Second Generation Patents in Pharmaceutical Innovation
Zusammenfassung
Die Entwicklung neuer Medikamente und deren Verbesserungen sind entscheidend, um deutliche Fortschritte in der Gesundheitsversorgung zu gewährleisten. Der Entwicklungsprozess ist lang und teuer, insbesondere der Aufwand,der betrieben werden muss,, um den hohen Regulierungsanforderungen gerecht zu werden.
Im Gegensatz dazu verursacht die Nachahmung von Medikamenten vernachlässigbare Kosten und birgt deutlich weniger Risiken. Dies ist einer der Gründe, warum der Patenschutz für die die pharmazeutische Industrie von so großer Bedeutung ist.
Trotz des bestehenden Patentsystems ist gerade während des letzten Jahrzehnts die Zahl der neuen Medikamente pro Jahr zurückgegangen. Im Vergleich dazu hat sich die Zahl der Patente und Produkte der zweiten Generation drastisch erhöht.
Der Pharmaindustrie wird vorgeworfen, ihre ursprüngliche Aufgabe, die Entwicklung neuer Medikamente, zu vernachlässigen, indem sie Produkte der zweiten Generation erzeugt und die Einführung von Generika verhindert. Die Dissertation überprüft, ob diese Bedenken gerechtfertigt sind, und wenn ja, ob oder wie das Patentsystem den Konflikt zwischen Pharma-Unternehmen und der Gesellschaft im Hinblick auf eine bedarfsgerechte Arzneimittelversorgung lösen kann.
Abstract
The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and mainly to produce the information to meet high regulatory requirements. In contrast, imitation involves negligible costs and much reduced risks. This is one of the reasons the pharmaceutical industry depends greatly on patent protection. Despite the existing patent system, however, the number of new medications per year has decreased, especially during the last decade. In comparison, the number of second generation patents and products has been drastically increased. This industry is accused both of neglecting its real mission of providing new medications while generating second generation products, and of preventing the entry of generics. The dissertation reviewed whether the concerns are justified, and, if so, whether or how the patent system can improve the situation that confronts pharmaceutical companies and society.
- Kapitel Ausklappen | EinklappenSeiten
- 22–28 I. INTRODUCTION 22–28
- 246–312 VI. PROPOSALS 246–312
- 313–321 VII. FINAL CONCLUSIONS 313–321
- 324–333 List of Case Laws 324–333
- 334–355 Bibliography 334–355
- Abbott, Alison, Europe Rules Against Stem-Cell Patents, 471 Nature 280 (2011). doi.org/10.1038/471280a
- Abramowicz, Michael, Perfecting Patent Prizes, Law and Economics Working Paper Series No 01-29, Arlington: George Mason University School of Law (2003).
- Abramowicz, Michael/Duffy, John F., Intellectual Property for Market Experimentation, 83 N.Y.U. L. Rev. 337 (2008).
- Abramowicz, Michael/Duffy, John F., The Inducement Standard of Patentability, 120 Yale L.J. 1590 (2011).
- Agranat, Israel/Caner, Hava, Intellectual Property and Chirality of Drugs, 4 Drug Discov. Today 313 (1999). doi.org/10.1016/S1359-6446(99)01363-X
- Agranat, Israel/Wainschtein, Silvya R., The Strategy of Enantiomer Patents of Drugs, 15 Drug Discov. Today 163 (2010). doi.org/10.1016/j.drudis.2010.01.007
- Alazraki, Melly, The 10 Biggest-Selling Drugs that are about to Lose Their Patents, DailyFinance, February 27, 2011.
- Allison, John R./Lemley, Mark A., The Growing Complexity of the United States Patent System, 82 B.U. L. Rev. 77 (2002).
- Angell, Marcia, The Pharmaceutical Industry: To whom Is It Accountable?, 342 New Eng. J. Med. 1902 (2000). doi.org/10.1056/NEJM200006223422509
- Angell, Marcia, The Truth about the Drug Companies: How They Deceive Us and What to Do about It, New York: Random House (2004).
- Ann, Christoph, Patent Trolls – Menace or Myth? in: Zu Waldeck und Pyrmont, Wolrad P., Adelmann, Martin J., Brauneis, Robert, Drexl, Joseph, Nack, Ralph (eds), Patents and Technological Progress in a Globalized World, Liber Amicorum Joseph Straus, Berlin, Heidelberg: Springer (2009).
- Anonymous, Bigger isn't Always Better, 418 Nature 353 (2002).
- Anonymous, Daiichi Sankyo to Buy Control of Ranbaxy of India for up to $4.6 Billion, New York Times, June 11, 2008.
- Anonymous, The Disclosure Function of the Patent System (or Lack Thereof), 118 Harv. L. Rev. 2007(2005).
- Anten, Lewis, What's new with novelty - Section 102 of S. 643, 54 J. Pat. Off. Soc'y 75 (1972). doi.org/10.1136/bmj.3.5827.643
- Arbex, Danieli S. Costa, Essay on Incentives for Pharmaceutical Research: A Double Push-Pull Program, Ann Arbor: Proquest LLC (2009).
- Ariëns, Everhardus J./Wuis, Eveline W., Bias in Pharmacokinetics and Clinical Pharmacology, 42 Clin. Pharmacol. & Ther. 361 (1987). doi.org/10.1038/clpt.1987.163
- Armstrong, Drew, Eli Lilly CEO Says Cost Cutting Won’t Solve Drug Sales Loss, Bloomberg, April 12, 2012, available at: http://www.bloomberg.com/news/ 2012-04-12/eli-lilly-ceo-says-cost-cutting-won-t-solve-drug-revenue-losses.html.
- Arora, Ashish/Ceccagnoli, Marco/Cohen, Wesley M., R&D and the Patent Premium, 26 Int. J. Ind. Organ. 1153 (2008). doi.org/10.1016/j.ijindorg.2007.11.004
- Arrow, Kenneth, Economic Welfare and the Allocation of Resources for Invention, in The Rate and Direction of Inventive Activity 609, 619-22, Princeton: Princeton University Press ofNati'l Bureau of Econ. Research (1962). doi.org/10.1515/9781400879762-024
- Arrowsmith, John/Harrison, Richard, Drug Repositioning: The Business Case and Current Strategies to Repurpose Shelved Candidates and Marketed Drugs, in: Barratt, Michael J. and Frail, Donald E. (eds), Drug Repositioning: Bringing New Life to Shelved Assets and Existing Drugs, New Jersey: John Wiley & Sons, Inc (2012).
- Arundel, Anthony/Kabla, Isabelle, What Percentage of Innovations are patented? Empirical Estimates for European Firms, 27 Res. Policy, 127, 138 (1998).
- AstraZeneca, AstraZeneca Annual Report 2010, available at: http://www.astrazenecaannualreports.com/AZ_AR_100311_single.pdf.
- AstraZeneca, AstraZeneca Annual Report 2011, available at: http://www.astrazenecaannualreports.com/2011/documents/pdfs/annual_report_pdf_entire.pdf.
- AstraZeneca, AstraZeneca Annual Review 2000, available at: http://www.astrazeneca.com/cs/Satellite?blobcol=urldata&blobheader=application%2Fpdf&blobheadername1=Content-Disposition&blobheadername2=MDT-Type&blobheadervalue1=inline%3B+filename%3DAnnual-Review.pdf&blobheadervalue2=abinary %3B+charset%3DUTF-8&blobkey=id&blobtable=MungoBlobs&blobwhere=1285635038761&ssbinary=true.
- Avorn, Jerry, Sending Pharma Better Signals, 309 Science 669 (2005). doi.org/10.1126/science.1117448
- Bacher/Melullis, in: Benkard, Georg, et al., Patentgesetz, Gebrauchsmustergesetz, 10th Ed. München: C. H. Beck (2006).
- Barnett, Jonathan M., Cultivating the Genetic Commons: Imperfect Patent Protection and the Network Model of Innovation, 37 San Diego L. Rev. 987 (2000).
- Barratt, Michael J./Frail, Donald E.(eds), Drug Repositioning: Bringing New Life to Shelved Assets and Existing Drugs, New Jersey: John Wiley & Sons, Inc (2012). doi.org/10.1002/9781118274408
- Bartfai, Tamas/Lees, Graham V., Drug Discovery: From Bedside to Wall Street, Burlington: Elsevier Academic Press (2006). doi.org/10.1016/B978-012369533-8/50031-3
- Barth, Gerhard/Zimmer, Franz-Josef, The Olanzapine Patent Dispute: German Court Grants a Preliminary Injunction on a Patent Invalidated by the First-Instance Federal Patent Court, 28 Biotechnology L. Rep. 532 (2008). doi.org/10.1089/blr.2008.9902
- Barton, John H./Abbott, Frederick M./Correa, Carlos M./Drexl, Josef/Foray, Dominique/Marchant Ron (eds), Views on the Future of the Intellectual Property System, Geneva: ICTSD (2007).
- Beary, John F., Chirality and Drug Development, 339 Lancet 495 (1992). doi.org/10.1016/0140-6736(92)91104-G
- Belenzon, Sharon, Knowledge Flow and Sequential Innovation: Implications for Technologz diffusion, R&D and Market Value, Discussion Paper Series No 256, Oxford: Oxford University (2006).
- Benjamin, Stuart M./Rai, Arti K., Who’s Afraid of the APA? What the Patent System Can Learn from Administrative Law, 95 Geo. L. J. 269 (2007).
- Benkard, Georg/Asendorf, Claus Dietrich/Rogge, Rüdiger/Bacher, Klaus/Schäfers, Alfons/Goebel, Frank Peter/Scharen, Uwe/Grabinski, Klaus/ Schmidt, Christof/Melullis, Klaus-Jürgen/Ullmann, Eike (eds.), Patentgesetz, Gebrauchsmustergesetz, 10th Ed. München: C. H. Beck (2006).
- Berger, Jonathan M., Tripping over Patents: AIDS, Access to Treatment and the Manufacturing of Scarcity, 17 Conn. J. Int'l L. 157 (2002).
- Berndt, Ernst R., Pharmaceuticals in U.S. Health Care: Determinants of Quantity and Price, 16 J. Econ. Perspect. 45 (2002). doi.org/10.1257/089533002320950975
- Bernstein, Joel, Polymorphism in Molecular Crystals, New York: Oxford University Press (2002).
- Bessen, James/Maskin, Eric, Sequential Innovation, Patents and Imitation, Working Paper No 11/99, Massachusetts: MIT (1999).
- Bessen, James/Maskin, Eric, Sequential Innovation, Patents, and Imitation, 40 RAND J. Econ. 611 (2009). doi.org/10.1111/j.1756-2171.2009.00081.x
- Bessen, James/Meurer, Michael J., Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk, Princeton: Princeton University Press (2008).
- Blair, Roger D./Cotter, Thomas F., Rethinking Patent Damages, 10 Tex. Intell. Prop. L. J. 1 (2001). doi.org/10.2139/ssrn.261357
- Blanco White, Thomas A., Patents for inventions and the protection of industrial designs, London: Stevens & Sons, 5th Ed. (1983).
- Bohsem, Guido, Wie Medikamente Billiger Werden Sollen, Süddeutsche Zeitung, January 23, 2012, available at: http://www.sueddeutsche.de/wirtschaft/pharmaindustriewie-medikamente-billiger-werden-sollen-1.1264493.
- Bond, Ronald S./Lean, David F., Sales, Promotion, and Product Differentiation in Two Prescription Drug Markets, Washington, DC: U.S. Federal Trade Commission. Bureau of Economics (1977).
- Boyd, Karen I., Nonobviousness and the Biotechnology Industry: A Proposal for a Doctrine of Economic Nonobviousness, 12 Berkeley Tech. L.J. 311 (1997).
- Brandi-Dohrn, Matthias, Der zu weite Patentanspruch, GRUR Int 1995, 541.
- Brandt, Karsten, Die Schutzfrist des Patents, Munich: C.H. Beck (1996).
- Bresalier, et al., Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial, 352 New Eng. J. Med. 1092, 1098 (2005).
- Brittain, Harry G, Theory and Principles of Polymorphic Systems, in: Brittain, Harry G. (ed), Polymorphism in Pharmaceutical Solids, New York: Informa Healthcare, 2nd Ed. (2009).
- Brown, Lucille J., The Markush Challenge, 31 J. Chem. Inf. Comp. Sci. 2 (1991). doi.org/10.1021/ci00001a001
- Bublak,Wolfgang/Coehn, Markus., Offenbarungsgehalt der Vorveröffentlichung einer chemischen Strukturformel (Disclosure in the Prior Publication of a Chemical Structural Formula), GRUR 2009, 382.
- Buhrow, Astrid/Nordemann, Jan B., Grenzen ausschließlicher Rechte geistigen Eigentums durch Kartellrecht (Q 187), GRUR Int 2005, 407.
- Burgess, Lesley J./Terblanche, Marli, The Future of the Pharmaceutical, Biological and Medical Device Industry, 3 Open Access J. Clin. Trials 45 (2011).
- Burk, Dan L./Lemley Mark A., Biotechnology's Uncertainty Principle, 54 Case W. Res. L. Rev. 691 (2003).
- Burk, Dan L./Lemley Mark A., Is Patent Law Technology-Specific?, 17 Berkeley Tech. L.J. 1155 (2002). doi.org/10.2139/ssrn.349761
- Burk, Dan L./Lemley Mark A., Policy Levers in Patent Law, 89 Va. L. Rev. 1575 (2003). doi.org/10.2307/3202360
- Cadot, Olivier/Lippman, Steven, Barriers to Imitation and the Incentive to Innovate", Working Paper No. 434, Los Angeles: Western Management Science Institute (1995).
- Caira, Mino R., Crystalline Polymorphism of Organic Compound, in: Weber, Edwin, Design of Organic Solids, Berlin: Springer (1998).
- Caldwell, John, Do Single Enantiomers Have Something Special to Offer?, 16 Hum. Psychopharm. S67 (2001). doi.org/10.1002/hup.339
- Carmichael, Begley S., Desperately Seeking Cures, News Wk. May 15, 2010, available at: http://www.newsweek.com/id/238078.
- Chakrabarti, Jiban K./Horsman, Linda/Hotten Terrence M/Pullar Ian A./Tupper David E./Wright Francesca C., 4-Piperazinyl-10H-thieno[2,3-b][1,5]benzodiazepines as potential neuroleptics, 28 J. Med. Chem. 874 (1980). doi.org/10.1021/jm00182a013
- Chandy, Rajesh/Hopstaken, Brigitte/Narasimhan, Om/Prabhu, Jaideep, From Invention to Innovation: Conversion Ability in Product Development, 43 J. Marketing Res. 494 (2006). doi.org/10.1509/jmkr.43.3.494
- Chang, Howard F., Patent Scope, Antitrust Policy, and Cumulative Innovation, 26 RAND J. Econ. 34 (1995). doi.org/10.2307/2556034
- Chisum, Donald S., Chisum on Patents, Newark: LexisNexis (2012).
- Chisum, Donald S., Comment: Anticipation, Enablement and Obviousness: An Eternal Glden Braid, 15 AIPLA Q. J. 57 (1987).
- Chou, Teyu/Haller, Hans, The Division of Profit in Sequential Innovation Reconsidered, Department of Economics Working Paper no. E95-02, Blacksburg: Virginia Polytechnic Institute and State University (1995).
- Christie, Andrew F./Dent, Chris/McIntyre, Peter/Wilson, Lachlan/Studdert, David M., Patents Associated with High-Cost Drugs in Australia, 8 PLoS Med 1 (2013). doi.org/10.1371/journal.pone.0060812
- Cockburn, Iain M., Is the Pharmaceutical Industry in a Productivity Crisis?, in: Jaffe, Adam B., Lerner Josh, and Stern, Scott (eds), Innovation Policy and Economics, volume 7, Cambridge: MIT press (2006).
- Coggio, Brian D./Cerrito, Francis D., The Application of the Patent Laws to the Drug Approval Process, 52 Food & Drug L.J. 345 (1997).
- Cohen, Mesley M./Nelson, Richard R./Walsh, John P., Protecting Their Intellectual Assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (or Not), NBER Working Paper No. 7552. Cambridge: NBER (2000). doi.org/10.3386/w7552
- Comanor, William S., Research and Competitive Product Differentiation in the Pharmaceutical Industry in the United States, 31 Economia, 372 (1964). doi.org/10.2307/2550516
- Cornelli, Francesca/Schankerman, Mark, Patent renewals and R&D Incentives, 30 RAND J. Econ. 197 (1999). doi.org/10.2307/2556077
- Cornish, William R./Llewelyn, David/Aplin, Tanya, Intellectual Property : Patents, Copyright, Trade marks and Allied Rights, London: Sweet & Maxwell, 7th Ed. (2010).
- Correa, Carlos M., Public Health and Patent Legislation in Developing Countries, 3 Tul. J. Tech. & Intell. Prop. 1 (2001).
- Correa, Carlos, Guidelines for the Examination of Pharmaceutical Patents:Developing a Public Health Perspective - A Working Paper, Geneva: ICTSD, WHO, UNCTAD (2006).
- Crews, Kenneth D., Looking Ahead and Shaping the Future: Provoking Change in Copyright Law, 49 J. Copyright Soc'y U.S.A. 549 (2001).
- Crouch, Dennis D., Nil: the Value of Patents in a Major Crisis such as an Influenza Pandemic, 39 Seton Hall L. Rev. 1125 (2009).
- Crouch, Dennis D., The Patent Lottery: Exploiting Behavioral Economics for the Common Good, 16 Geo. Mason L. Rev. 141 (2008). doi.org/10.2139/ssrn.1095810
- Dam, Kenneth W., The Economic Underpinnings of Patent Law, 23 J. Legal Stud. 247 (1994). doi.org/10.1086/467923
- Daniels, Jonathan M./Nestmann, Earle R./Kerr, Alex, Development of Stereoisomeric (Chiral) Drugs: A Brief Review of Scientific and Regulatory Considerations, 31 Drug Info. J. 639 (1997). doi.org/10.1177/009286159703100303
- Danzon, Patricia M./Epstein, Andrew/Nicholson, Sean, Mergers and Acquisitions in the Pharmaceutical and Biotech Industries, 28 Manage. Decis. Econ. 307 (2007).
- Darrow, Jonathan J., The Patentability of Enantiomers: Implications for the Pharmaceutical Industry, 2 Stan. Tech. L. Rev. 1 (2007).
- Dasgupta, Partha, Patents, Priority and Imitation or the Economics of Races and Waiting Games, 98 Econ. J. 66 (1988). doi.org/10.2307/2233511
- Davis, Steven J./Murphy, Kevin M./Topel, Robert H., Entry, Pricing and Product Design in an Initially Monopolized Market, NBER Working Paper No. 8547, Cambridge: NBER (2001). doi.org/10.3386/w8547
- den Exter, André, The Pharmaceutical Sector Inquiry:‘Hamlet’ in a Nutshell, 17 Eur. J. Health L. 125 (2010).
- Denicolò, Vincenzo, Patent Races and Optimal Patent Policy, 44 J. Ind. Econ. 249 (1996).
- Denicolò, Vincenzo, Two-Stage Patent Races and Patent Policy, 31 RAND J. Econ. 488 (2000).
- Denicolò, Vincenzo/Zanchettin, Piercarlo, How should forward patent protection be provided?, 20 Int'l. J. Indus. Org. 801 (2002). doi.org/10.1016/S0167-7187(01)00080-7
- Dessemontet, François, The Legal Protection of Know-How in the United States of America, Geneva: Librairie Droz, H.W. Clarke trans., 2nd Ed. (1976).
- DeStevens, George, Lead Structure Discovery and Development, in: Hansch, Corwin, Sammes, Peter G., and Taylor, John B. (eds.), Comprehensive Medicinal Chemistry: The Rational Design, Mechanistic Study and Therapeutic Applications of Chemical compounds, Oxford: Pergamon Press (1990).
- Deutsches Patent- und Markenamt, Jahresbericht 2007, München: DPMA (2008).
- DG Competition, Pharma Sector Inquiry - Final Report (2009), available at http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf.
- Dickson, Michael/Gagnon, Jean Paul, Key Factors in the Rising Cost of New Drug Discovery and Development, 3 Nat. Rev. Drug Discov. 417 (2004). doi.org/10.1038/nrd1382
- Dickson, Michael/Gagnon, Jean Paul, The Cost of New Drug Discovery and Development, 4 Discov. Med. 172 (2004). doi.org/10.1038/nrd1382
- DiMasi, Joseph A./Hansen, Ronald W./Grabowski, Henry G., Cost of Innovation in the Pharmaceutical Industry, 10 J. Health. Econ. 107 (1991). doi.org/10.1016/0167-6296(91)90001-4
- DiMasi, Joseph A./Hansen, Ronald W./Grabowski, Henry G., The Price of Innovation New Estimates of Drug Development Costs, 22 J. Health Econ. 151 (2003). doi.org/10.1016/S0167-6296(02)00126-1
- Dinwoodie, Graeme B./Dreyfuss, Rochelle C., Diversifying without Discriminating: Complying with the Mandates of the TRIPS Agreement, 13 Mich. Telecomm. Tech. L. Rev. 445 (2007).
- Doi, Teruo, The Territoriality Principle of Patent Protection and Conflict of Laws: A Review of Japanese Court Decisions, 26 Fordham Int'l L.J. 377 (2002).
- Domeij, Bengt, Pharmaceutical patents in Europe, Hague: Kluwer Law International (2000).
- Donohue, Julie M/Cevasco, Marisa/Rosenthal, Meredith B., A Decade of Direct-toConsumer Advertising of Prescription Drugs, 357 N. Eng J. Med. 673 (2007). doi.org/10.1056/NEJMsa070502
- Drexl, Josef, Responding to the Challenges for Development with a Competition-Oriented Approach, in: Barton, John H., Abbott, Frederick M., Correa, Carlos M., Drexl, Josef, Foray, Dominique, and Marchant Ron (eds), Views on the Future of the Intellectual Property System, Geneva: ICTSD (2007).
- Drexl, Josef/Hilty, Reto M./Boy, Laurence/Godt, Christine/Remiche, Bernard (eds), Technology and Competition : Contributions in Honour of Hanns Ullrich, Bruxelles: Larcier (2009).
- Duffy, John F., Rethinking the Prospect Theory of Patents, 71 U. Chi. L. Rev. 439 (2004).
- Duffy, John F., Rules and Standards on the Forefront of Patentability, 51 Wm. & Mary L. Rev. 609 (2009).
- Durham, Alan L., Patent Law Essentials: A Concise Guide, Westport: Praeger (1999).
- Dutfield, Graham, Intellectual Property Rights and the Life Science Industries, London: World Scientific Publishing Co., 2nd Ed. (2009). doi.org/10.1142/6917
- Dutfield, Graham/Suthersanen, Uma, The Innovation Dilemma: Intellectual Property and the Historical Legacy of Cumulative Creativity, 8 Intell. Prop. Q. 379 (2004).
- Eidson, B. Scott, How Safe Is the Harbor? Considering the Economic Implications of Patent Infringement in Section 271(e)(1) Analysis, 82 Wash. U. L. Rev. 1169 (2004).
- Eisenberg, Rebecca S., Analyze This: A Law and Economics Agenda for the Patent System, 53 Vand. L. Rev. 2081 (2000).
- Eisenberg, Rebecca S., Obvious to Whom? Evaluating Inventions from the Perspective of PHOSITA, 19 Berkeley Tech. L.J. 885 (2004). doi.org/10.1628/093245604773861168
- Eisenberg, Rebecca S., Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. Chi. L. Rev. 1017 (1989). doi.org/10.2307/1599761
- Eisenberg, Rebecca S., The Problem of New Uses, 5 Yale J. Health Pol’y L. & Ethics 717 (2005).
- Eisenberg, Rebecca S., The Role of the FDA in Innovation Policy, 13 Mich. Telecomm. Tech. L. Rev. 345 (2007).
- Ellery, Tony/Hansen, Neal, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand, New Jersey: John Wiley & Sons, Inc (2012).
- Engelberg, Alfred B., Special Patent Provisions for Pharmaceuticals: Have they Outlived Their Usefullness - A Political Legislative and Legal History of U.S. Law and Obersvations for the Future, 39 IDEA 389 (1999).
- Engelberg, Alfred B./Kesselheim, Aaron S./Avorn, Jerry, Balancing Innovation, Access, and Profits--Market Exclusivity for Biologics, 361 New Eng. J. Med. 1917 (2009). doi.org/10.1056/NEJMp0908496
- Eswaran, Mukesh/Gallini, Nancy, Patent Policy and the Direction of Technological Change, 27 RAND J. Econ. 722 (1996). doi.org/10.2307/2555879
- European Federation of Pharmaceutical Industries and Associations, The Pharmaceutical Industry in Figures, 2012, available at: http://www.efpia.eu/sites/www.efpia.eu/ files/EFPIA%20Figures%202012%20Final.pdf.
- EvaluatePharma, World Preview 2014, (2009) available at: http://www.evaluatepharma.com/pdf/EvaluatePharma%20World%20Preview%202014.pdf.
- FDA, FY 2011 Innovative Drug Approvals, (2011), available at: http://www.fda.gov/ downloads/aboutfda/reportsmanualsforms/reports/ucm278358.pdf.
- Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration, an FTC Study, 2002, available at: http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf.
- Federsel, Hans-Jürgen, Process R&D under the Magnifying Glass: Organization, Business Model, Challenges, and Scientific Context, 18 Bioorgan. Med. Chem. 5775 (2010).
- Fitt, Robert, Selection Patents and Markush Claims in Europe, 20 Biotechnol. Law Rep. 17 (2010). doi.org/10.1089/blr.2010.9990
- Frank, Richard G., Behavioral Economics and Health Economics, NBER Working Paper No. 10881. Cambridge: NBER (2004). doi.org/10.3386/w10881
- Frank, Richard. G., Editorial: New Estimates of Drug Development Costs, 22 J. Health Econ. 325 (2003). doi.org/10.1016/S0167-6296(03)00002-X
- von der Freien, Klaus Roth, Von Vollmilch bis Bitter, edelste Polymorphie, 39 Chemie in Unserer Zeit 416 (2005). doi.org/10.1002/ciuz.200590084
- Friebel, Guido/Koch, Alexander K./Prady, Delphine/Seabright, Paul, Objective and Incentives at the european Patent Office, Toulouse: Institut d'Economie Industrielle (2006).
- Gagnon, Marc-André/Lexchin, Joel, The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States, 5 PLOS Med. e1 (2008). doi.org/10.1371/journal.pmed.0050001
- Gallini, Nancy/Scotchmer, Suzanne, Intellectual Property: When Is It the Best Incentive System,in: Jaffe, Adam B., Lerner, Josh, Stern, Scott (eds), Innovation Policy and the Economy, Vol. 2, Massachusetts: MIT Press (2002).
- Gaudillière, Jean-Paul, Professional or Industrial Order? Patents, Biological Drugs, and Pharmaceutical Capitalism in Early Twentieth Centry Germany, 24 Hist. & Tech. 107 (2008). doi.org/10.1080/07341510701810922
- Gaudry, Kate S, Evergreening: a Common Practice to Protect New Drugs, 29 Nature Biotech. 876 (2011). doi.org/10.1038/nbt.1993
- Germinario, Claudio, Double Patenting in the Practice of the European Patent Office, IIC 2011, 387.
- Gervais, Daniel, The TRIPS Agreement: Drafting History and Analysis, London: Sweet & Maxwell, 4th Ed. (2012).
- Ghofrani, Hossein A./Osterloh, Ian H./Grimminger, Friedrich, Sildenafil: from Angina to Erectile Dysfunction to Pulmonary Hypertension and Beyond, 5 Nat. Rev. Drug Discov. 689 (2006). doi.org/10.1038/nrd2030
- Gilbert, Richard/Shapiro, Carl, Opimal patent length and breadth, 21 RAND J. Econ. 106 (1990). doi.org/10.2307/2555497
- Gilbody, Simon/Wilson, Paul/Watt, Ian, Benefits and harms of direct to consumer advertising: a systematic review, 14 Quality & Safety in Health Care 246 (2005). doi.org/10.1136/qshc.2004.012781
- Gilfillan, S. C., The Root of Patents, or Squaring Patents by Their Roots, 31 J. Pat. & Trademark Off. Soc'y 611 (1949).
- Giron, Danielle, Chracterisation of Salts of Drug Substances, 73 J. Thermal Analysis & Calorimetry 441 (2003). doi.org/10.1023/A:1025461625782
- Glasgow, Lara J., Stretching the Limits of Intellectual Property Rights: Has the Pharmaceutical Industry Gone Too Far?, 41 IDEA 227 (2001).
- GlaxoSmithKlein, GSK's Position on Evergreening, 2011 available at: http:// www.gsk.com/policies/GSK-and-evergreening.pdf.
- Gordon, Wendy J., A Property Right in Self-Expression: Equality and Individualism in the Natural Law of Intellectual Property, 102 Yale L. J. 1533 (1993). doi.org/10.2307/796826
- Grabowski, Henry G./Kyle, Margaret, Generic Competition and Market Exclusivity Periods in Pharmaceuticals, 28 Manage. Decis. Econ. 491 (2007). doi.org/10.1002/mde.1356
- Grabowski, Henry G./Kyle, Margaret, Mergers and Alliances in Pharmaceuticals: Effects on Innovation and R&D productivity, in: Gugler, Klaus and Yurtoglu, B. Burcin (eds.), The Economics of Corporate Governance and Mergers, Cheltenham: Edward Elgar (2008).
- Grabowski, Henry G./Vernon, John M., Brand Loyalty, Entry, and Price Competition in Pharmaceuticals after the 1984 Drug Act, 35 J. Law Econ. 331 (1992). doi.org/10.1086/467257
- Grabowski, Henry/Vernon, John, Longer Patents for Increased Generic Competition in the US. The Waxman-Hatch Act after One Decade,10 Suppl 2 Pharmacoeconomics 110 (1996). doi.org/10.2165/00019053-199600102-00017
- Grady, Mark F./Alexander, Jay I., Patent Law and Rent Dissipation, 78 Va. L. Rev. 305 (1992). doi.org/10.2307/1073310
- Green, Jerry R./Scotchmer, Suzanne, On the division of Profit in Sequential Innovation, 26 RAND J. Econ. 20 (1995). doi.org/10.2307/2556033
- Grubb, Philip W./Thomsen, Peter R., Patents for Chemicals, Pharmaceuticals and Biotechnology : Fundamentals of Global Law, Practice and Strategy, Oxford: Oxford Univ. Press, 5th Ed. (2010).
- Günzel, Brigitte, Die Anhängigkeit der Stammanmeldung als Voraussetzung für die Einreichung einer Teilanmeldung – ein Bericht und viele Fragen, IIC Int 2008, 644.
- Gugler, Klaus/Yurtoglu, B. Burcin (eds.), The Economics of Corporate Governance and Mergers, Cheltenham: Edward Elgar (2008). doi.org/10.4337/9781848443921.00006
- Hall, Bronwyn H./Rosenberg, Nathan (eds.), Handbook of The Economics of Innovation, Oxford: Elsevier B.V. (2010). doi.org/10.1016/S0169-7218(10)01001-4
- Hall, Stephen S., The Claritin Effect; Prescription for Profit, The New York Times, March 11, 2001, available at:http://www.nytimes.com/2001/03/11/magazine/the-claritin-effect-prescription-for-profit.html?pagewanted=all&src=pm.
- Hansch, Corwin/Sammes, Peter G./Taylor, John B. (eds.), Comprehensive Medicinal Chemistry:The Rational Design, Mechanistic Study and Therapeutic Applications of Chemical compounds, Oxford: Pergamon Press (1990).
- Hansen, Bernd/Hirsch, Fritjoff, Protecting Inventions in Chemistry - Commentary on Chemical Case Law under the European Patent Convention and the German Patent Law, Weinheim: Wiley-VCH (1997).
- Haracoglou, Irina, Competition Law and Patents: a Follow-on Innovation Perspective in the Biopharmaceutical Industry,Cheltenham: Edward Elgar (2008). doi.org/10.4337/9781848440111
- Harhoff, Dietmar, Economic Cost-benefit Analysis of a Unified and Integrated european Patent Litigation System, Tender No MARKT/2008/06/D, Munich: Ludwig-Maximilians-Universität München (2009).
- Harmon, Robert L./Homan, Cynthia A./McMahon, Charles M., Patents and the Federal Crcuit, Arlington: BNA Books, 10th Ed. (2010).
- Harrelson, John A., Trips, Pharmaceutical Patents, and the HIV/AIDS Crisis: Finding the Proper Balance between Intellectual Property Rights and Compassion, 7 Wid. L. Symp. J. 175 (2001).
- Harris, Gardiner, Prilosec's Maker Switches Users To Nexium, Thwarting Generics, The Wall Street Journal, June 6, 2002, available at: http://online.wsj.com/article/ 0,,SB1023326369679910840,00.html Hays, Thomas, An application of the European Rules on Trademark Exhaustion to Extramarket Goods, 91 Trademark Rep. 675 (2001).
- Heilman RD, Drug development history, "overview," and what are GCPs?, 4 Quality Assurance, 75 (1995).
- Heller, Michael A., The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, 111 Harv. L. Rev. 621 (1998). doi.org/10.2307/1342203
- Heller, Michael A./Eisenberg, Rebecca S., Can Patents Deter Innovation? The Anticommons in biomedical Research, 280 Science 698 (1998). doi.org/10.1126/science.280.5364.698
- Hemphill, C. Scott/Sampat, Bhaven N., Evergreening, Patent Challenges, and Effective Market Life in Pharmaceuticals, 31 J. Health Econ. 327 (2012). doi.org/10.1016/j.jhealeco.2012.01.004
- Hemphill, C. Scott/Sampat, Bhaven N., Drug Patents at the Supreme Court, 339 Science 1386 (2013). doi.org/10.1126/science.1235857
- Henderson, Rebecca/Cockburn, Iain, Scale, Scope, and Spillovers: The Determinants of Research Productivity in Drug Discovery, 27 RAND J. Econ. 32 (1996). doi.org/10.2307/2555791
- Henkel, Joachim/Jell, Florian, Alternative Motives to File for Patents: Profiting from Pendency and Publication (2009), Working paper, available at: http://ssrn.com/abstract=1271242.
- Herper, Matthew, Solving The Drug Patent Problem, Forbes, February 5, 2002, available at: http://www.forbes.com/2002/05/02/0502patents.html.
- Higgins, Matthew J.,/Rodriguez, Daniel, The Outsourcing of R&D through Acquisitions in the Pharmaceutical Industry, 80 J. Financ. Econ. 351 (2006). doi.org/10.1016/j.jfineco.2005.04.004
- Higgins, Matthew J./Graham, Stuart J. H., Balancing Innovation and Access: Patent Challenges Tip the Scales, 326 Science 370 (2009). doi.org/10.1126/science.1176116
- Hilty, Reto M., The Role of Patent Quality in Europe, in: Drexl, Josef, Hilty, Reto M., Boy Laurence, Godt, Christine, Remiche, Bernard (eds), Technology and Competition : Contributions in Honour of Hanns Ullrich, Bruxelles: Larcier (2009).
- von Hippel, Eric, The Sources of Innovation, New York: Oxford University Press (1988).
- Hoffman, David C., A Modest Proposal: Toward Improved Access to Biotechnology Research Tools by Implementing a Broad Experimental Use Exception, 89 Cornell L. Rev. 993 (2004).
- Holbrook, Timothy R., Possession in Patent Law, 59 SMU L. Rev. 123 (2006).
- Holmes, David, Skies Darken over Drug Companies, 379 Lancet 1863 (2012). doi.org/10.1016/S0140-6736(12)60793-4
- Hopenhayn, Hugo A./Mitchell, matthew F., Innovation Variety and Patent Breadth, 32 RAND J. Econ. 152 (2001). doi.org/10.2307/2696402
- Hopkins, Andrew L./Groom, Colin R., The Druggable Genome, 1 Nature Rev. Drug Discov. 727 (2002). doi.org/10.1038/nrd892
- Horton, Richard, Vioxx, the implosion of Merck, and aftershocks at the FDA, 364 Lancet 1995 (2004). doi.org/10.1016/S0140-6736(04)17523-5
- Hovenkamp, Herber/Janis, Mark D./Lemley, Mark A./Leslie, Christopher R., IP and Antitrust - An Analysis of Antitrust Principles Applied to Intellectual Property Law, Austin: Wolters Kluwer Law & Business, Aspen Publ, 2nd Ed. (2010).
- Howard, Leighton, Use of Patents in Drug Lifecycle Management, 4 J. Generic Med 231 (2007). doi.org/10.1057/palgrave.jgm.4950065
- Hunt, Robert M., Nonobviousness and the Incentive to Innovate: An Economic Analysis of Intellectual Property Reform, Working Paper No. 99-3, Philadelphia: Federal Reserve Bank Of Philadelphia (1999).
- Hutt, A.J./Valentová, J., The Chiral Switch: The Development of Single Enantiomer Drgs from Racemates, 50 Acta Facultatis Pharmaceuticae Universitatis Comenianae 7 (2003).
- IMAP, Global Pharma and Biotech M&A Report-2012 (2012), available at: http:// www.imap.com/imap/media/resources/Pharma_Report_2012_FINAL_2F6C8ADA76680.pdf.
- IMS Health, Top 20 Global Products(2010), available at: http://imshealth.com/deployedfiles/imshealth/Global/Content/StaticFile/Top_Line_Data/Top_20_Global_Products.pdf.
- Ionescu, Corina/Caira, Mino R., Drug Metabolism - Current Concepts, Dordrecht: Springer (2005). doi.org/10.1007/1-4020-4142-X
- Jack, Andrew, Drugs Groups Forced to Put Squeeze on R&D, Fin. Times, October 17, 2011.
- Jackson, Richard T., A Lockean Approach to the Compulsory Patent Licensing Controversy, 9 J. TECH. L. & POL’Y, 117 (2004).
- Jacob, Robin, Novelty of Use Claims, IIC 1996, 170.
- Jacob, Robin, Patents and Pharmaceuticals – a Paper given on 29th November at the Presentation of the Directorate-General of Competition’s Preliminary Report of the Pharma-sector Inquiry, December, The Chartered Institute of Patent Attorneys 711 (2008).
- Jacob, Robin, Some Recent Cases of Significance in the UK, IIC 1997, 880.
- Jaenichen, Hans-Rainer, The Grant of a Compulsory License for Recombinant γ-IFN in Germany, 11 Biotechnol. Law Rep. 369 (1992).
- Jaffe, Adam B., Lerner Josh, and Stern, Scott (eds), Innovation Policy and Economics, volume 7, Cambridge: MIT press (2006). doi.org/10.1086/ipe.7.25056187
- Jaffe, Adam B., The U.S. Patent System in Transition: Policy Innovation and the Innovation Process, 29 Res. Policy 531 (2000). doi.org/10.1016/S0048-7333(99)00088-8
- Jaffe, Adam B./Lerner, Josh, Innovation and Its Discontents - How Our Broken Patent System Is Endangering Innovation and Progress and What To Do About It, Princeton: Princeton University Press (2004).
- Janis, Mark D., On Courts Herding Cats: Contending with the “Written Description” Requirement (and Other Unruly Patent Disclosure Doctrines), 2 Wash. U. J. L. & Pol’y 55 (2000).
- Janis, Mark D., Second Tier Patent Protection, 40 Harv. Int'l L. J. 151 (1999).
- Jantzen, Gwen M./Robinson, Joseph R, Sustained- and Controlled- Release Drug-Delivery System, in: Banker, Gilbert S and Rhodes Christopher T.(eds), Modern Pharmacetics, 4th Ed. New York: Marcel Dekker (2002).
- Johnson-Laird, Andrew, Software Reverse Engineering in the Real World, 19 U. Dayton L. Rev. 843 (1994).
- Julian-Arnold, Gianna, International Compulsory Licensing: The Rationales and the Reality, 33 IDEA 349 (1993).
- Karmien, Morton I./Schwartz, Nancy L., Market Structure and Innovation, Cambridge: Cambridge University Press (1982).
- Kash, Don E/Kingston, William, Patents in a world of complex technologies, 28 Sci. & Pub. Pol’y 11 (2001). doi.org/10.3152/147154301781781660
- Katzenberger, Paul, Mannheim Conference on fundamental Questions of Patent Protection for Chemical Inventions, IIC 1972, 357.
- Keeling, David T., Intellectual Property Rights in Eu Law: Free Movement and Competition Law, Oxford: Oxford University Press (2003).
- Kefauver, Estes, In a few hands : Monopoly power in America, Harmondsworth: Penguin Books (1966).
- Kieff, Scott F., On the Ecnonomics of Patent Law and Policy, in: Toshiko Takenaka (ed), Patent Law and Theory, Cheltenham: Edward Elgar Publishing Limited (2008).
- Kieff, Scott F., Property Rights and Property Rules for Commercializing Inventions, 85 Minn. L. Rev. 697 (2001).
- Kieff, Scott F., The Case for Registering Patents and the Law and Economics of Present Patent-Obtaining Rules, 45 B.C.L.Rev., 55 (2003).
- Kieff, Scott F./Schwartz, Herbert F./Newman, Pauline, Principle of Patent Law, New York: Foundation Press, 5th Ed. (2011).
- Kilger, Christian/Feldges, Joachim/Jaenichen, Hans-Rainer, The Erosion Of Compound Protection In Germany: Implementation Of The EU Directive On The Legal Protection Of Biotechnological Inventions -- The German Way, 87 J. Pat. & Trademark Off. Soc'y 569 (2005).
- Kitch, Edmund W., Graham v. John Deere Co.: New Standards for Patents, 1966 Sup. Ct. Rev. 293 (1966). doi.org/10.1086/scr.1966.3108745
- Kitch, Edmund W., The Nature and Function of the Patent System, 20 J. Law Econ. 265 (1977). doi.org/10.1086/466903
- Klemperer, Paul, How Broad should the Scope of Patent Protection Be?, 21 Rand J. Econ. 113 (1990). doi.org/10.2307/2555498
- Kling, Jim, From Hypertension to Angina to Viagra, 1 Modern Drug Discov. 31 (1998).
- Klöpsch, Gerald, The Patentability of Pharmaceuticals According to the European Patent Collection (EPC), IIC 1982, 457.
- Knowles, Jonathan/Gromo, Gianni, Target Selection in Drug Discovery, 2 Nat. Rev. Drug Discov. 63 (2003). doi.org/10.1038/nrd986
- Kola, Ismail/Landis, John, Can the pharmaceutical industry reduce attrition rates?, 3 Nat. Rev. Drug Discov. 711 (2004). doi.org/10.1038/nrd1470
- Kraßer, Rudolf, Patentrecht, 6th Ed. München: C. H. Beck (2009).
- La Manna, Manfredi, M.A., Optimal Patent Life vs Optimal patentability standards, 10 Int'l. J. Indus. Org. 81 (1992).
- Lakdawalla, Darius N./Goldman, Dana P./Michaud, Pierre-Carl/Sood, Neeraj/Lempert, Robert/Cong, Ze/Vries, Han de/Gutierrez, Italo, U.S. Pharmaceutical Policy In A Global Marketplace, 28 Health Affairs w138 (2009). doi.org/10.7249/RP1380
- Landes, William M./Posner, Richard A., The Economic Structure of Intellectual Property Law, Cambridge: The Belknap Press of Harvard University Press (2003).
- Langreth, Robert/Murphy, Victoria, Perennial Patents, Forbes, Apr. 2, 2001, available at: http://www.forbes.com/forbes/2001/0402/052_print.html. doi.org/10.1093/gmo/9781561592630.article.41781
- Lanjouw, Jean O./Schankerman, Mark, Patent Quality and Research Productivity: Measuring Innovation with Multiple Indicators, 114 Econ. J. 441 (2004). doi.org/10.1111/j.1468-0297.2004.00216.x
- Lemley, Mark A., Rational Ignorance at the Patent Office, 95 Nw. U. L. Rev. 1495 (2001). doi.org/10.2139/ssrn.261400
- Lemley, Mark A., The Economics of Improvement in Intellectual Property Law, 75 Tex. L. Rev. 989 (1997).
- Lerner, Joschua, The Importance of Patent Scope: An Empirical Analysis, 25 RAND J. Econ. 319 (1994). doi.org/10.2307/2555833
- Lerner, Josh/Merges, Robert P., The Control of Strategic Alliances: An Empirical Analysis of Biotechnology Collaborations, NBER Working Paper No. 6014. Cambridge: NBER (1997). doi.org/10.3386/w6014
- Lessig, Lawrence, Intellectual Property and Code, 11 St. John's J. Legal Comment. 635 (1996).
- Levin, Richard C./Klevorick, Alvin K./Nelson, richard R/ Winter, Sidney G., Appropriating the Returns from Industrial Research and Development, 1987 Brookings Paper on Econ. Activity, 783 (1987). doi.org/10.2307/2534454
- Lichtenberg, Frank R., Are The Benefits Of Newer DrugsWorth Their Cost? Evidence From The 1996 MEPS-The newer the drug in use, the less spending on nondrug items, 20 Health Affair. 241 (2001). doi.org/10.3386/w8147
- Lichtenberg, Frank R., The Impact of New Drug Launches on Longevity: Evidence from Longitudinal, Disease-Level Data from 52 Countries, 1982–2001, 5 Int. J. Health Care Fi. 47 (2005).
- Lichtman, Douglas/Baker, Scott/Kraus, Kate, Strategic Disclosure in the Patent System, 53 Vand. L. Rev. 2175 (2000). doi.org/10.2139/ssrn.243414
- Lindgardt, Zhenya/Reeves, Martin/Wallenstein, Judith, Waking the giant: business model innovation in the drug industry, 26 In Vivo: Bus. Med. Rep. 1 (2008).
- Long, Clarisa, Our Uniform Patent System, 55 Fed. Law. 44 (2008).
- Luski, Israel/Wettstein, David, An Optimal Patent Policy in a Dynamic Model of Innovation, 1 Probl. Perspect. Manage. 31 (2004).
- Machlup, Fritz, An Economic Review of the Patent System : Study No. 15 of the subcommittee on Patents, Trademarks, and Copyrights of the Committee on the Judiciary, United States Senate, 85th Congress, 2nd Sess. / Fritz Machlup. - Washington : G P O (1958).
- Macomber, Roger, Organic Chemistry, Sausalito: University Science Books (1996).
- Mahajan, Anthony J., Note, Intellectual Property, Contracts and Reverse Engineering after ProCD: A Proposed Compromise for Computer Software, 67 Fordham L. Rev. 3297 (1999).
- Mahato, Ram I./Narang, Ajit S., Pharmaceutical Dosage Forms and Drug Delivery, Boca Ranton: CRC Press, 2nd Ed (2012).
- Mahn, Terry G., Patenting Drug Products: Anticipating Hatch-Waxman Issues during the Claims Drafting Process, 54 Food & Drug L.J. 245 (1999).
- Mann, Ronald D./Andrews, Elizabeth B, Introduction, in: Mann, Ronald D., and Andrews, Elizabeth B (eds), Pharmacovigilance, Chichester: John Willey & Sons, Ltd. (2007).
- Mansell, Peter, Who is afraid of the patent cliff? 1 Scrip Executive Briefing 1 (2008).
- Mansfield, Edwin, Patents and Innovation: An Empirical Study, 32 Manage. Sci. 173 (1986). doi.org/10.1287/mnsc.32.2.173
- Mansfield, Edwin/Schwartz, Mark/Wagner, Samuel, Imitation Costs and Patents: an Empirical Study, 91 Econ. J. 907 (1981). doi.org/10.2307/2232499
- Mansfield, Peter/Henry, David/Tonkin, Anne, Single-Enantiomer Drugs: Elegant Science, Disappointing Effects,43 Clin. Pharmacokinet. 287 (2004).
- Martin, Ben R./Nightingale, Paul (eds.), The Political Economy of Science, Technology, and Innovation, Cheltenham: Edward Elgar Publishing Limited (2000).
- Martinez, Barbara/Mathews, Anna Wilde/ Lublin, Joann S./Winslow, Ron, Merck Pulls Vioxx from Market After Link to Heart Problems, Wall St. J., Oct. 1, 2004, available at: http://online.wsj.com/article/0,,SB109654671320932405,00.html.
- Matutes, Carmen/Regibeau, Pierre/Rockett, Katharine, Optimal Patent Design and the diffusion of Innovation, 27 RAND J. Econ. 60 (1996). doi.org/10.2307/2555792
- Mauer, Stephen M./Scotchmer, Suzanne, The Independent-Invention Defense in Intellectual Property, 69 Economica 535 (2002).
- Mazzoleni, Roberto/Nelson, Richard R, The Benefits and Costs of Strong Patent Protection: A Contribution to the Current Debate. 27 Res. Policy, 273 (1998). doi.org/10.1016/S0048-7333(98)00048-1
- McGuire, Alistair/Drummond, Michael/Rutten, Frans, Reimbursement of pharmaceuticals in the European Union, in: Mossialos, Elias, Mrazek, Monique F. and Walley, Tom (eds.), Regulating pharmaceuticals in Europe: striving for efficiency, equity, and quality. European Observatory on health systems and policies . Maidenhead: Open University Press (2004).
- Meier-Beck, Peter, Die Rechtsprechung des Bundesgerichtshofs zum Patent und Gebrauchsmusterrecht im Jahr 2008, GRUR 2009, 893.
- Merck, Merck Press Release, Merck Settles Thousands of Vioxx Claims for $4.85 Billion, Nov. 9, 2007, available at: http://www.officialvioxxsettlement.com/documents/Offical%20Press%20Release%20-%20Vioxx%20Settlement.pdf.
- Merges, Robert P., A Brief Note on Blocking Patents and Reverse Equivalents: Biotechnology as an Example, 73 J. Pat. & Trademark Off. Soc'y 878 (1991).
- Merges, Robert P., Commercial Success and Patent Standards: Economic Perspectives on Innovation, 76 Cal. L. R. 803 (1988). doi.org/10.2307/3480538
- Merges, Robert P., Intellectual Property Rights and Bargaining Breakdown: the Case of Blocking Patents, 62 Tenn. L. Rev. 75 (1994).
- Merges, Robert P., One Hundred Years of Solicitude: Intellectual Property Law, 88 Cal. L. Rev. 2187 (2000). doi.org/10.2307/3481215
- Merges, Robert P., Uncertainty and the Standard of Patentability, 7 High Tech. L. J. 1 (1992).
- Merges, Robert P./Duffy, John F., Patent Law and Policy: Cases and Materials, Newark: LexisNexis, 5th Ed. (2011).
- Merges, Robert P./Nelson, Richard R., On Limiting or Encouragine Rivalry in Technical Progress: The Effect of Patent Scope Decision, 25 J. Econ. Behav. Organ. 1 (1994). doi.org/10.1016/0167-2681(94)90083-3
- Merges, Robert P./Nelson, Richard R., On the Complex Economics of Patent Scope, 90 Colum. L. Rev. 839 (1990). doi.org/10.2307/1122920
- Meurer, Michael J., Business Method Patents and Patent Floods, 8 Wash. U. J. L. & Pol’y 309 (2002). doi.org/10.2139/ssrn.311087
- Michele Boldrin/David K. Levine., Against Intellectual Monopoly, Cambridge: Cambridge Univ. Press (2010).
- Miller, Christ P./Evans, Mark J. The Chemist's Companion Guide to Patent Law, New Jersey: John Wiley & Sons, Inc (2010). doi.org/10.1002/9780470636916
- Morgan, Steven G/Bassett, Kenneth L/Wright, James M/Evans, Robert G/Barer, Morris L/Caetano, Patricia A/Black, Charlyn D, “Breakthrough” Drugs and Growth in Expenditure on Prescription Drugs in Canada, 331 Brit. Med. J. 815 (2005). doi.org/10.1136/bmj.38582.703866.AE
- Mueller, Janice M., The Evolving Application of the Written Description Requirement to Biotechnological Inventions, 13 Berkeley Tech. L.J. 615 (1998).
- Mueller, Janice M./Chisum, Donald S., Enabling Patent Law’s Inherent Anticipation Doctrine, 45 Hous. L. Rev. 1101 (2008).
- Munos, Bernard, Lessons from 60 Years of Pharmaceutical Innovation, 8 Nat. Rev. Drug Discov. 959 (2009). doi.org/10.1038/nrd2961
- Nastelski, Karl, Product Protection for Chemical Inventions in Germany, IIC 1972, 267.
- Nathan, Carl/Goldberg, Frederick M., The Profit Problem in Antibiotic R&D, 4 Nat. Rev. Drug Discov. 887 (2005). doi.org/10.1038/nrd1878
- National Institute for Health Care Management Research and Educational Foundation, Changing patterns of pharmaceutical innovation. Washington, DC;NIHCM (2002). Available at: http://nihcm.org/pdf/innovations.pdf.
- Nelson, Richard R., The Simple Economics of Basic Scientific Research, in: Martin, Ben R./Nightingale, Paul (eds.), The Political Economy of Science, Technology, and Innovation, Cheltenham: Edward Elgar Publishing Limited (2000).
- Nelson, Richard, R./Winter, Sidney G., An Evolutionary Theory of Economic Change Cambridge: The Belknap Press of Harvard University Press (1982).
- Nordhaus, William D., Invention, Growth, and Welfare - A Theoretical Treatment of Technological Change, Massachusetts: MIT Press (1969).
- Norrby, S. Ragnar/Nord, Carl Erik/Finch, Roger, Lack of Development of New Antimicrobial Drugs: a Potential Serious Threat to Public Health, 5 Lancet Infect. Dis. 115 (2005). doi.org/10.1016/S1473-3099(05)70086-4
- O’Donoghue, Ted, A Patentability Requirement for Sequential Innovation, 29 RAND J. Econ. 654 (1998). doi.org/10.2307/2556088
- O'Donoghue, Ted, Patent Protection When Innovation is Cumulative, Ann Arbor: UMI Company (1996).
- O'Donoghue, Ted, Suzanne Scotchmer, and Jacques-François Thisse, 7 J. Econ. Manage.Strat. 1 (1998). doi.org/10.1162/105864098567317
- Oellerich, Michael/Armstrong, Victor W., Prodrugs Metabolites: Implications for Therapeutic Drug Monitoring, 47 Clin. Chem. 805 (2001).
- Osterrieth, Christian/Köhler, Martin/Haft, Klaus (eds), Patentrecht, Festschrift für Thomas Reimann zum 65. Geburtstag, Köln: Carl Hezmanns Verlag (2009).
- Outterson, Kevin/Samora,Julie B./Keller-Cuda, Karen, Will Longer Antimicrobial Patents Improve Global Public Health?, 7 Lancet Infect. Dis. 559 (2007). doi.org/10.1016/S1473-3099(07)70188-3
- Owen-Smith, Jason/Powell, Walter W, To Patent or Not: Faculty Decisions and Institutional Success at Technology Transfer, 26 J. Technol. Transfer 99 (2001). doi.org/10.1023/A:1007892413701
- Pagenberg, Jochen, Beweisanzeichen auf dem Prüfstand Für eine objektive Prüfung auf erfinderische Tätigkeit, GRUR Int 1986, 83.
- Parthasarathy, R/Goddar, Heinz, Patentability of Pharmaceutical Products in India - The Novartis Case, IIC 2009, 38.
- Patented Medicine Prices Review Board, Annual Report 2004, Ottawa: PMPRB (2005).
- Paul, Steven M./Mytelka, Daniel S./Dunwiddie, Christopher T./Persinger, Charles C./ Munos, Bernard H./Lindborg, Stacy R./Schacht, Aaron L., How to Improve R&D Productivity: the Pharmaceutical Industry’s Grand Challenge, 9 Nat. Rev. Drug Discov. 203 (2010). doi.org/10.1038/nrd3078
- Peterson, John M., Finite Mathematics, New York: Holt, Rinehart and Winston (1974).
- Pfizer, Annual Review 2009, (2009), available at: http://www.pfizer.com/files/annualreport/2009/annual/review2009.pdf.
- Pifferi, G./Perucca, E., The Cost Benefit Ratio of Enantiomeric Drugs, 20 Eur. J. Drug Metab. Ph. 15 (1995). doi.org/10.1007/BF03192284
- Pisano, Gary P., Science Business: the Promise, the Reality, and the Future of Biotech, Boston: Harvard Business School Press (2006).
- Power, Eddie, Impact of Antibiotic Restrictions: the Pharmaceutical Perspective, 12 Clin. Microbiol. Infec. 25 (1998).
- Privitera, Michael, Large Clinical Trials in Epilepsy: Funding by the NIH versus Pharmaceutical Industry, 68 Epilepsy Res. 52 (2006). doi.org/10.1016/j.eplepsyres.2005.09.020
- Rai, Arti K., Fostering Cumulative Innovationin the Biopharmaceutical Industry: The Role of Patents and Antitrust 16 Berkerly. Tech. L. J. 813 (2001).
- Rai, Arti K., Intellectual Property Rights in Biotechnology: Addressing New Technology 34 Wake Forest L. Rev. 827 (1999).
- Rai, Arti K., The Information Revolution Reaches Pharmaceuticals: Balancing Innovation Incentives, Cost, and Access in the Post-Genomics Era, 2001 Ill. L. Rev. 173 (2001).
- Rautio, Jarkko/Kumpulainen, Hanna/Heimbach, Tycho/Oliyai, Reza/Oh, Dooman/Järvinen, Tomi/Savolainen, Jouko, Prodrugs: Designs and Clinical Applications, 7 Nat. Rev. Drug Discov. 255 (2009).
- Reichman, Jerome H., Intellectual Property in the Twenty-First Century: Will the Developing Countries Lead or Follow? 46 Hous L. Rev. 1115 (2009).
- Reichman, Jerome H./Hasenzahl, Catherine, Non-Voluntary Licensing of Patented Inventions: Historical Perspective, Legal Frame-work under TRIPS, and an Overview of the Practice in Canada and the USA1-2, (2003), Issue Paper, Geneva: ICTSDUNCTAD, available at: http://ictsd.net/downloads/2008/ 06/cs_reichman_hasenzahl.pdf.
- Reichman,Jerome H./Dreyfuss, Rochelle C., Harmonization without Consensus: Critical Reflections on Drafting a Substantive Patent Law Treaty, 57 Duke L. J. 85 (2007).
- Roberts, Tim, Broad Claims for Biotechnological Inventions, EIPR, 1994, 371.
- Robinson, Christopher, Patent Protection for Chemical Products in Canada, Great Britain and the United States, IIC 1972, 139.
- Rockett, Katharine, Property Rights and Inventions, in: Hall, Bronwyn H./Rosenberg, Nathan (eds.), Handbook of The Economics of Innovation, Oxford: Elsevier B.V. (2010).
- Roin, Benjamin N., Unpatentable Drugs and the Standards of Patentability, 87 Tex. L. Rev. 503 (2009).
- Rose, Carol M., Possession as the Origin of Property, 52 U. Chi. L. Rev. 73 (1985). doi.org/10.2307/1599571
- Rosenbaum, Sara E., Basic Pharmacokinetics and Pharmacodynamics, An Integrated Textbook and computer Simulations, New Jersey: John Wiley& Sons, Inc (2011).
- Rucker, T. Donald, Public Policy and Drug Cost: Legitimate and Bastard Options, in: Smith Mickey C (ed), Studies in Pharmaceutical Economics, Binghamton: The Haworth Press, Inc (1996).
- Russ, Andreas P./Lampel, Stefan, The Druggable Genome: an Update, 10 Drug Discov. Today. 1607 (2005). doi.org/10.1016/S1359-6446(05)03666-4
- Sachs, George/Shin, Jai M./Howden, Collin W., Review Article: the Clinical Pharmacology of Proton Pump Inhibitors, 23 (Suppl. 2) Aliment Pharm. Ther. 2 (2006). doi.org/10.1111/j.1365-2036.2006.02943.x
- Safir, Peter O., Current Issues in the Pioneer Versus Generic Drug Wars, 50 Food & Drug L. J. 335 (1995).
- Sampson, Margaret, The Evolution of the Enablement and Written description Requirements under 35 U.S.C. § 112 in the Area of Biotechnology, 15 Berkeley Tech. L.J. 1233 (2000).
- Satchell, Ralph D., Chemical Product Patent Practice in the United Kingdom, IIC 1970, 179.
- Scherer, Frederic M./Ross, David, Industrial market structure and economic performance, Boston: Houghton Mifflin Co., 3rd Ed. (1990).
- Scherer, Frederic M., Innovation and Growth: Schumpeterian Perspectives, Cambridge: The MIT Prress (1984).
- Scherer, Frederic M., Pharmaceutical Innovation, Massachusetts: John F.Kennedy School of Government (2007). doi.org/10.2139/ssrn.902395
- Scherer, Frederic M., The Link Between Gross Profitability and Pharmaceutical R&D Spending, 20 Health Affair. 216 (2001). doi.org/10.1377/hlthaff.20.5.216
- Scherer, Frederic M., The Pharmaceutical Industry — Prices and Progress, 351 New Eng. J. Med. 927 (2004). doi.org/10.1056/NEJMhpr040117
- Schmied-Kowarzik, Volker, Chemical Inventions According to the New German Patent Act, IIC 1970, 190.
- Schneider, Dieter R., Patenting of Pharmaceuticals – Still a Challenge?, IIC 2008, 511. doi.org/10.2174/138920108786786394
- Schumpeter, Joseph A., Kapitalismus, Sozialismus und Demokratie, Bern: Verlag A. Francke AG. (1942).
- Schumpeter, Joseph, Business Cycle, New York: McGraw-Hill Book Company (1939).
- Schumpeter, Joseph, Theorie der Wirtschaftlichen Entwicklung, Berlin: Duncker & Humbolt (1964).
- Schuster, Daniela/Laggner, Christian/Langer, Thierry, Why Drugs Fail - A Study on side Effects in New Chemical Entities, 11 Current Pharmaceutical Design 3545 (2005).
- Schweitzer, Stuart O., Pharmaceutical Economics and Policy, Oxford: Oxford University Press (2007).
- Scotchmer, Suzanne, On the Optimality of the Patent Renewal System, 30 RAND J. Econ. 181 (1999). doi.org/10.2307/2556076
- Scotchmer, Suzanne, Protecting Early Innovators: Should Second-Generation Products be Patentable?, 27 Rand J. Econ. 322 (1996). doi.org/10.2307/2555929
- Scotchmer, Suzanne, Standing on the Shoulders of Giants: Cumulative Research and the Patent Law, 5 J. Econ. Perspect. 29 (1991). doi.org/10.1257/jep.5.1.29
- Scotchmer, Suzanne/Green, Jerry, Novelty and Disclosure in Patent Law, 21 RAND J. Econ. 131 (1990). doi.org/10.2307/2555499
- Scudellari, Megan, Teaching an Old Drug New Tricks, The Scientist, April 1, 2011, available at: http://www.the-scientist.com/?articles.view/articleNo/29617/title/ Teaching-an-Old-Drug-New-Tricks/. doi.org/10.1038/nm0311-234a
- Seager, Spencer L./Slabaugh, Michael R., Chemistry for Today - General, Organic, & Biochemistry, Belmont: Brooks/Cole (2010).
- Seißer, Goetz, Perfecting Imperfect Competition, Economics Discussion Papers No 2008-28, Kiel Institute for the World Economy (2008), available at: http://www.economics-ejournal.org/economics/discussionpapers/2008-28 Seymore, Sean B., Rethinking Novelty in Patent Law, 60 Duke L. J., 919 (2011).
- Shadowen, Steve D./Leffler, Keith B./Lukens, Joseph T., Bringing Market Discipline to Pharmaceutical Product Reformulations, IIC 2011, 698.
- Shavell, Steven, Foundations of Economic Analysis of Law, Cambridge: Belknap Press of Harvard Univ. Press (2004).
- Singer, Romuald/Singer, Margarete, The European Patent Convention : a Commentary / Raph Lunzer, rev. English, London: Sweet & Maxwell (1995).
- Smith, Austin, 'No' to Ban on Stem-Cell Patents, 472 Nature 418 (2011). doi.org/10.1038/472418a
- Somaya, D. 2012. Patent Strategy and Management. 38 J. Manage. 1084 (2012). doi.org/10.1177/0149206312444447
- Spellberg, Brad/Miller,Loren G./Kuo, Melissa N./Bradley, John/Scheld, William M./Edwards, John E., Societal Costs Versus Savings from Wild-Card Patent Extension Legislation to Spur Critically Needed Antibiotic Development, 35 Infection 167 (2007). doi.org/10.1007/s15010-007-6269-7
- Spenner, Jonathan M., Obvious-to Try Obviousness of Chemical Enantiomers in View of Pre-and Post-KSR Analysis, 90 J. Pat. & Trademark Off. Soc’y, 477 (2008).
- Stafford, Randall S., Regulating Off-Label Drug Use —Rethinking the Role of the FDA, 358 N Engl J Med, 1427 (2008). doi.org/10.1056/NEJMp0802107
- Steele, Henry, Monopoly and Competition in the Ethical Drugs Market, 5 J. Law Econ. 131 (1962). doi.org/10.1086/466587
- Strandburg, Katherine J., Patent Fair Use 2.0, 1 UC Irvine L.R.,265 (2011).
- Straus, Joseph, Patent Application: Obstacle for Innovation and Abuse of Dominant Position under Article 102 TFEU? 1 J. E. C. L. & Pract. 189 (2010). doi.org/10.1093/jeclap/lpq011
- Straus, Joseph, Zur Rolle klinischer Versuche beim Zustandekommen von so genannten Auswahlerfindungen, in: Osterrieth, Christian, Köhler, Martin, Haft, Klaus (eds), Patentrecht, Festschrift für Thomas Reimann zum 65. Geburtstag, Köln: Carl Hezmanns Verlag (2009).
- Svatos, Michele, Biotechnology and the Utilitarian Argument for Patents, 13 Soc. Philos. Policy. 113 (1996). doi.org/10.1017/S0265052500003484
- Sweet, Miles J., The Patentability of Chiral Drugs Post-KSR: The More Things Change, the More They Stay the Same, 24 Berkeley Tech. L.J. 129 (2009).
- Szabo, George S. A, The Problem and Solution Approach in the European Patent Office, IIC 1995, 457.
- Talbot, George H./Bradley,John/Edwards, John E./Jr., Gilbert, David/Scheld, Michael/ Bartlett, John G., Bad Bugs Need Drugs: An Update on the Development Pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America, 42 Clin Infect Dis. 657 (2006).
- Teece David J., Profiting from technological innovation: Implications for integration, collaboration, licensing and public policy, 15 Res. Policy 285 (1986).
- Temin, Peter, Technology, Regulation, and Market Structure in the Modern Pharmaceutical Industry, 10 Bell J. Econ. 429 (1979). doi.org/10.2307/3003345
- ter Meer, Nicolaus, German Chemical Patent Law 1965-1975, 57 J. Pat. Off. Soc'y 763 (1975).
- Teschemacher, Rudolf, Enlarged Board of Appeal of the EPO Restores Legal Certainty for Divisional Applications – Established Practice Confirmed, IIC 2007, 703.
- The Association of the British Pharmaceutical Industry, Did you know? Facts and Figures about the Pharmaceutical Industry in the UK, 2nd Ed. (2011).
- The Infectious Diseases Society of America (IDSA), Bad Bugs, no Drugs: as Antibiotic Discovery Stagnates, a Public Health Crisis Brews, Alexandria: ISDA (2004), available at: http://cdm266901.cdmhost.com/cdm/singleitem/collection/p266901coll4/id/ 801/rec/14.
- Thomas, John R., Formalism at the Federal Circuit, 52 Am. U. L. Rev. 771 (2003).
- Thomas, Katie, Pfizer Races to Reinvent Itself, The New York Times, May 1, 2012, avilable at: http://www.nytimes.com/2012/05/02/business/pfizer-profit-declines-19after-loss-of-lipitor-patent.html.
- Thomas, Kimberly M. , Protecting Academic and Non-Profit Research: Creating a Compulsory Licensing Provision in the Absence of an Experimental Use Exception, 23 Santa Clara Computer & High Tech. L. J. 347 (2007).
- Thomson Reuters, Top 100 Global Innovators (2011), available at: http:// blogs.reuters.com/mediafile/files/2011/11/analysis.pdf.
- Thomson Reuters, Top 100 Global Innovators (2012), available at: http://img.en25.com/ Web/ThomsonReutersScience/1001639.pdf.
- Tilmann, Winfried, Validity of Selective Product Claims – Venice Conferences III and V, Lundbeck and Olanzapine, IIC 2010, 149.
- Tucker, Geoffrey T., Chiral Switches, 355 Lancet 1085 (2000). doi.org/10.1016/S0140-6736(00)02047-X
- Tuominen, Nicoleta, Patenting Strategies of the EU Pharmaceutical Industry Crossroad between Patent Law and Competition Policy, Research Papers in Law 1/2011, Belgium: European Legal Studies (2011).
- U.S. Department of Commerce International Trade Administration, Pharmaceutical Price Controls in OECD Countries - Implications for U.S. Consumers, Pricing, Research and Development, and Innovation, Washington, DC: USITA (2004), available at: http://www.ita.doc.gov/td/chemicals/drugpricingstudy.pdf.
- UK Office of Fair Trading, The Pharmaceutical Price Regulation Scheme, London: Crown Copyright (2007), available at: http://www.oft.gov.uk/shared_oft/reports/ comp_policy/oft885.pdf.
- UNCTAD-ICTSD, Resource Book on TRIPS and Development, Cambridge: Cambridge University Press (2005). doi.org/10.1017/CBO9780511511363.016
- United States General Accountability Office, Prescription Drugs: Trends in FDA's Oversight of Direct-to-Consumer Advertising (2008) available at: http://www.gao.gov/ new.items/d08758t.pdf.
- United States General Accounting Office, Prescription drugs: FDA oversight of directto-consumer advertising has limitations (2002) available: http://www.gao.gov/ new.items/d03177.pdf.
- Valance, Edward H., Understanding the Markush Claim in Chemical Patents, 1 J. Chemical Documentation, 87 (1961). doi.org/10.1021/c160002a022
- Van Dijk, Theon, Patent Height and Competition in Product Improvements, 44 J. Ind. Econ. 151 (1996). doi.org/10.2307/2950643
- Vernon, John A, Drug Research and Price Controls, Winter, Regulation, 22 (2002-2003). doi.org/10.1007/BF03257365
- Vivian, Michael F., Novelty and Selection Inventions, IIC 1989, 303.
- Voet, Martin A., The Generic Challenge- Understanding Patents, FDA and Pharmaceutical Life Cycle Management, Florida: Brown Walker Press, 3rd Ed. (2011).
- Vossius, Corinna/Vossius, Tilman/Vossius, Volker, Der Terfenadin-Verletzungsstreit; zum Standard der Neuheitsprüfung, GRUR 1994, 472.
- Vossius, Volker, Selection Inventions in Chemistry According to German Patent Law A Problem of Novelty, 59 J. Pat. Off. Soc'y 180 (1977).
- Vossius, Volker, Stoffschutz für Auswahlerfindungen auf dem Gebiet der Chemie, GRUR 1976, 165.
- Wagner, R. Polk, (Mostly) against Exceptionalism, 50 Adv. Genet. 367 (2003).
- zu Waldeck und Pyrmont, Wolrad P./Adelmann, Martin J./Brauneis, Robert/Drexl, Joseph/Nack, Ralph (eds), Patents and Technological Progress in a Globalized World, Liber Amicorum Joseph Straus, Berlin, Heidelberg: Springer (2009). doi.org/10.1007/978-3-540-88743-0
- zu Waldeck und Pyrmont, Wolrad Prinz, BGH: Enantiomer eines bekannten Razemats kann patentiert warden- „Escitalopram“, GRUR-Prax, 2010, 13.
- Weaver, Mark/Perakis, Nikolaos/Riolo, Joseph, Novelty-Current Trends in the Jurisprudence of the boards of Appeal of the European Patent Office, 15 World Pat. Info. 81 (1993). doi.org/10.1016/0172-2190(93)90162-P
- Weissman, Robert, A Long, Strange Trips: The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries, 25 U. Pa. J. Int’l Econ. L. 1079 (2004).
- Wermuth, Camille G., Strategies in the Search for New Lead Compounds or Original Working Hypotheses, in: Wermuth, Camille G. (ed), The Practice of Medicinal Chemistry, Burlington: Elsevier Ltd, 3rd Ed. (2008).
- Wertheimer, Albert I./Santella, Thomas M./Chaney, Nicole M., The World Health Organization’s Essential Medicines List: An Endorsement of Incremental Innovation and Follow-On Research, 17 J. Pharmaceut. Marketing Manage. 25 (2005). doi.org/10.3109/J058v17n02_04
- Wertheimer, Albert/Levy, Richard/O'Connor, Thomas, Too many drugs? The Clinical and Economic Value of Incremental Innovations, in: Farquhar, Irina, Summers, Kent and Sorkin, Alan (eds), Investing in Health: The Social and Economic Benefits of Health Care Innovation, Oxford: Elsevier Science Ltd. (2001).
- Whalen, Jeanne/Stovall, Sten, AstraZeneca Plans to cut 7300 Jobs, the Wall Street Journal, February 2, 2012, available at: http://online.wsj.com/article/ SB10001424052970203711104577198264263381758.html.
- White, C. Michael, Why a Seventeen Year Patent, 38 J. Pat. Off. Soc'y 839 (1956).
- Wibbelmann, Jobst, Broad Claims: a Nuisance, EIPR 1997, 515.
- William, Johnson. A., Invitation to Organic Chemistry, Sudbury: Jones and Barlett (1999).
- Willkens, Robert F./Segre, Eugene J., Combination Therapy with Naproxen and Aspirin in Rheumatoid Arthritis, 19 Arthritis & Rheumatism 677 (2006).
- Wilson, Duff, Drug Firms Face Billions in Losses in ’11 as Patents End, The New York Times, March 6, 2011, available at: http://www.nytimes.com/2011/03/07/business/ 07drug.html?pagewanted=all.
- WIPO, PCT, The International Patent System, Yearly Review, Development and Performance in 2012, (2012), available at: http://www.wipo.int/freepublications/en/ patents/901/wipo_pub_901_2012.pdf.
- Witherspoon, John F. (ed), Nonobviousness:The Ultimate Condition of Patentability: Papers Compiled in Commemoration of the Silver Anniversary of 35 USC 103,Washington: The Bureau of National Affairs, Inc (1980).
- World Bank, The World Bank Legal Review: Law and Justice for Development, Washington D.C.: Inc. World Bank (2003). doi.org/10.1596/0-8213-5064-1
- Yu, Yu/Sachin,Gupta, Pioneering Advantage in Generic Drug Competition, Johnson School Research Paper Series No. 37-06, Ithaca: The Johoson School at Cornell University (2008). doi.org/10.2139/ssrn.925346
- Zentiva, Zentiva the Unifying Brand for Sanofi-aventis’ European Generics Business, Zentiva Press Release, Apr. 4, 2011, available at: http://www.zentiva.com/mediacentre/press-releases/pages/press-release-detail.aspx?ItemId=6.
- Zhang, Yuting/Soumerai, Stephen B., Do Newer Prescription Drugs Pay For Themselves? A Reassessment Of The Evidence, 26 Health Affair. 880 (2007). doi.org/10.1377/hlthaff.26.3.880
- Zins, Gerald D., The History of the Development of Minoxidil, 6 Clin. Dermatol. 132 (1988). doi.org/10.1016/0738-081X(88)90078-8
- OTHER SOURCES EPO glossary, available at: http://www.epo.org/service-support/glossary.html.
- Espacenet, available at: http://worldwide.espacenet.com.
- European Patent Register, available at: https://register.epo.org/espacenet/regviewer.
- FDA, Drugs@FDA Glossary of Terms, available at: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm FDA, Generic Drugs: Same Medicine, Lower Cost, available at: http://www.fda.gov/ downloads/ForConsumers/ConsumerUpdates/UCM340458.pdf FDA, Information for Consumers, available at: http://www.fda.gov/ Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ ucm144456.htm.
- O’Hagan, P/Farkas, Charles, Bringing pharma R&D back to health. Bain Insights [online], (2009) available at: http://www.bain.com/Images/BB_Managing_RandD_HC.pdf.
- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, available at: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm.
- Posner, Richard A., Do Patent and Copyright Law Restrict Competition and Creativity Excessively?, Sep, 30, 2012, available at: http://www.becker-posner-blog.com/ 2012/09/do-patent-and-copyright-law-restrict-competition-and-creativity-excessively-posner.html Teva, Teva Completes Acquisition of Cephalon, Teva News Release, October 14, 2001, available at: http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1617357&highlight= USPTO, USPTO Press Release #09-21 (Oct. 8, 2009), available at: http://www.uspto.gov/ news/09_21.jsp.
- WHO, International nonproprietary name, available at: http://www.who.int/medicines/ services/inn/en/.
- WHO, Pharmaceutical products, available at: http://www.who.int/topics/pharmaceutical_products/en/.