This is an update to a post in 2015 about finding patents of interest. Attached is a “How to find patents” in pdf format from my course at Johns Hopkins on “Legal Aspects of Biotechnology”. Just click to download. It walks through the basic search strategies for finding patents and visualizing their global patent families using a great, free patent repository “lens.org”. This site is also a great source for keyword searchable text.
With appreciation to the masters degree program in biotechnology at JHU for providing a forum for online teaching — these topics are among the “core” competencies for managing innovation strategically and effectively! This semester (Spring 2017), my course in “legal aspects” focuses on managing legal (and business) risk in both for-profit and not-for-profit biotechnology enterprises. I’ve been using VoiceThread as a presentation/sharing tool on the Blackboard platform this year, and it’s been popular with students after getting past the interface training. Despite my initial misgivings, this is not just for high school students. It’s truly an effective way for grad students to develop a sense of community because commenting in context on presentations by voice or text is so easy to do and to review!
Let’s say you’ve heard about a product or a patent infringement lawsuit and want to know about the relevant patents. Or you’re developing a similar product in an academic research department and want to scope out the competition or potential funders. Here are a couple of efficient ways to go about that.
And this is something that I do several times a week for clients who need to about the competition years before they anticipate their own product approval or who want an independent opinion about their own current patent position. With the right search tools, these kinds of projects are manageable, useful and often fascinating. Moreover, there are some great, no-cost approaches to getting the lay of the competitive landscape!
Here’s one that’s really simple but has limitations, so I often use it first to hit the target — Google Patent Search — and then switch to another tool.
Somewhat arbitrarily, I’ll start with the first new molecular entity (NME) approved by FDA in 2015, a drug called Savaysa that reduces the risk of stroke in patients with atrial fibrillation. That’s its “brand” name as marketed by Daiichi Sankyo, Inc., and the active ingredient’s name is “edoxaban” (or more precisely, edoxaban tosylate monohydrate). I looked for this on the FDA’s list of “New Molecular Entity and New Therapeutic Biological Product Approvals for 2015”.
No hits on Google Patent Search, however, with the name “Savaysa.” We would have better luck searching the product name, finding 322 hits. There’s also a tongue twister of a chemical name that you can find with a link from the product’s website under the tab called “Prescribing Information,” N-(5-Chloropyridin-2-yl)-N’-[(1S,2R,4S)-4- (N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c] pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzene- sulfonate) monohydrate. And even though Google didn’t search this full name, because it was longer in length than the permitted search query of 32 characters, we still got another 51 hits.
So which of these records is important and how to begin finding them? Either with a double shot of something caffeinated or with a cheat! Sticking to one place where I can add value to your search, look at this FDA webpage — called the “Orange Book,” so named when there was a physical report with an orange cover — and then search by the product name or its active ingredient. Once you find the product, you’ll also see a list of the three approved formulations. Click on the FDA application number for any of the them, which takes you to a page that for each of the formulations has a list with the last entry being “Patent and Exclusivity Info for this product: View”.
My July 18 event post talked about The National Academy of Medicine’s “Global Health Risk Framework” program, just held in Hong Kong from August 19-21, one of four related sessions this summer. I had the privilege of participating in the “Workshop on Research and Development of Medical Products.” The world’s response to Ebola was discussed frequently, particularly lessons learned and potential improvements in many dimensions to get out in front of the next potential epidemic.
(The following video, recently posted by the Centers for Disease Control, may be a helpful introduction to the topic of “Getting to Zero” for further outbreaks. You can find many more videos and photos at the Ebola information at CDC website and other health organizations.)
This program took a fascinating and multidisciplinary look at impediments and potential improvements in preparedness in how the world responds to global health threats posed by infectious diseases. Clearly, we can do a much better job responding to epidemic and pandemic disease threats. I’m keen to see the Commission’s synthesis and report, which will be released by the Academy later this year. Key recommendations from the report also will be provided to the World Health Organization in time for high level meetings in November.
My own panel session dealt with impediments to sharing of research materials and data, including material transfer agreements, liability and patents. And my remarks focused on the exchange of materials and data, which include not only viral isolates from infected patients, but genomic sequences of suspected pathogens and clinical data about safety and efficacy of candidate therapeutics, vaccines and diagnostics. These items are transferred between various researchers and institutions over extended periods of time as a threat is recognized and addressed.
I’ve blogged before about the importance of asking questions in the context of material transfer agreements and also developing a vision of what outcomes are possible. That’s still very much part of the solution in this global context. My slides expand upon some points to consider that would facilitate the exchange of research materials and data. You can download them here.
If you’re interested in evaluating a therapeutic product, your own or a potential competitor’s, and are new to why we do clinical trials and how they are organized, have a look at clinical trials at NIH and follow a few links for a high level overview. In particular, check out this page with a host of disease-related registries, through which patients and their families can find and share additional information and think about participating in clinical trials.
When I’m undertaking a competitive assessment for a client, I usually spend some time on another website operated by NIH, which catalogs all of the clinical trials in the US. It’s called “clinicaltrials.gov.” You’ll find it helpful to look at the guide to searching and do some of the sample searches further down on this page. For practice, I suggest that you choose a disease like “malaria” or a disease and a population, for instance “hepatitis” AND “children”. Or search the term “genomic” with any second medical term of interest. Then click through a few of the clinical trials that pop up, and get a sense for the kind of information that is available about the trials, particularly who is sponsoring the study and what “active pharmaceutical ingredient (“API”) is being evaluated.
To get more proficient with this data gathering tool, try searching for any other API or disease that is relevant to your own research or other interests! Then when you need to evaluate the competitive landscape for a disease of company or product, you’ll have have some “muscle memory.” These sites are some of the best sources of information about potential products in clinical development.
The Federal Laboratory Consortium for Technology Transfer (FLC) is a national network of federal laboratories that are involved with the patenting and licensing of inventions. These labs include, as examples, the National Institutes of Health, National Institute of Standards and Technology. Moving technology from place to place, usually from innovator to commercial developer, is a major part of an overarching strategy to manage innovation.
I was involved in the early 90s with the FLC while heading up the NIH technology transfer office, and appreciated very much the networking and information sharing with colleagues. As an historical footnote, the Association of Federal Technology Transfer Executives (AFTTE) was also very active in this space. I was involved in its launch along with a few colleagues and good friends, Joe Allen, Jon Soderstrom, Mary Ann Guerra, among others. Members were later encouraged to move to the FLC and to the Association for University Technology Managers, another excellent professional society.
The FLC publishes a very helpful reference book (linked to this post’s title), which is free to download. I recommend Section 3 for anybody looking for a general overview of the considerations involved in the technology transfer process. And, particularly, the graphic on page 20 of the book. Section 7 about marketing and communications could also be useful to skim. Overall, it’s mostly useful for the staff of a federal technology transfer office as it gets a bit granular about how to do what they do. But there is some great background coverage that could be useful as various stages along the path arise. However, it doesn’t have much by way of practical guidance. Look to up-coming posts in this blog for some “how-tos” and best practices!