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Rethinking global patent linkage regime in the time of pandemic

Saransh Chaturvedi

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Introduction

 The outbreak of Covid-19 has set the eyes of the world towards finding a suitable vaccine for the virus. Undoubtedly, the vaccine will have a huge global demand once it is prepared. This prevailing situation has made various countries to re-think some of the most pressing issues with regard to the patent regulation. Patent linkage is perhaps one of the most debatable aspects in patent regulation around the world. Various countries have often tried to explain different ambits of patent linkage in accordance with the situation prevailing. The system of ‘patent linkage’ refers to the practice of linking the market approval of the generic product to the status of the patent of the innovator’s product. This way, patent linkage has the involvement of two different authorities, one being the regulatory body which grants the market access to the pharmaceutical industry and other is the patent office which grants the patent rights to the patentee. If there being an existing patent on the subject drug then the regulatory authority can refrain from providing market approval to the generic manufacturer as per the regulation.

The denial of the market entry often concerns the access to essential and cheaper medicines and in larger picture, the public health issue. The availability of generic drug being subjected to such preceding condition irrespective of any infringement does affect the larger issues of access to medicine. Issue of patent linkage must be discussed globally, in the light of ongoing pandemic when access to medicine is of utmost concern for every country. In the past few years, we have seen countries, especially the developed ones, trying to encourage other countries, to include “linkage regulation” in their domestic régime, frequently. This encouragement is done through various bilateral and multilateral agreements.

Free trade Agreements and TRIPs

 The US- South Korea Free Trade Agreement, commonly known as KORUS FTA, is one of the examples where due to this agreement; South Korea changed its domestic laws to insert the notion of Patent Linkage. Trans-Pacific Partnership is another agreement which did not come to force, due to US withdrawal primarily because the measures were inconsistent with that of US commitments of free and fair trade as notified by the US government. US wanted to implement TRIPs-plus provisions which were countered by different developing countries on board. Consequently, the remaining members re-negotiated the draft and entered into new agreement known as Comprehensive and Progressive Agreement for Trans-Pacific Partnership. Similar, Re – gional Comprehensive Economic Partnership (RCEP) too witnessed India’s walkover owing to the requirement of adopting TRIPS-plus provisions by countries. India rejected this requirement on grounds of under developed IP laws of various countries, including India’s.

It becomes imperative to understand the provision of linkage in TRIPS agreement. Too much surprise, TRIPS provisions do not talk about any linkage regulation. The countries supporting this regulation however, adopted a literal interpretation of TRIPS agreement resulting into TRIPs-plus regime, as mentioned above. In the TRIPs Agreement, if anywhere the rights of patentee are elaborated; it is Article 28.1(a) which provides that “where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product”. Also one article that deals this domain is Article 39.3 which says 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 reading of both the article might give us some insight that the notion of Linkage must have come from the interpretation of these two articles but cannot be confirmed. It purportedly, being one of the barrier, it’s difficult to assume TRIPs giving such notion.

Claims vs Critique

 Claims made for favoring linkage regulations were such that it was necessary for providing incentive to originator firms making high risk research and development. But all these grounds offered in support does not validly relates to other mechanism for intellectual property protection such as data protection and patent term extension etc. If we talk about the US Hatch Waxman Act, it brings the linkage regime into force for the explicit need to balance the brand pharmaceuticals firms and the generic firm to bring cheaper medicine “as soon as possible”. Through this the US publishes the Orange Book which contains all the approved drugs in the US which are having the same Therapeutic Evaluation. The Food and Drug Administration (FDA) updates the list of all the drugs and provides the exclusivity information and all the industry while filing for the Abbreviated New Drug Application must show which drug has been used and what is the expiration of the same. The inability of the generic manufacture to rely over the originator’s clinical trial test data makes it simply impossible to bring cheaper medicine “as soon as possible”. This framework seems to be used for avoiding competition by the originator.

Too much surprise, the European Union does not have a system of patent linkage. There were instances where various industry have tried to introduce such provision but they failed and even in a 2006 press release, the European Generic Medicines Association had stated that patent linkage is contrary to EU regulatory law as it undermined the Bolar provision which sought to encourage quick access to the post patent market for EU generic medicines

Why this clause is generally added to the various agreements might also be because this shifts the onus of regulating the infringement from the patent holder to the authority. This way the authorities take the responsibility of a patent office to which they don’t have any expertise. This linkage also gives the power to patent holder to have an injunction on the claim without evaluating the merit of the same. Even previous research have concluded that even in US, this clause is moreover used in avoiding the competition among the products with the originator drug and delaying the very entry of generic drugs. Undoubtedly, pharmaceuticals companies will be the major supporter for the linkage framework to be adopted by countries, especially developing countries. If we try to analyze the economic perspective of this framework, most of the justification follows the tendency to respond to positive incentive and rewards. But these incentives must be ‘locked’ up at least ‘temporarily’, for the primary purpose of providing net benefit to society, in the time of pandemic.

Currently, we are seeing various Asian Countries amending their local laws to insert the linkage clause. China, South Korea, Singapore are some which have linkage regulations. Latest entrant to the list is Taiwan which amended its law in 2019. Still some of the Asian Countries like Indonesia, Thailand, Brunei, Malaysia, Philippines and Vietnam does not have the patent linkage regime. It is imperative to see whether countries like Malaysia, Vietnam, and Brunei will change their patent law, they being the member of Comprehensive and Progressive Agreement for Trans-Pacific Partnership, which requires the members to have a law for preventing the issuance of marketing approval to avoid the risk of infringement.

The linkage framework will be inconsistent with the double benefits that pharmaceutical companies are getting with the prolonged market exclusivity for the drug. All scientific development is built upon a pre-existing knowledge and concept. This framework kills the substantial interest of the developing countries with weak IP regulations for their much needed purpose of access to medicine. The automatic stay over the market approval is an unintended consequence of this regime. It is imperative to analyze two cases which are very important for this discussion. The Delhi High Court in the case of Bristol-Myers Squibb Co. vs. Hetero Drugs gave an ex parte injunction to Bristol, preventing Drug controller to approve generic version by Hetero, which created lot of distress among generic manufacturer. In 2010 landmark decision of Delhi HC in Bayer Corporation vs. Cipla, the court made it clear that patent linkage is impermissible in India.

Conclusion

The two authorities have different functions, of which no linkage is possible. The primary problem is not the linkage as a whole but the legal nexus being created under this regime. It is very hard to understand the drug regulatory approval taking the responsibility of the patent office, of which they don’t have expertise. This process delays the entry of the generic manufacturer without any proven infringement thereby largely affecting the access to medicine and in larger picture, cheaper medicine. This pandemic does make us realize the importance of not only cheap medicines but also a rapid access to medicines. It is necessary to have a global linkage regime which must address this pertinent issue at large. It should not be limited to individual countries, especially during such global pandemic. Till now we don’t find any such guidelines or regulation which addresses this issue globally. Prompt and affordable access to essential medicine is a component of all domestic and public health models and barring the generic drugs is doctrinally weak which prejudices the historical, epistemological and jurisprudential foundation of intellectual property.

 Saransh Chaturvedi is pursuing LLM at the Rajiv Gandhi School of Intellectual Property Law. Indian Institute of Technology, Kharagpur.

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Policy & Politics

Partnerships, technology and behaviour change key for agriculture growth, said Union Agriculture Minister

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Partnerships, technology and behaviour change key for agriculture growth, said Union Agriculture Minister

India has the potential to become “aatmnirbhar” in agriculture and also meet the food requirement of the world, said Narendra Singh Tomar, Union Minister of Agriculture & Farmers Welfare.
Speaking during the session, Food for All: From Farm to Fork, during the 3rd edition of LEADS 2022—— a global thought leadership initiative of the industry chamber FICCI, the minister said the country is steadfastly moving ahead in the direction. However, everyone must work together for the goal. “We would like to collaborate. I use this opportunity to invite the international community to join hands with us for the benefit of coming generations,” he said.
He noted that country’s agri exports had crossed the milestone of ₹4 lakh crores. “We are working to increase it further,” he said.
Minister Tomar said that the government is constantly working to make the country “aatmnirbhar”. As a result, Indian agriculture recorded a robust growth of 3.9% despite the pandemic. In addition, the minister reiterated that the government aims to make Indian agriculture internationally competitive by aiding the small farmers in the country. He alluded to several government programmes to reduce farming-related challenges. “Due to increase in investment in basic infrastructures like irrigation system, storage, warehousing, and cold storage, the Indian agriculture is expected to record robust growth in the coming years,” he added.
On occasion, H.E. Mr Damien O’Connor, Hon’ble Minister for Trade & Export Growth; Agriculture; Biosecurity; Land Information & Rural Communities, New Zealand, alluded to the challenge emanating from climate change. “agricultural emissions from livestock are a real challenge for New Zealand and food systems around the world. It contributes 35% to the global greenhouse gas emissions and 48% to New Zealand’s emission profile.”
He also alluded to Global Research Alliance and encouraged Indian parliamentarians “to look at investigating partnering up with a Global Research Alliance” to gather global technologies “in a way that is not seeking to maximise commercial benefit but to maximise the climate change benefit from this collaboration.”
Sanjiv Mehta, President, FICCI and CEO & Managing Director, Hindustan Unilever Limited (HUL), said achieving food and nutrition security is a multifaceted challenge. “Food systems can play a big role in protecting food security and nutrition if careful attention is paid to targeting the poor, reducing inequalities, including gender inequality and incorporating nutrition goals and actions were relevant.”
Dr Anish Shah, Vice President, FICCI and Managing Director and CEO, Mahindra & Mahindra, said the world will have 10 billion people by 2050. “Today, we do not have enough food to provide for everyone, so we have to do a number of things to feed everyone.” He pointed to three themes that can help address the challenge. The first is partnerships to reduce carbon footprint and improve productivity. Second, adopting technology to transform agriculture and thirdly, inducing behaviour change.
Sunny Verghese, Co-Founder and Group CEO, Olam International, said, the biggest priority is to help decarbonise.

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Policy & Politics

Digital Agriculture Mission to digitalise the farmer: Manoj Ahuja, Secretary, Agriculture

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Digital Agriculture Mission to digitalise the farmer: Manoj Ahuja, Secretary, Agriculture

Contextual and correct information to anybody associated with agriculture has the potential to unlock a lot of value, said Manoj Ahuja, Secretary, Union Ministry of Agriculture & Farmers Welfare, at the Release Ceremony of the FICCI compendium on “Enhancing Farmers’ Income”.
In this regard, Ahuja alluded to the Digital Agriculture Mission, which essentially tries to digitalise the farmer in terms of identity, linking up the farmers’ land and geo-referencing it, and crops grown. “These are some of the basic things we are trying to put in the agristack,” he said. “We have made some headway; hopefully, next year, we should show substantial results,” he added.
Ahuja said, “I’m seeing the benefits information contextualised to the various partners in the agricultural ecosystem can bring”.
On occasion, Samuel Praveen Kumar, Joint Secretary, Union Ministry of Agriculture & Farmers Welfare, spoke on backstopping agriculture startups that are coming up with innovative technologies and solutions to enhance farm incomes. In this regard, Mr Kumar alluded to the three C’s— convergence, capacity building, and collectives like (FPOs and cooperatives) as the vital elements.
Elaborating on convergence, Kumar said, “if the government can package the schemes in such a manner that you give more benefits, in a unified manner to the businesses or startups, I think they will be able to sustain their business.” Similarly, on capacity building, he noted, “when we talk about capacity building for farmers or extension workers, it’s not like that. It is for everybody in the ecosystem.” Mr Kumar also alluded to developing climate-resistant crops, reducing carbon footprints using technology, and developing infrastructure.
Elaborating on the compendium, TR Kesavan, Chairman, FICCI National Agriculture Committee & Group President, TAFE, noted the need to document the best practices and give them to people so that “people can touch, feel, do and understand the practices.” He added, “small and marginal farmers are going to be one of the greatest strengths of the country. Some of the case studies in the compendium tell how they are changing.”
The FICCI compendium of guidelines presents select case studies, and successful projects and interventions rolled out by various organisations in achieving higher crop connectivity, resource use efficiency, cropping intensity and diversification towards high-value agriculture.

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Policy & Politics

Supreme Court: An Order Is In Given Factual Circumstances; Judgement Lays Down Principles Of Law

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Supreme Court

The Supreme Court in the case Akil Valibhai Piplodwala observed and has issued a notice on a petition filed by a man seeking a direction that he should not be deported to Pakistan until his claim to be an Indian citizen is decided as per Section 9(2) of the Citizenship Act, 1955.
The bench comprising of Justice Surya Kant and the Justice J. B. Pardiwala observed and has also issued status quo in the matter. Thus, the notice on the plea has been issued to the District Superintendent of Police (Godhra), State of Gujarat and the Ministry of Home Affairs, Union of India.
According to the plea, the was born at Godhra, Gujarat in 1962 and had completed his education in India. The petitioner moved to Pakistan in 1976 but in 1983 he returned to India and got married at Godhra to an Indian woman on 2nd March 1984 and had three children from the wedlock. Thus, the petitioner again went away and finally returned to India in 1991 after obtaining all the requisite permits including a residential permit and continued to reside in India with his family.
However, out of fear of getting deported, the petitioner moved a regular civil suit before the Court of Civil Judge praying to declare him a citizen of India under Section5(1)(C) of the Indian Citizenship Act, 1955 since he was married to an Indian citizen. It is also prayed by him to restrict authorities from deporting him till his application under Section 9(2) of the Act is decided by the Union of India. In 1999, it was held by the Civil Judge that the Court did not have jurisdiction to decide the citizenship of the Petitioner. However, the decree was allowed by the Civil Judge partly to direct that he should not be deported back until his application under the Citizenship Act is decided.
Further, after the period of 4 years, the Union of India preferred a delayed appeal under Section 96 of CrPC against the order of the Civil Judge before the Principal District Judge. On 12.07.2022, the District Judge set aside the decree passed by the Civil Judge.
The petitioner being aggrieved by the order of the District Judge, moved the High Court of Gujarat. On 02.08.2022, the High Court dismissed his appeal holding that no substantial question of law arose.
Senior Advocate IH Sayed, appearing for the petitioner submitted that the High Court disregarded the fact that the Petitioner has been rendered vulnerable to deportation and if he is not protected till his application is adjudicated upon it would be violation of the procedure established by the principle of law.
The present petition was filed through Advocate Taruna Singh Gohil.

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Policy & Politics

Delhi HC Asks Centre: What Is The Procedure For Undertrial Foreign Nationals’ Visa Renewal?

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Delhi HC Asks Centre: What Is The Procedure For Undertrial Foreign Nationals’ Visa Renewal?

The Delhi High Court in the case Uchenne v. State observed and has directed the Centre to place on record the necessary steps and procedures required to be followed by foreign nationals, who are in the jail as undertrials, for renewal of their visas.
The bench comprising of Justice Jasmeet Singh observed while dealing with a plea filed by a foreign national seeking bail in an NDPS case, said there are many foreign nationals lodged in the national capital’s prisons, whose visa applications have not been processed.
The court stated that he i.e., the Central Govt Counsel shall also place on record necessary steps and procedures so that foreign nationals who are in jail as undertrial know the procedure for renewal of their visas. The Uchenne, accused had moved the High Court last year wherein seeking regular bail in an FIR registered under Section 21 of the Narcotic Drugs and Psychotropic Substances Act, 1985. Thus, after the completion of investigation, charge-sheet was filed under Section 21 of the NDPS Act as well as Section 14 of the Foreigners Act.
It was observed that Section 21 of the NDPS Act states punishment for contravention in relation to manufactured drugs and preparation, Section 14 of Foreigners Act provides various penalties under the statute, in case of violation of any of the provisions.
The Additional Public Prosecutor on March 30, told the court that before proceeding with the bail matter, accused’s visa needs to be re-validated. The Advocate J.S. Kushwaha appearing for the foreign national submitted before the Court that although his passport was renewed, he is required to be taken to the Foreign Regional Registration Office (FRRO) for visa renewal on April 29.
Accordingly, it has been directed by the court to Uchenne to complete all procedural formalities and ordered that he be taken to the FRRO in accordance with law and established procedures.
On August 2, over three months, Uchenne’s counsel apprised the Court that despite earlier orders, his visa was neither renewed nor any reasons were given regarding the delay or rejection. Also, the court was informed that Uchenne had applied for visa on January 28, in 2019.
However, during the recent hearing on September 19, it was sought by the Centre’s counsel seeking further time to get instructions in writing from FRRO before the next date of hearing.
Accordingly, the court listed the matter for hearing next on October 10.

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Policy & Politics

“Indian Pharma aspires to reach 400 billion dollars by 2047,” MoS of Chemical and Fertilizer

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“Indian Pharma aspires to reach 400 billion dollars by 2047,” MoS of Chemical and Fertilizer

To commemorate the 100 years of independence, the Central government has begun working on a vision plan for a ‘future-ready India’. In this context Confederation of Indian Industry (CII) organised the 4th Life Sciences Conclave with the theme “Roadmap for Indian Life Sciences @ 2047”. A white paper released by CII on the Way Forward for lifesciences. To achieve the biggest milestones in the lifesciences and Pharmaceutical sectors over the next 25 years, India needs to focus on four strategies; Innovation & Commercialisation, Sustainable Production, Internationalisation and create a Business Environment and develop the lifesciences infrastructure and regulatory frameworks for ease of doing business.
Speaking at the virtual platform, Bhagwanth Khuba, MoS Chemical & Fertiliser and Ministry of New and Renewable energy, said in his message“ The Indian pharmaceuticals market has characteristics that make it unique. . India plays an important role in manufacturing various critical, high‐ quality and low‐cost medicines for Indian and global markets. The industry has contributed immensely not just to Indian but to global healthcare outcomes. The sector forms a major component of the country’s foreign trade as well, with attractive avenues and opportunities for investors. The outbreak of the COVID-19 brought out the risk of disruption of supply chain of critical bulk drugs for the Indian pharmaceutical sector, highlighting the need for India to attain a sufficient degree of self-reliance in bulk drugs. In this regard the Department of Pharmaceuticals prepared two schemes for promoting domestic manufacturing of critical KSMs/ Drug Intermediates and APIs by attracting investments in the sector to ensure their sustainable domestic supply and thereby reduce India’s import dependence on other countries for critical KSMs/Drug Intermediates and APIs.”
S Aparna, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers said, “ Showed three important routes to bring mainstream of lifesciences research that are biosimilars and RNA vaccines, stem cell and gene therapy and ability to bring natural products.

Inclusion, Innovation and Integration are the key words
Dr V.K Saraswat, Member, NITI, Aayog said, that the emerging important areas are genome sequencing, DNA splicing, CRISPR CRAS are the fastest growing domains. With development of nano robotics, transgenic free varieties of GM food will be common entity in future. Agriculture scientists will develop edible vaccines. Precision agriculture, genome engineering will help in innovative technology. Early intervention and better prognosis of diseases will drive the lifesciences sector. Another field emerging is tissue engineering in generating artificial organs. India needs to secure rich biological wealth. Lifesciences is an important part of healthcare and projected to touch 150 billion dollar by 2025. Some of the initiatives have taken place in the last decade has broadened the scope. Investment is key. Private equity firms are going to bolster new areas. Sustaining position in novel vaccine, reducing morbidity and mortality. Ethical policy development and venture technologies are important areas
Vivek Kamath, Co-Chairman CII National Committee on Pharmaceuticals & Managing Director Abbott India Ltd, said, “ Healthcare is one of the priority sectors for 2047. Government through various policies and schemes are encouraging of an efficient lifesciences sector. The covid affected the healthcare sector but gave opportunity for the industry to transform. One key word that came up during the pandemic was ‘collaboration’ that helped in combatting the pandemic. Collaboration can become a burning desire
Satish Reddy, Chairman, Dr Reddy’s Laboratories, mentioned, “ We are in the 75th year of independence and the theme of the conclave resonates very well with what the industry has to achieve. All around the globe 20% of generic medicines are made in India. Aspiration is to reach 400 billion dollars by 2047. One area where we are aspiring to be demonstrating capability is in innovation. Need to disrupt existing ways. There is immense opportunity in expanding the entire lifesciences biosimilars innovation. Success eludes us. We have the ability for new drug discovery as well as achieve discovery of newer molecules. For this adequate funding and investments are required as well as tax rebates for R&D. Also there is a need for industry academia collaboration for translational research.
Dr Renu Swarup said “Moving to the next 25 years we need to leverage on the opportunities we have built for ourselves but cannot be based on an incremental increase of what we have done. We have to keep up with the pace of technology. Collaborations are the key to success and there need to be convergence in research.”
At the platform CII and Cadila Pharma launch joint national campaign for rabies-free India by 2030. As a part of the campaign to make India rabies-free by 2030, several activities for awareness and prevention of rabies will be undertaken at the national and state level under the aegis of the government of India.
By 2047 we will see the beginning of a demographic, epidemiological and environmental shifts so we should be ready with Lifecourse immunisation.- UNICEF.

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Nation

Top opposition leaders gather at INLD rally to challenge ‘Delhi Sultanate’

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Sharad Pawar, the head of the NCP, Nitish Kumar, the chief minister of Bihar, Sitaram Yechury, and Sukhbir Singh Badal, the leader of the Shiromani Akali Dal, were among the prominent opposition figures that attended the INLD’s large gathering on Sunday in Fatehabad, Haryana.

JDU leader KC Tyagi addressed the crowd and claimed that the Bihar CM has come from Patna to challenge the Delhi Sultanate at a time when eight former Congress CMs had switched to the BJP. He claimed that Kumar has no fear of the ED, the income tax, or any other organisations.

To commemorate the birth anniversary of Devi Lal, the founder of the INLD and a former deputy prime minister, a rally is being conducted.

Tejashwi Yadav, the deputy chief minister of Bihar and the head of the RJD, as well as Arvind Sawant of the Shiv Sena, also showed up at the gathering to demonstrate the unity of the opposition.

The coming together of so many regional satraps is seen as part of efforts to forge opposition unity. Kumar and RJD president Lalu Prasad are likely to meet Congress president Sonia Gandhi after the rally to take the process forward.

Veteran socialist leader Tyagi had already declared that the gathering would be historic because it would unite like-minded forces against the BJP in the run-up to the 2024 Lok Sabha elections.

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