This article is written by Aarathi Namboodiri of 10^th semester of SASTRA Deemed University, Thanjavur, an intern under Legal Vidhiya

ABSTRACT

This research paper delves into the intersection of human rights and public health, with a specific focus on pharmaceutical issues. It examines the global disparities in access to healthcare and medication, particularly in developing regions, and explores the role of intellectual property rights (IPRs) in exacerbating these disparities. Through a comprehensive analysis of international legal frameworks, such as the TRIPS agreement and the Doha Declaration, and case studies from India, the paper evaluates the complex dynamics between patent protection and public health imperatives. Additionally, it discusses India’s pivotal role in promoting global health equity and presents innovative strategies, including patent pooling and multisectoral collaboration, to address the challenges of access to essential medicines. Drawing insights from the COVID-19 pandemic, the paper advocates for a nuanced approach to global health policies that prioritizes equity, inclusivity, and resilience in healthcare systems.

Keywords

Human rights, public health, pharmaceuticals, intellectual property rights, global health disparities, access to medicines, TRIPS agreement, Doha Declaration, India, COVID-19, health equity.

INTRODUCTION

The intersection of human rights and public health, particularly in the realm of pharmaceutical issues, has become a crucial legal and policy perspective.[1] Health stands as a fundamental necessity for all individuals, with the highest attainable standard being a basic right devoid of discrimination based on race, religion, economic status, or other factors.[2] Despite advancements in the past few decades, significant global disparities persist in access to healthcare and medication.

Infectious diseases claim over 13 million lives annually, with the majority occurring in developing regions such as Asia, Africa, and South America. The prevalence of diseases like cancer, HIV/AIDS, respiratory infections, malaria, and tuberculosis exacerbates the health challenges in these areas. [3]Particularly alarming is the daily toll of AIDS-related deaths in developing nations, revealing the ongoing crisis of health inequality.

The burden of “diseases of poverty” remains disproportionately high in developing countries, primarily due to limited access to essential medicines. Reports indicate that only a third of necessary medications are available in the public sector, with the remainder predominantly found in the private sector. High drug prices, often attributed to strong intellectual property protection, contribute significantly to this disparity.[4]

Intellectual property laws, encompassing patents and other rights, play a pivotal role in regulating the creation and distribution of pharmaceutical products. While patents confer exclusive rights to inventors, they also lead to monopolies that restrict competition and inflate prices. This relationship between intellectual property rights and the right to health has sparked considerable debate and scrutiny in legal and academic circles.

In recent years, international efforts have emerged to address the intersection of intellectual property rights and the right to health. These endeavors aim to navigate the complex terrain where legal protections intersect with public health imperatives, offering new avenues for understanding and addressing these critical issues.

GLOBAL HEALTH DISPARITIES: THE CONTEXT FOR INTELLECTUAL PROPERTY RIGHTS

Global health disparities persist as a pressing challenge, particularly impacting populations in developing regions. These disparities encompass various dimensions, including access to essential medicines, healthcare infrastructure, and preventive measures. Intellectual Property Rights (IPRs), notably patents, play a significant role in exacerbating these disparities, particularly in the pharmaceutical sector. Patents often grant exclusive rights to pharmaceutical companies, enabling them to monopolize markets and set high prices for life-saving medications. Consequently, individuals in low-income countries face barriers in accessing essential medicines, leading to preventable suffering and loss of life. The unequal distribution of healthcare resources further exacerbates these disparities, with marginalized communities bearing a disproportionate burden of disease. Addressing global health disparities requires a multifaceted approach that considers the intersection of IPRs and public health, aiming to ensure equitable access to healthcare for all individuals, regardless of their socioeconomic status or geographic location.

INTELLECTUAL PROPERTY RIGHTS AND ACCESS TO ESSENTIAL MEDICINES

In the contemporary landscape, the intersection of Intellectual Property Rights (IPRs) and access to essential medicines presents a critical challenge in global public health. Despite strides in medical innovation, disparities persist in the availability and affordability of life-saving drugs, particularly in developing countries. Pharmaceutical companies often wield patents as powerful tools to safeguard their inventions, thereby monopolizing markets and setting prices beyond the reach of many individuals. This situation underscores the tension between incentivizing innovation through IPRs and ensuring equitable access to healthcare as a fundamental human right. Legal frameworks, both international and domestic, attempt to navigate this complex terrain, with agreements like the TRIPS agreement and the Doha Declaration seeking to strike a balance between patent protection and public health imperatives. However, challenges persist in translating these legal principles into tangible access to medicines for those in need. As such, a critical examination of the current scenario is imperative to identify gaps and explore innovative solutions that reconcile the interests of patent holders with the imperative of ensuring access to essential medicines for all.

TRIPS, THE DOHA DECLARATION, AND THE WTO ALL ADDRESS PUBLIC HEALTH

Globalization has significantly facilitated trade practices worldwide, including the pharmaceutical industry, which plays a pivotal role in trade between developed and underdeveloped nations. The TRIPS agreement, by establishing global minimum standards for protecting intellectual property rights, has introduced a framework for safeguarding pharmaceutical data against unauthorized use. Prior to this agreement, there were no specific standards for patents and owners’ rights, leading to inconsistencies in intellectual property protection.
The inclusion of intellectual property rights within the World Trade Organization (WTO) framework has empowered proponents of robust intellectual property rights (IPRs) to enforce compliance through binding dispute procedures, potentially resulting in trade sanctions for non-compliant WTO members. The TRIPS Agreement also includes for the first time in any area of international law “rules on domestic enforcement procedures and remedies”. The requirement for strong rules and regulations has been a difficult step for the developing as well as the least developed nations who depend on the developed nations for the supply of their medicines in the industry.[5]

However, the exclusive rights granted under the TRIPS agreement limit flexibility related to public access, particularly during natural disasters, creating an imbalance in the international pharmaceutical landscape. The Doha Declaration reaffirmed countries’ rights to utilize TRIPS safeguards, such as compulsory licenses and parallel importation, to overcome patent barriers and promote access to medicines.

The ongoing debate surrounding international law revolves around balancing the interests of creators with public welfare, especially in ensuring global access to essential medicines. This discussion has gained traction during the pandemic, as nations, including India, advocate for waivers on stringent intellectual property regulations to facilitate access to medicines, including vaccines, for poorer and underdeveloped nations.

RIGHT TO HEALTH IN INDIA

The Indian Constitution’s Article 21 guarantees the “right to life,” which also includes the “right to health,” which the courts have deemed to be an inalienable right.[6] In other words, having well health is an essential human right that is required to exercise other rights. The right to an adequate standard of life includes the right to health, as stated in Article 25 of the 1948 Universal Declaration of Human Rights. The government must provide facilities and easily available healthcare since the right to health is a fundamental right that is a part of the right to life. As a result, the government has to make sure that patent holders do not unfairly exploit their patents by abusing their exclusive rights to use them for a long time.

INDIAN PATENT LAWS

India was required to alter the Indian Patent Act 1970 and fulfill its obligations in three revisions to the Indian Patent Acts (1999, 2002, and 2005) as a member of the World Trade Organization.

The Indian Patents Act,1970

The patent system serves as an incentive for innovation by granting inventors statutory rights and a temporary monopoly over their creations in exchange for full disclosure. To qualify for patent protection, a product or process must be novel, involve an inventive step, and be capable of industrial application, while also not falling under non-patentable categories. Patents are effective within the jurisdiction in which they are filed and are crucial for preventing copying, taking legal action against infringement, earning revenue from licenses, and enhancing the value of business assets.

However, patent protection also entails challenges, including the disclosure of sensitive information, difficulties in meeting novelty and efficacy criteria, and the costs associated with filing and prosecuting applications. In the field of healthcare and pharmaceuticals, the Patents Act outlines guidelines for patentability, including provisions regarding efficacy criteria, substance admixture, and processes for treatment.

For instance, Section 3(d) of the Patents Act specifies that a mere discovery of a new form of a known substance without significant therapeutic advantages is not patentable.[7] Similarly, Section 3(e) states that a substance obtained by mere admixture or a process resulting only in the aggregation of properties is not an invention.[8] Furthermore, Section 3(i) prohibits the patenting of processes for medical treatment.[9]

The Act also includes provisions for compulsory licensing under Section 84, allowing for licenses to be granted if the needs of the public are not satisfied, the invention is not available at an affordable price, or the patented invention is not manufactured in the country.[10] India’s first compulsory license was granted in the case of Natco vs. Bayer[11] for the anti-cancer drug Sorafenib Tosylate, based on the grounds that Bayer’s patent did not meet the reasonable requirements of the public and the drug was not available at an affordable price.
Additionally, Section 92 enables the issuance of compulsory licenses by the Controller of Patents in cases of national emergency, extreme urgency, or public non-commercial use. The patentee retains the right to be heard in the compulsory licensing application process.

CASE LAWS

In the case of Novartis AG vs Union of India[12], the Supreme Court affirmed India’s parliament’s authority to enact public health safeguards under the TRIPS agreement. The case revolved around Novartis AG’s application for a patent on the anticancer drug ‘Glivec’ in 1998. However, the Madras Patent Office rejected the application, citing lack of novelty and failure to meet the non-obviousness test. The drug was deemed non-patentable under Section 3(d) of the Patents Act as it did not exhibit significant therapeutic efficacy compared to existing forms.
Novartis challenged the constitutionality of Section 3(d) of the Patents Act, arguing that it violated Article 14 of the Constitution and was non-compliant with TRIPS. After various legal proceedings, including petitions before the Intellectual Property Appellate Tribunal and the Supreme Court, the issue centered on interpreting the meaning of a known substance and efficacy under Section 3(d).

In its 2013 judgment, the Supreme Court ruled that the beta crystalline form of Imatinib Mesylate, the active ingredient in Glivec, was indeed a new form of the known substance. However, the drug did not demonstrate an increase in therapeutic efficacy, thereby rendering it ineligible for patent protection.

The judgment aimed to prevent the practice of ‘evergreening’ patents, wherein pharmaceutical companies make minor modifications to existing drugs to extend their patent rights. This practice, deemed unsustainable in a populous country like India where there is a constant need for affordable life-saving drugs, could hinder access to essential medicines. The ruling underscored the importance of ensuring availability of medicines at reasonable prices, a critical consideration for public health in developing nations.

In the case of Bayer Corporation v. Natco Pharma Ltd[13], Bayer, a pharmaceutical company, held patent rights for the cancer treatment drug ‘Nexavar’ in 2008. Natco Pharma applied for a compulsory license to manufacture the drug, arguing that Bayer had not met the reasonable requirements of the public, the drug was not available at a reasonable price, and it was not manufactured in India.

The controller considered several factors, including the unmet demand of the public, the high cost of the drug, and Bayer’s failure to manufacture it in India. As per the conditions outlined in Section 84 of the Patents Act, the controller granted a compulsory license to Natco.
Bayer appealed this decision before the Intellectual Property Appellate Board (IPAB), raising concerns about the availability of a generic version at a lower price by another company, Cipla. However, the IPAB dismissed Bayer’s petition, emphasizing the duty of the patentee to make the drug available at a reasonable price.

The Bombay High Court, in July 2014, upheld the IPAB’s findings. Bayer further filed a special leave petition with the Supreme Court of India, but it was dismissed, affirming the compulsory license.
The significance of the Novartis and Bayer cases lies in their demonstration that global public opinion no longer tolerates denying access to life-saving drugs due to monopoly pricing. These cases highlight that governments, particularly those in developing countries with economic and political influence like India, are willing to challenge major pharmaceutical companies. Notably, Section 3(d) of the Patents Act was amended to prevent the prolonged patenting of products through insignificant modifications, reinforcing the commitment to balancing patent protection and public access to essential medications.

INDIA’S ROLE IN GLOBAL HEALTH EQUITY: SEIZING OPPORTUNITIES AND CONFRONTING CHALLENGES

India, with its vast population and diverse healthcare landscape, holds a pivotal position in the quest for global health equity. As a nation straddling the realms of innovation and access, India faces both opportunities and challenges in shaping equitable health outcomes worldwide.

Opportunities

• Pharmaceutical Manufacturing Hub:

India’s robust pharmaceutical industry has earned global recognition for its capacity to produce affordable generic drugs. As the “pharmacy of the world,” India plays a crucial role in supplying essential medicines to low- and middle-income countries, thereby enhancing access to life-saving treatments. Leveraging its manufacturing prowess, India can contribute significantly to reducing health disparities on a global scale.

• Innovation and Research:

India boasts a vibrant ecosystem of research institutions, biotech companies, and academic centers, fostering innovation in healthcare technologies. From developing low-cost medical devices to pioneering vaccine research, Indian scientists and entrepreneurs are at the forefront of driving breakthroughs that address pressing health challenges. By nurturing innovation and fostering collaboration, India can accelerate progress towards achieving health equity worldwide.

• Leadership in Global Health Initiatives:

India has emerged as a key player in various global health initiatives and partnerships. Through organizations like the Coalition for Epidemic Preparedness Innovations (CEPI) and the Global Alliance for Vaccines and Immunization (GAVI), India actively contributes to initiatives aimed at expanding access to vaccines and strengthening healthcare systems in resource-limited settings. By assuming leadership roles in such initiatives, India can exert its influence on shaping equitable health policies and interventions globally.

Challenges

• Healthcare Infrastructure and Access Disparities:

Despite significant progress, India grapples with stark disparities in healthcare access and infrastructure across regions. Rural areas often lack essential healthcare services, exacerbating disparities in health outcomes. Addressing these disparities requires concerted efforts to strengthen healthcare infrastructure, enhance primary care services, and ensure equitable distribution of resources.

• Quality of Healthcare Services:

While India’s healthcare system provides affordable access to basic services, challenges persist concerning the quality and effectiveness of care. Inadequate training of healthcare professionals, insufficient regulation of medical practices, and disparities in healthcare quality contribute to suboptimal health outcomes. To achieve global health equity, India must prioritize investments in healthcare workforce development, quality assurance mechanisms, and patient-centered care approaches.

• Intellectual Property Rights and Access to Medicines:

India’s role as a major producer of generic medicines has occasionally clashed with international intellectual property regimes, leading to disputes over patent rights and access to essential medicines. Balancing the imperatives of patent protection with the need to ensure affordable access to medicines remains a complex challenge for India. Negotiating these tensions requires navigating international legal frameworks while safeguarding public health interests.

CLOSURE AT THE EXPENSE OF HUMAN LIFE: LESSONS FROM THE COVID-19 PANDEMIC

Advocates for public health and researchers have long argued that monopolies on life-saving medications hinder access, affordability, and availability. For instance, PCV13, a crucial pneumonia vaccine primarily for infants, owned by Pfizer, is priced prohibitively high, despite the prevalence of preventable infant pneumonia deaths in India, totalling over 100,000 annually. This monopoly dynamic also affects the response to COVID-19, as rapid rollout of essential supplies like testing kits and respirators has made it challenging for new manufacturers to produce medical-grade face masks at scale. Additionally, monopolies exist for promising COVID-19 treatments like Remdesivir, Favipiravir, and Lopinavir/Ritonavir, further exacerbating access issues.

Seeking a solution, Costa Rica’s government has urged the WHO to establish a voluntary pool of intellectual property rights for COVID-19 treatments. This initiative aims to facilitate multiple manufacturers in supplying new medications and diagnostics at more affordable prices. Drawing from the success of the Medicines Patent Pool in expanding access to treatments for HIV/AIDS, hepatitis C, and tuberculosis, the proposal advocates for patent pools, prize funds, and similar mechanisms to transform the development and availability of life-saving drugs. The overarching goal is to shift from a monopoly-driven system to one grounded in collaboration and shared knowledge. Accordingly, patent pooling should be extended to include COVID-19 vaccines.

Furthermore, innovative financial instruments, like vaccine bonds, have been effective in mobilizing capital for vaccines in the past and should be utilized for COVID-19 vaccine development. For instance, the International Finance Facility for Immunization (IFFIm) raises capital by issuing bonds with specific commitments. Investors provide funds to vaccine manufacturers, who, in return, pledge to supply vaccines at prices affordable to low and middle-income countries. These mechanisms can play a crucial role in ensuring equitable access to COVID-19 vaccines globally.

WHAT POSITION DOES INDIA HOLD?

India holds a prominent position as one of the largest producers of generic medications and vaccines globally. With around six major vaccine manufacturers and numerous smaller ones, India produces doses for diseases such as Polio, Meningitis, Pneumonia, Rotavirus, BCG, Measles, Mumps, and Rubella, among others. Notably, the Serum Institute of India stands as the world’s largest vaccine manufacturer by the quantity of doses produced and sold worldwide.
Building on its reputation as the “pharmacy to the world,” India has taken proactive measures to accelerate vaccination efforts. Currently, more than six firms are actively engaged in vaccine production. To further bolster vaccine accessibility and affordability, the Government of India has the option to utilize TRIPs-compliant mechanisms such as compulsory licensing. This approach would enable vaccines to be developed by external manufacturers at reasonable prices, contributing to global efforts to combat diseases and improve public health outcomes.

TOWARDS A NUANCED APPROACH FOR EQUITABLE GLOBAL HEALTH POLICIES

The pursuit of equitable global health policies is an endeavor that requires a nuanced and multifaceted approach. While significant progress has been made in improving healthcare access and outcomes worldwide, persistent disparities and emerging challenges demand innovative and inclusive solutions.

• Understanding Contextual Realities: A nuanced approach to global health policy begins with a deep understanding of the diverse contextual realities that shape health outcomes across regions and populations. Recognizing the social, economic, and political determinants of health is essential for developing targeted interventions that address the root causes of health disparities. By acknowledging the unique challenges faced by different communities, policymakers can tailor policies and programs to meet specific needs and promote equitable health outcomes.
• Embracing Intersectionality: Health disparities often intersect with other forms of inequality, including gender, race, ethnicity, and socioeconomic status. A nuanced approach to global health policies must embrace intersectionality, recognizing the interconnected nature of various social identities and their impact on health outcomes. By adopting an intersectional lens, policymakers can design interventions that address multiple dimensions of inequality simultaneously, promoting more equitable and inclusive health systems.
• Leveraging Multisectoral Collaboration: Achieving equitable global health requires collaboration across multiple sectors, including healthcare, education, housing, and sanitation. A nuanced approach involves leveraging multisectoral collaboration to address the underlying determinants of health comprehensively. By bringing together stakeholders from diverse sectors, policymakers can develop holistic strategies that tackle the social, economic, and environmental factors that influence health outcomes.
• Promoting Health Equity in Global Governance: Global health governance plays a crucial role in shaping health policies and priorities at the international level. A nuanced approach to global health policy involves advocating for governance structures that prioritize health equity and social justice. This includes promoting the meaningful participation of marginalized communities in decision-making processes, advocating for fair allocation of resources, and holding global health institutions accountable for advancing equitable health outcomes.
• Investing in Resilient Health Systems: Building resilient health systems is essential for ensuring equitable access to quality healthcare, particularly in the face of emerging health threats such as pandemics and climate change. A nuanced approach involves investing in health system strengthening efforts that prioritize primary healthcare, community-based interventions, and disease surveillance capabilities. By bolstering the capacity of health systems to respond effectively to both current and future challenges, policymakers can enhance health equity and promote sustainable development.

CONCLUSION

Public health is indeed a global challenge that demands international cooperation, with the World Health Organization (WHO) serving as the primary authority for health-related matters. However, the intersection between health issues and various policy domains, including human rights, development policy, intellectual property (IP), and international trade, necessitates collaboration between the WHO and other international organizations like the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO).
The complex relationship between intellectual property systems and human rights often leads to conflicts, particularly regarding access to essential medicines and healthcare. Many people, especially in developing countries, still lack access to innovations due to weak supply systems and unaffordable prices. This situation underscores the need for balancing intellectual property rights with fundamental human rights such as the right to health, education, participation in scientific progress, and cultural life.

In countries like India, where a significant portion of the population struggles to afford healthcare and medicines, Article 21 of the Constitution, which guarantees the protection of life and personal liberty, assumes great importance. Since the right to health is inherent in the right to life, the government has an obligation to provide health facilities and ensure access to essential medicines. Therefore, it becomes essential for the government to regulate patent rights to prevent patent holders from exploiting their exclusive rights for extended periods, which could hinder access to life-saving drugs.

While acknowledging the importance of protecting inventors’ patent rights and their associated benefits, it is equally crucial to prioritize the rights of individuals to access affordable healthcare. Striking a balance between incentivizing innovation and ensuring public health is paramount for promoting equitable access to essential medicines and advancing global health outcomes. The pursuit of equitable global health policies demands a nuanced approach that acknowledges the complexities of health disparities and the interconnected nature of social, economic, and political determinants of health. By leveraging legal frameworks, such as patents laws and international agreements, countries like India can navigate the tension between intellectual property rights and the right to health. Case law, exemplified by landmark judgments, reinforces the commitment to safeguarding public health interests. India’s role as a global healthcare leader offers opportunities to drive progress towards health equity through initiatives like patent pooling and innovative financing mechanisms. However, addressing monopolies on life-saving medications remains a pressing challenge, exacerbated by the COVID-19 pandemic. Collaborative efforts, informed by an intersectional understanding of health disparities, are essential for promoting equitable access to healthcare worldwide. Investing in resilient health systems and advocating for health equity in global governance are crucial steps towards achieving sustainable development goals and ensuring the highest attainable standard of health for all individuals, regardless of their socioeconomic status or geographic location.

REFERENCES

1. World Health Organization, World Intellectual Property Organization and World Trade Organization (2012). Public health Policy, promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade. Geneva: World Health Organization, World Intellectual Property Organization and World Trade Organization (2013). Available at http://wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf (Last visited on March 06 2024)
2. WHO Constitution
3. Ellen F. M. ‘tHoen (2002). Trips, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond. Chicago: Chicago Journal of International Law pp. 39. Available at http://www.who.int/intellectualproperty/topics/ip/tHoen.pdf
4. A Cameron, M Ewen, D Ross-Degnan, D Ball, R Laing (2009) Medicines prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis”, Lancet, vol. 373, issue 9659, (January 2009), p. 240-249. doi:10.1016/S0140-6736(08)61762-6
5. https://bnblegal.com/article/ipr-and-right-to-health-in india/#:~:text=The%20Supreme%20Court%20in%20Novartis,Intellectual%20Property%20Rights%20(TRIPS). (Last visited on March 06 2024)
6. Article 21, The Constitution of India
7. Section 3(d), Indian Patents Act, 1970
8. Section 3(e), Indian Patents Act, 1970
9. Section 3(i), Indian Patents Act, 1970
10. Section 84, Indian Patents Act, 1970
11. Bayer Corporation v. Natco Pharma Limited, 2014(60) PTC 277 (BOM)

12.  Novartis Ag v. Union of India, AIR 2013 SUPREME COURT 1311

1. Supra at 11

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[1] World Health Organization, World Intellectual Property Organization and World Trade Organization (2012). Public health Policy, promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade. Geneva: World Health Organization, World Intellectual Property Organization and World Trade Organization (2013). Available at http://wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf (Last visited on March 06 2024)

[2] WHO Constitution

[3] Ellen F. M. ‘tHoen (2002). Trips, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond. Chicago: Chicago Journal of International Law pp. 39. Available at http://www.who.int/intellectualproperty/topics/ip/tHoen.pdf

[4] A Cameron, M Ewen, D Ross-Degnan, D Ball, R Laing (2009) Medicines prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis”, Lancet, vol. 373, issue 9659, (January 2009), p. 240-249. doi:10.1016/S0140-6736(08)61762-6

[5]https://bnblegal.com/article/ipr-and-right-to-health-in india/#:~:text=The%20Supreme%20Court%20in%20Novartis,Intellectual%20Property%20Rights%20(TRIPS). (Last visited on March 06 2024)

[6] Article 21, The Constitution of India

[7] Section 3(d), Indian Patents Act, 1970

[8] Section 3(e), Indian Patents Act, 1970

[9] Section 3(i), Indian Patents Act, 1970

[10] Section 84, Indian Patents Act, 1970

[11] Bayer Corporation v. Natco Pharma Limited, 2014(60) PTC 277 (BOM)

[12] Novartis Ag v. Union of India, AIR 2013 SUPREME COURT 1311

[13] Supra at 11

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