Inventorship and Authorship - CSHL Pperspectivesinmedicine.cshlp.org/content/5/11/a020859.full.pdf · the UCLA group successfully cloned single, ad-ipose-derived cells. Meanwhile,

Inventorship and Authorship

Antoinette F. Konski and Linda X. Wu

Foley and Lardner LLP, Palo Alto, California 94304-1013

Correspondence: [email protected]; [email protected]

Ownership of a U.S. patent is based on inventorship. In the United States, an inventor is theowner of the claimed invention unless it is assigned to another entity. The correct naming ofinventors is important, and the improper naming of inventors in a patent can be grounds forrendering the patent unenforceable. Each inventor must make an intellectual contribution,solely or jointly, to at least one element of a claim in the patent. This is in contrast toauthorship of a research article, where authors may be named to acknowledge contributionto the reported research rather than an intellectual contribution. Thus, identifying inventorsfor a patent is not the same as identifying authors for a publication.

Two professors meet and design experimentsto prove that knocking out a gene will treat afatal neurodegenerative disease. One professor,a neurophysiologist and expert physician, hasstudied the disease and its symptoms, and con-ceived of the idea to treat the disease by knock-ing out the gene. However, she lacks the ex-pertise to design and perform the experimentsto actually knock out the gene. The other, anexpert molecular biologist, has the expertise toknock out the gene but has never studied neu-rophysiology and has no expertise in treatingthe fatal neurodegenerative disease. The two de-sign the experiments to show that knocking outthe gene will treat the disease in an experimentalanimal model. In his laboratory, the molecularbiologist and those working under his directionand supervision apply techniques well known inthe field to knock out the gene selected by theneurophysiologist. A graduate student, studyingunder the molecular biologist, is assigned to the

project. During the course of the project, thereis trouble with the conventional techniquesfor knocking out the gene and the graduate stu-dent modifies the procedure, creating new tech-niques she independently developed. She beginscorresponding directly with the physician–sci-entist. However, the techniques require reagentsthat are not commercially available. Anotherlaboratory donates the materials. The initialproof of concept is successful, and two techni-cians are assigned to the project to complete theexperiments, acting under the direction andsupervision of the graduate student utilizingthe procedures developed by the graduate stu-dent. A manuscript is prepared and submittedto a prestigious journal. The two professors, thegraduate student, and the two technicians arenamed coauthors. A patent application was filedprior to submission of the manuscript. Who arethe inventors of the patent application claimingthe new method to knock out the gene and the

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.a020859Cite this article as Cold Spring Harb Perspect Med 2015;5:a020859

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treatment of the neurological disorder? Shouldall the coauthors named on the manuscript benamed as joint inventors?

Naming all coauthors on a journal articleas joint inventors may be the less controversialmeans to determining inventorship of a patentclaim because many in academia and industryare familiar with the requirements for author-ship. In addition, acknowledging all who con-tributed to a project is encouraged. However,U.S. patent law does not equate authorshipwith inventorship.

U.S. patent law requires that only a personor persons who invent patentable subject matterbe named as a sole or joint inventor of a claimin a pending application or issued patent.1 Thedifficult question is, especially when more thanone individual is involved in designing or per-forming the experiments in the course of a pro-ject, who is an inventor?2

Inventorship is determined based on the“claimed invention” and must be determinedon a claim-by-claim basis. Thus, the inventor-ship of the application or patent as a whole maychange during examination of the applicationas the claims of a patent application are modi-fied or dropped.

Thought and diligence should be used tounderstand each individual’s contribution tothe claims of the patent application and issuedpatent because the question of inventorshipis an important one. Under U.S. law, inven-tors own all inventions claimed in a pendingapplication or issued patent absent a contractor agreement to the contrary. In addition, eachinventor owns an equal right in a patent appli-cation or patent and can therefore make, use, orsell the invention without permission of his co-inventors. Incorrectly identifying inventors canbe grounds to invalidate the patent (see James-bury Corp. v. United States (518 F.2d 1384, 1395)(Ct. Cl. 1975)3 and C.R. Bard, Inc. v. M3 Sys-tems, Inc. (157 F.3d 1340, 1353) (Fed. Cir.

1998)),4 and omitting an inventor can rendera patent unenforceable (Frank’s Casing Crew &Rental Tools, Inc. v. PMR Technologies, Ltd. (292F.3d 1363, 1376) (Fed. Cir. 2002)). Moreover,to bring a patent infringement action, all in-ventors must be included as plaintiffs, and ifa court finds that an inventor has been omit-ted, the omitted inventor must join as a plaintifffor the litigation to proceed (Ethicon, Inc. v. U.S.Surgical Corp. (135 F.3d 1456, 1465–1466) (Fed.Cir. 1998)).

This work reviews the criteria for inven-torship, and in particular joint inventorship,as well as several court decisions that have ap-plied the criteria and concepts to various factualscenarios. It also touches on the distinction be-tween inventorship and authorship. It reviewsgeneral concepts of inventorship, includinga detailed discussion regarding “conception”and contributions that have and have not beendetermined to be inventive contributions to aninvention. It also reviews the requirementfor collaboration when more than one individ-ual has been alleged to contribute to the inven-tion.

INVENTORSHIP—GENERAL CONCEPTS

An inventor, under U.S. patent law, is “whoeverinvents or discovers any new and useful process,machine, manufacture, or composition of mat-ter, or any new use and useful improvementthereof.”5 Moreover, whoever so “invents or dis-covers” may obtain a patent, which expresslyconfers on the inventor of the patent an exclu-sive right to exclude others from making, sell-ing, or offering to sell the patented invention inthe United States and from importing the pat-ented invention into the United States for a pe-riod of years.

Conception is considered to be the touch-stone of inventorship, and where more than oneindividual contribute to an invention, each must

135 U.S.C. §§ 101, 111, and 116.235 U.S.C. §116.3Inclusion of more or less than the true inventors renderspatent void and invalid.

4“To invalidate a patent based on incorrect inventorship itmust be shown not only that the inventorship was incorrect,but that correction is unavailable under section 256.”535 U.S.C. §101.

A.F. Konski and L.X. Wu

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show contribution to its conception.6 Con-ception, in terms of inventorship, has been de-fined as:

the complete performance of the mental part ofthe inventive act. All that remains to be accom-plished, in order to perfect the act or instrument,belongs to the department of construction, notinvention. It is therefore the formation, in themind of the inventor of a definite and permanentidea of the complete and operative invention, asit is therefore to be applied in practice, that con-stitutes an available conception, within the pat-ent law (Coleman v. Dines (754 F.2d 353, 359)(Fed. Cir. 1985) (citing Gunter v. Stream (573F.2d 77, 80) (C.C.P.A. 1978))).

The U.S. Court of Appeals for the Federal Cir-cuit (CAFC) has stated that the test for concep-tion is whether the inventor had an idea that wasdefinite and permanent enough that one skilledin the art could understand the invention; theinventor must prove his conception by corrob-orating evidence, preferably by contemporane-ous disclosures (Burroughs Wellcome Co. v. BarrLaboratories, Inc. (40 F.3d 1223, 1228) (Fed. Cir.1994)). An inventor need not know that hisinvention will work for conception to be com-plete; he needs only show that he had the com-plete mental picture and could describe it withparticularity.7 That the invention actually worksis part of its reduction to practice.8 In a jointinvention, each inventor must contribute to thejoint arrival at a definite and permanent idea ofthe invention as it will be used in practice.

TIMING OF THE “INVENTIVE”CONTRIBUTION

Inventive contribution is based on the timingand quality of the contribution to the con-ception of the claimed invention. Thus, deter-mining whether or not an individual made an“inventive” contribution requires determiningwhen the conception is “complete,” which inturn requires evaluating the amount of experi-mentation necessary to reduce the invention topractice (proof of concept) and the amount ofinformation necessary to distinguish the inven-tion from the prior art. Those who join a re-search project after conception has been com-pleted cannot be inventors.

For example, in the case of University ofPittsburgh v. Hedrick (573 F.3d 1290) (Fed.Cir. 2009), the U.S. Court of Appeals affirmedthe decision of the trial court that Hedrick, Ben-haim, Lorenz, and Zhu were not coinventorsbecause their contribution to the research effortcame after conception of the claimed inventionwas complete.

The lawsuit involved U.S. Patent No.6,777,231 (the ’231 patent) directed to an adi-pose-derived stem cell that can differentiate intotwo or more of a bone cell, a cartilage cell, anerve cell, or a muscle cell. Katz and Llull atthe University of Pittsburgh initiated researchrelated to the isolation, culturing, and passagingof stem cells isolated from human liposuctionedadipose tissue (adipose-derived stem cells).9

They hypothesized that these cells could differ-entiate into other cell types, including bone,cartilage, muscle, and nerve. Although not sci-entifically certain, Katz and Llull believed thatthey had observed adipose stem cells changinginto cells resembling muscle and fat cells, andcommented to another colleague via E-mailthat they might have seen the cells transformedinto nerve cells. Katz and Llull decided to sub-stantiate what they had observed (i.e., that thecells indeed were nerve cells).

Thereafter, Hedrick joined the University ofPittsburgh laboratory for a yearlong fellowship.Around the same time, Katz submitted a grant

6Indeed, the U.S. patent statute expressly allows for morethan one individual to invent and apply for a patent. 35U.S.C. §116(a) recites:

When an invention is made by two or more personsjointly, they shall apply for patent jointly and eachmake the required oath, except as otherwise providedin this title. Inventors may apply for a patent jointlyeven though (1) they did not physically work togetheror at the same time, (2) each did not make the sametype or amount of contribution, or (3) each did notmake a contribution to the subject matter of everyclaim of the patent.

See also Ethicon (135 F.3d at 1460–1461) (citing BurroughsWellcome Co. v. Barr Laboratories, Inc. (40 F.3d 1223, 1227–1228) (Fed. Cir. 1994)).7Id.8Id. at 1229. 9Id.


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proposal summarizing his work with Llull, andHedrick was not mentioned in the grant pro-posal. Hedrick, however, wrote his own researchproposal setting forth some experiments onKatz’s cells. A few months later, Katz, Llull,and Hedrick submitted an invention disclosureto the University of Pittsburgh stating that theisolated cells could be induced to transform intofat, bone, cartilage, and muscle tissues.

A few months later, Hedrick’s fellowshipended, and he left for UCLA, where he formeda new laboratory with Benhaim, Lorenz, andZhu. There the UCLA group worked on thesame cells as the Pittsburgh group. The UCLAgroup determined that this adipose stem cellpopulation was distinct from the prior art stemcell populations because they responded differ-ently to induction media. In late 1999 and 2000,the UCLA group successfully cloned single, ad-ipose-derived cells. Meanwhile, Katz and thePittsburgh group continued to research the ex-ploitable potential of his adipose-derived stemcells.

The Pittsburgh group and the UCLA groupeach filed patent applications to adipose-de-rived stem cell populations. The Pittsburgh ap-plication named Katz, Llull, Futrell, Hedrick,Benhaim, Lorenz, and Zhu as inventors. Theapplication contained information from He-drick regarding compositions and methods toinduce the adipose-derived stem cells to differ-entiate into nerve cells. At the request of He-drick, UCLA’s patent application also includedthe concept that the adipose-derived stem cellscould differentiate into nerve cells, although hehad not conducted any nerve differentiation ex-periments. The Pittsburgh application was is-sued as the ’231 patent.

In late 2009, the University of Pittsburghfiled a lawsuit seeking to remove Futrell, He-drick, Benhaim, Lorenz, and Zhu as named co-inventors. Futrell voluntarily dismissed himselffrom the lawsuit.

In agreeing with Pittsburgh that Hedrick,Benhaim, Lorenz, and Zhu should be removedas named coinventors, the district court deter-mined that conception was complete prior toHedrick’s arrival at Pittsburgh and that Katz’snotebooks enabled one to reproduce the differ-

entiation of the adipose-derived stem cells intoeach of the lineages claimed in the ’231 patent.

On appeal the U.S. CAFC agreed with thedistrict court and noted that the fact that Katzand Llull were uncertain that the adipose-de-rived stem cells could actually differentiateinto all claimed lineages was immaterial. TheCAFC stated that “Proof that the inventionworks to a scientific certainty is reduction topractice . . . it is immaterial that their knowledgewas not scientifically certain and that the . . .[UCLA] researchers helped them gain such sci-entific certainty.”10

EXPERIMENTATION AND CONCEPTIONS

As stated above, conception is the formation inthe mind of the inventor of a definite and per-manent idea of the complete and operative in-vention. For the conception to be complete,however, there must be a means to make and/or use the invention. For inventions in predict-able technologies that are therefore less complexto make or use, for example, a mechanical ormedical device, all that may be required to com-plete the conception is a drawing of the device ina manner that distinguishes the invention fromthe prior art. When the invention is in an unpre-dictable technology, for example, in chemistryor biotechnology, conception may not be com-plete until the inventor or joint inventors are inpossession of an operative method for making it(see Burroughs Wellcome (40 F.3d at 1229)).

If the invention can be made in accordancewith conventional techniques, it is deemed tohave been conceived when it was described, andthe question of whether the conceiver is in pos-session of a means of making it is simply notraised (Oka v. Youssefyeh (849 F.2d 581, 583)(Fed. Cir. 1988)). Thus, in situations in whichnothing more than routine skill is needed toshow proof of concept or to reduce the inven-tion to practice, the invention is complete si-multaneously with the idea itself. For chemicalcompounds with straightforward chemical syn-thesis, conception is complete with a descrip-

10Id. at 1299.



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tion of the structure of the compound, as noth-ing more is required to put the compound in thehands of the public (see Rey-Bellet v. Engelhardt(493 F.2d 1380, 1387) (C.C.P.A. 1974)). In sucha situation, even subsequent routine testing andexperimentation will not preclude a finding ofconception at the time of mental formulation.11

In contrast, when the claimed inventioncannot be made with conventional techniques,conception requires not only the idea of theinvention but also possession of an operativemethod of making and/or using it. This factualscenario was addressed in the case of Okav. Youssefyeh (849 F.2d at 583). In Oka the orig-inal date of conception was alleged to be Feb-ruary 27, 1980, the date when the inventorsbelieved the compounds could be preparedin accordance with conventional techniques.However, a skilled chemist assigned to the proj-ect found that conventional methods were un-successful to synthesize the compounds. In-deed, it was not until the last week of October1980 that the conception was complete, becauseit was only at that time that an operative methodof making the compounds was known (see Oka(849 F.2d at 584); see also Alpert v. Slatin (305F.2d 891, 894) (C.C.P.A. 1962)).12

Thus, in situations in which the inventioncannot be made with conventional techniques,conception is not complete until it is actuallyreduced to practice.

In certain situations conception is not com-plete until the invention is actually reduced topractice or until proof of concept has been com-pleted, such that it can be distinguished fromthe prior art. This scenario is known as the doc-trine of simultaneous conception and reductionto practice. The doctrine has been particularly

applicable to the field of biological materialsbecause an inventor is often unable to envisionthe detailed constitution of a compound so asto distinguish it from other materials, as well asa method for obtaining it, such that conceptionis not achieved until reduction to practice hasoccurred, that is, until after the compound hasbeen isolated.

Conception of isolated genes had been ad-judicated to be complete when the completesequence of the gene was determined becausethe sequence of the gene is required before itcan be distinguished from the prior art (Amgen,Inc. v. Chugai Pharmaceutical Co., Ltd. (927 F.2d1200, 1206) (Fed. Cir. 1991)). It was explainedthat:

a product is not conceived until one can define itother than by its biological activity or function.13

The difficulty that would arise if we were to holdthat a conception occurs when one has only theidea of a compound, defining it by its hoped-forfunction, is that would-be inventors would filethe patent applications before they had madetheir inventions and before they could describethem. That is not consistent with the statute orthe policy behind the statute, which is to pro-mote disclosure of inventions, not of researchplans. While one does not need to have carriedout one’s invention before filing a patent appli-cation, one does need to be able to describe thatinvention with particularity (Fiers v. Revel (984F.2d 1164, 1169) (Fed. Cir. 1193)).

However, that is not to say that an invention to agene cannot be complete if other methods areavailable to distinguish it from the prior art. InSanofi-Aventis v. Pfizer, Inc. (733 F.3d 1364)(Fed. Cir. 2013), the CAFC affirmed the U.S.Patent Office’s (USPTO) determination thatan invention was complete when Pfizer isolatedthe complementary DNA (cDNA) sequenceeven though the initial sequence contained er-rors because Pfizer could define the cDNA so asto distinguish it from other materials and definehow to obtain it.

11See id. (wherein the court stated that subsequent testingand experimentation routinely done for drugs did not au-tomatically bar a claim that the antidepressant was con-ceived prior to completion of testing and experimentation);see also Burroughs Wellcome (40 F.3d at 1230) (stating thatconception does not require reduction to practice where noprolonged period of extensive research, experiment, andmodification followed the alleged conception).12The mental embodiment of the invention was a mere hopeor expectation, a statement of a problem, but not an inven-tive conception, because additional experimentation wasnecessary for enablement.

13Although the court loosely used the term “biological ac-tivity or function,” the product under consideration by thecourt was a gene or nucleic acid sequence. An actual reduc-tion to practice had not yet taken place, and a biologicaldeposit of the gene was not made in support of enablement.



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QUALITY OF CONTRIBUTION

In addition to evaluating when conception hasbeen completed, the quality of the contributionof a putative invention must be evaluated. Theinventive contribution of each inventor neednot be of the same kind or degree, but must insome manner relate to at least one claim (Ethi-con, Inc. v. U.S. Surgical Corp. (135 F.3d 1456,1460–1461) (Fed. Cir. 1998)).

One court noted that:

[a]ll that is required of a joint inventor is thathe or she (1) contribute in some significant man-ner to the conception or reduction to practiceof the invention, (2) make a contribution to theclaimed invention that is not insignificant inquality, when that contribution is measuredagainst the dimension of the full invention, and(3) do more than merely explain to the real in-ventors well-known concepts and/or the currentstate of the art” (Pannu v. Iolab Corp. (155 F.3d1344, 1351) (Fed. Cir. 1998)).

It is not necessary that “the entire inventive con-cept should occur to each of the joint inven-tors,” so long as each inventor “makes someoriginal contribution, though partial, to the fi-nal solution of the problem” (Kimberly-ClarkCorp. v. Procter & Gamble Distributing Co.(973 F.2d 911, 916–917) (Fed. Cir. 1992)).Each joint inventor must have contributed tothe conception of that invention in a way notobvious to one ordinarily skilled in the art(AcroMed Corp. v. Sofamor Danek Group, Inc.(253 F.3d 1371, 1379–1380) (Fed. Cir. 2001)).

Inventorship requires a contribution fromeach inventor that is not insignificant in qualitywhen that contribution is measured against thedimensions of the full invention (Pannu (155F.3d at 1351)). The contribution of each inven-tor need not be the same type or amount, normust each inventor make a contribution to ev-ery claim of a patent (Ethicon (135 F.3d at1460–1465)).14 Additionally, “[o]ne [inventor]may do more of the experimental work while

the other makes suggestions from time to time”(Monsanto Co. v. Kamp (269 F. Supp. 818, 824)(D.D.C. 1967)).

Determining what constitutes “not insignif-icant” is subjective and fact-specific. The courtshave required more than merely suggesting anidea of a result, providing services or ideas, oraiding in perfecting an already fully conceivedinvention (Eli Lilly & Co. v. Aradigm Corp. (376F.3d 1352, 1363) (Fed. Cir. 2004)). It is im-portant to note, however, that a person is not“precluded from being a joint inventor simplybecause his [or her] contribution to a collabo-rative effort is experimental” (Burroughs Well-come (40 F.3d at 1229)).

One who suggests an idea of a result sought,but not the means of accomplishing it, doesnot qualify as an inventor (Eli Lilly & Co. v.Aradigm Corp. (376 F.3d 1352, 1359) (Fed. Cir.2004), citing Garrett Corp. v. United States (422F.2d 874, 881) (Ct. Cl. 1970); see also Ex ParteSmernoff (215 U.S.P.Q. 545, 547) (B.P.A.I.1982)). Thus, courts have not recognized in-ventorship status for those who suggest someway to improve an invention casually but takeno further role in working on the invention.15

Similarly, “[a]n inventor ‘may use the services,ideas, and aid of others in the process of per-fecting his invention without losing his rightto a patent’” (Shatterproof Glass Corp. v. Lib-bey-Owens Ford Co. (758 F.2d 613, 624) (Fed.Cir. 1985), quoting Hobbs v. U.S. Atomic EnergyCommission (451 F.2d 849, 864) (5th Cir.1971)). In addition, a joint inventor must domore than merely explain to the real inventorswell-known concepts and/or the current stateof the art (Pannu (155 F.3d at 1351); see also

14Individual was joint inventor, even though he only con-tributed to one element each of two claims of the 55 totalclaims that were issued.

15See Mueller Brass Co. v. Reading Industries, Inc. (352F. Supp. 1357, 1373) (E.D. Pa. 1972) (affirmed without opin-ion, 487 F.2d 1395) (3rd Cir. 1973) (district court deniedcoinventorship status to “a person who suggests some way toimprove an invention casually but takes no further role infitting the rough suggestion into the scheme of the inventionworkably”); Pro-Mold & Tool Co., Inc. v. Great Lakes Plastics,Inc. (75 F.3d 1568, 1575–1576) (Fed. Cir. 1996) (finding ofno inequitable conduct for failure to disclose a coinventorbecause alleged coinventor merely planted seeds for the ideabut did no work on creating invention).



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Hess v. Advanced Cardiovascular Systems, Inc.(106 F.3d 976, 981) (Fed. Cir. 1997)).16

For example, in the case of Hess v. AdvancedCardiovascular Systems, Inc. (106 F.3d 976)(Fed. Cir. 1997), Hess, an expert in materialsscience, was determined not to be an inventorbecause his contribution was only providing in-formation well known and found in textbooks.The invention related to a balloon angioplastycatheter. The catheter initially was conceivedby two doctors but required a different materi-al for the catheter. The doctors were referred toHess because his company was one of the larg-est manufacturers of heat-shrinkable material.After the doctors consulted with Hess, he sug-gested specific tubing made by his company andexplained how it worked and might be used forthe catheter. By using the tubing suggested byHess, the doctors developed and patented thesuccessful balloon angioplasty catheter.

The court determined that Hess was notentitled to be named as a joint inventor of thecatheter because the two doctors performed ex-tensive research and development work thatproduced the catheter. Hess’s contribution waswell known and “did no more than a skilledsalesman would do in explaining how his em-ployer’s product could be used to meet a cus-tomer’s requirements.”17 The court, in reachingthis conclusion, quoted an 1853 Supreme Courtdecision involving Samuel Morse’s invention ofthe telegraph. The Supreme Court determinedthat only Morse was the inventor even thoughhe consulted with others during the develop-ment of the invention. It was explained that

[n]o invention can possibly be made, consistingof a combination of different elements . . . with-out a thorough knowledge of the properties ofeach of them, and the mode in which they oper-ate on each other. And it can make no difference,

in this respect, whether he derives his informa-tion from books, or from conversation with menskilled in the science. If it were otherwise, nopatent, in which a combination of different ele-ments is used, could ever be obtained (O’Reillyv. Morse (56 U.S. 62, 111) (1853)).

Although there is no exact test to determinewhat contribution would qualify as an inventivecontribution, one legal commentator (Chisum2008) has compiled a list of contributions thatthe courts have found to be insufficient to sat-isfy inventorship:

† suggesting a desired end or result, with nosuggestion of means (see Cohen 2013);

† only following the instructions of the personor persons who conceive the solution to theproblem;18

† acting to reduce to practice or demonstratethe efficacy of an already completely con-ceived invention;19

† only providing general information on de-sign elements or the state of the art, with noknowledge of the ultimate goal or idea.20

In sum, inventorship requires each inventorto make a contribution to the conception of theinvention that is collaborative, novel, nonobvi-ous, sufficiently significant in quality, and notmerely an explanation of the current state of theart or a reduction to practice of an already fullyconceived invention. However, that contribu-tion may be minimal, that is, only to an elementof a single claim.

Consider the case of Ethicon, Inc. v. U.S. Sur-gical Corp. (135 F.3d 1456) (Fed. Cir. 1998), inwhich a technician who assisted with a projectwas named as a coinventor of a patent based onhis contribution to portions of two claims of thepatent.

In the late 1970s Dr. Yoon, a medical doctorandprior inventor,conceivedofanewendoscopicdevice that would prevent accidental injury dur-ing use. The device also would advise the surgeon

16Plaintiff did no more than supply state-of-the-art prod-ucts and explain well-known principles that could be foundin textbooks; see also Board of Education v. American Bio-science, Inc. (333 F.3d 1330, 1341) (Fed. Cir. 2003) (“It is alongstanding principle of patent law that one who simplyprovides the inventor with well-known principles or ex-plains the state of the art without ever having a firm anddefinite idea of the claimed combination as a whole does notqualify as a joint inventor.”).17Id. at 981.

18Id. at 393 n.77.19Id. at 393 n.78.20Id. at 393 n.79.



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when the surgical incision was complete. In 1980Yoon met Mr. Choi, an electronics technician,who had some college training but no college de-gree. Yoon asked Choi to assist him with severalprojects, one of which was the improved endo-scopic device. In 1982, after collaborating for�18 months, their relationship ended. Choithought that Yoon found his work unsatisfactoryand withdrew from working with Yoon.

In the same year Yoon filed a patent appli-cation on the device. Without informing Choi,Yoon named himself as the sole inventor. In1985 the USPTO granted the application, andU.S. Patent No. 4,535,773 (the ’773 patent) wasissued.

Yoon exclusively licensed the ’773 patent toEthicon, Inc., and sometime later, Yoon andEthicon sued U.S. Surgical Corp. for infringe-ment of the ’773 patent. During the course ofthe lawsuit, U.S. Surgical contacted Choi regard-ing his involvement with the patented device.After Choi confirmed his role in the develop-ment of the patented device, U.S. Surgical ob-tained a retroactive license from Choi and movedto add Choi as an inventor on the ’773 patent.

The trial court determined, and the CAFCaffirmed, that Choi was a joint inventor withYoon of the ’773 patent because he contributedto at least one part of two claims of the patent,noting that “a co-inventor need not make a con-tribution to every claim of a patent.”21 The law-suit was dismissed because the original defen-dant, U.S. Surgical Corp., was licensed to use thepatent by the license granted from Choi. There-fore, they could not infringe a patent that theywere authorized by license to use.

This case illustrates that an inventor needsonly contribute to the conception of a part of atleast one claim of a patent and that credentialsdo not dictate whether or not an individual is oris not an inventor.

COLLABORATION

It is not uncommon for researchers in academicinstitutions to move among laboratories and

apply skills and knowledge acquired in one lab-oratory to another. However, individuals alleg-ing inventorship must establish that they collab-orated during conception.

In the context of inventorship, what activi-ties are considered to be qualitative collabora-tion? The U.S. courts have stated that the inven-tors need not work together at all times of aproject, but they must at least be connected insome way to the project (Kimberly-Clark Corp.v. Procter & Gamble Distributing Co. (973 F. 2d911, 917) (Fed. Cir. 1992)). There must also besome connection between or among the jointinventors (Eli Lilly & Co. v. Aradigm Corp. (376F.3d 1352, 1362) (Fed. Cir. 2004)).

The issue of collaboration was addressed inthe case of Huang v. California Institute of Tech-nology (705 F. Supp. 2d 692) (E.D. Tex. 2010),wherein the court held that Huang was not aninventor because he could not establish that hecollaborated with the named inventors.

Nevertheless, give-and-take interactions be-tween joint inventors are not required. In IPInnovation v. Red Hat, Inc. (9705 F. Supp. 2d692) (E.D. Tex. 2010), three inventors workingfor the same employer were named on a patent,but the alleged evidence showed that onlytwo had developed the claimed invention. Thecourt denied summary judgment for invalidityfor incorrect inventorship because an articleshowed that the two later inventors knew ofthe earlier inventor’s work at the company andmay have built their invention upon the earlierwork.22

The courts differ, however, on whether analleged coinventor must communicate with thenamed inventors or if collaboration with some-one connected to the named inventors can besufficient.

In Ultra-Precision Manufacturing, Ltd. v.Ford Motor Co. (411 F.3d 1369) (Fed. Cir.2005), the court denied joint inventorship wherethe evidence showed that there was no interac-tion between the plaintiffs and the named in-ventors during the time of the invention. Theplaintiffs alleged that they had communicated

21Id. at 1460. 22Id.



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with another Ford employee, but not the namedinventors. The court held that even if the plain-tiffs’ work were considered a prior conceptionof the invention, they were not part of the col-laborative efforts of the named inventors whoengaged in the subsequent modifications andprocesses to arrive at the final invention.23

Similarly, in Arbitron, Inc. v. Kiefl (No. 09-cv-04013 (PAC), 2010 U.S. Dist. LEXIS 83597(S.D.N.Y. Aug. 13, 2010)), the court dismisseddeclaratory judgment with the defendant’sclaim for joint inventorship for lacking of col-laboration because he did not interact with thenamed inventor. He only alleged that he previ-ously had an open line of communication withthe patentee’s counsel, but did not offer factualallegations of a common inventive goal sharedwith the named inventor.24

On the other hand, in Memry Corp. v. Ken-tucky Oil Technology (No. C-04-03843 RMW,2007 U.S. Dist. LEXIS 73315 (N.D. Cal. Sept.20, 2007)), the court held that collaborationmay be satisfied where evidence showed the al-leged inventor had disclosed inventive conceptsto a third party, who then communicated andcollaborated with the named inventors. Thecourt held that the evidence suggested that itwas possible that the alleged inventor had col-laborated in the inventive contributions provid-ed by the third party, thus precluding summaryjudgment seeking to dismiss the correction ofinventorship claim.25

In Rubin v. General Hospital Corp. (No. 09-10040-DJC, 2011 U.S. Dist. LEXIS 45859 (D.Mass. Apr. 28, 2011)), coinventorship was de-nied where it was established that the groupshad not worked together. Back in 2000 Dr. Ru-bin and his team identified an IKAP gene mu-tation as causing a syndrome known as familialdysautonomia. Rubin sent his article to theAmerican Journal of Human Genetics, whichforwarded the abstract to Dr. Gusella at Massa-chusetts General Hospital for peer review. Gu-sella then filed a provisional patent application

in January 2001, shortly before Rubin’s articlewas published. Gusella’s team had been workingon the same genetic problem as Rubin, whichwas why Rubin’s article had been sent to him forpeer review. Rubin had particularly requestedthe journal not to send it to Gusella because ofthe lab–lab competition, but the journal sent itanyway.

After Gusella’s patent issued, Rubin suedunder 35 U.S.C. §256, asking the court to addhim as a joint inventor. The district court dis-missed the case because there was no evidenceof collaboration between Rubin and Gusella, asrequired for joint inventorship.26

On appeal the CAFC affirmed the districtcourt’s decision. The CAFC stated that “the in-dependent relationship between these teams ofscientists, and the nature of this communica-tion of information, do not support joint inven-tion in accordance with §116, or warrant changeor substitution of inventorship under §256”(Anderson v. General Hospital Corp., No. 2011-1439, 2013 U.S. App. LEXIS 6157, at �10 (Fed.Cir. Mar. 28, 2013)).

CORROBORATION

Those who allege inventorship must validatetheir contribution by corroborating evidence.Corroboration ensures that the inventor actual-ly prepared and knew that the invention wouldwork. The purpose of requiring corroborationis to prevent fraud (Sandt Technology, Ltd. v.Resco Metal & Plastics Corp. (264 F.3d 1344,1350) (Fed. Cir. 2001)). The corroborating evi-dence must meet the particular party’s burdenof proof and must show that the inventor dis-closed his “complete thought expressed in suchclear terms as to enable those skilled in the artto make the invention” (Coleman v. Dines (754F.2d 353, 359) (Fed. Cir. 1985), quoting Fieldv. Knowles (183 F.2d 593, 601) (C.C.P.A. 1950)).

To establish joint inventorship, each “pur-ported inventor must provide corroborating ev-idence of any asserted contribution to the con-ception” (AcroMed Corp. v. Sofamor Danek

23Id.24Id.25Id. 26Id.



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Group, Inc. (253 F. 3d 1371, 1379) (Fed. Cir.2001), citing Fina Oil & Chemical Co. v. Ewen(123 F.3d 1466, 1474) (Fed. Cir. 1997)). Thetestimony of joint inventors is insufficient toestablish independent corroboration (Andersenv. Piepper (442 F.2d 982) (C.C.P.A. 1971)). Bothconception and reduction to practice must becorroborated by evidence other than given byjoint applicants (Manny v. Garlick (135 F.2d757, 773) (C.C.P.A. 1943)). Such evidencemust be “clear and convincing” (Eli Lilly (376F.3d at 1364–1365)).

A “rule of reason” analysis is applied to de-termine corroboration (Price v. Symsek (988F.2d 1187, 1195) (Fed. Cir. 1993)). Under thisanalysis an evaluation of all pertinent evidencemust be made.27 Corroborating evidence maytake many forms. Typically, an inventor’s tes-timony or unwitnessed notebook alone will beinsufficient to corroborate inventive contribu-tion (see Mikus v. Wachtel (542 F.2d 1157)(C.C.P.A. 1976)28 and Price (988 F.2d at 1194)(Fed. Cir. 1993)).29 Documentary or physicalevidence that is made contemporaneouslywith the inventive process is the most reliable(Woodland Trust v. Flowertree Nursery, Inc. (148F.3d 1368, 1373) (Fed. Cir. 1998)). However,circumstantial evidence about the inventiveprocess may also corroborate, especially whenthe circumstantial evidence is of an indepen-dent nature (see In re Jolley (308 F.3d 1317,1325) (Fed. Cir. 2002) and Trovan, Ltd. v. Soky-mat SA (299 F.3d 1292, 1303) (Fed. Cir. 2002)).Oral testimony by someone other than the al-leged inventor may also serve as corroboration(Jolley (308 F.3d at 1325); see also Trovan (299F.3d at 1303)).

THE DIFFERENCE BETWEEN INVENTORSHIPAND AUTHORSHIP

As a result, an inventor must contribute to theconception of an invention, and an individual

who only contributes concepts or techniqueswell known in the art is not, under the law, aninventor. Thus, identifying an inventorship fora patent is not the same as identifying author-ship for a publication. It is important not toconfuse authorship with inventorship.

It is common that a scientific publicationnames many coauthors, including the princi-pal investigator, graduate students, postdoctor-al fellows, technicians, collaborators, and theirstaff members who are involved in perform-ing the experiments and/or providing materi-als and equipment. As such, the authorship ofa publication can be based on various factors,one of which may be an individual’s contribu-tion to the data produced in the publication orreduction to practice of the inventive ideas inthe publication.

In contrast, the inventorship of a patent isstrictly construed based on the conception ofthe inventive subject matter. A person whomerely reduces the conception of an inventionto practice by exercising ordinary skill in the art,such as a graduate student or technician work-ing under the direction and supervision of aprofessor in contributing data included in thepatent application, is not an inventor. A personwho contributes to an element to the inven-tion that is known to a person of ordinary skillin the art is not an inventor. A person who pro-vides mere technical support is not an inventor.A person who provides suggestions or improve-ments that are well known and can be found inthe textbooks is not an inventor. A person whomerely suggests an idea of a result to be accom-plished, rather than means of accomplishing it,is not an inventor.

Authorship and inventorship differ in twoadditional, important aspects. There is no re-quirement that the authors work together orcollaborate for authorship, and there is no re-quirement similar to corroboration of contri-bution for authorship of a publication.

The USPTO recognizes that coauthors arenot necessarily inventors. For example, an in-ventor’s prior publication could have beenraised as prior art during the examination ofthe patent if the publication names additionalindividuals who are not named as inventors

27Id.28Inventor’s unwitnessed notebook was insufficient corrob-oration.29An inventor’s testimony, standing alone, is insufficient toprove conception.



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of the application. If the article was published,1 year from the effective filing date of theclaim, prior art effect of the publication canbe removed by a showing that the authors notnamed as inventors did not contribute to therejected claims. This is accomplished by the in-ventors filing a paper attesting that the authorsnot named as inventors were correctly notnamed; for example, they were acting underthe direction and supervision of one or moreinventors. This is the situation that was ad-dressed in In re Katz (687 F.2d 450) (C.C.P.A.1982). An article, alleged to fully describe aclaimed invention by Dr. Katz, was published8 months prior to his filing of a patent applica-tion. The article listed three coauthors, Katz andhis two students. During the prosecution ofKatz’s patent application, the USPTO cited thearticle as a prior art reference negating patent-ability of the patent application. Katz filed adeclaration declaring that he was the sole inven-tor of the subject matter described and claimedin the application. In his declaration Katz statedthat the other two authors were students work-ing under his direction and supervision andthat they were not coinventors, even thoughthey were coauthors of the article. The courtheld that authorship of an article by itself didnot “raise a presumption of inventorship withrespect to the subject matter disclosed in thearticle” (In re Katz (687 F.2d at 455)). By estab-lishing that the unnamed authors were not in-ventors, the publication was shown to be theinventor’s own publication and therefore notdisqualifying prior art.

INVENTORSHIP OF THE KNOCKOUTGENE INVENTION

With knowledge of the standards of inventor-ship, who is an inventor of the method to treatthe fatal neurodegenerative disease by knockingout the gene, as described at the beginning ofthis review? To determine inventorship, it is im-portant to establish when the conception of theinvention was complete. Was conception of theinvention complete prior to the engagement ofthe molecular biologist, or was it complete afterthe development of new techniques for knock-

ing out the gene? Or yet further, was conceptioncomplete only after the animal model was cre-ated and the proof of concept completed withthe reagents donated by another laboratory?

The preceding case law suggests that if theinvention was not predictable and could not bemade with conventional techniques, conceptionmay not be complete until an operative methodof making the invention was known. For thatreason it is likely that conception under theabove facts was not complete until the methodof making the knockout model was completed.

Thus, any individual who was actively en-gaged in the project is a putative inventor: theneurophysiologist and expert physician whoconceived of the idea to treat the disease byknocking out the gene; the molecular biologist;the graduate student studying under the mo-lecular biologist; the two technicians assignedto the project; and individuals from the labora-tory who created the reagents that were neces-sary to establish proof of concept. The questionthen becomes, who in the group made an in-ventive contribution? Without doubt, the phy-sician who originally conceived of the methodto treat the disease and the proof of concept isan inventor. Provided that the molecular biolo-gist contributed in a manner that was beyondthe knowledge of one of skill in the art, he couldbe a joint inventor. However, the facts suggestthat he only provided textbook knowledge andtherefore his contribution likely did not rise tothe level of inventorship.

Is the graduate student who created tech-niques to knock out the gene an inventor? Thefacts suggest that the invention was not completewithout this contribution, and the facts estab-lish that the physician–scientist and the gradu-ate student directly collaborated during the proj-ect. Thus, it is likely that the graduate studentwould be an inventor because her contributionwas necessary to complete conception and wasbeyond the contribution of ordinary skill.

There are no facts establishing that the tech-nicians or donating laboratory provided anycontribution to the conception. Although thematerials and skill donated by them were nec-essary to complete conception, they did nomore than “ordinary skill.”



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Contrast the inventorship analysis with con-ventional authorship, which would likely namethe inventor–scientist, the molecular biologistand his graduate student, and individuals whomay have contributed the materials to carry outthe proof-of-concept experiments. In some in-stances, one or both technicians would havebeen named as well. Using an authorship anal-ysis to determine inventorship would have ex-panded the list of inventors to include thosewho did not collaborate with the physician–in-ventor and only contributed conventional skillin the art.

A NOTE ABOUT THE AMERICA INVENTS ACT

In 2011 the Leahy–Smith America Invents Act(AIA)30 was enacted, which modified many ofthe procedures that are used to procure a patentin the USPTO. One significant change is thatthe United States has transitioned from a “firstto invent” system to a “first inventor to file”system.31 Prior to the AIA, a person(s) who firstconceived an invention and reduced it to prac-tice or was first to conceive the invention anddiligent in reducing it to practice was consideredto be the inventor or joint inventor. In contrast,under the AIA, the person(s) who is first to filean application on an invention is considered tobe the inventor or joint inventor, even if anotherperson(s) invented it prior to the first filer.32

Although the AIA introduced significantchanges to U.S. patent law, the core conceptsregarding inventorship remain unchanged. Itis said that the inventorship remains to be de-termined almost exclusively based on the con-ception of the inventive subject matter claimed.As seen above, the courts have defined the term“conception” to mean “the formation in themind of the inventor, of a definite and perma-nent idea of the complete and operative inven-

tion, as it is thereafter to be applied in practice”(Burroughs Wellcome Co. v. Barr Laboratories,Inc. (40 F.3d 1223, 1228) (Fed. Cir. 1994)). Inother words, if a person of ordinary skill in theart (e.g., a professor) can reduce the invention topractice without undue experimentation, thenthe conception is complete and the person whoconceived the subject matter is the inventor.

CORRECTING INVENTORSHIP

Inventorship may be corrected in a pending pat-ent application and even an issued patent if themistake in inventorship is not made with anydeceptive intent. On the other hand, a patentis invalid if the mistake is made with deceptiveintent, which is defined as a fraudulent or delib-erate act of an inventor or applicant for reasonsunrelated to the considerations of inventorshipto name a noninventor as an inventor on a pat-ent or patent application. Deceptive conduct isinequitable and actionable, which can render apatent unenforceable.

In Frank’s Casing Crew & Rental Tools, Inc. v.PMR Technologies, Ltd. (292 F.3d 1363) (Fed.Cir. 2002), two individuals who did not actuallyinvent the claimed invention applied for a pat-ent application. They named themselves asinventors and concealed the true inventor’sidentity from the USPTO. Although the trueinventor subsequently established the true andcorrect inventorship, the patent was unenforce-able because the error in inventorship was madewith deceptive intent by those who applied forthe patent application. The court held that thetrue inventorcould not enforce the patent even ifhe was innocent and had no deceptive intent onhis part.33

If the error in naming inventors is madewithout deceptive intent, the courts have heldthat incorrect inventorship should be easilycured because it is often a technical defect.There are many types of incorrect inventorship;for example, no true inventor is named, or somebut not all true inventors are named, or somenoninventors are named as inventors, or a mix-

30Leahy-Smith America Invents Act, Pub. L. No. 112-29(2011).31Id.32Id. There are provisions under the AIA to grant a patent tothe second patent filer, such as when the first patent filerderived the invention from a subsequent patent filer. How-ever, these concepts are beyond the scope of this review (see,e.g., Konski 2013). 33Id.



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ture of a few true inventors and noninventorsare named as inventors while some other trueinventors are not named. Incorrect inventor-ship can also result during patent prosecution,when claims are added, amended, and/or can-celled because inventorship is determined ona claim-by-claim basis. For example, if an in-ventor contributes to one claim, which is can-celled during examination of the application,then he can no long be an inventor, and theinventorship should be amended to reflect thechange.

Correcting inventorship during prosecu-tion when the patent application is still pendingis made by filing a petition with the USPTO, andtherefore is less complex and costly than after

the patent issues. For that reason, investigatinginventorship prior to the filing of a patent ap-plication and monitoring it during examinationand pendency of the application is the mostprudent course to follow.

REFERENCES

Chisum D. 2008. Chisum on patents, §2.02. Matthew Bender,New York.

Cohen ER. 2013. Clear as mud: An empirical analysis of thedeveloping law of joint inventorship in the Federal Cir-cuit. Berkeley Tech Law J 28: 383–416. http://scholarship.law.berkeley.edu/btlj/vol28/iss4/4.

Konski AF. 2013. Derivation and derivation proceedings. InAmerica Invents Act: Law & analysis (ed. Baluch AS, etal.), §3. Aspen Publishers, New York.



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http://scholarship.law.berkeley.edu/btlj/vol28/iss4/4http://scholarship.law.berkeley.edu/btlj/vol28/iss4/4http://scholarship.law.berkeley.edu/btlj/vol28/iss4/4http://scholarship.law.berkeley.edu/btlj/vol28/iss4/4http://scholarship.law.berkeley.edu/btlj/vol28/iss4/4http://scholarship.law.berkeley.edu/btlj/vol28/iss4/4http://perspectivesinmedicine.cshlp.org/

August 7, 20152015; doi: 10.1101/cshperspect.a020859 originally published onlineCold Spring Harb Perspect Med

Antoinette F. Konski and Linda X. Wu Inventorship and Authorship

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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Inventorship and Authorship - CSHL Pperspectivesinmedicine.cshlp.org/content/5/11/a020859.full.pdf · the UCLA group successfully cloned single, ad-ipose-derived cells. Meanwhile,