Wednesday, July 19, 2006

Lessons to be learned from the use of false data?

In the famous Quillen and Webster [QW] paper of 2001 on patent grant rate, the authors assumed that a patent could NOT issue on BOTH a parent AND a continuing application in order to get their elevated bound (97%) for patent grant rate. That high number later worked its way into the eBay brief before the US Supreme Court.

The patent practitioner of ordinary skill would know that it is true that a patent can issue on BOTH a parent AND continuing applications, and thus that a contrary assumption is against known facts and leads to false numbers.

In "A Patent System for the 21st Century," editors Stephen A. Merrill, Richard C. Levin, and Mark B. Myers handled Quillen and Webster's "assumption" in the following way:

Quillen and Webster noted the possibility that more than one patent could issue from a single disclosure, but because they did not have the data to correct for such occurrences, they based their calculations on the assumption that “parent” patent applications are abandoned when a continuation application is filed.

That is, because QW did not have the correct data, they used wrong data. The wrong data led to a wrong grant rate, which was used in the eBay brief to the Supreme Court. The wrong grant rate was also used in a note in the Harvard Law Review. [The grant rate used by eBay and Harvard is wrong because once accounting is made of multiple patent families, there is no "estimate" for grant rate of 97%, and, if the correct data had been used to begin with, there never would have been a 97% number. Both the first and third papers by QW present "grant rates" in excess of 100%, clearly the result of an unreasonable approach. Parenthetically, one notes that the QW approaches will lead to an incorrect grant rate whenever more than one patent issues from a patent family, whether or not there is a patent on the parent.]

In a discussion by Lisa Jardine of the scandal surrounding Hwang Woo-Suk, one finds

[The Hwang scandal] has brought into the public domain the process of "peer review" - the method of assessment used within the academy to regulate and control research activity. In scientific research, that process is supposed to ensure that the methodology is sound, and that interpretation of data does not lead to misleading or unreasonable claims.


At the outer envelope of current laboratory research, perhaps the great leap forward might be in the direction indicated by the ambitious investigator, whose impatience to arrive first at the next great scientific milestone overcomes his or her proper experimental caution.


Had the truth come out at the time, Pasteur would probably have been disgraced. As it was, the vaccine's success was such that no doubts were ever raised. Pasteur was a scientific gambler, whose bet paid off. Gamblers try to force the pace of research, wagering that the experimental results they are currently fudging will come good.

By the time the breakthrough has been properly made - a rabies vaccine, a cure for Parkinson's disease - they hope to have successfully produced the genuine evidence, achieved properly verifiable outcomes.

On the other hand, the scientific community pursues a policy of systematic self-regulating - making sure that the procedures followed are sound, and the data have not been exaggerated or manipulated. False claims, strenuously checked and tested, will eventually fail and be rejected.

Sooner or later, Hwang's bogus stem-cell results would have come to light, when they could not be replicated. But financial incentives in the form of massive amounts of government funding are another matter. Political pressure from governments, pouring money directly into work in research areas they have set their hearts on leading, surely does have the capacity to distort even the best-established procedures.

The Hwang scandal, and the correlative uncertainty of "where" the state of the art in current embryonic stem cell research is located, have not been much discussed in events leading to the Bush veto on July 19, 2006.

The Mercury-News stated:

Bipartisan majorities in Congress oppose his [Bush's] stand. So do a majority of the American people, polls show. They agree with scientists who argue that the spare embryos in question come from fertility clinics, where they'd otherwise be destroyed. Scientists say research on stem cells could lead to cures for Parkinson's disease, Alzheimer's, spinal cord injuries and other illnesses that afflict millions of Americans.

The president's choice for such a signature event is thus fraught with potential political consequences. While it may curry favor with religious conservatives, who compose the cornerstone of his political base, his stand may alienate moderate Republicans, independent voters and others who see the research as key to helping save lives. Most Democrats champion the stem-cell bill, as do many Republicans, including Nancy Reagan, California Gov. Arnold Schwarzenegger and Sen. Orrin Hatch, R-Utah.

Congressional Democrats made clear Wednesday [July 19] that they intend to make Bush's veto a central campaign issue in November's elections, as they vowed at a Capitol Hill rally to fight on to pass the legislation. They lack the two-thirds majorities needed to override Bush's veto in Congress, however; the House of Representatives fell 50 votes short of the total needed when it voted 235-193 Wednesday night to override, cementing Bush's veto at least for this year.

The lesson from Hwang Woo-Suk has yet to be learned.

[IPBiz post 1798]


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