Monday, October 16, 2006

Will Thomson's stem cell claims survive an obviousness challenge?

In 88 JPTOS 743 (Sept. 2006) various assertions made by the journal Science about patent law, specifically as to continuations, were questioned. There is also some fuzziness in press coverage of the re-examination challenge of PubPat/FTCR to the Thomson patents of WARF.

From the Wisconsin State Journal at on October 15, 2006:

A federal review of Wisconsin's embryonic stem-cell patents won't question what everyone concedes: that UW-Madison scientist James Thomson was the first to grow a colony of the cells from humans in a lab. IPBiz notes that the re-examination filing by PubPat and FTCR does question the issue of the novelty of the claims of Thomson, because the filing raises an anticipation argument over US 5,166,065 to Williams. IPBiz noted that Thomson's '780 patent did cite the WORK of Williams: Mouse ES cells maintain an undifferentiated state through serial passages when cultured in the presence of fibroblast feeder layers in the presence of Leukemia Inhibitory Factor (LIF) (Williams, et al., Nature 336: 684-687, 1988). If LIF is removed, mouse ES cells differentiate. Moreover, the '780 patent mentions (and the re-exam request does not mention) a previous failed attempt to isolate hESC using LIF. IPBiz notes that it would be helpful for the popular press to be more specific in discussing what did, and did not, happen in re-examination requests.

The Journal also notes PubPat and FTCR "say the broad patents are impeding research. They argue that the patents should not have been issued because the stem-cell recipe Thomson followed for humans and other primates had already been published for other species.
WARF's stance, that Thomson's work is worthy of patents, "is like saying that just because heating in water works for cooking a chicken egg, it's novel to consider using heating in water to cook a duck egg," said Jeanne Loring, a stem-cell researcher at the Burnham Institute for Medical Research in California.

For starters, the quote uses improper language. Novelty, in the patent world, concerns whether all elements of a patent claim have, or have not, been disclosed publicly prior to the filing of the claim. Novelty relates to the concept of anticipation. The argument made by FTCR and PubPat about "stem-cell recipes" relates to obviousness, not to novelty. Obviousness requires a structural similarity between the disclosed prior art AND a motivation to combine. (see for example In re Dillon).

In KSR v. Teleflex, currently pending before the US Supreme Court, there is much discussion about motivation to combine. Specifically, does the ABSENCE of a motivation to combine correctly indicate NONOBVIOUSNESS?

In the "stem cell recipe" argument made by FTCR, PubPat and Loring, one has a different situation. There was plenty of "motivation" to go FROM a recipe for mouse stem cells TO a recipe that worked for human stem cells. The trouble with this argument is at least #1. years and years elapsed between isolation of mouse and human stem cells and #2. things that worked for mouse cells didn't work for human cells (absence of similarity).

Of point #1, ipkitten.blogspot has some words (from British patent law) that are relevant:

A patentee will invoke industry's failure to act because it will be assumed that had the alleged invention been obvious it would have been made by someone else, and in some cases this assumption is entirely justified — see Vickers v Siddell (1890) 15 App Cas 496, 7 RPC 292, a good example where the invention contributed to safety in forges and the need for safety would have contributed a strong incentive.

In the stem cell biz, "everybody" wanted to isolate human embryonic stem cells, so Loring et al. have much to explain as to "strong incentive" but no results prior to those of Thomson.

Elsewhere, CIRM has yet to come to grips with the intellectual property issue presented by WARF's patents as well as CIRM's own royalty and publication problems.

Californiastemcellreport noted on Oct. 15 of CIRM's Oversight Committe:

Intellectual Property – Discussion was deferred on the policy on intellectual property for businesses, including open access on scholarly publications involving CIRM-funded research. Time ran short at the Wednesday session so IP was taken off the agenda.


In a case of relevance to issues raised in the re-exam, in Old Town Canoe Company v. Confluence Holdings Corp., the CAFC reversed the district court's grant of JMOL on both motivation and undue experimentation fact questions.

In Quinton Instruments v. Impra ( Marhurkar), the CAFC affirmed a decision by Judge Easterbrook (sitting by designation) which, among other things, allowed a claim of priority to a design patent by a later utility patent. An award of damages for lost profits, based on lost sales and price erosion, was found acceptable. The award of damages was consistent with our precedent, see, e.g., Brooktree Corp. v. Advanced Micro Devices, Inc., 977 F.2d 1555, 1578- 81, 24 USPQ2d 1401, 1417-19 (Fed. Cir. 1992); Bio-Rad Lab., Inc. v. Nicolet Instrument Corp., 739 F.2d 604, 615- 17, 222 USPQ 654, 663-64 (Fed. Cir.), cert. denied, 469 U.S. 1038 (1984).

In Wireless v. Sony Ericsson, the CAFC affirmed a denial of a preliminary injunction. Gemstar TV v. ITC, 383 F.3d 152, is cited.

***In terms of obviousness

In the area of IVF, one recalls that the first in vitro fertilization of a human egg occurred in 1944 (John Rock and Miriam Menkin) decades before the first successful implantation and growth of a fertilized human egg. Advancement in the area was set back mainly because one person (Menkin) left the program.


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