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.
Here is a superb questionnaire posted by the Office of Research Services at the University of Manitoba.
It’s intended to identify several issues that need to be managed before a research institution accepts tangible, biological materials. In my own experience, it’s easy for busy people who submit or process material transfer agreements (MTAs) to overlook an question like whether the material will be described in a student’s thesis or what other third party materials — and from which sources — might be part of the contemplated research. This approach is just as important and useful at for-profit enterprises as well as academic institutions.
Viva questionnaires like this and also checklists for helping to manage innovation risk and ensure a high quality transaction!
Often it’s very useful to be able to search and find key words through the text of a patent. I do this to find examples of particular intended uses or formulations, for instance to see if a stem cell patent contemplates cellular therapy or if a chemical formulation might be administered via an implantable device. It’s also a quick way to find the places where dosages are discussed. These findings help determine the potential scope of a patent or sometimes even whether or not it’s likely to be valid or enforceable. These can be important dimensions of a competitive assessment.
However, the pdf versions of the patents and patent applications that you’ll typically find in the databases generated by the US Patent and Trademark Office (US PTO) or the other major world patent offices like, for instance the European Patent Office (EPO), are pdfs of images rather than of text based documents.
While I like to use a pdf to highlight and to read more quickly than a text document, when I find a patent that I need to save for my analysis, I generally also download a text version. For instance, in today’s other post about finding patents for a competitive landscape study, I discussed U.S. Patent No. 7, 736,205, the full text of which is here on lens.org. My usual modus operandi is to cut and paste it into a MS Word document or a text editor, my favorite of the latter being nvALT (by Brett Terpstra) on the Apple platform. If I forget the text download, it’s also usually good enough to OCR the pdf to create a text layer. Typically, I’ll use PDFPenPro for this, again on the Mac ecosystem.
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”.
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.