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Bibliography of The Editor's Journal Publications

(1) Glass, Gregory “Inter Partes Reviews and Paragraph IV Cases” Self-Published, issued exclusively to subscribers of November 2015 This paper analyzes the first three years of IPR filings and their impact on both Paragraph IV cases and the PIV Market.

(2) Glass, Gregory “ANDA Approval Dynamics and The Paragraph IV Market – Part II: The Impact of Increased Activity on ANDA” Self-Published, issued exclusively to subscribers of August 2015 This paper analyzes the increase of ANDA filings and how they impact ANDA approval and launch dynamics.

(3) Glass, Gregory “ANDA Filing Dynamics and The Paragraph IV Market – Part I: The Impact of Increased Activity on First-Filings” Self-Published, issued exclusively to subscribers of January 2015 This paper analyzes the increase of ANDA filings and how they impact first-filing ANDA dynamics.

(4) Glass, Gregory “The Paragraph IV Market and the Forfeiture of Exclusivity” Self-Published, issued exclusively to subscribers of July 2014 This paper examines the impact of the forfeiture provisions of the Medicare Modernization Act (2003) on Paragraph IV ANDA filers ten years after passage.

(5) Glass, Gregory "Legal Defenses and Outcomes in Paragraph IV Patent Litigation" Journal of Generic Medicines, March 2013, Volume 10, Issue 1, Pages 4-13. This paper examines district court outcomes in Paragraph IV cases from 2009- 2012 and considers the success rates of legal defenses raised and adjudicated.

(6) Glass, Gregory; Collins, Erin "Citizen Petitions: Barriers to Entry for Generic Medicines? An update and evaluation of petitions, their management, and disposition from 2004-2010" Journal of Generic Medicines, July 2011, Volume 8, Issue 3, Pages. 166 - 171. As the title suggests, this paper updates the one directly below, examining petitions filed from 2004-2010.

(7) Glass, Gregory; Collins, Erin "The Citizen Petition: For the good or brands behaving badly?" Journal of Generic Medicines, January 2007, Volume 4, Number 2, Pages 87-97. This journal paper presents data of all citizen petitions filed with the US Food and Drug Administration from 2004 through the first half 2006. The paper examines the thesis of the whether the petitions serve to create an obstacle to generic entry.

(8) Glass, Gregory, "From the Analysts Couch -- Authorized Generics." Nature Reviews Drug Discovery, December 2005, Volume 4, Pages 11-12. This article briefs the reader on the growing trend of authorized generics and where they might be headed, particularly in the light of the Crawford v. Teva decision. It contains some financial analysis and a detailed box on many recent authorized generics arrangements.

(9) Glass, Gregory; Worrell, Chrisopher, "Who's Afraid of Authorized Generics?" Pharmaceutical Executive, October 2005, Volume 25, Number 10, Pages 64-70. This article analyzes the genesis of authorized generics in the context of Paragraph IV Challenges and also lays out a foundation for brand companies to create and implement an authorized generics life-cycle strategy.

(10) Glass, Gregory. "Pharmaceutical Patent Challenges -- Time for Reassessment?" Nature Reviews Drug Discovery, December 2004, Volume 13, Number 12, Pages 1057-1063. This Opinion piece examines the possible long-term impact of Paragraph IV challenges to both branded and generic companies. The issue is complicated from either perspective, with no simple answers.

(11) Glass, Gregory, "Patent Attack." Pharmaceutical Executive, April 2005, pp 77-86. This article discusses the financial impact and dilemma for brands when they receive a Paragraph IV challenge and offers recommendations on just how to manage a product under patent challenge. For the record, the title was the idea of the editor of Pharmaceutical Executive.

(12) Glass, Gregory, "Why Settle?" Food and Drug Law Institute Update, September/October 2005, pp 17-19. This article takes a look at comparing rates of settlements of Paragraph IV cases between the Federal Trade Commission Report of 2002 and a more recent sample of cases. An interesting observation results in that fewer settlements of cases were made and also that brand companies won more lawsuits. The paper takes a somewhat wry look at settlements particularly in light of a March 2005 Court of Appeals Opinion that may encourage more of them.

(13) Glass, Gregory. "From the Analysts Couch -- Cardiovascular Combinations." Nature Reviews Drug Discovery, September 2004, Volume 3, Number 9, Pages 731-732. This brief assessment offers some insight into the success factors of recently-launched cardiovascular combination products.

(14) McCaffery, Tom; Glass, Gregory; and Satterfield, Heather. "The Electronic Barrister: Delivering Client Value with Information Technology Solutions." The American Corporate Counsel Docket, November/December 1998, Volume 16, Number 6, Pages 18-30. This paper describes an innovative database solution which provides companies real-time legal advice and assistance with the execution of standard form contracts.

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