In the fabulous world of business, there is thunderous demand and there is sweet supply.  People start businesses to satisfy some particular demand.  Along the way they hope to recover some of the elusive spondulix.  This is what makes the world go round.

In the glamorous world of custom chemical manufacture, a company seeks to make new material exclusively for a single customer or application.  Let me say that this essay is not about the byzantine world of pharmaceutical manufacturing or drug development. Pharma is a brutal and cutthroat business and it absolutely escapes me why any sane person would launch a pharma business today.

Bringing a new chemical entity to the market for commercial use is technically challenging and increasingly complicated due to regulatory requirements.  We’ll leave the regulatory nightmare for another time and focus on intellectual property.

Here is a common scenario:  Customer X emails and makes the following query- “Gimme a price for 10, 100, and 500 kg of QRT”.  The sales guy squints at the email and says “Cripes, we gotta figure out how to make this stuff, if we can make it, and SWAG (Scientific Wild-Assed Guess) a price!” It is the “if we can make it” part that is of concern today.

Before a manufacturer can actually offer a material or use a process to execute a sale, they must first perform their Due Diligence.  Due diligence has many manifestations and if you want a lecture on it, just get a recent MBA drunk and ask for a detailed explanation (I am preparing a blistering diatribe on MBA’s for a later essay).

In the matter of intellectual property, a manufacturer has a responsibility to determine if they are barred from practicing some process or making a particular composition of matter.  Given the gigantic body of literature that can be searched by SciFinder or Beilstein, you’d think getting a clear answer would be an easy, if not tedious, thing to do. Sometimes it is easy.  Other times you follow Alice down the rabbit hole.

The key question for the chemical vendor to resolve is this: Are there patent claims out there that are in force that would bar a manufacturer from practice?  To resolve this, we have to deconvolute the query into at least four questions- 1) Can we think of key words or structures that, when put into the sorting hierarchy, will lead us to the answer set? 2) Do the claims cover a process or a composition of matter? 3) Is the patent still in force? And 4) If we fail to find claims, are we confident in our search?

The USPTO website may not be that helpful and, in my experience, might give a false sense of security when your search comes up empty. The search engine at the PTO site will search for character strings in a variety of fields, and while this is useful, it is possible to miss a compound if it has an unanticipated name or is represented in some other fashion.

A common thing to find in the chemical patent literature is the Markush claim. In this representation, a set of analogs are claimed from which a preferred embodiment may be taken. A Markush group is depicted by a formula with generic substituents and each generic substituent is subsequently defined as being comprised of particular groups in chemical taxonomy, e.g., hydrocarbyl groups.  Here is a simple example of a Markush Group- “QR(4-n)Xn, where n= 0 to 4. Q is a tetravalent member of Group IV of the Periodic Table of the Elements; R is a hydrocarbyl group consisting of C1 to C12; and X is a member of Group VII of the periodic Table fo the Elements”. 

I’ve noticed that lawyers and USPTO people tend to use the patent classification system to sort the technology or the composition. Lawyers may also use specialists who have proprietary databases or some dark art known only to them.  Unless a chemist has spent time with the PTO system of taxonomy, it may be a bit daunting and less than useful. 

SciFinder collates patent data into patent family output and provides a very useful entry into the patent literature. Nevertheless, it is still a fairly blunt instrument and many patents may have to be viewed by hand.  Perhaps someone can comment.

It would be great if SciFinder had a way of flagging any given compound for the presence of process claims and composition of matter claims. This would be extremely useful to those trying to verify that they are not in infringement. 

A very useful tool for those seeking pdf downloads of patents can be found on pat2pdf.org.  It takes the individual pdf pages from the PTO site and assembles them into a single pdf  file. And it’s free.