Wednesday, May 31, 2006

Scary developments for Proposition 71

I. Steven Milloy on embryonic stem cell research

Steven Milloy, curator of the junkscience site, has weighed in against federal funding of embryonic stem cell research.

Now that Dr. Hwang’s claims have been exposed as fabrications, embryonic stem cell research has virtually no track record of progress.

No other embryonic stem cell researchers – not those who are privately- or state-funded (and not subject to federal funding restrictions) or who work in other countries ­– have made any advances toward disease treatments.

Progress in other research areas is even starting to raise questions about the need for embryonic stem cell research in the first place.


Milloy points out that there is private support available AND that anecdotes, rather than a driving need, furnish a lot of the support for taxypayer-financed embryonic stem cell research:

The University of California-Irvine, for example, just announced that it will use private funding to create five new lines of embryonic stem cells from embryos donated by patients from fertility clinics who no longer need the embryos and want to donate them to science. But it will take years just to create new stem cell lines before any research can be conducted.

Though there is no reason for taxpayer funding of embryonic stem cell research, rationality is not what drives this debate.

Pennsylvania Republican Sen. Arlen Specter underwent chemotherapy last year for Hodgkin’s disease and has held himself up as an example of someone who could benefit from embryonic stem cell research. Other members of Congress also seem to be falling back on their personal experiences with cancer and other diseases as reasons for supporting funding legislation.

With the fond memory of former President Ronald Reagan and his long struggle against Alzheimer’s disease still fresh in the public mind, Nancy Reagan wrote a private letter to Sen. Orrin Hatch, R-Utah, urging the Senate to pass a bill in spite of President Bush’s threatened veto, according to an Associated Press report.


Milloy concludes: Moreover, the lack of federal funding doesn’t in any way impede research progress as privately-funded and foreign researchers are free to conduct whatever research they please on embryonic stem cells.

That freedom, however, has produced no results. What good can come from federal funding of futility?


IPBiz expected Milloy to make a comment about how none of Hwang Woo-Suk's scientific peers questioned Hwang's work. The virtually complete acceptance of Hwang's work stands in stark contrast to the situation with Jan-Hendrik Schon, wherein a lot of peers were questioning the work PRIOR TO the Beasley report. With Hwang, US counterparts were lining up to obtain Hwang's (fake) stem cell lines.

II. CaliforniaStemCellReport on political squabbling within CIRM

The rather unimaginative and wooden approach to intellectual property in the April 27 meeting was a bad sign for CIRM. Posts on californiastemcellreport on May 31 about internecine squabbling at CIRM are a further bad sign: "Dualing" Execs at CIRM: Touchy Issues Between Klein and Hall [The fundamental problem, however, is not going to go away easily, as more than one Oversight Committee remarked. ] and CIRM Travel Comments [Hall: My understanding is that all out-of-state travel and out-of-the-country travel requires my approval. Pomeroy: "I have to get approval every time I travel." Pizzo: "Well, that's why I left the NIH actually, to be honest with you."]

File these comments under "It's bound to scare you boy."

I hope New Jersey State Senate President Codey is paying attention.

New Jersey bond issue for stem cell research is on hold

Tucked away on page 29 of the May 25, 2006 issue of the Newark Star-Ledger is an article "Codey says budget concerns to delay stem cell bond issue," which announces that both the $325 million package to fund scientific studies on stem cells AND the $250 million to build stem cell research centers (in New Brunswick, Newark, and Camden) will not appear on the ballot until November 2007 at the earliest. Ironically, Senate President Codey's announcement on May 24, 2006 (at the W.M. Keck Center for Collaborative Neuroscience in Piscataway) came while Governor Jon Corzine was in Asia, pitching New Jersey as a center for stem cell research.

Neither funding package ever passed the New Jersey Assembly. Reports to the contrary in several media outlets are incorrect.

The Star-Ledger article is authored by Stuart Margolin.

Re-exam of claims of cord blood patent; another reexam/litigation combo

Biotech company ViaCell, Inc. said May 30, 2006 that the U.S. Patent and Trademark Office [USPTO], has rejected, based on prior art, two patent claims of PharmaStem Therapeutics, Inc. relating to certain aspects of collection, cryopreservation, storage and use of hematopoietic stem cells from umbilical cord blood.

PharmaStem had filed patent infringement actions against Cambridge, Massachusetts-based ViaCell. A district court judge had overturned a jury verdict against ViaCell. PharmaStem, founded in 1985 as Biocyte Corp., appealed the decision and the U.S. Court of Appeals for the Federal Circuit heard oral argument in the appeal on April 4, 2006. In 2003, the European Patent Office revoked all the PharmaStem patent claims.

"We believe the PTO's actions support our position that the patents are invalid based on prior art," said Anne Marie Cook, General Counsel and Senior Vice President, Business and Corporate Development of ViaCell.

Themes discussed by CIRM's IP group are old chesnuts

The patent pool idea, mentioned in the April 27, 2006 meeting of CIRM's IP group, has been discussed for a while. For example, Merrill Goozner discussed a version in his article "Prizing Stem Cell Research." However, one notes that Goozner's main idea, a prize for successful stem cell treatments, was not mentioned at the April 27 meeting. One also notes that the story of Jeanne Loring and WARF/Geron is mentioned by Goozner, although by reference to an article in Nature in May 2005, rather than to the article in Science in March 2006 (and the op-ed by Jennifer Washburn in the LA Times) which made their way into the CIRM transcript; this one story is being recycled.

The idea that the Bayh-Dole Act encourages patenting of basic research discoveries has been around for a while. Keep in mind that the patent at issue in the Metabolite v. Lab Corp case was generated by three university professors, not by workers in private industry. The patent at issue in Ariad v. Lilly was generated by university professors. The patent rights surrounding "Dolly the Sheep," created by research by government workers, ended up in private hands (Geron and ACT) and produced, among other things, a fierce patent interference.

Excerpts from Merrill Goozner, Prizing Stem Cell Research,

This slowdown in [pharmaceutical] innovation has led many observers to begin questioning some of the assumptions behind the current U.S. medical innovation system. Specifically, they’ve focused on how research institutions handle the intellectual property generated by biomedical innovators, which is the foundation upon which the current pricing and innovation systems rest.

The current rules of the road were established in 1980 by the Bayh-Dole and Stephenson-Wydler technology transfer acts, which govern university-based and government-based researchers, respectively. (...) The new laws encouraged universities and federal labs to patent basic science discoveries with practical use and gave them the right to grant exclusive licenses to private firms. (...)

The stem cell field, which is still years away from its first approved therapy, is a perfect example of commercialization fever. While James Thomson of the University of Wisconsin was isolating and growing the first embryonic stem cells with funds from Geron Inc., other stem cell researchers, including many key backers of Proposition 71, had already launched start-ups firms to commercialize patented insights based on adult stem cell research funded by the federal government. For instance, senior researcher Irving Weissman, who runs Stanford University’s Institute for Cancer/Stem Cell Biology and Medicine, holds numerous patents in the field and has launched at least three firms in recent years – Systemix Inc., Celltrans Inc. and StemCell Inc. Douglas Melton of Harvard, whose children have Type I diabetes and has garnered numerous sympathetic press accounts for his research efforts, founded two biotech companies, including Curis Inc., which is specifically devoted to developing stem cell products. Lawrence Goldstein of the University of California at San Diego, a frequent spokesman in the Proposition 71 campaign, helped start Cytokinetics Inc.

Article about Loring in Nature on May 18, 2005

In May 2005, a controversial article in Nature drew attention to the emerging patent thicket problem in embryonic stem cell research. [Meredith Wadman, “Licensing fees slow advance of stem cells,” Nature, published online May 18, 2005 (http://www.nature.com/news/2005/050516/pf/435272a_pf.html)]. Jeanne Loring, an embryologist now at the Burnham Institute in La Jolla, California, claimed her start-up firm collapsed when it couldn’t get access to embryonic stem cells at a reasonable price from the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin’s technology transfer arm which owns the Geron-funded Thomson patents.

Patent pool recommended

CIRM can become the catalyst for cutting through this patent thicket. It can require that all of its grant recipients agree to donate the exclusive license to any insights, materials and technologies they patent with state funding to a common patent pool administered by a third party outside CIRM. [The article cites Ted J. Ebersole, J.D., Ph.D., Robert W. Edmond, J.D., Ph.D. and Robert A. Schwartzman, Ph.D., “Stem Cells – Patent Pools to the Rescue?” Sterne Kessler Goldstein & Fox, p. 1, available at http://www.skgf.com. IPBiz: the article may be found
here. The article does not explain why an entity in the position of WARF would want to participate in a pool. Recall that the Wright Brothers did not want to participate in a patent pool. The article also mentions issues with contamination of stem cell lines caused by use mouse feeder cells. One recalls that the restriction on federal funding by Bush in 2001 did NOT apply to ANY stem cell line in existence at the time of the restriction.]

Holding of Merck v. Integra misstated

Their concerns were driven by a recent court decisions (Madey v Duke University and Integra LifeSciences I, Ltd. v Merck KGaA) that, in the former case, limited universities’ royalties research exemption but, in the latter case, gave that exemption to pharmaceutical firms when developing new drug applications for the FDA. [IPBiz: Merck v. Integra indicates that the research exemption of 35 USC 271(e)(1) is available to ANY entity doing research reasonably related to obtaining federal approval, including INDs from the FDA]

Conclusion

Combining a patent pool, an open-source model of IP development and a shared prize system for developing stem cell therapies, the California state stem cell program can pave the way for a new medical innovation system for the 21st century, one that can generate cures for terrible diseases at prices that are affordable for all.



[IPBiz post 1615]

Tuesday, May 30, 2006

How does eBay v. MercExchange impact patent reform efforts?

Of the impact of eBay v. MercExchange on patent reform, recall that BusinessWeek said:

And the opinion likely will take the wind out of efforts in Congress to reform a system that's granting patents on processes that are already in wide use or techniques so simplistic that avoiding infringement is nearly impossible.

The Los Angeles Times took a different tact on May 17:

The patent office is second-guessing itself on some MercExchange
patents as well, which points to a fundamental problem that the Supreme Court
didn't address. The system yields too many bad patents, particularly when
business methods are concerned. Proposals that would significantly strengthen
the process have been bottled up in Congress. Now that the Supreme Court has
started fixing the patent morass, lawmakers need to finish the job.


IPBiz notes: the fact that different industries have taken divergent positions on the permanent injunction issue did not change with the Supreme Court's eBay decision. The different industries will still lobby Congress, so it is naive to expect Congress to come down hard, one way or another, on the permanent injunction issue. BusinessWeek has the better sense of the matter, in that the Supreme Court decision may be perceived as having defused the issue, so that there will be LESS PRESSURE on Congress to take a strong position or "to finish the job." The irony of course is that the Supreme Court cut out the legs for the district court's rationale for NOT granting an injunction, so the district court will have a harder time denying the injunction this time around. If the injunction is granted, to a patentee perceived by many to be a troll, then the net effect of this particular case will be to maintain the strong position of patentee as to permanent injunctions. Nevertheless, by throwing out the "grant injunction absent exceptional circumstances" rule, the Supreme Court may have created uncertainty which encourages litigation, even though most outcomes will be the same (injunction granted).


The Observer had written: Patent litigation has become the continuation of
commercial rivalry by other means.

IPBiz adds: Patent reform has become the continuation of commercial rivalry by other means.

IPBiz further adds: Writing amicus briefs to the Supreme Court has become the continuation of commercial rivalry by other means.

The Recorder on IP boutiques: business is booming

The Recorder: Two years ago, Palm Inc. General Counsel Mary Doyle spent 20 hours combing the Web for patent lawyers. Her target was the smallest of IP boutiques, with no more than three to six lawyers. Today, they are no easier to find.

"They don't get a lot of attention, yet they are the bread and butter of our patent prosecution strategy," she said.

While some of these mini-boutiques are so small they don't even have an online presence, what they have to offer is irresistible to GCs constrained by tight budgets: a highly specialized legal expertise, familiarity with the industry and cost competitiveness.


One sees that (applications/dollar) is a key factor:

"Like most [Silicon] Valley companies, we look for exceptional quality at a good price," Doyle said. "We're looking to file as many patent applications as we can for our investment dollar. In our experience, big firms can't consistently compete on price in this area."

One sees that the lawyer's hourly rate is also a factor:

"At Skjerven as a senior partner I would make 50 percent of my billings," Brian Ogonowsky said. "Here [Patent Law Group] I make 75 percent, so I make a lot more money, and I don't work as hard."

Part of the micro-boutique strategy is to pass the cost savings onto the client. The Patent Law Group's four lawyers, all senior-level, charge between $250 and $340 an hour.

"I have more than 20 years of experience," Ogonowsky said. "I would be billing $500 per hour at a large firm."

Are good patent attorneys scarce?

While IP boutiques are quite happy to exist in their little niche, they do acknowledge one major threat from the bigger firms: the ability to recruit seasoned attorneys.

"With patent law you can't just be a good lawyer. You need to have a good technology background, so it's hard to find lawyers with good tech backgrounds," said Magen.

Further analysis of eBay v. MercExchange: the trial lawyers won

Kieff and Wagner on eBay v. MercExchange: Unfortunately, besides flagging the two outer limits -- no "general rule" in favor of injunctions nor any "broad swath of cases" exempt from them -- the court said little other than the four-factor general test for injunctions should be applied. The effect of this watershed case on innovation turns on how close the courts avoid "writing on an entirely clean slate" by adhering to the status quo.

They discuss the 1908 Continental Paper case: Even when a patentee is not looking for a deal, the infringer can still offer him one too attractive to pass up. This presumably motivated the court to reject exceptions based on a patentee's "willingness to license" or "lack of commercial activity" and to affirm the century-old Continental Bag decision that a patentee need not practice the patented invention. As the court noted: "Some patent holders, such as university researchers or self-made inventors, might reasonably prefer to license their patents, rather than undertake efforts to secure the financing necessary to bring their works to market themselves."

They conclude: In the end, who won? It may be too soon to tell. To the extent we've entered a new uncertain domain ruled by an all-things-considered analysis in each case, the trial lawyers win. To the extent the present practice is an acceptable general tendency to issue injunctions -- though short of a "general rule" -- innovation wins.

There is a reference to the patent quality issue: It would be ironic and harmful to let fears about the weakest patents prevent injunctions for those shown to be the strongest. If we think the possibility of invalid patents is so great that all seem tarnished, the culprit is the institutional problem of policing bad patents. And a direct attack on these problems is far likelier to yield gains. Why not weaken or abandon the judicial presumption of validity and publish patents soon after filing?

*****

Of Kieff, see also THE CASE FOR REGISTERING PATENTS AND THE LAW AND ECONOMICS OF PRESENT PATENT-OBTAINING RULES

Rejection of some claims in re-exam of Forgent's US 4,698,672

According to IDG, The U.S. Patent and Trademark Office has rejected 19 of the 47 claims in US patent 4,698,672 held by Forgent Networks, which the company has been using to assert licensing rights related to the JPEG digital image standard. The request for re-exam was by the Public Patent Foundation.

This is an ex parte re-exam under 37 CFR 37 CFR 1.550(f), which is number 90/007,808, filed 11/21/2005. Claims 1,3,6,8, 11-13, 15, 25, 27, 30, 32, 35, 36, 38, 39, 41, 42, and 44 were rejected in the NON-FINAL Office Action.

Nineteen of the claims were rejected as anticipated under 35 USC 102(b) over Tescher, US 4,541,012, which disclosed a video bandwidth reduction system.

Specifically, US 4,541,012, entitled Video bandwidth reduction system employing interframe block differencing and transform domain coding issued 10 Sept 1985. It has been cited by 83 US patents, most recently by 7,020,204. It was NOT CITED by the 4,698,672 patent although it was cited in US 4,691,329, issued September 1, 1987. It was also cited in US 4,694,336 and US 4,700,226.

[IPBiz post 1611]

Sunday, May 28, 2006

Financial Times on eBay v. MercExchange

FT quotes Bruce Sewell, general counsel of Intel: "There will now be a greater
willingness to take cases to trial
. . . (since) if you lose a case there is a
potential you can compensate the plaintiff in dollars rather than having your
whole company shut down."

Does something WITH water inherently arise from something WITHOUT water?

Patently-O noted of SKB v. Apotex on paroxetine: the CAFC reversed that particular decision — finding that the patent was inherently anticipated because PHC hemihydrate “inevitably results from production of” PHC anhydrate.

Patently-O had noted earlier: In concurrence, Judge Gajarsa found that the manufacture of PHC hemihydrate could be "a natural physical process" occurring "under normal climactic conditions and with no human intervention," and thus found that it was an unpatentable process of nature.

In my article entitled Imagine: No More Indecision In Intellectual Property Cases (Intellectual Property Today, August 2005 at page 7), I had written:

As noted above, Ulysses S. Grant said that if he were wrong in his
decision, he could do the other thing. In the paroxetine case (SmithKline
Beecham v. Apotex, 403 F.3d 1328 (CAFC 2005)), there have been a number of false
starts.n11 One reader questioned whether the April, 2005 decision really altered
the law of inherent anticipation, on the basis that it was "inevitable" that
paroxetine anhydrate will form the hemihydrate. Although the various judges in
the case got bound up in the vanishing polymorph (Vonnegut ice-9) issue
presented, one notes the simple chemical reality that an anhydrate contains no water
and a hemihydrate contains water (i.e., this is more than a polymorph issue).
It is not inevitable that an anhydrate will convert to a hemihydrate. If the
anhydrate is kept away from water, it will never form the hemihydrate.
One of ordinary skill knows how to keep things away from water (e.g.,
maintaining anhydrous ferric trichloride purple, protecting alkali metals, using
titanium tetrachloride). While it may be "natural" for an anhydrate to form a
hemihydrate in the presence of water (driven by the thermodynamics of
hydration), it is not inevitable,n12 and, in the absence of water, the
conversion won't happen at all. Presumably, the word "natural" was a
proxy for "water-containing environment." The idea of "inevitability" may now
require elucidation of conditions.

Endnote 12 stated: All thermodynamically-allowed results do not happen at standard
conditions. Thus, no one is worried that diamonds will convert to
graphite, the thermodynamically stable form of carbon at STP.

**Separately, of the current discussion about embryonic stem cell patents involving CIRM and WARF, the article in the August 2005 IPT also noted:

In discussing the absence of the common law research exception from
both the Merck decision and the current patent law reform bill (H.R. 2795),
Joshua Sarnoff and Janice Mueller blamed a lack of vigorous advocacy by the
parties with the greatest interest, academic and research institutions.n13
However, one notes that the only amicus brief filed in the Merck case (by WARF) was
in favor of the patentee (Integra), not in favor of the "researcher" (Merck)

-->Curiously, the proponents of CIRM have not yet discussed research exceptions to patent law.

Pertinent stuff in recent issues of Science

Fullerene nanotubes made the cover of the May 19, 2006 issue of Science. See 312 Science 1003 on carbon nanotubes as high flux membranes.

See 312 Science 982 on Science's take on peer to patent. "PTO wants top experts." The article discusses how prior art suggestions will be ranked a la Amazon. I have discussed elsewhere how Amazon.com "ranked" reviews of Tom Carhart's book on Custer and Lee at Gettysburg. If that is the model "peer to patent" seeks to emulate, we really don't need peer to patent.

312 Science 987 talks about the nine justices in eBay v MercExchange. Will Science be surprised when MercExchange gets its permanent injunction?

312 Science 987 also mentions that China's DSP chip was a hoax. There is text about serious falsification and deception in the work of Chen Jin.

Patents are extremely important, except the ones we do not like

The transcript of the April 27 meeting of the IP Task Force of California's CIRM is available, and contains the memorable line: "patents are extremely important, but except the ones we don't like." [see page 114] Although the meeting was an attempt to define an intellectual property policy for CIRM's grants, there is little discussion of intellectual property issues, and on page 114 one has the observation that it "might be useful to hear from intellectual property lawyers on this issue."

The topic of patent pools came up, and it was presented as a viable option, with examples of the aviation industry, sewing machines, and electronics. [pages 15, 22] There was a conclusion about the U.S. aviation patent pool in World War I: "and that's what led to fighter planes being built for World War I." Sorry, but there weren't any US built fighter planes used in World War I. The patent pool agreement was drafted by Benton Crisp, the attorney Henry Ford provided to Glenn Curtiss. There was only one Wright around at the time, because Wilbur had died from eating tainted seafood in Boston on a visit related to the ongoing patent litigations. Orville sold out his interests, and later there was a merger between the (former) Wright interests and those of Curtiss.

One does not find any significant discussion of intellectual property until page 104 of the 125 page report. At that point, Duane Roth points out it is absolutely necessary, extraordinarily complicated, and very, very expensive. Of potential royalties, Roth warns at page 106: "a hundred percent of nothing is nothing."

At page 119 Jeanne Loring ut in a plug for her article in the March 24, 2006 issue of Science, and at page 120 there is mention of the article by Jennifer Washburn in the Los Angeles Times.

In the entire 125 pages, there is no mention of research exemptions in patent law, including that of 35 USC 271(e)(1) as articulated in the recent Supreme Court case of Merck v. Integra.

It is hard to understand how CIRM will implement a policy on intellectual property without understanding the law of intellectual property.

In a post titled WARF: Onerous and Outrageous, californiastemcell report presents various quotes from the April 27 transcript. Of WARF, there is the text:

"For private institutions, I think it is a big disincentive because what WARF does is it looks at the size of the institution or the company that wants to license this product and wants to charge an upfront payment, which is very steep in any licensing terms, and then, of course, royalties obligations which are twofold. one, a direct royalty obligation which depends on products directly produced using stem cells, human embryonic or primate embryonic stem cells, but they also have a reach-through royalty clause where they say anything you've invented remotely by using human embryonic stem cells will now have a royalty obligation back to WARF. So, for instance, even if you had a treatment that was somehow brought to the market that has touched an embryonic stem cell in the United States, you will have to pay a royalty back to WARF. I think this is particularly onerous...."

**Returning to the quote in post title, see also an article in
Drug Discovery News Basically, a "good" patent is one you enforce against others, while a "bad" patent is one that is enforced against you.

Saturday, May 27, 2006

MercExchange still getting its permanent injunction?

In the discussion over eBay v. MercExchange, not much is said about the text in the district court decision: As expected, each party argues that the balance of the hardships tips in their favor. Upon review of the record and factors listed above, the
court is of the opinion that the balance tips slightly in the defendants' favor.

[See an earlier post on IPBiz providing relevant text from both the district court and CAFC decisions.]

Given that the Supreme Court criticized the 4-factor analysis made by the district court (including a favorable citation by the Supreme Court to Continental Paper to criticize the district court's weighing of the "not practicing the invention" issue), IPBiz thinks it likely that MercExchange will get its permanent injunction directly from the district court on remand.

Thursday, May 25, 2006

More WARF/CIRM smoke over stem cell patents

Californiastemcellreport identifies the latest installment of the WARF/CIRM patent controversy, reported by Joe Vanden Plas in Wisconsin Technology Network. Of a statement by FTCR of the relevance of eBay v. MercExchange to the brewing WARF/CIRM patent impasse:

Andrew Cohn, government and public relations manager for WARF, said the ruling clearly does not apply to universities and characterized the foundation's [FTCR's] claims are "much ado about nothing."

"If they actually read the decision, they would see the specific mention of how this doesn't apply to universities because they clearly aren't going to be the ones who are going to commercialize the invention," Cohn said. "This decision will have absolutely no impact on our patent whatsoever."


IPBiz would not go as far as saying "no" impact. The Thomas opinion did not say "doesn't apply to universities." The Thomas opinion did say:

But traditional equitable principles do not permit such broad
classifications. For example, some patent holders, such as university researchers or self-made inventors, might reasonably prefer to license their patents, rather than undertake efforts to secure the financing necessary to bring their
works to market themselves. Such patent holders may be able to satisfy the
traditional four-factor test, and we see no basis for categorically denying them
the opportunity to do so.


In theory, WARF might be able to enjoin CIRM. Hard to predict the balance of factors when one public entity is suing another public entity, related to research efforts each funded by taxpayers wherein the infringer is going to have to meet FDA requirements. IPBiz still says "Merck v. Integra" and "Florida Prepaid Postsecondary". If Merck v. Integra rules WARF v. CIRM, then infringement is excused and the issue of injunction is never reached. If Florida Prepaid Postsecondary rules WARF v. CIRM, IPBiz doesn't like WARF's odds in a California state court.

Other text in the vanden plas article:

WARF has consistently rejected claims that its patents limit research, and recently noted that it has distributed stem cells to 350 academic researchers, and has entered into license agreements with 12 private research labs. Cohn reiterated that position in the wake of the FTCR's statement on the eBay ruling. "These folks are absolutely going off the deep end," Cohn said. "If it wasn't for WiCell and for the University of Wisconsin, they wouldn't have anything to spend the $3 billion on in the first place."

Don't you just love it?

Los Angeles Times the next Stanford Law Review?

A May 17 editorial in the Los Angeles Times had some sad errors concerning the case eBay v. MercExchange. Look here.

Copyright infringement asserted against Ludacris

Rap star Ludacris testified May 25 at a copyright infringement trial in SDNY that he never heard an expression (straight like that) that he allegedly swiped to create his 2003 hit "Stand Up." Ludacris, whose real name is Chris Bridges, also said he never received copies of a disk containing the song "Straight Like That" by the East Orange, N.J., group I.O.F.

Ludacris co-wrote "Stand Up" with Kanye West, who was also in court Thursday and expected to testify before the one-week trial ends.


"Straight Like That" never made it beyond some play time on college radio after copies of it were released in September 2001. [internet?] "Stand Up" was released in the fall of 2003 on Ludacris' album "Chicken and Beer," and became a huge hit.

Do patents tend to harm inventors?--part 3

In the abstract of the Bessen working paper, we have the text: The natural experiment that occurred when patent protection was extended to software in the 1980's provides a test of this model. Standard arguments would predict R&D intensity should have increased... Consistent with our model, however, these increases did not occur.

As pointed out earlier, patent protection was NOT extended to software in the 1980's so there is NO TEST OF THE BESSEN MODEL. Further, given that there was no new development opening up the "patenting of software" in the 1980's, then standard [static] arguments might predict a stagnant period of R&D spending, exactly the outcome Bessen found. Of course, the assertion that the [perceived] presence (or absence) of patent protection CAUSES an effect in R&D spending might be questioned.

Bessen's "dynamic" model [in a dynamic industry patents may reduce overall innovation] is just a model, and is not suggested by, or consistent with, the experimental "data" of the paper. The separate claim, that imitation promotes innovation, was merely a conclusory assertion to begin with.

Bessen stated a firm may be better off if other firms imitate it and compete with it. This is not at all how the Wright Brothers viewed the imitative activities of Glenn Curtiss. This is not how pharmaceutical companies view the world.

**
Noting that Bessen relied on the software patents/stagnant R&D correlation to "prove" his dynamic model, I observe that Mike at Techdirt wrote:

In the paper I read, the software patents issue is a minor side point. What the paper discusses is a model that shows why, in situations where innovation is
an ongoing process, the inventor can be harmed by patents. The discussion
of software patents is in no way the *basis* of the argument in the paper,
but rather a way to illustrate what is being discussed.


Mike also wrote:

The issue of the patents harming or helping the inventor is part of the
issue of the incentives behind patents.


Now, here is the "Where's Waldo" inquiry. Where in the Bessen working paper did Bessen state that patents harmed the inventor?

Recall, back in the first IPBiz post on the topic, we noted the text on techdirt:

David Levine points us to a new peer reviewed paper on "sequential innovation", which looks into this very issue and finds that, since innovation is such an ongoing process, patents tend to harm inventors more than help them.

Did Bessen, in the 1999 non-peer reviewed working paper, actually write "patents tend to harm inventors more than help them"?

**UPDATE**

Mike observed that the Bessen paper states:

"Indeed, society and even inventors themselves may be better off
without such protection. Furthermore, an inventor's prospective profit
may actually be enhanced by competition and imitation."


Mike continued: That certainly seems to support the point we made. The rest of the
paper then sets up different models of innovation, showing under which ones
inventors are hurt more by patents, and which ones inventors are helped
more.

Wednesday, May 24, 2006

Prior art: you come and go

What a surprise! On May 23, the article How did Woo Suk Hwang trick the scientific world about stem cells arose from the Google Dead. You come and go. Or is this the smile on the Cheshire Cat? Forgetting about the "rank" in the search, one will find that the absolute identity of Google search results depends on "when" the search is done. Sometimes the article is there; sometimes it goes away, and sometimes it comes back. It adds a whole new dimension to "the dog ate my homework." And, I can't wait for this issue to be litigated in a patent case. Is it prior art if it was there (and indexed by Google) and then not there? Sort of like "what if" the librarian at the German university threw away the entry of the thesis in the card catalog so no one had a systematic way of finding the thesis.

In answer to a query about "software" patents

One IPBiz commenter asked why patents to Microsoft, Google, Sun, etc. are not patents on the software.

Over the years, IPBiz has been posting representative claims of some patents granted (and applied for) of these software companies. For example, on 3 November 2005, IPBiz posted the first claim of published application 20050240580 to Google:

A method of personalizing placed content, comprising: determining an interest of a user; accessing a user profile associated with the user; identifying a set of placed content that matches the interest of the user; and ordering the set of placed content in accordance with the user profile.

This is not a claim to software for a search engine. This is not a claim to software of an operating system. It is a claim to a business method.

This type of patent claim was not common in the 1980's. There were no patent legal cases in the 1980's that magically opened up this type of claim. The one thing that was true in Bessen's paper, referenced obliquely by Mike at Techdirt, is that Microsoft itself was not filing a lot of such claims even by 1995 (much less in the 1980's), although in the last five years Microsoft has been filing a lot of such claims. The paper relied upon by Mike, in getting the law and the timeline wrong, provides no support for the proposition that inventors are better off in a world without patents.

Just mindlessly citing a paper, without reviewing the contents, should not be done for "working" papers in economics or for law review articles (e.g, on patent grant rate: the citations to a 97% patent grant rate in the legal literature, long after the original authors modified the number).

[IPBiz post 1600]

Tuesday, May 23, 2006

More on "software" patents.

In discussing "software" patents, one has to have a definition. One can't have a patent on an operating system, or a programming language. One can obtain copyright protection. Ask Apple about that issue.

People do talk about "software" patents. Shane Glynn wrote Rationalizing Software Patents: Suggestions for a Livable System which appears in 28 Hastings Comm. & Ent. L.J. 287 (Winter 2006).

Shane began:

In October 2004, a federal jury found that Sun Microsystems' Java
programming language violated a patent owned by the Eastman Kodak Corporation. n1
This decision was notable for two reasons: first, it was a high-profile
patent case between large corporations that involved a potential
billion-dollar damages award n2 and second, this case involved a software patent, a new and relatively controversial form of intellectual property.

Shane noted it was a METHOD patent:

The patent covered a method by which one computer program can "ask for help" from another program.

This is in the realm of what others call a business method patent.

Shane discussed some history, including the Benson case:

The Supreme Court has, until relatively recently, been skeptical of
claims involving software or computer algorithms. Benson was one of the first
Supreme Court cases that dealt with an attempt to patent a software algorithm.
n29 The respondents in Benson attempted to patent a computer algorithm used to
convert numbers from binary coded decimal (BCD) notation into pure binary
numbers. n30

Shane discussed Diamond v. Diehr:

Justices Stevens [IPBiz: part of the concurring Kennedy opinion in eBay], Brennan, Marhsall, and Blackmun disputed this conclusion. They argued in dissent that the claims at issue were not a process but a computer algorithm for measuring cure time, similar to the algorithm for calculating "alarm limits" rejected in Flook as nonstatutory under section 101. (...) Diehr did not hold that software was
patentable subject matter, only that the inclusion of software in a process claim
was not fatal.

Of Alappat in 1993: Software patents, although not fully endorsed by
Alappat, were now one step closer to express validity under section 101.


[IPBiz post 1599]

Part of Wen Ho Lee case pending at US Supreme Court

In the "reporter privilege" case involving the Wen Ho Lee matter, Lee attorney Brian Sun told the Supreme Court in a recent letter to the clerk "that there have been recent settlement discussions with the government in the underlying case, that resolution of the entire case may be imminent, but that there is not yet a final agreement."

At issue is what First Amendment privilege journalists may have, if any, to reject subpoenas in civil lawsuits demanding they reveal their sources of reporting.

If if does move forward, the case could serve to clarify conflicting legal standards over how the press deals with sensitive information it obtains.

Among the reporters fighting the subpoenas is Pierre Thomas, who was CNN's justice correspondent in 1999.

Thomas reported extensively on the government probe of Lee, a onetime Energy Department scientist who worked at the federal nuclear research facility in Los Alamos, New Mexico.

Government officials, including then-Energy Secretary Bill Richardson, publicly named Lee as a target of a probe into the alleged theft of highly secret documents from the lab, and investigators suspected he was spying for China.

Lee was later cleared of espionage and nearly all the other serious charges.

After his release from prison, Lee sued the government under the Privacy Act, alleging officials leaked false and incriminating information to several reporters, including Thomas, who now works at ABC News.

Thomas and four other reporters were subpoenaed in 2002, and a federal district court ordered them to testify or face contempt charges.

***
There were issues of confidentiality of information.

Monday, May 22, 2006

The 100th anniversary of issuance of Wright Brothers patent

AP reports: The Wright brothers made history on a smaller scale 100 years ago Monday.

The Dayton natives were granted U.S. Patent No. 821,393 for their flying machine, a moment not as significant as the first flight but important for Orville and Wilbur nonetheless, historians say.

"The patent's very important in their story," said Ann Honious, chief of education and resource management for the Dayton Aviation Heritage National Historical Park. "I think it was a step that was needed for the Wright brothers to market the airplane."

Henry Toulmin, an attorney in nearby Springfield, crafted a loophole-free description of the Wrights' method for controlling a flying machine.

Toulmin based the patent on the brothers' 1902 Glider rather than the powered - and now famous - 1903 Wright Flyer.

"What the Wright brothers wanted to do was patent their airplane. What Toulmin did was patent the control system," said Tom Crouch, a Wright brothers' biographer and senior curator of aeronautics at the Smithsonian Institution's National Air and Space Museum.

Tony Sculimbrene, executive director of the Dayton-based Aviation Heritage Foundation, said his group plans to observe the patent centennial later this year.


There are a few difficulties with the AP coverage.

#1. The application leading to U.S. Patent No. 821,393 was filed BEFORE the powered flight of December 1903 and BEFORE the Wright Brothers had met Toulmin.

#2. Toulmin came on board in January 1904, in large part because of the possibility of a patent interference.

#3. The claims of the patent are to three-dimensional control of an aircraft, unrelated to the craft's being powered (or not). Toulmin tried to include claims to a powered craft and got a new matter rejection.

#4. The Wrights were happy with Toulmin's work, and he remained their patent attorney for a long time.

#5. Although the Wright Brothers won their patent litigations, all aviation patents were pooled around World War I, and the Wrights did not obtain anywhere near the amount of money they had been seeking in royalties.

#6. Glenn Curtiss, supported by Benton Crisp (the attorney who had worked for Henry Ford)was planning a large attack on the Wright patent, which became irrelevant after the patent pooling.

Journal Science discusses Ariad v. Lilly

In May [312 Science 827 (12 May 2006)] the journal Science discussed the jury verdict in the Ariad v. Lilly case, concering NF-kB, a prolific transcription factor.

Also mentioned in the issue was the Cornyn/Lieberman bill which would require federally funded scientists make their accepted papers freely available online within 6 months after publication [312 Science 828]. Hmmm, IPBiz wonders if published patent applications count?

Journal Science mentions Stojkovic/Murdoch work

In an article "Picking up the pieces after Hwang," the journal Science [312 Science 516 (28 April 2006)] mentions the Newcastle work of Miodrag Stojkovic and Alison Murdoch as being the remaining unchallenged paper asserting SCNT human cloning (now that both Hwang's papers are retracted.) The Newcastle workers did not create a cell line from the SCNT blastocyst.

The April paper quotes Ian Wilmut: "necessary to spend some time unlearning some things we thought we had learned from Hwang's research."

Lorenz Studer, who had received a Hwang "cell line," hopes research groups will behave like informal collaborators rather than rivals. Well, if the Schatten/Hwang patent application saga is any guide, IPBiz wouldn't bet on that happening.

In an earlier article in Science [312 Science 366 (21 April 2006)] entitled "Ethics Issues in Stem Cell Research," the ISCF had noted that conditions for egg donation for IVF should be distinguished from conditions for egg donation for research. This is counter to the thinking of some American researchers.

The attitude of "peers" in peer to patent

In dealing with Mike's vociferous assertions that the patent system harms inventors (see IPBiz), I noticed a similarity to future issues in peer to patent. Every member of the public in peer to patent who comes up with prior art is apt to be certain that the prior art should deny the patent applicant a patent, just as Mike is certain that Bessen's paper proves that the patent system harms inventors.

In the reality of peer to patent, it is the examiner who evaluates prior art, obtained both from the USPTO search and from the public ("peers"). The peer to patent project places the examiner in an odd middle ground: if he denies an application, he will have to fend off challenges from the patent applicant (the prior art does not mandate claim rejection) but if allows the application, he will have to fend off challenges from the peer (the prior art does mandate claim rejection).

In asserting the goodness of prior art, the peer may resort to some of the claims Mike did (it's new, it's peer reviewed, it's been ignored), when in fact it's none of those. The peer will likely want to know why it doesn't invalidate. The examiner may be placed in the position of doing two examinations, one on the application and one on the relevance/"validity" of the prior art from the peer (because he is likely to be second-guessed).

If the examiner were given extra time to do all this, it might not be a bad thing for examination quality. If it's the same old, same old, then there won't be enough time to take advantage of "peer review."

There were some suggestions that peer to patent would streamline patent examination. It is far more likely that peer to patent will slow it down. All peer to patent does is give the examiner access to prior art identified by the public. Whether this is better or worse than that found in database searching remains to be seen. The examiner still does the examination, so "peer to patent" is not peer review. In the end, it will take more time.


From a post on July 14, 2005:

Web Could Unclog Patent Backlog
Wired
July 14 2005
Beth Noveck, director of New York Law School's Institute for Information Law and Policy, has introduced a proposal designed to streamline and improve the U.S. patent process, which many legal and scientific experts believe needs all the help it can get. Examiners at the U.S. Patent and Trademark Office are overwhelmed by a backlog of half a million cases; lawmakers are considering the Patent Reform Act of 2005, which would attempt to rein in patent litigation. Noveck's plan advocates the use of social software to allow experts in various fields to decide an application's fate en masse via a rating system not unlike that of eBay. To encourage adoption of such a system, Noveck suggests that inventors who submit their work for peer review should be eligible for a 20-year patent, while those who opt to use the existing system would be granted patents for just five years. Called Peer to Patent, Noveck's idea is an intriguing one — although it has garnered mixed reviews from patent experts.

Do patents tend to harm inventors? Part 2.

Mike at Techdirt is still writing me about my post on IPBiz about his claiming: patents tend to harm inventors more than help them. After I showed, contrary to his statements, that the Bessen article was not new, peer-reviewed, or ignored in the patent community, he replied:

I don't care about whether it's new or whether it's peer reviewed. I care about what's in the paper -- and in this case, it's a detailed explanation of how innovation can often be much greater in a world without patents.

Well, Mike, the Bessen paper is based only on comments about technology in software, semiconductors, computers, and the paper is based on a completely FALSE PREMISE that patent protection was extended to software in the 1980's. Patent protection has never been extended to software. [point elaborated below] Needless to say, the Bessen paper had no citation whatsoever for the proposition that patent protection was extended to software in the 1980's. The issue of business method patents, which is a different topic, did not come up until the State Street case in the late 1990's, but Bessen's empirical data showing no increase in research funding is for a time period before State Street. Thus, "what's in the paper" is a false statement of the law, and an observation about research spending, changes in which could occur for any number of reasons. Thus, there is no detailed explanation of how innovation can often be much greater in a world without patents.

Bessen also said: Pure software companies have not applied for many patents. Bessen mentions that Microsoft had 39 software patents in 1995. Mike, check out IPBiz for what Microsoft is patenting these days. The Bessen paper is out-of-date as to this century.

Bessen concludes: Imitation invariably inhibits innovation in a static world. The assertion is not supported by the data he has. In the static world, the existence of a patent precludes direct imitation but invites designing around the patent. The concept of "design-around" patents is well-known, wherein the existence of an initial patent fosters innovative improvements which are based on the initial patent.


***from the previous IPBiz post-->

The text --patents tend to harm inventors more than help them-- appears in techdirt. Working through the maze of links, I'm still not sure "where" (or "if") the original peer-reviewed article is published. IPBiz assumes no responsibility for the gibberish in the statements below.

from techdirt:

However, there's another, related, point where the conversation often breaks down: the idea that innovation is an ongoing process, rather than a single event. Supporters of the current patent system seem to assume that innovation is a single event -- and that event needs to be protected with the patent. The reality, however, is that innovation is an ongoing process. That's why we've said in the past that the idea of a sustainable competitive advantage is a myth. Companies compete by a series of fleeting competitive advantages. That's what innovation is. Even if your competitors can copy you, you keep on innovating and keep the lead in your market. The claims from strong patent system supporters always comes back to the idea that, without patent protection, others would just "steal" their idea. But, that's only true if the original innovator stops innovating and tries to rest on its laurels. That's not good for anyone -- but it's exactly what patents allow. In fact, there's increasing evidence of this exact problem with the patent system. David Levine points us to a new peer reviewed paper on "sequential innovation", which looks into this very issue and finds that, since innovation is such an ongoing process, patents tend to harm inventors more than help them. The report shows that if (as patent system supporters believe) innovation is a static event, then the patent system does make sense. However, since it's an ongoing process, patents tend to hurt more than help. In fact, they find that inventors tend to profit more without patent protection, but by focusing on the increased competition and the ongoing innovation. While they may not have been able to profit as much from the single event of invention, the increased innovation as an ongoing process means they end up profiting more in the long run by supplying increasingly better products to a growing market. Meanwhile, in cases where patent protection was increased, the research shows that investment in innovation actually decreased. This makes sense to us, but it's good to see it supported with research (which, if history is any guide, patent system supporters will ignore). However, it does help highlight how much of the disagreement may simply be due to a lack of understanding concerning the difference between the event of invention and the ongoing process of innovation.


It is false that --Supporters of the current patent system seem to assume that innovation is a single event--

It is false that --Even if your competitors can copy you, you keep on innovating and keep the lead in your market.-- Ask the Wright Brothers about that one. Without patent protection, Glenn Curtiss and friends would have eaten them alive. [Even with patent protection, the Wright Brothers did not fare well.]

**ALSO**

Stephen G. Kunin and Bradley D. Lytle wrote in 87 JPTOS 991 (Dec. 2005):

With that the Benson decision (in 1972) brought advancement of software patents to
a grinding halt. Following that, software programs were routinely dismissed as
mathematical algorithms that the United States Patent and Trademark Office (PTO)
refused to patent. Most software inventors either quit seeking patent
protection or disguised them as computer hardware
.

(...)

The Court in Diamond v. Diehr held that the only question was whether the patent claim as a whole was directed to an otherwise statutory process regardless of whether a mathematical algorithm was employed for performing a function (curing rubber) that the patent laws were designed to protect. If that's the case, as was the case in Diehr, then the claims satisfy 35 U.S.C. § 101 and are patentable subject matter.

[The mathematical algorithm at issue in Diamond v. Diehr was the use of the Arrhenius equation of chemistry directed to a method of curing rubber, and not what be considered a "software" patent or a business method patent. IPBiz doesn't think Microsoft, Oracle, and Sun are concerned with the use of chemical principles directed to chemical methods. Moreover, the use of a hundred year old piece of chemical knowledge hardly qualifies as a "software invention." ]


(...)

The next important case was decided 13 years later (1993), where, in In re
Alappat, n13 the Federal Circuit court ruled that a new and useful computer
software is patentable subject matter if it has a practical application that
produces a concrete, useful and tangible result.

***The State Street case was decided in 1998. Although I don't necessarily think that there weren't "business method" patents before State Street, I do think the State Street case highlighted to the public the potential patentability of such things. However, as to Bessen's contention, State Street was decided in 1998, not in the 1980's, and there wasn't any big push for "software patents" in the 1980's.

Sunday, May 21, 2006

Hwang saga: patents still a sore point

Ohmynews suggests that patent theft is still an issue in the stem cell saga: The other key point for Hwang's fans is their demand to "protect the patents," which they generally aim at Gerald Schatten, the University of Pittsburgh scientist who collaborated closely with Hwang. Schatten is said to be stealing the cloning technology developed in Hwang's lab.

Of relevance to CIRM's discussion about the protection offered by their standards, ohmynews also notes:

"Dr. Hwang [Woo-suk]'s work had never been done before," points out Dr. Lee Chang-kyu, an animal cloning expert who was named as a co-author of the discredited 2005 Science paper, though he took no direct role in the human work. "So, we were ahead of the regulations."

Lee is being either naive or a little disingenuous, because Korean civil society was quite vocal about the dangerous possibilities of genetic technology several years earlier. A formal Institutional Review Board system went into operation in 1995, mostly to cover clinical trials of pharmaceuticals. The Korean Bioethics Association issued a firm statement of concern about cloning in 1999, and called for formal government regulation; in response to the 2004 publication that brought Hwang global fame, it immediately complained, in a letter to Science, that the research should have been subject to more review, especially in light of the "Bioethics and Biosafety Act" that had recently been passed but had not yet gone into effect.


Of the egg donation issue:

For a while in 2005, it became quite impossible to express criticism. That space, however, is opening up again, and on all of the formerly active fronts. Korean Womenlink, an organization of 15,000 members, has taken the lead with the Korea Women's Association United (KWAU) coalition in suing on behalf of women who have fallen ill after supplying eggs.

Of the timescale issue:

The claim that Hwang's research is vital for the economic future of the nation has become the mantra of the "Hwang-ppa" or "Hwang fans." This is something of a change in emphasis: They used to focus on promises of cures. Nowadays, however, as a journalist said, "we are all experts on stem cells," and Hwang's supporters are as likely as anyone to suggest that cures are a long way off.

More on Supreme Court decision in eBay: uncertainty created?

Of the eBay case, PCAdvisor wrote:

The Supreme Court unanimously ruled against the US Court of Appeals for the Federal Circuit's practice of granting near-automatic injunctions in patent infringement cases. But it also ruled that a lower court had used flawed judgment when it refused to grant an injunction requested by patent holder MercExchange.

(...)

In the case, the US District Court for the Eastern District of Virginia had attempted to weigh four long-neglected factors in rejecting an injunction, but the Supreme Court, in a decision written by Justice Clarence Thomas, said the district court considered eBay's arguments against an injunction too broadly.

One notes that the factors are not long-neglected. When the CAFC reviewed the district court decision in MercExchange v. eBay, the CAFC did not say that using these factors was wrong. In fact, the CAFC went through each of the four factors as analyzed by the district court. The CAFC got into trouble for stating that an injunction should normally issue absent exceptional circumstances, an empirical position that got only three votes on the Supreme Court.

In February 2006, IPBiz posted text from both the district court and CAFC opinion in MercExchange v. eBay.

PCAdvisor continued:

The Supreme Court left patent lawyers with a confusing middle ground between the near-automatic injunctions and the district court's refusal to grant the injunction for the wrong reasons, said Erik Puknys, a patent lawyer in the office of the Finnegan, Henderson, Farabow, Garrett & Dunner law firm.

"[The decision] says what the wrong approach is," Puknys said. "The answer is somewhere in between."


IPBiz notes that a court saying "injunctions are near automatic" is now deemed a wrong approach. However, once "what are" and "what are not" appropriate factors are established, it may still be that "injunctions are near automatic," even if a court can no longer say that. Recall that the district court observed that this was a close case on the injunction issue. If one of the factors was misapplied (as even the Supreme Court suggests), then injunctions may, in most cases, issue.

One of the issues that troubled the district court was that MercExchange didn't make product. That may have been the telling factor in its decision. Although the Supreme Court ordered briefing on Continental Paper (which pertains to this issue), the Supreme Court did not speak to the issue of whether "not making product" is a legitimate factor weighing AGAINST patentee in the four-factor calculus. An opportunity missed.

PCAdvisor continued:

The Supreme Court action could eventually have a large impact on patent lawsuits, but it's too early to tell, Puknys added. "What the Supreme Court did, at least, is get rid of that [near-automatic injunction] threat," he said. "But it's replaced that with the threat of uncertainty."

The eBay case continues a string of Supreme Court decisions that leave significant major issues undecided.

Friday, May 19, 2006

Nomination of Kimberly Moore to CAFC

Both Patently-O and I/P Updates note that the nomination of Professor Kimberly Moore of George Mason University to the vacant seat (Clevenger) on the CAFC was sent to the Senate.

On March 23, 2006, Patently-O had mentioned a strong rumor that Kimberly Moore would be appointed.

Also on March 23, 2006, Peter Lattman at blogs.wsj had posted the following:

President Bush will nominate George Mason University law professor Kimberly Moore for a seat on the Federal Circuit court of appeals, according to the San Francisco Daily Journal (link unavailable). The Federal Circuit is the nation’s highest patent court. The news comes as a disappointment to intellectual property lawyers, says the DJ, many of whom had hoped Judge Ronald Whyte of the Northern District of California would get the nod. According to the DJ, Whyte is one of the most respected patent judges in Silicon Valley and was heavily supported by the Federal Circuit Bar Association, some of Silicon Valley’s largest companies and California senator Dianne Feinstein.

The story also points out that George Mason’s law school has deep ties to the Bush White House, and is apparently the only law school in the country with a chair endowed by the National Rifle Association.


Given the outcome, Lattman's post, in using the words "will nominate," seems to offer support for the idea that this decision was made in March 2006, right when the GMU basketball team was flying high in the NCAA.

Lattman's post also mentions the previous lobbying efforts on behalf of Judge Whyte. Brenda Sandburg had written on June 30, 2005:

At its annual meeting last weekend, the Federal Circuit Bar Association voted to support Whyte's nomination. And on Wednesday five Silicon Valley companies sent a letter to Sen. Dianne Feinstein, a member of the Senate Judiciary Committee, urging her to push for Whyte's appointment.

"Judge Whyte has honed his formidable judicial skills in the trenches resolving Silicon Valley high-tech disputes," said Edward Reines, a partner at Weil, Gotshal & Manges and newly elected vice president of the FCBA. "It is hard to envision a better judge to add to the Federal Circuit."

The Federal Circuit has never had a district judge among its ranks, which patent lawyers say is a shortcoming of the court. Such an addition would also be significant because the Federal Circuit has been criticized for failing to give deference to district judges in their patent decisions.


Mark Lemley, who is Kimberly Moore's co-author on Ending Abuse of Patent Continuations, was discussed in the June 2005 article:

A district judge "will be able to bring a more realistic view of how the Federal Circuit's legal rules will affect the practice of law," said Stanford Law School professor Mark Lemley. While some of the opinions the Federal Circuit has issued "seem perfectly reasonable in the abstract, in fact they create collateral consequences for litigators or trial courts that are unintended."

Harold Wegner is also mentioned in the June 2005 article:

"The No. 1 priority for the improvement of the Federal Circuit is to start with one and then get a stream of district court judges elevated to the court," said Harold Wegner, a partner at the Washington, D.C. office of Foley & Lardner. "Judge Whyte is superbly qualified and would be a tremendous boon for the system."

In the months between June 2005 and March 2006, something happened. One notes that Whyte is [USC Law] class of 1967, while Moore is [Georgetown Law] class of 1994, a difference of 27 years. Another factor might be geography; the June 2005 article mentioned:

Some members of the patent bar say Washington, D.C., insiders have often been appointed to the bench, while district judges have been overlooked. Judge Sharon Prost, the last appointee, had been chief counsel of the Senate Judiciary Committee. Judge Randall Rader also served as counsel to the Senate Judiciary Committee prior to his appointment, and Chief Judge Paul Michel was previously counsel and administrative assistant to Sen. Arlen Specter.

The citation in January 2006 by the USPTO to the Lemley/Moore BULR article in its notice of proposed rulemaking about continuing applications may have been a signpost on the road. The cite seemed anomalous for a number of reasons, one of which was the harsh treatment given in the Lemley/Moore BULR article to a paper in JPTOS by USPTO employee Robert Clarke, who was accused within the BULR article of making a mistake that Clarke never made. The Lemley/Moore BULR article then dismissed the conclusions of Clarke's JPTOS paper. Coincidentally, Clarke's paper had been motivated as response to a paper by Quillen and Webster, which appeared in the Federal Circuit Bar Journal, edited by Professor Moore. I emailed Professor Moore several times about the [false] statement in the BULR paper about Clarke, but got no response.

Long ago, someone did to me something that was directly analogous to what happened to Clarke. That is the prime motivation for my publishing papers in 86 JPTOS 568 (2004), 4 CHI-K. J. INTELL. PROP. 104 (2004), and 4 CHI.-KENT J. INTELL. PROP. 186 (2005). To this day, I have never met or spoken to Lemley, Moore, or Clarke.

As to patent law, the Whyte/Moore choice evokes Frost's The Road Not Taken. Best wishes to Professor Moore in her new arena.

Is "peer to patent" really "peer review"?

There are at least two different issues in determining how much "peer review" there is in peer to patent:

#1. What does it mean to have peer review of a patent?

#2. Is the peer to patent project actually about peer review?

Of the first, peer review, in the case of journals, involves a referee who has some knowledge in the field looking at a manuscript and determining that the conclusions presented are supported by the data, and that the data are acquired (and interpreted) in a scientifically acceptable way. If some relevant reference is missing, the referee will bring it up. It's a rare event when a journal referee says "all of this was done before" or "this is obvious in view of X." If peer review of patents were done in a way analogous to peer review of journals, this would be the approach. The question of "does it work?" [enablement] would be at the top, and "was it done before" [anticipation, obviousness?] would be at the bottom.

Of the second issue, the peer to patent project invites members of the public (experts in the field or not) to submit prior art for use by the Patent Office. The examiner takes the art and applies it to the claims. Because the examiner is doing the "review," it is not "peer" review. Because the role of the public is prior art (not enablement), it is not "peer review" as done in journals.

There is no harm in giving the examiner access to other sources of information. Whether it is effective depends on whether the prior art supplied by the public is MORE RELEVANT than what the examiner already has and on whether the examiner is going to be given sufficient time to review it.

In this, recall the absolute howling in the technical community about the Berkeley/Eolas patent that produced a re-examination ordered by USPTO Director Jon Dudas? Prior art presented by W3C, in the form of claim charts prepared by the well-known firm of Pennie & Edmonds, didn't even get to first base in the re-examination. In spite of all the complaints, Eolas/Berkeley won the re-examination and did not amend claims. If a well-articulated analysis such as this proved without merit, how frequently is John Q. Public going to hit a home run? Is the program cost-effective at the margins? Is the program going to change the world or is it merely a form of venting?

Back in February, I had brought up some OTHER issues with peer review of patents on techdirt:

http://www.techdirt.com/articles/20060207/0957257_F.shtml

I never did get a response.


***
A separate issue about the analysis of prior art by journals concerns what the journal does when there is a problem with the presence of prior art.

I had written

Wonder how Korea's Woo Suk Hwang pulled off one of the greatest scientific frauds of all time? The journals themselves bear some responsibility. First, they compete for the trendiest, cutting-edge research stories. Second, they tend to ignore conflicts-of-interest, as Science ignored the pending patent applications of Hwang and Schatten which existed at the time of article submission and which gave the authors a vested interest in seeing publicity of work which would financially benefit them. Third, once the article is on-board, the journals become stakeholders, very reluctant to accept criticism of an article published in their journal.

Of the third point, here's an excerpt from an article in Intellectual Property Today, titled "Zurko and the Optimization of Fact-finding: Who Can You Believe?," originally published in February 1999. (...)

see How did Woo Suk Hwang trick the scientific world about stem cells?

***

As important side point, one used to be able to find this article using a Google search of appropriate key words. As of May 19, 2006, this article cannot be found using Google. I don't mean it's on page 300 in a set of 10,000,000 results. I mean it's NOT FOUND AT ALL. It's not there now, but it was there in the past. As Boy George (Lieutenant Lush) said: You come and go.

Google can configure its search engine as it wants, but one needs to understand that search results of the "same search" change every day, not only as to search result order but also as to search result presence.

Thursday, May 18, 2006

Patent cited against Amazon's '411 one-click in re-exam

US 5,729,594 filed June 7, 1996 and cited to date by 126 US patents is being used against the Amazon one-click patent in a re-exam.

first claim:

1. A method of establishing on-line secure financial transactions for purchasing goods through electronic media, said method comprising:

providing a local subsystem disposed at a local location accessible to a user and responsive to a user input;

providing a remote subsystem located at a remote location, said remote location having at least one identifiable product remotely selectable by the user;

establishing a first communication link between the local subsystem and the remote subsystem;

selecting at least one of said identifiable products through the first communication link;

retrieving through the first communication link a telephone toll number from a predetermined numbering system associated with the selected product;

using said retrieved telephone number to establish a telephone toll connection through a second communication link between the local subsystem and the remote subsystem; and

downloading the selected product through the second communication link from the remote subsystem to the local subsystem,

whereby during said downloading of the product a fee is assessed and charged at a rate determined by the toll connection provider.

from the "summary of the invention":

It is therefore a principal objective of the present invention to provide an on-line financial transaction system that uses state-of-the-art computer telcom to provide secure and private purchasing capability of product goods. Another objective of the present invention is to provide a system of the type described which uses the 900 number system or a similar system to assess and collect user tolls for use of the system in performing financial transactions.

It is yet another objective of the present invention to provide a system for performing financial transactions wherein inexpensive servers can be employed, eliminating the need for digital signatures, authentication procedures and banking system connectivity.

Whither Ariad, whither patent law at the Supreme Court?

A May 18 post on PatentBaristas has some discussion on the Harvard/MIT/Whitehead patent (6,410,516), especially thorough about the re-examination thereof (90/007,503).

I've been interviewed a few times about the Ariad v. Lilly litigation. One person was pursuing an angle that the the Lilly lawyers lost the case. That is not a typical theme in the more lawyerly journals (lawyers don't want to see in print a story about how lawyers created a loss in an otherwise winnable case), but I do recall a recent story about the patent interference concerning the "Dolly the Sheep" patents that was unusually harsh toward a certain named patent lawyer.

PatentBaristas mentions the Amgen DJ action as to the Harvard/MIT/Whitehead patent. The tough part of going after the big guys is that they fight back, and weak patents, such as that of the University of Rochester on COX-2, get vaporized.

I've been drafting an article uniting themes in Ariad v. Lilly with some other cases, including Metabolite. HOWEVER, a recent blogpost about the potential that the "group of four" in eBay v. MercExchange might try to take down the Metabolite patent at the Supreme Court (instead of remanding) is making me wonder what might be going at the Supreme Court. For eBay, I was expecting an outcome more like that of the "group of three," and I had created a parody opinion modeled after Merck v. Integra.

The soft guidance of Merck obviously didn't happen in eBay. eBay creates more work for patent lawyers, and, if Integra wins its case in the end (as I suspect), there will be even more work, because there will be more uncertainty than ever.

It's a curious solution to issues of patent reform. Rather than solving the direct upstream problem (get the patent examination done right in the first place), one relaxes the downstream rules, so the picture gets fuzzier. Maybe there will be an injunction, maybe there won't be. Kinda depends on what I think about the patent (although I've determined it valid, it might be like a business method or a law of nature, so I'll discount it a bit) and the addiction the public has developed to the infringing product (if there's lots of infringing product, the public interest might be to continue the use, so I'll weight that factor for the infringer because he's been a very successful infringer). And the patentee does get money damages. Of course, patentee didn't get to pick who developed his invention, or how it developed, but patentee should be grateful because someone developed it.

Lanza: Sometimes I spend more time on the phone with lawyers than I do on the science

From an article in MIT Technology Review:

[ACT's] Lanza suspects that, because of the shortage of eggs and the unknown efficiency of the cloning process, the therapeutic use of cloned stem cells will end up looking more like a kidney transplant than like the ingestion of a widely prescribed drug. "We do recognize it's not the broad cure we had hoped, but I'm convinced it will save some individuals," he says. "Perhaps a mother would donate a round of eggs to create stem cells for her sick child." IPBiz note: that is, the use of therapeutic cloning is not going to be like a "blockbuster drug" for big pharma/biotech. The whole idea is to make genetically-customized cells for a single end user, not one drug that a zillion people all need to take. This basic reality suggests that patent strategy for [therapeutic] embryonic cloning is quite different from that of the typical big pharma blockbuster. But note that there is a different use for embryonic stem cells that is nearer to realization on the horizon, and will involve a still different patent strategy: disease models. The TechRev article does get into that [see below].

The TechReview article does mention New Jersey. A key point to contemplate is what the word "earmarked" means:

In addition, California, Connecticut, and New Jersey have all earmarked state funds to support stem cell research not funded by the federal government. The California initiative, by far the biggest at $3 billion, has encountered pitfalls at every turn, demonstrating the difficulties that arise when states get into the research-funding business. The California Institute for Regenerative Medicine, the oversight entity created by the state's Proposition 71, has grappled with accusations of conflicts of interest among those who determine the distribution of funds and with controversies over how the state will reap the financial benefits of stem cell research -- a promise that was part of the proposition.

The TechReview article gets into the egg donation issue at several places. For example:

Almost all embryonic-stem-cell research in the United States faces funding obstacles and ethical objections, but because nuclear transfer is the most contentious topic in the field -- it involves not only the destruction but also the creation of embryos specifically for research -- scientists and universities planning nuclear-transfer programs are extracautious. "The spotlight is on anyone doing this kind of research," says Lanza. For example, Massachusetts law mandates criminal penalties for people who violate laws governing egg and embryo procurement. "If we slip up anywhere, we'll be crucified," Lanza says. [IPBiz: ask Hwang Woo-Suk, but one could also ask ACT about the spotlight it got in 2001.]

There is a discussion of the UCSF program:
UCSF hopes the new facility will help it become a frontrunner in therapeutic cloning. The university was the first in the United States to attempt nuclear transfer, albeit unsuccessfully, in the 1990s. "Now we hope to start again where those studies left off," says Arnold Kriegstein, director of the university's Institute for Stem Cell and Tissue Biology. IPBiz: the TechRev article gives the misimpression that the UCSF work was "way back" in the 1990's. Actually, it was 1999-2001 (see earlier post on IPBiz), ending the year of the Bush funding restriction.

There is mention of the IVF connection:
Reijo Pera and colleagues started cloning experiments at another off-site facility in April, possibly the first U.S. group to try human nuclear transfer since Lanza's team halted its work in 2004. In the UCSF lab, they will use "fail to fertilize" eggs from an in vitro fertilization clinic, which are much easier to get than donor human eggs. When they have optimized the experimental conditions, they will start using human eggs donated specifically for research. IPBiz: As Bill Clinton would say, it depends on what you mean by "donor." For the above paragraph, "donor" means eggs donated specifically for research, while "fail to fertilize" eggs means eggs that did not work in an IVF procedure, and then are donated to research [for example, see the first "60 Minutes" stem cell program of Feb 06 (Feb 12?) for this nuance.]

There is mention of reprogramming:
During reprogramming, some still-unknown factors in the egg turn off the genes that make a cell, say, a neuron and turn on the genes that are expressed in embryos. To uncover the genes controlling this conversion, Brambrink [in Rudolf Jaenisch's lab at Whitehead] has engineered adult cells to express the genes that are selectively activated in eggs. If a particular gene expressed by one of these cells is crucial to the reprogramming process, it will activate genes that are known to be involved in the process's later stages; those genes have been tagged with markers that make the cell glow green. In the best-case scenario, the activator gene might trigger reprogramming itself, creating a clump of stem cells where once sat differentiated fibroblasts. ... Once scientists understand the [reprogramming] process, they can create new technologies to turn adult cells directly into stem cells.

Of a different impact of Hwang:
However, Lanza and his colleagues, who had been so close to cloning stem cells, watched dejectedly. "It was embarrassing," says Lanza. "This obscure group [Hwang's] announced they had done it." ACT was already on shaky financial ground, but Hwang's achievement made its situation even more precarious. The company also abruptly lost its supply of human eggs -- a crucial ingredient in cloning research -- because clinics that ran donor programs felt no further need to participate in research whose central goal had been achieved.

The Hwang fraud as a car wreck:
"It was like watching a car wreck taking place in slow motion. The magnitude of the problem was just really horrifying," says Snyder. "The world had been reset to pre-2004, like when Superman turned the world backwards. If you were pursuing cloning in 2004, you began pursuing it again. If you were sitting on the sidelines, you were back sitting on the sidelines." IPBiz: The TechRev article never mentions the Newcastle work, which purportedly achieved SCNT, but NOT a stem cell line.

Deja vu, all over again?
Ronald Green, an ethicist at Dartmouth College: "But Hwang's claims gave people a glimpse of what would be possible with cloned stem cells, and the consequence was a renewed interest in therapeutic cloning." IPBiz: Jules Verne? This reminds one of the attempted resurrection of Jan-Hendrik Schon's claims. One does note that there was criticism of Schon's claims BEFORE the Beasley report, but there was not much (nothing?) said about Hwang's claims by peers until people started paying attention to the insider's fraud claims. A "glimpse of what would be possible" has more than one meaning here, one as to possible good things and one as to ease of fraud.

Importantly, the article touches on the true, near-term value of embyronic stem cells--as disease models:

But Friedmann and Snyder are focusing on an application that could have much broader implications -- and is closer at hand. Instead of using the cells as a form of -therapy themselves, the researchers plan to use them to study Lesch-Nyhan disease and test new treatments. Experts say this type of application could dramatically improve our understanding of how any disease with a genetic component unfolds at the cellular level. "You could make a stem cell line that has ALS or Parkinson's, using DNA from a patient that really has the symptoms," says Snyder.

Scientists could prod the cells to develop into the type of cells damaged by a disease, such as dopamine neurons in Parkinson's, and study the intricate progression of the disease from its earliest stirrings to its final cellular death knell. Because the cells would be genetically identical to the patient's DNA, they would undergo many of the same molecular changes that underlie the patient's disease.


The article by Emily Singer appears in the May/June 2006 issue of the
MIT TechnologyReview.

The blog californiastemcellreport contains many posts of relevance to stem cell work.

Wednesday, May 17, 2006

U.S. patent lawyers may prey on Canada

Didn't the lawyer in Jurassic Park get eaten? from the nationalpost:

Patent litigators taking on deep-pocketed financial institutions in the United States could launch similar attacks on the Canadian financial services sector, according to some of Canada's top patent lawyers.

On surmises, post-RIM, US patent lawyers visiting Canada should masquerade as PI guys.

Where's Waldo?

from tmcnet (Gene Retske):

It turns out that many of the almost 1000 patents that are issued every day are owned by lawyers.

Complicating the picture is a mid-1990s law that enables so-called “business methods” patents. It was this type of patent that Amazon successfully enforced against Barnes & Noble over “One Click” ordering of books and other products. Patents in 1789 had to be for actual hardware; in 2006 you can patent business methods, which are very close to simple ideas.

How many mistakes can you spot in the above?

Too much of a good thing?

A story from LiveScience.com headlined "Some Americans May Get Too Many Nutrients" actually emphasized IM/NAS panel recommendations for MORE nutrients:

The panel recommends:

* Combined use of calcium and vitamin D supplementation for postmenopausal women to protect bone health.

* Anti-oxidants and zinc should be considered for use by non-smoking adults with early-stage, age-related macular degeneration, an eye condition that can cause blindness.

* Women of childbearing age should take daily folate to prevent birth defects of the brain and spinal cord.


If one wanted to find nutrients "not to take in excess" one would find the text:

Despite the general pubic [Yes, it said pubic, but probably meant public, one hopes] perception that MVMs are safe, the panel identified several possible risks. Too much of certain nutrients can have adverse effects, the scientists said. And the combined effects of eating fortified foods, taking MVMs, and consuming single vitamins or minerals in large doses can lead to overconsumption.

OK, that clears everything up.

Tuesday, May 16, 2006

AP quotes Merges on Supreme Court eBay decision

"What's happening today, particularly in the electronics industries, is a widespread misuse of the patent system," said Robert Merges, a University of California, Berkeley, law professor who filed a friend-of-the-court brief in the case on behalf of Web portal Yahoo. "People have been looking for tools to deal with it, and I think we just got a big one."

The Supreme Court unanimously ruled district court judges have flexibility in deciding whether to issue orders barring use of a technology after juries find a patent violation [ie, enjoining the practice by infringers of activities which fall within the scope of a valid patent claim after a decision of infringement by a judge or jury]. The ruling threw out a federal appeals court ruling that said injunctions should be automatic unless exceptional circumstances applied.

The AP story began: The U.S. Supreme Court handed a win to patent-reform supporters ...

Although many newspapers did emphasize the victory for "patent reform against patent troll" issue, BusinessWeek said this:

Make no mistake -- eBay was granted a reprieve. But the narrowly tailored and succinct, five-page opinion offered up no big winners, and no big losers, in a patent case that signifies a deep and long-simmering philosophical split in intellectual-property circles. At issue is the role of so-called patent trolls -- a derisive term applied to scrappy entrepreneurs who amass patents with the sole intent of extracting large licensing fees from alleged infringers, sometimes threatening court injunctions to help seal the deal.

Because the high court declined to take a side in the debate, choosing instead to hew to a narrow interpretation of existing statute, "both sides will find something to crow about in this opinion," says Sharon Barner, chair of the intellectual-property department at Foley & Lardner. And the opinion likely will take the wind out of efforts in Congress to reform a system that's granting patents on processes that are already in wide use or techniques so simplistic that avoiding infringement is nearly impossible.

**IPBiz-->

Entities who are adjudicated infringers now have a chance to avoid a permanent injunction, and they are a lot better off. In terms of predictability of outcome, the legal system is a lot worse off. The problem is thrown to the district courts with no clear guidance on what is proper, and what is improper, in conducting balances in the 4-factor test. It will take years to figure out "how much" was won by the infringers and lost by the patentees.

Monday, May 15, 2006

Sup Ct vacates CAFC decision in eBay and re-affirms traditional 4 factor text

eBay won a major procedural victory at the Supreme Court. The CAFC decision in MercExchange v. eBay is vacated, and the case goes back to the district court for analysis under the traditional 4 factor test for a permanent injunction.

**
PromoteTheProgress had noted a prediction: In the latest version of The List, Hal predicts that eBay v. MercExchange will be decided by a 6-3 (or possibly a 7-2) margin in favor of confirming the availability of injunctive relief for "non-working" patentees. He expects negative votes from Associate Justices Breyer and Stevens. His prediction is based on hearing the oral arguments and extensive study of the pleadings.

And, injunctive relief is available (in theory) to nonworking patentees. Trouble is, permanent injunctive relief is not necessarily available to working patentees.

The Supreme Court's mention of Continental Paper in eBay was interesting, as was the discussion of the district court decision in the eBay case, which did employ the 4 factor test. Wonder how the balance will come out the second time around?

This is the Supreme Court's effort on the "patent troll" issue. Permanent injunctions are no longer a given (absent exceptional circumstances) after the patentee shows validity and infringement. In the balance of hardships, will the infringer who has been very successful commercially, and who will lose lots of money if there were an injunction, prevail against the nonworking (nonproducing and nonselling) patentee? If so, does that amount to a compulsory license? The district courts will wrestle with this.

Sunday, May 14, 2006

Huntington Beach wins the trademark war over Surf City USA

The U.S. Patent and Trademark Office [USPTO] awarded Huntington Beach three official trademark registration numbers that permit it to use the designation "Surf City USA" in ads and on beach bags, hats and other beachwear, the city Conference and Visitors' Bureau announced May 12, 2006.

For years, both Huntington Beach and Santa Cruz have called themselves Surf City after the 1963 hit song by Jan and Dean that boasts of a place where there are "two girls for every boy."

In 2004, Huntington Beach applied for official recognition of the name. Santa Cruz opposed, and a battle began, with the cities trading legal challenges and taunts and talk of a surfing contest for the title.

***
As a separate matter, IPBiz was researching the defamation cases brought by Annie Oakley against various newspapers in 1903, the same year as the Wright Brothers' first powered flight. "Annie Oakley" was merely a stage name and the cases, and the underlying facts (the incident, not involving Oakley, happened in Chicago), are rather interesting. Some cases were in federal court (3rd Circuit from Delaware; 11th circuit from Florida) and there was one in the notorious Chemung County, New York. One opinion is quite relevant to law reviews in the 21st century, about the re-broadcast of false information. Curiously, at this pre-Lanham Act time, her lawyers apparently never brought an action in trademark/tradename, although that might have yielded better results.

Scholars criticizing "facts" in Brown's The Da Vinci Code

"In our experience, readers are taking it as true," said Ehrman, a religious-studies professor at the University of North Carolina and author of "Truth and Fiction in The Da Vinci Code." "Historians care about what happened in the past, and it's important ... to separate the fact from the fiction." [IPBiz: like knowing, counter to the Stanford Law Review, that Boone did not invent the integrated circuit?]

"As a scholar I'm very grateful to Dan Brown. People like me are in demand right now in a way we have never been before," said Gail Streete, a religious-studies professor and expert on Mary Magdalene at Rhodes College in Memphis, Tenn. "Most of the time nobody pays any attention to what we do." [IPBiz: like the attention paid to patent lawyers in the patent reform debate?]

Saturday, May 13, 2006

More on Hwang. Events related to egg donation issues.

On the Hwang timeline:

On November 18, 2005, Science (310 Science 1100) reported on Schatten's break with Hwang over egg donor issues. An important "fine point" to note is that Schatten's alleged concern was over egg donations for the 2004 paper in Science, of which Schatten is NOT a co-author. The Science article of November 18 is silent on issues with egg donations as to the 2005 paper. Schatten is a co-author of that paper AND Korean bioethics laws were in effect as to the eggs of that paper (and are explicitly mentioned in a footnote in the 2005 paper.)

Schatten accuses Hwang of misleading him about the source of oocytes for the 2004 Science paper. Schatten, who was not an author of the 2004 paper, did not detail his charges, but questions had been raised earlier about the source of the oocytes. In the first Science paper, the researchers said that their single cell line was the result of 242 tries with oocytes donated by 16 women. Shortly after the paper was published, Nature reported allegations that two junior members of the lab had donated oocytes for the work.

Science does allude to the 2005 paper.

The flap apparently grew out of a criminal investigation involving Hwang's collaborator Sung-Il Roh, a fertility specialist at MizMedi Hospital in Seoul, who helped collect many of the oocytes Hwang's team used in the 2005 Science paper. (...)On 10 November, Schatten wrote to editors at Science assuring them that no donors had been paid for eggs used in either paper. Two days later, he announced that he was ending the collaboration because of a "breach of trust."

There is no further mention of issues with the egg sources for the 2005 paper in the November 18 article, a rather odd omission.

There is other text: Hans Schöler of the Max Planck Institute for Molecular Medicine in Münster, Germany, who has visited Hwang's lab and had been discussing a possible collaboration, says his interactions with Hwang have given him no reason to doubt Hwang's honesty.

On December 2, 2005, Science reported Hwang's admission as to egg donors. On Thanksgiving Day, Korean researcher Woo-Suk Hwang resigned as president of South Korea's planned World Stem Cell Hub, acknowledging that two researchers in his lab had donated eggs for his research, and that donors had been paid for their contributions--something he had denied for months.

On December 9, 2005, Science (310 Science 1595) reported on the photograph problem in the 2005 Hwang paper.

Katrina Kelner, Science deputy editor for life sciences, says it appeared that the duplicate panels were not part of the original submission but had been sent in response to a request for high-resolution images after the paper had been received. "From the information that we have so far, it seems that it was an honest mistake," she says. "We have no evidence that there was any intent to deceive."

The figure in question is supposed to show patterns of expression for a range of ES cell markers in the 11 cell lines. But it contains four pairs of apparently duplicated images, even though they are labeled as showing different cell lines. Gerald Schatten of the University of Pittsburgh in Pennsylvania, who was the corresponding author on the paper and provided the high-resolution images to Science, declined to comment.

Rudolf Jaenisch of the Whitehead Institute for Biomedical Research in Cambridge, Massachusetts, says he still has confidence in the reported results. "This is an extremely important study, and I have no reason whatsoever to question any of the published data," he says.


In an editorial in Science on January 6, 2006, Donald Kennedy noted Hwang and G. Schatten, the corresponding authors of the paper, have notified Science of their intention to retract the paper. Hwang has sent us some language that he intends to use in the retraction. We have requested more information from the authors as well as agreement from all the co-authors to retract the paper.

In an article on January 6, 2006 (311 Science 22), Science reports on the role of MBC-tv's "PD Notebook."

Those hopes [of therapeutic cloning], however, began to unravel shortly after midnight on 1 June 2005, when someone sent a message to the "tip off " mailbox on the Web site of a long-running investigative TV news program called PD Notebook aired by the Seoul-based Munhwa Broadcasting Corp. (MBC). According to one of the program's producers, Bo Seul Kim, the writer said his conscience had been bothering him over problems he knew of with Hwang's research. Asking PD Notebook to contact him, he closed his message by writing: "I hope you don't refuse this offer to get at the truth."

Producer Hak Soo Han met the tipster that night. According to Han's recollection of the meeting, the tipster said he had been involved in the research leading to Hwang's 2004 paper in Science. The tipster also claimed that based on his knowledge of the team's work, Hwang couldn't have produced the patient-specific stem cells reported in the 2005 paper, although he admitted having no hard evidence of fabrication.

Han says he got the news of the lab test results on 19 October while he was in the United States preparing to interview Sun Jong Kim, another co-author of the 2005 paper who had left MizMedi to join the University of Pittsburgh research team led by Gerald Schatten, a Hwang collaborator and co-author of the 2005 paper. In an attempt to get an admission of wrongdoing from Kim, Han says, the TV team resorted to some misrepresentation of its own. When the producers met him on 20 October, Han and his partner filmed Kim with a hidden camera; they didn't reply when he asked if they were recording him. In the interview, Han told Kim they had information that could prove Hwang's work was falsified. He also tricked Kim into believing that Korean prosecutors had begun an investigation and told Kim he didn't want to see him get hurt.

With public opinion starting to turn, on 15 December, MBC broadcast the PD Notebook segment showing Kim-- with his face blurred--admitting that he doctored photographs at Hwang's direction. The next day, Hwang and Schatten told Science they wanted to withdraw the 2005 paper.


On January 10, 2006, Science retracts both the 2004 and the 2005 paper (311 Science 335). The issue of egg donation is not mentioned. The basis for retraction is as follows: Because the final report of the SNU investigation indicated that a significant amount of the data presented in both papers is fabricated, the editors of Science feel that an immediate and unconditional retraction of both papers is needed. We therefore retract these two papers and advise the scientific community that the results reported in them are deemed to be invalid.

On January 11, 2006, Lawrence B. Ebert submitted his manuscript to JPTOS on the Hwang matter. The article is published without any updates in March 2006 (88 JPTOS 239).

In an article in Science on February 10, 2006 (311 Science 754), it is noted two co-authors of the 2005 Science paper, including Sun Jong Kim, received $50,000 from Hwang's associates. The same issue announced that John I. Brauman will head an external panel investigating how the Hwang papers were handled by Science.
(see http://www.sciencemag.org/cgi/content/full/311/5762/754)

On May 12, 2006, Hwang and five associates are indicted by Korean prosecutors.

English.chosun made clear that the indictment against Hwang included breach of the bioethics law: The Seoul Central District Prosecutors’ Office on Friday indicted the scientist without arrest on charges of fraud, embezzlement and breach of the bioethics law. Canada's Globe and Mail, relying on the AP, also mentioned the three charges: South Korean prosecutors indicted disgraced cloning scientist Hwang Woo-suk yesterday on charges of fraud, embezzlement and bioethics violations in a scandal over faked stem-cell research that shook the scientific community. The Voice of America also mentioned the ethics issue: Lee says Hwang is being charged with criminal fraud and embezzlement. He is also accused of violating a law that forbids the purchase of human eggs for research.

One has to read between the lines. Because the Korean bioethics law was not in effect for the 2004 paper AND was in effect for the 2005 paper, the breach of the bioethics law charged to Hwang presumably relates to work for the 2005 paper.

The Los Angeles Times account of the Hwang indictment mentioned only embezzlement and fraud: South Korean prosecutors announced today that they had charged scientist Hwang Woo-suk with embezzlement and fraud, saying he misused public funds for his fabricated experiments in human cloning. The same for The Scientist: Hwang Woo-suk, the South Korean researcher who admitted fabricating data on human stem cell lines, has been charged with criminal fraud and embezzlement The same for the International Herald Tribune (NY Times): Hwang Woo-Suk, the disgraced cloning expert, was indicted on fraud and embezzlement charges today, months after an investigative panel determined that he had fabricated evidence to prove that he had cloned human cells.

See also
www.sciencemag.org/sciext/ hwang2005/science_statement.pdf