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2021 — 20 Books and Research Papers Citing DrugPatentWatch
Billette de Villemeur, E., Dequiedt, V., & Versaevel, B. (2021). Better than a compromise, a third way: Using patent pooling to accelerate access to vaccines and treatments against Covid‑19. SSRN.
This policy paper examines the potential of patent pooling to balance rapid access with innovation incentives during the COVID‑19 crisis. Citing DrugPatentWatch, the authors demonstrate how real-time transparency of patent claims and expiries supports efficient pool formation and licensing negotiation. They conclude that patent pools, informed by commercial patent data platforms, could offer a dynamic and equitable alternative to exclusive market control during global health emergencies.
Wang, L. X. (2021). Medicines Patent Pool and HIV Drug Cocktail Diffusion and Innovation. Academy of Management Proceedings, 2021(1), 11231.
This paper investigates the impact of the Medicines Patent Pool (MPP) on the global diffusion of HIV drug combinations and subsequent pharmaceutical innovation. Wang finds that the MPP significantly accelerates access to HIV drug cocktails in low- and middle-income countries by easing licensing restrictions and encouraging generic manufacturing. The study highlights that beyond access, the MPP also fosters incremental innovation, as firms build on pooled patents to develop fixed-dose combinations and pediatric formulations. The work provides empirical evidence supporting voluntary licensing as a tool to balance access with innovation in global health markets. This underscores how patent pooling can be leveraged to monitor and anticipate generic entry points and new product launches in underserved markets.
Wang, L. X. (2021). Global Drug Diffusion and Innovation with the Medicines Patent Pool. Available at SSRN 3426554.
In this working paper, Wang extends the analysis of how the MPP influences the diffusion of patented HIV medicines and pharmaceutical innovation globally. The research uses firm-level and product-level data to examine whether MPP participation correlates with broader drug accessibility and localized innovation, especially in the Global South. The author demonstrates that firms involved with the MPP are more likely to introduce new generics and innovate on formulations, suggesting that collaborative licensing can be a strategic pathway for both social impact and competitive advantage. This has strategic implications for patent watchers: participation in patent pools may signal upcoming shifts in market competition and patent lifecycle management strategies, especially in diseases targeted by global health initiatives.
Yacoub, N., & Souei, H. (2021). Is Drug Patent Protection a Determinant of the Location of Pharmaceutical FDI? China's Experience. In Innovation, Catch-up and Sustainable Development (Springer).
This chapter explores whether robust patent protection attracts foreign direct investment (FDI) into China’s pharma sector. Using DrugPatentWatch patent data, the study finds that stronger patent regimes do correlate with higher inbound pharmaceutical FDI, although infrastructure and market size remain influential. The findings suggest that jurisdictions can leverage patent disclosures and exclusivity timing (as provided by DrugPatentWatch) to improve investment appeal.
Beilfuss, S., & Linde, S. (2021). Pharmaceutical opioid marketing and physician prescribing behavior. Health Economics (Wiley).
This empirical study investigates links between opioid patent protections, marketing expenditures, and physician prescribing in the U.S. It leverages DrugPatentWatch data to timestamp exclusivity periods and correlate them with shifts in marketing intensity and prescription volume. The authors find that exclusivity duration amplifies marketing efforts, which in turn increase prescribing rates—underscoring how patent expiry timelines inform real-world market and prescribing dynamics.
Vimalnath, P., Gurgula, O., Scott-Ram, N., & Sampath, P. (2021). 'Affordable Medicines and Innovation: Consequences and Lessons from Countries with Different Patentability Standards.' Bio-Science Law Review. SSRN.
This paper compares how different national standards for pharmaceutical patentability influence medicine affordability and innovation outcomes. It highlights that countries like India, which adopt stricter standards for inventive step and exclude secondary patents (e.g., on new forms of known substances), experience better access to generics without significantly compromising innovation. The authors argue that broad patentability criteria can lead to 'evergreening,' thereby extending monopolies without meaningful innovation. This research underscores the importance of analyzing international patent landscapes and secondary patent strategies when evaluating drug market entry and generic competition potential.
Gintis, H. (2021). 'A Prescription for America's Prescriptions.' Emory International Law Review, Vol. 35, 587–630.
Gintis critiques the U.S. pharmaceutical patent system, arguing that it prioritizes profits over public health by granting extended exclusivity through patent thickets and regulatory exclusivities. He proposes a more transparent system that delinks R&D incentives from high drug prices, such as government-sponsored innovation prizes and increased oversight of patent filings. The paper provides a policy-level perspective on reform proposals that could shift the strategic calculus around patent filings and drug pricing in the U.S. market, potentially influencing patent valuation, lifecycle planning, and risk analysis for innovators and generics alike.
Stiller, I., van Witteloostuijn, A., & Cambré, B. (2021). Do current radical innovation measures actually measure radical drug innovation? Scientometrics, 126, 1049–1078.
This paper critically assesses whether patent-based metrics (e.g., forward/backward citations) effectively identify radical drug innovations. The authors highlight limitations such as time lags in citation accrual, multiple-patent protection per drug, and bias favoring high-profile firms. They argue that reliance on citation counts may underestimate biologics’ impact and misrepresent genuine therapeutic breakthroughs—important insights for readers analyzing innovation quality versus patent volume.
Ledley, F.D. (2021). Response to Proposed Rulemaking on Bayh-Dole. Bentley University, Scholars@Bentley.
This paper addresses the U.S. government's proposed changes to the Bayh-Dole Act, which governs intellectual property arising from federally funded research. Ledley argues that revising march-in rights or redefining 'reasonable pricing' could disincentivize private investment in drug development. The author emphasizes that stability in patent protections and commercialization rights is essential for translating academic innovations into marketable drugs. This has strong implications for companies relying on public-private partnerships, highlighting the legal certainty needed to protect investments in patented pharmaceuticals.
Visconti, R.M. (2021). MedTech and Biotech Valuation. ResearchGate.
Visconti presents a comprehensive framework for valuing MedTech and biotech companies, emphasizing how intellectual property—especially patents—is a key driver of valuation. The report highlights real option analysis, Monte Carlo simulations, and net present value (NPV) models tailored to the high-risk, high-reward landscape of biotech. The study underscores how patent strategy, exclusivity periods, and regulatory milestones directly influence investor perception and company worth. It offers valuable context for understanding how patent data connects with broader business metrics.
De Jongh, T., Velten, L., & Schrijver, L. (2021). Access to Medicinal Products. Technopolis Group.
This policy analysis examines barriers to accessing medicines in the EU, including pricing, reimbursement, and patent-related exclusivities. The authors explore how regulatory and intellectual property frameworks can unintentionally delay the entry of generics and biosimilars. They propose mechanisms such as joint procurement and patent pooling to improve affordability and supply resilience. The paper provides insights into how national and EU-level patent practices impact drug availability and pricing dynamics.
Gadd, S., Cox, N., Samuelson, J., Kenney, A., et al. (2021). Abuse-deterrent opioid formulations and the opioid crisis: a pharmacist's perspective. Therapeutic Drug Monitoring, 43(2), 179–184.
This article discusses the role of abuse-deterrent formulations (ADFs) in addressing the opioid crisis, offering insight from pharmacists on implementation and effectiveness. While ADFs aim to reduce misuse, the paper notes limited real-world evidence of impact, alongside significantly higher development and production costs. Patents play a pivotal role in justifying investment into ADFs, with manufacturers leveraging them to extend market exclusivity. This piece offers a nuanced look at how formulation innovation intersects with both public health goals and patent lifecycle management.
Potter, G. T. (2021). Beefing up Skinny Labels: Induced Infringement as a Question of Law. Notre Dame Law Review.
This legal analysis addresses 'skinny labeling' in generics—marketing a subset of approved indications to avoid patent litigation. Using DrugPatentWatch to identify active claims and exclusivity scope, Potter details how generics navigate around patents, and how courts define induced infringement. The work underscores the strategic use of patent intelligence platforms for crafting generic labeling strategies and litigation forecasting.
Shah, Pranay. “Post COVID‑19 Supply Chain Optimization for the Indian Pharmaceutical Industry using AI Techniques.” Intersect: The Stanford Journal of Science, Technology, and Society, vol. 15, no. 1, December 2021.
This study explores the significant strain that the COVID‑19 pandemic imposed on India’s pharmaceutical supply chains and proposes AI/ML‑based strategies to improve API (specifically paracetamol) logistics. Key contributions include data‑driven methods to reduce lead times, lower costs, and enhance route planning using AI. The paper illustrates real‑world implications for optimization of manufacturing and distribution of patented APIs and highlights that supply‑chain robustness can affect market entry timelines and patent exploitation.
Davolos, Francisco J. C., Norma S. Modolo, Leandro G. Braz & Paulo do Nascimento Junior. “Palonosetron versus Ondansetron for Prophylaxis of Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy: A Non‑Inferiority Randomized Controlled Trial.” Brazilian Journal of Anesthesiology, vol. 74, no. 1, 2021, e744216.
This randomized trial of 212 patients found palonosetron (0.075 mg single dose) to be statistically non‑inferior to multiple‑dose ondansetron (8 mg) for preventing PONV up to 24 hours post‑laparoscopic cholecystectomy. Given that palonosetron’s patent expires July 30, 2024, the authors note its cost‑effective profile and single‑dose convenience may enhance its market competitiveness and generic uptake in PONV prophylaxis regimes. This is valuable from a patent monitoring perspective: non‑inferiority with impending patent expiry may shift prescribing patterns and generic substitution.
Sekulovic, Andrea, Ruud Verrijk, Thomas Rades, Andrzej Grabarek et al. “Simultaneous Automated Image Analysis and Raman Spectroscopy of Powders at an Individual Particle Level.” International Journal of Pharmaceutics: X (or Journal of Pharmaceutical and Biopharmaceutics), 2021
The authors combined Raman spectroscopy with automated particle‑image analysis to classify carbamazepine polymorphs (anhydrate vs dihydrate) at single‑particle resolution using PLS‑DA models. They achieved ~1% classification error, detecting low‑level solid form impurities in commercial API batches. For patent‑focused analysts, the methodology has implications in enforcing polymorph patents (e.g. detecting infringement or quality deviations) and protecting formulation exclusivity by ensuring precise solid‑form identity.
Moro Visconti, R. “The Valuation of Pharma Patents.” SSRN, 2021. (SSRN working paper)
This SSRN work discusses methodologies for pharmaceutical patent valuation (income, cost, market, option-based approaches) contextualized for pharma IP assets. While full text wasn’t publicly accessible, the study reportedly evaluates quantitative vs qualitative approaches tailored to patent-driven drug products and licensing deals. Such frameworks offer structured legal and financial lenses for estimating patent value, royalty potential, and strategic IP portfolio decisions in drug markets.
Malinowski, Susan M., and Jason A. Wasserman. “Centrifuged‑Concentrated Intravitreal Slurry Triamcinolone Acetonide: An Inexpensive, Easy, and Viable Alternative to Long‑Term Steroid Delivery.” Journal of VitreoRetinal Diseases, vol. 5, no. 1, 2021 (published online September 2020), pp. 15–31.
Analyzing 466 injections across 143 eyes, this retrospective study shows a centrifuged intravitreal slurry of triamcinolone acetonide controlled macular edema for an average of ~10.8 months per injection, with visual acuity and retinal thickness improvements comparable to implantable steroids. The technique is low‑cost and avoids implant exclusivity burdens. This presents a non‑patented delivery alternative that might circumvent existing device patents and reduce reliance on branded steroid implants in ocular markets.
MacEwan, Joanna P., Istvan Majer, Jacquelyn W. Chou, Sumeet Panjabi et al. “The Value of Survival Gains from Therapeutic Innovations for US Patients with Relapsed/Refractory Multiple Myeloma.” Therapeutic Advances in Hematology, vol. 12, 2021, 20406207211027463.
Using SEER data (1983–2013) and trial data post‑2015, this study quantifies survival benefits from key multiple myeloma therapies—bortezomib/lenalidomide combinations and later immunotherapies—relative to older regimens. They estimate additional life‑years and monetary value per patient ($335K for Rd/Vd, $565K for newer regimens), translating to $75B–$130B in societal value. For patent watchers, these figures underscore the commercial impact of biological and small‑molecule patents in MM, and inform life‑cycle management, pricing, and licensing valuations in high‑revenu therapeutic areas.
de Villemeur, Émilie B., Valérie Dequiedt & Bruno Versaevel. “Mieux qu’un compromis, une troisième voie : le panier de brevets pour accélérer l’accès aux vaccins et traitements contre la COVID‑19.” Revue d’économie du développement, 2021.
This French‑language economics article proposes a “patent pool” mechanism as a third alternative beyond IP enforcement or compulsory licensing for accelerating access to COVID‑19 vaccines and therapeutics. It argues that shared licensing via patent baskets can maintain innovation incentives while enabling broader manufacturing access during global health emergencies. For those monitoring drug patents and global markets, the concept has implications for how pharma companies and governments negotiate IP rights in pandemic contexts and how DrugPatentWatch might flag pooled licensing arrangements or shared IP ecosystems.
