By Gabriella Chan
On June 11, 2018 the United States Federal Court of Appeals (the “Court”) heard the case of Medtronic Inc. v. Mark Barry. Medtronic is a global manufacturer of various medical devices including spinal surgery tools and devices. Spinal surgeon Dr. Mark Barry sued Medtronic, alleging that some Medtronic products infringed a group of his patents that were directed to methods of improving spinal column deviations using pedicle screws to correct conditions such as scoliosis.
Medtronic sought to disprove infringement by alleging that Barry’s inventions were not patentable because they were anticipated by Medtronic’s prior art. Medtronic cited one of its own patents as prior art against Dr. Barry ’s patents, as well as a video demonstration and a slide presentation of de-rotation surgeries, including with pedicle screws, to correct scoliosis (the “Materials”). Medtronic first presented the Materials to 20 spinal deformity experts at a Spinal Deformity Study Group (“SDSG”) meeting in Scottsdale as part of Medtronic’s sponsorship of medical education courses at industry meetings and conferences. It subsequently presented the Materials at two additional conferences; the first in Colorado Springs, attended by 20 SDGS surgeons, and the second in St. Louis, attended by 55 SDSG surgeons. Notably, at least 75 non-SDSG surgeons also attended the Colorado Springs and the St. Louis meetings.
Medtronic initiated Inter Partes Review (IPR) proceedings against Barry’s patents though the U.S. Patent and Trade Mark Office’s Patent Trail and Appeals Board (the “Board”). The Board determined that the Materials were not prior art citable against Barry because they were not ‘publicly accessible’, and therefore were not ‘printed publications’. While an inventor who disclosed un-protected material at a conference would have been elated with this determination, Medtronic, wishing to invalidate Barry’s patents, hoped for the opposite result so it sued Barry in Court. Medtronic argued that Barry’s patents were invalid because, while the Scottsdale disclosure of the Materials may not have been to the public, its disclosure of the Materials at the Colorado Springs and St. Louis meetings did constitute a public disclosure and the Materials were publicly accessible. Therefore, the questions before the court were whether (i) the distribution of certain materials to groups of people at one or more meetings renders such materials printed publications and (ii) the materials were sufficiently disseminated at the time they were distributed at the two conferences to have been made available to the public.
The crux of the prior art evaluation analysis depends, subject to some exclusions, on whether the Materials became public before the date on which the patent application for the invention was filed. Section 102(b) of 35 USC requires that an invention must not have been (i) described in a printed publication, (ii) in public use, (iii) offered for sale, or (iv) otherwise available to the public. Similarly, section 28.2(1) of Canada’s Patent Act, requires that a patentable invention must not have become “available to the public in Canada or elsewhere”.
To determine whether a piece of prior art (also referred to by the courts as a reference) is a printed publication requires a legal exercise based on the underlying facts and the circumstances under which the reference was allegedly disclosed to the public. The courts have used ‘public accessibility’ as a proxy to determine whether the dissemination of a reference constitutes a printed publication (re Hall, Fed. Cir. 1986).
In this case, the Court determined that the Board did not address the potentially critical difference between the SDSG meeting in Scottsdale and the conferences in Colorado Springs and St. Louis so it remanded the case to the Board for re–evaluation. The Board must now determine whether the dissemination of the Materials to a set of “supremely-skilled experts in a technical field precludes finding such materials to be printed publications and were publicly accessible”. In its re-evaluation, the Board must determine whether the Materials were published without restrictions at the Colorado Springs and St. Louis meetings and whether the SDGS members were expected to maintain the confidentiality of the Materials or whether they were permitted to share or publicize the Materials and the insights they may have gained at the meetings. In addition, the Board must treat the relatively exclusive nature of the SDSG membership as only one factor in the public accessibility analysis and it must consider the purpose of the meetings.
By way of a review of other factors to be considered in a prior art analysis, the Medtronic Court reiterated that a printed publication need not be easily searchable after publication if it was sufficiently disseminated at the time it was published. Divulging the existence of a paper, and then proceeding to inform a captive group of persons of ordinary skill in the art of its contents in an oral presentation, can be a factor in determining public accessibility. Similarly, although not dispositive of the inquiry, the length of time any material is exhibited, the ease with which the material presented or displayed could have been copied, and the expertise of the intended audience can help determine how easily those who viewed the material could retain it.
Additional analysis factors include the presence or absence of an expectation of confidentiality between the presenter and the audience. Importantly, even without a formal notice or requirement of confidentiality, such as “Confidential” marking or a non-disclosure agreement, the Court noted that one must still determine whether any policies or practices associated with a particular meeting, or any academic or professional norms, may give rise to an expectation that a disclosure would remain confidential.
Although this case outlines a few potentially exculpatory factors against a finding of public disclosure, if inventors themselves were to disclose the information, they may avail themselves of the applicable grace period in a few jurisdictions. However, the grace period is no saving grace in a first to file jurisdiction if a third-party were to race to the patent office to file an application before the inventors do. Using the facts of this case as a hypothetical example, if Barry learned about the use of pedicle screws at Medtronic’s first conference, then filed patent applications for a Medtronic invention in his name and applying the Board’s finding that Medtronic’s Materials did not constitute prior art against Barry’s patents means that Barry’s patents stand. As the Medtronic case demonstrates, an inventor’s disclosure at a meeting may or may not constitute prior art against a third party so, in the words of the prolific inventor Ben Franklin, “an ounce of prevention is worth a pound of cure”. There is no better substitute for inadvertent disclosure of patentable information than filing at least a provisional patent application to protect it before presenting it anywhere.
Featured Photo by Kyle Glenn on Unsplash
Throughout its history, the Institute of Medical Science (IMS) at the Faculty of Medicine has developed a tradition of incubating new multidisciplinary programs. In 2011, the IMS stepped forward to explore and develop a graduate program in translational research. After much consultation, a proposal was put forward and approved and the first cohort of 17 students began in September 2015.
In October 2018, the TRP had an external review. The reviewers noted that “There is no question in the reviewers’ minds as to the value, uniqueness and innovation of this exciting and visionary program. In every meeting concerning this new program, there was high energy, and positivity regarding its format, content…” Then they noted that the TRP, “would never have flown without the immense efforts of the IMS director and his support, thus all future success of the MHsc program will reflect strongly back to the IMS program due to its generosity in providing a nurturing environment for its beginnings.” But they also noted that the apparent growth and trajectory requires more strategic thinking about faculty development, evaluation and retention; and that “a new and more appropriate administrative home” will need to be found.
Responding to this feedback, Dean Young has decided that the Translational Research Program (TRP) will move its administrative home to the Department of Laboratory Medicine and Pathobiology no later than July 1st, 2019.
The move marks a major milestone for the IMS and the TRP. It marks the successful initiation and incubation of a new innovative multidisciplinary program. It marks the effective implementation of a new curriculum and a significant contribution by the IMS to the training of professionals in a burgeoning field of inquiry; and it will provide the TRP with the opportunities for greater capacity for faculty development, review and promotion.
However, this milestone will not mark the end of the program’s relationship with the IMS. The TRP faculty will remain cross-appointed to the IMS, TRP students will continue to be engaged with IMSSA and other co-curricular programming at IMS, and students from TRP and IMS will have continued access to modules from across the academic units. In fact, this is an opportunity to bring another department into our family, to become more engaged with more researchers and students, and to build new bridges and establish new collaborations moving forward—at the end of the day, we all remain part of one Faculty, and we all remain dedicated to training and research that will advance improved medicine, health and care.
“We must be willing to let go of the life we’ve planned, so as to have the life that is waiting for us.”
– Joseph Campbell
Written by: Paige Gilbank
“Canada is a leader for the development of innovative health technologies. However, in Ontario, there are no widely accepted, consistent pathways or processes for implementation and many seemingly great innovations fail to penetrate our health care system due to its complexity and lack of transparency.”
This fundamental gap called Ahlexxi Jelen and Robby Spring into action. Throughout their research careers, they saw a need for different approaches to translate research findings that had a practical impact in health care. In Fall 2016, Ahlexxi and Robby began their Master of Health Science in the Translational Research Program (TRP). The TRP is a two-year, professional Master of Health Science degree that encourages students to integrate their domain expertise with experiential learning and translational thinking to advance problem-solving designs in medical and health sciences.
Ahlexxi and Robby share over 20 years of research experience and shortly after completing their degree, they transitioned from their roles as laboratory managers at the Hospital for Sick Children and Baycrest, respectively, to forge new paths as part of their career aspirations within the health care system.
“The lack of clarity and transparency for implementing innovative health technologies in Ontario creates a system that is difficult to understand and navigate. This poses a major challenge for health innovators who lack knowledge about the structure and function of the system and pathways for commercialization.”
Ahlexxi and Robby recognized the complexity of health care innovation in Ontario and identified that there was a need to streamline the process to be more understandable. This sparked their interest to develop a solution that would demystify the implementation process for innovative health technologies in Ontario.
This idea became a reality once they began their TRP capstone project. The capstone project is the second year focus and a primary requirement as a graduating student in the TRP. Students embark on a self-directed capstone project where they apply their newly developed knowledge and tools to explore a health care problem. Using a Co-Translational FrameworkTM developed by the program, students take on a human-centred design approach to innovate within health care to mobilize this knowledge into practice.
The duo began their capstone using a translational thought strategy to leverage the knowledge and insights of subject matter experts and key opinion leaders in the field. Through their initiative, they interviewed and consulted numerous experts across the pillars of health, gaining perspectives from government, academia, industry and health care. From these discussions, Ahlexxi and Robby developed a framework and iteratively constructed the prototype in a co-creative manner. At their final capstone presentation, Ahlexxi and Robby showcased their process and product: an informational resource designed to help guide health innovators through the complex processes and pathways for implementation of innovative health technologies in Ontario. The tool is a free accessible resource available to the health care community and acts as a “choose your own adventure” style based on the specific context of the innovation. In December 2018, Ahlexxi and Robby launched HIIO (Health Innovation Implementation in Ontario).
“The Ontario health care system requires a framework to support health innovators navigate the innovation ecosystem in order to improve decision-making among health innovators, engagement among stakeholders, and sharing and accessing information and services.”
To validate the content and function of the tool, the pair sought expert feedback from the health and innovation community. Since graduating, Ahlexxi and Robby have continued to execute their vision and collaborate with field experts to refine the resource into a meaningful tool for health innovators and other key players in the community.
“Through HIIO, we aim to support Health Innovators in Ontario by providing the information and resources needed to navigate the complexities of our health care system. Using a phased approach, we have highlighted the processes and pathways for implementation and offer comprehensive insights throughout the innovation lifecycle — from idea generation to diffusion.”
This project was not without hurdles. While the Co-Translational FrameworkTM is displayed as a step-wise approach, the practice of applying it is non-linear. There were many pivots, challenges and iterations throughout their journey; Ahlexxi and Robby share some of their lessons learned:
- “[Your] solution is only as good as your understanding of the problem.”
- “Work with someone you’re compatible with and who shares a common goal and vision.”
- “Be flexible and learn to adapt within your environment.”
Ahlexxi and Robby had a vision to create a meaningful solution that would enforce and benefit the health innovation community. Both entered the Translational Research Program determined to make an impact, and both moved on with their degree and a dynamic set of tools and expertise to make it happen.
By Christopher A. Klinger, PhD
“Patients need to be involved in all aspects of research,” reads one of the guiding principles of the Strategy for Patient-Oriented Research (SPOR). All SPOR partners are encouraged to “… bring [in] the collective voice of specific, affected communities” and to create tools collaboratively, reaching the “… common goal of timely implementation of quality research”. What does this look like in practice?
On Wednesday, November 07, 2018, I had the opportunity to attend the first Annual General Meeting (AGM) of the SPOR Evidence Alliance in Toronto, a Canada-wide network of healthcare providers, patients, policy makers and researchers dedicated to informed decision making in health and/or healthcare. The Evidence Alliance, led by Andrea Tricco, PhD, is geared toward a rapidly learning healthcare system, “… where patients receive the right care at the right time, by supporting access to high-quality information…”. To drive their patient-oriented initiative, the Evidence Alliance includes patients in key governance structures and all its decision-making processes.
The AGM focused on discussing the Evidence Alliance’s progress to date and strategizing their next steps, growth and sustainability. At the core of operations of the Evidence Alliance is the response to knowledge user needs in knowledge synthesis, clinical practice guideline development, patient-oriented research, and knowledge translation. The AGM provided a platform to discuss how to facilitate a meaningful patient engagement in the research process, highlighting areas research teams and Evidence Alliance themselves can improve.
In my work with the National Initiative for the Care of the Elderly (NICE), a Toronto-based knowledge translation network dedicated to the care of older adults, we are currently in the process of enhancing our report on the opioid crisis in seniors, launched in August 2018, to contain lived experience. This inclusion of patient/consumer voices will ensure that policy and practice recommendations meet the needs of older adults, with potential treatment strategies tailored to this specific population in light of metabolic differences and drug interactions as part of aging. Including lived experience puts the patient voice at the forefront of the research.
Disclaimer: The author is a trainee with the SPOR Evidence Alliance, member of its Knowledge Translation Committee and chairs the End-of-Life Issues Theme Team for NICE.
Feb 4, 2019
By: Brianne Tulk, Faculty of Medicine University of Toronto
Leaders in the basic sciences, clinical epidemiology and patient care discussed how best to translate research into new treatments for patients at a recent event presented by the Department of Medicine and the newly established Eureka HUB for Translational Research.
Called TR Talk, the event drew an interdisciplinary audience made up of researchers, clinicians, health practitioners and health innovators. Facilitated by graduate students from the Translational Research Program, it featured a panel discussion followed by smaller group discussions.
The panelists offered diverse perspectives on the barriers of translating research to humans, and also the opportunities of translational research.
“The great questions come from listening to our patients,” said Dr. Gillian Hawker, Chair of the Department of Medicine. Hawker, who has a background as a rheumatologist and clinical epidemiologist, brought perspective from the frontlines of patient care and outlined some of the challenges that surround translating research to inform treatment options.
“Most of my patients have multiple conditions that aren’t represented in the clinical trials,” Hawker said. “The perfect patients aren’t the ones showing up at our doorsteps. Translation is about getting real world data.”
By way of example, Hawker explained that research can illustrate the use of stem cell therapy to treat arthritis, however that research may not be applicable if it doesn’t consider other factors that impact the patient, such as a person’s age, sex, weight or other health issues.
“A translational researcher needs to speak two languages,” explained Dr. Martin Offringa, a neonatologist and professor of paediatrics at U of T. “They need to understand the clinician perspective and the scientist perspective. They walk between different worlds.”
Dr. Ramsey Foty from the Rutgers Robert Wood Johnson Medical School and Dr. Thomas Prevot, Program Manager of the Drug Development Program in the Sibille Lab at CAMH, said some of the biggest barriers to translating research is moving it beyond the research paper and demonstrating applications for patients. For Foty, this includes repurposing a common drug for other uses.
“I’m teaching an old drug new tricks,” said Foty. “Some science isn’t ‘sexy,’ but it will make a difference to patients. So, how do you convince the ethics boards, the granting agencies, the pharmaceutical companies, that this pursuit is still worthwhile?”
“There is a barrier in moving your research past publication,” added Prevot. “A translational researcher needs a team of people with diverse expertise to go from discovery to pre-clinical studies, to clinical trials, to commercialization. Translation is too vast to be done alone.”
This TR Talk was one of a series of sessions hosted by the Translational Research Program in collaboration with Health Innovation Hub(H2i) and the Eureka Translational Hub this season. TR Talks are open to the public and are geared towards interprofessional clinicians, researchers and trainees to provoke discussion and community building.
Read the original article featured on the Faculty of Medicine website here.
by: Sandy Marshall
Meet Simon and Ian. They met when they were ~5 months old and over the following months, a friendship grew. They played, read, ate, laughed, giggled, and cried together. They learned to trust, connect, be gentle, and share with each other–all before knowing how to talk.
Trust is the piece that I envy and admire most. Trusting someone with whom you’ve never spoken. And, more impressively, earning their trust.
Science communication is starving for trust. Rival researchers competing for the next publication. Patients asking for 2nd, 3rd, and 4th opinions from health care practitioners. Health care practitioners doubting information from patients and their families.
Fritz and Holton published an article last month, called, “Too much medicine: not enough trust?”1 Tests are being ordered with increasing frequency and the threshold for treatment has lowered.2-4 Fritz and Holton propose that a lack of trust between patients and physicians has led to excess tests and treatment. They point out that ordering extra tests or prescribing extra treatments as a way to build a patient’s trust may have the opposite effect,
“The potential secondary gain of building trust for future encounters is undermined by the dishonesty which accompanies this motive: it is not trustworthy behaviour to manipulate a patient into trusting you by preforming an unnecessary test.”1
I wonder, at what age do we forget how to connect and engage with one another? Does language actually make it harder to be honest and open? Most importantly, how do we build trust?
Fritz and Holton offer continuity and questioning as solutions. Trust builds over time, so continuity of care is crucial. Welcoming questions and acknowledging uncertainty may help, too. Excellent recommendations, but these strategies still sound a bit like chess moves.
In Alan Alda’s book, “If I understood you, would I have this look on my face?”5 he emphasizes that empathy is the key to effective communication. Once we are able to understand how someone else may be feeling and thinking, we can explain what we are passionate about in a way that they will understand and may even trust.
Thinking back to Simon and Ian, I wonder, what if we brought all of the parts of engaging to the table, with the words. What if the next scientific conference you attended was full of eye contact, sharing, and giggles? What if the next medical appointment that you had was jammed with gentleness, patience, and teamwork? Notice your whole body–eyes, hands, gestures, toe-tapping–the next time you communicate science.
Through connecting we might find clarity.
- Fritz Z, Holton R. Too much medicine: not enough trust? J Med Ethics. 2018.
- Alsan M, Morden NE, Gottlieb JD, Zhou W, Skinner J. Antibiotic Use in Cold and Flu Season and Prescribing Quality: A Retrospective Cohort Study. Med Care. 2015;53(12):1066-1071.
- Hensher M, Tisdell J, Zimitat C. “Too much medicine”: Insights and explanations from economic theory and research. Soc Sci Med. 2017;176:77-84.
- Klang E, Beytelman A, Greenberg D, et al. Overuse of Head CT Examinations for the Investigation of Minor Head Trauma: Analysis of Contributing Factors. J Am Coll Radiol. 2017;14(2):171-176.
- Alda A. If I Understood You, Would I Have This Look on My Face? (ed First). United States: Random House; 2017.
Featured Image source.