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Disclosure Activities in University Settings

August 12, 2015

By: Drew Meunier

Introduction

Ever since the Bayh-Dole Act[1] of 1980 gave intellectual property rights in federally-funded inventions to universities, technology transfer offices have struggled to balance the traditional mission of academic institutions to publically disseminate knowledge, with the challenges of protecting and commercializing university inventions. Although academic institutions recognize the value of academic entrepreneurs who translate their research into patents, licenses, and commercial products, there remains a strong scholastic motivation for faculty and students to publish their research findings in journals and at academic conferences to advance their reputation and career. As a result, intellectual property is often an afterthought for faculty and students. However, a university’s valuable intellectual property can be permanently lost if it is disclosed to the public before patent protection is sought. The following summary addresses disclosure activities common in university settings and evaluates the potential risk that they will result in forfeiture of intellectual property rights.

Legal Standard for Public Disclosure

The patent system is based on a quid pro quo bargain, where the inventor is granted a limited monopoly on his new and useful invention in exchange for disclosure of the invention to the public.[2] This bargain is not satisfied if the invention is already in the public domain. Therefore, at the heart of the patent system is a requirement that an invention be novel. An invention may no longer be novel if the inventor discloses the invention publically prior to filing a patent application. The legal standards in the U.S. and Europe that determine when a public disclosure by an inventor bars the patentability of a claimed invention are summarized below.

  United States

For a public disclosure event to bar patentability in the U.S., the event must 1) be a “disclosure” as contemplated under the statute, 2) provide an enabling disclosure of the claimed invention, and 3) be sufficiently “public” to warrant a loss of rights. In other words, one must consider the nature of the disclosure (e.g., printed publication, verbal communication, poster presentation, etc.), the extent of the disclosure (i.e., whether it was enough to enable the audience to practice the invention), and the expectation of confidentiality to determine whether the disclosure bars a claimed invention.

    Relevant Types of Disclosure in U.S.

The sources of prior art disclosures that can be used to challenge the novelty of a claimed invention in the U.S. are defined in 35 U.S.C. § 102. However, there are two different versions of this section for evaluating prior art, depending on when the patent application was filed. Section 102 was amended in the Leahy-Smith America Invents Act of 2011 (“AIA”)[3] to harmonize U.S. patent law with the laws of other countries, in part by switching the U.S. from a first-to-invent system to a first-inventor-to-file system. The AIA laws apply to any patent or application having an effective filing date on or after March 16, 2013. Therefore, it is important to determine which version of section 102 applies to a given patent or application when evaluating the effect of a “public disclosure” event on novelty. Since this memorandum provides guidance on prospective disclosure activities, only the AIA version of section 102 should be at issue. However, both versions are discussed for historical context.

      Pre-AIA version of 35 U.S.C. § 102

The pre-AIA version of section 102 states in relevant part:

A person shall be entitled to a patent unless (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States . . . .[4]

Therefore, for pre-AIA patents and applications, “public disclosures” must fall into one of the following categories in order to be used to challenge a claimed invention for lack of novelty:

1) knowledge or use by others,
2) patents or printed publications,
3) public use in the United States, and
4) sales activities in the United States.

Note that sales do not have to be public to bar the patentability of pre-AIA patents and applications.[5] However, there is a geographical limitation on public use and sales activities. Therefore, prior public use and sale of an invention outside the U.S. has no consequence for pre-AIA inventions in the U.S. Because even a confidential sale or offer to sell an invention can be a bar to patentability, an inventor must either seek patent protection or be content to keep the invention as a trade secret prior to these acts.[6]

Importantly, purely oral descriptions of an invention generally do not qualify as printed publications under pre-AIA section 102.[7] However, researchers rarely discuss their ideas without some visual aids. For example, a poster can also be considered a “printed publication” under 35 U.S.C. §102, depending on the following factors: 1) the length of time the display was exhibited, 2) the expertise of the target audience, the 3) existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and 4) the simplicity or ease with which the material displayed could have been copied.[8] The distinction between an oral disclosure and a poster or slide presentation is likely a difference in degree rather than kind. Moreover, the standard is different outside the U.S. Therefore, it was prudent under pre-AIA section 102 to seek patent protection before even oral descriptions of an invention to the public.

      AIA version of 35 U.S.C. § 102

The AIA version of section 102 states in relevant part:

A person shall be entitled to a patent unless (a) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . .[9]

It should be noted that geographical limitations for public use and sale have been removed and a public use or sale outside the U.S. can now be a bar to patentability. The phrase “or otherwise available to the public” is believed to have two important effects on the scope of prior art covered by the statute. First, it is considered a catch-all provision, such that any activity that is “public” in nature, including purely oral descriptions of the invention, may be used to challenge the novelty for AIA patents and applications.[10] Some commentators have also concluded that this phrase modifies the preceding “on sale” term and that secret commercialization activities are no longer a bar to patentability in the U.S.[11] Therefore, under the AIA, inventors may be able to choose to maintain certain inventions as trade secrets without losing the ability to seek patent protection later down the road.

    Public Nature of Disclosure

As discussed above, with the exception of the pre-AIA on sale bar, disclosures only qualify as prior art if they are publically available. A printed publication has been made publically available if such document has been “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it and recognize and comprehend therefrom the essentials of the claimed invention without need of further research or experimentation.”[12] It is sufficient if accessibility to the reference was confined to one person.[13] Moreover, once accessibility of a reference is shown, it is not necessary to show that anyone actually inspected or understood the reference.[14]

Likewise, the public use bar under pre-AIA section 102 arises where the invention 1) is in public use before the critical date and 2) is ready for patenting.[15] The test for the public use prong includes the nature of the activity that occurred in public, public access to the use, confidentiality obligations imposed on members of the public who observed the use, and commercial exploitation.[16]

However, courts have been reluctant to consider something publically accessible or in public use under pre-AIA section 102 when there is a reasonable expectation that the disclosure or use was confidential.[17] This does not require binding agreements of confidentiality.[18] If an inventor uses protective measures, such as non-disclosure agreements, anti-copying software, or even simple disclaimers, a court will determine whether these measures create a reasonable expectation on the part of the inventor that the displayed information will not be copied.[19] Moreover, professional and behavioral norms, such as academic norms relating to codes of practice that occur in academic circles, can support expectations of confidentiality without any formal agreements in place.[20] Note, however, that confidentiality can only negate a public use disclosure if there has been no commercial exploitation.[21]

Although courts have yet to analyze what it means to be “otherwise available to the public” under AIA section 102, it is reasonable to assume that they will rely on their prior precedent for evaluating the public nature of a disclosure. It is important to note, however, that a “reasonable expectation of confidentiality” only protects the initial disclosure by the inventor to the confidential party. Therefore, if the confidential party nevertheless chooses to break confidence by making a subsequent disclosure, that subsequent disclosure could be considered an unprotected prior art event.

    Enablement of Disclosure

In order for a public disclosure to anticipate a claimed invention, the disclosure must be sufficient to enable one of ordinary skill in the art to practice the claimed invention without undue experimentation.[22] Therefore, for some technologies, it may be possible to publicly disclose the nature of an invention without providing an enabling disclosure that qualifies as prior art. Of course, this is risky and difficult to predict in advance. The USPTO places the burden on the inventor to demonstrate that the prior disclosure was not enabling, and this presumption can be quite difficult to overcome.

    Grace Period

The U.S. provides a grace period that gives an inventor one year to file a patent application after disclosing an invention to the public.[23] The grace period provides some protection against third party activities that occur after the inventor’s disclosure, since the inventor’s disclosure evidences invention prior to the third party disclosure. However, the AIA grace period can only be invoked if the subject matter in the third party disclosure is substantially identical to the subject matter previously disclosed by the inventor.

Therefore, while the inventor’s disclosure within the grace period cannot be used as prior art, a publication by a third party that occurs after the inventor’s public disclosure, even a review article citing the inventor as the source of the information, may be available as prior art under AIA section 102 if it is not sufficiently identical. Also, many other countries, such as Europe, do not provide any grace period, but instead require absolute novelty of an invention. Therefore, patent applications should be filed before public disclosures if possible, or as soon as possible after a public disclosure if necessary.

  Europe

The AIA was intended to harmonize U.S. patents laws with those of other jurisdictions. For example, the AIA’s expansion of relevant prior art to that which is “otherwise available to the public” is similar to the definition provided in Article 54 of the European Patent Convention (EPC), which covers “everything made available to the public,” including mere oral disclosures.[24] Three conditions are important in determining if a disclosure is “available to the public” under the EPC. The relevant disclosure must be available to at least one member of the public; the disclosure has to actually teach the information to be used in evaluation of patentability; and the technical teaching of the prior art must be enabled.[25] Under this first condition, the EPO requires that a disclosure be both accessible and non-confidential to affect novelty of a claimed invention. Therefore, information disclosed to a third party under conditions of secrecy, either expressly or impliedly, is generally not “available to the public” under the EPC.[26] Moreover, secrecy can be inferred based on the specific nature of the industry.[27]

Examples

As shown above, the legal effect of an inventor’s public disclosure before a patent application is filed can be very fact dependent. The following examples are therefore provided to illustrate the effect of disclosure activities common in university settings on potential patent rights.

  Submitted Manuscripts and Online Publications

As a general rule, manuscripts submitted to peer-reviewed journals are treated with confidentiality by the journal’s editors and reviewers. Some journals have written guidelines stating that the submitted manuscript will remain confidential and will not be released to the public prior to publication. Moreover, there are academic norms that give rise to a reasonable expectation that a submitted manuscript will be treated as confidential by reviewers prior to publication.[28]

Of course, a submitted manuscript becomes a “printed publication” available to the public under 35 U.S.C. §102 (pre-AIA or AIA) and Article 54 of the EPC as soon as it is either published in print by the journal or made available online. Journals often publish articles online ahead of print, and occasionally without advance warning. Therefore, it is important to determine in advance the exact dates for both online and printed publication, and then to file a patent application before publication occurs. If publication has already occurred, then a patent application should be filed as soon as possible within the U.S. grace period.

  Theses and Dissertations

A thesis or dissertation is generally sufficiently accessible to the public to constitute prior art as a “printed publication” under 35 U.S.C. §102 (pre-AIA or AIA) once it is indexed and shelved in a library.[29] Even if access to the library is restricted, a reference will constitute a “printed publication” as long as a presumption is raised that the portion of the public concerned with the art would know of the invention, e.g., by being informed of its existence or by means of customary research aids available in the library.[30] Moreover, the university library will usually contain a catalogued and publically available copy of a thesis or dissertation. Copies of a student’s thesis or dissertation are also often available for purchase through various companies (such as ProQuest and UMI) that copyright these works.

Therefore, a patent application should be filed before any thesis or dissertation describing the invention is either indexed and shelved in the library or published by a third-party. Note that some schools provide the option to embargo a dissertation or thesis for a limited time, which can be used to allow the university more time to submit a patent application.

  Scientific Meeting Presentations

There are several opportunities for “public disclosure” at a scientific meeting. For example, faculty and students can present their discoveries in abstracts, posters, oral presentations, and in casual conversation with other attendees.

Attendees that want to present either a poster or an oral presentation often submit their abstract ahead of the meeting, which is then compiled into a volume that is typically made available to meeting attendees one or two months prior to the meeting. This abstract would likely be considered a “printed publication” under 35 U.S.C. §102 (pre-AIA or AIA) and Article 54 of the EPC. Therefore, if the abstract describes the invention sufficiently to enable one of ordinary skill in the art to comprehend the essentials of the claimed invention without need of further research or experimentation, then it would be a “public disclosure” of the invention with the potential to bar patentability.

A poster presentation can also be considered a “printed publication” under 35 U.S.C. §102 (pre-AIA or AIA)[31] and Article 54 of the EPC. In the U.S., whether a temporarily displayed reference that was neither distributed nor indexed (e.g., poster) is sufficiently publicly accessible to count as a “printed publication” depend on the following factors: 1) the length of time the display was exhibited, 2) the expertise of the target audience, the 3) existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and 4) the simplicity or ease with which the material displayed could have been copied.[32] All of these factors relate to the ability of the audience to copy and/or retain the displayed material. According to the Federal Circuit, “The duration of the display is important in determining the opportunity of the public in capturing, processing and retaining the information conveyed by the reference.”[33] This is balanced by the ease or simplicity with which a display can be copied and the expertise of the audience.[34] Also, as discussed above, the presenter’s reasonable expectation that the information will not be copied is also a factor in determining whether a disclosure is sufficiently accessible to the public to be a “public disclosure.”

For pre-AIA patents and applications, purely oral presentations generally did not constitute “printed publications” under 35 U.S.C. §102—no matter how public the presentation.[35] Moreover, visual aids during an oral presentation (such as slides) may be considered too transitory to be considered printed publications for pre-AIA patents and applications.[36] However, these same activities could be considered “otherwise available to the public” for AIA patents and applications. In either case, recordings of the presentation or copies of the slides made available to the attendees would likely constitute a printed publication. A recording could even be performed unknowingly by an attendee of the presentation and can constitute prior art.

  Grant Applications

As with manuscript submissions, grant applications submitted to private foundations or federal agencies are generally held in confidence while under review. With federal grants however, certain details, such as the project title, principle investigator, amount of reward, and the grant abstract are generally made available to the public once the grant is funded.[37]

At least one district court has concluded that a funded government grant proposal constituted a printed publication since it was filed, indexed by title, author, institution and grant number, and it was available from the agency under the Freedom of Information Act (FOIA)[38] before the date of application.[39] However, this court did not consider the ability of the agency to withhold information pursuant to a FOIA request relating to trade secrets and patent or other commercial rights (“exempt” information).[40] If the granting agency has substantial reason to believe that the grant proposal contains information that could reasonably be considered exempt, they should notify the grantee and give them an opportunity to identify commercially valuable information that should not be disclosed. The agency should then redact any exempt information before providing the grant proposal in response to the FOIA request. However, it is best not to rely on these exemptions and to treat a federal grant proposal as publically accessible as soon as it is funded.

  Collaborations

Perhaps the most difficult situations to control and account for are presentations and informal conversations that occur on the university campus. Students and faculty routinely discuss their research with colleagues, both inside and outside of their lab and department. They engage in meetings and presentations, which may be open to collaborators at other institutions. They also have telephone calls to discuss sharing of reagents and protocols. In other words, they engage in scientific research, collaboration, and scholarship, which involve the flow of information.

As discussed above, there are professional norms relating to codes of practice that occur in academic circles that can support expectations of confidentiality without any formal agreements in place.[41] These norms should provide protection for collaborations with colleagues at other academic institutions. However, these norms are also changing as the lines between academia and industry begin to blur.

A survey of 194 U.S. academic institutions published by the Association of University Technology Managers (AUTM) for FY2012 showed a growing role for industry-sponsored university research.[42] Unlike traditional academic collaborations, communications with industry may lack implicit expectations of confidentiality, and require formal agreements with clear confidentiality provisions. The situation is less clear where the inventor is collaborating with a student or faculty who is the recipient of an industry-sponsored research agreement. Does the inventor have a reasonable expectation of confidentiality based on professional norms if the colleague has a contractual relationship with an industry partner? What if the colleague maintains an academic appointment as well as employment or directorships at private companies?

Therefore, while there are professional norms providing some protection for collaborative disclosures that are part of the day-to-day activities of academic research, the lines between academia and industry are becoming blurred. While it may be impractical to file patent applications prior to these activities, efforts should nevertheless be taken to ensure that expectations of confidentiality are maintained. This may not require a formal confidentiality agreement. However, it may be prudent to mark communications to collaborators as “confidential” and request that they agree to maintain this confidentiality until it becomes publically available.

Conclusion

As discussed above, academic research necessarily involves a flow of information that, while necessary, can create a bar to patentability. At a minimum, a patent application should be filed for important inventions prior to any disclosure that is not protected by a reasonable expectation of confidentiality, such as publications and presentations to the public. However, this standard of confidentiality is fact-dependent and difficult to predict. Moreover, even if a communication to a third party is clearly confidential, that does not protect one from the effect of public disclosure by the third party in violation of their confidentiality requirement. It is therefore prudent to file a patent application before any disclosure of the invention to someone who is not part of the research team. In addition, communications with collaborators at other institutions or with outside affiliations should be treated with care so that expectations of confidentiality are evident and maintained.

 

The research and opinions provided above provided educational purposes only, and are not intended to provide specific legal advice, to be any form of legal opinion, or to be a solicitation. If you have any questions regarding a specific legal question, you should contact a qualified patent attorney for guidance.

 

 

[1] Pub. L. 96-517, December 12, 1980; codified in 35 U.S.C. § 200-212; implemented by 37 C.F.R. § 401.

[2] Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002) (“[D]escription [of the invention] is the quid pro quo of the patent system; the public must receive meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.”); 3 Donald S. Chisum, Chisum On Patents § 7.01 (2010).

[3] Pub. L. No. 112-29, § 3(n)(1), 125 Stat. 293 (Sept. 16, 2011).

[4] 35 U.S.C. §§ 102(a), (b) (2006).

[5] Pfaff v. Wells Electronics, Inc., 525 U .S. 55 (1998).

[6] Metallizing Eng’g Co. v. Kenyon Bearing & Auto Parts Co., 153 F.2d 516,518 (2nd Cir. 1946).

[7] In re Klopfenstein, 380 F.3d 1345, 1349 and n.4 (Fed. Cir. 2004)(“With regard to scientific presentations, it is important to note than an entirely oral presentation at a scientific conference that includes neither slides nor copies of the presentation is without question not a "printed publication" for the purposes of 35 U.S.C. § 102(b).”)

[8] Id. at 1350–52 (three day poster presentation at academic conference without any paper distribution or indexing was a printed publication under 102(b)).

[9] 35 U.S.C. § 102(a) (newly amended by the Leahy-Smith America Invents Act of 2011).

[10] MPEP §§ 2128.01(II), 2152.02(e); Senator Leahy stated:

One of the implications of the point we are making is that subsection 102(a) was drafted in part to do away with precedent under current law that private offers for sale or private uses or secret processes practiced in the United States that result in a product or service that is then made public may be deemed patent defeating prior art. That will no longer be the case. In effect, the new paragraph 102(a)(1) imposes an overarching requirement for availability to the public, that is a public disclosure, which will limit paragraph 102(a)(1) prior art to subject matter meeting the public accessibility standard that is well-settled in current law, especially case law of the Federal Circuit.  

112 Cong. Rec. Vol. 157, Number 35, S1496 (statement by Senator Leahy).

[11] The AIA’s use of the phrase “otherwise available to the public” appears to suggest that the AIA’s on-sale bar applies only to public sales or offers for sale. Under pre-AIA section 102(b) it has long been held that the term “public” modifies only “use”—not “sale”—meaning that the current on-sale bar is triggered equally by public and private sales or offers for sale. Hobbes v. United States, 451 F.2d 849 (5th Cir. 1971). And, the principles of statutory construction suggest that the new on-sale bar has not changed in this regard because the AIA does not expressly state that it applies only to public sales or offers. But, it is likely that the courts will need to confirm whether the AIA’s on-sale bar is triggered by all sales and offers before anyone may act with certainty in timing the commercialization of inventions.

[12] Cordis Corp. v. Boston Scientific Corp., 561 F.3d 1319, 1333 (Fed. Cir. 2009) (quoting In re Wyer, 655 F.2d 221, 226 (C.C.P.A. 1981)).

[13] Egbert v. Lippmann, 104 U.S. 333, 336 (1881).

[14] See In re Lister, 583 F.3d 1307, 1314 (Fed. Cir. 2009).

[15] Invitrogen Corp. v. Biocrest Manufacturing L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005); Whether an invention is “ready for patenting” in the context of the on sale and public use bars “may be satisfied in at least two ways: by proof of reduction to practice before the critical date; or by proof that prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.” Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67 (1998).

[16] Id.

[17] In re Klopfenstein, 380 F.3d at 1350–51 (“Whether a party has a reasonable expectation that the information it displays to the public will not be copied aids our § 102(b) inquiry. Where professional and behavioral norms entitle a party to a reasonable expectation that the information displayed will not be copied, we are more reluctant to find something a ‘printed publication.’ This reluctance helps preserve the incentive for inventors to participate in academic presentations or discussions.”).

[18] Cordis, 561 F.3d at 1333–34.

[19] In re Klopfenstein, 380 F.3d at 1351.

[20] Cordis, 561 F.3d at 1334.

[21] Invitrogen Corp., F.3d 1374 at 1380, 1382.

[22] Elan Pharm., Inc. v. Mayo Found. For Med. Educ. & Research, 346 F.3d 1051, 1054 (Fed. Cir. 2003); Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354 (Fed. Cir. 2003); Bristol-Myers Squibb v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1374 (Fed. Cir. 2001).

[23] Pre-AIA 35 U.S.C. § 102(b); AIA 35 U.S.C. § 102(b)(1).

[24] European Patent Convention art. 54, Oct. 5, 1973, 1065 U.N.T.S. 199 (as amended Nov. 29, 2000).

[25] EUROPEAN PATENT OFFICE, CASE LAW OF THE BOARDS OF APPEAL 69–85 (Legal Research Serv. for the Boards of Appeal ed., 6th ed. 2010)

[26] Sekisui Kaseihin Kogyo Kabushiki Kaisha v. Owens-Illinois, Inc., [1996] T 0472/92 [E.P.O.]; Hareus Quarzglas GmbH & Co. KG v. Nikon Corp., [2000] T 0633/97 [E.P.O.]; Marposs Societa’ per Azioni v. FAG Kugelfischer George Schäfer & Co., [1995] T 1076/93 [E.P.O.]

[27] Id.

[28] See Cordis, 561 F.3d at 1334.

[29] In re Hall, 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986).

[30] In re Bayer, 568 F.2d 1357, 1361 (CCPA 1978).

[31] In re Klopfenstein, 380 F.3d 1345, 1352 (Fed. Cir. 2004) (three day poster presentation at academic conference without any paper distribution or indexing was a printed publication under 102(b)).

[32] Id. at 1350.

[33] Id. at 1350–51.

[34] Id. at 1351.

[35] In re Klopfenstein, 380 F.3d at 1349 and n.4

[36] In re Klopfenstein, 380 F.3d at 1350–51 and n.4; Regents of the Univ. of Cal. v. Howmedica, Inc., 530 F. Supp. 846, 860 (D.N.J. 1981) (holding that a presentation of lecture slides that was of limited duration was insufficient to make the slides "printed publications" under § 102(b)).

[37] See e.g., NIH Research Portfolio Online Reporting Tools (RePORT) website available at http://projectreporter.nih.gov

[38] 5 U.S.C. § 552 and 45 C.F.R. § 612 et seq.

[39] E.I. du Pont de Nemours & Co., v. Cetus Corp., 1990 U.S. Dist. LEXIS 18382 (N.D. Cal. 1990).

[40] 5 U.S.C. § 552(b)(4)

[41] Cordis Corp. v. Boston Scientific Corp., 561 F.3d 1319, 1334 (Fed. Cir. 2009).

[42] AUTM U.S. Licensing Activity Survey: FY2012, available at www.autm.net/FY2012_Licensing_Activity_Survey/12351.htm. Of the total $63.7 billion total sponsored research expenditures in FY2012, $40 billion was from federally funded research, while $4.1 billion was from industry sponsored research.

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