Miami University employees who plan to travel outside the U.S. should carefully consider data security issues. Employees must not transport sensitive university data out of the country. Such information includes, but is not limited to, data subject to HIPAA, FERPA, Export Administration Regulations, International Traffic in Arms Regulations, or other state or federal statutes, as well as any information received from an external party that is subject to a non-disclosure or confidentiality agreement.
Anecdotal reports from other institutions of higher education — primarily ones located in California — indicate that some of their faculty and staff are currently being subjected to additional scrutiny by Customs and Border Protection (CBP) upon re-entering the U.S. from overseas . Specifically, CBP officers are reportedly searching computers, phones, and other electronic devices, and, at least in some cases, may be copying data from those devices.
In some cases, CBP officers may be checking a traveler’s device for evidence of data theft the traveler may not even be aware occurred. This type of data theft can be accomplished by surreptitious access to the traveler’s electronic devices while they are traveling in foreign countries.
According to Miami University General Counsel Robin Parker, the broad authority of CBP to search individuals and their possessions at ports of entry has been repeatedly upheld by federal courts.
Because CBP agents may legally seize electronic devices and hold them for inspection, all sensitive data should be secured and wiped from any device a Miami employee plans to take out of the country, prior to exiting the U.S. Faculty and staff who need to access sensitive data while abroad should consult with Joe Bazeley, Miami University Information Security Officer, to determine the best approach for accessing the data upon arrival at their overseas destination.
Finally, Miami University employees are advised not to refuse CBP officers access to any university-owned device because doing so puts the device at risk of being seized.
Photo of Customs and Border Protection officers by Gerald Nino, U.S. Customs and Border Protection via Wikimedia Commons, public domain. Information security image by Pixabay via Pexels, used under Creative Commons license.
My father-in-law, Carl, ran a precision machining business for the better part of 40 years. Although he’s now retired, he still retains an interest in new technologies as part of his relationship with a local college. As my son approaches his 14th birthday later this month, Carl asked me if he had a 3D printer. The answer is no, but his question prompted me to think again about the larger implications of 3D printing and IP rights and how they echo the earlier challenges that arose with digital music and illicit, unlicensed downloads.
Unlicensed downloads posed significant challenges for higher education as the new millennium approached. Institutions found themselves hosting file sharing services such as Napster that often facilitated breaches in copyright law. For the music industry, it wasn’t just the establishment of digital formats and distribution as an industry standard, but also the data transfer speed students enjoyed in their dorm environs that opened the floodgates. As the music industry grappled with how to enforce their artists’ rights, higher education institutions (HEIs) began to face both philosophical and practical consequences as ethical, legal, and bandwidth issues coalesced and landed with a reverberating thud. As (sometimes inadvertent) hosts of peer-to-peer sharing systems, HEIs felt the heat from legislators, who began to approach the intractability of the problem with regulatory compliance rules. But for many of the music industry’s smaller and independent players – who struggled the most with how to preserve and protect their intellectual property rights – it was too little too late.
Federal lawmakers are often well behind the curve when it comes to dealing with unanticipated consequences of new technology paradigms, and many in tech transfer see similar issues looming with new additive manufacturing or 3D printing technology. Low entry costs and existing advanced computer aided design (CAD) software give a tremendous breadth of possibilities for 3D printing IP development. But with that development also comes the possibility of IP infringement.
Additive manufacturing is now an important part of many engineering and advanced manufacturing programs at colleges and universities worldwide. More than 7000 patent applications related to 3D printing have been filed in recent years, including one owned by Miami University. At a 2016 conference hosted by the US Patent and Trademark Office (USPTO), USPTO Deputy Director Russ Slifer indicated that patent filings related to 3D printing technology grew 23-fold in a five-year period (USPTO blog).
One key concern surrounds the IP that resides in a basic CAD file. In some circumstances the IP extends beyond a copyright that might exist in the file itself to patent rights attributable to the printed product. Therein lies an interesting distinction: copyright protection can extend to the digital domain, whereas the patent in the generic case relates to the object produced. A digital rendering of a patented medical device has little practical utility, but a digital CAD file of the device might be highly valuable.
US patent law provides remedies against infringers, as well as individuals or entities who induce others to infringe. In the earlier example of digital music files, most people – even those who have no experience creating or producing music – have some understanding of copyright comprising the artist’s intellectual property. How, though, would a typical end-user, especially a non-commercial home user, be aware of patent rights that might exist for a product that can be printed via a downloaded CAD file? Because the current patent rights enforcement regime requires the infringer (or those who induce infringement) to have knowledge of the existence of a patent, this leaves a loophole of sorts in the protections provided to innovators.
A second, and equally important aspect is the IP nature of the printed product itself. A digital CAD file of a three-dimensional figurine from a well-known movie franchise may be copyrighted, but the printed object itself may also be subject to various elements of copyright protection, as well as trademark protection. A large part of the challenge for companies or individuals who hold these IP rights is that the low cost of some of the new additive manufacturing devices could allow end users to bypass elements of the basic business supply chain that have precluded this type of infringement in the past.
Written by Reid Smith, Director of Technology Transfer and Business Partnerships, Miami University.
3D printer photo by Jonathan Juursema via Wikimedia Commons. Music piracy photo by Santeri Viinamäki via Wikimedia Commons. Both used under Creative Commons license.
The framework of export control regulations (ECR) in the United States is an immensely complex structure with historical underpinnings that date to the Cold War era. Much of the statutory authority for today’s laws dates back to the 1970s, yielding regulations that were designed to mitigate threats that have evolved greatly over the subsequent decades. The essential purpose of export controls remains the same, that being to require governmental authorization to export certain information and items to foreign entities, but the patchwork of existing regulations challenges even the most seasoned export control administrator due to the multiplicity of agencies and overlapping, highly technical nature of the regulations.
All Presidential administrations since Kennedy have undertaken various efforts at restructuring export controls to improve and enhance national security and foreign policy objectives. President Obama’s announcement in 2009 of a broad inter-agency review of export regulations was welcomed by industry. In remarks to the Department of Commerce Annual Export Controls Update Conference in 2010, the President said, “We need fundamental reform in all four areas of our current system, in what we control, how we control it, how we enforce those controls, and how we manage our controls.” The timing, though, invited speculation that perhaps a shift toward deregulation was afoot, in light of the administration’s work on the National Export Initiative (NEI). The NEI was indeed focused on economic growth, embodying the President’s stated goal of doubling exports between 2010 and the beginning of 2015. The Administration’s current export control reform initiatives were not developed as a component of the NEI and are expected to enhance and support current national security and foreign policy objectives with respect to items on the International Traffic in Arms Regulations (ITAR) munitions list and the Department of Commerce’s Commerce Control List (CCL).
In spite of the recent rise in enforcement actions against higher education institutions (HEIs) for violations of export control laws, there persists a misconception among many in the HEI community that export regulations do not apply to post-graduate educational institutions. While this deficit in awareness has not been a primary driver, or even a key factor, in the move toward recent reform initiatives, the impact on HEIs from the changes that have been proposed for implementation is expected to be mixed. These effects derive from the fact that HEIs collectively are an important locus of activities that reflect global-scale societal changes which are reshaping the risk landscape for militarily critical technology. University research and education is a fundamental driver of the rapidly increasing pace of technological development worldwide, channeling information into ever more freely-flowing conduits of knowledge exchange to a world population that is more connected and mobile than ever. These trends are well-represented on the campuses of many U.S. HEIs, with the Brookings Institution reporting that the number of foreign students on F-1 visas in U.S. colleges and universities grew almost five-fold between 2001 and 2012. Foreign students and visitors on campus, coupled with the long-standing ethos of openness in academia, present risk for HEI’s in certain circumstances related to “deemed exports.”
The long-term blueprint for the President’s export control reform plan involves three overarching changes. The first change involves the creation of a single list of controlled items, merging the ITAR-based U.S. Munitions List (USML) and the Commerce Department’s CCL, while in the interim transferring thousands of items from the USML to the CCL under a new export control classification number, known as the 600 Series. The second major reform will result in a single licensing entity having jurisdiction over military and dual-use items, with the intent of producing more consistent and higher quality licensing decisions. A Single IT System to integrate these changes is proposed as an additional major reform. Finally, a single enforcement agency is proposed to streamline and harmonize coordination with existing intelligence infrastructure to produce more robust investigation and prosecution with fewer jurisdictional uncertainties.
Update on the Reform Process
In April 2013, the Departments of Commerce and State issued the first set of a number of anticipated final rules that will begin the process of implementing the first phase of the reforms laid out by the President and the Secretary of Defense. Additional rules were issued in October 2013, and January 2014, resulting in the transfer of thousands of ITAR controlled items (primarily parts and components) to the jurisdiction of the Export Administration Regulations administered by the Department of Commerce through the CCL. All of these items will now be classified under a new Export Control Classification Number (ECCN) structure designated as the 600 Series, with a smaller set of items now classified within 9×515 (satellites, spacecraft and components).
These new ECCNs remain restrictive, but pose new challenges for the university export compliance administrator in that they don’t follow the prior standard for dual-use technology established by the “use technology” definition. The technology controls applicable to these new categories may require more careful analysis of licensing requirements and more diligence in avoiding deemed export risk when items from these categories are involved in campus research activities. In addition to reclassification for items, changes have been made to reduce the vagaries and confusion of jurisdiction and classification by moving away from the old “design intent” standard to a new approach of specific enumeration of performance characteristics or other specifications for the highest levels of controls. When this level of specificity is not possible within the USML or CCL, a new definition for “specially designed” will be applicable. Both approaches are intended to apply more objective criteria to the classification process by moving away from the subjective standard of “design intent” that industry felt was the source of variability, uncertainty and risk in the commodity classification process. The newly classified 600 series items will also benefit from more flexibility in the tailoring of controls under the CCL regulations, affording many items the benefit of much more limited control based on item sensitivity, country of destination and end use/user, in contrast to ITAR’s “one size fits all” broad-based controls, which offer very few country-based exemptions. This, coupled with a new Strategic Trade Authorization exception, will benefit commercial exporters of controlled items, but is not expected to offset the increased burden of compliance review that the new rules will require for 600 Series and 9×515 items.
The Bureau of Industry and Security within the Department of Commerce maintains an ECR dashboard that periodically updates progress on the various elements of the President’s ECR priorities. The most recent update available indicates that final rules have been set for a number of categories, and implementations . However, it may be some time before definitions related to public domain and fundamental research, which are important to HEIs, are finalized and the Single IT System is fully implemented.
Written by Reid Smith, Director of Technology Transfer & Business Partnerships, Miami University.
Photo of White House by Black and White on en.wikipedia (public domain) via Wikimedia Commons. Map and flag image by Merasoe via Wikimedia Commons, used under Creative Commons license.
The innovation enterprise in academia is dependent on two complementary processes: the recognition of an innovation or discovery by the innovators, and the harvesting of those opportunities by the university. Because the pursuit of patents is costly and university budgets are constrained, the university must evaluate each case to assess its commercial potential and patent prospects prior to deciding whether to move forward into the patent process.
Patent preparation and prosecution are the most time-consuming elements of the commercialization process for most inventors. Because inventions tend to be very technical, the patent attorney assigned to the invention case usually needs substantial input and review from the inventor to best capture the key elements of the technology that will inform the scope of the patent claims. While patent attorneys will have technical expertise in subject matter areas they routinely handle, they also need the innovator’s input to structure the claim set and support those claims effectively.
Once the application enters the prosecution phase at the U.S. Patents and Trademark Office (USPTO), inventor input is critical to helping inform the USPTO about the prior art most closely related to the invention. The key here is to identify and report information that is material to the patentability of any claim in the application. This obligation extends to the inventors, the patent attorney, and any other individual (associated with the inventor or owner of the invention) who is substantively involved in the preparation of the application. In this case, the inventor does not have a duty to search for references or descriptions of closely related technology, but merely has to provide copies of the information about which they are aware through their work on the technology. This information is communicated to the patent office by way of an Information Disclosure Statement (IDS).
Section 2016 of the Manual of Patent Examination Procedures (MPEP) specifies that “a finding of ‘fraud’, ‘inequitable conduct’, or violation of duty of disclosure with respect to any claim in an application or patent, renders all the claims thereof unpatentable or invalid.” Therefore, diligence must be applied when completing an IDS.
Responding to USPTO Office Actions also requires substantial input from the inventor. An Office Action is an official, time-sensitive notification indicating whether the patent is allowed or rejected (for reasons stated in the Office Action). If a claim is rejected for any reason, the patent attorney will seek analysis and input from the inventor to help overcome the examiner’s rejection(s). The inventor’s technical expertise and intimate knowledge of the invention are critical factors in convincing the examiner that the innovation should be allowed to issue as a patent.
In many cases, academic technology transfer offices have an inventory of applications and patents that need further development before they are marketable. This intellectual property must be marketed to potential licensees by the technology transfer office.
Often, the inventor’s role in marketing is simply to connect the technology transfer office with individuals who are already aware of the research program and have an interest in pursuing licensing opportunities. This is especially common when the inventor has partnered with a corporate research sponsor in the development of the innovation, and in many cases the corporate sponsor will have certain option or license rights through the funding agreement. In other cases, the inventor’s familiarity with the target market will provide potential leads.
The technology transfer office will also attempt to establish leads by examining ownership of related patents, reading market research reports from subscription services, conducting independent analysis of potential product markets, and leveraging business contacts and relationships. The inventor should be active in asking about marketing strategy and offering to review potential target lists. Later in the process, the inventor will likely be asked to assist with the review of marketing materials, or to meet with company representatives to provide insight on what makes the innovation commercially valuable.
Once a licensing negotiation has begun, the inventor can assist with the process of identifying opportunities for non-royalty components, such as appropriate milestone achievements for future development, future sponsored research to continue with development of the technology, or consulting opportunities.
Although some inventions from the academic realm may have found significant commercial success without substantial assistance from the inventor after issue of the patent, a hallmark of most successfully commercialized academic inventions is a motivated inventor or group of inventors who communicate a vision for achieving a successful outcome for an innovation that is measured in terms that extend beyond royalty rates or license fees. Public benefit from an invention or discovery is derived in a number of additional ways, such as transfer of knowledge and research resources. Each element of success relies on a partnership between the inventor and the technology transfer office.
Written by Reid Smith, Director of Technology Transfer & Business Partnerships, Office for the Advancement of Research & Scholarship, Miami University.
A common misconception about the inventive process is the idea that great inventions with strong commercial value are almost always the result of a flash of brilliance, sparked by the combination of intuition and creativity. The invention, in this idealized scenario, is essentially complete and ready for a patent attorney simply to translate it into the stylized format of the patent application and submit to the U.S. Patent and Trademark Office (USPTO) for examination. The reality, of course, is that successful inventions owe as much to longer term planning and strategy — together with commensurate investment of resources — as to serendipity or chance. This is even more true in the academic research environment, where constrained resources and competing priorities make research programs and investments that are purely commercialization-oriented much more uncommon than in the business world.
In the university research environment, the first step in the inventive process — conception — often takes place quite some time before the development of a prototype or other constructive reduction to practice occurs. Generally, the process of invention development in academia is a more linear or serial process where funding and time are allocated according to the “next best step” rather than to a comprehensive development plan where many paths run in parallel toward a quicker commercialization outcome. In light of recent changes in U.S. patent law, this approach creates timing issues that bear on how early in the process the inventor should engage with their patent management office. However, in most cases the right time to submit an invention disclosure form is between three and six months prior to making a public disclosure of information or results that would create a patent bar. Once the Office of Technology Transfer & Business Partnerships (TT&BP) receives this report of an invention, it is reviewed for completeness and assigned a case number. Following that, an initial meeting will be scheduled with the inventor(s) to discuss the technology. The most important role of the inventor in this step is to provide as much information as possible about the commercial potential for the invention and the elements of the technology that are novel.
Although copyright/software is an important component of many university innovation portfolios, patented technologies remain the primary revenue source for protectable innovations in academia. For that reason, the assessment process for new invention disclosures focuses on two equally weighted elements: commercial potential and patentability. The inventor can play a substantial role in helping to gauge these two aspects. First, in the area of patentability, many larger technology transfer offices have a broader range of subject matter expertise among the licensing staff, and in some cases have revenue volume that will support the use of external search consultants for prior art or formal patentability opinions. Smaller offices, like Miami’s, depend on the inventor to help provide subject matter expertise and to review and provide feedback on prior art found during literature and patent searches.
Statistics from the USPTO show that about half of all applications will eventually issue as patents, with the caveat that many go through substantial changes in the scope of patent claim coverage during examination. In this respect, the odds are favorable, but the expense associated with applications that do not result in patents represents a significant risk for the technology transfer office with a limited patent budget. The criteria for patentability require inventions to be novel, non-obvious, useful, and enabled. The inventor can provide much needed guidance on how likely the invention is to survive the examination process of evaluating these factors, and thus how risky the patent investment may be relative to other cases. Most offices make positive filing decisions on one-half to two-thirds of their disclosure volume. Differentiating among different technologies and their prospects is challenging in the best of circumstances. The ability of the inventor to provide candid, timely responses to prior art queries is a valuable contribution to the assessment process.
The commercial potential for an invention is not entirely distinct from the patentability aspect because statutory monopoly plays a role in the development of capital- and time-intensive innovations such as pharmaceuticals or medical devices. Other factors, though, are important as well, and the inventor is often in a position to provide valuable advice on the state of the product market that the new innovation would enter if successful. In some cases, new innovations truly create new markets, but many successful academic innovations find their way into more mature markets where existing products present substantial barriers to market penetration in the absence of distinct differentiators that are valued by the end user. An understanding of the advantages that the innovation might achieve are important, as are other factors such as:
state of maturity or stage of development of the invention,
need for access to background intellectual property,
market size, and
recent trends in the market that might lend attractiveness to the innovation’s potential.
Here the role of the inventor can be significant as well, but there is less of an expectation that their subject matter expertise extends deeply into the commercial realm. When it does, though, the input from the inventor can be crucial to affording TT&BP the best prospects for making high- quality investments in patents that can benefit society in the future.
Written by Reid Smith, Director of Technology Transfer & Business Partnerships, Office for the Advancement of Research & Scholarship, Miami University.