or drug regulation agency. In Brazil, the Drug Regulation Agency was given the power to grant or withhold prior consent for the grant of patents. The final word on the grant of patents would rest with the Ministry of Health, which had an effective veto right to the grant of a patent. This provision has been applied in Uruguay, Paraguay and Egypt. Prof. Correa also explained that this requirement did not impose any additional criteria to patentability, as the Drug Regulatory Agency would apply these criteria as well.
Summing up, Experiences Sharing and Conclusion
The final session concluded with a statement of thanks by the participants and resource persons.
Dr. German Velasquez of the WHO thanked all participants for contributing to the development of the guidelines. He added that this exercise had also been useful for the WHO, which has been studying public health and its relationship to intellectual property. He said that the guidelines took on particular relevance in light of the fact that the medical bill for developing countries would steadily increase in the next five to twelve years. He noted that the goal of this document had been the stimulation of debate, and from that perspective, it had been successful here, with many people making points that could be useful for the Indian Patent Office.
Mr. Gopakumar, Research Officer, CENTAD, expressed his gratitude to the participants and the Indian Patent Office, which had provided a great deal of input, which had provided a truly fruitful opportunity for debate, discussion and education. He also thanked the facilitators for their role in making the event possible.
Prof. Correa concluded the session by stating that he had been extremely pleased that the meeting had been useful for him. He also expressed his gratitude towards the organisers and the participants.
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