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
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.
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.
by Carey Toane
Images are often an afterthought when sending our translational research communications out into the world. That perfect picture of a patient or a researcher in a lab you grabbed off a Google image search might be perfectly acceptable for a course assignment, but posting it in a public forum is less than ideal.
Why, you ask? Images are subject to copyright, and breach of copyright is arguably illegal and certainly unprofessional in most contexts. So, if you wouldn’t use content from an academic article or textbook without citing your source, don’t use images unless you have permission*.
Never fear. Thanks to the open source movement, there are plenty of options for free and open source images you can use, if you’re not able to create your own image or infographic. Let’s start with the gold standard, Creative Commons Image Search. Do yourself a favour and just save that link into your browser toolbar right now. Working under a mandate to make the world’s content more equitable and accessible, Creative Commons search isn’t a search engine, but rather a one-stop platform for you to search a range of other sources you may have heard of, like Google, Flickr, and Pixabay.
Using the search is straightforward. Select a platform, search using keywords, and set parameters based on your needs. For instance, if you want to adapt images or use them as-is, select the box that says “modify, adapt, or build upon.” If you need an image for content you’re being paid for, or for a publication that makes a profit, select “use for commercial purposes.” This aligns your needs as a user with the conditions that the content creators have set for its use.
This agreement is laid out in the Creative Commons licence attached to the image. These are often abbreviated into something like “CC BY 4.0,” which means you can freely share or adapt the content, but you must give attribution to the creator, and you can’t put any restrictions on its use by anyone else. This is easily and neatly done in a link in a caption beneath any image. Seems fair to me.
It’s not a fail-proof system. Because it doesn’t create the content, Creative Commons urges users to follow the link to ensure that the content is indeed covered under a CC licence. It takes a bit of clicking, but when you consider that paid stock images can run hundreds of dollars, it’s worth a bit of effort to enjoy the advantages that open source has to offer.
If you’re looking for something specialized, it’s worth checking out the University of Toronto Libraries or your public library collections to see what they might offer. Many libraries and museums around the world are putting their image collections online for free use. And it’s not limited to photography: a search engine query for free or open source vector graphics or public domain artworks will bring back dozens of possibilities as well. You’ll never need to steal an image again.
* If you absolutely need to use a copyrighted image and no other will do, you can ask for permission. Note however that this can be a long process, and may very well include paying for the right.
Feature image by Jon Tyson from Unsplash
Before Fran left the TRP student partner presentations on the Thursday before her passing, she announced “That’s a great project. If you need a partner, I’m interested”. She was always interested and generous with her time. She was always willing to help and to engage with students and projects that would help others. That was the kind of woman she was, curious, humble, kind and always there to help.
When we first met, Fran and I spent three hours sharing stories and towards the end of our chat, she said, “Maybe I should take the program instead of being a Mentor”. And in a way, she was both a student and a mentor. She attended every presentation, classes and socials, she sat during her summer mentor hours talking with every student who was looking for advice or guidance—about their projects, careers or personal lives.
Fran had to fight to get to where she was, it wasn’t always easy, and it wasn’t always pleasant. When she was applying for her Ph.D., Fran told me during our very first conversation, her supervisor refused to support her. He told her that investing in her education was a waste of time and effort, that she would just end up meeting some guy and having kids, that she would never become an academic. Maybe that’s what made her so kind and giving, and so devoted to students and mentorship—she even apologized (more than once) for planned vacations that conflicted with her mentorship activities.
Fran did get accepted into her Ph.D., and she did meet ‘some guy’ and she did have kids, but she also became a professor, a researcher, an academic and a role model. And she became part of our community, a mentor and a friend.
Thank you for all your kindness and devotion. I’m sorry we didn’t have more time together, Fran. Let’s grab that coffee next time we meet.