The challenge to the WARF/Jamie Thomson patents/IP on human embryonic stem cells (hESC) is at an end.
The US Supreme Court declined to hear the case.
Earlier, the USPTO had turned down the challenge leading to a winding road in the courts.
What do you all think of this stem cell IP challenge and the outcome?
The hESC IP includes 3 patents: 5,843,780, 6,200,806, and 7,029,913.
For two great stories with helpful background on this development see here and here by David Jensen and Bradley Fikes, respectively.
Scripps stem cell researcher Jeanne Loring was a driving force in the challenge.
You can read a newer piece that Loring did on the Hwang hESC patent situation here.
These patents are silly. I’m just a grad student, but I think this patent should’ve never been granted. Thank God Dr. Loring was able to get the scope of the patent narrowed (Thanks WARF for slowing down research for years). I’m actually astonished SCOTUS refused to hear the case. Fortunately these patents should expire soon and hopefully, they’re not renewable. They should’ve never been granted in the first place. I guess not too many people are interested in this, but thank you, Dr. Loring, for standing up for what’s right. I’m just assuming the judges involved in all this were mesmerized by the science and made poor decisions because they don’t have the background needed to understand that using mouse methods with primate cells is obvious (not novel).
Hi Shinsakan (and anyone else not yet bored by this)
Here are a couple of links that factor in the history of this challenge. I wonder if having the head of WARF advise the PTO had anything to do with its (strange- to me, at least) actions on the WARF patents.
http://www.nature.com/nature/journal/v435/n7040/full/435272a.html
http://www.uspto.gov/about-us/news-updates/commerce-secretary-gutierrez-names-new-members-patent-and-trademark-public-3
Cheers,
Jeanne
Hi Shinsakan:
I too found the wrapper intriguing- it almost humanizes the patent system. About obviousness- I was skilled in the art, but so were dozens of others, including Doug Melton, Chad Cowan, and Alan Trounson, who wrote declarations to the PTO saying that the approach was obvious. There was some skill involved, and intuition…not everyone was successful in even deriving mouse lines using the published protocol. For their rebuttal, WARF paid an “expert” to state that it wasn’t obvious to use the published methods. They couldn’t have paid me enough to lie about science, but that wasn’t true of everyone.
Isn’t there something patently (sorry) absurd about suggesting that only Jamie had the idea to follow the published methods? What Jamie had that Doug, Chad, Alan, and I did not have, were Rhesus and human blastocysts. Did you know that all but one of the blastocysts used for the first human ES derivation paper came from Israel? Joseph Itskovitz-Eldor brought them to Wisconsin in his pocket!
And Joseph wasn’t on the patent as an inventor. Don’t argue- I know the legal strategy, but I’m more concerned about professional ethics.
Dr. Loring,
Yes, I can’t help it! I only wanted to point out that a rejection based on obviousness is more complicated than just being obvious to do something, as there also has to be a reasonable expectation of success without undue experimentation, and even then, the finding of obviousness can be overcome by a showing of unexpected results. Therefore, things can be found non-obvious and patentable even when conceptually obvious (e.g., taking a method known to work in one species and simply applying it to another).
That being said, I am only commenting on the patent process and what appears to have happened in this case- as to whether it is actually obvious or not and how much experimentation/innovation would have been actually been required vs. just following a set protocol in a different species and arriving at success, I think that you are a much better judge than me, although I think that both you and Dr. Thomson are of much greater than ordinary skill in the art!
As for using already-published methods, my understanding is more that they were saying that Dr. Thomson used already-published methods but then arrived at an unexpected result, i.e., the increased longevity of the cultured cells, which would then be considered innovative (and patentable). As a result, the actual reason for allowance given by the examiner was the long-term stability of the cells.
Yes, it took a ridiculously long time for the message to get from the director’s office to the publisher’s office…if I were the petitioner, I would be pretty upset. I think that at that time when everything was on paper, things were pretty disorganized. Even the records for the file wrapper in this application and its parent are spotty- for example, even though the response to the petition is there, the petition itself is not. In the parent case, only the first page of the examiner’s office action is present, so we don’t know how she actually responded to the arguments of the applicant. Interestingly, the file was even reported lost on 2/7/2000 and wasn’t found again until 10/13/2000! I think that things have gotten better at the PTO now that everything is automated, but it is still not unheard of for applicants’ submissions to fall through the cracks and not be docketed to the examiner or wherever else they are supposed to go in a timely manner.
Yes, the board of appeals at the PTO did initially overturn the patent because they found that the generation of the cells was indeed obvious. However, they reconsidered and then overturned this invalidation and re-instated the patent based on a declaration indicating that the methods of the prior art used for other species could not be used as-is to generate human ES cells, and also that there was no reasonable expectation of success without undue experimentation for human/primate cells when applying the previous methods. They also found that one of the references previously used to support obviousness in the invalidation actually cited Thomson’s work, thus instead suggesting that Thomson’s work was innovative and not obvious. They also provided other objective indicia for non-obviousness such as acclaim by others indicating that Dr. Thomson had achieved a breakthrough. So in the end, the PTO ended up affirming the patent rather than invalidating it.
I don’t work for WARF. I do currently work in patents, and so I actually spend a fair portion of my working hours reading file wrappers. In cases like this (or Hwang or Yamanaka), I am happy to read the file wrappers for free because I think it is really interesting to know what considerations were made when granting or rejecting patents on such world-changing inventions (maybe it’s like when ESPN replays classic sports matches?); beyond that, I would simply like to have as much information as possible before forming an opinion. So I am right there with you in digging through old file wrappers to try to piece together what actually happened and why!
Hi Shinsakan:
I should have known it would be hard for you to resist a patent discussion. When I say something is obvious, I mean that any people who had derived mouse ES cells, when given a blastocyst from another species, would use the mouse methods, which were the only published methods for making ES cells.
The published mouse methods worked for Rhesus for Jamie and they would have worked for anyone else who was given a Rhesus or human blastocyst. We’re all just technicians following in Martin Evans’ footsteps.
I found it amusing that WARF said that the novelty was that Jamie used already published methods. What’s novel about using the only published method?
It was also amusing how long it took for a message to get from the director’s office to the publisher’s office. I like to think of them as people, and people make mistakes.
The PTO did overturn the patents, as you know.
Are you working for WARF? I can’t imagine anyone reading file wrappers for free…except me.
(Edit) WARF patent is valid and NOT obvious at all.
Editor note: this comment was edited for content not allowed per the comment policy.
Dr. Loring, Why would you want the patents invalidated?
Dr. Loring,
About the two things you mentioned for the patent prosecution:
(1) As you noted, the methods used are the same used to derive mouse ESCs, which would make it obvious to try to use the method to produce primate ESCs, and this point was actually made by the examiner on 1/17/1996 during the prosecution of the parent application (which was abandoned). However, at that time (on 7/23/1996) the applicant countered with a reference that noted that “the methods devised for ES cell production for one species may not be directly applicable to another species” and thus argued that even if it would have been obvious to try the method to make primate ESCs based on the known method of making mouse ESCs, there would have been no reasonable expectation of success without undue experimentation, which is also required for a rejection based on obviousness. The applicant also pointed out that even if success would have been reasonably expected, they obtained unexpected results for the longevity of the obtained primate ES cell cultures. Unexpected results are a secondary consideration that can be used to overcome obviousness. Possibly as a result of one or both of these arguments, the rejection over murine (and sheep) ESCs was not subsequently made again in the child application (which was the one that issued in 1998). If the argument for lack of reasonable expectation of success for different species was indeed considered persuasive, though, it is a little weird that the patent was granted to generally cover all primates (including humans) when only rhesus and marmoset data were presented by the applicant.
(2) The patent office did not miss that the claims could also cover humans. Human ESCs were actually considered by the examiner as part of the scope of the claims from the very beginning (see the office action of 3/26/1997), and even in the parent application (see the office action of 1/17/1996). The letter that you mention from 11/19/1998 to block issuance of the patent actually appears to be in response to a petition filed by the applicant on 11/18/1998, where the applicant (and not the patent office) petitioned the patent office to stop issuance of the patent (see the petition decision of 12/10/1998). As you noted, the petition from the applicant was not seen by the appropriate patent office staff in time and the patent was issued anyway, as the applicant had already paid the issue fee. I am not sure why the applicant petitioned to withdraw the patent from issuance.
I don’t know about the Santa Monica post office, but I remember late nights at the 24-hour LAX post office on grant/fellowship submission deadlines because they would give postmarks right up to midnight!
I’ll start the discussion. I read the patent on “primate embryonic stem cells”, along with all of its file wrapper shortly after it issued in 1998. The patent was on work published in 1995, reporting the derivation of Rhesus monkey embryonic stem cells.
This was before human ESCs had been derived, but notably, since humans are also primates, the human ESCs derived later were also covered by this patent.
Two things struck me about this patent. First, the methods used to derive the lines were the same ones used to derive mouse ESCs in 1981; that means that the methods were obvious. Second, there was a peculiar event – a few days before the patent was issued, the director of the patent office sent an order to the patent “publication office” to stop issuance of the patent so it could be reexamined. That order took a few days to make it through the bureaucracy, and the publication office issued the patent before it received the order. I suspect that someone belatedly realized that this patent would also cover another primate, humans, and that was something that required more consideration.
I think I’ll leave this as chapter 1. Fast forward to 2006, after I met Dan Ravicher and John Simpson and we decided to challenge WARF’s patents. And on to 2015, when we finally reached the end of our quest. The story is too long for this venue- sometime I’ll talk about the ethically challenged judge, the three unpaid volunteers, the Santa Monica post office and other stories.
I do have a tremendous variety of feelings about this issue… I definitely would like to see what others say. But ultimately. .. I have to judge this one as a patient. Whatever the situation may be which leads to hescs getting funding. .. I am and must be for that. I don’t care who or where the funding comes from by this point. Hescs have been blocked for government funding again and again and again and again and again. If this court decision means that funding can come from somewhere. .. anywhere. .. hell itself for all that the desperate patients care… then I can’t be against it… no matter what I might think of the underlying principle. YMMV.