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Your company has been accused of patent infringement. Can you take advantage of the new “first inventor” defense? An accused infringer claims that your patent is invalid based on the prior art. Can you show that the invention was made before the publication date of the reference? A joint venture partner says it co-owns your technology. Can your R&D records establish that the technology was developed before the partnership began? In situations like these, research records often provide critical evidence. Inventors and their employers maintain research records for many purposes, including compliance with regulatory, tax and standards authorities. Whatever the purpose, the records must be accessible and reliable — years or even decades after their creation. And when proving a date of invention to establish priority, strict evidentiary requirements apply in the U.S. Patent and Trademark Office and the courts. Many organizations are moving away from paper records in favor of more functional and convenient electronic systems. Electronic records, however, may be deemed suspect, in part because they are easy to alter and because alterations are not often readily detectable. R-E-S-P-E-C-T For many years, the bound laboratory notebook was the “industry standard” medium for recording ideas, experiments, observations, results and plans for further research. Researchers who observed the standard protocol recorded information sequentially on consecutively numbered pages, in ink, without skipping space between entries. Errors were corrected without erasing or obscuring the original entries. Entries were dated, signed by the author and witnessed by at least one other person. The traditional system imbued records with an aura of credibility. It reinforced the notion that a given record was created on the date shown, and that it had not been altered. The signature connected the record to its author in a time-honored way. Witnessing both validated the existence of the record as of the witnessing date and identified a person potentially knowledgeable about the events recorded. Research records increasingly are created and maintained in electronic form. Records of experimental data and reports can be conveniently prepared using word-processing programs. Other computer programs are useful for creating and modifying graphical depictions of data, chemical structures and engineering diagrams. Various types of laboratory instruments generate electronic records. Indeed, many researchers have abandoned the traditional lab notebook in favor of computers, including laptops and handheld PCs. Even those who still record their ideas on paper in longhand likely rely, at least in part, on computerized instruments to generate, analyze and store data. For inventors and organizations that may, someday, have to rely on electronic records in court, the question is: Will they receive the respect traditionally accorded the lab notebook? After all, one of the great benefits of electronic records is the ease with which they can be updated or revised. In a high-stakes patent battle, there may be plenty of incentive to forge a date or even an entire document. And even where there is no suggestion of nefarious behavior, establishing the author of a particular electronic record may be a challenge. When the electronic records at issue were created by a person designated as an inventor, the situation is complicated by the requirement that an inventor’s proof regarding a date of invention be corroborated by evidence originating with someone or something independent of the inventor. That this requirement persists a century after its origin — in federal court — illustrates the courts’ concern that invention priority disputes may tempt litigants to prevaricate. In most cases, getting electronic records admitted into evidence will not be a problem. For 20 years, the federal courts have admitted computer-generated evidence after the custodian of the record — typically a records manager or information systems administrator — testifies about the computer system and procedures used to create and maintain the record. This foundation testimony is used to establish that the record is what it is claimed to be — for example, a researcher’s description of experimental work carried out on a particular day. Depending on whether the author of the record is available to testify regarding its contents, and why the record is offered into evidence, testimony relating to how the organization creates and keeps its records in the course of doing business will also be part of the foundation. In most cases, once the foundation is laid, admission follows as a matter of routine. CAN I GET A WITNESS? In a 1998 notice, the PTO specifically acknowledged that the same rules apply to electronic records submitted as evidence in priority disputes inside the agency. It also pointed out, however, that admissibility is only part of the story. Specifically, in interference proceedings, “[t]he weight to be given any particular record necessarily must be determined on a case-by-case basis.” In other words, it is the credibility, not the admissibility, of electronic records that would likely be at issue in a dispute. Skilled litigation counsel will exploit lapses or vulnerabilities in an opponent’s computer system or record-keeping procedures. With so much at stake — and with virtually no guidance from the courts on what constitutes reliable electronic evidence of invention — the challenge for research organizations is to design records management systems and procedures that are user-friendly, secure and capable of dependably recording the necessary information and preserving it, in accessible but unalterable form, for 20 years or longer. In facing this challenge, we should consider the following points. First, even if particular technologies and protocols for “electronic lab notebooks” are widely adopted, litigants will scrutinize the particular circumstances of a given record’s creation, storage and retrieval. Thus, in addition to employing secure and reliable technologies, companies must adopt procedures that bolster the credibility of the record and are easy to use. Second, we should appreciate that, for many years, instrument-generated reports and data, such as spectrographic, chromatographic, calorimetric and gravimetric analyses, have been admitted as evidence of invention in interferences and other patent proceedings. These analytical methods rely on complex hardware and programming, and there is no reason to regard the technologies now available for creating other electronic laboratory records as inherently more suspect. Third, whether an inventor’s evidence has been adequately corroborated is determined according to a “rule of reason” — all relevant evidence is to be evaluated in light of the “realities of technical operations in modern day laboratories.” Circumstantial evidence, including evidence of how research is routinely carried out in the facility in question has, in many cases, been accepted in lieu of “over the shoulder” corroboration. Examples of such evidence include the testimony of those who supplied the inventor with starting materials, analyzed the research product, or reviewed status reports or other documentation. Thus, in many cases, electronic records will constitute only one form of the evidence relied upon to establish an invention date. Nevertheless, just as researchers use specialized tools and follow particular procedures for keeping traditional notebooks, steps must be taken to ensure the accuracy, reliability and permanence of electronic notebooks. The PTO and the courts are accustomed to evaluating the sufficiency of paper notebooks, and most researchers have been exposed to traditional record-keeping techniques and procedures. It therefore makes sense to incorporate signing, dating and witnessing features into an electronic records system. “Signing,” for example, performs several functions. It provides a basis for authenticating entries, especially where the author is unavailable at the time of the proceeding, and it connects the entries with their author, distinguishing the “self-serving” records of the inventor from those of noninventors. “Witnessing” has both legal and practical value. And, obviously, undated records, whether traditional or electronic, have little value for establishing invention dates. Consequently, an accurate, automatic means of “date-stamping” entries, combined with a means for detecting and tracking alterations, is necessary. Food and Drug Administration regulations and guidelines promulgated by the American Intellectual Property Law Association (AIPLA) provide additional specific guidance. The FDA rules provide the criteria under which the agency will regard electronic records and signatures as equivalent to paper records and handwritten signatures, and impose requirements relating to system validation and access, the accuracy of copies, archival protection, time-stamped audit trails, systems documentation, personnel training, use policies and, for open systems, document encryption and digital signature standards. Specific requirements governing the use of biometric and nonbiometric signatures are included in the regulations, found in 21 C.F.R. Part 11. The AIPLA guidelines, available at http://www.foleylardner.com/ LNU/IP/AIPLA.html, mirror the FDA rules in many respects. See also http://www.foleylardner.com/ LNU/IP/admis_elec_rec.htmlor http://www.foleylardner.com/LNU/IP/ Presentations/index.html. Among the considerations addressed by the FDA rules and AIPLA guidelines: �Include the ability to generate accurate copies of records in both human readable and electronic form. �Limit system access to authorized individuals, and use authority checks to ensure that only those individuals can use the system, electronically sign a record, alter a record, or access the operation of the device. Control distribution and access to documentation for system operation and maintenance. �Establish written policies that hold individuals accountable for actions involving the creation of electronic records. �Use system audit trails that track the creation, use, modification and disposition of records. Each organization engaged in research should develop an electronic records system that accounts for its dependence upon patents, the relevant industry characteristics, the likelihood of patent and trade secret disputes, and the available resources. An active approach to electronic record-keeping is essential, because the devil is in the details of system and protocol design. Lisa A. Dolak is associate professor at Syracuse University College of Law, and of counsel to Nixon Peabody LLP.

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