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. 

Amend Patent Legislation to Expand Access to Pharmaceuticals during National Emergencies

As of February 2021, the COVID-19 pandemic has led to almost 109 million cases worldwide and over 486,000 American deaths (Johns Hopkins University 2021). With the federal government pouring more than $9 billion in taxpayer money to develop vaccines and treatments for COVID-19, accessibility to these taxpayer-funded products is a public concern (Witters 2020). Under current U.S. law, private entities of any size are allowed to keep patents funded by taxpayer dollars (Stevens 2004). Although government use of taxpayer funded patents exist in limited circumstances, there is little incentive beyond public and political pressure for pharmaceutical companies to forgo patent enforcement for public good. We recommend that Congress amend Title 35 of United States Code to allow patent term extensions when a patent holder agrees to forgo patent enforcement in times of presidentially declared public health national emergencies under the National Emergency Act.

Roadblock to Innovation: The Role of Patent Litigation in Corporate R&D

I examine how patent enforcement affects corporate research and development (R&D), exploiting the legal changes induced by the Supreme Court decision eBay v. MercExchange. This ruling increased courts’ flexibility in remedying patent cases and effectively lowered the potential costs of patent litigation for defendants. For identification, I compare innovative activity across firms differentially exposed to patent litigation before the ruling. Across several measures, I find that the decision led to a general increase in innovation. This result confirms that the changes in enforcement induced by the ruling reduced some of the distortions caused by patent litigation. Exploring the channels, I show that patent litigation negatively affects investment because it lowers the returns from R&D and exacerbates its financing constraints. This paper was accepted by Gustavo Manso, finance.

Exploding the Supply Chain

This chapter describes the relationship between secure patent enforcement, the disaggregation of technology supply chains, and reduced entry barriers in three core segments of the modern innovation economy. The establishment of the Federal Circuit in 1982, coupled with the relaxation of antitrust restrictions on licensing starting in 1977, inaugurated a strong-IP regime that has enabled firms to mitigate the expropriation risk inherent to the transfer and exchange of informational assets. In the biotechnology market, secure patents have facilitated transactions between R&D-intensive start-ups and large pharmaceutical companies that specialize in the testing, production, and distribution functions required to reach market. In certain segments of the semiconductor market, secure patents have facilitated transactions between chip-design firms and “foundries” that specialize in chip production. In certain information-technology markets, secure patents have facilitated IP-licensing structures that promote informational dissemination among a broad population of producers and other intermediate users.

Approaching Pharmaceutical Patent Enforcement Using Intellectual Property Rights and Product Innovation

No data was used for the manuscript.