臺灣博碩士論文加值系統

有些生物製劑公司被指控為單一個藥物申請了超過八十個專利。而這些專利所累積而成的「專利叢林」被許多專家與學者列為美國藥價高昂的主要罪魁禍首之一。然而，目前的文獻僅著重於該些專利叢林的專利數量，鮮少進一步探究此些專利叢林的特徵以及其所形成的原因。不過若要理解此現象並進一步解決此問題，更深入的研究勢在必行。
透過生物製劑及小分子藥物的美國專利比較與分析，本研究不僅證實了生物製劑專利叢林的存在，亦表明了在美國最暢銷的藥物中，生物製劑的美國專利數量大於小分子藥物的美國專利數量。基於更深入的分析，本文進一步論證所謂的「專利叢林」，實際上可進一步分為兩種類型。
本研究所定義的「第一型專利叢林」係由大量涵蓋藥物不同面向、非重疊且具有進步性的專利所組成。其是源自於生物製劑和生物相似性藥的複雜本質。另一方面，第二型專利叢林則是由大量重疊或不具進步性的專利所組成。它們涵蓋了藥物的同一面向，且來自於終端免責聲明（terminal disclaimers）。兩種專利叢林類型共同累積了使舉發者卻步的大量專利；產生了使生物相似性藥物延後進入市場的長青樹專利；並促成了於美國高昂的藥物價格。
雖然專利叢林具有上述之缺點，但不可否認的是，專利仍是有好處的。本文提出了兩個建議：其一為美國專利商標局可以減輕第二型專利叢林影響的調整，另一則是針對兩種專利叢林類型的制度改革。

Some drug companies, brand biologic companies, in particular, have been accused of covering only a single drug with more than eighty patents. These drug patents accumulate to what critics claim as one of the major culprits of high drug prices— “patent thickets.” However, current literature mostly focuses on the substantial patent counts and less on the characteristics and the causes of these patent thickets; but to effectively understand and tackle this issue, more thorough discussions are necessary.
This article aims to provide further insight regarding this issue by analyzing and comparing the U.S. patents that cover top-selling biologics and small-molecule drugs. Results not only confirm the existence of biologic patent thickets but also show that among the top-selling drugs, more patents cover biologics than small-molecule drugs. Based on more in-depth analysis, this article further argues that the so-called “patent thicket” is, in fact, a cooperative effort of two types of patent thickets—Type I and Type II—that should be distinguished due to their differences in nature and the causes that give rise to them.
Defined as large numbers of non-overlapping or inventive patents that cover different aspects of the drug, Type I Patent Thickets are formed due to the complex nature of biologics and biosimilars. Type II Patent Thickets, on the other hand, are arguably overlapping or non-inventive patents that are prone to double patenting. They cover the same aspect of the drug and owe their existence to the utilization of terminal disclaimers. The two types of patent thickets jointly contribute to the large number of patents that fend off patent challenges; the stretched year spans of collective patent terms that delay biosimilar entry; and the exorbitant drug prices that harm patients.
A perfect solution is not easily obtainable as the patents in the two types of the patent thickets are not entirely without merits. In order to prevent the negative impacts of patent thickets without completely sacrificing the benefits patents themselves provide, this article presents two proposals: one being a tweak the USPTO can implement to alleviate the adverse effects of Type II Patent Thickets, and the other being a more transformative reform that would target both types of patent thickets.

I. INTRODUCTION 1

II. BIOLOGICS AND BIOSIMILARS 3
A. What Are Biologics? 3
B. The Development, the Cost and the Market of Biologics 4
C. Biosimilars and the BPCIA as the Solution to High Biologic Prices 7
1. Biosimilarity and interchangeability 8
2. BPCIA’s patent dispute resolution system 9
D. Biosimilar Entry Barriers 11

III. EVIDENCE OF BIOLOGIC PATENT THICKETS: AN EMPIRICAL STUDY 13
A. What Is a Patent Thicket? 14
B. Biologic Patent Thickets 15
C. Research Method 17
1. Top three best-selling biologics and small-molecule drugs in the U.S. based on 2018 sales revenue 17
2. Patent retrieval of the top three best-selling biologics in the U.S. based on 2018 sales revenue 19
3. Patent retrieval of the top three best-selling small-molecule drugs in the U.S. based on 2018 sales revenue 23
4. Core Patents and peripheral patents 27
D. Research Results: Patent Portfolio Visualization 30
E. Preliminary Assessment of Patent Thickets 34
1. Patent counts as criterion 35
2. Adding time into perspective 36

IV. TYPE I AND TYPE II BIOLOGIC PATENT THICKETS 42
A. A Tale of Two Thickets 43
B. Assessment of Type I and Type II Patent Thickets 44
1. Reasoning of assessment methodology 45
2. Results of Type I and Type II Patent Thicket assessment 46
3. A Type II Patent Thicket example: direct claim comparison of AbbVie’s Humira® patents 48

V. IMPACTS OF BIOLOGIC PATENT THICKETS: STACKING, STRETCHING AND SKYROCKETING 52
A. Type I and Type II Patent Thickets: Stacking Obstacles 53
B. Type I Patent Thickets: Stretching Across Longer Year Spans 55
C. Ultimate Impact: Skyrocketing Drug Prices 57

VI. CAUSES OF BIOLOGIC PATENT THICKETS 58
A. Motivations to File (Many) Patents 59
B. What Makes Biologic Patent Thickets (More) Possible? 61 
1. Type II Patent Thickets: Exploitation of Terminal Disclaimers 61
2. Type I Patent Thickets: Unique Nature of Biologics and Biosimilars 64

VII. SOLUTIONS TO THE BIOLOGIC PATENT THICKET PROBLEM 69
A. A Thorny Issue to Tackle 70
1. Definition 70
2. Babies and bathwater 71
3. Patent defenses are impractical 71
4. Misaligned interests 72
B. Increasing Transparency 73
1. Purple Book Continuity Act of 2019 73
2. Interchangeability patent listing 74
C. Ex Post Regulations 75
1. Antitrust litigation: In re: Humira (Adalimumab) Antitrust Litigation as the example 75
2. Affordable Prescriptions for Patients Act of 2019 79
D. Ex Ante Regulations 80
1. Targeting Type II Patent Thickets: the election of patents 81
2. Targeting Type I and Type II Patent Thickets collectively: the “All-in-One” approach 82

VIII. CONCLUSION 85

IX. REFERENCES 87

Abbott Laboratories, Abbott Laboratories Completes Separation of Research-Based Pharmaceuticals Business, BIOSPACE (Jan. 2, 2013), https://www.biospace.com/article/releases/abbott-laboratories-completes-separation-of-research-based-pharmaceuticals-business-/.
AbbVie, Inc., AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results, ABBVIE, INC. (Jan. 25, 2019), https://news.abbvie.com/news/abbvie-reports-full-year-and-fourth-quarter-2018-financial-results.htm.
Amended Answers, Defenses and Counterclaims, AbbVie Inc. et al v. Boehringer Ingelheim International GMBH et al, CIVIL No. 17-1065-MSG-RL (D. Del. Sep. 21, 2018) (No. 209-2) (Law 360).
Amgen, Inc., Amgen Reports Fourth Quarter and Full Year 2018 Financial Results, AMGEN, INC. (Jan. 29, 2019), https://www.amgen.com/media/news-releases/2019/01/amgen-reports-fourth-quarter-and-full-year-2018-financial-results/.
Amgen, Inc., Enbrel® (etanercept) Patent Issued, AMGEN (Nov. 22, 2011), http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-newsArticle&ID=1633115.
Application of Vogel 422 F.2d 438 (1970).
Aronson v. Quick Point Pencil Co., 440 U.S. 257 (1979).
Association for Accessible Medicine, Abuse of the Patent System is Keeping Drug Prices High for Patients, ASSOCIATION FOR ACCESSIBLE MEDICINE, https://accessiblemeds.org/campaign/abuse-patent-system-keeping-drug-prices-high-patients (last visited: Jun. 22, 2019).
Ayres, Ian & Parchomovsky, Gideon. Tradable Patent Rights, 60 STANFORD LAW REVIEW 863 (2007).
Bagley, Margo A. Patent Term Restoration and Non-Patent Exclusivity in the US, in PHARMACEUTICAL INNOVATION, COMPETITION AND PATENT LAW 111 (Josef Drexl & Nari Lee eds., 2013).
Big Molecular Watch, FDA Approvals, BIG MOLECULAR WATCH, https://www.bigmoleculewatch.com/fda-approved-ablas/?highlight=biosimilar (last visited: Mar. 29, 2019).
Biogen, Inc., Biogen Inc. Annual Report on Form 10-k for the Year Ended December 31, 2018, BIOGEN, INC. 63, http://www.annualreports.com/HostedData/AnnualReports/PDF/NASDAQ_BIIB_2018.pdf (last visited Jun. 28, 2019).
Boehm, Garth et al. Development of the Generic Drug Industry in the US After the Hatch-Waxman Act of 1984, 3 ACTA PHARMACEUTICAL SINICA B 297 (2013).
Brachmann, Steve. Bristol-Myers Squibb, Pfizer file ANDA lawsuits against makers of generic Eliquis, IPWATCHDOG (Apr. 12, 2017), https://www.ipwatchdog.com/2017/04/12/bristol-myers-squibb-pfizer-file-anda-lawsuits-against-makers-generic-eliquis/id=81883/.
BRILL, ALEX & ROBINSON, CHRISTY. STEPS TO REDUCING BARRIERS TO BIOSIMILARS IN THE UNITED STATES (2018), available at https://www.boehringer-ingelheim.us/sites/us/files/files/barrierstobiosimilars_september2018.pdf.
Bristol-Myers Squibb, Bristol-Myers Squibb Reports Fourth Quarter and Full Year Financial Results, BRISTOL-MYERS SQUIBB 11 (Jan. 24, 2019), https://s21.q4cdn.com/104148044/files/doc_financials/quarterly_reports/2018/q4/Q42018-Earnings-Release.pdf.
BROUGHER, JOANNA T. INTELLECTUAL PROPERTY AND HEALTH TECHNOLOGIES (2014).
BUSINESS LAW INCORPORATION, CORPORATE COUNSEL'S GUIDE TO INTELLECTUAL PROPERTY (2018 ed.).
Cahill, Joe. Taking Aim at Humira's Patent Fortress, CRAIN’S CHICAGO BUSINESS (Mar. 01, 2019), https://www.chicagobusiness.com/joe-cahill-business/taking-aim-humiras-patent-fortress.
CAMPBELL, MARY K. & FARRELL, SHAWN O. BIOCHEMISTRY (7th ed. 2011).
Carvalho, Lucas Silva et al., Production Processes for Monoclonal Antibodies, INTECHOPEN (Feb. 8, 2017), https://www.intechopen.com/books/fermentation-processes/production-processes-for-monoclonal-antibodies.
Celgene Corporation, Celgene Reports Fourth Quarter and Full Year 2018 Operating and Financial Results, CELGENE CORP. (Jan. 31, 2019), https://ir.celgene.com/press-releases/press-release-details/2019/Celgene-Reports-Fourth-Quarter-and-Full-Year-2018-Operating-and-Financial-Results/default.aspx.
Challener, Cynthia A. Fusion Proteins Pose Manufacturability Challenges, 30 BIOPHARM INTERNATIONAL 30, 30-31, 37 (2017).
Chen, Brian K. et al. Why Biologics and Biosimilars Remain So Expen¬sive: Despite Two Wins for Biosimilars, the Supreme Court’s Recent Rulings Do Not Solve Funda¬men¬tal Barriers to Competition, 78 DRUGS 1777, 1777 (2018), available at https://link.springer.com/article/10.1007%2Fs40265-018-1009-0.
Chirino, Arthur J. & Mire-Sluis, Anthony. Characterizing Biological Products and Assessing Comparability Following Manufacturing Changes, 22 NATURE BIOTECHNOLOGY 1383 (2004).
Clarkson, Gave & DeKorte, David. The Problem of Patent Thickets in Convergent Technologies, 1093 ANNALS NEW YORK ACADEMY OF SCIENCE 180 (2006).
Cohen, Lauren et al. The Growing Problem of Patent Trolling, 352 SCIENCE 521 (2016).
Cole, Rober J. SCM v. Xerox: Paper Blizzard for $1.8 Billion, NEW YORK TIMES (Jun. 27, 1997), https://www.nytimes.com/1977/06/27/archives/scm-v-xerox-paper-blizzard-for-18-billion-scm-v-xerox-case-of-18.html.
Collier, Roger. Drug Patents: The Evergreening Problem, 185 CMAJ e385 (2013).
Complaint, AbbVie Inc. et al v. Amgen Inc. et al, CIVIL No. 1:16-cv-00666-UNA (D. Del. Aug. 2, 2017) (No. 1) (MaxVal Litigation Databank).
Complaint, AbbVie Inc. et al v. Boehringer Ingelheim International GMBH et al, CIVIL No. 17-1065-MSG-RL (D. Del. Aug. 2, 2017) (No. 1).
Cox, Emily. Why Financial Incentives Aren’t Enough to Move the Needle on Compliance, 2 AMERICA HEALTH & DRUG BENEFITS 12 (2009).
Credit Suisse, Average Foreign Exchange Rates as per End of December 2018, CREDIT SUISSE, https://www.credit-suisse.com/media/assets/private-banking/docs/ch/unternehmen/kmugrossunternehmen/devisendurchschnittskurse-2018.pdf (last visited: Apr. 30, 2019).
Crespi-Lofton, Judy & Skelton, Jann B. The Growing Role of Biologics and Biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference, 57 JOURNAL OF AMERICAN PHARMACY ASSOCIATION e1 (2017).
Davio, Kelly. Class Action Lawsuit Filed Against AbbVie and Biosimilar Developers Alleges Collusion, THE CENTER FOR BIOSIMILARS (Mar. 19, 2019), https://www.centerforbiosimilars.com/news/class-action-lawsuit-filed-against-abbvie-and-biosimilar-developers-alleges-collusion.
DrugBank, Adalimumab, DRUGBANK, https://www.drugbank.ca/drugs/DB00051#reference-A39984 (last visited Jun. 28, 2019).
DrugBank, Apixaban, DRUGBANK, https://www.drugbank.ca/drugs/DB06605 (last visited Jun. 28, 2019).
DrugBank, Etanercept, DRUGBANK, https://www.drugbank.ca/drugs/DB00005 (last visited: Jun. 28, 2019).
DRUGBANK, https://www.drugbank.ca/ (last visited Jun. 28, 2019).
DrugBank, Lenalidomide, DRUGBANK, https://www.drugbank.ca/drugs/DB00480 (last visited Jun. 28, 2019).
DrugBank, Pregabalin, DRUGBANK, https://www.drugbank.ca/drugs/DB00230 (last visited Jun. 28, 2019).
DrugBank, Rituximab, DRUGBANK, https://www.drugbank.ca/drugs/DB00073#reference-A40017 (last visited Jun. 28, 2019).
Drugs@FDA: FDA Approved Drug Products, U.S. FOOD & DRUG ADMIN., https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.
Dunn, Andrew. 5th Humira Biosimilar Approved in EU as Market Entry Nears, BIOPHARMA DIVE (Sep. 20, 2018), https://www.biopharmadive.com/news/humira-biosimilar-europe-fifth-mylan-abbvie/532840/.
Dunn, Andrew. With Boehringer Settlement, AbbVie Completes Humira Sweep, BIOPHARMA DIVE (May 14, 2019), https://www.biopharmadive.com/news/abbvie-boehringer-ingelheim-settle-humira-patent-biosimilar/554729/.
Emer, Jason J. & Wolinsky, Claire. Rituximab: A Review of Dermatological Applications, 2 J. CLINICAL AESTHETIC DERMATOLOGY 29 (2009).
Erman, Michael. Drug Companies Greet 2019 with U.S. Price Hikes, REUTERS (Jan. 3, 2019), https://www.reuters.com/article/us-usa-drugpricing/drug-companies-greet-2019-with-u-s-price-hikes-idUSKCN1OW1GA.
F. Hoffmann-La Roche, Investor Update, F. HOFFMANN-LA ROCHE (Jan. 31, 2019), https://www.roche.com/dam/jcr:ac61cade-98ff-4671-9cfa-fee40210fc4d/en/190131_IR_Full_Year_Results_2018_en.pdf.
Fed. Trade Comm’n, Emerging Health Care Issues: Follow-on Biologic Drug Competition iii (Jun. 2008), available at https://www.ftc.gov/sites/default/files/documents/reports/emerging-health-care-issues-follow-biologic-drug-competition-federal-trade-commission-report/p083901biologicsreport.pdf.
Feldman, Robin. May Your Drug Price Be Evergreen, in UC HASTINGS RESEARCH PAPER no. 256 (October 29, 2017), available at https://ssrn.com/abstract=3061567.
Frakes, Michael D. & Wasserman, Melissa F. Does Agency Funding Affect Decisionmaking?: An Empirical Assessment of the PTO’s Granting Patterns, 66 VANDERBILT LAW REVIEW 67 (2013).
Frakes, Michael D. & Wasserman, Melissa F. Is the Time Allocated to Review Patent Applications Inducing Examiners to Grant Invalid Patents?: Evidence from Micro-Level Application Data (National Bureau of Economy Research Working Paper No. 20337, 2014), http://www.nber.org/papers/w20337 [http://perma.cc/BVC6-FG3R].
Frokjaer, Sven & Otzen, Daniel E. Protein Drug Stability: A Formulation Challenge, 4 NATURE REVIEWS DRUG DISCOVER 298 (2005).
Generics and Biosimilars Initiative, Biosimilars Launched in the US at a Significant Discount, GENERICS AND BIOSIMILARS INITIATIVE, http://www.gabionline.net/Biosimilars/News/Biosimilars-launched-in-the-US-at-a-significant-discount (last updated Dec. 14, 2018).
Goldberg, Elysa B. Fixing a Hole: Will Generic Biologics Find a Niche Within the Hatch-Waxman Act?, 20 FORDHAM INTELLECTUAL PROPERTY MEDIA AND ENTERTAINMENT LAW JOURNAL 327 (2009).
Gonzalez, Richard. AbbVie Long-Term Strategy (2015), available at http://www.biotechduediligence.com/uploads/6/3/6/7/6367956/abbvie_strategy_presentation__1_.pdf.
GOOGLE PATENTS, https://www.google.com/?tbm=pts (last visited Jun. 28, 2019).
Grabowski, Henry et al. Data Exclusivity for Biologics, 10 NATURE REVIEWS DRUG DISCOVERY 15 (2011).
Granger, Christopher B. et al., Apixaban Versus Warfarin in Patients with Atrial Fibrillation, 365 NEW ENGLAND JOURNAL OF MEDICINE 981 (2011).
Gu, Tao et al. Comparing Biologic Cost Per Treated Patient Across Indications Among Adult US Managed Care Patients: A Retrospective Cohort Study, 3 DRUGS - REAL WORLD OUTCOMES 369 (2016).
Hakim, Danny. Humira’s Best-Selling Drug Formula: Start at a High Price. Go Higher, NEW YORK TIMES (Jan. 6, 2018), https://www.nytimes.com/2018/01/06/business/humira-drug-prices.html.
HALL, BRONWYN H. ET AL. A STUDY OF PATENT THICKETS (2013), available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/311234/ipresearch-thickets.pdf.
Hargreaves, Ben. Boehringer Ends ‘Distraction’ by Signing Humira Biosimilar Deal, BIOPHARMA-REPORTER (May 15, 2019), https://www.biopharma-reporter.com/Article/2019/05/15/AbbVie-and-Boehringer-resolve-Humira-litigation.
Heller, Michael M. The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, 111 HARVARD LAW REVIEW 622 (1998).
Herper, Matthew. Solving the Drug Patent Problem, FORBES (May 2, 2002), https://www.forbes.com/2002/05/02/0502patents.html#3be4544317bc.
Hirsch, Dov. The Riddle of the Mysterious Patent Dance Wrapped in an Enigma: Is the Patent Dance of the BPCIA Optional or Mandatory?, 27 FORDHAM INTELLECTUAL PROPERTY MEDIA & ENTERTAINMENT LAW JOURNAL 645 (2017).
Hirschler, Ben & Shields, Michael. Novartis Launches First U.S. 'Biosimilar' Drug at 15 Percent Discount, REUTERS (Sep. 3, 2015), https://www.reuters.com/article/us-novartis-drug/novartis-launches-first-u-s-biosimilar-drug-at-15-percent-discount-idUSKCN0R30C220150903.
HOLMES, WILLIAM C. & MANGIARACINA, MELISSA. ANTITRUST LAW HANDBOOK (2018-2019 ed.).
Holson, Laura M. & Petersen, Melody. Pfizer and Warner-Lambert Are Seen in Merger Deal, NEW YORK TIMES (Feb. 3, 2000), https://www.nytimes.com/2000/02/03/business/pfizer-and-warner-lambert-are-seen-in-merger-deal.html.
In re Van Ornum, 686 F.2d 937, 948 (C.C.P.A. 1982).
In re: Humira (Adalimumab) Antitrust Litigation, No. 93, (N.D. Ill. Jun. 4, 2019).
In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011).
INITIATIVE FOR MED., ACCESS & KNOWLEDGE, OVERPATENTED, OVERPRICED: HOW EXCESSIVE PHARMACEUTICAL PATENTING IS EXTENDING MONOPOLIES AND DRIVING UP DRUG PRICES (2018), available at http://www.i-mak.org/wp-content/uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf.
INITIATIVE FOR MED., ACCESS & KNOWLEDGE, OVERPATENTED, OVERPRICED: SPECIAL HUMIRA EDITION (2018), http://www.i-mak.org/wp-content/uploads/2018/09/i-mak.humira.report.final_.0917.pdf.
INSTITUTION OF MEDICINE (US) COMMISSION ON ACCELERATING RARE DISEASES RESEARCH AND ORPHAN PRODUCT DEVELOPMENT (Marilyn J. Field & Thomas F. Boat eds., 2010).
Kaiser Found. Health Plan, Inc. v. Abbott Labs., Inc., 552 F.3d 1033 (9th Cir. 2009).
Kelly, Lindsay. Biologics in the Practice of Law, 39 HARVARD JOURNAL OF LAW AND PUBLIC POLICY 21 (2016).
Kempeni, Joachim. Preliminary Results of Early Clinical Trials with the Fully Human Anti-TNFá Monoclonal Antibody D2E7, 58 ANNALS OF THE RHEUMATIC DISEASES I70, I70-I72 (1999).
King, John L. Patent Examination Procedures and Patent Quality, in PATENTS IN THE KNOWLEDGE-BASED ECONOMY (Wesley M. Cohen & Stephen A. Merrill eds., 2003).
Kingsdown Med. Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867 (Fed.Cir.1988).
Kivitz, Alan & Segurado, Oscar G.. HUMIRA®Pen: A Novel Autoinjection Device for Subcutaneous Injection of the Fully Human Monoclonal Antibody Adalimumab, 4 EXPERT REVIEW OF MEDICAL DEVICES 109 (2007).
Kodjak, Alison. How a Drugmaker Gamed the System to Keep Generic Competition Away, NPR (May 17, 2018), https://www.npr.org/sections/health-shots/2018/05/17/571986468/how-a-drugmaker-gamed-the-system-to-keep-generic-competition-away.
Kozlowsk, Steven. Developing the Nation’s Biosimilars Program, 365 NEW ENGLAND JOURNAL OF MEDicine 385 (2011).
Ladonnikov, Alexej. The Biosimilar Patent Dance - If You Don't Dance, You're No Friend of Mine, 35 SANTA CLARA HIGH TECHNOLOGY LAW JOURNAL 135 (2018).
Landau, Josh. Inter Partes Review: Five Years, over $2 Billion Saved, PATENT PROGRESS (Sep. 14, 2017), https://www.patentprogress.org/2017/09/14/inter-partes-review-saves-over-2-billion/.
Lemley, Mark A. & Sampat, Bhaven Examiner Characteristics and Patent Office Outcomes, 94 REVIEW OF ECONOMY & STATISTICS 817.
Liu, Jodie. Compulsory Licensing and Anti-Evergreening: Interpreting the TRIPS Flexibilities in Sections 84 and 3(d) of the Indian Patents Act, 56 HARVARD INTERNATIONAL LAW JOURNAL 207, (2015).
Loftus, Peter & Roland, Denise. By Adding Patents, Drugmaker Keeps Cheaper Humira Copies Out of U.S., WALL STREET JOURNAL (Oct. 6, 2018), https://www.wsj.com/articles/biosimilar-humira-goes-on-sale-in-europe-widening-gap-with-u-s-1539687603.
Lupkin, Sydney & Hancock, Jay. Trump Administration Salutes Parade Of Generic Drug Approvals, But Hundreds Aren’t For Sale, KAISER HEALTH NEWS (Feb. 7, 2019), https://khn.org/news/trump-administration-salutes-parade-of-generic-drug-approvals-but-hundreds-arent-for-sale/.
LYBECKER, KRISTINA M. THE BIOLOGICS REVOLUTION IN THE PRODUCTION OF DRUGS (2016), available at https://www.fraserinstitute.org/sites/default/files/biologics-revolution-in-the-production-of-drugs.pdf.
Manova, Manoela. Comparative Price Analysis of Biological Products for Treatment of Rheumatoid Arthritis, 9 FRONT PHARMCOLOGY art. 1070.
Manual of Patent Examining Procedure § 804.
MATTHEWS JR., ROBERT A. 1 ANNOTATED PATENT DIGEST (updated: Jun, 2019).
Memorandum and Order Concerning Doc. No. 71, AbbVie Inc. et al v. Boehringer Ingelheim International GMBH et al, CIVIL, No. 17-1065-MSG-RL (D. Del. Jun. 4, 2018) (No. 112) (CaseText), available at: https://casetext.com/case/abbvie-inc-v-boehringer-ingelheim-intl-gmbh-boehringer-ingelheim-pharms-inc-2.
Memorandum concerning Plaintiff's Motion for more Complete Interrogatory Answers, AbbVie Inc. et al v. Boehringer Ingelheim International GMBH et al, CIVIL No. 17-1065-MSG-RL (D. Del. Feb. 22, 2019) (No. 234) (Justia), available at: https://docs.justia.com/cases/federal/district-courts/delaware/dedce/1:2017cv01065/62839/428.
MILLS III, JOHN GLADSTONE ET AL. PATENT LAW BASICS (last updated Nov. 2018).
Minniti III, Carl J. Sandoz v. Amgen: Why Current Interpretation of the Biologic Price Competition and Innovation Act of 2009 Is Flawed and Jeopardizes Future Competition, 97 J. PATENT & TRADEMARK OFFICE SOCIETY 172 (2009).
Mohs, Richard C. & Greig, Nigel H. Drug Discovery and Development: Role of Basic Biological Research, 3 ALZHEIMER’S & DEMENTIA 651 (2017).
Moorkens, Evelien et al. Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies, 7 FRONT PHARMACOLOGY at 1 (2016).
Mossoff, Adam. The Rise and Fall of the First American Patent Thicket: The Sewing Machine War of the 1850s, 53 ARIZONA LAW REVIEW 165 (2011).
Mulcahy, Andrew W., et al. Biosimilar Cost Savings in the United States: Initial Experience and Future Potential, 7 RAND HEALTH Q. 3 (2018).
Navarro, Cindy. It Takes Two to Tango: The BPCIA's Mandatory Patent Dance, 45 AIPLA QUARTERLY JOURNAL 291 (2017).
Overley, Jeff. Meet the Top Attorneys In AbbVie's Antitrust Battle Royal, LAW360 (Jun. 7, 2019), https://www.law360.com/articles/1145098/meet-the-top-attys-in-abbvie-s-antitrust-battle-royal.
P. J. Federico, Commentary on the New Patent Act, 35 USCA p. 49 (1954).
Palmer, Eric. Enbrel, FIERCEPHARMA, https://www.fiercepharma.com/special-report/enbrel (last visited Jun. 28, 2019).
Pfizer, Inc., Appendix A 2018 Financial Report, PFIZER, INC. 26, https://s21.q4cdn.com/317678438/files/doc_financials/Annual/2018/2018-Financial-Report.pdf (last visited Jun. 28, 2019).
Pharm. Tech., Humira: The Highs and Lows of the World’s Best-Selling Drug, PHARM. TECH. (Sep. 5, 2018), https://www.pharmaceutical-technology.com/features/humira-abbvie-drug/.
Pharmacia Corp. v. Par Pharm., Inc., 417 F.3d 1369 (Fed. Cir. 2005).
Pollack, Andrew. Idec to Merge with Biogen in $6.8 Billion Deal, NEW YORK TIMES (Jun. 24, 2003), https://www.nytimes.com/2003/06/24/business/idec-to-merge-with-biogen-in-6.8-billion-deal.html.
Pollack, Andrew. Roche Agrees to Buy Genentech for $46.8 Billion, NEW YORK TIMES (Mar. 12, 2009), https://www.nytimes.com/2009/03/13/business/worldbusiness/13drugs.html.
PORTAL, https://portal.unifiedpatents.com/ (last visited Jun. 28, 2019).
Prasad, Vinay & Mailankody, Sham. Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval, 177 JAMA INTERNAL MEDICINE 1569 (2017).
Professional Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc., 508 U.S. 49 (1993).
Rai, Arti K. Growing Pains in the Administrative State: The Patent Office’s Troubled Quest for Managerial Control, 157 UNIVERSITY OF PENNSYLVANIA LAW REVIEW 2051 (2009).
Revlimid.com, Mechanism of Action, REVLIMID.COM, https://www.revlimid.com/mm-hcp/mechanism-of-action/?mm-self-id=yes (last visited Jun. 28, 2019).
Roche, MabThera®/Rituxan® (rituximab), ROCHE https://www.roche.com/products/product-details.htm?productId=b0eb216f-addf-4ed1-b01e-0b12fe0b1ef6 (last visited: Jun. 11, 2019).
Roche, Our History, ROCHE, https://www.roche.com/about/history.htm (last visited Jun. 28, 2019).
RPX, IPRs: Balancing Effectiveness vs. Cost, RPX (2016), https://www.rpxcorp.com/intelligence/blog/iprs-balancing-effectiveness-vs-cost/.
Sagonowsky, Eric. AbbVie Offers Up 80% Humira Discount in EU Tender Market to Hold Off Biosimilars: Report, FIERCE PHARMA (Oct. 31, 2018), https://www.fiercepharma.com/pharma/abbvie-offers-up-80-humira-discount-eu-tender-market-to-hold-off-biosims-report.
Sagonowsky, Eric. AbbVie's Humira Antitrust Woes Snowball as Class-Action Plaintiffs Pile In, FIERCEPHARMA (Apr. 3, 2019), https://www.fiercepharma.com/pharma/police-miami-city-officials-baltimore-and-trade-workers-minnesota-join-class-action-over.
Saha, Atanu et al., Generic Competition in the US Pharmaceutical Industry, 13 INTERNATIONAL JOURNAL OF ECONOMY AND BUSINESS 15 (2006).
Sarkisian v. Winn-Proof Corp., 697 F.2d 1313 (9th Cir. 1983).
Schmidt, Charlie. Negotiating the RNAi Patent Thicket, 25 NATURE BIOTECH. 273 (2007).
Shapiro, Carl. Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard Setting, in 1 INNOVATION POLICY AND THE ECONOMY 119 (Jaffe, Adam B. et al. eds., 2001), available at https://www.nber.org/chapters/c10778.pdf.
Shrank, William H. et al., Physician Perceptions About Generic Drugs, 45 ANNALS PHARMACOTHERAPY 31 (2011).
Silbersher, Zachary. Did AbbVie Create a Wrongful “Patent Thicket” Around Humira®?, MARKMAN ADVISORS (Aug. 27, 2018), https://www.markmanadvisors.com/blog/2018/8/27/did-abbvie-create-a-wrongful-patent-thicket-around-humira.
Silbersher, Zachary. Is Boehringer Ingelheim Planning to Launch Its Humira Biosimilar At-Risk?, MARKMAN ADVISORS (Dec. 13, 2018), https://www.markmanadvisors.com/blog/2018/12/13/is-boehringer-ingelheim-planning-to-launch-its-humira-biosimilar-at-risk.
Silbersher, Zachary. What Are the Lessons from Boehringer’s Settlement with AbbVie Over Its Humira Biosimilar?, MARKMAN ADVISORS (May 17, 2019), https://www.markmanadvisors.com/blog/2019/5/17/what-are-the-lessons-from-boehringers-settlement-with-abbvie-over-its-humira-biosimilar.
SimpleAir, Inc. v. Google LLC, 884 F.3d 1160 (Fed. Cir. 2018).
Standard Oil Co. of New Jersey v. U.S., 221 U.S. 1 (1911).
Statista, United States: Inflation rate from 1990 to 2018 (2019), STATISTA, https://www.statista.com/statistics/191077/inflation-rate-in-the-usa-since-1990/.
Statt, Nick. Apple Ordered to Pay Patent Troll More Than $500 Million in iMessage Case, THE VERGE (Apr. 10, 2018), https://www.theverge.com/2018/4/10/17222380/apple-virtnetx-patent-troll-litigation-500-million-imessage-facetime-case.
SUNG, LAWRENCE M. & SCHWATZ, JEFF E. PATENT LAW HANDBOOK § 5:7 (2018-2019 ed.).
SURECHEMBLBETA OPEN PATENT DATA, https://www.surechembl.org/search/ (last visited Jun. 28, 2019).
Tanaka, Jon. "Shall" We Dance? Interpreting the BPCIA's Patent Provisions, 31 BERKELEY TECH. L.J. 659 (2016).
Taylor, Charles P. Pharmacology and Mechanism of Action of Pregabalin: The Calcium Channel 2— (alpha2—delta) Subunit as a Target for Antiepileptic Drug Discovery, 73 EPILEPSY RESEARCH 137 (2007).
Terry, Mark. Drum Roll, Please! Top 10 Bestselling Drugs in the U.S., BIOSPACE (May 21, 2018), https://www.biospace.com/article/drumroll-please-top-10-bestselling-drugs-in-the-u-s-/.
Thomas Felicity. Rising to the Challenge of Biologic Drug Formulation, PHARMTECH (Mar. 2, 2019), http://www.pharmtech.com/rising-challenge-biologic-drug-formulation.
Tribble, Sarah Jane. Why the U.S. Remains the World’s Most Expensive Market For ‘Biologic’ Drugs, KAISER HEALTH NEWS (Dec. 20, 2018), https://khn.org/news/u-s-market-for-biologic-drugs-is-most-expensive-in-the-world/.
Tu, Shine. Invalidated Patents and Associated Patent Examiners, 18 VANDERBILT JOURNAL OF ENTERTAINMENT AND TECHNOLOGY LAW 135 (2015).
U.S. Food & Drug Administration, Biosimilar and Interchangeable Products, U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm#generic (last visited Mar. 18, 2019).
U.S. Food & Drug Administration, Biosimilar Development, Review, and Approval, U.S. FOOD & DRUG ADMINISTRATION, https://
www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580429.htm (last visited Mar. 18, 2019).
U.S. Food & Drug Administration, FDA at Rare Disease Day / February 28, 2011, U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/industry/developing-products-rare-diseases-conditions/fda-rare-disease-day-february-28-2011 (last updated: Nov. 3, 2017).
U.S. Food & Drug Administration, Frequently Asked Questions About Therapeutic Biological Prod¬ucts, U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm (last visited Mar. 9, 2019).
U.S. Food & Drug Administration, Generic Competition and Drug Prices, U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/about-fda/center-drug-evaluation-and-research/generic-competition-and-drug-prices (last updated: Nov. 20, 2017).
U.S. Food & Drug Administration, Highlights of Prescribing Information, U.S. FOOD & DRUG ADMINISTRATION, https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s056lbl.pdf#page=1 (last visited Jun. 29, 2019).
U.S. Food & Drug Administration, Highlights of Prescribing Information, U.S. FOOD & DRUG ADMINISTRATION, https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5454lbl.pdf#page=1 (last visited Jun. 29, 2019).
U.S. Food & Drug Administration, Highlights of Prescribing Information, U.S. FOOD & DRUG ADMINISTRATION, https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf#page=1 (last visited Jun. 29, 2019).
U.S. Food & Drug Administration, Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplicatio-ns/TherapeuticBiologicApplications/Biosimilars/ucm411418.htm (last visited Mar. 18, 2019).
U.S. Food & Drug Administration, Remarks from FDA Commissioner Scott Gottlieb, M.D., as Prepared for Delivery at the Brookings Institution on the Release of the FDA’s Biosimilars Action Plan, US. FOOD & DRUG ADMIN. (July. 18, 2018), https://www.fda.gov/news-events/press-announcements/remarks-fda-commissioner-scott-gottlieb-md-prepared-delivery-brookings-institution-release-fdas.
U.S. Food & Drug Administration, Risk Evaluation and Mitigation Strategies (REMS), U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems (last updated: Feb. 2, 2018).
U.S. Food & Drug Administration, Small Business Assistance: Frequently Asked Questions on the Patent Term Restoration Program, U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-patent-term-restoration-program (last visited Jun. 14, 2019).
U.S. Food & Drug Administration, Statement from FDA Commissioner Scott Gottlieb, M.D., On New Policies to Reduce the Ability of Brand Drug Makers to Use REMS Programs as a Way to Block Timely Generic Drug Entry, Helping Promote Competition and Access, U.S. FOOD & DRUG ADMINISTRATION, (May 31, 2018), https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-policies-reduce-ability-brand-drug-makers-use-rems.
U.S. Food & Drug Administration, U.S. Food & Drug Admin.’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, U.S. FOOD & DRUG ADMINISTRATION, https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm (last visited Jun. 28, 2019).
U.S. National Library of Medicine, National Center of Biotechnology Information, Blastp Suite-2sequences, U.S. NATIONAL LIBRARY OF MEDICINE, NATIONAL CENTER OF BIOTECHNOLOGY INFORMATION, https://blast.ncbi.nlm.nih.gov/Blast.cgi?PAGE=Proteins&PROGRAM=blastp&PAGE_TYPE=BlastSearch&BLAST_SPEC=blast2seq.
U.S. Patent & Trademark Office, Help on the Advanced Search Page, U.S. PATENT & TRADEMARK OFFICE, PAT. FULL TEXT & IMAGE DATABASE, http://patft.uspto.gov/netahtml/PTO/help/helpadv.htm (last visited Jun. 28, 2019).
U.S. Patent & Trademark Office, Patent Term Calculator, U.S. PATENT & TRADEMARK OFFICE, https://www.uspto.gov/sites/default/files/documents/patent_term_calculator.xls. (last visited Jun. 28, 2019).
U.S. Patent & Trademark Office, USPTO Public Patent Application Information Retrieval, U.S. PATENT & TRADEMARK OFFICE, https://portal.uspto.gov/pair/PublicPair (last visited Jun. 28, 2019).
U.S. Patent Application Ser. No. 10/222,140, filed on Aug. 16, 2002 (now abandoned).
U.S. Patent No. 5,635,517.
U.S. Patent No. 6,090,382.
U.S. Patent No. 7,465,800.
U.S. Patent No. 7,485,704.
U.S. Patent No. 7,855,217.
U.S. Patent No. 8,143,286.
U.S. Patent No. 8,163,522.
U.S. Patent No. 8,216,583.
U.S. Patent No. 8,231,876.
U.S. Patent No. 8,314,225.
U.S. Patent No. 8,431,598.
U.S. Patent No. 8,728,730.
U.S. Patent No. 8,802,100.
U.S. Patent No. 8,802,101.
U.S. Patent No. 8,802,102.
U.S. Patent No. 8,822,499.
U.S. Patent No. 8,911,741.
U.S. Patent No. 8,916,157.
U.S. Patent No. 8,916,158.
U.S. Patent No. 8,932,591.
U.S. Patent No. 8,940,305.
U.S. Patent No. 8,992,476.
U.S. Patent No. 9,062,106.
U.S. Patent No. 9,085,618.
U.S. Patent No. 9,150,645.
U.S. Patent No. 9,220,781.
U.S. Patent No. 9,234,032.
U.S. Patent No. 9,234,033.
U.S. Patent No. 9,255,143
U.S. Patent No. 9,272,041.
U.S. Patent No. 9,272,042.
U.S. Patent No. 9,284,371.
U.S. Patent No. 9,289,497.
U.S. Patent No. 9,295,725.
U.S. Patent No. 9,302,011.
U.S. Patent No. 9,327,032.
U.S. Patent No. 9,353,080.
U.S. Patent No. 9,365,538.
U.S. Patent No. 9,371,309.
U.S. Patent No. 9,408,973.
U.S. Patent No. 9,505,833.
U.S. Patent No. 9,683,033.
U.S. Patent No. 9,732,152.
U.S. Patent No. 9,738,714.
U.S. Patent No. 9,750,808.
U.S. Patent No. 9,943,649.
U.S. Patent No. 9,950,066.
U.S. v. Grinnell Corp., 384 U.S. 563 (1966).
Urquhart, Lisa. Top Drugs and Companies by Sales in 2018, 18 NATURE REVIEW 245 (2019).
Van de Donk, Niels W. C.J. & Dhimolea, Eugen. Brentuximab Vedotin, 4 MABS 458 (2012).
Verizon Communications Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 U.S. 398 (2004).
Vishnubhakat, Saurabh & Rai, Arti K. When Biopharma Meets Software: Bioinformatics at the Patent Office, 29 HARVARD JOURNAL LAW & TECHNOLOGY 205, 211 (2015).
Waltz, Emily. It’s Official: Biologics Are Pharma’s Darlings, 32 NATURE BIOTECHNOLOGY 117 (2014).
Wang, Yixin (Iris) et al., Manufacturing and Regulatory Barriers to Generic Drug Competition: A Structural Model Approach 33 (Mar. 21, 2018), available at http://dx.doi.org/10.2139/ssrn.3145635.
Woolman, Stu et al. Evidence of Patent Thickets in Complex Biopharmaceutical Technologies, 53 IDEA 1 (2013).
Young, Jeffrey & Ferro, Shane. Pharma Bro Emails Reveal Just How Greedy Drug Companies Can Be, HUFFPOST (Feb. 2, 2016, last updated Dec. 19, 2016), https://www.huffpost.com/entry/martin-shkreli-pharma-bro-drug-prices_n_56b0fac5e4b0655877f75453.