Innovation Council Analysis

The World Intellectual Property Organization (WIPO) recently hosted discussions about the relationship between artificial intelligence (AI) and intellectual property (IP). Mr. Corey Salsberg, a globally recognized attorney in the fields of IP and innovation law and policy, and Vice President and Global Head of IP Affairs for Novartis, was invited to take part in the second panel featuring Stories from Innovators – A Real Life Business View on AI Innovation. This note is based on his remarks, which provide examples from Novartis’ R&D and other activities to illustrate how AI can be applied to enhance bio-pharma innovation, along with the related IP implications.

Clich here to read more.

This Innovation Council one-paper illustrates the importance of policy coherence in the realm of biopharmaceutical manufacturing and R&D. Specifically, it shows that investing in diversified, geographically dispersed sources of R&D and production can increase manufacturing capacity and strengthen health security by complementing existing pharmaceutical production chains, thus making them less vulnerable to future supply chain shocks. It shows that counterproductive trade measures, such as tariffs on the development and production of vaccines and other health technologies, can slow development, and that—especially in light of the experience of Covid-19—distributed manufacturing and R&D capabilities are particularly useful in the area of biopharmaceuticals.

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The Innovation Council and Bobab organised a discussion on expanding BioManufacturing production capacity in emerging regions. Biologics, a category of pharmaceuticals which includes products such as vaccines and monoclonal antibody treatments, are quickly becoming among the most important medical products in the world. By combining enabling government policies and technology transfer between innovators and their global partners, it will be possible to improve availability of biologics, increase health security, and enhance scientific and industrial capacity in developing countries.

Click here to see the transcript.

Innovation Council is monitoring changes to the Brazilian Patent Law. The recent Supreme Court ruling, published on May 12, 2021, finding that the sole paragraph of Article 40 of the Brazilian IP Law, which granted a minimum patent term of 10 years from grant, was unconstitutional, has significant implications for patents related to pharmaceutical products and processes, as well as equipment and processes related to healthcare that were granted prior to May 12, 2021. Unlike all other patents granted prior to May 12, 2021, those excepted patents lose the benefit of a minimum patent term of 10 years from grant, and they will expire 20 years from their filing dates. All patents granted after May 12, 2021, will expire 20 years after their filing dates. Delays in the examination of patent applications and the grant of patents after more than 10 years from the filing dates will result in lesser terms of enforcement from those that were entitled to a minimum term of 10 years from grant.

Although the average pendency of patent applications is being steadily reduced by INPI, Brazilian patent applicants should take advantage of procedures implemented by INPI to accelerate the grant of patents and to maximize the term of enforcement of the patent. From an innovator perspective, the Brazilian legislature would do well to accelerate passage of the pending bill, which provides for extension of the patent term in the case of unreasonable delays in examination by INPI.

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Innovation Council Director Jennifer Brant, alongside co-authors Elodie Carpentier, Utsav Bahl, and Aikaterini Kanellia published a global literature review earlier this spring (May, 2024) in WIPO’s Economic Research Working Paper No.86, titled ‘Closing Innovation and Intellectual Property Diversity Gaps: a Global Literature Review’.

See below for the full abstract:

Innovation is a driver of competitive advantage and economic growth, with patent rights playing a critical supporting role. However, differential access to patent rights and relatively less participation in innovation can affect women and people from other historically underrepresented groups, thereby hindering progress and limiting the potential economic benefits generated by innovation. This paper reviews the global literature on these “diversity gaps”, identifies their key drivers, and documents international policies and initiatives that show promise in addressing them. Building upon Shapanka and Fechner (2018), it expands the geographic scope and reinforces the scientific basis of their analysis. The paper also provides recommendations for a wide range of stakeholders and offers insights for fostering more inclusive and equitable innovation ecosystems.

See here for the full publication.

Innovation Council in collaboration with co-authors Mark Schultz and Douglas Park created the policy brief Empowering Innovation, Enabling Collaboration: A Blueprint for Pandemic Preparedness to highlight key lessons from the COVID-19 pandemic response and explains how to incorporate them into the new pandemic preparedness treaty being negotiated by the World Health Organization (WHO) and its member states.

This paper by Qualcomm outlines key findings from qualitative and quantitative data obtained from 168 women involved in academic innovation. It puts forth a set of recommendations based on the survey feedback, follow-up interviews, and the collective experience of technology transfer professionals who work daily with academic innovators. 

We trust these recommendations will provide valuable insights into concrete actions that can be taken to ensure systemic changes that will foster greater engagement of academic women and other under-represented populations in all stages of the innovation lifecycle. 

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This one-pager by the Innovation Council explains the importance of sound IP management for SMEs, including complementary and hybrid strategies and recommendations for governments. To read more about innovative SMEs, click through the Innovation Council gallery for World IP Day 2021 here.

Innovation Council has created a running list of resources on various issues related to Gender and IP, based on work by Morgan Schreur. 

Click here to see the reading list.

Bio-pharmaceutical R&D and manufacturing inputs include: chemical or biological reagents; equipment used in laboratories; microscope parts; equipment for manufacturing such as single-use bioreactors; and the full range of raw materials used for R&D and production of vaccines and other bio-pharmaceuticals, such as guanidine thiocyanate. Researchers use these tools to make scientific breakthroughs, and bio-pharmaceutical companies rely on them to discover, develop, validate, and manufacture lifesaving vaccines, drugs, and therapies – including those necessary to address COVID-19 and future global health crises.

Some countries impose tariffs on bio-pharmaceutical inputs, in some cases as high as 25%. This raises costs and makes it more difficult for fledgling producers to compete. Eliminating tariffs on bio-pharmaceutical inputs could help to resolve some of the current global distribution challenges for COVID-related products, thereby helping to make the global COVID-19 response more equitable, affordable, and sustainable.

Unilateral elimination of COVID-19 related tariffs would provide substantial benefits in terms of the short-term dissemination of pharmaceutical inputs and vaccines.  Ultimately, however, tariff elimination should be made permanent and should cover a broader range of products. This would create legal certainty and predictability for actors along global value chains.

An appropriate vehicle for tariff elimination on inputs could be the WTO plurilateral agreement known as Zero for Zero, for which product coverage should be expanded to include the full range of COVID-19 bio-pharmaceutical inputs. In this respect, Innovation Council has developed a list of HS codes showing tariffs related to the inputs used for developing and producing COVID-19 vaccines, therapeutics and diagnostics. The list was developed in partnership with private sector actors in these value chains. A list of COVID-19 MFN product examples is available here.

Innovation Council spoke online with experts Dr. Malathi Lakshmikumaran and Dr. Axel Braun to discuss IGC developments and negotiation conversations at the World Intellectual Property Organization.

Both are patent lawyers with scientific backgrounds who shared their insight about patent disclosure requirements (PDR) for inventions that are based on genetic resources (GR) and/or associated traditional knowledge (TK) in different countries. They drew attention to shortcomings of the so-called Chair’s text, which is the basis for the WIPO negotiations aimed at delivering a new WIPO international instrument setting forth a PDR. Drawing from their perspectives from both the biopharmaceutical and agriculture biotech sector, they discussed specific examples of problems that arise when PDR-related legislation is unclear.

Click here for the one-pager and for the full transcript.

In this Q&A, WIPO Director Wend Wendland walks us through the history and key elements of the WIPO IGC talks, providing useful references along the way for those seeking more in-depth background information about the technical aspects. He clears up some common misconceptions about the negotiations and the negotiating text, and calls on all stakeholders to make their voices heard at the Diplomatic Conference in May 2024 in Geneva. Click here to read the full Q&A.

Innovation Council Director Jennifer Brant and co-author Craig Moss, Executive Vice President-Measurement of Ethisphere published a guide titled “Improving Diversity & Inclusion in Intellectual Property Development and Management: A Guide for Organizations”.

The information and recommendations are based on research and insights that were shared during a series of closed-door roundtables convened by the World Intellectual Property Organization (WIPO) and Invent Together in Europe, the Americas, Asia, Africa, and the Arab region during the period from October 2021 to June 2023.

72 representatives from corporations, technology transfer offices of universities and research centers, NGOs, and government agencies contributed their insights about the current state of intellectual property (IP) diversity, their reasons for prioritizing action in this area, challenges encountered, and actions taken to address the issue. While participants acknowledged that IP gaps affecting all historically underrepresented groups must be closed, these roundtables focused on gender.

This Guide is intended to provide a straightforward roadmap for organizations wishing to improve IP diversity and inclusion in relation to how innovation, that is, the creation and management of intellectual property, is managed internally. The core goal is to reshape the processes for managing and rewarding innovation within organizations to make them more inclusive.

See here for the full paper.

This detailed analysis by the Innovation Council critically examines the proposed international instrument with respect to the patent system, R&D, and avoiding legal uncertainty.  We highlight challenges in achieving transparency, legal certainty, and the impact on R&D commercialization. With insights into the balance between protecting indigenous knowledge and fostering innovative landscapes through the patent system, this report underscores the need for clear definitions and harmonized global standards.

Click here to read our analysis.

The Japanese IP Association, JIPA, recently interviewed Innovation Council Director Jennifer Brant about her work on DEI and intellectual property issues.

See here for the full interview, which has been produced in Japanese.

The 57^th WIPO General Assemblies will take place in Geneva from July 9 to 17, 2024. You may follow the live transmission of available hybrid proceedings online.

See here for Innovation Council’s Opening Statement from Director Jennifer Brant.

Innovation Council put together its opening statement at the May 2024 IGC Diplomatic Conference. The statement emphasized how important it is that negotiators safeguard legal certainty in the patent system as this not only affects both small and large patent owners, but also the organizations they partner with and those that interact with their IP. Three things that will be important to pay attention to include : 1) clearly and narrowly defining the scope, 2) clarifying and confirming appropriate PDR administrative requirements, and 3) excluding patent-based sanctions.

See here for the full statement.

In this Innovation Council Q&A, Dr. Braun — a former Swiss and European patent attorney — discusses the challenges of legal certainty and innovation risks within the context of patenting genetic resources and traditional knowledge and how this might with the IGC negotiations. He offers a unique perspective on the potential impacts on R&D and patent validity, highlighting the critical balance needed between transparency, legal harmonization, and innovation incentives.

Click here to read our Q&A.

In this Innovation Council Q&A with Olivier Sauvageot of Syngenta, key issues around WIPO’s IGC negotiations on IP and genetic resources are discussed. Sauvageot, an experienced patent attorney, delves into the complexities of patenting in agriculture, highlighting the challenge of defining and managing genetic resources and associated traditional knowledge. He underscores the potential impact on R&D, patent validity, and innovation, while advocating for clear, fair, and effective IP frameworks.

Click here to read our Q&A.

Innovation Council released a statement at the WIPO Standing Committee on the Law of Patents highlighting how SEPs licensing, as part of a commitment to standardize development organizations, plays as a major success from a tech transfer perspective.

In the field of cellular technology, it has led to accessible, affordable connectivity in devices to achieve pressing societal challenges and SDGs. It also helps provide information and evidence for SMEs and other stakeholders so they can be empowered to make informed decisions for their R&D and commercialization, alongside having options for dispute resolution and litigation.

See here for our full statement.

Innovation Council released a statement to the WIPO Standing Committee on the Law of Patents presenting recent research on tech transfer. We highlighted the work we did with two Innovation Council members, Merck Life Science and Biovac.

With Merck Life Science, Innovation Council published a paper called Making Biologics, which found four pathways for building bio-manufacturing and innovative capacity that required collaboration, tech transfer, and IP protection.  One uncovered strategy involved building vaccine production capacity through a process of “backwards integration,” that involved working with tech transfer partners to gain expertise to ultimately help perform R&D. Biovac demonstrated an example of a backwards integration success story through their work.

See here for our full statement.

Innovation Council submitted these perspectives to the ITC investigation of COVID-19 Diagnostics and Therapeutics and Flexibilites under the TRIPS Agreement.

https://innovationcouncil.org/wp-content/uploads/2023/06/Innovation-Council-ITC-Submission.pdf

Innovation Council presents the summary of Closing Innovation and Intellectual Property Diversity Gaps: A Global Literature Review. Authored by Elodie Carpentier, Jennifer Brant, Utsav Bahl, Aikaterini Kanellia, the report was published in the WIPO Economic Working Paper Series no. 86.

This academic paper explores the underrepresentation of women and people from other historically underrepresented groups in patenting and innovation. It highlights the economic and societal benefits of closing these gaps through an extensive review of existing research on the topic. The authors share insights for fostering more inclusive and equitable innovation ecosystems, making recommendations for a wide range of stakeholders.

See here for the full summary.

Innovation Council released a piece sharing their perspectives on the IGC Negotiating Text at the start of the May 2024 IGC Diplomatic Conference. It goes over concerns with the text including sections that touch on their definitions, retroactivity, patentability criteria, items of unknown origins, ABS requirements, fraudulent intent, correcting disclosures, and lastly on scope and DSI.

See here for the full perspectives.

Innovation Council’s newest member, All-Weather Roads Engineering based in South Africa, commercialises a novel asphalt–binding solution. Here, Emmanuel Mothabi, the company’s founder, shares insights about his company’s invention, impact, and challenges. Click here to read more.

The Innovation Council has developed four IP mentoring pilot programme guides that mentors can use to provide support materials to their mentees for each of the four designated sessions for mentors and mentees.

The purpose of developing these materials is to test this methodology for supporting SMEs in developing an IP strategy. The IC would like as many people as possible to test this methodology and is grateful for feedback to determine if the guides are useful.

Modul 1 Mentor

Modul 1 Mentee

Modul 2 Mentor

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Modul 3 Mentor

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Modul 4 Mentor

Modul 4 Mentee

Artificial Intelligence is rapidly evolving to provide accurate information and solutions to problems. AI solutions can be extremely useful in many fields of endeavor.

There are various components and aspects of such systems. Currently, there is some uncertainty – especially with respect to patent protection – as to how intellectual property (IP) rights can be used to protect those components along with the outputs of AI systems.

Click here to read more.

The Innovation Council team wrote an article that was published in the June issue of WIPO Magazine. The article, by Phil Wadsworth, with Jennifer Brant and Peter Brown, highlights key IP considerations for smaller companies. In particular, the article highlights the importance for small and medium-sized enterprises (SMEs) of patents, trade secrets, copyright protections, and trademarks, as well as design rights, and discusses how these protections can facilitate collaboration, successful commercialization, and other beneficial outcomes for small businesses.

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