Introduction to Intellectual Property: A U.S....

Introduction to Intellectual Property: A U.S.Perspective

Amanda Murphy, Michael Stramiello, Stacy Lewis, and Tom Irving

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, D.C. 20001-4413

Correspondence: [email protected]

This review introduces patents and trade secrets, the two mechanisms that U.S. law providesinventors to protect their inventions. These mechanisms are mutually exclusive: Onedemands disclosure and the other calls for concealment. Many biotechnology innovatorsopt for patents, which grant legal, time-limited monopolies to eligible inventions. To obtain apatent in the United States, an invention must be useful to the public and made or altered bythe hand of man. It must then clear the hurdles of noveltyand nonobviousness. If an inventioncan do that, obtaining a patent becomes a matter of form: Who qualifies as an inventor? Doesthe application demonstrate possession, stake a clear claim to the protection sought, andenable “ordinary” colleagues to replicate it? Has the inventor purposely withheld anything?This review addresses each of these hurdles as they apply to biotech inventions.

The United States recognizes four categoriesof intellectual property: copyrights, trade-

marks, trade secrets, and patents. Copyrightsprotect writings, illustrations, and other worksof authorship. Trademarks protect words, sym-bols, designs, sounds, fragrances, and colors thatdesignate the origin of a product. This articlefocuses on patents and trade secrets, the mech-anisms by which inventors can protect their in-ventions.

A trade secret is something that confersa business advantage, is not generally known,and must be maintained as a secret in order tobe protected. A patent is a legal monopoly thatis granted in exchange for disclosure of how tomake and use an invention. Because trade secretprotection requires secrecy and patent protec-tion requires disclosure, the two are generallyconsidered to provide mutually exclusive op-

tions for protecting an invention. Ordinarily,an inventor must choose to seek either patentprotection for an invention or trade secretprotection.1

In the sections that follow, the authors pro-vide a general overview of these two mecha-nisms for protecting inventions in the UnitedStates. Other articles in this collection containmore detailed discussions of both topics.

Editors: Salim Mamajiwalla and Rochelle Seide

Additional Perspectives on Intellectual Property in Molecular Medicine available at www.perspectivesinmedicine.org

Copyright # 2015 Cold Spring Harbor Laboratory Press; all rights reserved; doi: 10.1101/cshperspect.a020776

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1It remains possible, however, that a trade secret could evolvefrom an earlier-patented invention, as patent owners haveno obligation to disclose later innovations related to patent-ed subject matter. In this regard, patent owners should notethat obvious improvements of an earlier patented inventionare not eligible for further patent protection beyond theduration of the originally patented subject matter. Thus,trade secret protection may be the only option for suchinventions.

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TRADE SECRET LAW

What Is a Trade Secret?

In its simplest form, a trade secret is informa-tion. The information may relate to anythingfrom a method of manufacturing a product toa recipe for its formulation. The Uniform TradeSecrets Act (UTSA) defines “trade secret” as:

information, including a formula, pattern, com-pilation, program, device, method, technique, orprocess that:

i. derives independent economic value, actualor potential, from not being generally knownto, and not being readily ascertainable byproper means by, other persons who can ob-tain economic value from its disclosure oruse, and

ii. is the subject of efforts that are reasonableunder the circumstances to maintain itssecrecy.2

The Restatement of the Law of Unfair Com-petition defines a trade secret as:

any information that can be used in the opera-tion of a business or other enterprise and thatis sufficiently valuable and secret to afford anactual or potential economic advantage overothers.3

Thus, for information to qualify as a trade se-cret, it must remain generally unknown by thepublic; confer an economic benefit on its own-er; and be the subject of reasonable effortsto maintain its secrecy. Trade secret protec-tion generally does not apply to matters of pub-lic knowledge or general knowledge in anindustry.4

Protecting Trade Secrets

Trade secrets are protected by state laws. Moststates have enacted some variation of the UTSA,which provides rules for deciding disputes thatarise when someone improperly acquires tradesecret information.

The owner of a trade secret (often called the“originator”) has the rights to possess the ideaand its physical embodiments, to limit its dis-closure to others, and to contract for the termsof its use by others (Lariscey v. U.S. (949 F.2d1137, 1141) (Fed. Cir. 1991)). An originatormay enforce these rights through several legaltheories, including trade secret misappropria-tion, breach of contract, breach of trust or con-fidence, and quasi-contract.

To recover for trade secret misappropria-tion, the plaintiff must identify the specificsubject matter alleged to be a trade secret. TheRestatement (First) of Torts provides severalfactors that a court may consider in determiningwhether a trade secret, in fact, exists:

1. the extent to which those outside the origi-nator’s business know the information;

2. the extent to which those involved in theoriginator’s business know the information;

3. the measures the originator has taken to keepthe information secret;

4. the value of the information to both the orig-inator and to his competitors;

5. the amount of effort or money the origina-tor has spent in developing the information;

6. the ease or difficulty with which others couldproperly acquire or duplicate the informa-tion.

In addition, courts may also consider thenature of the alleged misconduct and the pub-lic interest in permitting access to the tradesecret.

If a trade secret does exist, the plaintiff mustthen establish ownership of the trade secret. Hetypically does this by showing sufficient evi-dence that he developed the trade secret.

After establishing ownership, the plaintiffmust then prove that the defendant obtainedthe trade secret through improper means. Boththe UTSA and the Restatement impose liabilityfor acquiring a trade secret through impropermeans. The defendant, however, may defendagainst an allegation of trade secret misappro-priation by establishing that he properly ob-

2UTSA §1(4) (1985).3Restatement (Third) of the Law of Unfair Competition,§39.4Restatement (First) of Torts §757, comment (b) (1939).

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tained the trade secret through either indepen-dent development or by working backwardfrom a publicly available product (a processcalled “reverse engineering”) (Aerospace Ameri-ca, Inc. v. Abatement Technologies, Inc. (738 F.Supp. 1061, 1072) (E.D. Mich. 1990)). This isbecause public information provided withoutrestriction may be copied at will.

After establishing that the defendant im-properly obtained the trade secret, the origina-tor must prove that the defendant actually usedor disclosed the information without autho-rization. Mere possession of a trade secret, with-out more, will not support a claim for tradesecret misappropriation (Gibson-Homans Co.v. Wall-Tite Inc. (26 U.S.P.Q.2d 1867) (C.D.Cal. 1992)).

But “slavish copying” is not required to es-tablish trade secret misappropriation (Richard-son v. Suzuki Motor Co. (868 F.2d 1226, 1244)(Fed. Cir. 1989)). A defendant who uses anoth-er’s trade secret is liable even if he modifies orimproves upon the trade secret, as long as thesubstance of the defendant’s use is derived fromthe originator’s secret (Forest Laboratories, Inc.v. Pillsbury Company (452 F.2d. 621, 625) (7thCir. 1971)).

If a court ultimately finds trade secret mis-appropriation, UTSA §§ 2–4 provide reme-dies for the plaintiff. These include injunctions,monetary damages (including the plaintiff ’sactual loss and the defendant’s unjust enrich-ment due to the misappropriation), and attor-ney’s fees.

Trade Secrets versus Patents

There are several reasons why an inventor mightchoose to protect an invention as a trade secretrather than seek patent protection. Of course,if an invention is not patentable (e.g., because itis not subject-matter eligible or because it is notnovel and nonobvious over the prior art), tradesecret protection may be the only option. Buteven if an invention is patentable, an inventormay choose to maintain it as a trade secret forother reasons. For instance, if an invention willhave a long shelf life, the unlimited duration oftrade secret protection provides a clear advan-

tage over the finite duration of patent protection(discussed below). Alternatively, for inventionsthat may soon become obsolete, trade secretprotection provides a promising alternative tothe lengthy process of patenting. And businessesseeking to protect inventions that are difficultto reverse engineer, such as complex manu-facturing methods or formulations (e.g., CocaColaw), might prefer trade secret protection tothe limited duration of a patent monopoly.

Ultimately, however, the decision of whetherto seek patent protection or to maintain an in-vention as a trade secret must be made on a case-by-case basis after examining the specific factsof each case. The role of trade secrets in protect-ing biotech innovations is discussed in greaterdetail in other articles of this publication.

PATENT LAW

What Is a Patent?

A patent is a grant, from the U.S. federal gov-ernment, of a limited monopoly. Of note, a pat-ent does not give its owner the right to practicean invention—but it does confer the right toexclude others from making, using, or sellingthe claimed invention in the United States andto exclude others from importing the inventioninto the United States.5

The patent owner’s right to exclude runsfor the life of the patent, which is fixed by statuteto be, in most cases, 20 years from its earliestrelevant filing date. This monopoly, limited interms of geography and time, is justified by thebenefit to society of having inventors share theirideas as soon as possible. But because issuedpatents are not self-enforcing, a patent ownermust bring a legal action against an infringerto secure the benefits of his granted patent.

To obtain a U.S. patent, an inventor mustfile, with the U.S. Patent and Trademark Office(USPTO), a patent application that containsone or more “claims.” In much the same waythat a fence defines the boundaries of a person’sreal property, a claim defines the boundaries ofan inventor’s intellectual property. And as with

535 U.S.C. §271(a).

U.S. Perspective of Intellectual Property

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real property, patents may be bought, sold,shared, or rented (“licensed”).

The USPTO recognizes two types of patentapplications: provisional and nonprovisional.The USPTO is tasked with examining non-provisional applications to determine whetherthe inventors are entitled to the full scope ofprotection requested in the claims. Provisionalapplications are not examined by the USPTOand serve only to secure an effective filing datefor an invention that will ultimately be claimedin a nonprovisional patent application. Thus,generally speaking, a provisional applicationmarks the point after which any disclosures ofthe invention will not prevent patentability.6

Sources of Patent Law

The U.S. Constitution establishes that patentsare governed by federal law:

The Congress shall have the power . . . [t]o pro-mote the Progress of Science and useful Arts, bysecuring for limited Times to Authors and In-ventors the exclusive Right to their respectiveWritings and Discoveries[.]7

Acting under its Constitutional authority, Con-gress has promulgated the patent laws, whichare codified in Title 35 of the United StatesCode (35 U.S.C. §101 et seq.). These laws gov-ern, among other things, the requirements forpatentability, the examination of patent appli-cations, the issuance of patents, and the en-forcement of patents against infringement.8

Congress also created the USPTO as an admin-istrative agency under the executive branch.Congress authorized the USPTO to promulgate

rules implementing the patent laws. Those rulesare contained in Title 37 of the Code of FederalRegulations (37 C.F.R. §1.1 et seq.). The USPTOalso publishes a Manual of Patent ExaminingProcedures (MPEP) providing instructions forUSPTO personnel regarding the examinationof patent applications. Finally, Congress createda single appellate court, the United States Courtof Appeals for the Federal Circuit, to hear ap-peals in most patent-related cases.

With one exception, the U.S. federal courtshave exclusive jurisdiction over causes of actionarising under the patent laws. There are 94 fed-eral district courts, which are the courts offirst instance for patent infringement litigation.The one exception is the United States Inter-national Trade Commission (USITC), which isan executive branch agency that hears cases inthe first instance to stop importation of infring-ing goods. Under the U.S. common law system,the judicial branch (i.e., the federal courts) hasdeveloped a body of case law interpreting thepatent laws. Figure 1 presents a graphical depic-tion of the U.S. federal court system and theinterplay of the USITC and USPTO.

Requirements for Obtaining a Patent

The USPTO grants three general types of pat-ents:

1. utility patents, relating to a “new and usefulprocess, machine, manufacture, or composi-tion of matter, or any new and useful im-provement thereof”;9

2. plant patents, relating to “any distinct andnew variety of plant”;10

3. design patents, relating to “any new, originaland ornamental design for an article ofmanufacture.”11

This section focuses on the requirements forobtaining utility patents, which are the mostcommon category of patents in the field of mo-lecular medicine.

6The authors encourage all inventors, and especially those indisciplines that encourage public presentation and writtenpublication of new innovations, to file provisional applica-tions before publicly disclosing their inventions.7U.S. Constitution, Article I, Section 8, Clause 8.8With the signing of the America Invents Act (AIA) onSeptember 16, 2011, the U.S. patent law underwent a majoroverhaul. Some of the changes applied immediately, on Sep-tember 16, 2011; others 1 year later, on September 16, 2012;and still more 18 months later, on March 16, 2013. The AIAwas not retroactive, however, so the old law (pre-AIA) willbe in effect and coexist with the new law (AIA) until approx-imately 2034.

935 U.S.C. §101.1035 U.S.C. §161; a plant can also be the subject of a utilitypatent if it satisfies the standard requirements.1135 U.S.C. §171.

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What Can Be Patented?

Not all scientific research—regardless of howinnovative it may be—will result in a patentableinvention. An invention must be directed topatent-eligible subject matter and must alsohave utility. These requirements are set forthin 35 U.S.C. §101:

Whoever invents or discovers any new and usefulprocess, machine, manufacture, or compositionof matter, or any new and useful improvementtherefor, may obtain a patent therefore, subjectto the conditions and requirements of this title.

An invention is “useful” under §101 if it is ca-pable of providing some identifiable benefit tothe public (Juicy Whip, Inc. v. Orange Bang, Inc.(185 F.3d 1364, 1366) (Fed. Cir. 1999)). Section101 has been interpreted to exclude inventionsdeemed to be immoral (Tol-o-matic, Inc. v.Proma Produkt-und Marketing Gesellschaft(945 F.2d 1546, 1522–1553) (Fed. Cir. 1991)).In addition, if an invention is scientifically im-possible, it lacks utility (EMI Group NorthAmerica, Inc. v. Cypress Semiconductor Corp.(268 F.3d 1342, 1349) (Fed. Cir. 2001)). Gener-ally speaking, the threshold for satisfying theutility requirement is not difficult to demon-strate for most biological inventions. Neverthe-less, a mere “unsupported hypothesis” generallywill not satisfy the utility requirement (In re’318 Patent Infringement Litigation (583 F.3d1317, 1327) (Fed. Cir. 2009)). In addition, anyasserted utility should be commensurate withthe scope of the claims.12

Besides having utility, the invention mustalso be of a nature that is appropriate for patentcoverage. Section 101 authorizes patents onlyfor machines, compositions of matter, articlesof manufacture, and processes. Subject mattermust fall within one of these four categories tobe eligible for patent protection.

Generally speaking, “anything under thesun that is made by the hand of man” shouldbe patent-eligible (Diamond v. Chakrabarty(447 U.S. 303, 309) (1980)). For example, inthe Chakrabarty case, the U.S. Supreme Courtheld that a living, genetically engineered bacte-rium was patent-eligible as an article of manu-facture because it did not exist in nature.

Still, there exist exceptions to “anything un-der the sun.” Long-standing case law bars pat-enting of certain innovations directed to “laws ofnature, physical phenomena, and abstract ideas”(Diamond v. Chakrabarty). Two recent examplesimpact biotech innovators. First, the U.S. Su-preme Court decided that naturally occurringgene sequences are not patent-eligible becausethey exist in nature.13 Second, the SupremeCourt decided that claims instructing practi-tioners to gather data and then draw certain in-ferences in light of newly discovered therapeuticcorrelations are not patent-eligible, becausethey merely recite a law of nature and ineligiblemental steps (Prometheus Labs., Inc. v. MayoCollaborative Services (132 S. Ct. 1289, 1297)(2012)). A more detailed discussion of patenteligibility with respect to biotech inventions isprovided in other articles of this publication.

Who Can Obtain a Patent?

Section 101 authorizes patents only for thosewho “invent” or “discover.” Therefore, in theUnited States, an inventor can obtain a patent.And for patent applications filed after Septem-ber 15, 2012, an assignee of an inventor can alsoobtain a patent.14 In either case, the patent ap-plication must identify the true and original

USPTO

94 federaldistrict courts

USITC

U.S.Supreme Court

Court ofAppeals for theFederal Circuit

Figure 1. Graphical representation of the U.S. federalcourt system and its interplay with the USITC andUSPTO.

12Id.

13Association for Molecular Pathology v. Myriad Genetics, Inc.(133 S. Ct. 2107) (2013) (holding that synthetically pro-duced gene sequences are patent-eligible).1435 U.S.C. §118.



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inventor(s), and those inventors must submitan oath declaring their true inventorship.15

Determining inventorship is a key step inpreparing and prosecuting patent applications,as well as when enforcing issued patents. Thecase law concerning inventorship disputes pro-vides some guidance for identifying inven-tors. Completing an invention requires threesteps: (1) conception, (2) activities leading to-ward a reduction to practice, and (3) reductionto practice. Reduction to practice may be “actu-al,” by making the invention and demonstratingthat it works for its intended purpose, or “con-structive,” by filing a patent application thatcomplies with the applicable disclosure require-ments.

To be an inventor, one must have made orcontributed to the conception of the inven-tion (Burroughs Wellcome Co. v. Barr Laborato-ries, Inc. (40 F.3d 1223, 1227–1228) (Fed. Cir.1994)). Although the inventor, or someone act-ing under the inventor’s direction, can accom-plish the second and third steps to complete aninvention,16 only the inventor can complete thestep of conception. Unless a person participatesin the conception of the invention, he or shedoes not qualify as an inventor (In re Hardee(223 U.S.P.Q. 1122, 1123) (Comm’r Pat. 1984)).

Conception is the “formation in the mindof the inventor, of a definite and permanent ideaof the complete and operative invention, as itis hereafter to be applied in practice” (Hybritech,Inc. v. Monoclonal Antibodies, Inc. (802 F.2d1367, 1376) (Fed. Cir. 1986)). “[T]he test forconception is whether the inventor had anidea that was definite and permanent enoughthat one skilled in the art could understand theinvention. . . . An idea is definite and permanentwhen the inventor has a specific, settled idea, a

particular solution to the problem at hand, notjust a general goal or research plan that he hopesto pursue” (Burroughs Wellcome v. Barr). Thus,vague notions of a goal to be achieved, or gen-eral suggestions of an approach to a problem, donot rise to the level of conception.

Joint inventorship is also allowed in theUnited States. This is particularly useful for bio-tech inventions, which often result from collab-orative efforts among multiple inventors. Sec-tion 116(a) of the patent statute, as recentlyamended by §20 of the America Invents Act(AIA), states that inventors may jointly applyfor a patent even if they did not physicallywork together, did not make the same type oramount of contribution, or did not contributeto every claim in the patent. A party claimingjoint inventorship must “prove his contributionto the conception of the claims by clear andconvincing evidence” (Symantec Corp. v. Com-puter Associates Int’l, Inc. (522 F.3d 1279, 1295)(Fed. Cir. 2008)). For joint inventorship, each“joint inventor must contribute in some signif-icant manner to the conception of the inven-tion” (Gemstar-TV Guide Int’l, Inc. v. ITC (383F.3d 1352 at 1381) (Fed. Cir. 2004), quotingFina Oil and Chemical Co. v. Ewen (123 F.3d1466, 1473) (Fed. Cir. 1997); see also Bard Pe-ripheral Vascular, Inc. v. W.L. Gore & Associates,Inc. (670 F.3d 1171) (Fed. Cir. 2012)).

Improper inventorship may invalidate apatent. It may also serve as grounds for a findingof unenforceability if the applicant had decep-tive intent when listing improper inventors (see,e.g., Ajinomoto Co., Inc. v. Archer-Daniels-Mid-land Co. (228 F.3d 1338) (Fed. Cir. 2000) andFrank’s Casing Crew & Rental Tools v. PMR Tech-nologies (292 F.3d 1363) (Fed. Cir. 2002)). Ifa litigant alleges invalidity based on improperinventorship, the patent owner may have theopportunity to correct inventorship before acourt declares the patent invalid (CheckpointSystems, Inc. v. All-Tag Security S.A. (412 F.3d1331, 1340) (Fed. Cir. 2005), quoting Pannuv. Iolab Corp. (155 F.3d 1344) (Fed. Cir. 1998)).

Inventorship also has ownership implica-tions because in the United States, the inventoris the first owner of a patent. This is importantbecause co-owners of a U.S. patent may make,

1535 U.S.C. §115 requires that a patent applicant “shall makeoath that he believes himself to be the original and firstinventor. . . .” See also 77 Fed. Reg. 48776 (Aug. 14, 2012)for the USPTO’s rules relating to the AIA changes in theinventor’s oath provisions that went into effect for applica-tions filed after September 15, 2012.16“An inventor may solicit the assistance of others whenperfecting the invention without ‘losing’ any patent rights.”Trovan, Ltd. v. Sokymat SA (299 F.3d 1292, 1302) (Fed. Cir.2002).

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use, offer to sell, and sell the patented inventionwithout regard to the wishes of any other co-owner.17 Finally, proof of inventorship may haveimplications for derivation proceedings andeligibility for prior art exceptions under newAIA provisions.18 Thus, care should be takento maintain a proper chain of title in all assign-ments. Inventorship and ownership consider-ations are discussed in greater detail in otherarticles of this publication.

Novelty

An invention must be new to qualify for patentprotection. This “novelty” requirement stemsfrom §§ 101 and 102 of the patent statute:§101 authorizes patents only for “new” inven-tions, while §102 “covers in detail the condi-tions relating to novelty” (Diamond v. Diehr(450 U.S. 175, 189) (1981)).

An invention’s novelty is necessarily mea-sured against the background of what hascome before. This background information iscalled “prior art.” Section 102 of the patent stat-ute defines the items of prior art against whichan invention’s novelty will be assessed, and in-cludes prior patents and patent applications,printed publications, prior knowledge and use,and prior sales.

Two policies underlie the novelty require-ment for patentable inventions: “firstness” and“promptness.” The firstness requirement gen-erally guarantees that only the first inventor iseligible to receive a patent, although situationscan exist in which the second party to file re-ceives the patent (see, e.g., Chen v. Bouchard(347 F.3d 1299) (Fed. Cir. 2003) (interferenceproceeding granting priority to second filer)).The promptness requirement generally ensuresthat inventors file their patent applications at anearly date.

The AIA brought major changes to U.S. pat-ent law. Some of the most significant changes

involved the novelty provisions of §102. TheAIA’s changes to §102 are discussed in thenext article of this publication. Here we discusspre-AIA §102,19 which will coexist with the newlaw until at least approximately 2034.

Pre-AIA (and AIA) §102 defines circum-stances under which an inventor is not entitledto a patent. Pre-AIA §102(a), (e), (f ), and (g)address the firstness requirement of novelty andproscribe an inventor from receiving a patentfor an invention if the invention was:

1735 U.S.C. §262. See also Falana v. Kent State University(669 F.3d 1349) (Fed. Cir. 2012) and Ethicon, Inc.v. United States Surgical Corp. (135 F.3d 1456, 1461) (Fed.Cir. 1998).18AIA 35 U.S.C. §102(b).

19Pre-AIA §102: A person shall be entitled to a patent unless:

(a) the invention was known or used by others in this coun-try, or patented or described in a printed publicationin this or a foreign country, before the invention thereofby the applicant for a patent, or

(b) the invention was patented or described in a printedpublication in this or a foreign country or in publicuse or on sale in this country, more than one year priorto the date of application for patent in the United States,or

(c) he has abandoned the invention, or(d) the invention was first patented or caused to be patented,

or was the subject of an inventor’s certificate, by theapplicant or his legal representatives or assigns in a for-eign country prior to the date of the application forpatent in this country on an application for patent orinventor’s certificate filed more than twelve months be-fore the filing of the application in the United States, or

(e) the invention was described in—(1) an application forpatent, published under section 122(b), by another filedin the United States before the invention by the applicantfor patent or (2) a patent granted on an application forpatent by another filed in the United States before theinvention by the applicant for patent, except that aninternational application filed under the treaty definedin section 351(a) shall have the effects for the purposesof this subsection of an application filed in the UnitedStates only if the international application designatedthe United States and was published under Article21(2) of such treaty in the English language; or

(f ) he did not himself invent the subject matter sought to bepatented, or

(g) (1) during the course of an interference conducted un-der section 135 or section 291, another inventor in-volved therein establishes, to the extent permitted insection 104, that before such person’s invention thereofthe invention was made by such other inventor and notabandoned, suppressed, or concealed, or (2) before suchperson’s invention thereof, the invention was made inthis country by another inventor who had not aban-doned, suppressed, or concealed it. In determining pri-ority of invention under this subsection, there shall beconsidered not only the respective dates of conceptionand reduction to practice of the invention, but also thereasonable diligence of one who was first to conceive andlast to reduce to practice, from a time prior to concep-tion by the other.



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† “known or used by others in this country”before the inventor’s date of invention (pre-AIA §102(a));

† “patented or described in a printed publi-cation in this or a foreign country” beforethe inventor’s date of invention (pre-AIA§102(a));

† described in a published patent applicationthat was filed in the United States beforethe inventor’s date of invention (pre-AIA§102(e));

† described in a patent that was “granted onan application for patent by another filed inthe United States” before the inventor’s dateof invention (pre-AIA §102(e));

† invented bysomeone else (pre-AIA §102(f ));or

† “made in this country by another inventorwho had not abandoned, suppressed or con-cealed it” before the inventor’s date of inven-tion (pre-AIA §102(g)).Unless it can be shown that the inventor’s

date of invention was earlier than any of theseevents, the inventor will not be granted a patentfor his invention. To satisfy the firstness provi-sions of pre-AIA §102(a), (e), (f ), and (g), thedate of invention needs to be earlier than theeffective date of the prior art event in question.

Pre-AIA §102(b), (c), and (d) address the“promptness” requirement of novelty and pro-scribe an inventor from receiving a patent for aninvention if he waited too long before filing apatent application. For example, §102(b) statesthat an inventor is not entitled to a patent if,more than 1 year before the priority date of theinventor’s U.S. patent application, the inventionwas “patented or described in a printed publi-cation in this or a foreign country”20 or “in

public use or on sale in this country.” Similarly,§102(c) prevents an inventor from obtaininga patent for an invention he has abandoned.Finally, §102(d) bars an inventor from receivinga patent if the inventor has already received apatent for his invention in a foreign countrybased on an application filed more than 1 yearprior to the filing date of his U.S. application.Thus, §102(d) provides an incentive for inven-tors who have filed a patent application in aforeign country to file a corresponding U.S. ap-plication within 12 months.

The promptness sections of pre-AIA§102(b), (c), and (d) are referred to as “statu-tory bars” to patentability. This is because, un-like the firstness provisions of pre-AIA §102(a),(e), (f ), and (g), an inventor cannot overcomethe promptness prior art events by showing anearlier date of invention.

Another important difference between thefirstness provisions of pre-AIA §102(a), (e), and(g) and the promptness provisions of pre-AIA§102(b) and (d) is that an inventor’s own workmay preclude patentability for lack of prompt-ness, but is not considered prior art in deter-mining firstness. Thus, if an inventor publishesa scientific article disclosing his invention morethan 1 year before filing a patent application,that publication will prevent the inventor fromobtaining a patent under pre-AIA §102(b) be-cause he did not promptly file his application.On the other hand, if the inventor filed his pat-ent application within a year of the publication,the firstness provisions will not necessarily ne-gate patentability.

In the jargon of patent law, an inventionlacks novelty if it is “anticipated” by the priorart. Anticipation requires a two-step analysis:First, the claim must be construed to determinewhat the inventor has invented, and second, theprior art must be compared to that invention.

20Inventors should take care when sharing their findings.Although a presentation including a transient display ofslides will not necessarily count as a “printed publication,”continuously displaying slides on poster boards for two anda half days at a conference has barred at least one inventorfrom patenting. See In re Klopfenstein (380 F.3d 1345) (Fed.Cir. 2004). Likewise, giving a paper to the head of a confer-ence, then orally presenting it at that conference, and thendistributing copies “on request, without any restrictions, toas many as six persons” has barred another inventor from

patenting. See Massachusetts Institute of Technology v. A.B.Fortia (774 F.2d 1104, 1108–1109) (Fed. Cir. 1985). On theother hand, sending six copies of an article to a “friend” maynot serve as a bar to patenting. See Preemption Devices,Inc. v. Minnesota Mining & Manufacturing Co. (732 F.2d903, 906) (Fed. Cir. 1984). Of course, the best advice is tofile a provisional application before making any public dis-closures of an invention.

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In general, an invention is anticipated if allof its elements are contained, either expresslyor inherently, in a single item of prior art. Ifone must “reach beyond the boundaries of asingle reference to provide missing disclosureof the claimed invention,” the invention is notanticipated.21 In addition, the reference mustteach those skilled in the art “to make or carryout what it discloses in relation to the claimedinvention” (In re Antor Media Corp. (689 F.3d1282, 1290) (Fed. Cir. 2012)). Thus, the priorart reference must generally provide an enablingdisclosure in order to anticipate a claimedinvention.22

The purpose of the novelty requirement is toensure that patents will not issue if an inventionis already in the public’s possession. An appli-cant will not be permitted to remove technologyfrom the public domain. Thus, §102 of the pat-ent statute serves a gatekeeping function byguaranteeing that only truly innovative technol-ogies are granted as U.S. patents.

Nonobviousness

Under pre-AIA (and AIA) U.S. patent law, aninvention is not patentable if it would have beenobvious to someone of ordinary skill in the artat the time of the invention. Even when an in-vention is novel over the prior art, if the inven-tor has merely made an obvious modification tothe existing body of knowledge, he will not beawarded a patent. The requirement that an in-vention be nonobvious over the prior art is setforth in §103(a) of the pre-AIA patent statuteand was largely unchanged in the AIA.23

As the statutory language makes clear, non-obviousness does not require a “flash of genius.”Still, “the results of ordinary innovation arenot the subject of exclusive rights under thepatent laws” (KSR International Co. v. Teleflex,Inc. (550 U.S. 398, 427) (2007)). To be patent-able, an invention must be “more than the pre-dictable use of prior art elements according totheir established functions.”24

The Supreme Court has identified four fac-tors that must be considered when determiningwhether a prior art reference, or combination ofreferences, renders a claim obvious (Grahamv. John Deere Co. (383 U.S. 1) (1966)):

† the scope and content of the prior art;

† the differences between the prior art and theclaimed invention;

† the level of skill in the art;

† any objective indicia of nonobviousness.

The provisions of §102 define what is priorart for purposes of an obviousness determina-tion. However, the prior art must be analogousto the claimed invention; art that is “too re-mote” should not negate patentability. Priorart is analogous to a claimed invention if it iswithin the field of the invention or in a field thatis reasonably pertinent to the problem the in-ventor tried to solve, such that a person skilledin the art would look to the reference to solvethat problem.

The proper inquiry under §103 is whetherthe invention, as a whole, would have been ob-vious to someone of ordinary skill in the art atthe time of invention. However, “a patent com-posed of several elements is not proved obviousmerely by demonstrating that each of its ele-ments was, independently, known in the priorart.”25 This is so because inventions in most, ifnot all, instances build on work that was known

21Scripps Clinic & Research Foundation v. Genentech, Inc.(927 F.2d 1565, 1577) (Fed. Cir. 1991).22The one exception to this enablement requirement is priorpublic use. See pre-AIA §102(b).23Pre-AIA §103(a): “A patent may not be obtained thoughthe invention is not identically disclosed or described as setforth in section 102 of this title, if the differences between thesubject matter sought to be patented and the prior art aresuch that the subject matter as a whole would have beenobvious at the time the invention was made to a personhaving ordinary skill in the art to which said subject matterpertains. Patentability shall not be negatived by the mannerin which the invention was made.”

AIA §103: “A patent for a claimed invention may not beobtained, notwithstanding that the claimed invention is not

identically disclosed as set forth in section 102, if the differ-ences between the claimed invention and the prior art aresuch that the claimed invention as a whole would have beenobvious before the effective filing date of the claimed inven-tion to a person having ordinary skill in the art to which theclaimed invention pertains. Patentability shall not be negat-ed by the manner in which the invention was made.”24Id. at 417.25KSR, at 418.



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in the prior art.26 A key question is whetherthe claimed invention would have been pre-dictable in view of the teachings of the priorart. Put differently, an invention is obviousif those skilled in the art would have had a rea-sonable expectation of success in arriving atthe invention based on the teachings of the pri-or art. In this regard, it is important to note that“[a] person of ordinary skill is . . . a personof ordinary creativity, not an automaton.”27

Thus, the nonobviousness requirement ex-tends beyond what is expressly taught in theprior art.

In addition to comparing the claimed in-vention to the prior art, an obviousness de-termination should also evaluate objective indi-cia of nonobviousness. Such considerationsinclude:

† long-felt but unresolved need;

† commercial success;

† unexpected results;

† copying by others;

† praise for the invention;

† disbelief or skepticism of those skilled in theart;

† evidence that others tried and failed;

† licenses.

Factors such as these can be used to dem-onstrate the nonobviousness of a claimed in-vention. However, any such evidence shouldgenerally be commensurate in scope with theclaims if it is to weigh against a finding of obvi-ousness for the claimed invention.

Disclosure and Claiming

A U.S. patent application must contain a spec-ification, including at least one claim. Section112 of the pre-AIA and AIA patent statutes gov-erns those requirements:

The specification shall contain a written descrip-tion of the invention and of the manner and

process of making and using it, in such full, clear,concise, and exact terms as to enable any personskilled in the art to which it pertains, or withwhich it is most nearly connected, to make anduse the same, and shall set forth the best modecontemplated by the inventor of carrying out hisinvention.

The specification shall conclude with one ormore claims particularly pointing out and dis-tinctly claiming the subject matter which theapplicant regards as his invention.28

The first paragraph of §112 deals solely with thewritten disclosure of the invention, and the sec-ond paragraph deals exclusively with the claims.

§112, First Paragraph—Requirementsfor the Specification

The first paragraph of §112 recites three inde-pendent and distinct requirements for the spec-ification:

1. To describe the manner and process of mak-ing and using the claimed invention in suchfull, clear, concise, and exact terms as to en-able one skilled in the art to make and use theinvention. This is referred to as the “enable-ment requirement” and is itself made up oftwo separate elements: “how-to-make” and“how-to-use.”

2. To describe the subject matter defined in theclaims. This is referred to as the “writtendescription requirement.”

3. To set forth the best mode contemplated bythe inventor of carrying out the invention atthe time of filing. This is referred to as the“best mode requirement.”

These requirements ensure that the publicwill receive something in exchange for the peri-od of exclusivity granted to the inventor. A fulland complete disclosure of the invention, in-cluding the manner of making and using it,confers two benefits to the public. First, it in-creases the body of public knowledge availablefor further research and innovation. Second, it

26Id.27KSR, at 421.

2835 U.S.C. §112. (The AIA did not change the substance ofthe pre-AIA §112 requirements of a patent application; itsimply redesignated the paragraphs of §112 with letters.)

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ensures that the invention will be freely availableto the public once the patent term has expired.

To satisfy the enablement requirement,one skilled in the art, upon reading the disclo-sure, must be able to practice the claimed inven-tion. Generally speaking, the patent disclosureshould satisfy both the “how-to-make” and“how-to-use” prongs mentioned above for thefull scope of the claims in order to be enabling.Still, the enablement requirement generallydoes not require a patent disclosure to enableone of ordinary skill in the art to make and use aperfected, commercially viable embodiment ofthe invention (CFMT, Inc. v. Yieldup Int’l Corp.(349 F.3d 1333, 1338) (Fed. Cir. 2003)).

A patent application may be enabling even ifthose skilled in the art would have to conductsome amount of routine experimentation topractice the claimed invention. But if it wouldrequire undue experimentation to practice theinvention in view of the disclosure, the applica-tion likely will not satisfy the enablement re-quirement (Hybritech, Inc. v. Monoclonal Anti-bodies, Inc. (802 F.2d 1367) (Fed. Cir. 1986)).

A determination of whether undue experi-mentation is needed to practice an invention is afact-intensive inquiry and typically involvesanalysis of one or more of the following factors:

† the nature of the invention;

† the breadth of the claims;

† the state of the prior art;

† the predictability or unpredictability of theart;

† the level of skill in the art;

† the quantity of experimentation needed;

† the amount of direction or guidance provid-ed by the application;

† the presence or absence of working examplesin the application.

These are often called the “Wands factors,”after the Federal Circuit decision that providedthe factors as useful guidance for determiningenablement (In re Wands (858 F.2d 731, 737)(Fed. Cir. 1988)). If a patent application pro-vides sufficient guidance, in view of these fac-tors, such that one skilled in the art can practicethe claimed invention without undue experi-

mentation, the disclosure should satisfy the en-ablement requirement.

In March 2010, the Federal Circuit reiterat-ed, en banc, that the enablement requirementis separate from the written description require-ment (Ariad Pharmaceuticals, Inc. v. Eli Lillyand Co. (598 F.3d 1336, 1341) (Fed. Cir. 2010)(en banc)). Specifically, a patent specificationmust teach one of ordinary skill in the art howto make and use the invention and, separately,must describe the invention sufficiently so thatone of ordinary skill in the art would under-stand that the inventor possessed the subjectmatter claimed.

To satisfy the written description require-ment, the specification should demonstratethat the inventor had possession of the claimedsubject matter as of the filing date of the appli-cation. It generally will not be sufficient that thedisclosure renders the claims obvious (Lock-wood v. American Airlines, Inc. (107 F.3d 1565)(Fed. Cir. 1997)). The written description re-quirement is satisfied if one skilled in the art,reading the original disclosure, is able to discernthe claimed invention from the words, struc-tures, figures, diagrams, and/or formulas setforth in the patent application (Purdue PharmaL.P. v. Faulding, Inc. (230 F.3d 1320, 1323) (Fed.Cir. 2000)).

Whether a claim is supported for purposesof the written description requirement dependson a variety of factors, including (see Ariad at1351; see also Capon v. Eshhar (418 F.3d 1349,1359) (Fed. Cir. 2005) and In re Smythe (480F.2d 1376, 1382–1383) (C.C.P.A. 1973)):

† the nature of the claim;

† the scope of the claims;

† the level of detail provided;

† the extent and content of the prior art;

† the complexity and predictability of the priorart;

† the existing knowledge in the field;

† the maturity of the technology.

If the art is predictable, a very brief disclo-sure may be sufficient to satisfy the written de-scription requirement. But when the art is un-predictable, a more extensive disclosure may be



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required. That being said, the written descrip-tion generally need not include informationthat is well-known to those skilled in the art atthe time the application is filed (Hybritech, Inc.v. Monoclonal Antibodies, Inc. (802 F.2d 1367,1384) (Fed. Cir. 1986)). And the written de-scription generally need not describe the inven-tion in exactly the same words that are used inthe claims (Martin v. Johnson (454 F.2d 746,751) (C.C.P.A. 1972)).29 As long as the disclo-sure reasonably conveys to those skilled in theart that the inventor had possession of theclaimed subject matter as of the application’sfiling date, the disclosure should satisfy thewritten description requirement.

Finally, the first paragraph of §112 also re-quires that the specification set forth the bestmode contemplated by the inventor for carry-ing out his invention. Although the best mode isstill a required part of the specification underthe AIA, as of September 16, 2011, failure todisclose the best mode for practicing the inven-tion cannot be the grounds for finding a patentinvalid or unenforceable.30

Thebestmoderequirementcanbeconsideredas requiring disclosure of information that mightotherwise be considered a trade secret. However,this does not necessarily mean that the inventormust disclose the optimum mode for practicingthe invention—the patent law allows patent ap-plicationsto be filed when the inventionhas neverbeen reduced to practice in any form, much lesscommercial form. Moreover, there is no require-ment that the best mode be identified as such inthe application. And when the inventor does notknow of a best mode, there is no duty to find one.When a best mode is known, however, the inven-tor should disclose it in the specification so that

the public receives what it bargained for in con-ferring a patent by allowing competitors to com-pete fairly with the patentee following expirationof the patent.

§112, Second Paragraph—Requirementsfor the Claims

Certain conventions must be applied when draft-ingclaimsforU.S.patentapplications.Eachclaimis a fragment of a single sentence that begins withthe phrase “I claim” or “We claim” or “What isclaimed is” and ends with a period. Claims canstart with a preamble phrase announcing the ge-neral subject matter of the claim, for example, aproduct, a process of making, a process of using,or a method. The preamble is followed by a tran-sition phrase (usually “comprising,” “consistingessentially of,” or “consisting of”), which is thenfollowed by a statement of the invention.

The second paragraph of §112 contains tworequirements for the claims of a patent applica-tion. The first requirement calls for precisionand definiteness. In other words, one skilledin the art must be able to tell with a reasonabledegree of certainty whether his or her conduct iswithin or outside the scope of the claim. Simplystated, the claims should not be “vague or in-definite” and should clearly set out the bound-aries of the subject matter for which the patentgrants protection.

The second requirement is that the claimsmust be directed to the subject matter that theapplicant regards as his or her invention. Theclaims should distinguish the invention fromwhat came before in the art and circumscribewhat is foreclosed from future enterprise duringthe limited period of exclusivity associated withthe patent (United Carbon Co. v. Binney & SmithCo. (317 U.S. 228, 236) (1942)). This means notonly that an applicant may claim whatever heregards as his invention, but also that an appli-cant may not claim subject matter that he doesnot regard as his invention.

Consequently, a claim that is understand-able to one skilled in the art, and that definessubject matter that the applicant regards as theinvention, should meet the requirements of thesecond paragraph of §112. In other words, if

29Stating “the description need not be in ipsis verbis (i.e., ‘inthe same words’) to be sufficient.”30AIA Sec. 15(c), 125 Stat. 328. Under the AIA’s amend-ments, 35 U.S.C. §282 now reads:

(3) Invalidity of the patent or any claim in suit for failure tocomply with—(a) any requirement of section 112, except that the fail-

ure to disclose the best mode shall not be a basis onwhich any claim of a patent may be canceled or heldinvalid or otherwise unenforceable; or

(b) any requirement of section 251.

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the claims set out and circumscribe, with a rea-sonable degree of precision, a particular areathat the applicant regards as the invention, theclaims should satisfy the statutory requirementsof §112, second paragraph.31 This calls for spe-cificity that allows one of ordinary skill in the artto determine the boundaries of the claim (Hal-liburton Energy Services, Inc. v. M-I LLC (514F.3d 1244, 1249–1250) (Fed. Cir. 2008)).

Claims satisfy the definiteness requirementif they provide both a clear definition of theinvention (to facilitate determinations of pat-entability) and a clear warning to others (toplace potential infringers on reasonable noticeof what they can and cannot do).32 These as-pects of the definiteness requirement ensurethat the walls an inventor has erected to definehis patent claims are made of something otherthan quicksand.33 The claims of a patent shouldbe designed to provide adequate notice to otherparties regarding the metes and bounds of thepatented invention.

Duty of Disclosure

In the United States, everyone involved inobtaining a patent owes the USPTO a duty ofcandor and good faith.34 This duty, which isgrounded in a long history of judicial deci-sions, seeks to prevent patent applicants fromdeliberately deceiving the USPTO to procure

a patent. Failure to comply with the duty mayrender a patent unenforceable if an accused in-fringer raises a defense of inequitable conductand a court determines that the duty of goodfaith and candor was breached in obtaining thepatent.

The duty of good faith and candor extendsto inventors, agents, attorneys, and every otherperson who is substantively involved in prepar-ing, prosecuting, or assigning an application.One way to comply with the duty is to discloseto the USPTO, in writing, all informationknown to be material to patentability.

According to USPTO Rule 1.56, informa-tion is material if it refutes or is inconsistentwith a position the applicant takes during pros-ecution. In other words, the USPTO considersinformation to be material if it establishes, ei-ther alone or in combination with other infor-mation, a prima facie case of unpatentability ofa claim. A prima facie case of unpatentability isestablished when information compels, by apreponderance of the evidence, the conclusionthat a claim is unpatentable, giving each claimterm its broadest reasonable interpretation inlight of the written description and before con-sidering any rebuttal evidence.35

As mentioned in footnote 34, however, theUSPTO has suspended 37 C.F.R. §1.56 in re-sponse to a recent decision by the Federal Circuitthat raised the standard for materiality (Thera-sense Inc. v. Becton, Dickinson and Co. (649 F.3d1276) (Fed. Cir. 2011) (en banc)). Specifically,the Federal Circuit held that to prove inequitableconduct, a defendant must establish “but-for”materiality. In other words, if the USPTO wouldnot have allowed the claim had it been aware ofthe undisclosed information, then the informa-tion is material. Because such determinationsare often difficult to make absent guidancefrom the USPTO or a court, the USPTO recom-mends erring on the side of disclosure when themateriality of information seems unclear.36

31See Nautilus, Inc. v. Biosig Instruments, Inc. (134 S. Ct.2120) (2014), holding that a patent is invalid for indefinite-ness if its claims, read in light of the patent’s specificationand prosecution history, fail to inform, with reasonable cer-tainty, those skilled in the art about the scope of the inven-tion.32Chisum DS. 2014. Chisum on patents. Matthew Bender,New York.33Enzo Biochem, Inc. v. Applera Corp. (605 F.3d 1347, 1349)(Fed. Cir. 2010) (Plager, J., dissenting from denial of rehear-ing en banc).3437 C.F.R. §1.56: “Each individual associated with the filingand prosecution of a patent application has a duty of candorand good faith in dealing with the Office, which includes aduty to disclose to the Office all information known to thatindividual to be material to patentability[.]”

Author commentary: As of the writing of this article, theUSPTO has suspended Rule 1.56. Nevertheless, many prac-titioners still continue to follow the rule, and courts contin-ue to hold patents unenforceable for inequitable conduct ifthe USPTO was deliberately deceived into issuing the patent.

35MPEP §2001.36Id. at §2004.



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March 27, 20152015; doi: 10.1101/cshperspect.a020776 originally published onlineCold Spring Harb Perspect Med

Amanda Murphy, Michael Stramiello, Stacy Lewis and Tom Irving Introduction to Intellectual Property: A U.S. Perspective

Subject Collection Intellectual Property in Molecular Medicine

Patentability of Stem Cells in the United StatesSarah E. Fendrick and Donald L. Zuhn, Jr.

and Diagnosticsand Commercialization of DNA-Based Therapies

on the Future DevelopmentMyriadThe Impact of

Michele Wales and Eddie CartierInventorship and Authorship

Antoinette F. Konski and Linda X. WuGoing to Become More Bureaucratized?Biological Resources: Is Scientific Research Protecting Traditional Knowledge Related to

Prashant Reddy and Malathi LakshmikumaranThe Patentability of Stem Cells in Australia

Jenny Petering and Prue CowinProtecting Trade Secrets in Canada

Noel Courage and Janice Calzavara

Intellectual PropertyImpact of America Invents Act on Biotech

Stroud, et al.Amanda Murphy, Michael Stramiello, Jonathan

Biotechnology IndustriesInherent Anticipation in the Pharmaceutical and

ZappiaMichael Goldman, Georgia Evans and Andrew

PerspectiveIntroduction to Intellectual Property: A U.S.

et al.Amanda Murphy, Michael Stramiello, Stacy Lewis,

Property: Part IIThe Role of Regulatory Agencies and Intellectual

Kevin E. Noonan

Property: Part IThe Role of Regulatory Agencies and Intellectual

Kevin E. Noonan LitigationMyriad GeneticsJudicial Treatment of DNA in the

Baseball Bats and Chocolate Chip Cookies: The

Ian Binnie and Vanessa Park-Thompson

PropertyCompliance) Proceedings and Intellectual Canada's Patented Medicines (Notice of

Henry Bian and Conor McCourt Patenting Not Complicated Enough?)Spurred or Disincentivized? (Or Was BiotechAdvancements in the Biological Sciences Be

: WillMayo and MyriadThe Impact of

Jennifer Gordon

PerspectivePatentability of Genes: A European Union

Paul ColeCompaniesTrade Secrets in Life Science and Pharmaceutical

Tara Nealey, Ronald M. Daignault and Yu Cai

http://perspectivesinmedicine.cshlp.org/cgi/collection/ For additional articles in this collection, see

Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved


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