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.

At the recent American Chemical Society meeting there were numerous seminars regarding proposed rule changes in the regulations pertaining to patent prosecution. Some attorneys from major law firms were present and there was considerable hand wringing. Changes affecting the scope of inequitable conduct were of special concern.

It seems to me that the proposed changes, while not trivial and possibly even a net benefit, fail to sum up to a significant re-think of the US patent system. The strategic plan proposed by the PTO seems to address for the most part mechanisms for increasing the velocity of patent examinations. Given the substantial growth in patent applications, the PTO definitely does need to staff-up and streamline the system.

However, inventors and assignees need to have a better idea of how the PTO operates. Currently, only attorneys seem to have a grasp of the system, and barely at that. The quality of patents will increase only when inventors and assignees have a better idea of how to assemble a packet of disclosures for the patent attorneys.

All too often the attorney receives an incomplete and poorly articulated stack of scribblings from an inventor. Since patent attorneys are by nature predisposed to “find a way” to patent the invention, they “find a way” to do it. That is why you hire an attorney. But all too often a sketchy disclosure to the attorney results in poorly executed claim construction and a patent that is too narrow in scope.

In order for the US patent system to work well, the inventing and patenting public needs to become more familiar with the system.

There are companies within any industry that are inventive and there are those that are not. Inventive companies value innovation as company treasure and will provide a means for its capture.  Inventive companies have protocols for the screening of new intellectual property and the decision to patent, retain as trade secret, or disclose an invention.

While it is possible to be smart about patenting, it is also possible to be quite foolish about it. It is very easy to expend large sums of money over the life of a patent to get it issued and to protect it from trolls and other challengers. If the patent covers technology that is the core of your business, then this is justified. But if the patent claims processes or compositions that provide only a minor uptick in value, the assignee needs to look inward and decide if the possible downstream opportunity costs outway the patent expense. The answer is rarely clear cut since it involves predicting the future. Accordingly, most choose to fail on the conservative side and elect to file a patent application.

Many companies will have a set of core technology patents around which they file “picket fence” patents to ward off outside innovators who may claim conditions or variations that were not thought of initially. Companies with large legal budgets can afford to do this.

When you invent something in a competitive field, there is immediate pressure to protect the invention. A monopoly on an enabling technology can rocket a company to a dominant position in it’s market. Likewise, loss of the right to practice can be a disaster.

There is something that I have come to call “patent sickness”. Someone afflicted with patent sickness will present symptoms of paranoia or mania. Patent sickness is like gold fever. Perfectly intelligent and well meaning people can succumb to it and become lost for months or years.

First, I’m not a patent lawyer or agent. But I do find myself strangely enchanted by the Byzantine ways of this league of office workers and their Masonic-like temple, the USPTO.  Just so there is no misunderstanding, there are many legitimate reasons to get a patent. I’m not against patenting. But I do believe that inventors and assignees need to be smarter about the patenting process and more circumspect about the need to patent.

It is possible to make bad choices from the very start. One of the worst things you can do after you realize that you have invented something is to run directly to a patent lawyer. When you are a hammer, everything looks like a nail. When you’re a patent lawyer, everything looks like an invention. OK, that is an exaggeration, but only slightly. Many attorneys do have your best interests at heart, but always remember that they are in the business of generating billable hours for the firm. That’s perfectly fine- it’s allowed. But when you retain a lawyer to prosecute your appln you need to remember that the assignee, not the inventor or the lawyer, is really driving the boat.  Too many people simply hand the disclosure documents to the attorney and say “do it”. And do it they will.

Fine. You don’t run off to a patent lawyer immediately. What should you do? First, stop and THINK.  What are you going to actually do with it? You have this 20 year monopoly over some set of processes and/or compositions. Is it a global or a local type of innovation? That is, does it offer a whole new way of doing something or does it just offer some incremental improvement? Will potential licensees have to drop some other established technology, change their manufacturing process, and face revalidation of their product with their customer just to adopt your invention? If so, what is the clear cost advantage? 

Will the patent be defensive in nature, i.e., is it meant to prevent others from inventing it independently and possibly shutting you out? Or, is it a technology that you plan to run with aggressively out in front of god and everyone? Will a trade secret suffice?  What about a defensive disclosure? Will it be enough to disclose it in an obscure publication and hide in plain site?  That way you bar others from claiming the technology, but in exchange you let others have an easy entry.

Your initial slide down the slippery slope of patent prosecution will seem completely reasonable.  Patent lawyers are officers of the court and they have many solemn liabilities that you are unaware of, but by nature they are inclined to “find a way” to get a patent appln allowed.  The patent lawyer should ask some basic questions- Who are the inventors? Has this been offered for sale? Has it been disclosed to the public? Has this already been invented? Who really owns the invention? etc. After these questions have been answered to the lawyers satisfaction, the inventor/assignee may be advised to submit a provisional or a regular appln.

It is at this point that the inventor may find him or herself in the early stages of patent disease.  Sitting there talking with the attorney, the dizzying realization of the invention’s potential washes over you like the first gasp of nitrous oxide at your ex-girlfriends party. As the attorney drones along, advising you of the application process and the fees, your mind reels through the business possibilities. You’re hooked.