Thursday, August 31, 2006

Creative Technology to utilize patent against other makers of portable media players

Further to an earlier post on IPBiz, MacWorld reports that Creative spokesman Phil O'Shaughnessy confirmed the Creative's intentions this week, speaking to Dow Jones. "As the patent covers the hierarchical user interface on portable media players, many manufacturers are using the Zen patent today," he said.

A quote in the MacWorld article confirms the "first to get there" aspect of patent law:

Discussing the company's decision to pursue the patent against other firms, IDC analyst Claudio Checchia stressed the need for an amicable settlement: "I think it has been acknowledged that Creative was there first, so they won the patent - so their rights have been recognised. If they are going to go after other manufacturers, it really depends on what they goal is, and the problem with these lawsuits is that they can be quite expensive."

All the discussion in the software community about NOT reading the patents of others (purposeful ignorance) just promotes economic waste for society as the wheel is rediscovered. Patent law is a race, but it is a race to disclose what one has done.

Wednesday, August 30, 2006

RFID World takes on Wal-Mart in ED Texas

from RFID Journal:

RFID World has filed suit in the United States District Court for the Eastern District of Texas, Tyler Division, which reportedly finds in favor of the plaintiff 88 percent of the time, compared to 68 percent nationwide. The original complaint reads: "Wal-Mart, on information and belief, uses an inventory-control system utilizing the RFID technology claimed in [Bormaster's patent]. By utilizing such systems, Wal-Mart has in the past and continues to infringe at least claim 1 of the patent."


"Because RFID technology has not only become cheaper to obtain, but is being required by both the private and government sectors, lawsuits like the RFID World suit will probably become more common in the near future."

Judge upholds jury verdict; KCI loses on vacuum bandage

from AP:

A federal court judge from the Western District of Texas upheld a jury verdict delivered earlier this month that BlueSky's Versatile 1 System, a negative-pressure wound therapy device, did not directly infringe on Kinetic Concepts' patents for a similar device, the VAC, according to McClanahan & Clearman LLP on Aug. 30.


A different concept is the use of drains in surgery wherein a surgeon places 1 or 2 drains (called Redons -suction drains). Vacuum bandages draw blood to the surface of the wound.

Plagiarism in academic contexts: a look at the past

In a case (274 F. Supp. 2d 71) alleging certain discriminatory motives in a charge, and finding, of plagiarism in a CHEMISTRY paper [IPBiz: !!], one has the following text:

Chandamuri states that Dr. Roepe reported him for plagiarism because, in his paper, he did not place direct passages of previously-published articles within
quotation marks. Chandamuri alleges that Dr. Roepe's definition of plagiarism is
not supported by the Honor Council materials on the basis that Chandamuri cited
the authors upon whose work he relied and therefore did not intend to pass off
the work of others as his own. Chandamuri maintains that his actions do
not meet Georgetown's definition of plagiarism and alleges that the Honor
Council hearing was severely flawed because the Honor Council never defined plagiarism for the purpose of the hearing or established the procedures by which the
hearing was to be run.

[The Honor Code] defines plagiarism as "the act of passing off as one's own ideas the writing of another. (...) The Honor Council conducted the investigation and
hearing, and decided, based on its published definition, that Chandamuri had
committed plagiarism.

Yes, coincidental to the issues with the Chemistry Department at Columbia (Sezen Sames matter), one has a recent Columbia case related to plagiarism, 2005 U.S. Dist. LEXIS 26480. Some text:

Plaintiff submitted a report to his instructor for the class Music
Humanities. Based on a comparison to a website showing substantial
similarities, the instructor notified the Dean of Students, who then notified Mr.
Shelton on December 16, 2002, that he had been accused of academic dishonesty.

The Subcommittee found Plaintiff guilty of plagiarism and recommended Plaintiff's
dismissal from the University. The decision was affirmed by the full Committee.

The University disciplinary policy is outlined in the University Bulletin and provides that acts of plagiarism are punishable by "suspension or dismissal from the School."

[There is a reference to a case involving New York Law School]: "Strong policy considerations militate against the intervention of courts in controversies relating to an educational institution's judgment of a student's academic performance." Susan M. V. New York Law School, 76 N.Y.2d 241, 245, 556 N.E.2d 1104, 557 N.Y.S.2d 297 (N.Y. 1990).

In a different and more recent case (2006 U.S. Dist. LEXIS 58346), one has the text:

Plaintiff was conditionally admitted into the University of Houston Doctoral Degree Program in the Department of English to pursue a Doctorate of Philosophy in English Literature.

Dr. Maria Gonzalez, a professor in the English Department at the University of Houston, accused plaintiff of plagiarism. (...) plaintiff was again accused of plagiarism, this time by Dr. Voskuil.

In the more distant past, there was a certain case at Princeton University, 186 N.J. Super. 548; 453 A.2d 263:

plaintiff was a student in her senior year at Princeton University, a member of the Class of 1982. During the Fall Term of the 1981-1982 academic year Professor Molloy
taught Spanish 341, a course entitled "The Spanish American Novel."
Plaintiff elected to become a student in that course. It was her submission of a
term paper for that course which gave rise to the disciplinary proceedings
here under review.

[Princeton had a Committee on Discipline (COD) for] academic violations, such as plagiarism on essays, term papers or laboratory reports [IPBiz: !!],

[The text of the case had some lengthy definitions]:

General Requirements for the Acknowledgment of Sources in Academic

The academic departments of the University have varying
requirements for the acknowledgment of sources, but certain
fundamental principles apply to all levels of work. In order to prevent any
misunderstanding, students are expected to study and
comply with the following basic requirements.

Quotations. Any quotations, however small, must be placed in
quotation marks or clearly indented beyond the regular margin.
quotation must be accompanied (either within the text or in a
footnote) by a precise indication of the source -- identifying the
author, title, place and date of publication (where relevant), and
page numbers. Any sentence or phrase which is not the original
work of the student must be acknowledged.

Paraphrasing. Any material which is paraphrased or summarized
also be specifically acknowledged in a footnote or in the text. A
thorough rewording or rearrangement of an author's text does not
relieve one of this responsibility.
Occasionally, students
maintain that they have read a source long before they wrote their papers
and have unwittingly duplicated some of its phrases or ideas. This is
not a valid excuse.
The student is responsible for taking adequate
notes so that debts of phrasing may be acknowledged where they are due.

Ideas and Facts. Any ideas or facts which are borrowed should
be specifically acknowledged in a footnote or in the text,
even if the idea or fact has been further elaborated by the student.
Some ideas, facts, formulae, and other kinds of information which are
widely known and considered to be in the "public domain" of common
knowledge do not always require citation. The criteria for common
knowledge vary among disciplines; students in doubt should consult
a member of the faculty.

Occasionally, a student in preparing an essay has consulted an
essay or body of notes on a similar subject by another student.
If the student has done so, he or she must state the fact and
indicate clearly the nature and extent of his or her obligation.
The name
and class of the author of an essay or notes which are consulted
should be given, and the student should be prepared to show the work
consulted to the instructor, if requested to do so.

Footnotes and Bibliography. All the sources which have been
consulted in the preparation of an essay or report should be
listed in a bibliography, unless specific guidelines (from the academic
department or instructor) request that only works cited be so
included. However, the mere listing of a source in a bibliography
shall not be considered a "proper acknowledgement" for
specific use of that source within the essay or report.

Plagiarism. The deliberate use of any outside source without
proper acknowledgment. "Outside source" means any work, published
or unpublished, by any person other than the student.


Plaintiff told Professor Molloy that she wanted to write her paper
on the family ties in a novel entitled Cien anos de soledad [*556] (100
Years of Solitude) by Gabriel Garcia Marquez. Professor Molloy approved the
topic and told plaintiff that she ought to read Cien anos de soledad:
una interpretacion by Josefina Ludmer (Ludmer), a book which Professor
Molloy had put on library reserve at the beginning of the Fall Semester.

A simple comparison of plaintiff's paper and Ludmer reveals numerous
sections of the paper which are taken verbatim, or in other portions
virtually verbatim, from Ludmer, but which are not put into quotation marks or
indented and which are not footnoted. At the end of her paper plaintiff wrote
and signed the acknowledgment of originality required by RRR, in Spanish: "This
paper represents my own work in accordance with University regulations."


After hearing oral argument the trial judge decided to remand the
matter for a rehearing at Princeton. He found that a conviction for the academic
fraud offense of plagiarism must be based upon a finding of "intent to pass
off the submitted work as the student's own."

It is clear that plaintiff was charged with plagiarism -- in other words,
that plaintiff attempted to pass off as her own work, the work of another.
That act, if proven, constituted academic fraud. We do not view this case as
involving an appeal from a finding of general misconduct; instead, we are concerned
with the application of academic standards by the authorities at Princeton.

IPBiz notes that some of the above illustrates that there is precedent in previous academic disciplinary actions for what has happened in the matter at Ohio University in the mechanical engineering master theses matter. HOWEVER, that said, some of the defenses raised in, for example, the Coulter plagiarism matter, do not square with, for example, the policy noted above for Princeton University. It does seem that there are differences in what is expected of students and what is expected of adults working in the real world, as was pointed out in the Laurence Tribe matter by, for example, the Harvard Crimson.

**IPBiz update**

Although the factor which motivated the Chandamori case was a charge of plagiarism, the issues that Chandamori brought to court were charges of retaliation. Universities have to be aware of the issue.

In a brief in Jackson v. Birmingham Board of Education, the Solicitor General wrote:

Finally, the question whether Title IX authorizes a private right of action for retaliation is one of recurring importance. That issue and the related issue whether Title VI authorizes a private right of action for retaliation have arisen with increasing frequency in the lower courts. See Burch v. Board of Regents of University of California, No. Civ. 8-04-0038 (E.D. Cal. Mar. 16, 2004); Atkinson v. Lafayette Coll., No. 01-CV-2141, 2003 WL 21956416 (E.D. Pa. July 24, 2003), appeal pending, No. 03-3426 (3d Cir.); Chandamuri v. Georgetown Univ., 274 F. Supp. 2d 71 (D.D.C. 2003); Mock v. South Dakota Bd. of Regents, 267 F. Supp. 2d 1017 (D.S.D. 2003); Johnson v. Galen Health Insts., Inc., 267 F. Supp. 2d 679 (W.D. Ky. 2003).

The question in Jackson was Whether the private right of action for violations of Title IX of the Education Amendments of 1972, 20 U.S.C. 1681 et seq., encompasses redress for retaliation for complaints about unlawful sex discrimination.

More coverage of ACT's work: the good and the bad

One can find many variations of reporting on the ACT work. In the following, one unfavorable, one favorable.

From Australasian, article titled THE RISE AND FALL OF A STEM CELL ETHICAL FIX

The article started: History or hype? This was the question swirling about the widely publicised announcement by a Massachusetts company that it had mastered a technique for creating "ethical" embryonic stem cells which could break the logjam in America's stem cell politics. [IPBiz query to californiastemcellreport: what happened to the California connection here?]

The article included a negative quote: "A pitiful attempt to look morally acceptable, rather than do valuable science," sneered Glenn McGee, editor of the American Journal of Bioethics.

The article discussed media coverage: Although this seems unfair, there is no doubt that the episode shows how credulous the media -- even leading scientific journals -- can be about therapeutic cloning. Lanza's work represented a small technical advance, but it hardly passed muster as a "breakthrough". [IPBiz: the issue remains in the details of how the one extracted cell did grow in the two cases in which the one cell did grow. Of the media, Nature did have to alter its press release, so there is a science coverage issue here. Separately, be sure to see my Sept. 06 article on bad coverage by Science in its July 28 issue.]

Yes, the article did mention a past ACT problem: Furthermore, Advanced Cell Technology has a track record as a publicity hound. A listed company which is perpetually in the red, it burst onto the front page back in 2001 claiming that it had cloned a human embryo and initiated a stem cell line. Nothing came of that extraordinary wave of publicity, but it no doubt put ACT scientists in the rolodexes of journalists across the world. [IPBiz note: does someone remember the patent interference?]

In the following, "totally ignored" is perhaps too strong: Japanese scientists reported in another major journal, Cell, that they had reprogrammed an adult mouse cell and converted it into something closely resembling an embryonic stem cell. Scientists from the Harvard Stem Cell group grudgingly acknowledged in a commentary that it was a "significant step" "unencumbered by neither the logistical constraints nor the societal concerns presented by somatic cell nuclear transfer [ie, cloning]." If this success can be replicated with human cells, it might indeed transform America's stem cell politics.

Meanwhile, at the New York Daily News on August 30, 2006:

Well, thanks to a scientific breakthrough announced last week, it turns out that embryos can do almost the same thing: They can give up a single cell to science while still going on to become a viable fetus. That cell can be grown into the holy grail of research: a new embryonic stem-cell line, the kind that holds such scientific promise.


The new technique, developed by a company called Advanced Cell Technology, works this way: A tiny eight-cell "blastomere" [sic] is grown in a petri dish, as it would be for any in-vitro fertilization. At this superearly stage, one cell is removed. This does not kill the embryo the way the older method of harvesting stem cells did. [IPBiz note: the older method was not done on an eight cell blastocyst.]

That same single cell can, we now learn, be grown into two cells, with one used for testing and the other used to create a new stem-cell line. Thus you end up with three gifts: a viable embryo, a test to make sure the embryo is healthy and a new stem-cell line for science. [IPBiz: that's one theory of use. For this to be implemented in practice, the success of growth has to be increased.]


The fact is: This technique holds great promise and does not harm potential life. New York University's Dr. James Grifo, who pioneered preimplantation genetic diagnosis [PGD] here, estimates there are 10,000 babies alive today who all started life minus one cell.

SpiralFrog/Universal Music do deal on music downloads

CNET reports that SpiralFrog has signed a deal with record label Universal Music Group to offer songs for free, hoping to make money by showing ads to users as they download the music.

The report noted: Battling back after years of Internet-fueled file sharing, record companies are looking for business models that offer them revenue for their music. Meanwhile, more and more content-based companies are starting with the hope that widespread availability of high-speed Internet access will mean that more and more dollars will shift from traditional media to the Web.

Remember criticism of the Supreme Court decision in Grokster? Well, Kazaa settled, and life goes on with more business models to distribute music over the internet. There is life after Napster.

Ranbaxy wins LIPITOR case in Norway

An Oslo city court found that Ranbaxy's generic form of the drug LIPITOR, whose chemical name is atorvastatin, was not infringing two of Pfizer's Norwegian patents. [Reuters, August 29, 2006]

Relevant to the patent quality debate, one notes that different countries can have different rules on patents, and reach different results. Comparing patent grant rates from different countries can be perilous.

Separately, the Jerusalem Post reported that Teva Pharmaceutical Industries Ltd. (the world's largest generic-drug maker) said it will continue to sell a version of Purdue Pharma Ltd.'s OxyContin painkiller for an undisclosed period after settling a lawsuit.

The agreement will end a case in federal court in the southern district of New York [SD NY] and calls for Teva to halt sales at an unspecified date.

The report noted that "The accord requires approval of the Federal Trade Commission, the Justice Department and the court, Petah Tikva-based Teva said Tuesday" (Aug. 29).

A reminder required by Apotex and Plavix?

The report also noted: Last month, Purdue and Endo Pharmaceutical Holdings Inc. reached a settlement in an OxyContin patent dispute that required Endo to stop selling a generic version at the end of the year. In return, Purdue released the company from liability for any infringement of three Purdue patents.

Tuesday, August 29, 2006

Culberson reads Science

Texas Congressman John Culberson is something of a geek. In his spare time he says he reads scientific journals, like Science and Nature, as well as popular science magazines.

A question: if he reads in Science that one can add new facts into a continuation patent application, and claim the earlier priority date [Science, July 28, 2006], does John Culberson factor that thinking into patent reform? Would such writing cause him to favor limitations on continuing applications, when perhaps more accurate writing might have a different result?

An interview discussed why he is vastly more supportive of nanotechnology than embryonic stem cell research, which the Texas medical center would like to do more of.

The article even talks about nanoshells. [Nanoshells are a new type of optically tunable nanoparticle composed of a dielectric (for example, silica) core coated with an ultra-thin metallic (for example, gold) layer. Gold Nanoshells possess physical properties similar to gold colloid, in particular a strong optical absorption due to the collective electronic response of the metal to light. ]

Monday, August 28, 2006


From CNET:

WikiPatents is not the first site to take aim at what some deem an epidemic of undeserving patents, although with its more than 3 million patent listings and more to come, it appears to be the most ambitious. The open-source software community, which has sounded alarms in recent years over what it calls a rash of "bad patents," has also devised systems aimed at allowing the public to view patent applications and prior art more readily.


But what about the inevitable concern that such sites will fall prey to the sort of tomfoolery that has plagued postings at the Web's best-known wiki site?

"As long as prior art is put into the system where it's readily available to search ahead of (filing for a patent), and it's properly vetted, it's not every harebrained thing somebody throws out, then I think that's great," Riley said. "But I've looked at Wikipedia, and it's a real mixed bag."

WikiPatents, for one, said it will attempt to weed out spam and abusive comments, but the reliability of its content remains a use-at-your-own-risk proposition.

"Even though a reference may have been voted to the top by 10 users as a five-star reference, the patent examiner ultimately has to determine whether it's a five-star reference for him," Johnson said. "The same thing goes for licensees, applicants and litigants."

Of content issues, one notes that the good folks at the Sacramento Bee completely misunderstood an invalidity issue in the stem cell area, apparently with the assistance of a Stanford Law Professor. If well-meaning people can screw up on invalidity, think about what competitors can do.

More on the coverage of ACT's embryonic stem cell work

Relevant to coverage of the new ACT work on embryonic stem cells:

From Robert George on National Review about the ACT work published in Nature:

First, the study did not involve the removal of one cell from an embryo that then continued to develop. Instead, researchers disaggregated 16 living embryos, killing them all, and took an average of six cells from each. The 91 resulting embryonic cells were then placed near one another in dishes and allowed to divide. Some divided, while others died, and from the cells that divided researchers were able to produce two lines of embryonic stem cells. In other words, the study did virtually nothing to prove the point that Advanced Cell Technology (ACT, the company that carried out the experiments) had argued in the press: that single cells removed from an early embryo and cultured by themselves can produce lines of embryonic stem cells.
[IPBiz: the issue here is cultured by themselves. ACT does claim that in certain cases, a single cell removed from a multicell blastocyst did produce a stem cell line.]

George went on to write:

So far as I am aware, only the Los Angeles Times took note of this little wrinkle in ACT’s heavily publicized tale, but even the Times didn’t pay it much heed. The paper noted: “Although the embryos were destroyed in this experiment, Lanza said it was not necessary to destroy the embryos for the procedure to work.” If it was not necessary, why did his team do it? Certainly they would have had a better story to tell if they hadn’t. In reality, the fact they had to resort to the technique they used, culturing numerous cells from the same embryo near each other on a dish, suggests they tried to use just single cells but failed. In other words, the ACT study did not show it is possible to extract a single cell from an eight-cell embryo and produce a line of stem cells.

[IPBiz note: the LATimes was NOT the only paper to cover this aspect.]

George wrote:

ACT’s scientist-salesmen imprudently dismissed these concerns in the press, and hyped their findings. “There is no rational reason left to oppose this research,” Dr. Robert Lanza, ACT’s vice president told the New York Times. This was mere bravado. It did not, and will not, make serious questions go away. Indeed, the media is now in full retreat from the original story, and reporters are not at all happy with ACT for having sold them a bill of goods.

[IPBiz notes that George did not mention ACT's patent application on this process. George did not mention the criticism by British scientists of the ACT work.]

Relevant to coverage of the IMPACT OF ACT work ON Thomson / WARF patents:

One has to distinguish between invalidity issues and noninfringement issues.

--> The ACT work, which has taken place long after the Thomson work of the 1990's, is NOT prior art to the Thomson work and is NOT going to invalidate the earlier Thomson work.

--> The ACT work may supply an alternate method to make embryonic stem cell lines to that disclosed by Thomson in the 1990's. HOWEVER, Thomson has composition of matter claims in his patents. No evidence has been put forth that ACT's compositions do NOT fall within the scope of Thomson's composition claims. In the absence of such evidence, one notes that the practitioners of the ACT method would have to license from WARF. The discovery of a new method "B" to make composition "Z", wherein there was a previous method "A" to make composition "Z" does NOT evade a composition claim to "Z". If discovery of a new method were to evade a composition claim, think about how valueless pharma composition patents would be. One could avoid Pfizer's LIPITOR composition claim merely by figuring out a different way to make LIPITOR. That isn't the law.

Sunday, August 27, 2006

Nature corrects wording in release about ACT stem cell work

Rick Weiss of the Washington Post has covered some issues with the ACT work:

But in an unusual move yesterday [August 25, 2006], Nature corrected wording in a lay-language news release it had distributed in advance and posted clarifying data it had asked the scientists to provide.

[Weiss reported criticism by Doerflinger]

First, he [Doerflinger] said the scientists did not make it clear that no embryos survived their experiments. In fact, data in the paper do make that clear, but Nature's initial release said otherwise. It is well established that a single cell can be removed from an eight-cell human embryo without causing any apparent harm to the embryo [IPBiz: the use of PGD in IVF has established this], and the new report aimed only to show that such single cells can become stem cells, lead researcher Robert Lanza said yesterday. In the experiments, the scientists took as many cells as they could from each embryo, destroying them in the process, to make the most of the embryos donated for their study.

[Second] Doerflinger said it was also deceptive for the scientists to say that single embryo cells were coaxed to grow into colonies of stem cells. In the experiment, he noted, those single cells were allowed to feed on hormones secreted by other cells in the nutrient media in which they were grown. That leaves open the question, he said, of whether a single cell can become a colony on its own.

A third point of contention is the fact that the published report includes a photo of a mature embryo, healthy and poised to grow into a fetus after having survived the removal of a single cell. Doerflinger said the photo is deceptive because no embryos in the experiment were allowed to develop that far.

IPBiz notes that Weiss did not discuss the criticism of ACT by Ian Wilmut "the authors make unjustified claims for their techniques."

By only mentioning the criticism of Richard Doerflinger of the U.S. Conference of Catholic Bishops, Weiss perhaps suggests that the only problems are being raised by those motivatd by a religious/ethics concern. This is consistent with the last words of the article:

"They're really going after everything they can," Lanza said. "They've got the whole machine geared up."

Examiner hiring and retention at the USPTO

The POPA website currently has the post:

A Senate Appropriations Committee Report proposes $1.771 billion for the USPTO in FY07, down from the President's proposed budget of $1.843 billion. The Report includes harsh language concerning the USPTO's failures in examiner hiring/retention and its need for better management. The Report states,"[T]he Inspector General has received repeated complaints that PTO has allowed or encouraged unfair personnel practices. The IG has identified these problems as one of the top 10 management challenges of the Department of Commerce. Even with increased funding, the problems at PTO are getting worse, evidence that what is needed is better management."

The link provided in the POPA post contains the text:

Hiring, Retention, and Human Resource Practices- An innovation friendly Government depends on an efficient patent system. Since fiscal year 2004, the Committee has provided a 45 percent increase in funding for PTO, including funding to hire thousands of new patent examiners. Yet during the same time period, the backlog of pending patent applications has grown to over 500,000, and it still takes an average of over 2.5 years to process a patent application. Meanwhile, the Inspector General has received repeated complaints that PTO has allowed or encouraged unfair personnel practices. The IG has identified these problems as one of the top 10 management challenges of the Department of Commerce. Even with increased funding, the problems at PTO are getting worse, evidence that what is needed is better management. The Committee notes that in June 2005, the Government Accountability Office [GAO] recommended several steps PTO should take to improve retention of patent examiners. The Committee directs PTO to provide a report to the Senate Committee on Appropriations, by March 2, 2007, on the status of implementation of GAO's recommendations, as well as, additional steps PTO will take to improve hiring, retention, and human resource practices.


Patent Prospector contains the text from the USPTO draft strategic plan:

One of the most vexing problems in the area of assessing patent examination quality has been the wide-held belief that the current quality review measures of the USPTO inspire little confidence as to the accuracy and meaningfulness of the data and the propriety of any established performance targets. Additionally, whereas the primary quality measure of the USPTO, the allowed application error rate, has varied between 4 and 7 percent over more than a twenty year period, the perception of continuously improving quality has not been achieved to date. The USPTO has undertaken numerous efforts to address these issues by expanding the data considered in this process and refining its assessment processes including introducing an in-process review component to the quality data, employing quality review results to guide the development of examiner training programs, looking at customer satisfaction data, using larger samples of data, using data more targeted to the individual examiner level and considering data from both the supervisory and quality assurance review processes. None of these efforts has achieved the desired results of continuously improving examination quality and increased public confidence in the USPTO quality measures.

Determining what should be the appropriate measures of patent quality and what should be the performance targets given the current initial examination process and levels of resource funding provided to support that process is of critical interest to both the USPTO and the patent community. The patent community could assist in developing an objective, to the maximum extent practical, set of review criteria that could be applied across all selected review processes to promote greater consistency and credibility for the measurements of quality. Further, this effort could determine what measures should be used to assess examination quality, how these measures should be reported and what meaningful quality targets should be the goals of an initial system of patent examination. A critical component in the process of determining these measures and targets would be achieving the proper balance between the desire for assured high quality results from and the inherent realities of the resource limitations and ambiguities of the initial examination process.

Saturday, August 26, 2006

What's happening with conflict of interest and error correction at Science?

In August 2006, IPBiz mentioned the coverage by Science of the conflict of interest issue with the Nemeroff publication.

Flashback to USAToday in September 2003 (three years ago):

Two leading scientific journals are reviewing their editorial policies after complaints that they published material by researchers with undisclosed financial interests in their research fields.

Editors at Science, located in Washington, and London-based Nature said none of the examples involved results of experiments.

Instead, the articles in question fall into a secondary category of editorials, commentaries and data reviews of other scientists' work. Generally, these are not covered by disclosure policies.

"I think there is no bombshell," said Donald Kennedy, editor-in-chief of Science and a former Stanford University president. He called the complaint "a useful reminder" from "responsible critics."


The critics said Emory University's psychiatry chairman Charles Nemeroff reviewed mood disorder therapies in the monthly journal Nature Neuroscience without revealing his ownership of a patent on one of the treatments.

Now, flash forward to 2006. By January 2006, it was understood that Science had published primary research papers of Hwang Woo Suk and co-authors without disclosing the separate patent interests of some of the Korean authors and of Gerald Schatten of the University of Pittsburgh. By August 2006, Science itself was reporting certain issues with the publication of a research paper by Nemeroff.

Three years ago, Science could say: none of the examples involved results of experiments. Now they can't say that.

Of the publication in "News of the Week" in Science on July 28, 2006 alleging that new detail could be add to a patent application while claiming an earlier priority date, I had informed Eli Kintisch (after Science had declined to publish a letter to the editor) that the statement was wrong and that I would publish concerning the inaccuracy. I later informed Science that the article was accepted. There was no response to either. My article concerning the errors in Science/July 28 will be coming out in September 2006. The issue of what was "news" in the July 28 article also remains to be addressed.

***UPDATE on conflict of interest

On Dec. 9, 2006, the Washington Post stated:

A senior government scientist [Pearson "Trey" Sunderland III] who was a focus of a congressional probe into conflicts of interest in medical research admitted in federal court yesterday that he improperly failed to disclose payments of $285,000 he received as a consultant for the pharmaceutical manufacturer Pfizer Inc.


Sunderland, 55, admitted to entering consulting agreements with the drugmaker beginning in 1998 without receiving the required approval in advance or disclosing his income after the fact. Sunderland was paid as a consultant on two projects in which his department was collaborating with Pfizer on research to identify chemical warning signs of Alzheimer's disease.

The criminal prosecution of a researcher for violating conflict-of-interest rules is a rarity. But Sunderland's consulting arrangements, which first surfaced in 2004, were among the most egregious of the possible conflicts detailed during the probe by a congressional subcommittee.


U.S. Attorney Rod J. Rosenstein said the case should send a message to other government researchers. "Dr. Sunderland violated the fundamental rule that government employees cannot accept payment from interested private parties without the permission of their supervisors," Rosenstein said in a statement.

[IPBiz notes separately the recent flap over the panel investigating drug-releasing stents, wherein conflict of interest rules were waived.]

The Mudhopper case

In Wald v. Mudhopper, 2006 U.S. Dist. LEXIS 51669, the WD Ok considered a permanent injunction issue. Plaintiffs [Wald et al.] asked the Court to enter an injunction barring sales activities related to Hole Sweep Sticks, Poly Drill Sticks, or any other infringing variation of those products.

The court noted:

The respective hardships to the parties, when balanced, and the public's
interest also weigh in favor of a permanent injunction. Defendants have not
identified any specific hardship they might suffer as a result of an injunction.
Instead, Defendants' object to an injunction as unnecessary. As support, they
note the immediate cessation of Hole Sweep Stick sales upon learning of the Wald
patent and profess [*17] the intention not to sell Poly Drill Sticks again
unless the Court enters a judgment of non-infringement. However, given the
finding of willful infringement and because there have been no indications that
Defendants do not still possess an inventory of these products or the ability to
secure more, the Court is unpersuaded that there is no need for an injunction.
Cf. W.L. Gore & Assocs., Inc. v. Garlock, Inc., 842 F.2d 1275, 1281-82 (Fed.
Cir. 1988)(noting absence of reason for stopping infringement, failure to
profess an intention not to infringe in the future, and the capacity to resume
production as supporting the grant of an injunction). Plaintiffs bear the risk
of future infringement, while there appears to be no harm to Defendants or the
public's interest resulting from an injunction. Therefore, the Court finds that
equitable considerations support Plaintiffs' request for a permanent injunction
on the terms proposed.


In the Mudhopper case, the patentee (Wald) got a permanent injunction. In CHRISTIANA INDUSTRIES INC. v. EMPIRE ELECTRONICS, INC., 2006 U.S. Dist. LEXIS 54210, the court considered Defendant's Emergency Motion for reconsideration of the Court's Order granting a preliminary injunction and Emergency Motion to amend or correct the Order granting a preliminary injunction. For the following reasons, the Court: (1) DENIES Defendant's Motion for reconsideration; and (2) GRANTS its Motion to Amend the Order.

In the specific area of irreparable harm, the district court wrote:

Defendant asserts that in Ebay, Inc. v. Mercexchange, LLC, 126 S. Ct. 1837, 164
L. Ed. 2d 641 (2006), the Supreme Court eliminated the presumption of
irreparable harm for preliminary injunctions upon a showing of validity and

Plaintiff argues, and this Court agrees, that Ebay did not invalidate the
presumption. The Ebay Court addressed the proper analysis for permanent
injunctive relief.
It held that courts err by categorically granting permanent
injunctive relief on a showing of infringement and validity, without analyzing
the traditional four factors for injunctive relief. The Court reiterated that
the grant or denial of injunctive relief rests with the equitable discretion of
the Court, which must consider the four factors.

The Christiana court did not get into differences in standards between a PRELIMINARY injunction and a PERMANENT injunction.

The difference is not trivial. As pointed out elsewhere:

In ZEN INVESTMENTS, 2006 U.S. Dist. LEXIS 37171 (decided June 2, 2006), the court noted: "The Third Circuit has been unsettled n5 on whether a plaintiff must prove irreparable harm to receive a permanent injunction, as opposed to a preliminary injunction which always requires a showing of irreparable harm." The eBay decision squarely brings back "irreparable harm" into the permanent injunction calculus without giving much guidance on how to evaluate irreparable harm. The immediate impact will be more uncertainty.

The Zen Investment court quickly identified a problem in the eBay decision: that the Supreme Court did not give guidance on how to evaluate irreparable harm.

[IPBiz post 1900]

Medical malpractice in New Jersey

The MIIX Group, (MIIX) was until September 28, 2004, the parent company of a group of medical malpractice insurance and insurance-related subsidiaries. As a result of net losses reported in 2000 and 2001, the insurance subsidiaries ceased writing new or renewal business in all states by September 1, 2002. By December 31, 2003, all insurance policies written by MIIX had expired. Since ceasing to write new insurance policies in 2002, the Company's business has consisted principally of managing the runoff of existing claims, the Company's investment portfolio, and the operations of a New Jersey insurance company, MIIX Advantage Insurance Company of New Jersey, which was renamed MDAdvantage Insurance Company of New Jersey (MDAdvantage). Lawrenceville Re, Ltd. (Lawrenceville Re) is the sole remaining operating asset of the Company, and it has minimal activity. [from google/finance]

In 1993, Mr. Thomas B. Leyhane accepted the position as the first Staff Counsel for the MIIX Group of Insurance Companies concentrating on defense medical malpractice litigation. In November, 2002, Mr. Leyhane became Of Counsel to the firm of Lenox, Socey, Wilgus, Forntidoni, Brown, Giordano & Casey in Trenton, New Jersey.

Sacramento Bee article on ACT stem cell work seriously flawed

The Sacramento Bee, which has produced many insights into Proposition 71 and embryonic stem cell research in California, came up with a real turkey in the August 25 article entitled Patent foes get a break in fight; Breakthrough in stem-cell engineering may weaken group's lock on research.

The "breakthrough" is the use of previously-known technology in the IVF area (methods for removing one cell of a blastocyst for PGD) to isolate the cell and then to grow a cell line from the REMOVED cell, leaving the remaining CELLS of the blastocyst viable.

One stupidity in the Bee article is: If the new method does help to invalidate the Wisconsin patents, it would be an unintended byproduct of the research, said Advanced Cell Technology President Michael West. Work that is done LATER, as here, is NOT PRIOR ART to work done EARLIER (the Thomson/WARF work in the 1990's). If it's not prior art, it's not going to be used to INVALIDATE the earlier patents.

Another problem is found in the text: Now, though, if the new method announced Thursday holds up under further testing, there may be a way around those patent restrictions, said Greely, an expert on legal issues related to stem cell research.

"The mere fact … of having a new way to make embryonic stem cells weakens the WARF (Wisconsin Alumni Research Foundation) patents, which I think is a good thing," he said.

Whether the patent is "weakened" when no challenge is made to the composition claims may be questioned. The Bee didn't get into the composition claims, so IPBiz will present them (again).

The first claim of US 5,843,780:

A purified preparation of primate embryonic stem cells which (i) is capable of proliferation in an in vitro culture for over one year, (ii) maintains a karyotype in which all the chromosomes characteristic of the primate species are present and not noticeably altered through prolonged culture, (iii) maintains the potential to differentiate into derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) will not differentiate when cultured on a fibroblast feeder layer.

The first claim of US US 6,200,806:

A purified preparation of pluripotent human embryonic stem cells which (i) will proliferate in an in vitro culture for over one year, (ii) maintains a karyotype in which the chromosomes are euploid and not altered through prolonged culture, (iii) maintains the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) is inhibited from differentiation when cultured on a fibroblast feeder layer.

IF the PRODUCT of the ACT METHOD falls within the scope of these two patents claims (which to date no one has denied), THEN in theory WARF could take legal action against practitioners of the ACT method who operate without a license from WARF. Whether WARF would take such action is not clear. However, the legal analysis in the Sacramento Bee article is simply wrong in suggesting there is an "alternative."

A related problem is in the text: The Alameda firm, Advanced Cell Technology, has applied for patent protection for its work, as well. Still, as a rule, licensing fees should come down as the number of choices for researchers grows, said Ann Hanham, managing director for Burrill & Co., a San Francisco life sciences venture capital firm.

"Competition is always good," she said.

Of the text: By contrast, he [Greely] said, "WARF is making enemies."

The matter could be decided in court. If the Wisconsin foundation felt that its patents were being infringed, it could sue, and the judge's ruling would effectively establish the validity of the patents, Greely said.

One questions, what "matter"? WARF has already said it is not suing anyone until there is some commercial product, and the research exemption of 35 USC 271(e)(1) would be the most likely defense of any researcher.

Things omitted by the author Jim Downing:

--> Comments by British researchers on problems with the ACT "invention". Ian Wilmut, of Dolly the Sheep fame, said: "the authors make unjustified claims for their techniques."
--> The mere presence of a re-exam request on the Thomson patents, and the weakness of the arguments for invalidity therein
--> The obvious issue that if the Thomson patents cover the composition itself, there is no "way around" the patent claims merely by having a different method to make the same composition. Licensing fees are NOT going to go down, because there is no alternative to the composition claim.
--> Previous (and current) interactions between WARF and Geron.

UPDATE, August 29.

The californiastemcellreport suggests I called the Sacramento Bee a turkey. Look above and see what you think.

As to quotes of individuals in the Bee article, I have no idea if they were quoted in context, etc., so I do not comment on the people quoted. Of the substance, the new work by ACT in 2006, as reported, does nothing to invalidate the Thomson WARF patents from the 1990's. Something else might, but not work in 2006. Separately, how the Thomson WARF patents are "weakened" by the ACT work is not clear if claims of Thomson WARF patents "cover" the product of the ACT method. If someone wants to suggest the Thomson composition claims don't cover the product of the ACT method, that is a different story.

If, however, the claims of the Thomson WARF patents do cover products of the ACT method, then one might argue that the Thomson WARF patents are "strengthened" by the ACT work. Thomson WARF would be getting royalties for use not specifically contemplated by them in the 1990's.

[IPBiz post 1898]

Sikahema blasts money for Rutgers football; stem cells next?

In an op-ed piece on PHL's Channel 10 in the week of August 21, 2006, Vai Sikahema criticized expenditures by Rutgers University on the football program. Among them concerned the purchase of land next to a golf course for the head coach. Sikahema's launching point for the discourse was a news item that Rutgers was cancelling support for non-money making sports (such as men's swimming) and re-directing that money to football.

Sikahema noted that if this sort of the thing were for a successful program, such as at Penn State or Ohio State, it might be understandable, but that the Rutgers football program lost $8 million last year. Sikahema concluded with a remark --well, it's New Jersey.--

One might extend Sikahema's remarks to New Jersey's proposed expenditures in embryonic stem cell research. The idea that "if we build it, they will come" may be a good theme for a movie, but it hasn't worked for Rutgers football, and it likely won't work in stem cell research. Without some sort of intellectual property strategy in place, one can readily foresee that the New Jersey plan for stem cell research will be a failure.

On August 5, the Bridgewater Courier-News had put a more upbeat spin on the sports cuts.

Q: This summer was headlined by the story that Rutgers will be eliminating six sports (men's heavyweight and lightweight crew, men's and women's fencing, men's swimming and men's tennis) in the near future. What was your assessment of the whole situation?

A: Anytime that something existing is taken away, it's always hard for the people involved. I try not get too involved because I think the number of good things we have going in our athletic department, everybody has a role and does it, so I try to stick to what my role is and that's making sure I do everything I can to make the football program as successful as we can. I'm sorry that it had to happen to anybody, but I'm not very qualified to speak on it.

Q: In the aftermath, there were grumblings that while the administration is saving $2 million by cutting six sports it continues to sink more money into the football program. Is that a fair gripe?

A: I think it's a much larger issue than six sports. If you look across the university at things that because of the budget cuts had to happen, I think it's a bigger issue than just an athletics issue. It's a state issue. But one of the things that I really was intrigued with in taking this job was for this state to have something to call its own and for everybody to get behind. I think our program will be that certain something, so I think it's as important as ever that we have a successful program.

Sikahema had noted that Greg Schiano, the Rutgers football coach, is the highest paid state employee in New Jersey.

[IPBiz post 1897]

Thursday, August 24, 2006

ComputerWorld on EFF brief on obviousness (KSR v. Teleflex)

Relevant to KSR v. Teleflex pending before the Supreme Court, ComputerWorld notes that the Electronic Frontier Foundation [EFF] filed a brief asking the Supreme Court to shoot down the so-called "suggestion test," a method the U.S. Court of Appeals for the Federal Circuit [CAFC] has used to determine whether an invention should be obvious to others, and therefore, not patentable.

IPBiz notes: The test of the CAFC requires that there be a finding of motivation to go from various references which have elements of a later-proposed claim to combine in order to reach the invention of the later-proposed claim. The test is used in order to avoid the problem of hindsight reconstruction. Therein, someone challenging the patent claim could find the various elements of the later claim in several different earlier references and say "See, it was all there." Of course, it may or may not have been obvious at the time to combine all those references in order to reach the invention of the claim.

A different variant of this is in PubPat's challenge to Thomson's stem cell patents. Basically, PubPat says that a recipe for making mouse stem cells renders a later recipe for making human stem cells "obvious."

Grant Gross did not mention a dramatically different view of the hindsight problem in obviousness, available on SSRN. His failure to look through all the evidence is an interesting in view of his text:

The suggestion test "has forced litigants to search through haystack upon haystack of technical knowledge for the exact needle in which someone, somewhere, bothers to state the obvious," the EFF continued.

Help me, I've fallen and I can't get up.

Apple to pay Creative $100 million to settle patent litigation

On August 23, 2006, Apple and Creative Technology have agreed to settle their legal dispute over music player patents with Apple paying Creative $100 million.

Apple got a licence to a Creative patent for the hierarchical user interface used in that company's Zen music players.

With the settlement, all legal disputes between the two companies related to the patent will disappear.

Plagiarism, or how Edison got outsourced to India

Earlier in 2006, I wrote an article for Intellectual Property Today entitled "Edison as a Patent Troll?" which was supposed to be published in the April 2006 issue of Intellectual Property Today. It wasn't published. To get some information out (relevant to among other things current debate about proposed rules changes for continuing applications), I placed some of the content on ezines, with the title:
Edison as a Patent Troll, or Where is California Going in Stem Cell Research?

I learned today that Edison as a Patent Troll, or Where is California Going in Stem Cell Research? had made its way to onlypunjab with authorship attributed to Annie-Kaszina.

Edison as a Patent Troll, or Where is California Going in Stem Cell Research? by Annie Kaszina

Perhaps this is a new variant on "How Opal Mehta Got Kissed, Got Wild, and Got a Life" by Kaavya Viswanathan.

One notes that the plagiarism business at Ohio University involving certain masters theses in the mechanical engineering department has received a lot more publicity than did the incidents involving Viswanathan or Laurence Tribe or Harvard.

[IPBiz post 1894]

Wednesday, August 23, 2006

Are the ACT stem cell claims unjustified?

In "Row Over New Stem Cell Claims," Stewart Patterson writes that claims of ACT scientists have been greeted by skepticism among UK scientists.

The ACT team, led by Dr Robert Lanza, stated: "The ability to create new stem cell lines and therapies without destroying embryos would address the ethical concerns of many, and allow the generation of matched tissue for children and siblings born from transferred PGD (pre-implantation genetic diagnosis) embryos."

PGD has been used in IVF for years.

Ian Wilmut said: "the authors make unjustified claims for their techniques."

Do sellers of "medical devices" that work through the placebo effect violate the Lanham Act?

Relevant to earlier posts on Adam Dreamhealer, an IPBiz reader sent in something from the Aug. 23 Chicago Tribune which illustrates an intellectual property dimension of healers.

Placebo effect a key issue in trial over pain bracelet

By Michael Higgins, Tribune staff reporter. Staff reporter Kayce T. Ataiyero contributed to this report Published August 23, 2006

This week, however, a federal judge in Chicago could decide whether Andrew Park can keep his Q-Ray riches, or whether his company must forfeit up to $87 million in sales and permanently stop claiming that the bracelet relieves pain.

A Mayo Clinic study concluded that buyers benefited from a placebo effect, which occurs when people feel better simply because they expect a pill or therapy to help.

The idea that an advertiser could claim a product works when it does so only through a placebo effect is anathema to Federal Trade Commission officials and consumer advocates. Yet attorneys for QT Inc. argued last month in court that any relief could legitimize the claim.

The "mechanism is not an issue," argued Michael Ficaro, attorney for QT Inc. "More than three out of four people got relief from this product. And the other quarter who didn't got their money back. ... How in the world does that violate the [false advertising] act?"

When an FTC attorney said no previous court had accepted that argument about the placebo effect, Denlow replied: "Well, maybe I should be the first. ... That's never bothered me."

The placebo effect can be strong. In the Mayo study, more than 75 percent of people who used a "non-active" bracelet reported some pain relief, the same percentage that reported relief with the Q-Ray.

Just as important, experts say, is the fact that pain often increases and decreases over time. People tend to reach out for unconventional products when they are feeling their worst. When their condition naturally improves, they associate that result with the product.

[IPBiz post 1892]

Third trial in Rambus/Hynix case postponed till at least Feb. 07

In another installment in the Rambus/Hynix case, Judge Ronald Whyte said the third trial in the case will begin no sooner than February 2007.

This case presents issues of patenting industry standards, as came up, for example, in the Unocal case on gasoline.

The FTC ruled on August 2, 2006 that Rambus engaged in deceptive conduct. The issue is that Rambus attended meetings of a memory chip standards panel without disclosing its patent interests.

In a different vein, recall that Science published the two papers of Hwang Woo Suk et al. without disclosing that Hwang and Schatten had patent interests in the stem cell work being presented in the papers.

Damages upped against Microsoft in Z4 ED Tex case but NO INJUNCTION

US District Court Judge Leonard Davis upped damages against Microsoft by $25 million, but did not grant an injunction against Microsoft.

Thus, we have another data point in the eBay v. MercExchange aftermath.

CDC publishes paper in JAMA on keratitis problem associated with lens solution

Further to the fungus problem associated with Bausch & Lomb's ReNu, the CDC has new information on the causative factors:

"We think that there's something about the chemical make-up of the solution that allows the fungus to grow and cause infection," said study senior author Dr. Benjamin J. Park, medical officer with the U.S. Centers for Disease Control and Prevention. "We don't know the exact mechanism, but it's important that users of solution don't use Moistureloc."

In May, 2006, Bausch & Lomb stated that the combination of moisturizing agents exclusive to MoistureLoc could increase the risk of keratitis infections in unusual circumstances.

In the CDC work, which appears in the August 23/30 issue of the Journal of the American Medical Association, researchers looked at confirmed cases of Fusarium keratitis that occurred after June 1, 2005.

As of June 30, 2006, 164 cases had been identified in 33 states and one U.S. territory. About one-third (34 percent) of these patients required corneal transplantation. Almost all (94 percent) wore soft contact lenses.

This latest paper focused on 45 patients and 78 controls. Sixty-nine percent of patients had used ReNu with MoistureLoc, compared with 15 percent of controls.

[Getting back to DreamHealer, one does need controls to begin to make assertions about causation.]

Perelman says no to Fields Medal

Further to the discussion of prizes as motivators to innovation in the stem cell and energy fields, note that Russian Grigory Perelman, who published an outline of a proof for the Poincare conjecture back in 2003, has turned down the Fields Medal.

Separately, the Poincare conjecture is one of seven Millennium Prize Problems listed by the Clay Mathematics Institute, with a million dollar bounty offered for a solution. It is considered to be one of the most important questions in topology - the study of the nature of geometric structures.

Sunday, August 20, 2006

More on Dreamhealer

LiveScience discusses the silly ABC report on Adam Dreamhealer:

This case illustrates a common logical error in thinking, one that has Latin name: post hoc ergo propter hoc ("after this, therefore because of this").

Debbie assumed that because Trevor regained consciousness after Dreamhealer said he "healed" him, Dreamhealer caused Trevor to come out of his coma. But it is likely that Trevor would have emerged from the coma with or without Dreamhealer's efforts; people emerge from comas all the time without any psychic or "special healing" efforts. To find out if Dreamhealer's powers helped, we would need a control group: two sets of patients in the same condition, only one whom received Dreamhealer's "healings." This of course would be difficult and expensive to do, but it is the only way to verify powers such as those claimed by psychic healers.

Op-ed in Hartford Courant reveals ethical problems in stem cell funding

A different twist on the Princeton study on the possibility of US stem cell researchers leaving the US is given by Jesse Reynolds:

For example, the board [in Connecticut for stem cell funding] includes Xiangzhong "Jerry" Yang, the state's premier stem cell researcher. Last year, he threatened to move his work to China if the state did not pass the funding bill. Once he was on the committee, he made it clear that he'd be seeking big bucks. He's now applied for $5 million - from his own committee.


This lack of clarity in ethical standards likely suits Professor Yang. You may remember him from 1999 as one of the animal biologists who created the first cloned cow. He now wants to create cloned human embryos, not to create cloned children, but for stem cell research. This technique may lead to relevant discoveries, but it is an ethical minefield. Just this month, a top Australian stem cell researcher said that "the ethical problem is not the embryo, it is the human egg donor ... It's a surgical technique which has had side effects in the past."

Reynolds also addresses the intellectual property issue, an area in which California has set standards in fumbling the ball, but apparently closely followed by Connecticut:

The program is moving forward with awarding grants without adequate policies in place, leaving key questions unanswered: Who will own the patents of any discoveries made with state money? Will medical treatments discovered with taxpayer dollars be available to Connecticut residents at favorable prices? How can women be responsibly recruited to provide eggs for cloning-based stem cell research? There are rough sketches of some of the answers, but the details will be hammered out after the funding decisions are made.

Of conflicts-of-interest:

Instead, in January, 2006 the [Connecticut] General Assembly simply doubled the size of the committee - and exempted it from conflict-of-interest laws.

More on peer review of patents

Nicholas Varchaver of Fortune writes: -- The problem: an epidemic of shoddy patents.

The solution: Wikipedia? [i.e., peer to patent]

That's the basic concept behind a pilot program sponsored by IBM and other companies, which the U.S. Patent and Trademark Office appears poised to green-light. The project would apply an advisory version of the wiki approach to the patent-approval process.

The issue is that patent applications have tripled in the past two decades, leaving examiners only 20 hours on average to comb through a complex application, research past inventions, and decide whether a patent should be granted. [IPBiz query: how long has the 20 hour amount been in effect? Longer than the last 20 years?]

As a result, critics contend, quality has declined and lucrative patents have been granted for ideas that weren't actually new.

Varchaver did not mention the failure of BountyQuest.

The article notes: Patent examiners will be given only the ten highest-rated pieces of input, and attempts to sabotage a competitor's application by submitting phony material should theoretically be avoided.

IPBiz notes: Sorry dudes, but if you think the "highest rated" reviews on are the best reviews, you really are clueless. Further, the mutual back-scratching found in scientific citations illustrates how a cluster of common-thinkers (possibly competitors) could get into the ten highest rated pieces of input.

Varchaver quotes John Doll:

Says the commissioner for patents, John Doll: "We're just trying to put the finishing touches on the details before we roll it out to the [head of the Patent and Trademark Office] and get the final approval to move ahead."

Recall that Science quoted John Doll in the July 28 issue on another proposal to enhance quality of patents, that of limiting continuing applications. In fact, the quote of Doll was the only news in that article which appeared in the "news of the week" section in Science.

Thus, the USPTO is getting a lot of publicity on its efforts to place "quality" in patents.

Authorized generic dimension coming into play in PLAVIX saga?

Dr. Reddy's Laboratories [DRL] has already filed an ANDA [abbreviated new drug application] for Plavix with the US FDA in 2002. Also, BMS has admitted that it had engaged DRL in talks to settle the deal. Because DRL is an experienced player in the authorized generic area, DRL is a most suitable contender to the role to provide product for a PLAVIX authorized generic.

DRL is also collaborating with innovator Merck to bring out an authorized generic of cholestrol drug Zocor, on which Ranbaxy and Teva have secured 180-day exclusivity rights for their copycat versions [different strengths for Ranbaxy and Teva, with Teva having the preferred strength]. Generic versions of Zocor may undercut sales of Pfizer's Lipitor.

However, will an authorized generic really impact the situation?

From Marketplace:

Morningstar analyst Tom d'Amore says Apotex managed to ship out enough generic product to last pharmacists for months. The hearing on Friday, Aug. 18 in which BMS sought an injunction to stop Apotex shipping its generic, and to recall any product already in pharmacies. But it may be too late, says Nielsen Hobbs of the pharmaceutical letter The Pink Sheet.

D'Amore is also quoted: The management of Apotex has out-maneuvered Bristol Myers, both in terms of the negotiations and now in terms of their operations.


Of course, it may be that the patent position of BMS was exceptionally weak in this enantiomer/racemate case.


Saturday, August 19, 2006

Woo Suk, not in disguise, with pigs

Hwang Woo Suk is back in the stem cell business, albeit working on pigs for organ transplants.

A lot of folks in the U.S. don't appreciate the support Hwang Woo Suk still enjoys in South Korea. Most of Hwang's research team that previously worked with him in cloning pigs and humans have chosen to work with Hwang at the new foundation, Suam Biotechnology Institute.

Journal Science advancing PTO agenda on continuing applications?

In the journal Science, the article "US Wants to Curtail Add-On Patents to Reduce Backlog" appeared in the "News of the Week" section (see 313 Science 425 (July 28, 2006)).

The first two paragraphs were about the Chiron v. Genentech case decided years ago, which illustrated that patent applicants CANNOT continually add detail to a pending continuation application. The article mentioned the proposed rule change to limit the number of continuing applications, which was published in the Federal Register in January 2006. So far, this isn't news.

The new item was a quote from PTO Patent Commissioner John Doll: "Examiners review the same applications over and over instead of reviewing new applications." The Science article also said "The new limit, he told Science this week, will "improve quality and move [PTO] backlog." So the news is that Science is assisting the PTO with its proposed rules change.

The Science article did refer to the comment period. However, the article asserts that the changes have pitted biotech companies against computing and software sectors. The Science article did not mention the comments of intellectual property groups and intellectual property attorneys. The Science article did not mention that second (and further) continuing applications comprise only abut 5% of all applications and eliminating them entirely [which is not even the proposal] would not remove PTO backlog.

An earlier article in Science (about pubmedcentral) entitled SCHOLARLY PUBLISHING: NIH Flooded With Comments on Public Access Proposal was more directed to analysis of comments than about advancing government agency agenda. [See Science, 26 Nov 2004 at page 1451, (V. 303)]

Friday, August 18, 2006

On " Calling the Tune on ESC Research: Therapies or Tools?"

The californiastemcellreport.blogspot has a post titled " Calling the Tune on ESC Research: Therapies or Tools?" which reviews an article by Nicholas Wade in the NYT on August 14 which discussed the split between those who want to see development of stem cell therapies versus those who see embryonic stem cells as a research tool to study mechanisms of disease.

The blog notes That discussion has rumbled through CIRM for most of its existence and IPBiz has noted the different options, not in the context of CIRM, but in the general context that many researchers think the genetic profiling utilization is more likely to gain results in the short term.

The blog quotes Wade quoting Thomas M. Jessel: "'Many of us feel that for the next few years the most rational way forward is not to try to push cell therapies,' Dr. Jessell said. Scientists have spent the last five years mostly in learning how to grow human embryonic stem cells in the laboratory and how to make them differentiate, meaning to turn into the body’s various types of mature cells.'"

IPBiz ponders: how does that quote impact the PubPat/FTCR challenge to WARF's Thomson patents? PubPat asserts that once scientists had a recipe for growing MOUSE stem cells, growing human stem cells was OBVIOUS. Do scientists spend five years working on the OBVIOUS?

The blog noted: While scientists have preferences on the direction of stem cell research, no research is done without funding. Given the amount of money that CIRM can bring to bear on the subject (10 times the annual spending of the NIH on ESC research), the views of scientists oriented towards use of ESCs as research tools may not be the key factor in determining the main direction of new stem cell research in the United States.

IPBiz notes: The probability of getting royalties in the next ten years is far higher from patents of the research tool type than it is from patents of the human treatment type. It is a question of what objectives CIRM has.

IPBiz got a chuckle from the text in the blog: As the California stem cell agency wrestles with how to give away $3 billion – otherwise known as strategic planning – along comes a related article in the nation's most prestigious newspaper, the New York Times.

On August 17, the Times wrote that human stem cells were being obtained in Singapore through harvesting of blastocysts obtained through cloning of human embryos. Undoubtedly news to the rest of the world who are laboring under the perception that Hwang Woo Suk's work on SCNT cloning of hESC was a fraud.

Thursday, August 17, 2006

Claims of Synopsys '114 patent rejected in re-exam

All 15 claims of Synopsys' US 6,378,114 have been rejected in re-examination. Synopsys is involved in patent litigation with Magma Design.

New York Times promoting voodoo science?

On August 17, the New York Times had an article entitled "Luring Top Stem Cell Researchers With Financing and Freedom" which discussed Biopolis.

Of some interest is the paragraph:

Bush administration opposition to stem cell research is based on the argument that it requires destroying embryos, each potentially representing a human life. Singapore allows stem cells to be taken from aborted fetuses or discarded embryos, and these embryos can be cloned and kept for up to 14 days to produce stem cells.

Lest we forget, the only research group on the planet to claim the cloning of human embryos and creation of a stem cell line from blastocysts therefrom is the group of Hwang Woo Suk, assorted members thereof who are facing various criminal charges in South Korea. The two papers in Science making claims of SCNT cloning of human cells were formally retracted in January 2006. So the NYT voodoo science idea "these embryos can be cloned to produce stem cells" is in need of revision. I'd write the NYT myself but I'm still tired out from trying to convince the journal Science that new matter cannot be added in continuation patent applications. [Incidentally, no patent lawyer of any stripe has stepped forward to assert that new material can be added to a continuation application. I'm still waiting.]

Of some relevance to the Princeton University reports being used by the Proposition 71 / CIRM folks is the following:

Lavish salaries and lofty titles have helped Singapore staff Biopolis with a roster of foreign luminaries. In 2001, the same year President Bush first imposed limits on financing of stem cell research, Singapore snagged the National Cancer Institute researcher Edison Liu Tak-Bun.

Dr. Liu said he had felt hemmed in by outdated academic structures
and the biotechnology industry's preoccupation with financial survival.

''Singapore, however, welcomed new ideas and, because of its newness, provided degrees of organizational freedom necessary for me to succeed,'' Dr. Liu said in an e-mail interview. He now works at Biopolis as head of the Genome Institute.

In 2003, Singapore lured Jackie Y. Ying from the Massachusetts
Institute of Technology, where she had become its youngest tenured professor ever,
to head up its Institute of Bioengineering and Nanotechnology at Biopolis.

Earlier this year, Singapore scored another pair of Americans, the
dean of the University of California, San Diego's school of medicine, Edward W.
Holmes, and his wife, Judith L. Swain. Dr. Swain was the school's dean of
translational medicine -- the specialty of turning laboratory discoveries into
practical drugs or therapies.

[IPBiz note: Larry Lessig once promoted a translational theory of constitutional interpretation.]

Kean vs. Menendez on stem cell research

In an article about the US Senate race in New Jersey between Robert Menendez and Tom Kean Jr., Charles Babington noted:

A different nationally prominent issue -- embryonic stem cell research -- may prove more troublesome for Kean. Both candidates disagreed with Bush's veto of legislation to allow more federal research on such cell lines. Democrats, however, note that Kean voted three times as a state senator against bills to publicly fund embryonic stem cell research. Kean says he opposed the measures because they would have steered borrowed money to new buildings without voter approval.

The question of what New Jersey has done to fund stem cell research, while seemingly a simple one, is actually complicated. To date, no question involving the use of bonds to fund stem cell research has been on the NJ ballot. There were recently two bond proposals, one for buildings (3 different centers) and one for support for what was to be done in the buildings.

Various newspapers have suggested the New Jersey legislature has funded stem cell research. It is not clear that these reports are correct.

Firefox and blogspot

Although one Firefox user said he was picking up the latest posts on IPBiz.blogspot, some Firefox users are not so lucky.

Separately, in a number of tests, it is positively clear that Internet Explorer is picking up updates on the IPBiz blog a lot faster than Firefox is.

[IPBiz post 1877]

Apple gets design patent D526,648

Apple obtained a design patent direct to the design of the Mac mini. (D526,648)

Apotex PLAVIX play to impact Lilly's prasugrel?

AP has noted that Lilly's own blood-thinner, prasugrel, will face heightened competition if the cheaper, generic form of Plavix stays on the market. Lilly officials have said they expect to submit the medication to the Food and Drug Administration in late 2007.

Note that this is a variation of the impact on Lipitor caused by Zocor going generic. Once one member of a "class" goes generic, there will be price pressures from those paying the bills for patients to utilize the cheaper generic. AP noted--"I think we're in an area where you have to be materially better to justify the cost," said George Farra, a principal with Woodley Farra Manion Portfolio Management in Indianapolis. "If there isn't that much differentiation between the two, the cheaper version will be recommended by the insurance companies."

On Friday (Aug. 18), BMS and Sanofi go to federal district court to try to stop Canadian generic company Apotex from selling its version of PLAVIX and recall product already sold.

AP also noted--"The possibility that generic clopidogrel (Plavix) will become available earlier than expected underscores the validity of our clinical trial strategy," J. Anthony Ware, vice president and global brand development leader for prasugrel, told The Associated Press in a statement. "We chose this strategy chiefly because we had anticipated that clopidogrel (generic Plavix) would be available on a generic basis for most of prasugrel's life cycle."

Bear Stearns analyst John Boris called prasugrel Lilly's most important pipeline drug.

[IPBiz post 1875]

Wednesday, August 16, 2006

Patent prosecution business booming in Connecticut

U.S. patent attorneys in the later days of patent application offshoring?

According to an article by Douglas S. Malan: As high-tech innovations emerge from Asia and the Middle East, there's a new wave of expansion opportunities for intellectual property firms. Cantor Colburn, for one, is cashing in on the uptick in patent filings. An increased amount of patent prosecution in such fields as nanotechnology, life sciences and alternative energy sources has allowed it to carve its niche as a firm that can handle a large volume of patent analysis, clearance and preparation. "We keep hiring to meet the needs of the workload coming in," said name partner Michael A. Cantor. Now at nearly 70 lawyers, it is among the largest law firms in the state.

With his emphasis on Asia and the Middle East, it was surprising that Malan omitted mention of Cantor Colburn's offshoring / outsourcing of patent application drafting. As in many articles, it's what is NOT mentioned that is MOST interesting.

Of the pricing issue:

"We're doing a little more [discount work] than we have in the past," Linderman noted. "It's a pretty small percentage of our business ... less than five percent."

The current demand for discount pricing is something "that was almost unheard of 10 years ago," around the time McCormick merged with Chapin, Neal & Dempsey in Springfield, Mass., Linderman added.

Cantor Colburn partner Philmore H. Colburn II, however, said he has seen a decrease in the one-size-fits-all approach that sometimes leads to "lower quality patents." Companies, he said "want strong patents that hold up in court. ... A lot of clients realize when they [shop for the lowest price] they might not end up with what they wanted."

Of patent agents:

With the emergence of business in highly specialized industries, Cantor Colburn, he said, has attracted a stable of skilled professionals in various technical arenas that pass a federal examination to become patent agents. Some of these agents -- which at Cantor Colburn bill at a rate of $100-$250 an hour compared to $150-$390 an hour for a patent attorney -- resurrected their careers after layoffs from tech companies. They provide expert analysis of patents while being "heavily involved in backroom goings-on," Cantor noted.

Of solo practitioners:

There's also room for the solo practitioner. Armed with an extensive background in biology and chemistry, Milford attorney Michael James Chang, one year into his career as a solo, is banking on the vitality of the state's pharmaceutical startups to build his practice. Chang, a former associate at Cantor Colburn and the Fairfield, Conn., IP boutique Ryan, Mason & Lewis, also takes on work from independent inventors and small businesses.

Operating as a one-man firm allows him to present competitive prices -- he charges $200 per hour -- and give individual attention that might not always exist in larger firms, he said, adding he has yet to hear negative remarks from prospective clients about practicing on his own.

The real challenge, he said, is something he took for granted at his previous jobs. "It's really just trying to drum up business. When partners are doing that all the time, as an associate you don't appreciate it as much" as when networking alone, he said.

But the work certainly is there for the taking. "The word has gotten out that not only is IP hot, but it's here to stay," Cantor said.

Malan got an important legal fact wrong:

Observers say prosecution growth could be tempered by the Supreme Court's recent decision in KSR International v. Teleflex, a case that might result in tighter laws restricting the number of patent filings based on their obvious comparison to prior patents.

The Supreme Court has not yet heard oral argument in Teleflex, much less issued a decision. Further, any (hypothetical) impact of Teleflex (a case which will address the motivation requirement in obviousness determinations under 35 USC 103) on the number of patent filings is less than clear.

Tuesday, August 15, 2006

Conflict of interest issue in Nemeroff paper discussed by Science

An article in the August 4 issue of Science reveals a "conflict of interest" ethics matter in the publication of a paper on VNS without noting that the authors had a financial stake in VNS. Worse: one of the authors of the paper was the editor of the journal!!

Science omitted mention of its publication of two papers by Hwang Woo-Suk et al. without mentioning that Hwang Woo-Suk (and several co-authors) had filed patent applications and that Gerald Schatten had filed (independent) patent applications. Thus Science published two papers without revealing that the authors had a financial stake in the subject matter.

313 Science 598 (4 Aug 06):

The undisclosed background of a paper on a depression

An article on vagus nerve stimulation (VNS) published
in the journal Neuropsychopharmacology omitted an
important detail: All the authors are paid advisors
to the company that manufactures a device for VNS that
was approved last year by the US FDA.

Charles B. Nemeroff, lead author AND editor-in-chief
of the journal.

First draft of the paper was prepared by a
professional writer, hired by Cyberonics.

Bernard Carroll had written of Nemeroff "incestuously"
placing the article in his own journal.

Drummond Rennie is quoted in the article.

NJ AG Zulima V. Farber resigns on Aug. 15

PHL channel 10 carried the press conference with Corzine and Farber live.

Gov. Corzine spoke first. One could see that AG Farber was not a happy camper, stating that Corzine stole the headline of her resignation. Also, Farber said: “I am steadfast in my conviction that the findings do not compel my resignation, and no one has asked for it.”

The present accusations that Ms. Farber might have influenced officers when the police stopped her companion [Hamlet Goore]in late May in Fairview [Bergen County] had revived past criticism of her selection as AG earlier this year. At the time, her driving record — including 12 speeding tickets, 4 bench warrants and 3 license suspensions — was questioned, but Mr. Corzine dismissed such criticisms. Ms. Farber was taken to Fairview in her state car, driven by a state trooper. Farber acknowledged that Mr. Goore had told the police that his companion was coming to help remove some items from his van — and that his companion was the attorney general.

The investigation of Farber, led by a former state appeals court judge from Atlantic County, Richard J. Williams, found that although Ms. Farber broke no laws at the scene, her appearance there raised “serious ethical questions.” Judge Williams’s report cited three specific violations of the Department of Law and Public Safety’s code of ethics that prohibit officers and employees from accepting favors because of their position or appearing to influence others.

Not a great moment, and not handled well by Corzine, but in the scope of New Jersey politics...

Monday, August 14, 2006

Defect between Firefox and blogspot

As of noon on August 14, 2006, one cannot access a number of recent posts on IPBiz.blogspot through Firefox.

These include everything between


Internet explorer is reading them all.

Sadly, if you are using Firefox, you won't get this message either.

Blackboard sues Desire2Learn in ED Texas

Blackboard, an American maker of internet education systems, took the academic community by surprise in July 2006 when it announced it had been granted a broad patent in the US covering 44 claims related to learning management systems. Blackboard became the largest company in this market when it merged with Canadian-based WebCTin late 2005.

On the same day that it publicly disclosed its patent, Blackboard started a patent infringement suit in a Texas court against Desire2Learn.

The No Education Patents wiki ( purports to provide a plain-language explanation of all 44 claims contained in the Blackboard patent and it invites the community to submit specific examples of prior art.

IPBiz notes that, when big patent issues come up, those concerned respond without the need for "peer to patent." Generally, if a patent arises which includes claims anticipated by the prior art, it should be painfully easy to show this without invoking cumbersome bureaucracy.

[IPBiz post 1870]

Sunday, August 13, 2006

The Register on the Hatch-Leahy patent reform bill

Of the provision in the Hatch-Leahy bill restricting the award of damages for patent-holders to the value of the contested patent’s unique features – not the economic worth of the infringing product as a whole, The Register mentioned the troll word:

Yes, we’re talking about patent-trolls, folks. The damages limit is meant to lower the incentive to stockpile patents for the sole purpose of litigation, which will increase the public good by ensuring that these government-sanctioned monopolies we know as patents end up in useful products and services, and not just as leverage for suits against the tech companies that actually produce the goods and services.

Of the Kennedy concurring opinion in eBay v. MercExchange: That case contained a concurring opinion by Justice Kennedy highlighting the aforementioned patent-troll dilemma and suggested that courts should look unfavorably on patent-trolls when deciding whether to enjoin patent-infringers from continuing to manufacture goods or employ business systems. Since this was only a concurring, and not a majority, opinion, however, this statement amounts to mere legal dicta (or, in layperson’s terms, “a bunch of hot air”). While some courts may rely on it, it has no guaranteed effect as precedent. Moreover, that case dealt with injunctions, and not the legal damages referred to in the bill. (The former prohibits or compels actions, while the latter deals with money.)

Of first-to-file: The most innovative, and potentially most beneficial, development contained in the Senate bill is the proposed switch to a first-to-file system. In a rare move for the US Senate, the bill would draw the US patent regime in line with, well, every other patent regime on the planet. Moving US law towards congruence with international norms is a new trick for the Senate, but one that should improve the state of the law in this area and move the world a little closer to global patent uniformity.

Right now, the US employs a first-to-invent system for establishing patent priority. The patent code allows a previous inventor to interfere with the issuance of a patent by claiming that they, in fact, invented the subject of the application first. If the first inventor has “abandoned, suppressed or concealed” the subject of the patent, however, he loses his priority. Thus, if an inventor or developer sits on a new invention and does nothing, a subsequent inventor can come along and claim the patent. The subsequent inventor must have come up with the idea on his or her own, though – stolen inventions cannot receive a patent.

Bleepers go after Ebert

Further to the IPBiz post about Bob Park on the movie Bleep, Bleep people William Arntz et al. have taken on my namesake Roger Ebert:

Please do the research, Mr. Ebert. We would be happy to speak with you, answer any and all of your questions, do whatever we can to help you set the record straight. You are a highly respected mediator of American cultural values. Your words have power. Please do what you can to make sure that they do not misrepresent a film that is proving to be of great value (and a positive inspiration) to hundreds of thousands of Americans.

There's an allusion to Professor Tiller of Stanford, and to Einstein:

We wonder how a professor Emeritus from Stanford University is "not qualified," or a research physicist from CERN. The one "case in point" you printed about the chiropractor reminds us of the famous comment: "What does a patent clerk in Switzerland know about the physics of light?" This was the rebuttal of many "qualified" physicists to Einstein and his Theory of Relativity.

Following his three 1905 papers (one of which concerned special relativity), Einstein secured an academic position.

Bob Park on August 11 noted: An editorial by Donald Kennedy in today's issue of the journal Science, says the public is concerned about climate change and favors government action. State and local governments are voluntarily assuming what Kennedy refers to as a "neglected federal mandate." I say, "stay the course." When the world runs out of fossil fuel the greenhouse problem will begin to solve itself.

IPBiz is waiting for Kennedy to correct Science's error on patents presented in the July 28 issue. The world will run out of fossil fuel first.

OU prof sues OU over plagiarism business

While the Harvard Business Review encourages readers to "plagiarize with pride," things have gotten more complicated in the Ohio University plagiarism business.

On August 13, the Los Angeles Times reported:

A professor has filed suit accusing Ohio University of defamation, saying school officials wrongly accused him of allowing mechanical engineering students to plagiarize.

The lawsuit by Jay Gunasekera also claims that university officials characterized the former department head as unethical, dishonest and supportive of academic fraud. Thirty-seven engineering graduates were accused of plagiarizing parts of their master's research projects.

The Athens News reported:

The folks concerned with public relations at Ohio University can't be too happy about the story that graces the cover of The Chronicle of Higher Education this week -- it focuses on the recent plagiarism scandal at OU.

The publication is the main U.S. magazine covering higher education, and if college officials care about what their peers in higher education think of them, they care about what appears in The Chronicle of Higher Education.

The top-of-the-fold cover presentation includes a photo of former OU graduate student Thomas Matrka and the headline, "The Copycat's Foe: A Graduate Student Checked a Department's Theses for Plagiarism. Now 37 Degrees Are in Question."

Inside the lengthy story runs for three and a half pages, without ads, and includes more photos of Matrka and several photo examples of the alleged plagiarism.

The story reads, "Over the past two years, ferreting out plagiarism has become Tom Matrka's hobby, maybe even his obsession. And he's gotten very good at it. So adept, in fact, that the former graduate student at Ohio University -- now a project engineer at a nearby explosives factory -- has single-handedly blown the lid off a huge plagiarism scandal at his alma mater.


One OU professor who works in the mechanical engineering department where the plagiarism occurred questioned the seriousness of the plagiarism unearthed by Matrka. Hajrudin Pasic told The Chronicle that most of the plagiarism found at OU occurred in introductory chapters of theses, which is mainly boilerplate and doesn't reflect the actual research. He also noted that all but a few cases involved international students who, according to The Chronicle writer's paraphrase, "may have either not known correct citation practices or, struggling to write in a foreign language, been tempted to borrow another student's words."

Star-Ledger addresses Apotex launch of generic PLAVIX

George Jordan's article in the Newark Star-Ledger begins: Barry Sherman, the outspoken owner of the Canadian generic drug company Apotex, howled for years about Big Pharma's dirty tricks in battling the generics industry.

[Sherman's] latest maneuver -- flooding the American market last week with a copycat version of the top-selling blood thinner Plavix -- may rewrite the rules of the tug-of-war between generic drugmakers and the big, brand-name pharmaceutical companies.

[I]f a court later finds the brand-name's patent has been violated, the generics company faces triple the damages. Only a half-dozen times in the past two decades have drugmakers launched a copy-cat drug "at risk."

Sherman told The Star-Ledger in an interview that he planned all along for a product launch because he didn't expect U.S. regulators to sign off on the "reverse payment" deal.

In a line that could have come right out of Stalk and Lachenhauer's "Hardball:"

"This is a bold strike and consistent with his business strategy," Jim Keon, president of the Canadian Drug Manufacturers Association, said of Sherman. "You don't get to be No. 1 by sitting back and being conservative. Barry built his company from scratch."


Apotex has earned a reputation for being combative and litigious; during the 1990s the company was involved in 100 different court cases. It also has a long history of challenging big drugmakers before their patents expire.

In 2001, Apotex made copies of Bayer's antibiotic Cipro, and in 2004 Sherman sold a low-cost version of the antidepressant Paxil before GlaxoSmithKline's patent expired. In both cases, he avoided punitive legal judgments.

The article also states:

Several published reports have noted the central character in John Le Carre's novel "The Constant Gardener," which was made into a major motion picture in 2005, bears a striking resemblance to Nancy Olivieri, a renowned Canadian hematologist at the center of a whistler-blower dispute with Apotex.

Jordan's article did not get into the underlying legal and technical issues of the PLAVIX (S-clopidogrel) matter. PLAVIX is an example of the chiral switch, as is NEXIUM.

Of the Newark Star-Ledger's allusion to triple damages for intentional infringement, note that the "In the Pipeline" blog as a different story:

The ceiling tiles really began to rain down at that point. There was a clause in the agreement that if the deal didn't go through, Apotex could start selling its generic version with five days notice, and that's exactly what they've started doing as of earlier this week. The generic isn't all that much cheaper, but it's enough to torpedo the branded version.

What's more, it appears that BMS and Sanofi-Aventis limited their potential recourse. Under the usual rules, they'd be able to sue and obtain triple damages if they won, but they seem to have waived that right, along with several others. This would seem to be an indicator of just how much they wanted to keep the generic off the market, and how hard a bargain Apotex drove. It's enough to make you wonder if Apotex factored in, up front, the chance of the whole thing being rejected and decided to give their rivals enough rope with which to hang themselves.

It would seem that if Pipeline got the story right, then the Newark Star-Ledger got that part of the story wrong.

Pipeline also said:

It's difficult to see how this could have worked out more horribly for the two big companies here: their best-selling drug is under attack five years early, they've signed away their rights to do much about it, the analysts are downgrading their stock and the financial rating agencies are looking at lowering their credit ratings, and the criminal investigation is rolling right along. Short of a meteor strike or a plague of frogs, I'm not sure what else could go wrong. And the worst part is, they brought it on themselves. Their patent position should have been stronger in the first place to protect a compound of this importance, and they shouldn't have pushed the envelope so much with their go-away payments to Apotex. It didn't have to be this way. Did it?

One commenter on Pipeline got to the potential issue:

The original patent, which claimed the racemic form and explicitly both enantiomers of clopidogrel, expired in July 2003, while BMS and Sanofi have relied on the validity of a patent, US 4,847,265, filed in July 1989 but valid until 2011, which only claims the marketed enantiomer.

Although the Star-Ledger praised BMS CEO Dolan, one Pipeline commenter wrote:

The CEO of BMS is Peter Dolan, who hasn't made a major value-enhancing move for BMS since he became CEO six years ago. Why should he break his streak now?

And another wrote:

and the french taking on a business in Jersey? sanofi-aventis US headquarters is in NJ (Bridgewater) AND they just moved to the old AT&T complex at 55 Corporate Drive. They also have approval to build 3 new buildings there, in addition to the 3 already there. Mark my words, Sanofi will make a play for BMS.

IPBiz notes US 4,847,265 issued July 11, 1989 based on US app 07/155,550 filed Feb. 12, 1988. There are claims of foreign priority, but the '550 is not a continuation application.

The '265 patent cites to US 4,529,596, the abstract for which states: The invention also relates to the preparation process of new thieno [3,2-c] pyridine derivatives and to their therapeutic application as blood-platelet aggregation inhibiting agents and antithrombotics.