A Four Part Series on Open Notebook Science (Part 2)
The previous article in this series covered the role of laboratory notebooks for use in the reproducibility of scientific research. In part two of this series, I will examine laboratory notebooks and the law, specifically the changing legal value of laboratory notebooks.
First, I will look at a 2013 opportunity to legally mandate open notebook science which was not implemented by the U. S. Office of Science and Technology Policy (OSTP). Indeed, laboratory notebooks were deliberately excluded from a list of open access mandates for federally-funded research, with little explanation as to this decision. I will point out that this exclusion probably did not take into consideration the long-term value of laboratory notebooks or the needs of a variety of stakeholder constituents who could use them as tools for preventing fraud, for ensuring maximum value from research dollar expenditures, for reducing risk in commercial innovation initiatives, and for improving pubic transparency and trust when it comes to the scientific community.
Second, I will examine how a major overhaul in the American patenting system from "first to invent" to "first to file," known as the Leahy-Smith America Invents Act (AIA) of 2011, legislated a lasting change to the process of invention. These changes went into effect on March 16, 2013 and will have meaningful implications when it comes to financial incentives and market protections in the United States. In particular, I will discuss the way in which the wording of this law guides judicial interpretation; that is, how laboratory notebooks should be interpreted by the courts during patent litigation.
Did the OSTP Miss an Important Opportunity
When They Decided Not to Mandate Open Notebook Science in 2013?
The National Research Council of the National Academies recently published a report, Sharing Publication-Related Data and Material: Responsibilities of Authorship in the Life Sciences (2013), wherein they declared that “Sharing of materials integral to a published work is a responsibility of authorship ... materials described in a scientific paper should be shared in a way that permits other investigators to replicate the work described in the paper and to build on its findings. Sharing facilitates new scientific and commercial advances, eliminates duplicative efforts by others to recreate materials, and speeds the progress of science” (p.51). Yet, the February 2013 release of the U. S. OSTP policy memorandum requiring open access to governmentally-funded scientific research results and data sets online, in section 4, page 5, deliberately excluded laboratory notebooks: "For purposes of this memorandum, data is defined, consistent with OMB circular A-110, as the digital recorded factual material commonly accepted in the scientific community as necessary to validate research findings including data sets used to support scholarly publications, but does not include laboratory notebooks, preliminary analyses, drafts of scientific papers, plans for future research, peer review reports, communications with colleagues, or physical objects, such as laboratory specimens."
This exclusion occurred despite the fact that notebooks are a necessary step in the production of reproducible research and seven stakeholder groups have an interest in making these laboratory notebooks public:
1. Archivists, museum professionals and historians of science are interested in the preservation of materials for historical purposes.
2. Computer scientists and innovators are interested in data reuse and visualization.
3. Lawyers are interested in laboratory notebooks for their value in patent litigation and defense for any patents filed prior to March 16, 2013.
5. Scientists want a high number of citations of their work as well as the ability to reuse others’ data without the problem of vague descriptions, as is now often the case concerning the methodology section of published papers, as well as not specifying the names of equipment and software used in the experiments for data replication purposes.
6. Public taxpayers want nearly everything available in the interests of transparency and access, so that experts might scrutinize findings. As the public places more trust and financial investment in the sciences and expert findings that directly impacts their lives, greater transparency serves to allay public concerns about funding sources that might have a vested financial interest in wrongfully influencing the outcome. So too are there concerns that researchers might try publish false or misleading findings, motivated by the need to chase funding, self-preservation amid cut-throat competition, or simply in order to increase a list of publications to obtain grants and tenure to keep their existing position or to advance their careers.
7. Industry needs to apply basic science research for new inventions which may entail the risk of millions of dollars. Corporations and businesses need to know that the underlying science is right before risking their shareholders' or their personal fortunes. “Junk science” only derails commercial interests through failed product development and deflates their corporate stocks and shareholders’ confidence.
As I discussed in a previous article, "What is E-science and How Should it be Managed?," several individuals including Michah Altman (firstname.lastname@example.org), Director of Research and Head Scientist for the Program on Information Science at MIT Libraries, took note of this decision at a public forum in May 2014 that was conducted by the National Academy of Sciences in Washington DC. So too did I mention how R. Michael Tanner, of the Association of Research Libraries (ARL), publicly disagreed, stressing the omission of "critical aspects related to documenting research" like laboratory notebooks.
It is no surprise that some of the greatest changes in the open access publishing movement have resulted from disagreements with current policy leading to petitions by academics, such as British Fields Medalist, Sir William Timothy Gowers, and the public, through the “Open Access to the Results of Scientific Research” petition posted on The White House website.
The future possibility of legislating open notebook science may give rise to a contentious argument and will be debated more fully in part three of this series.
Under the America Invents Act, in the Long-term,
Published Notebooks are More Valuable than Unpublished Ones
Laboratory notebooks traditionally maintained their legal usefulness and long-term value because they were processed and stored in official archives. When processing an acquired collection of materials, libraries and archives differ from one another in two relevant ways. First, libraries impose a system of organization (such as the Dewey Decimal System or the Library of Congress Classification System) regardless of the creator's original order of information objects, whereas archival organization methodology respects and maintains the original order of the records' creator and does not mix items from different creators. This is referred to as respects des fonds. The rules governing archival administration, including an "unbroken chain of custody" (as introduced by the preeminent British archival theorist Sir Hilary Jenkinson), allowed the use of archival materials in British and American courts of law as admissible evidence, such as patent litigation cases.
The passing of The Leahy-Smith America Invents Act (AIA) of 2011, marked a major change to the protection of inventions by switching from a “first to invent” to a “first to file” system. America had been relying on the idea that the individuals who could prove they were the original inventor were awarded the patent. Often this involved showing original a preparatory work, like dated laboratory notebooks, to prove when an individual arrived at the concept and explained it in detail. In other words, the laboratory notebook documented that "AHA!" moment. In the meantime, the rest of Europe, the UK, Japan, and most other countries around the world relied on a system of inventorship based on the first individual to file a patent at that country's patent office. The discrepancies between the U. S. system and the manner in which the nearly all of the rest of the world pursued legal ownership over their intellectual property (their invention) were at odds for over 150 years. Under Article 9(2) and Article 2(ii) of the World Intellectual Property Organization (WIPO) Draft Treaty of 1991, all signatories would have to switch to the "first to file" system. The U. S. Bar Association opposed the U. S. yielding its position, arguing that such a change was unconstitutional. Unless America refused to participate in the finalized Patent Harmonization Treaty, however, its system would have to come into agreement with the rest of the world. And that is exactly what it did. In 2004, the U. S., Japan, and the European patent offices submitted a joint proposal to WIPO. Despite the fact that the Treaty remained yet unfinalized, President Obama signed into U. S. law the AIA on September 16, 2011 and specified the "first to file" transition date as March 16, 2013.
In light of these recent major changes, a reevaluation of the legal value of laboratory notebooks for U. S. patenting is needed.
In moving away from the “first to invent” benchmark, the AIA appears to devalue unpublished laboratory notebooks for patent litigation in the long-term. Such notebooks used to be the de facto standard defense of inventorship. The old recommendation to file a patent first, then publish, and save laboratory notebooks may still apply (under an institution’s policy), but people might be in for a few surprises if they do that. Under this new system, awards of inventorship still can be challenged and subject to interference, a remnant of the old system, but interference will eventually be eliminated and will only continue to apply to any claim filed prior to March 16, 2013. (GPO, Fed. Reg. 77, 43742- 43759 (2012)). Under the new system, public disclosures by others whether in English or other languages, such as conference presentations, published papers, and statements or documents from collaborators who did not sign a non-disclosure agreement or “joint research agreement,” before the patent application is filed will be problematic, because they will “destroy patentability,” by establishing prior art; “therefore, it is important for inventors to keep good records of conversations or meetings with collaborators. Lab notebook habits are even more important than they used to be.” (GPO, Fed. Reg. 77, 43742- 43759 (2012)). The USPTO requires, under the new policy enacted into law, that items (such as the actual patent application and any related journal article submitted to the USPTO as part of a patent application or challenge to an application for U. S. patent protection) must be submitted to them in English or translated into English. However it is not necessary for such translation to have occurred to consider any source to constitute a public disclosure. Additionally, should scientists seek protection or challenge an invention in the U. S., it is important to understand U. S. law will require that their materials be translated into English.
Under the new system, patent filings must include copies of any published works by the creator related to the patent under consideration. If they did publish, and their research had been funded under the new open data mandates, their underlying data sets would also have been published and as associated data to that paper would be available to the patent office. Theoretically, it could be possible to submit laboratory notebooks as related materials to a patent filing. They could serve as an additional measure to provide proof of inventorship, and help ensure reproducibility as an added protection to industry and consumers that the presented research is not "a blunder" prior to making huge investments in paying for rights to utilize that patent. Thus, publishing the laboratory notebooks with the patent or afterwards, or making them available to those who have paid to use the patent, would be of much greater value for stakeholders than keeping those notebooks hidden and inaccessible.
Under the new U. S. patent system, published laboratory notebooks would be covered, along with other types of permanently available publications that make the same claim as the patent — whether in print or online and peer-reviewed or not—under a one-year “grace period” following the date of publication to demonstrate prior art in a provisional application should someone else beat them to the patent office. Indeed the definition of what qualifies as a “publication” is quite liberal. In terms of the current cost for submitting materials (which might include a laboratory notebook), according to the Oppedal Patent Law Firm, on the electronic patent application itself, there is an attachment option for Form PTO/SB/429 to show “proof of publication” by a third party that is a “concise explanation permitted as a protest” (under rule 291), or a “concise description” (under rule 290), in which the “first and only” submission is comprised of up to three publications being free, and a fee of $180 USD per publication thereafter if an unanticipated need arises. Evidence obtained from unpublished sources prior to filing a patent such as unpublished laboratory notebooks will remain relevant, at least for a time, but will be less relevant than “disclosures” and communications to competitors who might use those to file first. Nevertheless, unpublished laboratory notebooks for patents filed prior to March 16, 2013 will remain useful in protecting the rights of inventorship for the duration of twenty years after the filing date of a non-provisional application, substantiating the life of the patent. According to Bret Field, an intellectual property attorney who spoke at Stanford University in 2013, a riskier, but valid, approach for claiming inventorship within the U. S. would be for the inventor to publish laboratory notebooks stating a claim of the discovery or invention (though this would lack the potential applications described in a provisional patent application). Due to increased risk and the expense involved in a patent application, some research institutions might decline their right to pursue a new patent following publication (which appeared to be Stanford's position, based on the question and answer session of this presentation), so it is best to consult the university's policy on publishing laboratory notebooks before proceeding if a patent application is planned. When filing patents internationally, this approach should work if a U. S. patent was granted prior to applying for a foreign patent without any pre-existing patent in the foreign country, as long as it falls within that one-year grace period; though, as Field pointed out, if there is an existing foreign patent it would be up to that country’s government to decide.
After filing a patent, up until this year, it has been very much in the interests of research institutions and corporations to keep these materials private for commercial purposes relating to additional patents and future discoveries, unless the patent happens to be challenged. Laboratory notebooks have also been useful in defending against cases alleging patent infringement. Under the new system, there is a “challenge” period during the “post grant review” process, wherein the availability of laboratory notebooks may assist the patent office in dismissing challenges in a Post-grant or Inter partes review or Ex parte re-examination. During these periods of review, patents previously granted may be challenged (J. Villasenor, Brookings Policy Brief Series 184 (2011)).
As an example of the value of laboratory notebooks in patent litigation, I cite the famous Supreme Court ‘Telephone Cases’ Decision of 1888—the cases surrounding whether or not Alexander Graham Bell actually was the inventor of the telephone. I will not go into extensive detail here about the cases challenging his inventorship, because they have already been the subject of several books, such as Seth Shulman's The Telephone Gambit: Chasing Alexander Graham Bell’s Secret (2009), A. Edward Evenson's The Telephone Patent Conspiracy of 1876: The Elisha Gray-Alexander Bell Controversy and Its Many Players (2001), and Charlotte Gray's Reluctant Genius: Alexander Graham Bell and the Passion for Invention (2006). (I recently attended an online webinar hosted by the AAAS called "Rediscovering Alexander Graham Bell," where Ms. Gray was an invited speaker, but the topic of the debated inventorship of the telephone did not arise. Interestingly Ms. Gray shares the same last name as Elisha Gray, Bell's main challenger).
On Feb. 14, 1876, [Elisha] Gray filed with the U. S. Patent Office a caveat (an announcement of an invention he expected soon to patent) describing apparatus 'for transmitting vocal sounds telegraphically.' Unknown to Gray, Bell had only two hours earlier applied for an actual patent on an apparatus to accomplish the same end. It was later discovered, however, that the apparatus described in Gray's caveat would have worked, while that in Bell's patent would not have. After years of litigation, Bell was legally named the inventor of the telephone, although to many the question of who should be credited with the invention remained debatable.
This case is an excellent example of how, under the old “first to invent” principle, Elisha Gray could have used Bell's laboratory notebooks in his claim against him. These "excerpts from Elisha Gray's patent caveat of February 14 and Alexander Graham Bell's lab notebook entry of March 8, demonstrat[ed] similarities."
One of the new regulations in the AIA "first to file" system discusses the importance of competitive communication when challenging a patent. The documentation in this case was, as physicist Lloyd William Taylor noted, that “the transmitter used by Bell on this famous occasion had previously been described by Elisha Gray, a free-lance inventor in the telegraphic field, in a confidential document about which Bell subsequently acknowledged having received information” (Taylor, L., Am J Phys 5, 243-251 (1937)). Gray could have also used his own communications to Bell, along with Bell's document containing these acknowledgements to make his case.
Under the new "first to file" regime, it is still possible to mount a court challenge. Let us look at this fictional example. Mr. Y filed a patent and Ms. X feels she invented it first and the two had an ongoing correspondence. If Ms. X decides to challenge Mr. Y's patent, Ms. X might come forward, present a piece of correspondence or email as evidence, and claim she told Mr. Y about the invention in detail, and try to get the patent instead. She might argue that she deserves some remuneration from Mr. X's profits that he has already received from that patent. Mr. Y might mount a defense by producing his dated laboratory notebooks, showing that while Ms. X thought she was providing Mr. Y with new information via her correspondence, in fact he had already discovered this independently. The inclusion of correspondence and laboratory notebooks is not part of the regular patent filing process, though a scientist might reference specific pages of his notebooks in a patent application. (An example of this will be provided in part 3 of the series).
However, now that the underlying data related to federally-funded research is required to accompany the papers, I believe that notebooks will become more important. What happens when people look at these data sets and cannot reproduce them in either an academic or laboratory context? What if a company paid to use a patent and its associated data to try to make a new product but it was not working? Then patent holders would need to provide more information, and might return to the notebooks. This is why notebooks for patented products must be maintained for many years. The Office of Research Integrity of the U.S. Department of Health and Human Services, for example, recommends notebooks be maintained for the "life of the patent plus six years." The life of a U. S. patent may be 17 years or 20 years. According to the U.S.-based global intellectual property specialist firm Oblon, Spivak, McClelland, Maier & Neustadt, "Prior to passage of the URAA, a US patent enjoyed a life of 17 years from the date the patent issued. With the passage of the URAA, the United States instituted a patent term of 20 years, beginning the date on which the patent issued and ending 20 years from the date on which the application for patent was filed. The passage of this legislation effectively has created a one time, automatic patent term extension for existing patents." The additional six years of preservation is done in order "to include the Statute of Limitations."
I have just provided two examples where, under the new AIA "first to file" system, laboratory notebooks could be used in patent litigation, in the first case by a plaintiff, Mr. Gray, and in the second case, by an individual mounting a defense, Mr. Y.
In summary, the advice offered by the Technology Transfer department of Johns Hopkins University is: “It is important for inventors to keep good records of conversations or meetings with collaborators. Lab notebook habits are even more important than they used to be.”
• Leahy–Smith America Invents Act (Public Law 112-29, September 16, 2011)
• Inter Partes Review
• Post-grant Review
• Transitional Period
• Supplemental Examination
• Inventor’s Oath (inventors no longer need to be the applicants through the introduction of assignees)
• Trial Practice Rules
• Trial Practice Guide
• USPTO explains the America Invents Act – Webinar, September 6, 2012
• World International Property Organization (WIPO) Treaties, Laws & Practices
In the first two parts of this series, several reasons for withholding scientific information have been discussed, such as protection of information for national security, patient rights, the protection of intellectual property rights through patenting, and the fact that sometimes a closed culture actually stimulates innovation and economic growth. In each of these cases, I raised arguments in which the availability of open notebooks, either within an organization for self-monitoring or ones made public (even if redacted), can have an added benefit to the dissemination of scientific results and work in cases where open data might be too difficult to achieve. In Part 3 of this series, I would like to begin with the premise that an open laboratory notebooks policy should be adopted and to examine what models best emulate the needs of the various stakeholders involved. In particular, I would like to compare a mandated versus a voluntary model of participation as well as contrast a centralized versus distributed model.
Disclaimer: This article series should not be interpreted as legal advice or counsel, but does provide some available legal resources for the readers’ consultation and the author’s personal opinions of them.