Archive for the ‘Tech Transfer’ Category

WARF and Life Sciences in Wisconsin – A Memoir

Monday, September 28th, 2009

Yesterday and today, the Minneapolis StarTribune has run lengthy stories contrasting the development of the biotechnology industry in Wisconsin with that in Minnesota. Today’s story focuses on the Wisconsin Alumni Research Foundation (WARF) and its successful efforts to found and promote life science start-ups based on technology developed at the University of Wisconsin.

While today’s article notes that WARF was founded in 1925, in my opinion, it could have given a better sense of just how long WARF has been contributing to the “state of the art” of bioscience in Wisconsin, and points beyond. For example, when I got to the office today, I opened my 1973 edition of “Choate on Patents,” the hornbook I used in law school in 1980. Two cases from the early 1940′s were abstracted involving the Steenbock process for enriching milk in vitamin D by irradiating it with UV light. This process was developed at the University of Wisconsin at about the time my father was a graduate student there, and WARF was already there to obtain the patents and to enforce them. Among other “home runs” in the late 1940′s and 50′s, WARF was involved in commercializing Warfarin (Coumadin), a “blood thinner” still widely in use, and in backing Professor Hector DeLuca’s successful effort to develop vitamin D metabolites and analogs in the sixties. Today WARF occupies one of the biggest buildings on campus and has revenue from investments in many aspects of Wisconsin’s economy.

A WARF fellowship to a young professor in the Department of Medicinal Chemistry made it possible for him to hire me as his first postdoctoral fellow in 1971. When a colleague, Professor Charles Sih, developed a practical synthesis of prostaglandins, he patented it through WARF, who licensed the patents to Miles Laboratories. Miles in turn opened a Natural Products Laboratory in Madison (renting space from a WARF subsidiary) and Prof. Sih hired me as the first Research Chemist for the lab in 1972. Miles employed about 15 people in the lab by the late 70′s and, believe me, in a town where Ph.D.’s drive cabs, these were “good-paying jobs.”

In contrast, the University of Minnesota did not have a “modern” tech transfer office until the mid-1980′s when it hired three patent attorneys, and began to do the missionary work necessary to attract disclosures of promising inventions from the faculty. To give you an idea of how little patenting the University of Minnesota had been doing prior to that time, Merchant & Gould, where I was then an associate, had only opened about thirty matters for the University of Minnesota in the entire history of the firm. The first patent application I filed for the University of Minnesota was in June of 1984 (U.S. Pat. No. 4,713,340), “Biodegradation of Pentachlorophenol.” (The Chakrabarty patent had only issued three years earlier, but life sciences patenting at the University was underway.) I was also fortunate enough to obtain the first of a series of patents for Professor Robert Vince that covers the anti-HIV drug Abacavir, which is marketed by Glaxo, and has yielded more licensing revenue over the years than almost any other invention patented at any university. Still, given what is essentially a sixty year head start, it is unrealistic to expect the University of Minnesota to somehow “catch up” to WARF. Our Office of Technology Transfer needs to be user-friendly, opportunistic and ready to set the hook and start reeling when the next big one strikes.

UNIVERSITY OF PITTSBURGH v. HEDRICK – ON A (CLEAR) CONCEPTION DAY

Monday, July 27th, 2009

From a prosecutor’s standpoint, the ’231 patent (link at bottom of this post) has “dream claims” to a new class of stem cells. Claim 1 reads:

An isolated adipose-derived stem cell that can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

Adipose is “fat”, and because there is so much of it around, and it is easy to obtain, it may nearly be an ideal source for “pluripotent stem cells.” During prosecution, the inventors had to convince the Examiner that these fat-derived stem cells were patentably distinct from mesenchymal stem cells (MSC). Other groups had derived these pluripotent MSCs from bone marrow, and they could be induced to form the same tissue types. Several companies are investigating the use of these cells to repair heart attack damage. For those two or three of you who have not been keeping up with stem cell technology and patent developments, I refer you to my article in JPTOS, vol. 83, 830 (2001).

An inventorship dispute arose between the two inventors who began the work that led to the ’231 patent at the University of Pittsburgh, and a visiting scientist who worked at Pittsburgh and then returned to UCLA and worked with another scientist to further characterize the cells. Although Pittsburgh listed both their inventors and the two UCLA inventors on a provisional, a PCT and the application that issued as the ’231 patent, Pittsburgh tried to remove the two UCLA inventors from the ’231 patent shortly after it issued. Not surprisingly, the UCLA inventors resisted being removed. (Decision is App. No. 2008-1468, July 23, 2009, a link is provided at the bottom of this post.)

The Federal Circuit found sufficient evidence to hold that the two Pittsburgh inventors had conceived of the claimed invention prior to the involvement of the UCLA researchers. The fact that the UCLA researchers confirmed certain properties of the cells was not a contribution sufficient to make them co-inventors, and ultimately, the court held that, while the Pittsburgh inventors were not certain that the stem cells would behave as expected, nonetheless they had the “firm and definite idea that these properties existed in [the cells].” At this point, work by others that confirms your educated guess is simply part of reduction to practice.

As interesting as is the resolution of the inventorship dispute, the resolution of the claim construction issue occupies almost four pages of the decision, and helps expand the notion of “patent profanity” that I discussed in the earlier post about the Sandoz decision. Here, the UCLA scientists urged a more limited definition of “adipose-derived stem cell” that they believed would encompass their contributions: “a species of stem cell distinct from the mesenchymal stem cell (MSC) that is obtainable from bone marrow tissue.”

The Federal Circuit affirmed that the plain meaning of the claim term was simply “derived from fat tissue.” The court then examined the specification and prosecution history to determine if there were any contradictory definitions in the specification or a “unmistakable disavowal” of the plain meaning by applicants during prosecution. The court found that the proposed narrower definition would require that the cells be a “separate species” than MSCs and that the specification did not assert that this was the case (even though the fat-derived stem cells have different isolation requirements).

Notably, even though the applicants submitted evidence derived from work at UCLA to establish that the cells were patentably distinct from MSCs, and the Examiner relied on this submission, the court specifically held: “This is not a disavowal.” The court found only a “weak inference from the summary [by the Examiner] that adipose-derived stem cells in this invention must be a different species from mesenchymal stem cells and a clear and unmistakable disavowal as required to limit a claim term.” The court even delved into the science to support its holding, stating that there was a theory that MSCs could travel to fat tissue and be changed by the new environment they encountered. (Are all adult stem cells the same cell?)

If there is a take-away lesson here, it is that unmistakable disavowal of otherwise undisturbed plain meaning must be really unmistakable before it will be used to narrow claim scope. Here, the patentee was saved from the effects of “patent profanity” because they apparently did not urge during prosecution that the claimed cells were a “distinct species” of stem cell, as opposed to simply having some distinct properties. A close call, but in the end, the Pittsburgh inventors were “safe” and the UCLA inventors were out at the plate.

Patent 206777231
Univ of Pittsburgh v Hedrick

In Search of University Patents

Monday, April 20th, 2009

Technology Transfer Tactics, in conjunction with FreePatentsOnline, has created a site (link below) which they state can allow the visitor to view all of a given university’s patents by just clicking on the name of the institution. However, while this is an interesting tool to get a snapshot of a university’s recent activity, it does not include “all of their patents, from the most recent to the oldest.” For example, clicking on the University of Minnesota (a client of SLW) shows 296 documents, mostly published patent applications, back to about 2002, plus some older reissues and plant patents. If you search for their in-force pharmaceutical patent U.S. Pat. No. 5,567,703, you can find it via FreePatentsOnline, but it is not listed as a University of Minnesota patent under “University of Minnesota.” Click on Iowa State and there are only eight patents that are not in the 7 million series; this does not comprise all of their unexpired patents. A more minor quibble is that many non-profit research institutions with substantial portfolios, such as RCT and Scripps, are not included. Also, it would have been helpful to show the legal name of the assignee of the patent documents, not just the popular name. A number of universities don’t have inventors, they simply assign applications to “The University of X,” or have changed the name of the entity that holds their patents. In summary, this is an interesting site to visit, but it is not ready for prime time analyses quite yet.

www.technologytransfertactics.com/university-patents
www.freepatentsonline.com
Technology Transfer Tactics Partners with Patents Online