Qualifying Intellectual Property II: A New Innovation Index for Pharmaceutical Patents & Products

By Bouchard, Ron A. | Santa Clara Computer & High Technology Law Journal, January 2012 | Go to article overview

Qualifying Intellectual Property II: A New Innovation Index for Pharmaceutical Patents & Products


Bouchard, Ron A., Santa Clara Computer & High Technology Law Journal


Table Of Contents  I. Abbreviations II. Introduction III. Why Qualify Intellectual Property?        A. Pancakes and Global Intellectual Property Waves        B. Product Clusters: Path of Least Resistance to Patent           Portfolios        C. Summary IV. Study Objectives V. Methods        A. Drug Approval Nomenclature and Classification        B. Innovation Index        C. Examples of LOI Compound-Indication           Classifications        D. Curve Fitting        E. Data Analysis VI. RESULTS        A. Presentation of Data        B. Total Approval Cohort        C. MP Approval Cohort        D. MP Patenting Cohort        E. MP Chemical Cohort        F. Class Trends Across Indicators VII. Discussion        A. Interpretation of the Data           1. Drug Approval           2. Drug Patenting           3. Drug Chemical Components           4. Class Trends Across Indicators           5. Limitations        B. Interpretation of the Model           1. Objective-Subjective Considerations           2. Intellectual Property Law Considerations        C. Relevance to Pharmaceutical Law and Policy           1. Patent and Innovation Policy           2. Listing of Patents on the Patent Register           3. Cluster-Based Drug Development           4. Impact on Competition VIII. SUMMARY & CONCLUSIONS 

I. ABBREVIATIONS

ANDS Abbreviated New Drug Submission

ER Expedited Review

FIC First in Class

NAS New Active Substance

NCE New Chemical Entity

NDS New Drug Submission

NDS NAS NDS drug containing a NAS

NDS ER NDS drug undergoing ER

NDS FIC FIC drug approved via NDS route

NDS Me Too Me Too drug approved via NDS route

NDS MI Most Innovative NDS Drug

NOC Notice of Compliance

NOC/c Notice of Compliance with Conditions

PR Priority Review

SANDS Supplemental Abbreviated New Drug Submission

SNDS Supplemental New Drug Submission

SNDS ER SNDS drug undergoing ER

SNDS FIC FIC drug approved via SNDS route

SNDS Me Too Me Too drug approved via SNDS route

II. INTRODUCTION

Governments around the world have become uniformly locked in to the political mandate of innovation, both in developed and developing nations. It is a race no one wants to lose. Yet, despite the non-rival nature of knowledge, (1) it is one few will win. Innovation is widely accepted to be a fundamental gateway to national and global productivity and prosperity. (2) Nowhere is this truer than in the fields of science and technology, particularly in the life sciences. (3) The argument in favor of patenting in the pharmaceutical industry has been made consistently and with vigor for over a half-century. (4) The pharmaceutical industry claims that its research and development (R&D) activities are responsible for most new and innovative medicines. (5) Indeed, a major justification for high and increasing drug expenditures is that such profits are necessary to underpin the development of new and innovative drugs. (6)

To date, innovation is measured using primarily quantitative methods. (7) Patents are usually used as the prime measure. (8) Methods most often reported include counting patents, patent citations, prior art citations and related litigation outcomes. (9) These measures are used extensively in prominent domestic, regional and global reports focused on productivity and prosperity. (10) indeed, much of what governments understand about innovation is currently shaped by measurements of patenting activity. For example, patenting licensing, litigation, and prior art citation data can be useful as indicators of how general knowledge flows within and between different industries, (11) and has helped to shape priority areas for government investment, (12) including several sectors within the life sciences rubric. (13) Citation counting has demonstrated differences between public and private patentees in the medical research and product development sector, leading some to conclude that non-profit patents, such as those to universities, are valuable to the ultimate commercialization of medicines. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Qualifying Intellectual Property II: A New Innovation Index for Pharmaceutical Patents & Products
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Author Advanced search

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.