Patent applications are no fun to write. You have to figure out just what you’re trying to cover (and how wide a space around it you want to try to clear), and the lawyers have to whip up language that casts just the right legal spell. The chemists have to write up detailed experimental procedures for all the important compounds and procedures, gather the matching analytical data, and make sure that it all fits together. Just getting the numbers assigned to the compounds right (and keeping them right through all the revisions) is a tedious job in itself. You always have to go through more drafts than you thought. No one enjoys it.
So maybe it’s not surprising that things sometimes, well, slip a little. But how about when they slip a lot? Take this morning’s example from Merck (a company that pitchforks out patent applications by the pile). Their WO2009091856 just published recently, directed at bicyclic beta-lactamase inhibitors. And everything looks normal for quite a while – 120 pages or so, in fact. Then the text suddenly snaps into bold face, and an authorial voice makes itself heard:
It appears that the data in Table 3 were generated in the same manner using the same enzymes as in Table 2 (Table 2 is unchanged from the provisional filing. I plan to DELETE the entries in Table 3 for Ex. 2,6,7 and 8 because this data duplicates the data in Table 2. . .Also, the entries in Table 2 for Ex.8 are both “1.6”, not “16” as shown in Table 3. Please clarify these differences. . .
Is the data shown for Ex 1A data generated in a separate run, or is it supposed to be the same as for Ex. 1?. . .You don’t want to include synergy data for these compouds (sic). It would be helpful to include it, at least for some of the examples (could put in a separate table). Recommend we include it for Ex. 14, since this is a likely backup candidate.
Now that’s not supposed to be in there! What you’re reading are the comments of someone in Merck’s legal department – the sorts of comments that every patent draft collects as it’s written, the sorts of comments that are supposed to be excised before you send in the application. Not this time! So if you were wondering which compound in this application represents the real candidate, and which ones are the backups to it, well, wonder no more. That query about including synergy data, for example, is an attempt to make it harder to figure out the most preferred compound itself – in vain, as it turns out. Oh, and those corrections that the comments say should be made? They weren’t. So you’ll want to fill in the correct numbers yourself.
That sort of thing goes on all the time in patent writing. You have to disclose your best compound – and in fact, you have to “teach toward” it in the claims. But you don’t have to spray-paint it orange, and there’s no sense in making things easy for your competition to figure out. A careful analysis of a patent application’s claim structure will narrow down what a patent’s authors are really interested in protecting, but there’s often still some doubt about which exact compound is the winner. There can be other clues. Sometimes it’ll be the compound with the most extensive biological characterization, or sometimes, if you look through all the experimental procedures, you’ll notice that everything’s being done on 50-milligram scale until one prep jumps to twenty grams. Bingo! Careful preparation of an application can scrub most of this stuff out. But all is for naught if your legal team’s strategy comments are included in the Special Bonus Director’s Cut version of the application.
Oh well, bonus dormitat Homerus. Anyone who’s interested in beta-lactamase inhibitors (which, I should add, I’m not) now has more data to work with. The patent analysts at Thomson-Reuters are the people who caught this mistake (a colleague forwarded their writeup on to me). As they note, the wayward legal paragraphs also mention the possibility of comparing compounds to “MK-8712”. That MK designation is Merck’s usual method of showing a compound that’s been recommended for the clinic, but this is the first that anyone seems to have heard about this one. But we can be pretty sure of something: someone in Merck’s legal department has had a very bad day of it within the past couple of weeks. . .