DETERMINING INVENTORSHIP - Patent law

Now that we have examined the important relationship between patent inventorship and initial ownership as well as the relationship between correct inventorship and patent validity, we can better appreciate the importance of determining inventorship correctly in the first place, so as to avoid any uncertainties that accompany a patent with improperly listed inventors. Unfortunately, inventorship determination is one of the “muddiest concepts in the muddy metaphysics of patent law”; it deigns to draw clear boundaries around subject matter that is often amorphous and subjective. Inventorship issues typically arise when joint inventorship is being considered and the question revolves around whether one or more individuals’ contributions qualify them as joint inventors.

In this vein, it is vital to realize that “getting inventorship right” begins with under standing that the issued claims determine the scope of the inventorship inquiry. If an individual contributed material that was part of the patent application but ultimately was not important to the issued claims, she is not an inventor. Once the subject matter of each claim is determined, that subject matter is then compared to each prospective inventor’s contribution to see if that contribution is inventive. The inventive contribution to the claims thus holds the key to unlocking this mystery of inventorship, and as we will soon see, not all contributions to the invention are inventive contribution; not all contributions are created equal.

As we learned earlier, inventions can be broken down into two parts: conception and reduction to practice. Conception has been defined as “the complete performance of the mental part of the inventive act.” One might think of the conception portion of the invention as the idea to do the thing that eventually becomes the invention.Sometimes the bulb burns very brightly in an individual’s head, and the conception for an invention comes about in a single, well-illuminated moment. Other times, the bulb glows only intermittently, perhaps borrowing its light from several individuals over a course of time. As a result, it is often the case that a claim to an invention requires the conceptual input of several inventors over a period of time. In either event, conception is completed when each and every element of the claimed invention has been mentally contemplated. As we already learned, reduction to practice can be actual or constructive. Actual reduction to practice refers to the production of the invention in a physical, tangible form that contains every element of the claim corresponding to that invention.

Furthermore, an actual reduction to practice requires that the invention has been sufficiently tested to demonstrate that it will work for its intended purpose. In contrast,a constructive reduction to practice means that the invention is described in such away that one of ordinary skill in the art can make and use the invention without undue experimentation, even though an actual working example has not been prepared—perhaps a well-detailed scheme or drawing is sufficient. In this case, one does notactually need to physically make the invention. A constructive reduction to practice normally occurs on the filing of a patent application since the patent application must, to be valid, provide sufficient instruction to allow one of ordinary skill ordinary skill in the art to make and use the invention without undue experimentation in the same way as a constructive reduction to practice requires.

Although it takes both conception and reduction to practice to make an invention, the two parts are not treated equally in terms of determining inventorship. In fact, a person cannot be an inventor unless they contributed to the conception of the claimed invention because “conception is the touchstone of invention.” However, the mere wish for the achievement of a particular result absent anything else is unlikely to qualify a person for inventorship. As was stated in a federal court decision where this issue was considered:

The party claiming conception of an invention must show that it was complete and operative and such as would enable a person skilled in the art to reduce the conception to practice without any further research or exercise of the inventive skill. It is not sufficient, therefore, to show that a party claiming an invention has conceived a result to be obtained; the patentable thing is the means provided and disclosed by him to accomplish that result.

Likewise, merely providing technical assistance to facilitate the reduction to practice of an invention does not qualify one as an inventor unless the reduction to practice itself required inventive contribution that became part of the claimed invention. In acommon scenario that often occurs in the chemical industry, one person may proposea compound or set of compounds or a particular composition that she wishes to see made and tested for a given property or activity. The actual production of the compound or set of compounds may ultimately be carried out by a different person. Atfirst blush, one might guess that the person who proposed the compound(s) for the particular activities is the one who conceived the invention and the chemists synthesizing the desired compounds were technical support providing the actual reduction to practice. Under this assumption, the person proposing the target compound(s) is likely the sole inventor. However, let’s recall that it is the patent claims that define the inventorship. Are the claims directed to the compounds only, or are there claims directed to processes for making the compounds as well? If the latter is true, it is possible that the persons making the compounds are co-inventors, provided they contributed to the conception of the process claims. Likewise, should the preparation of the compounds require skill beyond what is routine in the art or should the production of those compounds require additional research such that the means to achieve the intended result (the compound itself) is not present in the original conception, then the conception is incomplete without the additional experimental input. As a result, it is possible that the provider of that additional experimental input is also a provider of the conception of the invention and therefore a co-inventor of the invention as well. Let’s consider an inventorship hypothetical which will hopefully provide some color to the previous discussion.

Several chemists are working together on a top-secret project being conducted at the Acme “Miracles Happen Here” Drug Factory. The chemistry team consists of one project team leader (Gus), one lab leader (Curt) and two synthetic lab associates (Mike and Charles). Collectively, the team is trying to design compounds that will bind to and selectively modulate the “go-fast receptor.” One day at a meeting of the chemical team, Curt proposes a series of compounds for preparation and testing against the gofastreceptor and if successful, further animal testing in various models as needed. Gusdisagrees with Curt but after a heated discussion, acquiesces and finally even states:“Actually that is a really good idea, I strongly recommend you proceed with the compound sand make sure that you let me know if you need anything to make it happen.”

Within weeks of that meeting, Curt, Mike, and Charles begin to investigate routes for the production of the desired compounds. Curt proposes one route to the target compounds that uses known starting materials and proceeds by straightforward routes to the desired novel targets. A second route, proposed by Mike, uses novel starting materials that need to be prepared by chemical routes not directly known in the art although plausible via the scheme he has proposed. Curt approves the route because it might allow access to different members of the chemical series and it also increases the chances of getting at the target compounds if the more conventional route fails.

After several weeks of diligent work, Charles, working on the route proposed by Curt, produces some of the target compounds without any problems, and Mike’s proposed route produces some additional synthetic targets. In routine binding experiments,most of the compounds are found to have affinity for the go-fast receptor with some demonstrating fairly exciting potency. The lead biologist (Susan) directs her group to test the compounds in standard in vivo models associated with the target activity where many of the compounds again prove to have significant activity (it seems the compounds make the rats run much faster than normal rats). Curt explains the results to Gus who exclaims: “Great, let’s put together a record of invention, I think we’ve really got something here.”33 A record of invention is drafted that documents the technical details of the work together with the biological results. From the record of invention and additional background provided from the Curt, the project leader,the patent attorney drafts a provisional patent application that describes the group’swork. A list of potential inventors is put together that includes the entire chemistry team as well as the lead biologist. The patent attorney assigned to that therapeuticarea reviews the record of invention and decides to conduct interviews with each of the putative inventors, starting with the three chemists who have actually synthesized the target compounds. The three chemists are each interviewed separately:

Patent attorney: “Charles, I see you take credit for the synthesis of 30 out of the 38 compounds that have been specifically claimed in this patent application,can you explain to me exactly how you contributed to the claimed material in this patent application?”

Charles: “Well, it goes like this . . . you see, I work harder and I am more effective than anybody else in the lab. I am the only guy that knows how to walk and chew gum (though I don’t chew it in the lab) at the same time. I keep the HPLCrunning, and everybody comes to me when they have a problem isolating their compound. I make a lot of compounds because I set up a lot of reactions and purify them in parallel. That’s why I’m one of the most productive guys in the department.”

Patent attorney:“Well that’s pretty impressive but can you tell me whose idea these compounds were?”

Charles:“Well, I got my target list and synthetic scheme from Curt, our lab leader. But don’t think that means the compounds just make themselves. I had to play around with the reaction conditions to get the reactions to work, some of them go fine at room temperature but others I had to heat the heck out of.

You know, some of these compounds aren’t easy to isolate either. Without my hands on this HPLC you could bet that it would take a lot longer to get those same compounds made and tested.”

Patent attorney:“Anything else you might want to add?”

Charles:“Yeah, don’t rip me off me like last time. I need to list some patents on my r´esume´ because there have been a lot of lay-off rumors going around and I want to be ready in case my number gets called.”
The patent attorney next talks to Mike about his contributions to the work.

Patent attorney: “Mike, I see you take credit for 8 out of the 38 compounds that are claimed in this patent application, can you explain to me exactly how you contributed to the project?”

Mike: “Well, I made all of the in doles on the project. Curt’s scheme wouldn’t have worked to get them because they would have disintegrated in the deprotectionstep, so we needed a different scheme. I proposed the scheme because I thought it would be a cool way to make the compounds. Not much is known about that type of coupling reaction but I thought it was worth a shot. I love coming up with new reactions.”

Patent attorney: “Anything else”?

Mike:“Well,I think it is important to appreciate that without my scheme, we could not have synthesized the in doles, which are some of the better compounds from this work. Using my chemistry, we were able to explore areas in the receptor we could not have otherwise. Once those areas were opened up, Curt gave me free rein to analogue the series based on whatever starting materials I could buy. For example, the 3-methyl compound came from a commercially available starting material that I picked out since I knew I could get the chemistry to work. As it turned out, although the compound was not the very best of the group, it did have some good properties.”

Patent attorney: “Thanks!”
The patent attorney next calls in the lead biologist, Susan, on the project:

Patent attorney:“Susan, I see you’re the lead biologist for this project. You’ve had a chance to review the record of invention prepared by the chemists as well as the draft claims, can you tell me how you contributed to this work?”
Susan: “Well, let me give you a little background before we proceed. Many other companies have worked on this receptor, but our management thought we also needed to have a presence in this area and so I proposed the screening paradigm that we are currently following. First we test the binding, then we have our cellular assay to determine the functional activity, and then we have the standard in vivo models of activity. If a compound meets or exceeds our predetermined cut-offs, we select it for a pre clinical advancement candidate and proceed to look at other properties such as pharmacokinetics, safety, etc.”Patent attorney: “So the basic utilities we are screening for are already out therein terms of what is known?”

Susan:“Yes, I would say that. Although we do have some newer cellular constructs we are looking at that we think might be a better way to characterize the compounds.”

Patent attorney:“Make sure you write that work up when you’ve finalized it and maybe we can file something on it down the road”.

Susan:“Great, more work. Just what I need.[Laughs.] I’ll be in touch.”
The patent attorney next calls in the lab leader (Curt).

Patent attorney:“Curt, I see you’re the lab leader that was involved with this project. You’ve had a chance to review the record of invention prepared by the chemists as well as the draft patent application and claims, can you tell me how you contributed to this work?”

Curt:“Well, basically the idea for this template was mine. I also came up with the main chemistry plan, though Mike did come up with the other scheme that provided the in doles. Are you trying to determine the inventorship?”
Patent attorney: “Yes, I think I have gotten enough—”

Curt: “Well, I didn’t actually make any of the compounds. I’ve been busy with so much lab management responsibilities and meetings. It’s gotten to be nothing but meetings around here. I used to actually make compounds but—”

Patent attorney: “Oh that’s okay, I think I’Ave gotten what I needed from you,thanks.”
The last interviewee is the chemistry project team leader, Gus.

Gus: “I guess I’m here to sign some invention forms?”

Patent attorney: “You mean the assignments?”

Gus: “Yeah, whatever they are. I want to get the silver dollar, I promised my youngest son I would give him the next one I get.”34

Patent attorney: “Well not so fast, we haven’t filed the case yet.We are just doing the inventorship determination.”

Gus: “Well, I’m the project team leader from which this invention originated.
What else do you need to know?”

Patent attorney: “Well, I need to know how you contributed to this invention.
You’ve had a chance to review the record of invention as well as the draftclaims, can you tell me how you contributed to those claims?”

Gus: “I gave them the go ahead. I even told Curt that it was a good idea and that he should proceed with it. Not only that, I defended the idea to my upper line management. I took a lot of heat for it.”

Patent attorney: “Yes, but as to the actual substance of the claims, was any of it your idea?”

Gus: “Well no, but without my buy in and advocacy, this project would have been shut down before it even got off the ground!”
Patent attorney: “Sure, I believe that. Is there anything else?”
Gus: “When do I get my silver dollar?”
Patent attorney: “I’ll get back to you on that”.
Gus: “Hey, it’s been nice chatting but I’ve got a meeting to attend.”
Do any of these scientist’s situations sound familiar? If so, you might be curious to see how the inventorship analysis turns out.

Let’s talk first about Charles. While Charles is a very sympathetic and hardworking guy (and I know we are all pulling for him), it appears that his contributions would not qualify him as a co-inventor of the work being contemplated for a patent application.
His work, albeit skilled and important, did not contribute to the conception of any of the claimed subject matter (the process or the compounds). He appears to have made the compounds he was asked to according to a route that was provided. Although he had to vary certain parameters to optimize certain reactions or separations, those types of changes would appear to be within the normal technical purview of one of ordinary skill in the art.
Nowlet’s talk about Mike. While Mike did not make nearly as many compounds asCharles (8 versus 30) some of his contributions appear to be inventive. For example,Mike came up with an alternative route that allowed entry into the indole compounds that will be part of the claimed invention. Assuming the process of making thoseindole compounds is claimed in the final patent (remember that claims can change throughout the patent application prosecution), then there is no doubt that Mike would be an inventor of that claimed subject matter. However, even if the process itself is not claimed, Mike still is likely a co-inventor because it appears that he designed at least some of the analogues based on his synthetic scheme. Beyond the novelanalogues that he proposed, Mike’s contribution may have still risen to the level of inventorship since it appears that Curt’s synthetic scheme would have failed to produce the indoles, and thus Mike’s synthetic scheme represented an entry into theindole part of the claimed invention. Additional facts to be considered for this latterpossibility include the availability of other workable synthetic schemes for making those types of in doles and their likelihood of success. In other words, did Mike’s route to the in doles require skill beyond what is ordinary in the art? This latter analysis is more subjective and difficult in such a case because it turns on hypothetical posturing; nevertheless, a good-faith effort to get the right answer is all that is required.
Susan is unlikely to be listed as a co-inventor of this patent. It appears that Susan set up a routine paradigm for testing the chemists’ samples. The chemists knew the target and submitted their compounds anticipating that they would be active. Susan did not come up with any novel uses for these compounds that could be separately claimed. In this case, Susan (like Charles) has performed part of the actual reduction to practice but was not involved in the conception of the invention. This is not to say that a biologist could never be an inventor on a patent claiming only compounds and processes for making them. For example, a biologist may have found an unexpected utility in a compound where previously none was known (a compound with no utility cannot be patented). Likewise, a patent application claiming compounds may alsoclaim novel biological uses for those same compounds. Whoever conceived of the novel use would be listed as an inventor of that claimed subject matter.

Next let’s look briefly at Curt’s contributions. If you have determined that Curtis a co-inventor, give yourself a well-earned pat on the back. By recognizing Curt’scontribution, you have appreciated that conception truly is the touchstone of invention.Even though Curt did not make or test a single compound, he is an inventor.Remember, it was Curt who conceived of the compounds that were ultimately made and tested. Moreover, Curt’s idea was not simply a pie-in-the-sky wish for a certain result; he provided real molecular targets to be made and tested and provided ascheme for making them. So even though Curt never got physically involved with the work, his mental contributions earn him a well-earned spot at the inventor’s table.

Finally, let’s move onto our friendly chemistry project management figure, Gus. If you have determined that Gus is not an inventor then you are again congratulated. If you have the guts to explain this to Gus, then you are really congratulated! Explaining to people that they are not co-inventors is one of the more dreaded tasks of a patent agent or lawyer. This takes not only a keen sense for the right words but also real courage. One can see that Gus will not be very happy to receive the news that there will be no silver dollar for his kid, but we really have no choice in the matter. While it might be true that he made the work possible by exercising his managerial authority, there is no conceptual nexus between his efforts and the claimed invention.


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