Source: https://www.chemengonline.com/u-s-patent-rights-think-twice-disclosing-invention/
Timestamp: 2019-04-18 17:25:42+00:00

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Publish or perish is a maxim in the scientific community, where scientists are encouraged to share their work quickly and often. Scientists spend considerable time and effort seeking grants, submitting abstracts to conferences and scientific journals, and presenting and publishing their research. They may also collaborate with other scientists, discuss their work with investors, or offer their products for sale. Although each of these activities may lead to prominence or even profits, scientists who act too soon or share too much create a risk of forfeiting their own U.S. patent rights (Figure 1). Cautionary tales of inventors who have risked their own U.S. patent rights provide valuable insight for scientists in developing their own best practices.
Publicly available information in a grant application may present a possible problem for U.S. patent rights. Although most grant applications today are submitted and maintained on a confidential basis, certain information about federally funded grants may be accessible through a request under the Freedom of Information Act (FOIA). If the information includes a description of the claimed invention, and it becomes publicly available more than one year before a U.S. patent application is filed, it may preclude U.S. patent protection for that claimed invention.
For example, in 2014, the U.S. Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB) considered whether a University of Washington inventor’s own grant applications could be used as a basis for finding unpatentable his issued U.S. patent claims related to detecting analytes in liquid media [ 1] The inventor, having obtained grants from the National Human Genome Research Institute, then filed a U.S. patent application more than one year later. The patent issued and several years passed. In 2013, Oxford Nanopore Technologies Ltd. used FOIA requests to obtain redacted copies of the grant applications. Oxford then argued to the PTAB that the patent claims should be found unpatentable because the invention was publicly disclosed in the grant applications more than one year before patent filing, as shown in the 2013 versions of the grant applications. Copies of the grant applications dated more than one year before patent filing were not presented to the USPTO during the original prosecution of the patent or to the PTAB during this later proceeding. The PTAB determined that the 2013 versions of the grant applications did not indicate what was publicly available more than one year before patent filing, because additional information might have been redacted from the public if FOIA requests had been submitted back then. The PTAB thus declined to find the patent claims unpatentable based on prior public disclosure. Although the patent claims were not found unpatentable in this instance, this case may have turned out differently if the PTAB had been presented with publicly available copies of the grant applications dated more than one year before patent filing and they had disclosed the claimed invention.
This cautionary tale demonstrates that scientists should take steps to ensure that their grant applications are submitted and maintained on a confidential basis. In addition, out of an abundance of caution, inventors should consider filing a U.S. patent application within one year of submitting a grant application that describes the invention, or before submitting a grant application at all if they are considering global patent protection, since not all jurisdictions have the one-year grace period.
Abstracts and papers that are shared or maintained on a non-confidential basis may present a possible problem for U.S. patent rights. As with grant applications, if the abstract or paper describes the claimed invention and becomes publicly available more than one year before a U.S. patent application is filed, U.S. patent protection for that claimed invention may be precluded.
For example, in 1963, the USPTO considered whether an inventor’s submission of an advanced proof of a paper to a symposium precluded the inventor from obtaining a U.S. patent relating to distillation of volatile chlorides [ 2]. The inventor submitted an advanced proof of a paper to the Institution of Mining and Metallurgy for discussion at a symposium to be held at the Royal Society of the Arts in London in 1956. The Institution provided copies of the paper to the symposium registrants and attendees, and when the inventor applied for a U.S. patent more than one year later, the examiner rejected the claims over the advanced proof of the symposium paper. The inventor appealed, but the USPTO Board agreed with the examiner. It held that the prior disclosure in the advanced proof of the paper constituted public disclosure of the claimed invention more than one year before patent filing, and U.S. patent protection was thus precluded.
Whether an abstract or paper constitutes a public disclosure is often a fact-intensive inquiry that may turn on the evidence presented. For example, in 2004, the U.S. Court of Appeals for the Federal Circuit considered whether a meeting abstract could be used to invalidate U.S. patent claims owned by Norian Corporation related to tooth and bone repair [ 3]. The inventor had submitted an abstract for a meeting of the International Association for Dental Research (IADR) in 1991. More than one year later, Norian filed a U.S. patent application. The patent issued and Norian subsequently sued Stryker Corporation in the Northern District of California for infringement. During the litigation, Stryker argued that the patent claims were invalid based on prior disclosure in the IADR abstract. The district court disagreed, finding that the abstract was not disseminated at the IADR meeting and was thus not a prior public disclosure of the claimed invention. In making this finding, the district court relied on one presenter’s testimony that he could not recall whether copies of the abstract were available to attendees, and the other presenter’s testimony that no one asked him about the availability of the abstract. On appeal, the Federal Circuit affirmed. While Norian’s claims were not invalidated in this instance, this case may have turned out differently if the court found, for example, that the presenters or the IADR had distributed copies of the abstract to attendees. Filing a U.S. patent application before submitting the meeting abstract would have avoided this risk to the claims.
As another example, in 2009, the Federal Circuit considered whether a paper that the inventor shared with coworkers could be used to invalidate U.S. patent claims owned by Cordis Corporation related to stents [ 4]. The inventor was a medical resident who prepared a paper in 1980 relating to his work with stents. He provided copies of the paper to about six of his teachers, and orally presented it to them and several other colleagues. The inventor later gave copies of the paper to Vascor, Inc. and Shiley, Inc. while trying to commercialize his stent technology. The agreements between the inventor and the two companies did not require confidentiality, and the Shiley agreement specifically stated that Shiley was not required to keep the information secret. In 1983, the inventor joined the faculty at the University of Texas, San Antonio, and provided copies of a revised version of his paper to a doctor and technician there, and to the university as part of a research proposal. About two years later, the inventor filed a U.S. patent application. A patent issued, and Cordis subsequently sued Boston Scientific Corporation in the District of Delaware for infringement. During the litigation, Boston Scientific responded that the patent claims were invalid based on prior disclosure in the 1980 and 1983 papers. The district court disagreed, and on appeal, the Federal Circuit affirmed. The Federal Circuit held that the papers were not public disclosures of the claimed invention because there were expectations of confidentiality between the inventor and the individuals receiving copies. Although Cordis’s claims were not invalidated in this instance, this case may have turned out differently if the court had determined, for example, that some of the recipients were not expected to keep the paper confidential. This risk to the claims could have been avoided by filing a U.S. patent application before the 1980 papers were disseminated.
A publicly available abstract or paper that discloses the claimed invention more than one year before patent filing may present a possible problem for U.S. patent rights, even if the authors do not realize the significance of their work at the time they write the abstract. For example, in 2006, the Federal Circuit considered whether an abstract that the inventors published in the European Journal of Pharmaceutical Scientists could be used to invalidate U.S. patent claims owned by Nichols Institute Diagnostics, Inc. relating to antibodies for human parathyroid hormone [ 5]. The inventors published the abstract in 1994, and later realized the significance of their work. One year and ten days after the abstract was published, the inventors filed a U.S. patent application. A patent issued, and Nichols Institute Diagnostics subsequently sued Scantibodies Clinical Laboratory, Inc. in the Southern District of California for infringement. During the litigation, Scantibodies argued that the patent claims were invalid based on prior disclosure in the published abstract. The district court disagreed, finding that the abstract did not constitute a public disclosure of the claimed invention because the inventors did not know the significance of their work when the abstract was published. On appeal, however, the Federal Circuit overturned the district court decision, holding that the patent claims were invalid, because the abstract disclosed the claimed invention to the public more than one year before the U.S. patent application was filed and the significance of the work was inherent in the disclosure.
Learning from these cautionary tales, scientists should take steps to ensure that abstracts and papers describing their inventions are submitted to conferences and journals or shared with colleagues on a confidential basis. As an even better course, if practicable, inventors should consider filing a U.S. patent application within one year of submitting or sharing their abstract or paper, or, better yet, before submitting or sharing their abstract or paper at all if they are considering global patent protection.
Presentations that constitute public disclosure of a claimed invention more than one year before patent filing may present a possible problem for U.S. patent rights. For example, in 1985, the Federal Circuit considered whether a presentation by the inventors could be used to invalidate U.S. patent claims owned by the Massachusetts Institute of Technology (MIT) related to biological cell cultures [ 6]. The inventors had presented their work on microcarriers at the First International Cell Culture Congress in September 1976. The conference was attended by fifty to five-hundred cell culturists, and printed copies of the presentation were distributed to a number of scientists. One year and two months after the conference, the inventors filed a U.S. patent application. A patent issued, and MIT asserted it against AB Fortia at the International Trade Commission (ITC). The ITC determined that the patent claims were invalid because the presentation and handouts constituted public disclosure of the claimed invention more than one year before patent filing. On appeal, the Federal Circuit agreed.
As with abstracts and papers, whether a presentation constitutes a prior public disclosure of the claimed invention is often a fact-intensive inquiry. It may turn on who had access to the presentation, whether the access was confidential, and what the audience could learn about the claimed invention from the presentation. For example, in 1981, the U.S. District Court for the District of New Jersey considered whether a presentation by the inventors could be used to invalidate U.S. patent claims owned by the Regents of the University of California related to prosthetic knees [ 7]. The inventors had presented lectures about their work to approximately thirty physicians at the 101st Annual Session of the California Medical Association in 1972. One year and two days later, the inventors filed a U.S. patent application. The patent issued, and the Regents of the University of California subsequently sued Howmedica, Inc. in the District of New Jersey for infringement. During the litigation, Howmedica argued that the patent claims were invalid based on prior disclosure during the 1972 lectures. The district court disagreed, reasoning that even though the audience was not asked to keep the information confidential, the slides were projected only temporarily and did not adequately disclose how to make and use the claimed invention. Although the Regent’s claims were not invalidated in this instance, this case may have turned out differently if the court had found, for example, that the slides had been projected for additional time or that they provided more information about the invention. This risk to the patent claims could have been avoided if a U.S. patent application had been filed before the presentation.
As another example, in 2004, the Federal Circuit considered whether a presentation by the inventors at two different meetings precluded them from obtaining U.S. patent protection [ 8]. The inventors had presented their research relating to cholesterol at a meeting of the American Association of Cereal Chemists (AACC) and at an Agriculture Experiment Station (AES) at Kansas State University in 1998. The presentations involved displaying a poster with fourteen printed slides for about three days total. About two years later, the inventors filed a U.S. patent application. The USPTO examiner rejected the claims based on prior disclosure of the claimed invention at the two meetings. The inventors appealed to the USPTO Board, which agreed with the examiner, and then to the Federal Circuit, which also agreed with the examiner. The Federal Circuit reasoned that the presentation was a prior public disclosure of the claimed invention because the inventors displayed their poster for about three days to a target audience of cereal chemists, the audience was not precluded or discouraged from taking notes or photographs, and only a few slides on the poster needed to be copied for the claimed invention to be captured.
A presentation does not need to involve the inventor to present a possible problem for U.S. patent rights. For example, in 2016, the USPTO considered whether a presentation by an undergraduate student could be used to invalidate U.S. patent claims owned by the University of Washington relating to detecting analytes in liquid media [ 9]. The student had presented work from the laboratory at a 2007 University of Washington undergraduate poster session. Several years later, the University of Washington filed a U.S. patent application related to the work. The patent issued, but Oxford Nanopore Technologies Ltd. subsequently petitioned the USPTO to find the issued patent claims unpatentable based on prior disclosure in the undergraduate poster presentation. The USPTO Board disagreed, concluding that the presentation was not a public disclosure of the claimed invention because the poster session included a broad range of topics and that the viewers were primarily affiliated with the students. Although the University of Washington’s claims were not found unpatentable in this instance, this case may have turned out differently if the Board had determined, for example, that the posters were all related to the subject matter of the invention or if the audience included more scientists in the field. This risk to the claims could have been avoided by filing a U.S. patent application before the presentation.
Learning from these cautionary tales, scientists should keep their presentations as confidential as possible, for example, by asking that audience members not take notes or photographs and by displaying slides only temporarily, especially if the target audience includes scientists in the same field as the invention (Figure 2). In addition, out of an abundance of caution, inventors should consider filing a U.S. patent application within one year of presenting their work, or before presenting their work at all if they are considering global patent protection.
Public use of a claimed invention more than one year before patent filing may present a possible problem for U.S. patent rights. For example, in 2005, the Federal Circuit considered whether use of the invention in Invitrogen Corporation laboratories invalidated its U.S. patent claims [ 10]. Invitrogen had used its inventive process for producing competent E. coli cells in its laboratories for more than one year before filing a U.S. patent application. A patent issued, and Invitrogen subsequently sued Stratagene Holding Corporation in the Western District of Texas for infringement. During the litigation, Stratagene argued that the patent claims were invalid based on prior use. The district court agreed. On appeal, however, the Federal Circuit disagreed and determined that Invitrogen’s use did not invalidate its patent claims because it was not a public use of the claimed invention. The court reasoned that Invitrogen did not sell the claimed process or any products made using the process, and it maintained the process as a secret within the company. Although Invitrogen’s claims were not invalidated in this instance, this case may have turned out differently if the court found, for example, that Invitrogen’s use of the invention was not kept secret.
This cautionary tale demonstrates that scientists should keep any use of their inventions confidential. In addition, out of an abundance of caution, inventors should consider filing a U.S. patent application within one year of using their invention, or before using their invention at all if they are considering global patent protection.
Demonstrations of a claimed invention and communications about a claimed invention more than one year before patent filing may present a possible problem for U.S. patent rights. For example, in 1972, the U.S. District Court for the Northern District of Illinois considered whether an inventor’s demonstration of the invention and a subsequent discussion at an inter-company meeting could be used to invalidate U.S. patent claims [ 11]. Seeking to sell his invention, the inventor had demonstrated his machine for laying cable and other materials underground to an engineer at the Illinois Bell Telephone Company in 1963. The Bell Telephone engineer provided a written report to his supervisor, who then read it during an inter-company meeting of telephone company engineers. One year and three months after the meeting, the inventor filed a U.S. patent application. A patent issued, and the owner subsequently sued J.I. Case Co. in the Northern District of Illinois for infringement. During the litigation, J.I. Case argued that the patent claims were invalid based on prior disclosure during the 1963 demonstration and inter-company meeting. The district court agreed, reasoning that the demonstration and meeting were public disclosures of the claimed invention because there was no confidential relationship between the inventor and the engineer or the company.
A demonstration or communication need not involve the inventor to present a possible problem for U.S. patent rights. For example, in 1994, the Federal Circuit considered whether a conversation involving the inventor’s graduate advisor could be used to invalidate U.S. patent claims owned by National Research Development Corporation (NRDC) [ 12]. The graduate advisor had attended an Experimental Nuclear Magnetic Resonance (NMR) Conference in the United States in 1973. On the bus to the conference, he had an informal and non-confidential conversation with a scientist from Monsanto Company about the inventor’s work on NMR. Monsanto subsequently incorporated the invention into an NMR spectrometer it used for analyzing herbicides. About two years later, the inventor filed a U.S. patent application. A patent issued, and NRDC subsequently sued Varian Associates, Inc. in the District of New Jersey for infringement. During the litigation, Varian argued that the patent claims were invalid based on the 1973 disclosure by the graduate advisor and Monsanto’s subsequent use. The district court agreed, and on appeal, the Federal Circuit affirmed. The Federal Circuit reasoned that the graduate advisor’s unrestricted disclosure of the claimed invention more than one year before patent filing, coupled with the use of that information in the ordinary course of Monsanto’s business, invalidated the patent claims.
Learning from these cautionary tales, scientists should ensure that any demonstrations of their inventions and communications about their inventions are kept confidential (Figure 3). In addition, out of an abundance of caution, inventors should consider filing a U.S. patent application within one year of demonstrating or communicating about their invention, or before demonstrating or communicating about their invention at all if they are considering global patent protection.
Sales of a claimed invention and offers to sell a claimed invention more than one year before patent filing may present a possible problem for U.S. patent rights. For example, in 2016, the Federal Circuit considered whether Ben Venue Laboratories’ supply of batches of an anticoagulant product could be used to invalidate patent claims owned by the Medicines Company (MedCo) relating to a process for making the product [ 13]. More than one year after MedCo contracted with Ben Venue to manufacture three batches of MedCo’s anticoagulant product, MedCo filed a U.S. patent application. A patent issued, and MedCo subsequently sued Hospira Inc. in the District of Delaware for infringement. During the litigation, Hospira argued that the patent claims were invalid based on Ben Venue’s sale of the product to MedCo more than one year before patent filing. The district court disagreed, determining that the transaction between MedCo and Ben Venue was not a commercial offer for sale of the claimed invention because MedCo retained title to the product and the three batches were supplied for experimental purposes rather than commercial profit. On appeal, the Federal Circuit affirmed. While Ben Venue’s claims were not invalidated in this instance, this case may have turned out differently if the court had determined, for example, that the batches were supplied for commercial profit. This risk to the claims could have been avoided by filing a U.S. patent application before batches of the product were supplied.
A sale does not need to actually occur for an offer of sale more than one year before patent filing to present a possible problem for U.S. patent rights. For example, in 2016, the Federal Circuit considered whether a fax with price, delivery, and payment terms could be used to invalidate U.S. patent claims owned by Merck & Cie even though a sale did not take place [ 14]. A Merck manager had sent a fax in 1998 to Weider Nutrition International relating to the sale of a crystalline calcium salt of tetrahydrofolic acid. About one and half years later, Merck filed a patent application. A patent issued, and Merck sued Watson Laboratories, Inc. in the District of Delaware for infringement. During litigation, Watson Laboratories argued that the patent claims were invalid based on an offer for sale more than one year before patent filing. The district court disagreed, finding that there was no legally binding sale of the claimed invention because the agreement had not been reduced to writing and signed by both parties. On appeal, the Federal Circuit reversed, holding that the fax was an offer for sale that could invalidate the patent claims even though a sale never occurred, because both parties understood it to be an offer for sale of the claimed invention.
A sale more than one year before patent filing only presents a possible problem if the invention is ready for patenting at the time of the sale. Whether an invention is ready for patenting depends on the facts of the case and does not necessarily require a working prototype. For example, in 1988, the U.S. Supreme Court considered whether an inventor’s commercial offer for sale could be used to invalidate U.S. patent claims related to computer chip sockets [ 15]. The inventor had offered to sell his computer chip socket in commercial quantities to Texas Instruments in 1981. Although he had not yet made a working prototype, he showed sketches of the design concepts to Texas Instruments in relation to the offer for sale. One year and eleven days after confirmation by Texas Instruments, the inventor filed a U.S. patent application. A patent issued, and the inventor subsequently sued Wells Electronics, Inc. in the Northern District of Texas for infringement. During litigation, Wells Electronics argued that the patent claims were invalid based on the offer for sale more than one year before patent filing. The district court decided that some of the patent claims were invalid. On appeal, the Federal Circuit reversed, holding that all the patent claims were invalid based on an offer for sale of the claimed invention more than one year before patent filing. It reasoned that even though the inventor did not have a working prototype at the time he offered his product for sale, the invention was substantially complete. On appeal, the U.S. Supreme Court affirmed.
Learning from these cautionary tales, scientists should consider filing a U.S. patent application within one year of offering their invention for sale, or before offering it for sale at all if they are considering global patent protection.
1. Oxford Nanopore Technologies Ltd. v. University of Washington, IPR2014-00512, Paper 12 (P.T.A.B. Sept. 15, 2014).
2. Ex Parte Brimm & Gailey, 1963 WL 8018 (B.P.A.I. Oct. 29, 1963).
3. Norian Corp. v. Stryker Corp., 363 F.3d 1321 (Fed. Cir. 2004).
4. Cordis Corp. v. Boston Scientific Corp., 561 F.3d 1319 (Fed. Cir. 2009).
5. Nichols Institute Diagnostics, Inc. v. Scantibodies Clinical Laboratory, Inc., 195 Fed. App’x 947 (Fed. Cir. 2006).
6. Massachusetts Institute of Technology v. AB Fortia, 774 F.2d 1104 (Fed. Cir. 1985).
7. Regents of the University of California v. Howmedica, Inc., 530 F. Supp. 846 (D.N.J. 1981).
8. In re Klopfenstein, 380 F.3d 1345 (Fed. Cir. 2004).
9. Oxford Nanopore Technologies Ltd. v. University of Washington, IPR2014-00513, 2016 WL 853080 (P.T.A.B. Feb. 26, 2016).
10. Invitrogen Corp. v. Biocrest Manufacturing, 424 F.3d 1374 (Fed. Cir. 2005).
11. Jursich v. J.I. Case Co., 350 F. Supp. 1125 (N.D. Ill. 1972).
12. National Research Dev. Corp. v. Varian Associates, Inc., 17 F.3d 1444 (Fed. Cir. 1994).
13. Medicines Co. v. Hospira, Inc., 827 F.3d 1363 (Fed. Cir. 2016) (en banc).
15. Pfaff v. Wells Electronics, Inc., 525 U.S. 55 (1988).
Shana K. Cyr, Ph.D., is a partner and patent attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (11955 Freedom Drive, Reston, Virginia 20190; Phone: 571-203-2434; Email: shana.cyr@finnegan.com). She represents clients in complex patent litigations, contentious proceedings before the U.S. Patent and Trademark Office (USPTO), and appeals related to pharmaceuticals, biologics, combination products, diagnostics, and medical devices. She also counsels clients on issues arising under patent and U.S. Food and Drug Administration (FDA) law. Cyr employs her strong technical knowledge to specialize in working with experts and inventors in the chemical and pharmaceutical arts.
James M. Eaton, Ph.D., is a patent attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (11955 Freedom Drive, Reston, Virginia 20190; Phone: 571-203-2414; Email: james.eaton@finnegan.com), who focuses his practice on patent litigation, prosecution, and strategic counseling in the pharmaceutical, biotechnology, and chemical areas. Eaton prosecutes patent applications and prepares patentability opinions and freedom-to-operate analyses.

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