Sunday, January 30, 2005

More on California's Prop 71 and stem cell agency

There have been issues in constructing the appropriate interface between the public money of California's Proposition 71 and private companies. Although the stem cell initiative requires that all state money go to public or nonprofit institutes, biotech firms can partner with them and benefit from their discoveries. The name of the state stem cell agency is California Institute for Regenerative Medicine.

The San Diego Union Tribune reported on Jan. 19:

Dr. Evan Snyder, a stem cell researcher at the Burnham Institute,
said the state's scientific community expects the California stem cell initiative to operate much like the National Institutes of Health has for decades.

The NIH has grant applications that are "exquisitely detailed,"
thoroughly listing all steps the scientists plan to take, including materials and animal testing to be used, Snyder said.

Snyder also said the measure could become a fulcrum for scientists in
competing research institutions and private enterprise to collaborate. In that way each lab could work in the area of science it does best, which could accelerate the basic research that still needs to be done on the working of stem cells.

As government appointees, the members of the governing board of the California Institute for Regenerative Medicine were required to file with the state Fair Political Practices Commission. Information from the Sacramento Bee (January 21, 2005) indicates ten (10) appointees of the 29 directors of California's new stem cell program hold board positions or stock in a wide variety of pharmaceutical and biotech firms that opponents of Proposition 71 and consumer advocates said could one day benefit from the state's financing of stem cell research. Edward Penhoet reported owning at least $3.36 million in stocks and stock options in biotech firms, including more than $1 million each - the maximum required to be
reported - in Chiron Corp., Renovis and ZymoGenetics. Penhoet is also a partner in Alta Partners, a San Francisco venture
capital firm investing in biotech. Venture capitalists donated about 40 percent of the $27 million raised for the Proposition 71 campaign. But neither Penhoet nor any other Alta Partners employees are listed among the initiative's contributors.

A different situation was presented by Dr. Josephine Phyllis Preciado, a Fresno physician appointed to the stem cell board because of her advocacy for low-income people and minority communities affected by diabetes. She filed one of the shortest forms, detailing only one outside source of income: her husband's
salary as a sales associate at Home Depot.

Additionally, critics have noted that financial disclosures are not
mandated for scientific and other outside advisers who will be deciding on grant requests -- decisions the governing board is likely to rubber-stamp in all but a very few exceptional cases. (SF Chronicle, Jan. 19)

Jamie Court, head of the Foundation for Taxpayer and Consumer Rights: "If there are conflicts, there are always going to be questions about whether this research is being done for the public's interest or the pecuniary interests of those serving on the board."
[As a side point, I have not seen recent discussion on whether California taxpayers might be reimbursed if some treatment arising from the stem cell program is commercially successful.]

Wesley J. Smith of the Weekly Standard (Nov. 15) added a different dimension:

The passage of proposition 71 in California (the Stem Cell Research
and Cures Act) was an acute case of electoral folly. As Californians plunged headlong into a $6 billion quagmire of debt in a quixotic quest for "miracle cures" from human cloning and embryonic stem cells, they simultaneously rejected Prop. 67, an initiative that would have added a modest tax to phone bills to keep the state's
endangered emergency rooms and trauma centers from shutting down.

Car security code cracked by Hopkins researchers

from the AP:

A research team at Johns Hopkins University said it discovered that the "immobilizer" security system developed by Texas Instruments could be cracked using a "relatively inexpensive electronic device" that acquires information hidden in the microchips that make the system work.

The radio-frequency security system being used in more than 150 million new Fords, Toyotas and Nissans involves a transponder chip embedded in the key and a reader inside the car. If the reader does not recognize the transponder, the car will not start, even if the key inserted in the ignition is the correct one.

It's similar to the new gasoline purchase system in which a reader inside the gas pump is able to recognize a small key-chain tag when the tag is waved in front of it. The transaction is then charged to the tag owner's credit card.

Researchers said they were able to crack that code, too.

"We stole our own car, and we bought gas stealing from our own credit card," said Avi Rubin, a professor of computer science at Johns Hopkins who led the research team.

This is in the area of RFID technology. The Digital Signature wedge transponder is an authenticating device using a challenge/response (uni-directional) encryption method which makes the transponder response highly secure. Other features include a fixed, unique read-only code and optional password protection. The device is ideally suited for applications which demand the most secure authentication techniques in the smallest available package (such as vehicle immobilizers and locks).

Integrated Solutions wrote:

The rapid deployment of RFID (radio frequency identification) technology remains mired in a sea of standards and high-priced hardware. Yet, its few existing applications have already created a public perception that this technology is ubiquitous. Point of sale transactions, automatic toll collectors, and animal tracking are all examples of well-known RFID applications.

Recently, Ford and Toyota incorporated RFID into the security systems of select new vehicles. Now, thousands of new car and truck owners rely on this technology to disable their vehicles in the case of a theft attempt. This security process is accomplished by embedding RFID chips and antennas into a vehicle's ignition system and the owner's key fob. The chip in the fob sends a signal to the antenna in the steering column allowing the vehicle to be started. If the key fob isn't present, the vehicle can't be started.

Bruce McKinley quickly saw the implications this technology (and the auto industry's support of it) was going to have on his company. McKinley, CEO of Dealer Security Solutions (DSS) (Rancho Cordova, CA), specializes in selling aftermarket auto security systems to car dealers. "The allure of an RFID anti-theft device is its simplicity," McKinley explained. "There are no buttons to press or codes to remember as in the previous systems we were offering. Add to that the support of major auto manufacturers, and you have a whole new security industry." For McKinley, offering anything less than RFID seemed like trying to sell old technology. Thus, he began researching RFID in 1999.

Patent competition in Kansas?

The following discussion was made possible by the Bayh-Dole Act of 1980, wherein then-Senator Dole represented Kansas. Note also that the state of Kansas passed the Kansas Economic Growth Act in 2004, which will spend $500 million in bioscience research across Kansas over the next 10 years. Other states are funding research, including California and New Jersey on stem cells. The California initiative is generating some controversy, which I'll discuss in a separate post.

from Joel Mathis of Journal-World --

Kansas State University claimed nine patents during 2004, continuing a back-and-forth race with Kansas University [KU] that has seen the Manhattan university take a slight edge in patents since 1997, with a 52 to 49 lead.

"Yes, we do compete with KU, a friendly competition," said Marcia Molina, K-State's director of technology transfer. "We keep an eye on, not just KU, but the Big 12 and everybody else."

Even combined, however, KU and K-State have a long way to go to catch the leader. The University of California system, which will open its 10th campus this year, claimed 447 patents in 2004.

KU retains the rights to 93 patents, officials said, which have brought in about $4 million to the Lawrence campus over the past five years. One KU spinoff -- ProQuest Pharmaceuticals Inc. -- was sold in December for $7 million in stock.

The dream at all universities, Roberts said, is to come up with another Gatorade. The sports drink was invented at the University of Florida and provided an economic boon for the institution. [Query: what about Stanford's Cohen/Boyer patents?]

"There is always the possibility of something like a Gatorade happening, in which you have a big hit," Roberts said. "Those don't happen very often, but if you're not in the game, they don't happen at all."


The comments of Jim Roberts, KU's vice provost for research, remind one of the "patent as lottery ticket" theme that attended much of the discussion of the patenting of the SARS sequence a couple of years ago [QUERY: where are they now?] One wonders if the Wright Brothers viewed their efforts as buying a lottery ticket.

Lessig in Brazil with Windows?

from ALAN CLENDENNING of the AP, as published by the San Jose Mercury News (Jan. 29):

PORTO ALEGRE, Brazil - Activists at a leftist gathering where Microsoft is viewed as a corporate bogeyman urged developing nations Saturday to leap into the information age with free open-source software.

In a packed warehouse where tens of thousands are attending the World Social Forum, Grateful Dead lyricist John Barlow said poor nations can't solve their problems unless they stop paying expensive software licensing fees.

Open source software includes programs that are not controlled by a single company. The software can be developed by anyone, with few restrictions. The best known such software is the Linux operating system, which can be downloaded free from the Internet.

"Already, Brazil spends more in licensing fees on proprietary software than it spends on hunger," said Barlow, co-founder of the Electronic Frontier Foundation, a cyberspace civil liberties group.

Barlow said Brazil is trying to wean itself from Microsoft with a campaign to persuade Brazilians to shift from costly Windows products to applications that run on the Linux operating system.

Microsoft contends open-source software can be more expensive than Windows programs when service costs are factored in.

How much people spend on Microsoft products is unclear because the company often provides discounts when it senses it may lose business. However, competition from open-source software has prompted Microsoft to offer those discounts.

Brazil President Luiz Inacio Lula da Silva's administration says the open-source policy makes sense for a developing country where a mere 10 percent of the 182 million people have computers at home, and where the debt-laden government is the nation's biggest computer buyer.

China, France, Germany, Japan and South Korea also are pursuing open-source alternatives. In a partial response to the open-source threat and to piracy, Microsoft last year launched stripped-down, cheap versions of Windows in Indonesia, Malaysia and Thailand. Similar products are on the way for India and Russia.

Joining Barlow on Saturday were Brazilian pop superstar Gilberto Gil, who is Brazil's minister of culture, and Lawrence Lessig, Stanford University law professor and chairman of Creative Commons, a nonprofit organization devoted to sharing creative material online.

All the social forum's 800 computers are running on open-source software, but the loosely organized event ran into an embarrassing glitch Saturday's when two big screens betrayed the fact that the computer was running on Windows, with the operating system's toolbar visible at the bottom of the screens.

Lessig noticed and the computer was quickly disconnected and replaced with a laptop running on open-source software.

The story was also picked up by Fox News:,2933,145827,00.html

Saturday, January 29, 2005

More on the "patent grant rate" saga

Although not yet out as a published law review, the paper by Mark A. Lemley and Carl Shapiro, Probabilistic Patents, is already cited in the law review literature, given below. Further, the discussion by Lemley and Shapiro on the patent grant rate work of Quillen and Webster merits commentary.

Papers citing Lemley and Shapiro:

Joseph Farrell and Robert P. Merges, Incentives to Challenge and Defend Patents: Why Litigation Won't Reliably Fix Patent Office Errors and Why Administrative Patent Review Might Help,
19 Berkeley Tech. L.J. 943 (2004)

-->Thus, for instance, if there are five infringers of equal size, each gets only a fifth of the gains from a successful challenge because each is paying only a fifth of the patentee's total royalties. Therefore, the patentee has five times more incentive to prevail in litigation than any one challenger has. Professor Miller and others have noted this problem and suggested policies to address it such as permitting infringers who compete with one another to
coordinate a legal challenge to a patent,n24 offering a bounty to a successful challenger, n25 and relying on fee-shifting. n26

n24. Mark A. Lemley & Carl Shapiro, Probabilistic Patents, 19 J.
Econ. Persp. (forthcoming 2005) (manuscript at 17, on file with authors), available at <--

Joshua D. Sarnoff, Abolishing the Doctrine of Equivalents and Claiming the Future After Festo, 19 Berkeley Tech. L.J. 1157 (2004)

-->Even when patents do not convey market power, patentees may exploit uncertainty regarding the scope of patents to deter competition by posing the threat of high-cost infringement litigation. n174

n174. Injunctions to remove products from the market are rare. See
Mark A. Lemley & Carl Shapiro, Probabilistic Patents, at 21 (July 14, 2004), available
at (citing
Carl A. Shapiro, Antitrust Limits to Patent Settlements, 34 Rand J. Econ. 391 (2003)).

Carl Shapiro, Patent System Reform: Economic Analysis and Critique, 19 Berkeley Tech. L.J. 1017 (2004)

One may fairly ask whether market forces, in the form of patent
licensing agreements, can correct for poor patent quality, even if the underlying patent system is not well designed. Certainly, ceteris paribus, the "weaker" a patent, or the more likely that a patent will be found invalid if litigated, the lower
the royalties it can command in licensing negotiations. After all,
licensing takes place in the shadow of litigation, with licensing rates determined by the relative bargaining power of the patent holder and potential licensees/alleged infringers. Unfortunately, however, there is no reason to believe that the costs
of a flawed patent system are eliminated through the operation of
technology markets. To begin with, due to problems of free-riding and pass-through of royalties, we cannot count on litigation to invalidate patents that should never have been issued. n58

n58. See Joseph Farrell & Robert Merges, Incentives to Challenge and
Litigate Patents, 19 Berkeley Tech. L.J. 943 (2004); see also Mark Lemley & Carl Shapiro, Probabilistic Patents, J. of Econ. Perspectives (forthcoming 2005) (manuscript
at 25, on file with authors), available at

The paper by Shapiro also discussed the Quillen and Webster work on patent grant rate.

-->Turning to patent approval rates, or the percentage of patent
applications that ultimately result in patents, the FTC and NAS differ as to how to properly measure these rates. According to the FTC Report, one witness calculated the USPTO's grant rate at 98% in 2000, compared with 67% in Europe and 64% in Japan.
n46 However, a USPTO witness criticized these calculations and stated that, properly measured, the USPTO grant rate was about 75%. n47 The NAS cites a study by Quillen and Webster finding that, after certain corrections are made, "the USPTO eventually issued patents on between 85 percent and 97 percent of the applications filed between 1993 and 1998 - 20 to 30 percent higher than official
estimates, which have ranged between 60 percent and 70 percent for 20 years." n48 Recognizing that many factors influence patent approval rates, the NAS Study states, "The committee believes that high acceptance rates, especially if increasing over time relative to comparable rates in other industrialized countries would be reason to look more closely at examination quality." n49
[*1031] The NAS Sudy then observes that patent approval rates at the European Patent Office and the Japanese Patent Office declined more rapidly since 1998 than did the patent approval rates at the USPTO. n50<--

The content of footnote 48 is

-->n48. NAS Study, supra note 6, at 43 (citing C. Quillen and O.
Webster, Continuing Patent Applications and Performance of the U.S. Patent Office, 11 Fed. Cir. B.J. 1, 1-21 (2001), and R. Clarke, U.S. Continuity Law and its Impact on the Comparative Patenting Rates of the U.S., Japan, and the European Patent Offices, 8 J. Pat. & Trademark Off. Soc'y 335, 335-49 (2003)).<--

The Shapiro text is accurate as far as it goes; unfortunately, the cited NAS text is not entirely accurate, although analysis of more text than Shapiro presented would have attenuated the problem.

The NAS report in fact cites to both papers by Quillen et al., and in fact notes certain issues with the grant rate studies. [see below]

The paper by Lemley and Shapiro has some difficulties.

Page 7 of "Probabilistic Patents" mentions the work by Quillen and Webster: "As a result, the overwhelming majority of patent applications in the United States, perhaps 85%, ultimately result in an issued patent--far more than in Europe and Japan." citing Quillen et al. (2003) and NAS (2004).

Lemley and Shapiro cite the "right" Quillen et al. article here; they merely get the year wrong (they say 2003 even though the correct year is 2002).

The cite to the NAS report is tricky. The NAS report made no independent evaluation of patent grant rates. NAS merely referred to the work of Quillen et al. and to the work of Clarke. Both Lemley/Shapiro and NAS mistakenly reference the Quillen work as discussing "issued" patents; it doesn't. It follows the definition at the Trilateral Website. Some factors that enter into differences between "granted" patents and "issued" patents involve time delay AND withdrawal from issue [which I discuss in a recent paper].

**The NAS report itself

A Patent System for the 21st Century, Stephen A. Merrill, Richard C. Levin, and Mark B. Myers

Of the NAS report, page 53 has text that "the USPTO eventually issued patents on between 85 and 97 percent of applications filed between 1993 and 1998." The source for this would seem to be the first paper by Quillen and Webster, as noted in footnote 48 of the Shapiro paper. This first paper discusses a grant rate (not an issue rate) of 97%; the second paper discusses a grant rate (not an issue rate) of about 85%. This downward correction arose because of an erroneous assumption by QW in the first paper in obtaining the 97% number: that one could not have a patent on both a parent and on a continuing application. In reality, the first paper of Quillen et al. (2001) discusses grant rates of 97%, 87%, and 80%, although the 80% number arises from assumptions stated to be "contrary to fact." [see below]

The use by the NAS of the word "issued" is most unfortunate, because Quillen et al. made abundantly clear that their work pertained to "granted" as defined on the Trilateral Website. Curiously, the later work of Clarke was criticized as being related to "issued" patents (eg, Lemley and Moore, 2004). In fact, both Quillen et al. (2002, not 2001) and Clarke (2003) made certain corrections based on numbers derived from ISSUED patents.

The NAS report at page 54 has text "For this reason arriving at a consensus on a precise patent approval rate may be elusive."

The NAS report at page 54 also refers to a study by the Organisation for Economic Cooperation and Development (OECD, 2003) that showed that the grant rate for US priority applications with at least one subsequent EPO application was higher than the EPO grant rate for US priority applications. This is an interesting observation but one which does not prove that the USPTO is granting patents at a higher grant rate than the EPO for applications with the SAME claims. It is interesting that the NAS report relies on comparative data between regimes with different laws at the same time we have had a mini-debate between Justices Scalia and Breyer on the propriety of US courts citing to decisions of non-US courts.

***Text from Quillen et al. (2001) ["first paper"]

Calculations that do correct the PTO Grant Rates for continuing applications are in Table 6. n77 And, as can be seen from this table, the corrected Grant Rates are quite different from the uncorrected Grant Rates. For example, if it is assumed that all of the continuing applications represent a renewed attempt to patent the subject matter of their parent applications, then the number of net abandonments is the total number of abandonments less the total number of continuing applications filed. The overall Grant Rate for the 1993-1998 fiscal years on that assumption is 97%. n78

If instead it is assumed that continuation and CIP applications, but not divisional applications, represent renewed efforts to patent the subject matter of their parent applications, the number of net abandonments is the total number of abandonments less the number of continuation and CIPs filed. The resulting overall Grant Rate for the 1993-1998 fiscal years is 87%. n79

If it is assumed, contrary to fact, that only continuation applications represent a renewed effort to patent the subject matter of parent applications which are abandoned, then the number of net abandonments is the total number of abandonments less the number of continuation applications filed. The resulting overall Grant Rate for the 1993-1998 fiscal years in this case is 80%. n80

***Text from Quillen et al. (2002) ["second paper"]

Corrected Grant Rates (Appendix V) are calculated by adjusting the number of applications reported as abandoned by the number of refiled continuing applications so as to determine a net number of abandoned applications. Corrected Application Disposals are the sum of allowances and corrected applications abandoned (reported as Net UPR Applications Abandoned). n39 Net Disposals are the sum of Application Allowances and Net Abandonments, and the Grant Rate is the number of allowances divided by Net Disposals. The determination of the Grant Rate from Table 6A of the earlier paper is reproduced as Calculation 1 in Appendix V. The overall corrected Grant Rate for the six-year period was determined to be 97%. n40 Calculation 2 in Appendix V is a determination of the Corrected Grant Rate, adjusted to take into account the continuation applications on which a patent was granted on both the parent application and the continuation application (6.4% of the total number of continuing applications). Adjustment of the Grant Rate to take such continuation applications into account reduces the Grant Rate from 97% to 95%. Calculation 3 is the determination of the adjusted Grant Rate taking into account all continuing applications in which a patent was granted on both the parent application and the continuing application (31% of all continuing applications). The adjusted corrected Grant Rate on this assumption is 85%, which is substantially above the Grant Rates reported for the EPO, JPO and USPTO on the Trilateral Website.

Patent searching as vitamin shopping?

from, concerning the set of OSS patents recently donated to the public by IBM:

Andy Gibbs, PatentCafe's CEO, likens finding the best IBM patent to vitamin shopping online: "Think of it as someone who needs to find the most effective vitamin from 500 different brands - they would need to read the label on every brand. PatentCafe's semantic analysis patent search will identify the most relevant of IBM's 500 patents in only seconds."


Patent rating by PatentRatings, no law degree required?

Merely for information,
PatentRatings has developed and patented a proprietary rating system -- the Intellectual Property Quotient or "IPQ" -- for objectively scoring and rating patent assets based on a proven statistical methodology. IPQ scores are similar to the familiar IQ score for rating human intelligence (median = 100). IPQ scores provide a simple ("no law degree required"), easy to understand yard-stick for measuring and comparing patent quality/value based on the cumulative characteristics of patents that make them statistically either more likely or less likely to produce economic returns. IPQ scores can be mathematically combined/averaged so as to ascertain an average IPQ score for an entire patent portfolio or any other defined population of patents.

Scores are unique to each particular patent examined and are updated quarterly. Scores are based on certain identified predictor variables ("metrics") determined to have statistically significant correlation to the payment of patent maintenance fees (periodic taxes paid to the U.S. Patent Office). The premise of the rating model is that more valuable, higher-quality patents will be maintained at a higher frequency (have a longer life) than less valuable patents. Typical metrics include, for example, the number, length and type of patent claims, the amount and type of prior art cited, the number of forward citations or references made by later-issued patents [patent citations], the presence or absence of limiting claim language, the patent prosecution history and about 30 other relevant factors.

IPQ scores are directly predictive of patent maintenance rates and life expectancies. Thus, for example, the graph and table below illustrate estimated life expectancies for rated patents based on a study population of about 100,000 patents.

Friday, January 28, 2005

Merck loses Fosamax case to Teva

A judgment of Judge Farnan of D. Delaware was vacated/reversed by the CAFC in the case Merck v. Teva concerning Fosamax. Merck patent claims in US 5,994,329 went from valid and infringed to invalid and not infringed.

According to the CAFC [opinion by Judge Gajarsa], the district court had interpreted claim terms "about 35 mg" and "about 70 mg" to mean "exactly 35 mg" and "exactly 70 mg." That perhaps oversimplifies the problem, which arises from unusual (and perhaps questionable) claim drafting.

The weight [mass] element of the claims in question was written in an odd way:

"about 70 mg of alendronate monosodium trihydrate, on an alendronic acid basis..."

"about 35 mg of alendronate monosodium trihydrate, on an alendronic acid basis..."

WHAT DOES THIS MEAN? Is is 70 mg [or 35 mg in the other claim] of alendronate monosodium trihydrate or of alendronic acid? What does "about" modify? Intelligent minds differed, and Merck ended up losing.

Dissenting Judge Rader characterized the issue as Teva arguing that the word "about" could be analyzed separately, with "about" meaning approximately, and as Merck arguing that "about" should be analyzed in the context of the entire phrase, with "about" referring to the variable amounts of salt needed to correspond to 70 mg [or 35 mg in the other claim] of alendronic acid. Of course, in the context of the disputed claims, there was ONLY ONE salt mentioned, so the use of "about" became somewhat strange (ie, there is exactly ONE PRECISE AMOUNT of alendronate monosodium trihydrate THAT CORRESPONDS to 70 mg of alendronic acid [or 35 mg in the other claim]; the use of "about" in the context of the phrase only makes sense for situations where there is MORE THAN ONE salt)

Prior art at issue included articles in the Lunar News in April and July 1996.

The July 1996 reference referred to "oral alendronate" at 40 or 80 mg.

It is interesting to note that the district court discounted the Lunar News articles because they were NOT peer reviewed journals, 288 F. Supp. 2d at 628-629. The district court also discounted the statements of a Dr. Mazess, based in part on his academic training. The CAFC rejected both approaches.

The CAFC also dealt with secondary considerations, citing to among others McNeil, 337 F3d 1362. Here, Merck had ANOTHER patent, US 4,621,077, which excluded others from using alendronate sodium for treating osteoporosis. Thus, Merck's commercial success arose by its exclusionary right from a different patent, and was not a proper secondary consideration to rebut a prima facie case of obviousness.

Footnote 4 attempted to deal with some issues with possibly varying (chemical) forms of alendronic acid.

In his dissent, Judge Rader discussed the lexicographer rule, citing among others Boehringer, 320 F3d 1339. This is presumably a prelude to the upcoming battle in Phillips v. AWH, 376 F3d 1382. Judge Rader may have a good point about the application of the lexicographer rule to the Merck case. However, I notice that he did not comment on the legally separate (but not unrelated) issue that the majority vacated the determination that the '329 was not invalid through obviousness and held that there was obviousness. The judgment of infringement was REVERSED by the majority (result: patent claims invalid; Teva does NOT infringe). Most importantly, Judge Rader did not respond to the challenge set forth by the majority in footnote 10 (page 14 of the pdf file) that the claims were obvious under either the majority's or Rader's claim construction. Thus, the dispute about the lexicographer rule may not affect the outcome (Merck loses).

I [LBE] note in the claim text, "about 70 mg [or 35 mg in the other claim] of alendronate monosodium trihydrate, on an alendronic acid basis..." BOTH alendronate monosodium trihydrate AND alendronic acid are compounds of well-defined molecular weight. Talking about "variability" arising from the use of "a salt" is irrelevant, because the claim talks about ONE salt and ONE acid. If Judge Rader's reference to the specification is correct ['329 patent, column 10, line 65ff], the claim elements refer to a specific amount of a specific compound [alendronate monosodium trihydrate] which is equal to 70 mg of alendronic acid. Further, even if Judge Rader's interpretation of the claim term is correct, the claims are still likely going to be obvious.

As to the drafting, the USPTO database for the '329 lists
Attorney, Agent or Firm: Sabatelli; Anthony D., Winokur; Melvin

As to litigation, John F. Lynch of Howrey Simon represented Merck.

Under related applications: This application is a continuation of PCT/US98/14796, filed Jul. 17, 1998, and also claims priority to U.S. provisional applications Serial Nos. 60/053,535, filed Jul. 23, 1997, and 60/053,351, filed Jul. 22, 1997, both now abandoned, the contents of all of the foregoing of which are hereby incorporated by reference in their entirety.

This would appear to be an example of a continuation application from a PCT, an example of a continuation which is NOT a repeated attempt to obtain the same claims [that is, another counterexample to the approach of Quillen/Webster] Whether it is proper to say provisional applications become "abandoned" may be contemplated.

The '329 patent is itself cited by seven US patents, most recently by US 6,670,343.

from the AP on January 29, 2005:

A federal court invalidated the patent on Jan. 28 for Merck & Co.'s second-largest selling drug, the blockbuster osteoporosis treatment Fosamax, in a decision that offers millions of patients hope for a cheaper version sooner, but darkens the company's already clouded outlook.

Fosamax is the No. 2 drug for Whitehouse Station, N.J.-based Merck. It reported sales of $3.16 billion for Fosamax last year, more than 90 percent of which were for the 35 mg and 70 mg once-a-week versions, according to company spokesman Tony Plohoros.

Zocor, for high cholesterol, is Merck's biggest drug, with $5.2 billion in sales last year.

Although AP didn't address the issue, what happens if Ranbaxy beats Pfizer on Lipitor, which goes generic, and the market for Zocor bottoms out?

Teva won a similar legal battle in a British appeals court in November 2003, when the court unanimously affirmed the decision of a patents court and ruled in favor of Teva and two other companies, saying two Merck patents relating to Fosamax were invalid. (The two patents referred to the pharmaceuticals containing the active ingredient of Fosamax, and the once weekly administration). However, sales of Fosamax in Britain reach only $110 million a year, a far cry from the potential in the U.S. that Friday's court ruling has opened for the company.

Is there cite-checking at the Minnesota Intellectual Property Review?

In an article "The Implementation of FDA Determinations in Litigation: Why Do We Defer to the PTO but Not to the FDA?," 5 Minn. Intell. Prop. Rev. 155 (2004), we have text at footnote 15:

-->The USPTO states that approximately two of three patent applications result in an issued patent. See General Information, supra note 14. This proportion significantly overstates the rejection rate due to the unique role of continuations and continuations-in-part in the U.S. patent system. See generally Cecil D. Quillen & Ogden H. Webster, Continuing Patent Applications and Performance of the U.S. Patent and Trademark Office, 11 Fed. Cir. B.J. 1, 9-13 (2001) (concluding that the true "grant rate" is roughly 85 percent and the true "allowance rate" is 92 percent).<--

A note to author William G. Childs and the student cite checkers at the Minnesota Intellectual Property Review--

The paper cited, Quillen/Webster 11 Fed. Cir. B. J. 1 (2001) does NOT have the 85% and 92% numbers. Try instead the paper at 12 Fed. Cir. B. J. 35 (2002). The cite checkers could not possibly have checked the 2001 paper and found that information. For the exact relevant text in each Quillen paper, see the post on IPBiz: More on the "patent grant rate" saga.

Further, as a substantive point, both Quillen/Webster papers rely on data on CONTINUIING applications (which include divisionals, continuations, and continuations-in-part), not just continuations and continuations-in-part.

Also, one might question the text --This proportion significantly overstates the rejection rate due to the unique role of continuations and continuations-in-part in the U.S. patent system. --Note that the QW papers permit, and in fact at places report, a grant rate in excess of 100%. It may be that QW "overstate" the grant rate!

FastCompany on Microsoft

Merely for interest, from fastcompany:

Meantime, an upstart named Google, founded eight years after Gates announced his quest, has pretty much stolen the day. Google's string of Internet search innovations has not only won the hearts and minds of customers but also made a ton of money. It has spent a total of $233 million on research and development since 1998 -- just 3.4% of Microsoft's annual R&D budget -- yet its market value now tops $3.7 billion.

Which raises the question: Why not Microsoft? Here is a giant company that for two decades has dominated computer software. It generates $9 billion in cash flow and $8 billion in profits from $37 billion in sales, making it twice as operationally efficient as General Electric and more than twice as profitable as IBM. But when it comes to online search, arguably the hottest technology of the past five years, Microsoft has missed the boat. Heck, it hasn't even been near the dock.

Say the same for the Web browser (created by Netscape), the streaming media player (by RealNetworks), the game box (Sony), interactive television (TiVo), so-called smart phones (Nokia, Ericsson, and Motorola), and digital-music distribution (Napster and now Apple). Once the bellwether of the computing industry, Microsoft has watched from the sidelines as comparatively smaller, poorer companies brought to market virtually every important technical innovation of the past decade.

It's not the sort of track record that inspires confidence about Microsoft's prospects. "It's not good enough. And it's not just the incremental product innovations that matter. Microsoft's inability to create leadership in entirely new product areas . . . is a real problem," says Adrian Slywotzky, strategy guru at Mercer Consulting. "If they didn't have $61 billion in cash, if they had only $40 billion but they had dramatically stronger strategic positions in games, or [digital] music, or technology in the home -- which is where they really want to be -- then people would think very differently about this company."

Instead, Microsoft shares have gone nowhere in the past five years, more or less tracking the market in that time. In July, chief executive Steve Ballmer basically conceded that his company couldn't find enough opportunities in which to invest its enormous cash hoard, announcing plans to pay shareholders a $32 billion special dividend. And Wall Street analysts have quietly begun comparing Microsoft to a power utility circa 1990: well suited to generate steady cash flows and dividends, but not growth.

Microsoft may be the most striking example ever of the phenomenon that Harvard academic Clayton Christensen famously identified in his 1997 book, The Innovator's Dilemma: When New Technologies Cause Great Firms to Fail (Harvard Business School Press). Good managers, Christensen wrote, tend to direct resources toward protecting established lines of business, usually by investing in incremental improvements that help pad profit margins.

Of course, it's impossible to say exactly what the right balance is between offense and defense, or between the short and long term. Ultimately, observes Gary Hamel, innovation guru and chairman of Strategos, "really good ideas are just few and far between. Forgive the metaphor, but it is a little like the process of sperm trying to fertilize an egg. Increasing the number of really strong swimmers doesn't increase your success rate. That's not how biology works. Only one [sperm] gets to fertilize the egg."

In other words, innovation is often just a happy, creative accident, where the laws of numbers can actually get in the way. In this sense, Microsoft's size and wealth become obstacles rather than assets. Venture capitalists typically pore over 50 to 100 deals to find a good $20 million software investment. By that logic, Microsoft, with its $6.8 billion annual R&D budget, must consider as many as 35,000 new ideas just to find a few hundred worth investing in every year. Is it any wonder the company invests in so many dogs -- or, for that matter, toilets?


The Feb. 1 Wall Street Journal mentions that Microsoft plans to intensify its attack on Google with a four-month advertising and marketing campaign to promote its new Internet Search Engine.

One approach to product differentiation is to provide instant answers to questions, rather than just links.

So, when you are not first in innovation, go to marketing...

Thursday, January 27, 2005

Forbes' Drug Patent Peril?

In "Drug Patent Peril," Forbes criticizes the current form of the Hatch-Waxman Act. There are many issues here, to which I will return. Recall in the pre-Hatch-Waxman days, we knew when drugs would go off-patent.

Note that Forbes mis-states annual sales figures for Lipitor at 7.4 billion.

from Forbes:

If investors are treating unlikely patent upsets as if they were foregone conclusions, the stocks could be undervalued. But that points to a problem with the Hatch-Waxman Act, the U.S. law governing patent challenges. Generic firms are encouraged to challenge patents in the hopes of hitting a home run. If investors discount stocks even based on frivolous patent challenges, drug companies are not being rewarded for the drugs they actually have on the market.

At the end of the day, that means that medicines on the market are worth less--and that, in turn, there is less incentive to develop new treatments.

Already, it costs more than $800 million, by some estimates, to develop a new drug. That's as much as it cost to send robot probes to Mars. Yet Pfizer is actually spending that much on test for one new medicine to raise good cholesterol and clear clogged arteries. Sanofi is developing an anti-smoking, anti-obesity pill that doctors at the Cleveland Clinic plan to test to see if it prevents heart attacks and strokes. Lilly is in the middle stages of developing its own heart drug. In ten years, any of them might be one of the best-selling medicine in the world.

But investors seem numb to the potential. What are needed are clear rules about how to balance the need for cheap generic drugs against the need for new medicines.

One solution: Offer drug companies a set period of exclusivity, without fear of patent challenges, after a drug is approved. In return, they agree not to mount any challenge to generics. (See: "Solving The Drug Patent Problem.") That would make it crystal clear when drugs would go off patent from the outset--without all the lawsuits.

Some solution is necessary. Otherwise, generic drug firms may not have any new blockbusters to challenge.

***Comment on Forbes' "Drug Patent Peril"***

The Hatch-Waxman Act had two primary objectives: streamlining the procedures for bringing generic drug products to the market AND compensating "pioneer" companies for loss of time in the lengthy drug approval process.

When a generic company wishes to bring a drug to market BEFORE the expiry of a patent on a drug of a pioneer company, it makes a so-called "paragraph IV" certification that its product does not infringe or that the patent is invalid. If the pioneering company brings a Hatch-Waxman litigation over the filing, the generic company must present a good faith defense of infringement and/or invalidity. If the generic company fails to present a credible defense, it can lose the case on summary judgment AND it can be liable for attorneys fees. This is just like any other legal case. Thus, there are protections against "frivolous patent challenges." Furthermore, wise investors would look into the underlying merit of any litigation, as they have done, for example, in the recent challenge to LIPITOR.

When a pioneering company loses a Hatch-Waxman challenge, as for example with SmithKline Beecham over nabumetone (RELAFEN), there are usually very good reasons why they lose. With nabumetone, the chemical compound nabumetone already existed in the chemical literature BEFORE Beecham filed for a US patent on its composition of matter, and Beecham even knew about this prior art. Thus, it was foreseeable that the '639 patent would be found both invalid and unenforceable. In the particular case of nabumetone, there were later law suits by affinity parties who felt that they had paid too much for something in the public domain. A good investor would be able to see these issues coming down the line.

The Forbes article is notable for what it failed to say, sort of a variant of the legal concept of a "negative pregnant."

Forbes did not mention that pioneer drug manufacturers have
abused the original Hatch-Waxman Act by filing inconsequential patents just before their original patents expired in order to prevent competition from generics. Forbes did not mention that several recent drugs are just enantiomers of earlier discovered racemates, for which drug research costs are well below their proposed figure. Forbes did not mention that pioneer
manufacturers also have entered into competition-stifling
agreements, cutting deals with the first generic manufacturer to exploit a loophole under the Hatch-Waxman Act and effectively keep generic manufacturers off the market until (after)the expiry of the patent.

Forbes problem --If investors are treating unlikely patent upsets as if they were foregone conclusions, the stocks could be undervalued-- concerns lack of knowledge by investors, not problems with the Hatch-Waxman Act.

The Forbes proposal --Offer drug companies a set period of exclusivity, without fear of patent challenges, after a drug is approved-- is a mixed metaphor. The period of patent exclusivity is measured from the date of filing with the Patent Office, while the approval of the drug is by the FDA. Offering the drug companies the length of the patent itself is pre-Hatch-Waxman. There are a lot of issues with Hatch-Waxman, including those currently pending before the Supreme Court in Merck v. Integra. Maybe Forbes should evaluate the big picture.

Aircoat joins challenge to Plavix in UK

Nobody seems to know much about Aircoat. In the US, the pretrial hearing is scheduled for March 4, 2005.

More on Pfizer v. Ranbaxy on Lipitor

In the report below, the text --Ranbaxy charged that Pfizer withheld crucial scientific data that may have influenced the patent-review board's decision to grant an extension on the original patent and award the second patent.-- sounds more like an inequitable conduct defense than the previously discussed noninfringement/invalidity defense.

Reuters via Hindustan Times,00020013.htm

Ranbaxy chief executive Brian Tempest told Reuters on the sidelines of the World Economic Forum that he would await the outcome of any appeal before introducing a copycat version of the cholesterol-lowering medicine in the United States.

He expects a ruling in the US patent case to come around July this year. If it loses, Pfizer, the world's largest pharmaceuticals maker, will certainly appeal -- a process which could take about 12 months.

"We wouldn't launch at risk. We are a conservative company. We will wait until the appeal at the federal level," Tempest said.

Overturning Pfizer's patents on Lipitor, which sells $10 billion a year, would be a transforming event for Ranbaxy which, even as India's largest drugmaker, currently has revenues of only around $1.2 billion.

Ranbaxy put its case at a two-week trial in the US District Court of Delaware last month. It is trying to break two patents that currently protect Lipitor from generic competition until 2009 and 2011.

Ranbaxy charged that Pfizer withheld crucial scientific data that may have influenced the patent-review board's decision to grant an extension on the original patent and award the second patent.

Until recently, most commentators thought Ranbaxy had little chance of success. But Tempest said attitudes had started to change.

"A number analysts originally said we had the flimsiest of cases. I think now they see that this is a serious case," he said.

Ranbaxy is busy getting ready for a generic Lipitor launch ahead of the legal ruling, something it has already warned shareholders will weigh on earnings in 2005.

"We've already started to buy raw materials, so we are already on the track and we think that is the right thing to do for our investors," Tempest said.

The Indian company is also challenging patents on Lipitor in around a dozen other countries, with a decision expected in a case in Austria in April, he added.

Ranbaxy and other generic drug companies have enjoyed a boom in the United States as healthcare providers try to cut escalating costs. A public outcry for access to cheaper prescription drugs has also emboldened many generic companies to pursue high-stakes patent cases.

The Lipitor case is a "big deal" to Pfizer. From Bloomberg (19 Jan 05):

Revenue from two of Pfizer's biggest drugs, Lipitor and the Celebrex painkiller, jumped as much as 24 percent as the company took market share from rivals such as Merck & Co. The gains may slow after a study linked Celebrex to heart attacks and caused a year-end drop in prescriptions, and as generic competition damps demand for drugs such as the Neurontin epilepsy pill.

Sales of Lipitor, the world's best-selling drug, jumped 23 percent to $3.26 billion in the fourth quarter. Full-year sales increased 18 percent to $10.9 billion.

Lipitor has about 40 percent of the worldwide cholesterol market and more than 42 percent of the U.S. market in total prescriptions, Pfizer said today.

Doctors including Ira Nash, the associate director of the Cardiovascular Institute of the Mount Sinai Medical Center in New York, and Dr. William James Howard, vice president for academic affairs at Washington Hospital Center in Washington, said doctors are prescribing drugs such as Lipitor more widely because recent clinical trials have shown that it's beneficial to lower cholesterol aggressively.

Wednesday, January 26, 2005

CAFC delves into antitrust in Independent Ink v. Illinois Tool Works

In the case (2005 U.S. App. LEXIS 1205 ), Independent Ink, Inc. appealed from the judgment of the United States District Court for the Central District of California in a patent tying antitrust action. The CAFC held that a rebuttable presumption of market power arises from the possession of a patent over a tying product (here a printhead, with ink the tied product)

As to a Sherman Act section I claim, the CAFC found that once an antitrust plaintiff establishes the presence of a patent tying agreement, market power by the patentee-defendant is (rebuttably) presumed, and it is the burden of the patentee-defendant to rebut the presumption of the presence of market power and consequent illegality of the tying agreement.

In this case, because the patent holder did not present evidence rebutting the presumption of market power, a grant of summary judgment was reversed and the case remanded. The CAFC noted that if no adequate rebuttal evidence were presented, the antitrust plaintiff should be granted partial summary judgment as to the section 1 claim.

The patent in question was US 5,343,226 to Trident/Illinois Tool Works. An issue in the case was the tying of an unpatented product (ink) with the sale of a patented product (printhead covered by '226 patent).

The legal issue concerned Jefferson Parish, 466 US 2. The CAFC wrote the following:

The district court held that for patent tying to constitute a
violation of the antitrust laws, the plaintiff must affirmatively prove market power. Indep. Ink, 210 F. Supp. 2d at 1162. The district court, in a footnote, dismissed several Supreme Court cases holding to the contrary as "vintage." Id. at 1165 n.
10. Addressing the Supreme Court's more recent decision in Jefferson
Parish Hospital District No. 2 v. Hyde, 466 U.S. 2, 16, 80 L. Ed. 2d 2, 104 S. Ct. 1551 (1984), it declined to follow the rule announced by the majority in that case that "the sale or lease of a patented item on condition that the buyer make all his purchases of a separate tied product from the patentee is unlawful." Instead, relying on the concurring opinion in Jefferson Parish, the
dissent from a denial of certiorari by two members of the Jefferson Parish majority, n2 and academic criticisms of the presumption of market power, the district court dismissed the majority opinion of Jefferson Parish as dictum that should not be followed. Indep. Ink, 210 F. Supp. 2d at 1164-65. The district court found that
Independent submitted no affirmative evidence defining the relevant
market nor proving Trident's power within it, and therefore could not prevail in either antitrust claim. Id. at 1173-77.

Of "which law to follow (CA9 or CAFC)", the CAFC cited Nobelpharma, 141 F3d 1059, and used CAFC law. We have previously held that where an affirmative antitrust claim or antitrust misuse defense is based on "procuring or enforcing a patent," the central antitrust question is a matter governed by Federal Circuit law. Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1067-68 (Fed. Cir. 1998) (en banc in relevant part). We conclude that the antitrust
consequences of patent tying likewise is a question governed by our
law. n3

The CAFC discussed International Salt.
The Court's treatment of tying cases when the tying product is
patented or copyrighted, however, has been more consistent. In the 1947 International Salt case, the defendant held patents over "machines for utilization of salt products." 332 U.S. at 394. It leased these machines on the condition that the
lessee purchase from the defendant "all unpatented salt and salt
tablets consumed in the leased machines." Id. The Supreme Court held that this arrangement violated the Sherman Act, holding that "the patents confer no right to restrain use of, or trade in, unpatented salt." Id. at 395-96.

Also, of market power, the CAFC said:
In United States v. Loew's, Inc., 371 U.S. 38, 9 L. Ed. 2d 11, 83 S. Ct. 97 (1962), relying on International Salt, the Court made clear that, where the tying product is patented or copyrighted, market power may be presumed rather than proven.

Footnote 7 stated: n7 It is noteworthy that Congress has declined to require a showing of market power for affirmative patent tying claims as opposed to patent misuse defenses
based on patent tying. Proof of actual market power is required to
establish a patent misuse defense based on patent tying. Act of Nov. 19, 1988, Pub. L. No .100-703, § 201, 102 Stat. 4674, 4676 (codified at 35 U.S.C. § 271(d)(5) (2000) ).

The patentee-defendant prevailed on the section 2 claim.

Sun opens up 1,673 Solaris patents under CDDL agreement

On January 25, 2005, Sun said that it is going to give open source developers who get involved in the new open source Solaris project free access to 1,673 active Solaris-related patents that it holds.

By "free access", Sun means that the 1,673 patents will only be available to open source developers who are working on OpenSolaris under the company's newly described Common Development and Distribution License or CDDL (pronounced cuddle). CDDL forbids blending Solaris with Linux or any GPL code.

Under the new Mozilla-derived CDDL license, which just got approved by the Open Source Initiative, a sine qua non for any open source project, all modifications to the Solaris code have to be returned to the community. However, mixtures of OpenSolaris and other open source or proprietary code don't have to be, making it more commercial than Linux and the GPL.

Sun CEO Scott McNealy described the 1,600 patents as "patent indemnification" and a "non-trivial asset" of the company. He suggested that it took a bit of persuading to convince Sun's board to let the company open up the patents to open source developers.

from Maureen O'Gara

***UPDATE. from Linuxworld, January 29, 2005

"The announcement was so broad in comparison to the related legal documents, that serious questions now exist regarding what rights the public has to Sun's patents," wrote Daniel Ravicher yesterday - executive director of the Public Patent Foundation, a not-for-profit legal services organization working to protect the public from what it calls "the harms caused by the patent system" - in an Open Letter to Sun's Scott McNealy.
"Free and open source software developers," PUBPAT said in its letter, "must have clear answers to these questions so that they can understand what rights they have to Sun's patents."

PUBPAT laid out several questions resulting from Sun's patent grant, including which license must be used for software to be safe from Sun's patents and whether Sun has waived rights to make patent claims against software written by anyone other than Sun. There was also a question about Sun's relationship with Microsoft, and how it may impact patents and the open source community.

"In Sun's announcement," added Ravicher, "they make sweeping statements about how the open source community will immediately gain access to 1,600 active Sun patents for operating systems, but the legal nitty-gritty behind the announcement shows that Sun has retained the right to aim its entire patent portfolio at GNU/Linux or any other free and open source operating system, except, of course, for their soon to be released version of Solaris."

"Developers need to be very careful about the details here," he continued, "and not be misled into thinking Sun has given them more than it actually has."

To open source apostle Bruce Perens, of course, the whole issue is moot since he urges developers to steer clear of both MS and Sun completely.

"If you are satisfied with the Sun or MS product, it might not matter," Perens wrote, in a Slashdot discussion. "But the fastest developing OS technology today, the one most likely to bring you future improvements, is not the one from Sun or MS, it's Linux and the vast collection of Open Source that rides on top of it."

"Everything we've heard about Sun's strategy so far seems to be geared to act as a "spoiler" rather than a partner in the Open Source community," Perens added. "The most egregious part is the implicit threat: we've got 1600 patents held over your head, Linux users, and we've got an agreement with Microsoft about them..." he continued.

UPDATE from Richard Stallman on ZDNet:

Recently Sun made an announcement that superficially seems similar. It said that Sun had given us "free access to Sun OpenSolaris related patents under the Common Development and Distribution License." But those words do not really make sense. The CDDL is a licence for the copyright on software, not a policy for licensing patents. It applies to specific code and nothing else. (Copyright and patents have essentially nothing in common in the requirements they impose on the public.)

So what has really happened here? Reading the announcement clearly, I think that it doesn't announce anything at all. It simply describes, in a different and grandiose way, the previously announced release of the Solaris source code as free software under Sun's idiosyncratic license, the CDDL. Outside Solaris, few or no free software packages use that licence -- and Sun has not said it won't sue us for implementing the same techniques in our own free software.
Perhaps Sun will eventually give substance to its words, and make this step a real one like IBM's. Perhaps some other large companies will take similar steps. Would this make free software safe from the danger of software patents? Would the problem of software patents be solved? Not on your life. Neither one.


Toronto Star on Canadian government's amicus brief in blackberry case

The Toronto Star has some great quotes from an NTP brief, describing some amicus filers as "wolves" and "parrots."

Tyler Hamilton of the Toronto Star on the Canadian government's brief (in favor of en banc rehearing) in the NTP v. Rim case:

NTP snapped back in a court filing on January 24, 2005, calling the [Canadian] government's motion an inappropriate and belated attempt to protect a Canadian corporate icon.

"The appearance of a foreign government in the U.S. courts to advocate the narrow economic interests of one of its corporate nationals should, for good reason, be discouraged," according to the NTP filing.

"Otherwise, the U.S. courts would be swamped with filings by foreign governments in support of their largest and most well-connected corporate citizens."

In separate filings, NTP also asked the appeals court to deny similar amicus curiae briefs submitted by the Information Technology Association of Canada, the Canadian Chamber of Commerce and Earthlink Inc., a U.S. Internet service provider and distributor of BlackBerry devices. All three organizations support RIM's request for an appeals court rehearing [before all judges], known as an en banc.

NTP suggested Earthlink, as an ally of RIM, was a "wolf in sheep's clothing" and that the two other organizations were "parrots" that merely repeated RIM's own position.

"If this were a football game, RIM would be called for `piling on' and a 15-yard penalty would be assessed," said the court filings.

Donald Stout, a patent lawyer and co-founder of NTP, called Ottawa's filing "unusual" and "unprecedented" during an interview with the Star. "The Canadian government suggestion that this will hurt Canadian business just doesn't follow."

David Long, legal counsel for RIM, said the federal court, despite NTP's protest, accepted the briefs as filed.

"The federal circuit wanted to hear what those briefs had to say," said Long, adding that it may be two weeks to a month before a decision to rehear the case is made. If a rehearing is not permitted, he said, RIM will appeal to the U.S. Supreme Court.

RIM has refused so far to settle. "When you're dealing in the United States, you can't settle with everybody because it makes you an easy marker," said one legal expert.

Carrie Goodge, a spokesperson for International Trade Canada, said Ottawa didn't get involved earlier in the four-year-old dispute because concerns only surfaced in December and they related directly to the appeals court's interpretation of U.S. patent law. "It's not the first time the government has filed an amicus brief on behalf of a Canadian company," she said.

"Canada is concerned about the potential implications from this decision as it relates to cross-border e-commerce and telecommunications services."

The case has been ongoing since 2001. NTP, a patent holding company based in Virginia, owned patents on wireless email technology developed by recently deceased engineer Thomas Campana Jr.

After sending patent infringement letters to about four-dozen companies, NTP pursued legal action against RIM and was successful in getting a U.S. district court to award $53.7 million (U.S.) in penalties and an 8.6 per cent royalty on every BlackBerry sold in the U.S.

That decision also included an injunction, forbidding RIM from making or selling BlackBerry products on U.S. soil. The injunction has been stayed for now, but more bad news hit in December when the U.S. appeals court supported the findings of the lower court.

RIM, beyond challenging the validity of NTP's patents, has argued that it is not subject to U.S. patent law because a key component of its wireless email system is based in Waterloo.

"In the past, the courts usually said if you're not doing something in the U.S., you're not infringing a patent in the U.S.," said Don Cameron, a patent lawyer with Ogilvy Renault in Toronto. "This court is saying, if you're doing some stuff in the U.S. and some stuff outside the U.S., as far as I'm concerned you're still in the U.S."

Stout said the defence of operating in Canada is flawed because, while a BlackBerry email may pass through Waterloo, it begins and ends in the United States and the devices themselves are sold on U.S. soil and carried by U.S. wireless providers.

Cameron disagreed, pointing out that the U.S. might have a change of heart if China or the European Union started applying the same interpretation to their patent laws.

Rambus files infringement suits over DDR2, GDDR2/3 technology

Rambus has filed patent infringement suits in district court in San Jose [ND Ca] against Hynix Semiconductor, Infineon Technologies, Inotera Memories and Nanya Technology Corporation asserting infringement of claims of 18 distinct patents related to DDR2 memory chips and GDDR2 and GDDR3 graphics memory chips.

John Danforth, senior vice-president and general counsel at Rambus, was quoted: "With analyst firms projecting a rapid transition this year from DDR to DDR2 and GDDR-based systems, and with strong evidence of infringement of our patents already in the public domain, we have taken this step in filing our first new patent case in the US since August 2000." He said analysts predict that the type of memory at issue in the lawsuit, DDR2, will be used in an estimated 49 percent of chips for graphics and personal computers by the end of 2005.

The complaint is available at:

Tuesday, January 25, 2005

Another twist in NTP v. RIM on blackberries?


On Dec. 30, 2004, a company called Computer Leasco Inc. filed a lawsuit against NTP and added a new twist to the drama. The company claims NTP conducted a "wide-scale, fraudulent scheme" to steal CLI's patents-the same patents NTP claims RIM's BlackBerry violates.

CLI said it leased computer equipment to a company called Telefind in 1998. Telefind eventually went under, and CLI successfully sued the company for $3.83 million. However, CLI claims that Telefind's chief engineer, Thomas Campana, covertly managed to transfer several key patents from Telefind into another holding company called ESA Telecommunications Inc. ESA eventually became NTP. CLI is suing to get a hold of those patents, which cover technology for wireless e-mail systems.

Interestingly, an appeals court ruled in 1994 that the patents in question do in fact belong to NTP, but CLI claims it has been swindled.

NTP said it has no comment on the lawsuit. RIM generally does not comment on its legal issues.

In the following, note "beneficial use" is a legal term of art in 35 USC 271.

from an article by Ian Austen in the NYTimes

"One of the fundamental things about patent laws is that there are territorial limitations to them," said Henry Bunsow, a lawyer representing RIM Since the BlackBerry handheld units are effectively useless without the relay server in Canada, Bunsow contends that its entire system does not infringe on NTP's patents.

So far, the courts have shared the view of Donald Stout, a co-founder of NTP and the company's legal counsel.

"We don't care if one part of the system is run in Canada," Stout said. "The beneficial use of the system is in the United States."
Bunsow argued that the nature of the NTP patents makes them impossible to uphold. The NTP patents stem largely from work that Thomas Campana Jr. did for Telefind, a now-defunct pager company that was able to send a crude form of e-mail to subscribers during the last 1980s and early 1990s. Campana, who died last year, held about 50 patents and long used Stout as his intellectual property lawyer.

In the case of the wireless e-mail patents, Bunsow said they cover the system as a whole rather than individual components.

"They could have parsed the applications," Bunsow said. "But it's an entire system patent so that they could capture all the revenues in the system." As a result, Bunsow said, if any key part of that system is outside of the United States, the NTP patent does not apply. <--

Friday, January 21, 2005

Pfizer defeats Teva in Zoloft case

In this Hatch-Waxman case, Teva filed a paragraph III certification as to US 4,356,518 (composition of matter of sertraline hydrochloride) and a paragraph IV certification as to US 5,248,699 (novel crystalline form of sertraline hydrochloride). Pfizer failed to sue Teva for infringement of the '699 patent within 45 days, and Teva filed a DJ action for a declaration of noninfringement or invalidity. The district court dismissed Teva's case for lack of jurisdiction. Teva appealed to the CAFC and lost.

The CAFC gave some background on the Hatch-Waxman Act, background of relevance not only to this case but also to Merck v. Integra. Ivax submitted an amicus brief on behalf of Pfizer and the FTC, the AARP, and the Generic Pharmaceutical Association filed on behalf of Teva. The court noted that the ANDA of a generic may rely on safety and efficacy studies in an NDA provided information establishing bioequivalence is presented. The court discussed certifications described at 21 USC 355(j)(2)(A)(vii)(I-IV).

A legal issue was a 2004 amendment codified at 21 USC 355(j)(5)(C) and a factual nuance was that Ivax (then Goldline) had filed a paragraph IV certification as to the '699 in 1999, prior to Teva's filing. Pfizer did file suit against Ivax. In 2002, Pfizer and Ivax cut a deal, wherein Ivax would get a license to the '699 and begin marketing on the expiry of the '518 patent (June 30, 2006).

The CAFC discussed the two part test for DJ jurisdiction (citing, among others, EMC, 89 F3d at 811): explicit threat by patentee and present activity by DJ plaintiff. Reasonable apprehension based on threat by patentee was the issue in this case. The CAFC noted an absence of reasonable apprehension of IMMINENT suit. Along this line, the CAFC also noted that Teva could not receive FDA approval until AFTER the 180 day exclusivity period granted to Ivax, so Pfizer had no immediate need to sue Teva.

Teva argued that the reasonable apprehension test was prudential, rather than constitutional, in nature, citing to among other cases Arrowhead, 846 F2d at 736 and Ewen, 123 F3d 1466. The CAFC rejected this.

Judge Mayer dissented.

HP, Intergraph settle patent litigation

Hewlett-Packard Co has agreed to pay $141 million to settle patent disputes with software maker Intergraph Corp., both companies announced January 21, 2005.

Thursday, January 20, 2005

Apple sues 19 year old over disclosure of trade secrets

AP reported that Apple Computer filed a trade secret lawsuit on Jan. 4, 2005 in Superior Court in Santa Clara County against Nicholas Ciarelli, the publisher of the site and a 19 year old Harvard University student. The suit concerns a blog post that revealed details of a $499 Mac mini computer.

California has adopted a version of the Uniform Trade Secrets Act. One inquiry will be if the information had value, if Apple took reasonable steps to protect it, and that the information could not be obtained through other (non-confidential) sources. Ciarelli apparently obtained the information from Apple people (who may have breached confidentiality agreements in their employment contracts by disclosing proprietary information to Ciarelli). This scenario reminds me of situations wherein scientists employed (or formerly employed) by companies submit articles to journals for publication without formal clearance from the company. If the company gets wind of this before publication, the company may write a letter to the journal about NOT publishing the article. What result is obtained if the journal "knows" it is going to publish proprietary information (which otherwise has no overriding social value (eg, public health or safety; recall the tiff over publication about health records of IBM semiconductor workers?))?

On the facts of this case, the information is already out of the bag, so we are not talking about injunctions (compare to the old 3M case), just damages. Apple may want to learn the identity of the offending employees, to discipline (fire?) them. Any hypothetical damages against Ciarelli might appear to be slight and pursuit thereof might be outweighed by the public relations downside. Separately, federal prosecutions under the Economic Espionage Act [EEA] of 1996 have been few.

Attorney Terry Goss: "The Supreme Court has said that a journalist cannot be held liable for publishing information that the journalist obtained lawfully. Think Secret has not used any improper newsgathering techniques. We will be filing a motion asking the Court to dismiss this case immediately on First Amendment grounds under a California statute which weeds out meritless claims that threaten First Amendment rights." [The Register]

Matthew Gline of the Harvard Crimson went into greater detail:

[The suit] alleges that Ciarelli induced employees of Apple or Apple affiliates to reveal proprietary information in violation of contractual agreements, and then released known trade secrets to the public. These employees are also targeted by the lawsuit, though their names are not yet known: Apple hopes to compel Think Secret to release the details of its communication with its sources so that the company can ascertain their identities and seeks damages from Think Secret directly for publishing its findings.

There are important questions raised here that are essential to understanding the rights and responsibilities of news sources (for example, The Crimson)—particularly as the definition of “news source” expands in the era of the Internet to include blogs like Ciarelli’s Think Secret. The first of these is on the efficacy of a free press. Can someone in the media publish information if their source obtained that information illegally? It seems the obligations of the press ought generally to lie with the public, and not with personal or corporate interests. Still, we make exceptions to this in cases of slander or libel—might we also want to make one in this case?

The United States Supreme Court has addressed this issue several times, including in Bartnicki v. Vopper, a 2001 case involving negotiations between a Pennsylvanian teacher’s union and a district school board. During the discussions, an inflammatory cell phone call was illegally intercepted and the tape of that call was passed on to an anti-union intermediary, who gave the tape to Vopper, a radio news commentator. Vopper, knowing that the tape had been obtained in violation of wiretap and other privacy laws, aired it anyway. The court ruled that this was acceptable: “Privacy concerns give way when balanced against the interest in publishing matters of public importance.”

The situation with Think Secret is, of course, quite different from that in Bartnicki. For one, the interest being protected is not privacy in the broad sense but is rather a corporate trade secret. We also ought to ask whether the information about upcoming product announcements counts as a “matter of public importance.” It does appear that Think Secret’s actions are in violation of the California Uniform Trade Secrets Act, as Ciarelli probably knew that what he was disclosing had been “derived from...a person who had utilized improper means to acquire it.” And Apple, as their claim makes clear, most certainly takes steps to protect the privacy of information of the sort that was revealed.

So the question we must ask is, does the concern of protecting trade secrets give way as the wiretap concerns did? The answer appears intuitively to be “sometimes.”

Suppose I’m publishing an article about migraine medication, and a drug company representative mentions that his company has launched an internal investigation to determine if the drug causes severe heart problems. I’m then told by a supervisor that the information about the study is a trade secret, that the person I spoke to was in violation of his contractual agreement with the company, and that I am not to disclose what I’ve heard on threat of civil action. It seems in this case that I should be protected if I choose to provide this information: If I’m to be allowed to weigh fairly my claims about medications, I ought to be able to rely on everything I know.

On the other hand, what if the subject of my book is a television buying guide, and the proprietary information is that Sony is releasing a better, cheaper model of a high end television in two months time? Well, revealing this information might make my book on televisions more informative, but it also amounts to transferring money to my readers from Sony. In this case, which feels analogous to the Think Secret suit, the weight of the competing claims seems to depend on the complicated economic effects of granting this right to either party.

We ought to be able to come up with a law that properly distinguishes between these situations if economic analyses demonstrate the need; years of legal precedents including Bartnicki have tried. Still, even in such ambiguous circumstances, we must rely, when in doubt, on the Bill of Rights. It guarantees us freedom of the press, and this is a freedom not to be lightly infringed upon. Otherwise, as McKay Professor of Computer Science and former Dean of the College Harry R. Lewis ’68 suggests (not, as it were, on condition of anonymity), it would be advisable for University Hall to place everything in folders labeled “trade secrets:” Surely this would give them good recourse against the prying eyes of Crimson reporters. [end]

The future of Huawei

Reuters has an upbeat story on Huawei. In December 2004, it won its first major European contract from Sweden's Ericsson for a deal worth up to 400 million euros ($530.1 million) to build a third-generation (3G) mobile network for Telfort of the Netherlands.

Huawei had an IP problem when Cisco Systems Inc. sued it in 2003, accusing the firm of copying its intellectual property and infringing on patents. In 2004, Cisco dropped the suit after Huawei took steps to address its concerns.

Rambus prevails against Hynix in SJ action

Rambus announced on January 20, 2005 that a judge (Ronald Whyte) in the Northern District of California had acted favorably to Rambus in an infringement action against Hynix. Trial will begin on March 21, 2005 on matters not resolved in the summary judgment actions.

Of six summary judgment motions filed by the defendant Hynix, Judge Whyte granted one, according to the statement. This resulted in nine claims in four patents containing the term "second external clock signal" being removed from the case. The ruling reduces the number of claims against Hynix from 59 to 50, according to the statement.

Of summary judgment motions filed by the plaintiff Rambus, Judge Whyte made two sets of rulings on Rambus's summary judgment. First, he ruled that Hynix infringes 29 claims from four asserted Rambus patents. The judge also ruled that Rambus was limited in the way it could accuse Hynix in 11 of its claims.

Curiously, there is a report by the Seoul Economic Daily newspaper that Hynix was granted a motion this week by the European Patent Office DISMISSING Rambus' claims and clearing Hynix of infringement charges. This would be another case in which things came out differently in Europe than in America (remember Amgen-Kirin?) Such examples of divergent results between America and Europe throw water on the use by the National Academy of Sciences (NAS) of comparisons between the US and Europe on patent grant rates. [Stephen A. Merrill, Richard C. Levin, and Mark B. Myers, "A Patent System for the 21st Century"] The rules to get patents are different (see also Robert A. Clarke, U.S. Continuity Law and its Impact on the Comparative Patenting Rates of the U.S., Japan, and European Patent Office, 85 J. Pat. & Trademark Off. Soc'y [JPTOS] 335 (2003)), the patent one gets is different, and the litigtion results are different.

from Forbes (through AP):

The court found that Korea-based Hynix violated 29 claims from four patents held by Rambus after throwing out five of six motions filed by Hynix challenging the validity of the claims.

It also decided that a "fact issue" regarding a limitation appearing in 11 of 40 claims would have to be tried in court, Rambus said.

The first phase of the trial is scheduled to begin March 21 and will focus on the remaining patent-infringement and validity claims. Rambus added that a second phase will be tried in June over various non-patent disputes and counterclaims asserted by Hynix.

In all, Rambus had asserted that Hynix infringed on 59 claims from 15 patents, but a summary judgment granted Thursday by the U.S. District Court of Northern California reduced the number of claims to 50.

"This summary judgment of infringement is great news and a major step forward toward our goal of being fairly compensated for our innovations," John Danforth, Rambus senior vice president and general counsel, said in a statement.

Wednesday, January 19, 2005

NY Times editorial on Jan. 18 criticizes Indian patent policy

In an editorial on January 18, 2005, the New York Times criticized the Indian patent ordinance which became effective on January 1, 2005, which ordinance was for the purpose of India's compliance with WTO requirements.

One interesting thing about the editorial is that it criticizes the Indian government for not doing things that the United States has not done either.

For example, it criticizes the Indians for not making compulsory licenses easier to obtain, especially for AIDS drugs. The United States has not invoked compulsory licenses for AIDS drugs (though it did invoke them for airplane patents (eg, that of the Wright Brothers) during World War I.

It states Malawi, for example, could not import from India an inexpensive version of a medicine that is not under patent in Malawi. Can't import it from the US either, if the drug is under patent in the US.

It states that the decree would limit efforts to challenge patents before they take effect. It is talking about patent oppositions. There are no patent oppositions in the United States, either.

As to selling patented medicines to India's huge middle class, most of current consumption in India is of drugs patented before 1995, which are not covered by the Indian ordinance. This is more generous than in the United States, where in-force patents prior to 1995 do protect drugs.

So-called "evergreening" (as to polymorphs, enantiomers) currently exists in the United States.

There may indeed be some issues to discuss, but blaming India for taking actions similar to paths taken in the United States is absurdly inconsistent, a case of seeing the black pot but not the adjacent black kettle.

The editorial -->

For an AIDS patient in a poor country lucky enough to get antiretroviral treatment, chances are that the pills that stave off death come from India. Generic knockoffs of AIDS drugs made by Indian manufacturers - now treating patients in 200 countries - have brought the price of antiretroviral therapy down to $140 a year from $12,000.

That luck may soon run out. India has become the world's supplier of cheap AIDS drugs because it has the necessary raw materials and a thriving and sophisticated copycat drug industry made possible by laws that grant patents to the process of making medicines, rather than to the drugs themselves. But when India signed the World Trade Organization's agreement on intellectual property in 1994, it was required to institute patents on products by Jan. 1, 2005. These rules have little to do with free trade and more to do with the lobbying power of the American and European pharmaceutical industries.

India's government has issued rules that will effectively end the copycat industry for newer drugs. For the world's poor, this will be a double hit - cutting off the supply of affordable medicines and removing the generic competition that drives down the cost of brand-name drugs.

But there is still a chance to fix the flaws in these rules, because they are contained in a decree that must be approved by Parliament. Heavily influenced by multinational and Indian drug makers eager to sell patented medicines to India's huge middle class, the decree is so tilted toward the pharmaceutical industry that it does not even take advantage of rights countries enjoy under the W.T.O. to protect public health.

In November 2001, members of the World Trade Organization agreed that countries can issue compulsory licenses to permit generic production of patented drugs without the patent holder's agreement in order to protect public health, at home or abroad. But under the Indian decree, getting a compulsory license would be slow and difficult; each application would face a fight from multinational drug firms and the governments that do their bidding. India should adopt laws that expedite compulsory licenses, including allowing challenges to proceed after production begins instead of holding it up. In addition, India must close an important loophole affecting the sick overseas: under the current rules, Malawi, for example, could not import from India an inexpensive version of a medicine that is not under patent in Malawi. This needs to be changed.

Industry lobbyists managed to insert two noxious provisions in the decree that go well beyond the W.T.O. rules. The decree would limit efforts to challenge patents before they take effect. Also, it is uncomfortably vague about whether companies could engage in "evergreening" - extending their patents by switching from a capsule to tablet, for example, or finding a new use for the product. This practice, a problem in America and elsewhere, extends monopolies and discourages innovation.

While some drugs - those that existed before 1995 - will always be off patent in India, some widely used drugs are at risk. So are new generations of much more expensive AIDS drugs that will soon be needed worldwide as resistance builds to current medicines. If the decree is not changed before Parliament approves it, it will be very difficult for India to supply them. India's parliamentarians must keep in mind that this arcane dispute is actually a crucial battleground for the health of hundreds of millions of people in India and worldwide.

Trintec v. Pedre on personal jurisdiction

The case is about personal jurisdiction, and the CAFC cites to (among other cases) Silent Drive, 326 F3d 1194, HollyAnne, 199 F3d 1304, and Burger King, 471 US 462.

The case is an example of a remand because the district court did not create a sufficient record.

Roscoe v. Mirror Lite on testimony; inequitable conduct

In the nonprcedential Roscoe v, Mirror Lite, the CAFC noted that testimonial evidence of invalidity must be corroborated, citing to Finnigan v. ITC, 180 F3d 1354. It is worth noting that the testimonial evidence in the Finnigan case was by Keith Jefferts, who was a disinterested third party. So when the court noted that the corroboration could be by testimonial evidence other than from the inventor or interested party, remember that corroboration is required even when the initial testimony is from a disinterested party (Jefferts had no connection to Bruker-Franzen or to Finnigan).

Of the alleged corroborating evidence in this case (Exhibit 110), the CAFC noted that the district court was not one skilled in the art and should not have assessed technical aspects on its own, citing Dayco, 329 F3d 1358.

In the inequitable conduct portion of the case, the CAFC was not troubled that a witness described the term "convex" one way in the patents and another way in testimony, because in testimony he admitted it had two different meanings.

Summers and other economists: out of touch?

from Michael Dobbs of the Washington Post on Wed., Jan. 19, 2005:

During his four years as president of Harvard University, Lawrence Summers has earned a reputation for blunt, sometimes brutal comments. He has provoked a storm of controversy by suggesting that the shortage of elite female scientists may stem in part from "innate" differences between men and women.

"I felt I was going to be sick," said Nancy Hopkins, a biology professor at Massachusetts Institute of Technology, who listened to part of Summers' speech Friday [Jan. 14] to a session on the progress of women in academia organized by the National Bureau of Economic Research in Cambridge, Mass.

Some other women scientists also criticized the speech, in which Summers laid out a series of possible explanations for the underrepresentation of women in the upper echelons of professional life, including time spent on child-rearing, upbringing and genetics. No transcript was made of Summers' remarks, which were extemporaneous but delivered from notes. Summers' remarks were first reported by the Boston Globe in Monday's [Jan. 17] editions.

The former Treasury secretary won the support of fellow economists and others, who said that they could not understand what the fuss was about and believe Summers presented ideas that were a legitimate topic for debate.

"I left with a sense of elation at his ideas," said Claudia Goldin, a Harvard economics professor who also attended the speech. "I was proud that the president of my university retains the inquisitiveness of an academic."

from Eileen McNamara of the Boston Globe:

Summers suggested that women do not rise higher in the academic or professional firmament because they choose to become mothers and thus devote less time to their careers. "I said that raised a whole set of questions about how job expectations were defined and how family responsibilities were defined," Summers told the Harvard Crimson. [He did not return my call.] "But I said it didn't explain the differences [in the representation of females] between the sciences and mathematics and other fields."

Why doesn't it? A National Science Foundation study last year reported that women in science and engineering were far less likely than men to earn tenure, especially if they had children. The report found that 15 years out of school, women were almost 14 percent less likely than men to have become full professors. Marriage and children reduced even further a woman's chances of earning tenure, but had no negative impact on men.

That sounds like a cultural, not a biological, problem to me. Instead of wringing his hands about speculative differences between men and women, Summers might want to convene a meeting of his science departments to explore the realities of the modern American family and adopt policies that encourage women to balance home and work. Mentor women. Provide child care. Encourage flex-time. Stop the tenure clock during pregnancy or maternity leave.

The academy is tailor-made for just such experimentation. Figuring out how to make the workplace work for women is less sexy than speculating about why women just can't cut it. Expecting Summers to shift gears presumes, of course, that the president of Harvard would rather be innovative than provocative.

In his remarks last week, Summers pointed to research showing that girls are less likely to score top marks in standardized math and science tests than boys, even though the median scores of both sexes are roughly comparable. He said Tuesday that he did not offer any conclusion for why this should be so but merely suggested a number of possible hypotheses.

end Globe
Mr. Summers received a B.S. degree from the Massachusetts Institute of Technology in 1975 and a Ph.D. from Harvard University in 1982. He was Professor of Economics at Harvard from 1983-1993.


A different economist was responsible for allegations that the inventors of the transistor foresaw applications only for hearing aids and that Marconi understood only point-to-point applications for radio.

Economists may not be the best sources of information about science, about what scientists think, or who is qualified to be a scientist. Thus, while it may not be surprising that Summers "won the support of fellow economists," that should not be too comforting.


Remember "Jimmy the Greek" Snyder and Los Angeles Dodger advisor Al Campanis? Maybe it's time for Summers to go.

One respondent wrote me of Summers:

He sounded like a white guy--coming from a culture where men make very rigid rules and only women who act like men can win.

In a column "You can't say that at Harvard," (eg, Trenton Times, A13, Jan. 27, 2005), George Will wrote

Addressing a conference on the supposedly insufficient numbers of women in tenured positions in university science departments, he suggested that perhaps part of the explanation might be innate--genetically baased-- gender differences in cognition. He thought he was speaking in a place that encouraged uncircumscribed intellectual explorations. (...)

He was at Harvard, where he is president. Since then he has become a serial apologizer and accomplished groveler.

Tuesday, January 18, 2005

Another problem at Harvard?

The Independent on Harvard's Lawrence H. Summers:

His [Summer's] contention that boys outperform girls in science and maths because of genetic differences - he backed up his argument by saying his daughter treated two toy trucks as dolls, calling them mummy truck and daddy truck - is just not supported by the evidence, according to Britain's august scientific academy, the Royal Society.

Current A-level figures show that more girls are taking chemistry and biology than boys, according to the Royal Society spokesman Tim Watson. And while fewer girls take maths and physics at A-level, they do at least as well as boys, if not better. "It's a nonsense to say girls are incapable of doing these subjects," he said.

But he conceded that women were under-represented in the sciences at the top, professorial levels. Yet here, he said, it was social attitudes, not inherent brainpower, that was behind the difference.

"At least at the professor level there is an under-representation," he said. "Something like 9 to 10 per cent of professors in the sciences across the board are women. But then if we look at other academic subjects, it's similar. The fact that women are not being retained at senior levels is a general trend in the workplace. It's the culture of the workplace - the lack of career flexibility. If women want to take a career break to have children, there are barriers to them getting back in. But this is not just a problem with science - there's no difference to most other areas."

It is a source of some embarrassment to the Royal Society that while the most sought-after scientific distinction in Britain is one of its own fellowships, the proportion of fellows who are women is very low indeed. Of the 1,259 scientists who are entitled to add the cherished letters FRS after their names, only 58 - or 4.6 per cent - are women. (And although the society was founded in 1660, the first female fellows, Kathleen Lonsdale and Marjory Stephenson, were only elected in 1945.)

But the society would not remotely agree that this is an indicator of genetic distinction. Openly accepting that the figure is "disappointingly low", it says it "reflects the under-representation of women at senior levels of science in higher education and industry". The Royal Society communications manager, Bob Ward, says this is partly because the average age of fellows on election is about 55. Their election is usually on the basis of work undertaken 15 or 20 years previously, since it can take that long to build up a sufficient body of scientific work to justify election and to know whether the scientific work is indeed seminal. So current elections reflect the position in science at post-doctoral level in the 1970s, and at professorial level now, where women are under-represented. Mr Ward added: "The proportion of women within the fellowship is increasing slowly." For example, of the 254 fellows who had been elected in the past six years, 27, or 11 per cent, were women.

And of course the Harvard Law Review says the PTO grants 97% of patent applications, and there was Laurence Tribe's plagiarism. Is it the water?

Ciena sues Nortel

Ciena said on Jan. 18 that it has filed a patent infringement lawsuit against Nortel Networks Corp. in a federal district court in Texas, two years after the companies settled a separate case and pledged to forge a cross-licensing arrangement. The suit involves six patents, directed to three standards used for voice and data transmission.

Hatch-Waxman litigation over Lamictal

GlaxoSmithKline Plc will defend the patent on its best-selling anti-epileptic drug Lamictal in DNJ on Jan. 18 in a Hatch-Waxman infringement suit against Teva. Lamictal, which is also used to treat bipolar depression, represents about 4 percent of GSK drug sales. Worldwide Lamictal revenues were $928 million in the first 9 month of 2004, with the US share about 60%.

The main U.S. patent on Lamictal expires in mid-2008.


Business method patent in unit investment trusts?

WellSpring BioCapital has developed unit investment trusts that go by the name VIOLTs (vertical investments of life sciences trusts). In the trust, shares of pharma and biotech are grouped according to a specific disease, like Alzheimer's.

WellSpring BioCapital has filed a patent application on the business method.

[Newhouse, Jan. 18, 05]