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2022 — 22 Books and Research Papers Citing DrugPatentWatch
Friedman, Y. (2022). Six drugs facing key patent expirations and potential generic entry from May to June 2022. Pharmaceutical Patent Analyst, 11(4), 127–129. doi:10.4155/ppa-2022-0018
Friedman identifies six drugs slated for key patent expiry between May and June 2022, estimating their U.S. loss of exclusivity based on patent and FDA regulatory timelines. For each, he outlines potential generic entry windows—insightful for tracking shifts in competitive landscape. By examining both compound and formulation patents, the report highlights how layered protections can defer generic market entry, a critical concern tracked by DrugPatentWatch. The article also recommends extending this patent-mapping methodology to international jurisdictions by analyzing global patent families.
Wang, L. X. (2022). Global drug diffusion and innovation with the Medicines Patent Pool. Journal of Health Economics, 85, 102671. doi:10.1016/j.jhealeco.2022.102671
Wang evaluates the impact of the Medicines Patent Pool (MPP)—a licensing platform for patented drugs—on generic diffusion and innovation in developing countries. Using difference-in-differences and a novel dataset (licensing contracts, procurement, trials, approvals), she finds that inclusion in the MPP significantly boosts generic supply, especially in countries with strong patent protections. Intriguingly, the paper also documents increased upstream innovation—reflected in more clinical trials and new drug products following pool inclusion. These findings underscore how patent-pooling structures can reshape access dynamics and trigger follow-on drug development.
Kimball, J., & Ragavan, S. (2022). AI (Re)Defining Pharmaceutical Exclusivities. Biotechnology Law Report, 41(1), 23–39. doi:10.1089/blr.2021.29257.sr
Kimball and Ragavan explore how emerging AI, advanced biomarkers, and digital tools are compressing drug development timelines and reducing costs. They argue this efficiency challenges the traditional justification for long regulatory exclusivity periods—especially for biologics—advocating for policy reforms to shorten exclusivity durations. The authors highlight the necessity of recalibrating exclusivity in light of rapid innovation to foster public health access, a key consideration for monitoring lifecycle dynamics.
Schultz, M. (2022). Essential Medicines and Patents on the World Health Organization Essential Medicines List 22nd Edition (2021). Geneva Network Working Paper, March 2022, 1–19.
Schultz examines patent coverage of medicines listed in the WHO’s Essential Medicines List (22nd Edition, 2021). Findings show a decline—from 10.1% to 7.3%—in medicines under patent in low- and middle-income countries, with 35 out of 477 items still patented as of January 2022. He also highlights that about one-quarter of those patents are under access-facilitating programs like the Medicines Patent Pool. This analysis offers a valuable snapshot, illuminating global patent burdens on essential drugs and the effectiveness of licensing model
Peterson, L. K. N., & Devlin, J. W. (2022). Vasopressin: The Impact of Predatory Patents on a Captive ICU Marketplace. Critical Care Medicine, 50(4), 711–714. doi:10.1097/CCM.0000000000005348
Peterson and Devlin issue a sharp editorial critique on how strategic “predatory patents” surrounding vasopressin—a longstanding ICU drug—led to unjustified price hikes and restricted market competition. They underscore that new patent filings (e.g. formulations, delivery mechanisms) extended exclusivity while marginally adding therapeutic innovation. This case exemplifies non-innovative patenting practices that inflate costs and delay generics—insights crucial for surveillance of exploitative patent strategies.
Thomas, J. R. (2022). Noticing Patents. Columbia Science & Technology Law Review, 24(2), 299–347. doi:10.52214/stlr.v24i2.11630
Thomas critiques deficiencies in the U.S. patent notice regime—particularly inefficiencies in marking statutes and the FDA’s Orange and Purple Book disclosures—that impair the ability of generic manufacturers to identify relevant patents. He proposes specific reforms: a USPTO-managed virtual marking database, FDA strengthening of its patent-listing processes, and policy adjustments to mitigate so-called “patent trolls.” These suggestions are highly pertinent, as improvements in patent transparency could significantly enhance monitoring of patent landscapes and generic entry timing.
Moro‑Visconti, R. (2022). Pharma Patent Valuation. In R. Moro‑Visconti (Ed.), Corporate Valuation: From Digital Networking to ESG Applications (pp. 85–110). Springer. doi:10.1007/978-3-031-05084-0_5
Moro‑Visconti outlines quantitative methodologies for valuing pharmaceutical patents, combining discounted cash flow models, Monte Carlo simulations, and real options frameworks. He demonstrates how uncertainty parameters—market exclusivity duration, R&D costs, launch timelines—dramatically affect patent value estimations. This work offers a rigorous valuation toolkit to quantify the financial impact of upcoming patent expiries or litigation risks.
Selvakumar, M. D. (2022). Overlap of Trademarks with Other Intellectual Property Rights: The Strategies of Global Brands. Beijing Law Review, 13, 123–141. doi:10.4236/blr.2022.132009
Selvakumar analyzes how multinational brands manage trademark-IP overlaps—such as design, trade dress, and patents—to bolster exclusivity and combat counterfeit infiltration. The study includes pharmaceutical brand strategies, illustrating how patentholders often layer trade dress and trademarks (e.g., packaging or device design patents) to extend market protection beyond compound expiry. This layered-IP approach is a critical nuance to track, as it may obscure generic entry signals and affect market monitoring.
Raju, K. D. (2022). Patent Linkages and Its Impact on Access to Medicines: Challenges, Opportunities for Developing Countries. In Access to Medicines and Vaccines: Implementing the UN Political Declaration on Universal Health Coverage (pp. 45–67). OAPEN. doi:10.5281/zenodo.6345821 (2022)
Raju examines the implementation of patent linkage mechanisms—where drug regulatory approvals are tied to patent status—and their effect on medicine availability in developing nations. She discusses how such systems can delay generic entry through patent listing, opposition and litigation, citing both legal and health-economic consequences. The chapter also offers policy alternatives (e.g., exclusion lists, fast-track challenges) to balance IP rights with public health priorities. Raju’s insights provide essential context on how patent–regulatory interplay differs across jurisdictions and influences generic timelines.
Ranpariya, V., Kats, D., & Lipoff, J. B. (2022). Direct-to‑consumer teledermatology growth: a review and outlook for the future. Cutis, 109(2), 78–83. (Online publication via MDedge)
This review explores how consumer-facing teledermatology platforms accelerated in use—particularly during the pandemic—and examines regulatory aspects, including digital prescriptions and IP provisions for diagnostic algorithms. The authors highlight competitive strategies by telehealth companies, including trademarking platform technologies and seeking software patents. These discussions illustrate an inflection point in healthcare where patent and IP monitoring extends into digital service layers—a novel arena beyond traditional pharmaceuticals.
Thielen, F. W., Heine, R. J. S. D., & van den Berg, S. (2022). Towards sustainability and affordability of expensive cell and gene therapies? Applying a cost‑based pricing model to estimate prices for Libmeldy and Zynteglo. Cytotherapy, 24(5), 417–428. doi:10.1016/j.jcyt.2022.02.001
Thielen et al. develop a transparent cost‑based pricing model for two high-cost gene therapies—Libmeldy and Zynteglo—considering R&D amortization, manufacturing expenses, and margin assumptions. They argue that current pricing substantially exceeds cost‑based estimates, often enabled by strong IP protections and limited competition. The paper urges openness in pricing and the use of cost models to bolster payer negotiations post‑patent expiry. Readers can leverage this to assess how patent expiry timelines may impact pricing dynamics and generic/biosimilar entry.
Niazi, S. K. (2022). The coming of age of biosimilars: a personal perspective. Biologics, 16, 1–15. doi:10.2147/BTT.S272483
Niazi offers a comprehensive overview of the biosimilar field—covering regulatory frameworks, patent litigation strategies (e.g., patent thickets, interchangeability), and market uptake trends. He emphasizes how biosimilar manufacturers navigate complex patents (process, formulation, Indianized) and regulatory exclusivities. The paper provides case studies on biosimilar launches post-patent expiry, detailing timing, litigation strategies, and commercial adoption in the U.S. and Europe.
MacArthur, R. B., Ashworth, L. D., Zhan, K., & Parrish, R. H. (2022). How Compounding Pharmacies Fill Critical Gaps in Pediatric Drug Development Processes: Suggested Regulatory Changes to Meet Future Challenges. Children, 9(3), 345. doi:10.3390/children9030345
MacArthur et al. discuss the important role compounding pharmacies play in providing medications tailored to pediatric patients, especially where commercial formulations are lacking due to patent and market limitations. They analyze regulatory gaps affecting compounded drugs’ availability and safety, recommending reforms to ensure continued access without compromising innovation incentives. This highlights a unique intersection of patent expiration, formulation innovation, and niche market dynamics relevant to readers tracking pediatric drug patents.
Mishra, S., & Kumar, R. (2022). A REVIEW: 3D PRINTING IN PHARMA SECTOR. World Journal of Pharmacy and Pharmaceutical Sciences, 11(1), 345–360. doi:10.20959/wjpps20221-22454
This review covers recent advances in 3D printing technologies for pharmaceuticals, including customized dosing, novel drug delivery systems, and on-demand manufacturing. The authors note the evolving patent landscape surrounding 3D printing techniques and associated drug formulations, emphasizing how such technologies could disrupt traditional patent timelines by enabling more rapid innovation cycles. Readers should watch for emerging patents in 3D printed drugs and devices as potential new exclusivity layers.
Ohdo, S., Koyanagi, S., & Matsunaga, N. (2022). Chronopharmacology of immune-related diseases. Allergology International, 71(3), 299–309. doi:10.1016/j.alit.2021.12.006
Ohdo et al. explore how circadian rhythms influence drug pharmacokinetics and therapeutic efficacy in immune-related diseases. While not directly patent-focused, the article underscores opportunities for novel drug formulations and dosing schedules that could be patented to optimize treatment. These chronotherapeutic innovations can extend patent lifecycles or open new exclusivity avenues—important considerations for those following patent extensions via formulation patents.
Singh, C. K. (2022). SACUBITRIL/VALSARTAN (ENTRESTO): A REVIEW ON DEVELOPMENT OF ANALYTICAL METHODS AND ITS ASSESSMENT IN PURE, BULK AND DOSAGE FORM. Academia.edu, 1–24.
Singh provides a technical review of analytical methodologies used to assess Sacubitril/Valsartan (Entresto) in various forms, emphasizing quality control essential for both branded and generic versions. The paper touches on patents protecting analytical techniques and formulation processes, which can complicate generic manufacturing despite primary patent expiry. This deepens understanding for users of patent landscapes beyond active ingredients, influencing generic entry strategies.
Moro‑Visconti, R. (2022). Medtech and Biotech Valuation. In R. Moro‑Visconti (Ed.), Corporate Valuation: From Digital Networking to ESG Applications (pp. 145–172). Springer. doi:10.1007/978-3-031-05084-0_8
Building on his pharma patent valuation work, Moro‑Visconti expands into medtech and biotech companies, examining how patent portfolios and regulatory exclusivities affect overall firm valuation. He incorporates ESG (Environmental, Social, and Governance) factors and digital networking trends in assessing patent-driven competitive advantage. This provides a comprehensive framework for readers interested in broader IP valuation strategies beyond traditional pharma patents.
Sun, H. (2022). Patent Philanthropy. Cornell International Law Journal, 55(2), 345–390. Available at HeinOnline.
Sun explores the concept of “patent philanthropy,” where patent holders voluntarily license or donate patents to improve global health access. The article discusses strategic motivations behind this approach, including reputational benefits and regulatory incentives. Understanding philanthropic licensing initiatives complements traditional patent expiration data by highlighting alternative pathways for generic or biosimilar availability.
Papp, A. (2022). AstraZeneca equity research—Adapting to a dynamic pharmaceutical sector as a key to success. University of Nebraska–Lincoln Repository, 1–35.
Papp provides an equity research analysis focusing on AstraZeneca’s strategic shifts in oncology and biologics amid evolving patent landscapes and market competition. The report underscores AstraZeneca’s portfolio management to maximize patent-protected revenues while preparing for impending generic threats. This insight is valuable for those monitoring patent cliffs and lifecycle management in large pharma.
Kerkow, J. K. (2022). AstraZeneca equity research—Big pharma on the brink of future changes in oncology. University of Nebraska–Lincoln Repository, 1–29.
Kerkow examines how oncology drug patent expirations will reshape big pharma strategies, with AstraZeneca as a case study. He highlights patent litigation, reformulation patents, and biosimilar entry as key variables. Readers can leverage this to anticipate shifts in competitive dynamics and patent expiry impacts in oncology therapeutics.
Shalygina, N. S. (2022). РНТБ–45 лет на службе науке и производству. Информационно-ресурсное обеспечение научно-исследовательской деятельности [RNTB–45 Years Serving Science and Production. Information and Resource Support for Scientific Research]. Scientific and Technical Libraries, 1(58), 45–55.
Shalygina chronicles the 45-year history of the Russian Scientific and Technical Library (RNTB), a critical resource for patent and scientific information dissemination. The article emphasizes RNTB’s role in patent data accessibility supporting drug development and innovation, relevant for readers seeking comprehensive patent intelligence resources globally.
Viollier Bonvin, P. A., & Valenzuela Pulgar, S. (2022). Implementación del “linkage farmacéutico” en Chile. ¿A qué nos obliga el Tratado Integral y Progresista de Asociación Transpacífico? [Implementation of Pharmaceutical Linkage in Chile: What Does the Comprehensive and Progressive Trans-Pacific Partnership Obligate Us To?]. Revista de Derecho, 55(1), 123–142.
This article reviews Chile’s adoption of patent linkage rules under the CPTPP trade agreement, analyzing legal obligations and practical impacts on generic drug entry. The authors discuss potential challenges for public health and access to medicines due to extended exclusivity periods. Readers monitoring emerging markets will find this analysis pertinent to understanding evolving patent-regulatory frameworks outside the U.S. and Europe.
