Patent Opposition Research Articles

Patent opposition, IP firm capabilities, and technology entry: empirical evidence from European patent data

Patent opposition, IP firm capabilities, and technology entry: empirical evidence from European patent data

Patent Invalidation Procedures in the WTO Member BRICS Countries: India Provides a Model Legislation

Eighty percent of the world’s population lives in emerging markets, and a significant portion of this population is not receiving healthcare or at least is not receiving the healthcare they need. This is an issue experienced in all of the BRICS countries as well. The BRICS countries particularly need drugs for the treatment and management of infectious and communicable diseases. The affordability of healthcare is one of the key priorities of the BRICS countries. These goals may not necessarily be in line with the patent laws of the BRICS countries which are also members of the World Trade Organization (WTO). This article examines the patent invalidation procedures of the four WTO member BRICS countries, namely India, China, Brazil, and South Africa with the aim of evaluating the strengths and weaknesses of their procedural safeguards and learning from their experiences. The presence of a functional patent opposition model is of utmost importance for the BRICS countries, since this allows for the invalidation or opposition of patents that have been granted in their respective jurisdictions. However, except for India, none of the other WTO member BRICS countries have developed a well-thought-out patent opposition model. This study argues that the BRICS group provides a viable forum for India to promote its distinguished patent invalidation model. In turn, the WTO member BRICS countries can learn from India’s pro-health patent opposition model and reform their national patent laws to align with their public health priorities. This is especially important in the context of the pandemic like COVID-19, for example.

European patent opposition outcomes in biotechnology

Oppositions to patent grants are a means to attack competitors and protect a firm's own patent portfolio. Extant literature has analyzed the determinants of oppositions, while the drivers of opposition outcomes are less known. We study 290 EPO biotech patent oppositions filed in 2012–2019. There are three possible outcomes of opposition proceedings: patent revocation, patent amendment, and opposition rejection. We find that opponents who know the patent's technology are more likely to obtain a patent revocation, while opponents who compete in the product market with the patent owner are more likely to receive a rejection.

Let’s Talk About Patent Act, 1970

The Patent Act of 1970 is a pivotal legislation that has shaped India’s intellectual property landscape and played a significant role in fostering innovation, technological advancement, and economic growth. This abstract provides an overview of the Patent Act, its historical context, key provisions, and its impact on various stakeholders. The Patent Act, enacted in India in 1970, replaced the outdated and restrictive Patents and Designs Act of 1911. It aimed to align the Indian patent system with global standards while addressing the unique needs and challenges of the Indian economy. The Act provided legal protection for new inventions, encouraging inventors to disclose their innovations and contribute to the public domain in exchange for exclusive rights. One of the pivotal features of the Patent Act, 1970 was the introduction of a “process patent” system, which allowed for the patenting of manufacturing processes, thereby stimulating domestic innovation and entrepreneurship. This system also supported the growth of the pharmaceutical industry by facilitating the production of affordable generic drugs. The Act also introduced certain safeguards and limitations to ensure that patents did not hinder public welfare or create barriers to technological progress. It included provisions for compulsory licensing, enabling the government to authorize the use of patented inventions in specific circumstances, such as ensuring access to essential medicines. This provision balanced the interests of patent holders with the public interest. Furthermore, the Patent Act, 1970 established the Indian Patent Office, responsible for granting and administering patents in the country. It provided a framework for patent examination, opposition, and revocation, ensuring a fair and transparent patent granting process. Over the years, the Patent Act, 1970 has had a profound impact on various stakeholders. It has encouraged domestic research and development, leading to technological advancements and increased competitiveness in sectors such as pharmaceuticals, biotechnology, and information technology. The Act has also facilitated technology transfer and collaboration between Indian and foreign entities, fostering innovation ecosystems and attracting foreign investment. However, the Act has not been without its challenges. Critics argue that certain provisions, such as Section 3(d) related to patentability criteria for pharmaceuticals, may restrict access to essential medicines or discourage innovation. There have been ongoing debates regarding the balance between incentivizing innovation and ensuring affordable access to patented technologies.

Patent Laws and the Public Health Puzzle: Comparing India’s Well-Thought-Out Patent Opposition Model with the U.S. and EU Model

Patent Laws and the Public Health Puzzle: Comparing India’s Well-Thought-Out Patent Opposition Model with the U.S. and EU Model

Strategic Use of Patent Opposition Safeguard to Improve Equitable Access to Innovative Health Technologies: A Case Study of CAR T-Cell Therapy Kymriah

Strategic Use of Patent Opposition Safeguard to Improve Equitable Access to Innovative Health Technologies: A Case Study of CAR T-Cell Therapy Kymriah

An Evaluation of the Indian Legislative Framework for Patent Opposition Mechanism: Merits and Demerits of the Procedural Safeguard

An Evaluation of the Indian Legislative Framework for Patent Opposition Mechanism: Merits and Demerits of the Procedural Safeguard

Temporal motifs in patent opposition and collaboration networks

Patents are intellectual properties that reflect innovative activities of companies and organizations. The literature is rich with the studies that analyze the citations among the patents and the collaboration relations among companies that own the patents. However, the adversarial relations between the patent owners are not as well investigated. One proxy to model such relations is the patent opposition, which is a legal activity in which a company challenges the validity of a patent. Characterizing the patent oppositions, collaborations, and the interplay between them can help better understand the companies’ business strategies. Temporality matters in this context as the order and frequency of oppositions and collaborations characterize their interplay. In this study, we construct a two-layer temporal network to model the patent oppositions and collaborations among the companies. We utilize temporal motifs to analyze the oppositions and collaborations from structural and temporal perspectives. We first characterize the frequent motifs in patent oppositions and investigate how often the companies of different sizes attack other companies. We show that large companies tend to engage in opposition with multiple companies. Then we analyze the temporal interplay between collaborations and oppositions. We find that two adversarial companies are more likely to collaborate in the future than two collaborating companies oppose each other in the future.

Improving access to medicines in the SADC region through patent opposition: Law reform inspirations from an unlikely jurisdiction

This article surveys the patent opposition legal landscape in the SADC region and justifies the importance of patent opposition for access to essential medicines by SADC citizens. The article uses Thailand as a comparative jurisdiction and, after taking a closer look at the patent opposition provisions of the laws of Botswana, Malawi, Zambia and Zimbabwe, the article advances the view that the SADC patent law reform agenda can learn a lot from its Thai counterpart on pharmaceutical patent opposition. Most SADC members with patent opposition provisions in their laws provide for pre-grant rather than post-grant opposition. Generally, pre-grant and post-grant patent opposition procedures ensure that only deserving patents may be successfully applied for and granted. The article concludes that the Thai pre-grant opposition procedures are an example of progressive law, which the SADC region should consider emulating to improve access to affordable essential medicines. The Thai experience may provide helpful and practical pointers for some SADC members when their patent opposition procedures are eventually tested before the courts and intellectual property tribunals.

Clearing the CRISPR patent landscape: Towards a solution for South Africa

Patenting activity regarding new CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) genome editing technology has mushroomed to create a vast and complex patent landscape. However, because of South Africa’s current depository patent system, the South African CRISPR patent landscape contains foundational patents with overlapping claims, as highlighted by the ongoing litigation in the United States between the Broad Institute and the University of California. Both these parties were granted four patents in South Africa. Also, the South African landscape may contain multiple low-quality patents that have the potential to obstruct scientific research in South Africa. The solution in the South African context is threefold, but requires that the Intellectual Property Policy of South Africa: Phase I must first be operationalised to: (a) prioritise CRISPR patent applications for formal examination and substantive search and examination; (b) provide sufficient resources for extracurial patent opposition proceedings regarding all CRISPR patent applications and granted patents; and (c) create certainty by developing an obviousness standard with well-defined parameters. Although CRISPR is not yet advanced enough to fall within the class of life-saving technologies in the short-term, CRISPR may become critical in the treatment and eradication of priority diseases such as HIV/AIDS and tuberculosis. Accordingly, prioritising CRISPR-related patent applications serves the public interest in access to healthcare. By using (a), (b) and (c) in tandem, a triple layer of mechanisms will counter the problems of overlapping claims and of lowquality patents, and hence remove these potential obstructions to CRISPR research in South Africa.

Plaidoyer pour l’accès équitable aux nouvelles technologies de santé : le cas du Kymriah®

Patents have been thought of as an incentive model for research, conferring temporary monopolies to take advantage of an invention. In the pharmaceutical market, unmerited patents are granted, allowing firms to benefit from illegitimate monopolies and demand high prices. These abuses are at the expense of access to care and the financial sustainability of health care systems.These abuses have been demonstrated on treatments for HIV and hepatitis, and are also practiced on anti-cancer treatments such as CAR-T therapies (Chimeric Antigen Receptor T-Cell), whose particularly high prices are a challenge for health systems. Médecins du Monde and Public Eye, two NGOs advocating on price and access to treatment, wanted to question the patentability of CAR-T treatments as well as tostrengthen the capacity of health systems to negotiate fairer prices. These organizations filed a patent opposition against one of these treatments, Kymriah® (tisagenlecleucel). Through this initiative, these organizations alerted public opinion and policy makers on the high prices of CAR-T treatments. The opposition forced Novartis and the University of Pennsylvania to request the revocation of the patent. This action suggests that the patent was granted when it failed to meet the patentability criteria. The treatment is still covered by other patents, this opposition does not end the monopoly. Nevertheless, it weakens the intellectual property on this drug and strengthens the States during price negotiations.

Inter-organisational patent opposition network: how companies form adversarial relationships

Much of the research on networks using patent data focuses on citations and the collaboration networks of inventors, hence regarding patents as a positive sign of invention. However, patenting is, most importantly, a strategic action used by companies to compete with each other. This study sheds light on inter-organisational adversarial relationships in patenting for the first time. We constructed and analysed the network of companies connected via patent opposition relationships that occurred between 1980 and 2018. A majority of the companies are directly or indirectly connected to each other and hence form the largest connected component. We found that, in the network, many companies disapprove patents in various industrial sectors as well as those owned by foreign companies. The network exhibits heavy-tailed, power-law-like degree distribution, and assortative mixing. We further investigated the dynamics of the formation of this network by conducting a temporal network motif analysis, with patent co-ownership among the companies being considered. By regarding opposition as a negative relationship and patent co-ownership as a positive relationship, we analysed where collaboration may occur in the opposition network and how such positive relationships would interact with negative relationships. The results identified the structurally imbalanced triadic motifs and the temporal patterns of the occurrence of triads formed by a mixture of positive and negative relationships. Our findings suggest that the mechanisms of the emergence of the inter-organisational adversarial relationships may differ from those of other types of negative relationships, hence necessitating further research.

Strategic use of patent opposition safeguard to improve equitable access to innovative health technologies: A case study of CAR T-cell therapy Kymriah

ABSTRACT Kymriah is an innovative cancer therapy which works by removing disease fighting T-cells from patients, genetically modifying or reprogramming the immune cells to attack cancer, and re-infusing them back into the patients. It treats childhood blood and bone marrow cancer. The cost of this new hope-giving gene therapy is CHF 450,000 per treatment. This exorbitantly high price set by Novartis, in exercise of its exclusive rights resulting from patent protection, undermines the real-world impact of this revolutionary therapy. On December 16, 2019, Novartis relinquished its European patent on Kymriah as a result of a successful patent opposition lodged by ‘Public Eye’ and ‘Médicins du Monde’. This case study of Kymriah highlights the potential role of civil society in improving equitable and affordable access to innovative health technologies by using the procedural safeguard of patent opposition. This study finds that patent opposition is an important policy option to alleviate some of the financial burdens of health systems, especially in the wake of COVID-19.

The disciplinary effect of post-grant review – Causal evidence from European patent opposition

We study the causal impact of invalidating marginally valid patents during post-grant opposition at the European Patent Office on affected inventors’ subsequent patenting. We exploit exogenous variation in invalidation by leveraging the participation of a patent’s original examiner in the opposition division as an instrument. We find a disciplinary effect of invalidation: Affected inventors file significantly fewer patent applications in the decade after the decision. The effect is entirely driven by a reduction in low-quality filings, i.e., filings that examiners associate with prior art that threatens the application’s novelty or inventive step. We do not observe shifts into national patenting.

The Disciplinary Effect of Post-Grant Review - Causal Evidence from European Patent Opposition

We study the causal impact of invalidating marginally valid patents during post-grant opposition at the European Patent Office on affected inventors’ subsequent patenting. We exploit exogenous variation in invalidation by leveraging the participation of a patent’s original examiner in the opposition division as an instrument. We find a disciplinary effect of invalidation: Affected inventors file 20% fewer patent applications in the decade after the decision. This effect is entirely driven by a reduction in low-quality filings, i.e., filings that examiners associate with prior art that threatens the application’s novelty or inventive step. We do not observe shifts into national patenting.

Pathways to ensure universal and affordable access to hepatitis C treatment

Direct-acting antivirals (DAAs) have dramatically changed the landscape of hepatitis C treatment and prevention. The World Health Organization has called for the elimination of hepatitis C as a public health threat by 2030. However, the discrepancy in DAA prices across low-, middle- and high-income countries is considerable, ranging from less than US$ 100 to approximately US$ 40,000 per course, thus representing a major barrier for the scale-up of treatment and elimination. This article describes DAA pricing and pathways to accessing affordable treatment, providing case studies from Australia, Egypt and Portugal. Pathways to accessing DAAs include developing comprehensive viral hepatitis plans to facilitate price negotiations, voluntary and compulsory licenses, patent opposition, joint procurement, and personal importation schemes. While multiple factors influence the price of DAAs, a key driver is a country’s capacity and willingness to negotiate with pharmaceutical companies. If negotiations do not lead to a reasonable price, governments have the option to utilise flexibilities outlined in the Agreement on Trade-Related Aspects of Intellectual Property Rights. Affordable access to DAAs is underpinned by collaboration between government, civil society, global organisations and pharmaceutical companies to ensure that all patients can access treatment. Promoting these pathways is critical for influencing policy, improving access to affordable DAAs and achieving hepatitis C elimination.

Access to medicines and hepatitis C in Africa: can tiered pricing and voluntary licencing assure universal access, health equity and fairness?

BackgroundThe recent introduction of Direct Acting Antivirals (DAAs) for treating Hepatitis C Virus (HCV) can significantly assist in the world reaching the international target of elimination by 2030. Yet, the challenge facing many individuals and countries today lies with their ability to access these treatments due to their relatively high prices. Gilead Sciences applies differential pricing and licensing strategies arguing that this provides fairer and more equitable access to these life-saving medicines. This paper analyses the implications of Gilead’s tiered pricing and voluntary licencing strategy for access to the DAAs.MethodsWe examined seven countries in Africa (Egypt, Ethiopia, Nigeria, Democratic Republic of Congo, Cameroon, Rwanda and South Africa) to assess their financial capacity to provide DAAs for the treatment of HCV under present voluntary licensing and tiered-pricing arrangements. These countries have been selected to explore the experience of countries with a range of different burdens of HCV and shared eligibility for supply by licensed generic producers or from discounted Gilead prices.ResultsThe cost of 12-weeks of generic DAA varies from $684 per patient treated in Egypt to $750 per patient treated in other countries. These countries can also procure the same DAA for 12-weeks of treatment from the originator, Gilead, at a cost of $1200 per patient. The current prices of DAAs (both from generic and originator manufacturers) are much more than the median annual income per capita and the annual health budget of most of these countries. If governments alone were to bear the costs of universal treatment coverage, then the required additional health expenditure from present rates would range from a 4% increase in South Africa to a staggering 403% in Cameroon.ConclusionThe current arrangements for increasing access to DAAs, towards elimination of HCV, are facing challenges that would require increases in expenditure that are either too burdensome to governments or potentially so to individuals and families. Countries need to implement the flexibilities in the Doha Declaration on Trade Related Intellectual Property Rights agreement, including compulsory licensing and patent opposition. This also requires political commitment, financial will, global solidarity and civil society activism.

Dispute the patent, short the stock: Empirical analysis of a new hedge fund strategy

A new US patent legislation, called the America Invents Act, became effective in 2011. The reform strived toward facilitating the patent system. But soon it was also blamed for facilitating immoral third party profits. Urges for revision of the America Invents Act became even louder since hedge fund manager Kyle Bass had publicly outlined his questionable investment strategy: he challenges the validity of important drug patents, while shorting the owner's shares in order to eventually cash out on negative stock movements.The following questions aroused public interest the most: Does the mere filing of a patent opposition already result in negative stock returns? And is it really possible to earn money following such a strategy? The paper on hand is the first to empirically answer these questions. Event study methodology using three years of data from the United States Patent Trial and Appeal Board was employed.Findings were that the mere filing of a patent opposition in fact produces statistically significant negative returns. The result is robust with the abnormal return being −30 base points. In addition, multiple linear regression results confirm the conjecture that the higher the importance of the disputed patent, the higher the negative abnormal return on the filing date will be. However, transaction cost simulations prove that this strategy is still highly speculative and cannot be considered a real threat to patent holders or the US intellectual property system. The only ones who should start worrying are the few patent owners who really rely on absolutely unjustified and tenuous patent protection.

Patent Filing Strategies: Perspectives From the Cooperation Council for the Arab States of the Gulf

The protection and enforcement of intellectual property rights has become one of the most contentious issues in global commerce. Much of the traditional growth and development of countries in the Middle East over the past 30 years or so has come from oil and gas revenues. The main areas that have been covered in this article are: synopsis of patenting system in each country, the Cooperation Council for the Arab States of the Gulf patent filing system, patentability subject matter, prosecution of patent application, opposition and/or invalidation action(s) and issues that need to be resolved for an effective patent regime.

Deploying pre-grant patent opposition mechanisms in Africa to monitor abuse of the patent system

This article examines the extent to which African countries could deploy pre-grant patent opposition provisions in their domestic patent regimes to mitigate the abuse of the patent system. The author argues that the public has the right to participate in the patent system in order to oppose the grant of bad patents. Therefore, if African countries were to strengthen legislative provisions on pre-grant opposition civil society and non-governmental organisations that represent the interests and will of citizens would be able to invoke key provisions to challenge any abuse in the patent system in order to protect the public interest.