The part of competitive assessment about finding patents on pharmaceutical products

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”.

Click “View” and you’ll see a page with the US patents that the manufacturer has reported to FDA as covering the product. (More in another post on why the other Google Patent Search hits aren’t listed.) Now, we can take the only patent number here (7,365,205) and do the Google Patent Search again; it’s the first hit on the page. There’s also an advanced search that lets us refine the results if we’d needed to do that.

Another public site that I use all the time is called “lens.org” and it’s operated by an Australian non-profit called Cambia, whose mission is “to democratize innovation.” I think their Patent Lens product is a very helpful contribution. Search that patent number as you did with Google and you’ll get one hit again, but check out a few of the other tabs available here, including “Family Info.” Often it’s important to know where “sibling” patents have been issued or are still pending as a patent application. For instance, if there might be some countries where If the competitive landscape is important enough to even consider, you’ll find that it usually extends beyond any one country.