A sweeping overhaul to U.S. patent laws places increased importance on managing the relevant data for your application.
Inventors and their legal teams accepted sweeping changes in March, when longstanding U.S. laws granting patent rights to “the first-to-invent” were largely replaced by laws granting patent rights to “the first-inventor-to-file.” With ever-increasing patent filings in the United States, the shift brings the country in line with others—especially in Europe—where “first-to-file” has been in place for decades.
In the two years since the Leahy-Smith America Invents Act of 2011 (the AIA) fundamentally proposed to change the U.S. patent laws, legal experts have advised both large companies and smaller inventors about how to best prepare. In the life sciences industry, questions have risen about whether maintaining laboratory notebooks, including electronic laboratory notebooks (ELNs), is necessary in a post-AIA world that requires less data in the initial patent disclosure filing.
Robert Barr, a professor of intellectual property law at UC-Berkeley, is quoted in Wired saying, “Under the old system, if you kept lab notebooks … you could prove you were the first inventor even if you were not the first to file, so you didn’t necessarily have to be the first to get to the patent office...Now, with a few exceptions, you need to be the first. If two people come up with the same invention, and they often do … it’s not going to matter if you can prove you were the first inventor if you weren’t the first to file.”1
First-to-file raises two concerns for life sciences companies: time and security. ELNs can assist with both, and improved quality is an added, measurable result made possible by having the right electronic systems in place.
ELNs have long been viewed as simply replacements for paper-based data management, but many users have found that electronic data management provides better efficiency and new opportunities for collaboration. In an era of increased externalization for life sciences research, process development, and manufacturing, effective data sharing is paramount to success. Seventy-five percent of research directors say the typical research project now involves two or more external partners, and 47.7 percent expect that a typical research project will involve more external partners over the next three years. Twenty-five percent of companies expect the number of external partners to increase.2 Properly capturing data as a corporate asset allows it to be extracted—for regulatory filings and beyond—using knowledge to fuel decisions throughout product lifecycle management stages.
The need for speed as a driver
The role of ELNs in first-to-file relates, first and foremost, to speed. Although time was certainly of the essence in previous first-to-invent patent filings, speed is more critical than ever with intellectual property (IP) protection and documentation fueling the patent race. For life sciences’ long development times (sometimes 10 years to commercialization) the decision on when to file is important.
According to John Villasenor, a senior fellow at the Brookings Institution quoted in Fast Company, “The pre-filing disclosure by the first company starts the clock ticking on a one-year ‘grace period’ that, under the AIA’s first-to-file rules, is not only protective with respect to Company A’s U.S. rights to the invention, but also removes the ability of anyone else, including Company B, to obtain such rights. Thus, an early disclosure can be beneficial with respect to U.S. patent rights.”3
The major challenge for completing the patent filing in the new first-to-file world is being able to assemble and aggregate data on short notice to present by the one-year filing deadline. Every data point needed must be readily available to summarize and shape among organizations, including all scientific areas. If data is locked in spreadsheets owned by disparate groups, collection across corporate departments and geographic locations becomes time-consuming and often error-prone. Adopting new technologies and practices, including ELNs, to enable better data access for patent filing ensures required information can be gathered appropriately from a compliance perspective for this new era of “file fast, file often.”
ELNs enable workflow-based collaboration between scientific, business, information technology, and legal/IP stakeholders that enhances efficiencies and speeds product development, so the “need for speed” involved in first-to-file becomes a driver for having a better corporate data management system in place (Figure 1). Any sound organization would like to have better control over its data for decision making—with a portfolio of experimental detail readily available at its corporate level—in days rather than months, whether it desires a new patent or not.
Protecting your research
First-to-file ultimately is designed to protect intellectual property. With provisional filing, enough of a concept is made public to add significant risk, and little recourse is available if a corporation discloses too much information to competitors. Companies need to very carefully sort through data from scientists to capture their work and evaluate whether filing for a patent in the name of commercialization is worth the risk involved with exposing IP.
An ELN based on an open platform gives corporations better control of the data faster than manual data aggregation. With data integrated in a central place, an organization is less dependent on individuals’ recollections of data content, storage locations, and the necessary context of the knowledge created during research investigations. When all work records reside in a compliant format and location, records are secure if and when employees leave the company or project. With proper controls in place through electronic data, risks are minimized in terms of which employees and contractors can access records, and companies protect their IP with proper audit trails. Data is more accessible—moving from secure storage systems to PDFs that demonstrate who created records and when. Restricted access to records minimizes risks, but allows data retrieval when appropriate.
As an example, a company might race to be the first-to-file for a provisional patent on a new chemical compound, with outlined plans for synthesizing it. ELNs keep records of testing and help to establish electronic records policies that also can stand as proof in court in legal dispute cases. Important evaluative questions when implanting ELNs include asking what data recovery systems are in place in case of disaster and how cloud-based systems are secured.
Improving experimental quality
With an ELN in place, an organization is more likely to follow a procedure in a more readable, planned format versus using scribbled notes or inconsistent spreadsheets. This method allows records to be reviewed in a much more organized fashion. Quality of experiment documentation will improve with an ELN supporting proper capture during the research process. Real-time capture and authoring eliminates lengthy documentation after experimental efforts are completed and can help improve compliance. The ELN is front-loaded to ensure an organization is doing it right the first time, rather than having to recheck or recreate later. This can improve the experiment itself, along with ensuring electronic records can be submitted to regulatory agencies.
With the potential added quality benefits, it is important to summarize three features to leverage in an ELN that are most helpful with first-to-file:
• Workflow based collaboration between scientific, business, and legal/IP stakeholders;
• Automation of data aggregation and reporting that can speed filing and help meet one-year deadline;
• Personalization of ELN interfaces and reports to meet the needs of vastly differing user personas to ensure rapid, effective adoption.
In a large research organization it is challenging to have one central repository to tap all data. Nevertheless, it is critically important, so a solution should have built-in ways to tap existing data where it resides—whether that is in Excel files, shared databases, or even on paper. Open platforms enable such access with the least amount of disruption and, therefore, better adoption rates. Ultimately, this makes patent filing faster and more secure.
- Hurst N. How the America Invents Act Will Change Patenting Forever. Wired. Available at http://www.wired.com/design/2013/03/america-invents-act. Accessed on July 29, 2013.
- Louie AS. Business Strategy: Data Agility – Including Big Data – Core to Life Science Industry Transformation. IDC Health Insights. Available from http://www.idc-hi.com/getdoc.jsp?containerId=HI233057. Accessed on July 29, 2013.
- Villasenor J. Untangling the Real Meaning of First-to-File Patents. Fast Company. Available from http://www.fastcompany.com/1822846/untangling-real-meaning-first-file-patents. Accessed on July 29, 2013.
About the author
Dr. Schefzick has more than 15 years’ experience as a research scientist with a broad background in chemoinformatics, computational chemistry, data analysis/visualization, and therapeutic drug research and development.