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`EXHIBIT 30
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`Case 1:17-cv-00770-JDW Document 259-4 Filed 11/02/23 Page 2 of 48 PageID #: 29189
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`NORTH CAROLINA LAW REVIEW
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`Article 5
`
`Volume 87
`Number 5 Frontiers in Empirical Patent Law
`Scholarship
`
`6-1-2009
`
`Copying in Patent Law
`
`Christopher A. Cotropia
`
`Mark A. Lemley
`
`Follow this and additional works at: http://scholarship.law.unc.edu/nclr
`Part of the Law Commons
`
`Recommended Citation
`Christopher A. Cotropia & Mark A. Lemley, Copying in Patent Law, 87 N.C. L. Rev. 1421 (2009).
`Available at: http://scholarship.law.unc.edu/nclr/vol87/iss5/5
`
`This Article is brought to you for free and open access by Carolina Law Scholarship Repository. It has been accepted for inclusion in North Carolina
`Law Review by an authorized administrator of Carolina Law Scholarship Repository. For more information, please contact law_repository@unc.edu.
`
`

`

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`COPYING IN PATENT LAW*
`
`CHRISTOPHER A. COTROPIA** AND MARK A. LEMLEY ***
`
`Patent law is virtually alone in intellectual property (IP) in
`punishing independent development. To infringe a copyright or
`trade secret, defendants must copy the protected IP from the
`plaintiff, directly or indirectly. But patent infringement requires
`only that the defendant's product falls within the scope of the
`patent claims. Not only doesn't the defendant need to intend to
`infringe, but the defendant may be entirely unaware of the patent
`or the patentee and still face liability.
`
`Nonetheless, copying does play a role in some subsidiary patent
`doctrines, including damages rules, willfulness, and obviousness.
`More significantly, the rhetoric of patent law (and of IP law
`more generally) often seems to presuppose that defendants in
`patent cases are in fact engaged in copying. Similarly, the
`outcome of public policy debates over patent reform may well
`turn on the perception of patent infringers as either bad actors or
`as innocent businesspeople who accidentally ran afoul of a
`patent.
`
`Unfortunately, no one seems
`to know whether patent
`infringement defendants are in fact unscrupulous copyists or
`independent developers. In this paper, we seek to answer that
`
`* © 2009 by Christopher A. Cotropia and Mark A. Lemley.
`** Professor, Intellectual Property Institute, University of Richmond School of Law.
`*** William H. Neukom Professor, Stanford Law School; Partner, Durie Tangri LLP.
`We thank the Kauffman Foundation for research support,
`the Stanford IP
`Litigation Clearinghouse for providing us with the complaint sample, Michael Barclay,
`Robert Barr, Dawn-Marie Bey, Colleen Chien, Dennis Crouch, John Golden, Rose
`Hagan, Paul Heald, Andy Litteral, Rafael Pardo, Cecil Quillen, Arti Rai, Carl Shapiro,
`Ted Sichelman, Katherine Strandburg, Sam Vermont, and participants in workshops at the
`Kauffman Foundation, Berkeley Law School, and Stanford Law School for comments on
`an earlier draft, and Sarah Craven and Vinita Kailasanath for outstanding research
`assistance. We give special thanks to Andrew Chin, Lolly Gasaway, and the North
`Carolina Law Review staff for giving us the opportunity to present this paper at the
`Frontiers in Empirical Patent Law Scholarship Symposium and the participants at the
`Symposium for their comments.
`
`

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`question. We look both at the allegations made in a random
`sample of complaints and at the treatment of copying in recent
`reported decisions, including willfulness decisions. We find that
`a surprisingly small percentage of patent cases involve even
`allegations of copying, much less proof of copying. Copying in
`patent law seems to be very much the exception, not the rule,
`except in the pharmaceutical industry.
`
`1428
`
`1431
`
`1423
`INTRO D U CTIO N .....................................................................................
`COPYING'S CURRENT PLACE IN PATENT DOCTRINE ........... 1424
`I.
`A. Copying Is Not Required to Prove Liability ..................... 1425
`B. Copying Plays a Role in Other Patent Doctrines ............. 1428
`1. Copying as an Element of Specific Patent
`D octrines ........................................................................
`2. Copying as a Foundation for Particular Patent
`T heories ..........................................................................
`a. The Disclosure Bargain and Improvement
`T heory ......................................................................
`1431
`b. Design-Around Theory ...........................................
`1434
`c. Doctrine of Equivalents Theory ............................ 1435
`3. Copying as a Rhetorical Device ................................... 1436
`C. Reforms to Copying's Role in Patent Law ........................ 1437
`THE SCARCITY OF COPIERS IN PATENT CASES ..................... 1439
`A . A llegations of Copying ........................................................
`1440
`1. D ata C ollection ..............................................................
`1440
`2. Data on Allegations of Willfulness ............................. 1441
`3. Data on Allegations of Copying .................................. 1443
`B. Court Findings of Copying .................................................
`1449
`1. D ata C ollection ..............................................................
`1449
`2. Data on Claims of Copying ..........................................
`1451
`3. Data on Willful Infringement Findings ....................... 1453
`C. Interpreting the D ata ...........................................................
`1456
`1458
`IMPLICATIONS OF THE DATA ...................................................
`A. Understanding Policy Debates and Reform Proposals .... 1458
`B. Calibrating Patent Damages ...............................................
`1461
`C. Patents, Disclosure, and Technology Transfer ................. 1464
`D. Choosing Between Patents and Trade Secrets ................... 1465
`1466
`C O N CLU SIO N .........................................................................................
`
`II.
`
`III.
`
`

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`COPYING IN PATENT LAW
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`1423
`
`INTRODUCTION
`Patent law is virtually alone in intellectual property ("IP") law in
`punishing independent development. To infringe a copyright or trade
`secret, defendants must copy the protected IP from the plaintiff,
`directly or indirectly.' But patent infringement requires only that the
`defendant's product falls within the scope of the patent claims. It's
`not just that patent law doesn't require any intent to infringe. The
`defendant may be entirely unaware of the patent or the patentee and
`still face liability for independently creating a similar work.
`Nonetheless, copying does play a role in some subsidiary patent
`doctrines, as we discuss in Part I. For example, the question of
`whether patent damages should be set in order to deter infringement,
`rather than solely to compensate the patentee, depends critically on
`whether infringers are in fact aware they are infringing, or at least
`that they are using the plaintiff's technology. The definition of
`"willful infringement" turns on the question of culpability, at least in
`the popular understanding of that term. Copying-or at least intent
`to infringe-is also an element of claims for indirect infringement.2
`More significantly, the rhetoric of patent law (and of IP law more
`generally) often seems to presuppose that defendants in patent cases
`are in fact engaged in copying. Similarly, the outcome of public
`policy debates over patent reform may well turn on the perception of
`patent infringers as either bad actors or as innocent businesspeople
`who accidentally ran afoul of a patent.
`Unfortunately, no one seems to know whether most patent
`infringement defendants are
`in fact unscrupulous copyists or
`independent developers. In this Article, we seek to shed light on that
`question. Because copying is not an element of any patent cause of
`action, courts do not normally make explicit findings as to whether
`defendants have copied. Instead, we turn in Part II to a variety of
`
`1. The Copyright Act defines the rights as ones involving a "copy" of a protected
`work, 17 U.S.C. § 106 (2006), and courts are unanimous in requiring proof of copying,
`though that copying need not be intentional or even conscious. See ROBERT P. MERGES
`ET AL., INTELLECTUAL PROPERTY IN THE NEW TECHNOLOGICAL AGE 476-82 (rev. 4th
`ed. 2007). Similarly, trade secret law requires that the secret be acquired from the
`plaintiff, and makes independent development a defense. UNIF. TRADE SECRETS ACT
`§ 1, cmt. 1, 14 U.L.A. 529, 538 (2000) ("Proper means include ... [d]iscovery by
`independent invention."); RESTATEMENT (THIRD) OF UNFAIR COMPETITION § 43 (1995).
`For our definition of copying, see infra notes 24-30 and accompanying text.
`2. See infra notes 36-37 and accompanying text (detailing copying's relevance in a
`claim of indirect infringement).
`
`

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`[Vol. 87
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`proxies to try to identify the subset of cases in which copying is
`alleged or proven. We look both at the allegations made in a random
`sample of complaints and at the treatment of copying in recent
`reported decisions.
`We find that a surprisingly small percentage of patent cases
`involve even allegations of copying, much less proof of copying. Only
`10.9% of the complaints studied-21 of 193 complaints-contained
`even an allegation that the defendant copied the invention, either
`from the patent or from the plaintiff's commercial product. This
`percentage is even lower when looking at published decisions, with
`6.89% of the decisions-129 of 1871 cases-including an allegation of
`copying. Copying was found in 33 of these cases, meaning that
`copying was established in only 1.76% of all cases in our dataset.
`Copying seems to be the exception, not the rule in patent cases. And
`our data indicates that copying is particularly rare outside of the
`pharmaceutical and chemical arts. Pharmaceutical and chemical cases
`in both
`constitute more than half of the allegations of copying
`complaints and decisions and two-thirds of the reported findings of
`In other industries, such as computers and software, less
`copying.
`than 3% of cases involve allegations of copying, and less than 1%
`involve proof of copying.
`Our findings have significant implications for both patent theory
`(which often depends on assumptions about the role of patent
`disclosure and improvements) and patent policy. In particular, we
`caution against the modern trend of treating infringers as bad actors
`when assessing damages; overwhelmingly, they are not. We discuss
`these and other implications in Part III.
`
`I. COPYING'S CURRENT PLACE IN PATENT DOCTRINE
`
`One of the most significant differences between patent law and
`other areas of intellectual property is that, in patent law, copying is
`irrelevant to the determination of infringement.3 It is axiomatic that
`patent infringement is a "strict liability offense."4 However, many
`components of patent law, patent theory, and even the rhetoric used
`
`3. See Stephen M. Maurer & Suzanne Scotchmer, The Independent Invention
`Defence in Intellectual Property, 69 ECONOMICA 535, 535 (2002) ("Perhaps the most basic
`difference between patents and other intellectual property such as trade secrets and
`copyright is that independent invention is not a defence to infringement.").
`4. Mark A. Lemley, Should Patent Infringement Require Proof of Copying?, 105
`MICH. L. REV. 1525, 1525 (2007).
`
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`in patent cases make copying a relevant consideration. Proposed
`reforms to the patent system would make copying even more directly
`relevant.
`
`A. Copying is Not Required to Prove Liability
`Courts assess patent infringement by comparing the allegedly
`infringing product or process to the patent's claims. An individual
`literally infringes if her technology practices each and every element
`of the claimed invention.6 Patent law requires nothing more.
`Questions of infringement do not focus on the alleged infringer's
`intent.7 Nor does infringement require evidence of copying the
`patent or commercial embodiments of the patented invention.8 For
`the
`initial liability determination
`in patent law, an "innocent"
`infringer is treated the same as an individual who copied the patented
`technology. Put simply, copying is irrelevant to the issue of liability.
`Nor is copying relevant to the determination of infringement
`under the doctrine of equivalents. Determining whether the alleged
`infringer's actions, while not falling within the literal scope of the
`claims, are equivalent to the claimed subject matter does not involve
`an inquiry into the infringer's state of mind or actions of copying.9
`The Supreme Court of the United States has specifically held that
`copying (or its absence)
`is irrelevant to infringement under the
`doctrine of equivalents.1 0
`Accordingly, in patent law, an individual who develops an
`already-patented technology without knowledge of the patent and the
`
`5. Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1351 (Fed. Cir. 2002)
`(explaining that copying plays no role in the claim for allegedly infringing product or
`process comparison); see ROGER E. SCHECHTER & JOHN R. THOMAS, PRINCIPLES OF
`PATENT LAW 275 (2004).
`6. 35 U.S.C. § 271(a) (2006); Markman v. Westview Instruments, Inc., 517 U.S. 370,
`374 (1996) ("Victory in an infringement suit requires a finding that the patent claim
`'covers the alleged infringer's product or process .
`) (quoting HERBERT SCHWARTZ,
`PATENT LAW AND PRACTICE 80 (2d ed. 1995)).
`7. ROBERT P. MERGES & JOHN F. DUFFY, PATENT LAW AND POLICY: CASES AND
`MATERIALS 781 (4th ed. 2007) ("[T]he right to exclude does not depend upon the
`infringer's state of mind."); SCHECHTER & THOMAS, supra note 5, at 275 ("A defendant's
`intent is irrelevant to the outcome of an infringement inquiry.").
`8. See Allen Eng'g, 299 F.3d at 1351; MERGES & DUFFY, supra note 7, at 781 (noting
`that 35 U.S.C. § 271 "does not require any proof of access to the inventor's work").
`9. Allen Eng'g, 299 F.3d at 1351 (indicating that copying is irrelevant to the
`equivalents inquiry).
`10. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 35-36 (1997)
`(concluding that "intent plays no role in the application of the doctrine of equivalents").
`
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`technology's prior creation-a true "independent inventor"-is still
`liable if what she independently created falls within the scope of the
`patent's claims. Liability of an independent inventor turns solely on
`the question of timing, not the independent nature of the second
`inventor's actions. As long at the patent's inventor was the first to
`invent the claimed technology, she can exclude anyone else who
`develops the claimed technology, independently or not." The first
`individual to conceive of the invention-that is, mentally visualize the
`complete invention'-has superior rights to all future developers as
`long as she is diligent in either bringing her invention to the patent
`office or actually reducing the invention to practice from the time of
`conception by another inventor. 3 The second conceiver can even be
`the first to put the invention to actual use and still be considered an
`infringer. 4
`The lack of a copying requirement for liability places patent law
`in sharp contrast with copyright and trade secret law. Copyright law,
`as its name connotes, requires an individual to copy the protected
`work to be found liable. 5 While doctrines such as subconscious
`
`11. See MERGES & DUFFY, supra note 7, at 781.
`12. "Conception is the 'formation in the mind of the inventor, of a definite and
`permanent idea of the complete and operative invention, as it is hereafter to be applied in
`practice.' " Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir.
`1986) (quoting 1 ROBINSON ON PATENTS 532 (1890)). "Conception is the touchstone of
`inventorship ...." Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1227-28
`(Fed. Cir. 1994).
`13. 35 U.S.C. § 102(g) (2006) (defining the standard for determining priority between
`two inventors of the same technology); Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir.
`1998) (articulating the standard in reverse and noting that "priority of invention goes to
`the first party to reduce an invention to practice unless the other party can show that it
`was the first to conceive of the invention and that it exercised reasonable diligence in later
`reducing that invention to practice"); MERGES & DUFFY, supra note 7, at 440-41.
`Reduction to practice is established by either actually implementing the invention or filing
`an enabling patent application. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169
`(Fed. Cir. 2006). An actual reduction to practice that has been "abandoned, suppressed,
`or concealed" does not count for priority purposes. 35 U.S.C. § 102(g).
`14. Again, this holds true as long as the first conceiver is diligent from the "time prior
`to the conception by the other." 35 U.S.C. § 102(g).
`15. See Arnstein v. Porter, 154 F.2d 464, 468-69 (2d Cir. 1946). Some circuits allow
`copying to be established by a "striking similarity" between the protected work and
`infringing works, even if there is no evidence that the alleged infringer had any access to
`the copyrighted work. Gaste v. Kaiserman, 863 F.2d 1061, 1067-68 (2d Cir. 1988). But see
`Selle v. Gibb, 741 F.2d 896, 901 (7th Cir. 1984) (requiring proof of access even with a
`finding of striking similarity). Under such a test, some might argue that copying is not
`required to establish copyright infringement. However, the rationale for relying solely on
`striking similarity is
`that such evidence "preclude[s]
`the possibility of independent
`
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`copying potentially remove the state of mind from the copying
`requirement, 6 actual copying is still a fundamental first step in
`determining copyright infringement. 7
`to
`individual
`requiring an
`Trade secret
`law
`is similar,
`misappropriate the trade secret to be held liable. Misappropriation
`occurs when the trade secret is obtained through improper means or
`through a breach of confidence.18 Either trigger for liability entails a
`"copying" of the trade secret. The infringer obtains the information
`from someone else-in most cases the trade secret's creator. 9 And
`while trade secret law does preclude the use of information acquired
`by accident or mistake,2" the information must still be acquired from
`the
`trade secret owner and used with knowledge
`that
`it was
`inadvertently disclosed. By contrast, independent creation of the
`information, through normal means or reverse engineering,
`is a
`complete defense against a trade secret allegation.2
`Trademark
`law occupies a middle ground.
`Trademark
`infringement is based upon a finding of likely consumer confusion,
`which can occur without copying of the mark by the defendant. But
`intent to copy or deceive is one of the factors courts use in deciding
`consumer confusion, 22 and recent work by Barton Beebe has found
`
`creation." Ferguson v. NBC, Inc., 584 F.2d 111, 113 (5th Cir. 1978). Thus, copying is still
`established essentially by inference.
`16. See ABKCO Music, Inc. v. Harrisongs Music, Ltd., 722 F.2d 988, 998-99 & n.12
`(2d Cir. 1983) (finding liability even though the copying was subconscious and without
`intent); see also R. Anthony Reese, Innocent Infringement in U.S. Copyright Law: A
`History, 30 COLUM. J.L. & ARTS 133, 178-79 (2007) (detailing the irrelevance of intent in
`modern copyright law).
`17. See Ty, Inc. v. GMA Accessories, Inc., 132 F.3d 1167, 1169 (7th Cir. 1997) ("The
`Copyright Act forbids only copying; if independent creation results in an identical work,
`the creator of that work is free to sell it.").
`18. See UNIF. TRADE SECRETS ACT § 1, 14 U.L.A. 529, 537-38
`RESTATEMENT (THIRD) OF UNFAIR COMPETITION § 40 (1995).
`19. See, e.g., E.I. du Pont de Nemours & Co. v. Christopher, 431 F.2d 1012, 1015-17
`(5th Cir. 1970) (finding liability where the infringer obtained the trade secret by improper
`means, namely, by taking aerial photographs of a trade secret holder's chemical plant
`under construction); Smith v. Dravo Corp., 203 F.2d 369, 375-77 (7th Cir. 1953) (finding
`liability via a breach of confidence where the infringer obtained the trade secret in
`confidential negotiations with the trade secret holder).
`20. UNIF. TRADE SECRETS ACT § 1.
`21. See RESTATEMENT (THIRD) OF UNFAIR COMPETITION § 43 ("Independent
`discovery and analysis of publicly available products or information are not improper
`means of acquisition."); Maurer & Scotchmer, supra note 3, at 535.
`22. See Univ. of Notre Dame du Lac v. J.C. Gourmet Foods Imports Co., Inc., 703
`F.2d 1372, 1374 (Fed. Cir. 1983) (noting that intent is "pertinent to a determination of
`
`(2000);
`
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`that, in fact, evidence of intent is the most significant factor predicting
`a finding of trademark infringement.23 So, as a practical matter,
`infringement usually involves copying, or at least a
`trademark
`defendant's awareness of the plaintiff's mark. Patent law, then,
`stands alone among IP rights in not requiring or at least not strongly
`weighting evidence of copying.
`
`B. Copying Plays a Role in Other Patent Doctrines
`While copying isn't necessary for infringement, the existence of
`copying is not completely irrelevant in patent law. Many doctrines
`outside of the initial determination of infringement consider whether
`the alleged infringer or a third party has copied the patented
`technology. Some patent theory assumes, as a precondition, that
`others will copy the patented technology. Finally, much of the
`rhetoric used by courts and commentators when discussing patent
`infringement invokes the concepts of a copier and copying when
`identifying the infringer and describing her actions.
`
`1. Copying as an Element of Specific Patent Doctrines
`Whether a finding of patent infringement was the result of
`copying is relevant to the question of willful infringement and the
`accompanying enhancement of damages.24 "Willful infringement is
`... a measure of reasonable commercial behavior in the context of
`the tort of patent infringement. '25 The act of copying the patented
`technology evidences the infringer's "disregard[] [for] the property
`rights of the patentee" and "the deliberateness of the tortious acts. 26
`Patent law views such copying as "reprehensible" and, in turn, worthy
`
`likelihood of confusion"); Polaroid Corp. v. Polaroid Elecs. Corp., 287 F.2d 492, 495 (2d
`Cir. 1961) (indentifying "the reciprocal of defendant's good faith in adopting its own
`mark" as one of the variables for determining likelihood of confusion).
`23. Barton Beebe, An Empirical Study of the Multifactor Tests for Trademark
`Infringement, 94 CAL. L. REV. 1581, 1608 (2006) ("The court found an intent to confuse
`consumers in sixty-seven opinions. In sixty-five (97%) of these opinions, the court found
`an overall likelihood of confusion.").
`24. See In re Seagate Tech. LLC, 497 F.3d 1360, 1368 (Fed. Cir. 2007) (en banc)
`("Because patent infringement is a strict liability offense, the nature of the offense is only
`relevant in determining whether enhanced damages are warranted."); Knorr-Bremse
`Systeme Fuer Nutzfahrzeuge GmbH v. Dana Corp., 383 F.3d 1337, 1348-49 (Fed. Cir.
`2004) (en banc). A finding of willfulness is required to enhance damages but does not
`require such an enhancement. Seagate, 497 F.3d at 1368.
`25. Hoechst Celanese Corp. v. BP Chems. Ltd., 78 F.3d 1575, 1583 (Fed. Cir. 1996).
`26. Id.
`
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`
`of punitive damages in the form of enhanced damages.27 Courts have
`even justified raising a reasonable royalty award to compensate for
`copying despite a finding that the infringement wasn't willful. 28
`Notably, while copying is evidence of willful infringement, copying is
`not required to prove willful infringement.2 9 In fact, as we shall see,
`most willfulness claims do not involve allegations of copying at all.
`Nor does evidence of copying, by itself, mean the infringement is
`willful.3 °
`Copying is also relevant to the issue of patent validity as a
`secondary consideration of nonobviousness. 1
`Copying of the
`patented invention by the infringer or a third party is seen by patent
`law as an indicator that the invention is nonobvious 2 The rationale
`is that a competitor engages in such copying only if they need a
`solution to the problem the invention addresses and they cannot
`come up with one on their own.33 Patent law also assumes that others
`copy only those inventions of technical value.34 Both of these
`assumptions based on the existence of copying are indicators that the
`
`27. Knorr-Bremse, 383 F.3d at 1348-49.
`28. See, e.g., Monsanto Co. v. McFarling, 488 F.3d 973, 980 (Fed. Cir. 2007)
`(expressing a concern that a reasonable royalty that is too low would "create a windfall for
`infringers" who intentionally engage in unauthorized use of the patented technology; the
`court in that case had rejected a willfulness claim).
`29. See, e.g., Underwater Devices, Inc. v. Morrison-Knudsen Co., 717 F.2d 1380, 1389-
`90 (Fed. Cir. 1983) (setting out a multi-factor test to use in considering willfulness).
`30. Id.
`31. See Apple Computer, Inc. v. Articulate Sys., Inc., 234 F.3d 14, 26 (Fed. Cir. 2000);
`Specialty Composites v. Cabot Corp., 845 F.2d 981, 991 (Fed. Cir. 1988) (stating that the
`copying of the "claimed invention, rather than one in the public domain, is indicative of
`unobviousness" (quoting Windsurfing Int'l, Inc. v. AMF, Inc., 782 F.2d 995, 1000 (Fed.
`Cir. 1986))).
`32. Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1285-86 (Fed. Cir.
`2000)
`(citing
`the
`infringer's copying of the patented
`invention as evidence of
`nonobviousness).
`33. See Dow Chem. Co. v. Am. Cyanamid Co., 816 F.2d 617, 622 (Fed. Cir. 1987);
`Vandenberg v. Dairy Equip. Co., 740 F.2d 1560, 1567 (Fed. Cir. 1984) ("The copying of an
`invention may constitute evidence that the invention is not an obvious one.... This would
`be particularly true where the copyist had itself attempted for a substantial length of time
`to design a similar device, and had failed."); Christopher A. Cotropia, Nonobviousness as
`an Exercise in Gap Measuring, in 2 INTELLECTUAL PROPERTY AND INFORMATION
`WEALTH 21, 32 (Peter K. Yu ed., 2007) ("A competitor only engages in copying if they
`need a solution to the problem the invention addresses and they cannot come up with a
`solution on their own."). That rationale is open to question, however. A company may
`copy an invention not because it had no choice, but because it thought the invention was
`unpatented or unpatentable and therefore free to be used without need for reinvention.
`34. See Cotropia, supra note 33, at 32.
`
`

`

`Case 1:17-cv-00770-JDW Document 259-4 Filed 11/02/23 Page 12 of 48 PageID #: 29199
`
`1430
`
`NORTH CAROLINA LAW REVIEW
`
`[Vol. 87
`
`invention meets the nonobviousness requirement and is worthy of
`patent protection.
`Third, copying
`relevant
`is
`to some claims
`for
`indirect
`infringement. Specifically, the Federal Circuit has made it clear that a
`defendant is not liable for inducing infringement by another unless it
`intended that the conduct it induced infringe a known patent.3 6 An
`inducement claim doesn't necessarily involve copying-a defendant
`might independently develop a technology, then learn of a patent
`covering it, and still encourage another to infringe that patent.
`However, the fact that inducement requires both knowledge of the
`patent and intent to encourage infringement means that inducement
`is more likely than ordinary infringement cases to involve allegations
`of copying.37
`Finally, as an exception to the general rule that copying is
`irrelevant to the question of liability, an accusation of infringement
`under 35 U.S.C. § 271(e)(2)(A) almost by definition involves acts of
`copying. Section 271(e)(2)(A) allows a patent holder to sue a generic
`drug manufacturer who files an abbreviated new drug application
`("ANDA") that contains a paragraph IV certification.38 Such a
`certification alleges that the previously approved drug to which an
`ANDA pertains is covered by patents that are invalid or will not be
`infringed by the generic drug.39
`In order to file a proper and
`successful ANDA, the generic drug manufacturer must "copy" the
`original drug-the generic's
`active
`ingredient must be
`the
`bioequivalent of the listed drug.4" These sets of facts that give rise to
`
`id. (concluding
`35. See
`that copying provides second-order evidence
`the
`that
`technology gap between the prior art and the invention is such that patent protection is
`warranted).
`36. See DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1305-06 (Fed. Cir. 2006).
`37. Contributory infringement, by contrast, requires knowledge of the existence of the
`patent but not specific intent to infringe. Aro Mfg. Co. v. Convertible Top Replacement,
`Co., 377 U.S. 476, 488-89 (1964). These claims too must involve awareness of the
`patentee's technology but are less likely to involve copying.
`38. See 35 U.S.C. § 271(e)(2)(A) (2006); Bayer AG v. Elan Pharm. Research Corp.,
`212 F.3d 1241, 1245 (Fed. Cir. 2000). "A charge of infringement under § 271(e)(2) is
`technical
`in nature" given that the ANDA filer has only sought FDA approval.
`SCHECHTER & THOMAS, supra note 5, at 287.
`39. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`paragraph IV certification).
`40. An ANDA is proper only if the generic drug's active
`ingredient
`the
`is
`"bioequivalent" of the already approved drug. See 21 U.S.C. § 355(j)(2)(A)(iv). A
`generic drug is bioequivalent if the extent and rate of absorption of the drug are not
`significantly different from that of the already approved drug. See § 355(j)(8)(B)(i).
`
`the content of a
`
`(2006)
`
`(describing
`
`

`

`Case 1:17-cv-00770-JDW Document 259-4 Filed 11/02/23 Page 13 of 48 PageID #: 29200
`
`2009]
`
`COPYING IN PA TENT LAW
`
`1431
`
`a § 271(e)(2) allegation of infringement mean that the generic drug
`producer has copied the patent holder's technology. 1
`It does not,
`however, necessarily mean that the patented invention was copied; the
`patent might cover something other than the active ingredient to
`which the generic is bioequivalent 2
`
`2. Copying as a Foundation for Particular Patent Theories
`Copying also plays a role in a number of patent theories. The
`idea that a patent constitutes a bargain with the public, in which the
`patentee gets exclusivity for a limited time in exchange for giving the
`public information about the invention, presupposes that companies
`will read and learn from the patent in order to copy the invention
`(albeit after the patent has expired).
`Improvement theory assumes
`that one of the patent law's benefits is that others refer to the patent
`document and the technology it describes in order to build upon that
`technology. Design-around theory assumes that others read patents
`in order to create competing, noninfringing alternatives to the
`patented technology. The doctrine of equivalents is also grounded in
`the assumption that defendants copy from patent owners. One view
`of that doctrine is that it is meant to catch the "unscrupulous copyist"
`who has set out to copy the patented technology and makes a minor
`change in order to avoid infringement via a technicality.
`
`a. The Disclosure Bargain and Improvement Theory
`The improvement theory of patent law describes patenting as a
`mechanism
`to both
`assist
`and prompt others
`to develop
`
`41. See, e.g., Abbott Labs. v. Young, 920 F.2d 984, 991 (D.C. Cir. 1990) (Edwards, J.,
`dissenting) (noting that the ANDA process "emerged from Congress' efforts to balance
`two conflicting policy objectives: to induce name brand pharmaceutical firms to make the
`investments necessary to research and develop new drug products, while simultaneously
`enabling competitors to bring cheaper, generic copies of those drugs to market"); Takeda
`Chem.

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