Partnership agreements for regenerative medicines: a database analysis and implications for future innovation

Aim: Partnerships have been leveraged to advance the regenerative medicines (RMs) development. This study analyzed the evolution of partnership landscape for regenerative medicines (RMs). Methods: Partnership agreements publicly announced from January 2014 – June 2020 were described. Results: 1169 partnership agreements with total amount of US$63,496 million were identified. Most agreements concerned RMs that were for oncology (25.3%), in the discovery or preclinical phase (66.9%) and gene-based products (45.3%). The most common partnership type is collaborative agreements without licensing. The partnerships between ‘Biotechnology company and not-for-profit organizations’ represented the largest number (n = 416; 35.6%). ‘Big Pharma’ preferred collaboration and licensing agreements with a higher amount. Conclusion: Collaborations between highly specialized players with complementary expertise promote the successful translation of scientific discovery to RMs.

NIMble innovation - a networked model for public antibiotic trials

Antibiotic research and development (R&D) is at an inflection point. Faced with ongoing problems with commercial innovation, we argue for a networked public approach to sustainably moving promising compounds through clinical trials. We propose a global public infrastructure of institutes tasked with 1) conducting all trial stages up to market authorization, including small-scale compound production; 2) negotiating licensing agreements for global production and distribution by industry partners; 3) using public purchasing agreements or subscription models to ensure commercially viable drug production at equitable prices. We invite stakeholders to consider our Networked Institute Model’s (NIM) benefits for unblocking the antibiotic pipeline.

PROBLEMS OF COMPLEX DEVELOPMENT OF THE RESOURCE REGIONS, FOR EXAMPLE THE UTILIZATION OF ASSOCIATED PETROLEUM GAS

The paper identifies the main promising directions and conditions for increasing the level of efficiency in the use of associated petroleum gas in Russia. It is shown that the state strategy aimed at ensuring a 95% level of APG utilization is feasible in the development of a comprehensive system of incentives for companies, primarily in the use of the latest technologies and equipment for APG processing, as well as in fulfilling the requirements of licensing agreements.

Digital Consumer Contract Law without Prejudice to Copyright: EU Digital Content Directive, Reasonable Consumer Expectations and Competition

The EU Digital Content Directive sets out to facilitate the cross-border distribution of digital content and ensure a high level of consumer protection by harmonising certain aspects concerning contracts for the supply of digital content. The Directive acknowledges the variety of licensing agreements involved in the distribution of digital content, such as between the holders of intellectual property rights, intermediaries and end-users. It is recognised that the consumer’s use of digital content could be restricted under end-user licensing agreements pursuant to intellectual property rights; at the same time, the Directive is without prejudice to other EU law, including copyright. Rather, under Art. 10, the consumer is entitled to remedies from the trader of digital content for lack of conformity where restrictions resulting from a violation of intellectual property rights prevent or limit the use of the content. As the traders of digital content frequently are not the owners of intellectual property rights but rely themselves on a licence, the question arises as to the potential implications of Art. 10 for digital content markets. This paper discusses two such potential implications. The first is whether the efforts to safeguard reasonable consumer expectations could be undermined by the Directive leaving the arrangements between traders and intellectual property right holders out of scope. The second is whether Art. 10 could reinforce the network effects and dominant position of the established players on the market.

ASSESSMENT OF MODERN FEATURES OF THE ORGANIZATION

In modern conditions, there is a need to rethink the behavior and parameters of the organization. A business organization operating in uncertain and unpredictable conditions must be flexible in responding to new challenges. This is achieved through new ways to achieve market advantages such as strategic alliances, mergers and acquisitions, franchise and licensing agreements, etc. This article is devoted to the study of these possibilities.

Book Review: Library Licensing: A Manual for Busy Librarians

One of the many challenges librarians face is reviewing and negotiating licensing agreements. Halaychik and Reagan discuss these challenges in Library Licensing: A Manual for Busy Librarians. The scope of this book is much broader than the title seems to indicate, covering not only license-related topics regarding electronic resources in its six chapters, but also information on contract management software, Integrated Library Systems (ILS) and maintenance, and services agreements. For this reason, the book can feel unfocused at times. Chapter 1 briefly introduces basic information about contracts, while chapters 2 through 6 give a broad overview of the mechanics of a contract (including common clauses within contracts) and information concerning organizing, managing, and administering contracts, with examples of checklists and contracts in chapter 5 and subsequent appendixes.

Emerging Patterns in the Judicial Determination of FRAND Rates: Comparable Agreements and the Top-Down Approach for FRAND Royalties Determination

The massive adoption of wireless technologies over the past decades has also brought about disputes regarding the interpretation of FRAND in the context of actual commercial relations. Courts in several jurisdictions worldwide ‒ in the EU, the US, China, India and Korea, among others ‒ have been called upon to flesh out FRAND terms or to assess conformity with FRAND principles. This body of case law provides rich insights into the workings of the markets for standards, but also practical guidance for parties as well as policymakers seeking a better understanding of the situation ‒ business and legal ‒ on the ground. The present article outlines some of the emerging patterns in SEP litigation worldwide, focusing on the judicial determination of FRAND rates. The common thread across jurisdictions regarding FRAND-rate determination is reliance on evidence and data in comparable licensing agreements. It is argued that comparable licensing agreements, i.e. licensing agreements signed with similarly situated parties, provide for the most reliable evidence on how markets price standardised technologies and SEPs.