Case Law: A Review of selected Pharmaceutical Patents in the UK Courts during 2020

Patentslie at the interface between technology and law. This article provides a criticalreview of four high profile cases from 2020 in which patents relating topharmaceuticals were litigated in the UK Courts. The selectedcases om this review involved ‘sufficiency’, ‘inventiveness’, ‘plausibility’and ‘equivalency’ issues. The first case is a dispute between Regeneron Pharmaceuticals and Kymab Ltd in relation to Regeneron’spatent for a transgenic mouse platform. The second case relates to Pfizer’s patent for their Prevnar®13pneumococcal vaccineand the alleged infringement of this patent by concerns the validity of apatent belonging to NeurimPharmaceuticals Ltd relating to a slow-release formulation of melatonin fortreating primary insomnia. The final case is a dispute between FibroGen Inc. and AkebiaTherapeutics concerning FibroGen’spatents for hypoxia-inducible factor prolyl hydroxylase enzyme inhibitors (“HIF-PHIs”) for use in treating anaemia. The article aims to focus onthe technology behind the patents and to provide an insight into how science interactswith law in the context of patent enforcement and infringement. 

GOOD FAITH IN TRIPS COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS: LESSONS FROM PREVIOUS PANDEMIC CASES

The COVID-19 pandemic impacts the world of patents as countries prepare their legal framework to ease the process of compulsory licensing. Some like India and South Africa even went further by proposing a suspension for patents needed to combat COVID-19 which is still under discussion. It is a real possibility that a patented drug that is effective against COVID-19 would potentially see compulsory licensing in many countries its patent holder is doing business. This article discusses why compulsory licensing is an essential issue by examining its legitimacy, previous cases of compulsory licensing, and the conduct of states in cases of compulsory licensing issuance, particularly in examples of Thailand, Brazil, and India. The article will examine ways of remedy against compulsory licensing, including a theoretical possibility for constitutional review of treaties. The remedies discussed shall include international and domestic remedies, both litigation and alternative measures. The research shall use qualitative research methods with the use of primary and secondary legal sources. The result of this article found that a combination of soft law power of the Doha Declaration and the invocation of subsequent compulsory licensing cases be the support pillars of compulsory licensing practice. However, the practice of compulsory licensing both by the patent holder and the state actors is still not performed entirely in good faith according to the Vienna Convention of the Law of Treaties (VCLT) 1969 and the TRIPS Agreement. Hence, such patent holders need to be familiar with both international and domestic remedies, especially the possibility for constitutional review of treaties remedies.

Access to Pharmaceutical Patents in the COVID-19 Emergency: A Case for Government Use in Nigeria

The COVID-19 pandemic has continued to exert enormous pressure on public health policies and systems, with far-reaching implications. The race for vaccines has raised important intellectual property rights issues. These are evident in the need to advance the public interest and in the obligation of governments to address the challenge of access to vaccines, especially in sub-Saharan countries like Nigeria with relatively underdeveloped healthcare and innovation ecosystems. While the Nigerian Patents and Designs Act (PDA) establishes a compulsory licence regime that affords access to patented drugs, existing public healthcare is severely challenged in providing access to new medicines. This article examines the framework for patent protection of pharmaceuticals designed to meet public health challenges, such as those presented by the pandemic. It recommends the implementation of a government use provision under the PDA, with a view to addressing the challenge of access to COVID-19 vaccines.

Perverse Results from Pharmaceutical Patents in the United States

In the United States, pharmaceutical patents have had a number of perverse and anticompetitive effects on the development and marketing of prescription drugs. Although some of these effects are unique to the United States, others have implications for patent policy across the world. Among the negative effects of drug patents are: (1) examples of misguided, anti-social, and anticompetitive promotion of patented drugs; (2) misguided incentives that push drug firms toward too much or too little research and development in critical areas: and (3) cartel-facilitating conduct linked to patent licenses or settlements of litigation involving drug patents. Some of these issues can be addressed directly through reforms in patent and competition law policy. There is, however, a need for a broader study of the role of patents in promoting drug research. That study should consider alternatives to the patent system, such as a prize system structured to supplement or partially replace patent rewards for pharmaceutical R&D.

Proposed Title of the Project: Should China Implement Compulsory Drug Patent Licenses? - From the Perspective of COVID-19

<p>Although China has already issued laws and regulations on compulsory licensing of pharmaceutical patents, it has not yet implemented specific practices. After the outbreak of “COVID-19”, realistic needs have made it urgent for China to implement compulsory drug patent licensing. Therefore, this study will be based on China’s national conditions, combined with China’s laws and regulations on the compulsory licensing of pharmaceutical patents, and compare specific practices in other countries. Through qualitative analysis, it’s clear that China implements compulsory pharmaceutical patent licensing in three aspects: domestic system, international level, and government responsibility. To analyze the feasibility of China’s drug patent compulsory licensing system and provide suggestions.</p>