12 Apr WARF is likely to hold on to stem cell patent rights
Editor’s note: Grady Frenchick co-authored this commentary with Michael J. Cronin, Ph.D., J.D., an intellectual property associate with Whyte Hirschboeck Dudek in Madison.
A look at the facts in the dispute over three important University of Wisconsin stem cell patents – and the history behind similar disputes – shows a strong likelihood that the Wisconsin Alumni Research Foundation will retain all of its patent rights, even if some of its claims are changed or cancelled.
As two experts on patents who are not associated with the dispute, we like to provide some answers to a series of frequently asked questions involving the facts of the embryonic stem cell patent dispute between WARF and the Foundation for Taxpayer and Consumer Rights.
Q: What is the formal name for this type of dispute?
A: The formal name is Ex Parte or Inter Partes Patent Re-examination.
Q: What is the nature of the proceeding?
A: This is a one or two-year United States Patent and Trademark Office administrative proceeding possibly followed by a two to three-year federal court appeal to the Court of Appeals for the Federal Circuit in Washington, D.C. The PTO proceeding has three possible phases, evaluation of the request, examination (if the request is found to define a “substantial new question of patentability,” or SNQOP), and appeal.
Q: Who owns the patents?
A: The Wisconsin Alumni Research Foundation.
Q: Who is challenging the patents?
A: The challenging party, called the re-examination requesting party or “requestor,” is the Foundation for Taxpayer and Consumer Rights, which is represented by the Public Patent Foundation, Inc. The documents filed by the requestor are called “requests.”
Q: How many re-examination requests have been made?
A: Three, involving three patents.
Q: What type of re-examination requests are these?
A: Two are Ex Parte (meaning “from one party”) (“EPR”), one is an Inter Partes (meaning “between the parties”)(“IPR”). All were filed on 07/17/2006.
Q: What is the difference between EPRs and IPRs?
A: The difference between these two types of requests is that an Ex Parte requestor gets no right to participate or to appeal during the examination phase of re-examination, whereas the Inter Partes requestor has both rights of participation and appeal.
Q: What is the subject of the patents?
A: The patents are involved with purified primate and human embryonic stem cells, and methods of isolating or purifying primate and human embryonic stem cells.
Q: Who was the inventor?
A: The inventor of these patents is James A. Thomson, D.V.M., Ph.D., a developmental biologist and professor at UW-Madison. The patent rights were assigned to patent owner WARF for protection and marketing.
Q: What is the focus of the dispute?
A: The dispute focuses on the patentability of patent claims identified by the requestor in the request. The claims, which are the precise definitions of the patented invention, can be changed, but not broadened. No new information can be added to the patents.
Q: What is the determining factor in granting a re-examination request?
A: The question considered in deciding whether to grant a request is whether a reasonable examiner would consider the patent or printed publication “important” in deciding if a claim was patentable.
Q: Have any office actions been signed?
A: Yes, by a patent examiner other than the examiner who handled the first prosecution and, according to PTO policy, two conferees.
Q: Are these requests available for public examination?
A: Yes, at the U.S. Patent and Trademark Office’s public patent application information retrieval (“PAIR”) database; simply search the patent numbers and check on “continuity data.”
Q: What happens during re-examination?
A: Once re-examination is ordered, the proceeding continues to completion with issuance of what is called a Certificate of Re-examination that summarizes the results of re-examination. EPR is much like original prosecution. IPR has requestor input completely absent from initial patent examination. The results of re-examination is either the cancellation of some or all claims, amendment of some or all claims, and confirmation of the validity of all claims. (See Table 1 for PTO data).
Q: What is the prognosis for success or failure of the re-examinations?
A: In the course of more than 8,000 ex parte re-examination requests filed in the PTO over the last 25 years, about one re-examination proceeding in 10 produces complete invalidation of all claims of the re-examined patent. The other 90 percent of re-examination produces no change or some changes in patent coverage. (See chart below) It is important to know that if even if claims are amended, i.e., the 59 percent category, it does not follow that the breadth of the exclusive rights given by the patent will be reduced. Inter partes re-examination has only been requested about 200 times in the seven years of its existence. There is insufficient data regarding completed proceedings to characterize outcomes.
The history of the legislation that produced re-examination suggests that patent rights emerging from re-examination are to have greater “certainty” and “strengthened investor confidence.”
Re-examination – specifically
Q: How do re-examinations come about?
A: Re-examinations can be requested by any member of the public (including the director of the PTO and a patent owner requesting re-examination of its own patent). The requestor must identify and state the bases for the PTO to find a SNQOP. Only prior-art patents or printed publications are considered as bases for re-examination, i.e. findings of SNQOPs.
Once the EPR requestor has filed its request, the requestor is thereafter not permitted to participate in subsequent negotiations and discussions between the patent owner and the PTO. During IPR, the requestor is permitted to provide comments to the PTO in response to patent owner documents and arguments. The requestor also has the same rights of appeal as the patent owner, viz., to the PTO Board of Patent Appeals and Interferences, and to the Court of Appeals for the Federal Circuit.
Q: Do re-examinations get any special attention from PTO?
A: Re-examination procedures are conducted with “special dispatch” in the PTO. In the present phase of re=examination before the PTO, i.e., examiner evaluation and, if necessary, patent owner appeal to the PTO Board of Patent Appeals and Interferences, special dispatch means about two years or possibly much longer.
Time for appeal through the federal court system, if needed, (no special dispatch): two to four years.
Re-examination is, in essence, a review of the administrative process which produced the three WARF patents, albeit with a different examiner.
The re-examination proceedings as of 3/30/07
Q: What is the history of these re-examination proceedings?
A: Here is what has happened through March 30, 2007:
The dispute was started by the filing in the PTO on July 17, 2006 of the “Requests for [ ] Re-examination” (“Request”) of all claims of thee related (see Table 2) WARF U.S. patents, viz. 5,843,780, 6,200,806, 7,029,913 (see Table 2).
Each request was initially evaluated by the PTO, SNQOPs were found, (PTO statistics suggest this happens in nine of 10 proceedings) and re-examination was ordered, of all claims of all three WARF patents, on Sept. 30, 2006.
The finding of a SNQOP and ordering of re-examination meant that the next documents from the PTO (the 3/30/07 “Office Actions” as they are called) were required to articulate the bases for each of the SNQOPs and rejection of the re-examined claims. While patent owners have the right to file a statement in response to the finding of an SNQOP, none do because the rules then give the requestor the opportunity to file a second paper.
In short, rejections of all claims in the PTO on the 3/30/07 office action were expected since September 30, 2006.
The patent owner has been given two months (extendable by one month for “sufficient cause”) to reply.
Why Ex Partes re-examination requests generally confirm the patentability of some or all patent claims
Q: In general, what is usually the outcome of an Ex Partes re-examination requests?
A: Ex Partes re-examination requests generally confirm the patentability of some or all patent claims.
Re-examination is, after all, a repeat of the examination. Thus the PTO, all things being equal, is inclined to reaffirm its own initial examination.
In EPR, the requestor gets one opportunity, i.e. the request, to attack the validity of issued patent claims. The remainder of the EPR procedure is between the patent owner and the PTO. Hence, the title Ex Parte.
The PTO is inherently, technically and legally, at a disadvantage vis-a-vis the patent owner. The PTO personnel responsible for handling re-examination usually are neither lawyers nor advanced-degree scientists. The patent owner usually also has substantially greater resources and time to devote to this dispute than does the PTO.
For EPR, the patent owner only needs to win once, whereas the PTO must win at all three levels in order for revocation of all claims to occur. While this is also true of IPR, appeal rights provide the possibility of reversal. The patent owner must prevail in the last level of appeal.
IPR, while balanced slightly more in favor of the requestor, has some similar drawbacks. Patent examiners generally have no experience with adversarial proceedings. There is no pre-trial discovery, no depositions, no motions, i.e., none of the other procedural characteristics of court litigation generally known as “due process.” The absence of these safeguards accrues to the advantage of the patent owner. The basis for invalidation, in both EPR and IPR, is only written prior art consisting of patents and printed publications, a very narrow basis upon which to invalidate a patent. It fails to consider many other bases upon which patent claims can be invalidated in a court proceeding.
Table 1. Ex parte re-examination (third-party requester). Statistics obtained from USPTO fiscal report prepared for the U.S. Congress. (Statistics represent data through September 30, 2005.)
|Percentage of re-examination requests granted.||91%|
|Percentage of re-examination completed with all claims confirmed as valid.||29%|
|Percentage of re-examinations completed with all claims cancelled.||12%|
|Percentage of re-examinations completed with claims amended.||59%|
|Average pendency from filing to certificate being issued.||22 months|
Table 2. Relationship between the three WARF patents under re-examination.
|Application No.||08/591,246 (`246)||09/106,390 (`390)||09/982,637|
|Patent Issued||December 1, 1998||March 13, 2001||April 18, 2006|
|Patent Filed||January 18, 1996||June 26, 1998||October 18, 2001|
|Claim to Priority||Continuation-In-Part (CIP) of an earlier abandoned application filed January 20, 1995.||Divisional of `246 application above: That is a different aspect of the invention in 5,843,780.||Continuation of application 09/761,289, which was a continuation of the `390 application.|
|Claimed Subject Matter||(1) Purified preparation of primate embryonic stem cells; and (2) method of isolating a primate embryonic stem cell line.||(1) Purified preparation of pluripotent human embryonic stem cells; and (2) method of isolating a pluripotent human embryonic stem cell line.||A replicating in vitro cell culture of human embryonic stem cells.|
|Type of Re-exam Requested||Ex Parte||Ex Parte||Inter Partes|
Previous article by Grady Frenchick
• Grady Frenchick: WARF challenges show need for patent reform
• Is Wisconsin’s stem cell standing diminished?
• Patent office upholds challenge to WARF stem cell patents
• WARF will ease stem cell licensing restrictions
• WARF stem cell patents to be re-examined
• WARF expects review of stem cell patents
• Request to re-examine WARF stem cell patents escalates war of words
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