Thursday, June 30, 2005

RIM attorney sends letter about art to NTP, who files with USPTO

from Forbes:

In a filing with the U.S. Patent and Trade Office, NTP disclosed that it received a letter from RIM attorney David Long concerning six technical books published by the Norwegian telecommunications concern Telenor in 1986 and 1989, which describe a wireless e-mail messaging system.

These dates are key to casting doubt on a group of patents at the heart of the dispute between the companies. NTP has sued RIM over a group of patents that NTP filed as early as 1991 concerning a wireless e-mail system, and so far courts have found that RIM has been infringing on those patents. An injunction barring RIM from selling its popular BlackBerry device and messaging service in the U.S. has been stayed pending appeals and settlement talks.

The Telenor books describe an integrated system combining what it calls a Message Data Network with a Message Handling System that is capable of transferring e-mail messages on a store-and-forward basis via radio frequency transmission. This is similar to the way that RIM's BlackBerry network operates.

In a letter to NTP, Long wrote, "I bring to your attention information that is highly material to the patentability of those NTP patents so that you properly may fulfill your and NTP's duty of candor and good faith in dealing with the Patent Office with the NTP patents and related patent applications." [LBE note: The duty to disclose art to the PTO ends with patent issuance. Anyone may bring art raising a substantial issue of patentability to the attention of the PTO through a re-exam request. The failure to disclose such art to the PTO well after issuance would not raise an issue of "candor and good faith" but might not be a good business decision.]

Long goes on, "The Telenor publications openly disclosed and described to the public the mobile e-mail system sought to be claimed years later in NTP patents. Indeed, the Telenor publications openly disclosed that e-mail system long before NTP claims that its system was even conceived." Long's letter cites an NTP sworn statement saying its patent was first dreamed up in July 1990.

IBM selling LCD patents to AU Optronics ?

from etaiwannews through Bloomberg, July 1:

AU Optronics Corp., the world's third- largest maker of flat-panel displays used in computers and televisions, said it signed an agreement yesterday to buy about 170 U.S. patents related to liquid-crystal display technology from International Business Machines Corp.

The agreement, covering almost all LCD-related technology, includes IBM's counterpart patents in Japan, South Korea, Taiwan and other countries, AU said today in an e-mailed statement yesterday. It didn't reveal the dollar value of the transaction.

With the patents assigned, AU Optronics will further strengthen its intellectual property position, the statement said. IBM is the world's largest computer-services provider.

Cross-authorization of patents

AU Optronics and IBM also entered into an agreement on cross-authorization of LCD patents, the statement said.

The patents cover almost all aspects of the key TFT-LCD-related technology, it said.

AU Optronics, Taiwan's leading manufacturer of TFT liquid crystal display screens, ranks third in the world after Samsung and LG Philips of South Korea.

Merck v. Integra: Is "getting patents" reasonably related to getting FDA approval?

More on the Merck v. Integra decision of the Supreme Court,

from Mauricio A. Flores And Cathryn Campbell,Back to the Lab?;
Points Of View; Despite Supreme Court ruling, Integra may still show Merck's studies fall outside research exemption, Legal Times, p. 66 (June 20, 2005):

(...)

Integra learned that Merck had been sponsoring the research from
scientific papers written by Scripps scientists. Although Integra did not object to the use of its patented technology for research purposes only (and indeed had previously provided these peptides to Scripps scientists), Integra took the position that sponsored research that was part of Merck's commercial drug development
program required a license.

(...)

Merck and Scripps witnesses also admitted that there were reasons
for the Scripps research that did not pertain to FDA review, such as strengthening Merck 's patent position and validating the general scientific premise that the inhibition of a key receptor could inhibit the growth of blood vessels necessary to sustain tumors.

Patents per capita: are we entering the dark ages of innovation?

from a board:

Entering a dark age of innovation
02 July 2005
NewScientist.com news service
Robert Adler
19 June 2005


(...) we are fast approaching a new dark age. That, at least, is the conclusion of Jonathan Huebner, a physicist working at the Pentagon's Naval Air Warfare Center in China Lake, California. He says the rate of technological innovation reached a peak a century ago and has been declining ever since. And like the lookout on the Titanic who spotted the fateful iceberg, Huebner sees the end of innovation looming dead ahead. His study will be published in Technological Forecasting and Social Change.

It's an unfashionable view. Most futurologists say technology is developing at exponential rates. Moore's law, for example, foresaw chip densities (for which read speed and memory capacity) doubling every 18 months. And the chip makers have lived up to its predictions. Building on this, the less well-known Kurzweil's law says that these faster, smarter chips are leading to even faster growth in the power of computers. Developments in genome sequencing and nanoscale machinery are racing ahead too, and internet connectivity and telecommunications bandwith are growing even faster than computer power, catalysing still further waves of innovation.

But Huebner is confident of his facts. He has long been struck by the fact that promised advances were not appearing as quickly as predicted. "I wondered if there was a reason for this," he says. "Perhaps there is a limit to what technology can achieve."

In an effort to find out, he plotted major innovations and scientific advances over time compared to world population, using the 7200 key innovations listed in a recently published book, The History of Science and Technology (Houghton Mifflin, 2004). The results surprised him.

Rather than growing exponentially, or even keeping pace with population growth, they peaked in 1873 and have been declining ever since (see Graphs). Next, he examined the number of patents granted in the US from 1790 to the present. When he plotted the number of US patents granted per decade divided by the country's population, he found the graph peaked in 1915.

The period between 1873 and 1915 was certainly an innovative one. For instance, it included the major patent-producing years of America's greatest inventor, Thomas Edison (1847-1931). Edison patented more than 1000 inventions, including the incandescent bulb, electricity generation and distribution grids, movie cameras and the phonograph.

Medieval future
Huebner draws some stark lessons from his analysis. The global rate of innovation today, which is running at seven "important technological developments" per billion people per year, matches the rate in 1600. Despite far higher standards of education and massive R&D funding "it is more difficult now for people to develop new technology", Huebner says.

Extrapolating Huebner's global innovation curve just two decades into the future, the innovation rate plummets to medieval levels. "We are approaching the 'dark ages point', when the rate of innovation is the same as it was during the Dark Ages," Huebner says. "We'll reach that in 2024."

(...)

Tuesday, June 28, 2005

Amazon's 6,912,505 (method of using browsing activities)

In US patent 6,912,505 (issued June 28, 05), Amazon has a claim to:

A computer-implemented method of using online browsing activities of users to identify related products, comprising:

generating, for each of a plurality of users, a history of products viewed by the user during online browsing, to thereby generate a plurality of user-specific product viewing histories;

analyzing the plurality of product viewing histories to identify correlations between product viewing events reflected therein, wherein analyzing the plurality of product viewing histories comprises, for each of a plurality of product pairs of a first product and a second product, determining a number of product viewing histories in which both the first product and the second product occur; and

generating a data structure that maps each product of a plurality of products to a respective set of related products, wherein product relationships indicated by the data structure reflect said correlations between product viewing events.

Claim 15 recites:

A computer-implemented method of identifying products that are related to a first product, comprising:

(a) generating a plurality of user-specific product viewing histories for a plurality of users, wherein each product viewing history indicates products viewed by a user during online browsing of a collection of products;

(b) determining a degree of relatedness between the first product and a second product, such that the degree of relatedness reflects a frequency with which both the first and second products occur within the same product viewing history of the plurality of user-specific product viewing histories; and

(c) performing (b) for each of a plurality of additional second products.

The '505 is a continuation-in-part [CIP] of U.S. application Ser. No. 09/156,237, filed Sep. 18, 1998, now U.S. Pat. No. 6,317,722.

Bad coverage by Science of Merck v. Integra

Although the journal Science, in discussing the Supreme Court decision in Merck v. Integra, mentioned a

lower court ruling that had narrowed a legal exemption from infringement for "preclinical" studies

[308 Science 1725 (17 June 2005)]

the Supreme Court went out of its way to say that it did not understand the CAFC holding to exclude preclinical studies from the 271(e)(1) safe harbor.

Evidently, Science did not read footnote 6 of Merck v. Integra, 2005 U.S. LEXIS 4840, which said:

Although the Court of Appeals' opinion suggests in places that §
271(e)(1) 's exemption from infringement is limited to research conducted in clinical trials, see 331 F.3d at 866, we do not understand it to have adopted that position. The Court of Appeals recognized that information included in an IND would come within § 271(e)(1)'s safe harbor. Ibid. Because an IND must be filed before clinical trials may begin, such information would necessarily be developed in preclinical studies.

The Supreme Court basically said that two things were not per se bars to invoking the exemption of 35 USC 271(e)(1). Factual analysis is needed. Merck KGaA may still lose this case.

The Science article also quotes Kevin Noonan as "This is a big win for discovery drug companies." The case allows one "discovery drug company" to use the patents of another "discovery drug company" to generate information of relevance in seeking FDA approval of a drug or device.

Separately, my article on Merck v. Integra in the April 2005 JPTOS
[87 J. Pat. & Trademark Off. Soc'y 321] has appeared on LEXIS.

At page 327, I had quoted from the US brief, concerning the amended CAFC decision:

Although the court of appeals issued an "errata" sheet indicating that "the scope of the safe harbor is not limited to generic drug approval," Pet. App. 36a, the revised opinion
continues to hold that the statutory exemption should be construed to focus primarily on generic drugs, and appears to adopt the view that the exemption does not encompass pre-clinical studies prepared for an IND.

Footnote 6 of the Supreme Court decision shows that the Supreme Court did not see things this way.

Tiemann of Red Hat: "Patents are filed secretly."

A candidate for non sequitur of the week comes from Michael Tiemann, Red Hat's vice-president for open source affairs. Commenting on Sun's claim to document and identify the author of every line code in Sun's operating system, Tiemann said: "Patents are filed secretly, it is literally impossible for Red Hat to find out about every patent and fix it."

The whole point of "patents" is that they are publicly available. Even patent applications are published at 18 months. With little understanding of patent terminology or concepts, Red Hat's commentary on patent reform has little credibility.

from Benamin Koe of cmpnet:

Battling a common enemy, however, is not enough to stop Sun and Red Hat from clawing at each other's throats.

Phipps had boasted during a conference at the recent CommunicAsia 2005 in Singapore that Sun's OpenSolaris protects its users better, as Sun is able to document and identify the author of every line of code in its operating system.

"If you ask Red Hat, they wouldn't be able to tell you," remarked Phipps.

Tiemann pooh-poohed this, saying that no one can possibly know if each line of code is infringing on a patent.

"Patents are filed secretly, it is literally impossible for Red Hat to find out about every patent and fix it," he declared.

"We have an open source assurance programme that says if somebody makes us aware of some patent that we infringe -- and to my knowledge no one has made us aware of it -- we will modify the software so that it no longer infringes."

Monday, June 27, 2005

Grokster loses at Supreme Court on June 27

In METRO-GOLDWYN-MAYER STUDIOS INC., et al. v. GROKSTER, LTD., et al., 2005 U.S. LEXIS 5212, the decision of the 9th circuit at 380 F.3d 1154 was vacated and remanded.

Of Sony and the staple of commerce concept, the court noted:

On those facts, with no evidence of stated or indicated intent to
promote infringing uses, the only conceivable basis for imposing liability was on a theory of contributory infringement arising from its sale of VCRs to consumers with knowledge that some would use them to infringe. Id., at 439. But because the VCR was "capable of commercially significant noninfringing uses," we held
the manufacturer could not be faulted solely on the basis of its
distribution.
Id., at 442.

This analysis reflected patent law's traditional staple article of commerce doctrine, now codified, that distribution of a component of a patented
device
will not violate the patent if it is suitable for use in other ways. 35
U.S.C. §
271(c); Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U.S. 476,
485
(1964) (noting codification of cases); id., at 486, n. 6 (same).
The
doctrine was devised to identify instances in which it may be presumed
from
distribution of an article in commerce that the distributor intended
the article
to be used to infringe another's patent, and so may justly be held
liable for
that infringement. "One who makes and sells articles which are only
adapted to
be used in a patented combination will be presumed to intend the
natural
consequences of his acts; he will be presumed to intend that they shall
be used
in the combination of the patent." New York Scaffolding Co. v. Whitney,
224 F.
452, 459 (CA8 1915); see also James Heekin Co. v. Baker, 138 F. 63, 66
(CA8
1905); Canda v. Michigan Malleable Iron Co., 124 F. 486, 489 (CA6
1903);
Thomson-Houston Electric Co. v. Ohio Brass Co., 80 F. 712, 720-721 (CA6
1897);
Red Jacket Mfg. Co. v. Davis, 82 F. 432, 439 (CA7 1897); Holly v.
Vergennes
Machine Co., 4 F. 74, 82 (CC Vt. 1880); Renwick v. Pond, 20 F. Cas.
536, 541
(No. 11,702) (CC SDNY 1872).

In sum, where an article is "good for nothing else" but
infringement,
Canda v. Michigan Malleable Iron Co., supra, at 489, there is no
legitimate
public interest in its unlicensed availability, and there is no
injustice in
presuming or imputing an intent to infringe, see Henry v. A. B. Dick
Co., 224
U.S. 1, 48 (1912), overruled on other grounds, Motion Picture Patents
Co. v.
Universal Film Mfg. Co., 243 U.S. 502 (1917). Conversely, the doctrine
absolves
the equivocal conduct of selling an item with substantial lawful as
well as
unlawful uses, and limits liability to instances of more acute fault
than the
mere understanding that some of one's products will be misused. It
leaves
breathing room for innovation and a vigorous commerce. See Sony Corp.
v.
Universal City Studios, supra, at 442; Dawson Chemical Co. v. Rohm &
Haas Co.,
448 U.S. 176, 221 (1980); Henry v. A. B. Dick Co., supra, at 48.

The parties and many of the amici in this case think the key to
resolving it
is the Sony rule and, in particular, what it means for a product to be
"capable
of commercially significant noninfringing uses." Sony Corp. v.
Universal
City Studios, supra, at 442. MGM advances the argument that granting
summary
judgment to Grokster and StreamCast as to their current activities gave
too much
weight to the value of innovative technology, and too little to the
copyrights
infringed by users of their software, given that 90% of works available
on one
of the networks was shown to be copyrighted. Assuming the remaining 10%
to be
its noninfringing use, MGM says this should not qualify as
"substantial," and
the Court should quantify Sony to the extent of holding that a product
used
"principally" for infringement does not qualify. See Brief for Motion
Picture
Studio and Recording Company Petitioners 31. As mentioned before,
Grokster and
StreamCast reply by citing evidence that their software can be used to
reproduce
public domain works, and they point to copyright holders who actually
encourage
copying. Even if infringement is the principal practice with their
software
today, they argue, the noninfringing uses are significant and will
grow.

We agree with MGM that the Court of Appeals misapplied Sony, which
it read as
limiting secondary liability quite beyond the circumstances to
which the
case applied. Sony barred secondary liability based on presuming or
imputing
intent to cause infringement solely from the design or distribution of
a product
capable of substantial lawful use, which the distributor knows is in
fact used
for infringement. The Ninth Circuit has read Sony's limitation to mean
that
whenever a product is capable of substantial lawful use, the producer
can never
be held contributorily liable for third parties' infringing use of it;
it read
the rule as being this broad, even when an actual purpose to cause
infringing
use is shown by evidence independent of design and distribution of the
product,
unless the distributors had "specific knowledge of infringement at a
time at
which they contributed to the infringement, and failed to act upon that
information." 380 F.3d at 1162 (internal quotation marks and
alterations
omitted). Because the Circuit found the StreamCast and Grokster
software capable
of substantial lawful use, it concluded on the basis of its reading of
Sony that
neither company could be held liable, since there was no showing that their software, being without any central server, afforded them knowledge of
specific unlawful uses.

***
Of a separate point on VCRs, one notes that they haven't died yet:

posted Dec. 27, 2005: would spending the money buying a used $50 SVHS deck and a TBC-1000 make more sense than spending $300 on either of these decks (for purposes of capturing 15-20 year old oxidized tapes made with a camcorder).


posted Dec. 18, 2005: I would make the same claim about my old JVC HR-S6800 and HR-S4900 VCRs.
There are many older VCRs that can provide superior capture quality to the JVC TBC/DNR VCRs. Ironically, these older units often close for bargain prices on EBay.

Think of an older VCR as an addition, not just an upgrade.
Sometimes the TBC/DNR system is very helpful.
Sometimes the capture quality of the older VCR is noticeably superior.
I think you'd be glad to have both.

Saturday, June 25, 2005

Judge Pauline Newman urges caution in patent reform

from fdanews.com:

CONGRESS SHOULD MOVE CAUTIOUSLY ON PATENT REFORM LEGISLATION, JUDGE SAYS

Congress should proceed slowly on recently introduced legislation that would alter the U.S. patent system, according to a panel of federal judges, who said more review is needed before moving forward with broad reforms.

Judge Pauline Newman of the U.S. Court of Appeals for the Federal Circuit urged Congress to tread cautiously on patent reform until more economic and statistical analysis is conducted on the issue. "There's this sense [in Congress] that there are flaws in the system and in the way patents are treated in litigation," Newman told attendees at a patent reform conference [on June 9, 2005] sponsored by the FTC, the National Academy of Sciences and the American Intellectual Property Law Association in Washington, D.C.
"The thought that too many patents are being upheld is something that needs a firmer economic and statistical evaluation than I have seen so far."

[LBE note: the "patent grant rate" saga is but one example of this.]

Newman's comments centered on The Patent Reform Act of 2005, H.R. 2795, which was unveiled by Rep. Lamar Smith (R-Texas). The bill would result in sweeping changes to existing patent laws, including a switch from the current first-to-file patent system to a first-inventor-to-file system, the transfer of inequitable conduct proceedings from the courts to an administrative body within the Patent and Trademark Office, limits on the circumstances in which patent applicants may file a continuation, and the creation of a new postgrant opposition system.

While Smith contends such changes are needed to curb patent abuses in the U.S., Newman said Congress and industry need to examine the impact of the proposal on a broad national and global scale before moving forward with the legislation.

Microsoft to indemnify partners over IP litigation

from InformationWeek (A. Ricadela):

The world's largest software company said Wednesday, June 22 it will remove caps on the legal fees it would reimburse to PC makers that were the subject of such suits, and cover the costs of legal settlements or adverse judgments up to the amount of annual business they do with Microsoft. The moves apply to the largest manufacturers of PCs, such as Dell, Gateway, Hewlett-Packard, and Lenovo, as well as to smaller distributors and system builders. Collectively, those companies and independent software vendors that use Microsoft technology in their products--also covered by the new program--account for more than $18 billion of Microsoft's annual revenue. Microsoft said the largest PC makers had asked it to step up its coverage amid an environment of increased intellectual-property rights litigation in the technology industry.

"Intellectual-property issues are getting more important in software," says David Kaefer, director of business development for IP and licensing at Microsoft. "We've seen a general increase in IP litigation," he says, and "the largest PC makers for years have asked us to step in and indemnify them" against lawsuits. "Over the last couple of years, we've heard from smaller partners as well." A meeting last September in Redmond, Wash., between Microsoft general counsel Brad Smith and executives from large PC makers was a "catalyst" to the change, Kaefer says.

Microsoft indemnifies its distributors, corporate customers, and retail customers against lawsuits that charge infringement of patents, copyrights, trademarks, and trade secrets as a result of using its products, with varying degrees of compensation. Now, says Kaefer, the company is trying to be more consistent. "We want to set a high bar we think others are not matching in our industry as a reason to partner with Microsoft," he says.

A number of high-profile intellectual-property lawsuits in the technology industry in recent years have led companies such as Hewlett-Packard, IBM, Red Hat, and Sun Microsystems to offer or expand the protection they give customers:

--Three years ago, Lucent Technologies Inc. filed suit against Dell and Gateway alleging the PC makers had infringed on patents held by Lucent's Bell Labs and contained in Microsoft software, which Dell and Gateway distributed on their computers.

--In August 2003, startup Eolas Technologies won a $521 million judgment against Microsoft for infringing on Eolas patents in Microsoft's Internet Explorer Web browser. Microsoft is appealing the ruling. [LBE note: there is now an inequitable conduct defense in the mix, and there is a re-exam running in parallel.]

- SCO Group last year filed suits against DaimlerChrysler AG and AutoZone Inc. for infringements of its Unix holdings, and it has filed a related trade-secret infringement suit against IBM.

--In April 2004, Microsoft agreed to pay Sun Microsystems $900 million to resolve patent disputes between the companies related to the Java programming language, plus $350 million in royalties.

--Last October, Sun paid Eastman Kodak Co. $92 million to settle a patent dispute over Java.

Microsoft's Kaefer called the Lucent lawsuits "the marquee example" of actions it's trying to avoid [LBE note: Bell Labs as patent troll?]. Litigants who own software intellectual-property portfolios often file suit against small distributors that don't have the resources to defend themselves, he says. Even large companies such as Dell often don't have extensive patent portfolios that can be used as a defense in countersuits.

**The article confirms the current direction of Microsoft strategy:

Since 2003, Microsoft has been taking steps to bring its own intellectual-property mechanisms up to date. It's hired a former IBM executive as its deputy general counsel in charge of intellectual-property licensing; expanded the number of patents it issues [sic] from about 2,000 in fiscal 2004 to more than 3,000 this year; and entered cross-licensing agreements with large technology companies such as Cisco Systems, SAP, Siemens, and Toshiba to gain access to broad portfolios of patents. Kaefer says Microsoft plans to enter 30 to 40 such agreements over the next five years.

[note: the guys with decent size patent portfolios will be dealing, and the person with fewer patents will end up litigating.]

Google's US appl. 20050071741

Google's US application 20050071741 (Information retrieval based on historical data)
has been the subject of some discussion.

The first claim of the '741 application recites:

1. A method for scoring a document, comprising:
identifying a document;
obtaining one or more types of history data associated with the document; and generating a score for the document based on the one or more types of history data.

Doesn't citation analysis meet these claim elements?

Claim 15 of the '741 reads:

The method of claim 1, wherein the one or more types of history data includes information relating to how often the document is selected when the document is included in a set of search results; and wherein the generating a score includes: determining an extent to which the document is selected over time when the document is included in a set of search results, and scoring the document based, at least in part, on the extent to which the document is selected over time when the document is included in the set of search results.

Claim 22 gets into links:

The method of claim 1, wherein the one or more types of history data includes information relating to behavior of links over time; and wherein the generating a score includes: determining behavior of links associated with the document, and scoring the document based, at least in part, on the behavior of links associated with the document.

The spec notes: In the description to follow, documents may be described as having links to other documents and/or links from other documents. For example, when a document includes a link to another document, the link may be referred to as a "forward link." [LBE note: citing] When a document includes a link from another document, the link may be referred to as a "back link." [LBE note: cited] When the term "link" is used, it may refer to either a back link or a forward link.


Claim 52 (the second independent claim) is directed to a "system":

52. A system for scoring a document, comprising: means for identifying a document; means for obtaining a plurality of types of history data associated with the document; and means for generating a score for the document based, at least in part, on the plurality of types of history data.

The patent application has a "conclusion" section which recites:

CONCLUSION

[0134] Systems and methods consistent with the principles of the invention may use history data to score documents and form high quality search results.

[0135] The foregoing description of preferred embodiments of the present invention provides illustration and description, but is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. For example, while a series of acts has been described with regard to FIG. 4, the order of the acts may be modified in other implementations consistent with the principles of the invention. Also, non-dependent acts may be performed in parallel.

[0136] Further, it has generally been described that server 120 performs most, if not all, of the acts described with regard to the processing of FIG. 4. In another implementation consistent with the principles of the invention, one or more, or all, of the acts may be performed by another entity, such as another server 130 and/or 140 or client 110.

[0137] It will also be apparent to one of ordinary skill in the art that aspects of the invention, as described above, may be implemented in many different forms of software, firmware, and hardware in the implementations illustrated in the figures. The actual software code or specialized control hardware used to implement aspects consistent with the principles of the invention is not limiting of the present invention. Thus, the operation and behavior of the aspects were described without reference to the specific software code--it being understood that one of ordinary skill in the art would be able to design software and control hardware to implement the aspects based on the description herein.

Jill Whalen wrote:

I wasn’t surprised about the stuff in the patent that corresponded with Google’s aging delay and its “sandbox” as I had already seen a lot of discussion on this. For those who aren’t familiar with the aging delay and the sandbox, you’ll want to note that there is a lot of disagreement over what causes a site to be thrown in the sandbox.

However, based on my own observations and the experiences of some trusted SEO friends, it’s my belief that the sandbox is basically a purgatory database where Google places certain URLs based on a variety of predetermined criteria. (Much of this is spelled out in the first part of the patent application.)

The aging delay, on the other hand, is actually a subset of the sandbox. In other words, the aging delay is just *one* reason why a URL might get placed in the sandbox.

**UPDATE on 10 July 06**


There was later discussion by Darren Yates of the '741 application; however, keep in mind that, just because Google filed a patent application, does NOT establish that Google is practicing what is in the application.

It's common knowledge that Google relies heavily on inbound relevant links to rank a site. Now they explain exactly how it works.

As well as the number, quality and anchor text factors of a link. Google seems to also consider historical factors. Apparently the Google 'sandbox' or aging delay begins count down the minute links to a new site are discovered.

Google records the discovery of a link, link changes over time, the speed at which a site gains links and the link life span. With this in mind fast link acquisition may be a strong indicator of potential search engine Spam.

Gone are the days of pages and pages full of links. You must grow your links slowly to stay below the radar and be careful who you exchange links with. That means no more buying hundreds of links at once or other underhand tactics.

PR is now very valuable.

Your link anchor text should vary but remain consistent with your site content. No more using your main keywords on every link exchange you gain. That's 'anchor Spam'. Instead vary them around your top five to ten keywords.

Link exchanges are still very important but you must work and utilize them ethically. If you don't and you get caught the recovery from a ban can be months in coming and your host and IP may also be recorded.

Softly softly seems to be the message. The fact is fewer but better quality links will benefit you more anyway and they will be much more likely to be long-term which is also good.

• Site click through rates (CTR)

CTR may now be monitored through cache, temporary files, bookmarks and favorites via the Google toolbar or desktop tools. Many have suspected for some time that sites are reward for good CTR with a raise in ranking. Similar to how Adwords works.

CTR is monitored to see if fresh or stale contentis preferred for a search result.

CTR is also analyzed for increases or decreases relating to trends or seasons.

• Web page rankings are recorded and monitored for changes.

• The traffic to a web page is recorded and monitored over time.

• Sites can be ranked seasonally. A ski site may rank higher in the winter than in the summer.

Google can monitor and rank pages by recording CTR changes by season.

• Bookmarks and favorites could be monitored for changes, deletions or additions.

• User behaviour in general could be monitored.

As Google is capable of tracking traffic to your site you should closely monitor the small amount of copy returned in search results. Ideally you want to integrate a call to action in there to increase your listings CTR.

Clicks away from your site back to the search results are also monitored. Make your site as sticky as possible to keep visitors there longer. As mentioned above it may also help if you could get your visitors to bookmark you.

• The frequency and amount of page updates is monitored and recorded as is the number of pages.

Mass updates of hundreds of files will see you pop up on the radar.On the other hand few or small updates to your site could see your rankings slide. Unless your CTR is good. A stale page that receives good traffic may hold it's [sic: its] own and not require an update. So don't update for the sake of it.

A further indicator that Google is really cracking down on Spam is made clear in the following extract from the Patent [application]. Mention is made of changing the focus of multiple pages at once.

Here's the quote -

“A significant change over time in the set of topics associated with a document may indicate that the document has changed owners and previous document indicators, such as score, anchor text, etc., are no longer reliable.

Similarly, a spike in the number of topics could indicate Spam. For example, if a particular document is associated with a set of one or more topics over what may be considered a ’stable’ period of time and then a (sudden) spike occurs in the number of topics associated with the document, this may be an indication that the document has been taken over as a ‘doorway’ document.

Another indication may include the sudden disappearance of the original topics associated with the document. If one or more of these situations are detected, then [Google] may reduce the relative score of such documents and/or the links, anchor text, or other data associated the document.”

There's still more to look out for:-

• Changes in on page keyword density is monitored and recorded as are changes to anchor text.

• The domain name owner address is considered, most likely to help in a local search result.

• The technical and admin contact details are checked for consistency. These are often falsified for Spam domains.

• Your hosts IP address. If you are on a shared server it's possible somebody else on that server is using dirty tactics or Spaming. If so your site will suffer since you share the same IP.

The impression I get here is that Google have learned from the Spam 'attack' they suffered in early 2004 and they are determined to eradicate it from their listing results.

Another obviousness determination by CAFC

Lest we forget, in Sjolund v. Musland, 847 F.2d 1573 (CAFC 1988), the CAFC overturned a jury determination of nonobviousness, and found obviousness.

Group One v. Hallmark on obviousness (2005)

The litigation between Group One and Hallmark over US Patents 5,518,492 and 5,711,752 produced THREE visits to the CAFC. The claims of the patents concern a device, and a method, for curling ribbon. Within this, the dispute was about "stripping means" for separating the curled ribbon from a mechanical drive wheel means.

The pertinent obviousness issue in Group One v. Hallmark (2005) pertained to combining references which taught "stripping means" to references which taught all other elements of the claims in question. As the CAFC said: "The issue is whether there was a motivation to combine the Cerone or Watts patent with a stripping means."

Hallmark's expert asserted that one of ordinary skill when confronted with the problem of webs adhering to drive wheels would have been motivated to seek a conventional solution.

Group One's expert noted that others [including Hallmark employees] did not think to use a blower when faced with ribbon wrapping problems. Thus, although the problem was recognized in the art, the solution of an air blower was never suggested.

On the issue of the "nature of the problem," the 2005 court cited to Teleflex, 299 F.3d 1313 (CAFC 2002).

Group One [apparently a relatively small company] was represented by Baker & Botts in the 2005 appeal, and Hallmark by Fish & Richardson. The 2005 decision notes that Peter A. Sullivan of Hughes Hubbard and Reed was of counsel on the brief. Peter A. Sullivan is counsel of record on the amicus brief of Cisco, Microsoft, Hallmark, etc. Thus, the amicus brief before the Supreme Court in KSR v. Teleflex is by a lawyer who was on the losing side of a 2005 obviousness decision (Hallmark).

Amicus brief by Microsoft et al. in KSR v. Teleflex

The Patently-O blog presents a copy of an amicus brief by Cisco, Microsoft, Hallmark, V.F., and Fortune Brands in favor of cert in KSR v. Teleflex.

The filing parties represent companies who make actual products and who have been adversely affected by being defendants in patent litigation. As with the brief of the 24 professors in KSR v. Teleflex, the present brief attacks the motivation requirement of the CAFC in obviousness determinations. At page 5: "amici have experienced first-hand the stifling effect of the motivation test." By this, they mean that they have failed to invalidate through obviousness patents asserted against them because of not meeting the motivation requirement of the test.

At page 7 of the brief, there is a discussion of "patent portfolio companies" who do not sell products, and thus are not interested in cross-licensing.

The brief states at page 8: "Ultimately, it is the public that is the loser when the patent laws are diluted in favor of obvious patents."

At page 10 and following, the brief suggests that several Supreme Court cases would have been decided differently had the CAFC motivation test been applied. These include Graham itself, Dann v. Johnston, and four cases decided BEFORE obviousness was codified within 35 USC 103 (in the 1952 patent act).

The brief does NOT cite to recent CAFC cases on obviousness, with the exception of Group One v. Hallmark, 407 F.3d 1297 (CAFC 2005) [the next most recent cases date to 2000]. The 2005 case involves one of the filing parties (Hallmark) and for which there will soon be a petition for cert filed (see page 16 of the amicus brief). Although the brief does mention the brief of the 24 law professors, this brief does not appear in the Table of Authorities.

As with the brief of the 24 professors, the current brief complains about "what is wrong" but does not present any suggestions for what should be done. At best, the brief argues that the CAFC "should hew close to this Court's precedent."

As a separate matter, if the position of the amici were correct [that the basic law on obviousness is wrong], then the proposal to introduce an opposition mechanism (a procedure which would rely on the current law] is irrelevant. Further, all the complaints about bad "patent quality" at the PTO might be questioned if the PTO is in fact correctly enforcing current law.

Of the legal issue itself, it is significant to note that neither the brief of the 24 professors nor the current brief cite the numerous recent cases of the CAFC on obviousness. Further, although Microsoft, and the other amici, lament recent "obvious" patents, there has been a lot of criticism that Microsoft is obtaining "obvious" patents. They are complaining about what they themselves may be doing.

Friday, June 24, 2005

Some aspects of Merck v. Integra at the Supreme Court

I. The case cited by the Supreme Court

In Merck v. Integra, 2005 U.S. LEXIS 4840; 73 U.S.L.W. 4468, the Supreme Court cited the underlying Federal Circuit decision as Integra Lifesciences I, Ltd. v. Merck KGaA, 331 F.3d 860, 2003 U.S. App. LEXIS 11335 (Fed. Cir. 2003), rather than the amended decision of the Federal Circuit.

II. Common law exception not at issue

The earlier decision that activities before 1995 were covered by the common law research exemption was not at issue. The Supreme Court was deciding whether activities after 1995 fell within the scope of 35 USC 271(e)(1).

Thus, the activities at issue arose after Dr. Cheresh of Scripps submitted a detailed proposal for expanded collaboration between Scripps and petitioner Merck KGaA on February 1, 1995. This proposal set forth a 3-year timetable in which to develop "integrin antagonists as angiogenesis inhibitors," beginning with in vitro and in vivo testing of RGD peptides at Scripps in year one and culminating with the
submission of an IND to the FDA in year three. Merck agreed to the material terms of the proposal on February 20, 1995, and on April 13, 1995, pledged $ 6 million over three years to fund research at Scripps. Pursuant to the agreement, Dr. Cheresh directed in vitro and in vivo experiments on RGD peptides provided by petitioner from 1995 to 1998. These experiments focused on EMD 66203 and two closely related derivatives, EMD 85189 and EMD 121974, and were designed to evaluate the suitability of each of the peptides as potential drug candidates. Accordingly,
the tests measured the efficacy, specificity, and toxicity of the particular
peptides as angiogenesis inhibitors, and evaluated their mechanism of action and
pharmacokinetics in animals. Based on the test results, Scripps
decided in 1997 that EMD 121974 was the most promising candidate for testing in
humans.

On July 18, 1996, after licensing negotiations broke down, Integra filed a patent-infringement suit against petitioner, Scripps, and Dr. Cheresh in the District Court for the Southern District of California.

With the consent of the parties, the District Court gave the following instruction regarding the § 271(e)(1) exemption:

"To prevail on this defense, [petitioner-Merck] must prove by a
preponderance of the evidence
that it would be objectively reasonable for a party in [petitioner 's] and Scripps' situation to believe that there was a decent prospect that the accused activities would contribute, relatively directly, to the
generation of the kinds of information that are likely to be relevant in the
processes by which the FDA would decide whether to approve the product in
question.

"Each of the accused activities must be evaluated separately to
determine whether the exemption applies.

"[Petitioner] does not need to show that the information gathered
from a particular activity was actually submitted to the FDA."


III. Supreme Court's handling of "preclinical" boundary of CAFC

The Supreme Court made short work of the CAFC's discussion of preclinical work.

As an initial matter, we think it apparent from the statutory text
that § 271(e)(1)'s exemption from infringement extends to all uses of patented
inventions that are reasonably related to the development and
submission of any information under the FDCA. Cf. Eli Lilly, 496 U.S., at 665-669, 110 L. Ed. 2d 605, 110 S. Ct. 2683 (declining to limit § 271(e)(1)'s exemption from
infringement to submissions under particular statutory provisions that
regulate drugs). This necessarily includes preclinical studies of patented
compounds that are appropriate for submission to the FDA in the regulatory process.
There is simply no room in the statute for excluding certain information
from the exemption on the basis of the phase of research in which it is
developed or the particular submission in which it could be included. n6


Note 6 -->

n6 Although the Court of Appeals' opinion suggests in places that §
271(e)(1)'s exemption from infringement is limited to research conducted in
clinical trials, see 331 F.3d at 866, we do not understand it to have adopted
that position.
The Court of Appeals recognized that information included in
an IND would come within § 271(e)(1)'s safe harbor. Ibid. Because an IND must
be filed before clinical trials may begin, such information would necessarily be
developed in preclinical studies.


IV. Supreme Court's handling of CAFC's policy arguments

The Supreme Court noted:

The Court of Appeals' conclusion that § 271(e)(1) did not protect
petitioner 's provision of the patented RGD peptides for research at Scripps
appeared to rest on two somewhat related propositions.

First, the court credited the fact that the "Scripps-Merck experiments did not supply information for submission to the [FDA], but instead identified the best drug candidate to subject to future clinical testing under the FDA processes." 331 F.3d at 865; see also id., at 866 (similar). The court explained:

"The FDA has no interest in the hunt for drugs that may or may not
later undergo clinical testing for FDA approval. For instance, the FDA
does not require information about drugs other than the compound featured in an
[IND] application. Thus, the Scripps work sponsored by [petitioner] was not
'solely for uses reasonably related to' clinical testing for FDA." Ibid.

Second, the court concluded that the exemption "does not globally
embrace all experimental activity that at some point, however attenuated, may lead
to an FDA approval process." Id., at 867. n7

We do not quibble with the latter statement. Basic scientific
research on a particular compound, performed without the intent to develop a
particular drug or a reasonable belief that the compound will cause the sort of
physiological effect the researcher intends to induce, is surely not "reasonably
related to the development and submission of information" to the FDA. It does not
follow from this, however, that § 271(e)(1)'s exemption from infringement
categorically excludes either (1) experimentation on drugs that are not ultimately the subject of an FDA submission or (2) use of patented compounds in experiments that are not ultimately submitted to the FDA. Under certain conditions, we think the exemption is sufficiently broad to protect the use of patented compounds in both situations.


As to the first proposition, it disregards the reality that, even at
late stages in the development of a new drug, scientific testing is a
process of trial and error. In the vast majority of cases, neither the drugmaker
nor its scientists have any way of knowing whether an initially promising
candidate will prove successful over a battery of experiments. That is the reason they conduct the experiments. Thus, to construe § 271(e)(1), as the Court of
Appeals did, not to protect research conducted on patented compounds for which
an IND is not ultimately filed is effectively to limit assurance of exemption to
the activities necessary to seek approval of a generic drug [LBE note: no!]: One can know at the outset that a particular compound will be the subject of an eventual
application to the FDA only if the active ingredient in the drug being tested is
identical to that in a drug that has already been approved.

[As to the second proposition] For similar reasons, the use of a patented compound in experiments that are not themselves included in a "submission of information" to the FDA does not, standing alone, render the use infringing. The relationship of the use of a patented compound in a particular experiment to the "development and
submission of information" to the FDA does not become more attenuated (or less
reasonable) simply because the data from that experiment are left out of the
submission that is ultimately passed along to the FDA. Moreover, many of the
uncertainties that exist with respect to the selection of a specific [*26] drug exist as well with respect to the decision of what research to include in an IND or NDA. As a District Court has observed, "It will not always be clear to parties
setting out to seek FDA approval for their new product exactly which kinds of
information, and in what quantities, it will take to win that agency's approval."
Intermedics, Inc. v. Ventritex, Inc., 775 F. Supp. 1269, 1280 (ND Cal.
1991), aff'd, 991 F.2d 808 (CA Fed. 1993). This is especially true at the
preclinical stage of drug approval. FDA regulations provide only that "the amount
of information on a particular drug that must be submitted in an IND . . .
depends upon such factors as the novelty of the drug, the extent to which it
has been studied previously, the known or suspected risks, and the developmental
phase of the drug." 21 CFR § 312.22(b). We thus agree with the Government that
the use of patented compounds in preclinical studies is protected under §
271(e)(1) as long as there is a reasonable basis for believing that the experiments will produce "the types of information that are relevant to an IND or NDA." Brief of
United States as Amicus Curiae 23.

V. Merck will probably lose on remand

The Supreme Court said:

Thus, the evidence presented at trial has yet to be reviewed under
the standards set forth in the jury instruction, which we believe to be
consistent with, if less detailed than, the construction of § 271(e)(1) that we
adopt today.


Footnote 8:
The relevant jury instruction provided only that there must be a
"decent prospect that the accused activities would contribute, relatively
directly, to the generation of the kinds of information that are likely to be
relevant in the processes by which the FDA would decide whether to approve the product in question." App. 57a. It did not say that, to fall within § 271(e)(1)'s
exemption from infringement, the patented compound used in experimentation must
be the subject of an eventual application to the FDA. And it expressly
rejected the notion that the exemption only included experiments that produced
information included in an IND or NDA. Ibid.

[LBE note: meaning that the jury instruction did not include things that the Supreme Court rejected. That is, nothing in the jury instruction is incompatible with the Supreme Court's ruling.]

VI. Issues with "research tool" patents used in drug research were NOT addressed

Footnote 7:

The Court of Appeals also suggested that a limited construction
of § 271(e)(1) is necessary to avoid depriving so-called "research tools" of
the complete value of their patents. Respondents have never argued the RGD
peptides were used at Scripps as research tools, and it is apparent from the
record that they were not. See 331 F.3d at 878 (Newman, J., dissenting) ("Use of an
existing tool in one's research is quite different from study of the tool
itself"). We therefore need not -- and do not -- express a view about whether, or to what extent, § 271(e)(1) exempts from infringement the use of "research
tools" in the development of information for the regulatory process.

Wednesday, June 22, 2005

CAFC affirms ND Ca in Aptix/Mohsen case

In a case involving California state law, note the dissent of Judge Newman.

SD Ill reversed by CAFC in Prima Tek v Poly Pap

Note that the first paragraph of the CAFC in the "Discussion" section mentions policy issues and states that our patent system depends primarily on the PTO to screen out invalid patents.

Note that the CAFC cites Texas Digital, 308 F.3d 1193.

On inherent anticipation, the CAFC cites Schering v. Geneva 339 F.3d 1373.

Here, the CAFC finds anticipation based on a reference that was before the PTO during prosecution.

Claims of 4 of 5 NTP patents in NTP/RIM dispute rejected in re-exam

According to BusinessWeek on June 22, the PTO, in re-examination, has rejected claims within four of the five patents asserted by NTP against RIM.

Tuesday, June 21, 2005

Techcentral on patent reform

Quick query: is the patent reform bill of Lamar Smith HR 2795?

from TechCentral:

And it is happening now, as intellectual property, including patents, is regarded, justly, as an important component of wealth and national prosperity. Proposals for change are working their way through Congress, with a good head of steam, and H.R. 2527, a reform bill, introduced last week by Lamar Smith, Chair of the IP subcommittee of the House Judiciary Committee, is given an excellent chance of passage. Smith intends to move to markup before the end of this month.

**Also from TechCentral, on mind-numbing:

Avoiding the technicalities -- and a major reason the patent system gets limited attention from the public is the mind-numbing opacity of its language and details -- the proposed changes break down roughly into three major categories:



(1) Reducing the transaction costs of the system, especially litigation;

(2) The "patent quality" issue;

(3) The enforcement of patent rights -- should injunctions be used, or should the infringer just pay a toll?

**Yes, there is a discussion of "patent quality":

Patent Quality


The in-group is virtually unanimous that in recent years too many patents have been granted that should not have been, in that if the examiners had only found the proper literature references or existing patents, these patents would have failed the criteria of novelty, utility, and non-obviousness.

**On windows for opposition:

This problem of incentives triggers one of the most contentious features of the Smith bill -- the "second window." The bill would allow an attack on a patent not only within nine months after the patent grant, but within six months after an alleged infringer receives notice that the patent holder thinks it is infringing. On this one, business is badly split, with those who see themselves as primarily patent producers opposed the second window and advocating the need for certainty, and those who see themselves as more likely to be the defendants in infringement suits wanting the opportunity to start over once the patent holder starts to threaten.

**Yes, obviousness is mentioned. Note my article in the June 2005 issue of Intellectual Property Today.

from techcentral:

A deeper issue of quality is raised by a Petition for Certiorari now pending before the Supreme Court in KSR v. Teleflex. The petitioners argue that the standard for determining whether an invention is "nonobvious" has been made too stringent by the lower court -- that is, too many patents are granted that should be denied because the invention is within the ken of someone skilled in the field -- and that the Supreme Court should restore right and justice.



The view of the filers here (including PFF and a group of 24 law professors, both of which filed as amici in support) is that the advocates of post-grant review are going to be chagrined when the new mechanisms produce the result "yep -- that's a patent, all right!" The review processes will not improve things if the standard is not fixed.

**Also, on MAD:

The tech companies often simply pass the ball down the field, pray, and stand willing to litigate. They have also developed some practical coping methods, such as filing for as many patents as possible to create bargaining chips. Then, because the big tech companies are all in the same situation, they engage in massive cross-licensing. As an alternative, they play the old cold war game of Mutual Assured Destruction (MAD). If a company plays hardball with its patent portfolio, others will respond in kind, so it is better not to start a war.



Creative things are taking place in the area of standards, where firms with patents on crucial technologies proclaim to all the world a generalized willingness to license on reasonable terms. This allows others to develop first and work out the details later.



But these mechanisms don't work when the patent holders are not part of the network of big companies, and over half of inventions come from other sources. Innovation has always been somewhat separated from product development and marketing, as Thomas Edison demonstrated 150 years ago, and this trend may be accentuating. Universities are fertile sources of invention, and specialized innovation firms are betting that separating innovation from the downstream processes will work better than integration.



Firms of this type are not subject to retaliatory threats and are not interested in cross-licensing, so the big tech companies have no lever. So what the tech companies want is a limit on injunctions, and court-determined damages that are set in an amount that does not recognize the strategic value of the hold-out position at a late stage in the decision process.



Their goal is strikingly similar to the solution to analogous problems in the field of real property. The techies want the power of eminent domain, the right to take property and then have a court determine just compensation.



This would not be as novel as it sounds, and again the 19th Century is illustrative. Many network-type industries have been granted eminent domain powers by state legislatures, especially those that were building rights-of-way, where the last parcel problem can be acute.



Naturally, the IP owners, the innovation shops, and the universities object.

Monday, June 20, 2005

More discussion of Microsoft's 6,898,604 on XML serialization

Discussion of patents of Microsoft concerning XML which appear on ZDNet:

..there's also some question as to Microsoft's ability to enforce the licensing terms given the validity, or lack thereof, of the intellectual property rights that Microsoft claims to have to the technology. The eWeek story goes on to discuss how the Public Patent Foundation's executive director Dan Ravicher picked apart the legal language that Microsoft attached to the XML formats and how it's unclear as to what patents, or pending patents, are the lynchpins to the license's enforceability. Said Ravicher, according to the story, "If they had any applicable patents, they'd most assuredly tell people what those patents are. I can't see that they have done that. So, all they've said is that they may have patents and, if they do, these are the terms under which they'll license them to you. While it is true the terms of such a license are GPL-incompatible, there is no need to comply with them until we are certain they have something that must be licensed."

When asked about the specific intellectual property that applies to Office's XML file formats, a Microsoft spokesperson told me via e-mail: "Microsoft does not comment on the scope of patent applications or patents. The language of the patent application speaks for itself. Others are free to summarize or characterize the contents if they wish. Generally, however, like other major technology innovators, Microsoft routinely applies to obtain patents on its inventions. A patent establishes ownership of an invention and is only granted if government patent examiners conclude that it is a true innovation compared with existing technology. While Microsoft has committed to a royalty-free license to create and distribute programs that can read and write the Office 2003 XML Reference Schemas, if it doesn't take the responsible step of patenting its inventions, then someone else will likely do so. The company wants to avoid this unnecessary confusion for its customers."

Elsewhere around the Net, one of Microsoft's newer patents — one that's relevant to XML — is getting vetted quite aggressively in an attempt to demonstrate that at least some of the company's intellectual property rights may be baseless. In his blog, Sun director of Web technologies Tim Bray (also, the co-inventor of XML) replays an imaginary conversation that Microsoft might consider to be the basis of an invention, but that Bray warns is not. The implication of the mock conversation is that the core techniques behind Microsoft's patent on XML serialization and deserialization (US Patent no. 6,898,604) were already widely known (in other words, prior art existed) and that complementing it annotations is too simple and frivolous of an improvement to warrant new consideration by a patent body. But, if that's not enough of a prior art objection, Bray also excerpts a newsletter from Greg Aharonian of bustpatents.com, who unearthed what he considers to be significant prior art — prior art that already existed at the time Microsoft originally filed for the patent in June 2001.

Meanwhile, as a reminder, Microsoft has had several recent flirtations with the open source community, including one with Open Source Initiative acting president Michael Tiemann and another with Red Hat CEO Matthew Szulik. Between those meetings, the spotlight that's being placed on Microsoft's claim to openness as well as to certain intellectual property, and the fact that the company has already released 17 different code-bases (perhaps more by now) under a range of licenses that are not purely proprietary (everything from "shared-source" to OSI-certified open source), could Microsoft just be midway through the throes of a painful transition that it must make to survive in a fully open world?

***
Of US 6,898,604 (filed June 29, 2001), the first claim recites:

A method for serializing an object instance to a serial format, the method comprising steps of:

generating a mapping between an arbitrary annotated source code file and a schema, the arbitrary annotated source code file containing at least one programming type that describes a shape of an object instance and the schema describing a format of a document having a serial format, the mapping defining a correspondence between the shape of the object instance and the format of the document having the serial format; and

converting an object instance corresponding to the arbitrary annotated source code to the serial format by converting at least one of a public property, a public field and a method parameter of the object instance to a document having the serial format based on the mapping.

**
Issued May 24, 2005, the patent has not been cited as of June 14, 2005.

Aftermath of Purdue Pharma patent loss on OxyContin

The case between Purdue Pharma and Endo turned on inequitable conduct, specifically on what it meant to represent to the patent examiner that one had made a "discovery."

Elsewhere, I will be discussing an interesting parallel to the discovery of the buckyball (aka, buckminsterfullerene, C60), wherein the discoverers merely repeated the experiment of prior workers, obtained basically the same experimental results, but had a quite different interpretation.

For the moment, note the business and human consequences of the patent decision.

From the Fairfield County (CT) Business Journal:

With Stamford-based Purdue Pharma L P. losing an appeal in federal court to protect its patent on the brand-name pain medication OxyContin, more than 1,000 of its workers will feel the ache.

The drug manufacturer said it would layoff half of its U.S. work force in the next few weeks. The company employs 720 people in Stamford and 150 at a facility in nearby Ardsley, N.Y., but how many local employees may lose jobs was unclear.

James W. Heins, Purdue's director of public affairs, said information on how those facilities would be impacted was not yet available.

"The 50 percent reduction will be across the company's total U.S work force of 2,154 people, but it won't necessarily affect half of the Stamford workers," he added.

The cuts are in response to the expected impact on the company's revenues when competitors begin to sell generic alternatives to the drug for as little as one-third the price.

On June 7, a panel of three judges of the U.S. Court of Appeals upheld a U.S. District Court's decision in January 2004 that certain Purdue's patents for OxyContin tablets could no longer be enforced.

The appeals court supported an earlier ruling that said the company misled the patent office in its application by claiming the drug was unique because it was effective in very low dosages. The judges ruled that Purdue had no clinical evidence to support that claim before the patents were issued.

Following the decision, Endo Pharmaceutical Holdings Inc. of Chadds Ford, Pa., announced that it would immediately launch generic versions of all four strengths of OxyContin.

In a written statement, Purdue Pharma said it believes its patents were properly obtained and are enforceable. The company will seek a rehearing of this decision by all 12 appellate court judges.

"In our opinion, and that of our legal advisers, this decision is contrary to principles of patent law established by the Federal Circuit as well as by the Supreme Court of the United States," Howard Udell, executive vice president and chief legal officer at Purdue, said in the statement.

HQ could be sold

According to Heins, Purdue's headquarters houses employees in marketing, medical affairs, information technology, general administration, law, human resources and some in clinical development.

He acknowledged that the company is "exploring a number of options" regarding the headquarters. He said the company plans to stay in Stamford, but declined to give details when asked if Purdue would sell the building or lease portions of it.

Purdue Pharma and Purdue Frederick Co. purchased One Stamford Forum, the distinctive tiered office tower near I-95, from GTE in 2000.

Some local commercial real estate brokers speculated the company could sell the building to take advantage of the recent trend of local office properties fetching top dollars from foreign investment groups. The company could potentially lease back part of the building since the new owner would want tenants in the building.


Back to the drawing board

"While we are disappointed with this outcome, we have taken certain precautionary steps to prepare for the possibility of such a decision," president and chief executive officer Michael Friedman said in a statement. "We intend to continue the production and sale of our branded OxyContin product line. Additionally, as part of our contingency planning, we have entered into an agreement with IVAX Pharmaceuticals that allows IVAX to distribute authorized generic versions of OxyContin tablets in all four strengths. This will enable Purdue to introduce a quality product in the growing generic segment of the $2 billion oxycodone extended-release product category."

Immediately after that announcement, Endo said it would sue to prevent Purdue Pharma from authorizing its own lower-cost version.

Purdue said it is actively engaged in discussions with several other pharmaceutical companies to add other medications to its product portfolio.

"We're going to be smaller, but we are going to remain a viable company and we plan to emerge even stronger in a couple of years," noted Heins, who said the company has ongoing research and development efforts, but he could not discuss those details.

Sunday, June 19, 2005

Star Scientific v R.J. Reynolds

Patent infringement case in the tobacco industry.

from WAVY through AP:

A Chesterfield County company is waiting to see whether its patent-infringement lawsuit against tobacco giant R-J Reynolds can go before a jury. The decision could have enormous repercussions for the industry.

Star Scientific of Chester is suing R-J Reynolds, claming the company infringed on its patent for its reduced-toxin tobacco. Star Scientific founder Jonnie Williams says that Brown and Williamson agreed to buy the "StarCured" tobacco in 1999. But shortly after learning of Star's innovation -- R-J Reynolds announced that it had a similar system to reduce tobacco toxins.

Both sides are waiting for a federal judge in Baltimore to decide whether the case will go to a jury.

Analysts say R-J-R conceivably could be forced to pay billions of dollars in royalties and damages if Star prevails.

Biden run for president?

Consistent with the final outcome of the Tribe matter, Biden's possible candidacy suggests plagiarism is not that big of a deal.

from AP on June 19, 2005:

Sen. Joseph Biden, D-Del., said Sunday he intends to run for president in 2008.
But Biden, who also sought the nomination in 1988, said he would give himself until the end of this year to determine if he really can raise enough money and attract enough support.

Going after the nomination "is a real possibility," he said on CBS' Face the Nation.

"My intention, as I sit here now, is, as I've proceeded since last November as if I were going to run. I'm quite frankly going out, seeing whether I can gather the kind of support," Biden said.

Biden said he was taking his "game on the road, letting people know what I think."

He added, "If, in fact, I think that I have a clear shot at winning the nomination by this November or December, then I'm going to seek the nomination."

Biden dropped out of the 1988 presidential race after a series of disclosures that he had liberally borrowed from other politicians in his stump speeches [LBE note: charges of plagiarism] and after questions about his law school records.

****
from Brian Martin, Journal of Information Ethics, Vol. 3, No. 2, Fall 1994, pp. 36-47:

...most studies of plagiarism focus exclusively on the competitive variety and ignore its institutionalized forms. The example of Joseph R. Biden, Jr. illustrates this. Biden was a U.S. presidential aspirant who in 1987 was exposed for having plagiarized the speeches of some other politicians, such as British Labour Party leader Neil Kinnock. This caused much moralizing in the media (some of it ghostwritten) and contributed to Biden dropping out of the race for president. Yet the dependence of almost all leading politicians on speechwriters was little remarked. Biden was caught out in the sin of plagiarizing from other politicians (a type of competitive plagiarism), whereas plagiarizing from speechwriters was treated as acceptable because it was plagiarism of workers in a subordinate position (institutionalized plagiarism) [LBE note: possibly very similar to the Laurence Tribe matter]. Indeed, when Biden plagiarized from Robert Kennedy's speeches, it was actually the words of Kennedy's speechwriter Adam Walinsky that both used (Posner, Ari. 1988. "The culture of plagiarism." The New Republic, 18 April:19-24.).

A closer examination of the competitive and institutionalized types of plagiarism would show many overlaps and inconsistencies rather than a uniformly clear distinction. For example, some heads of university laboratories demand their name on every publication (institutionalized plagiarism in a competitive setting) and some corporate and government bureaucracies allow or even foster conventional individual authorship. Nonetheless, the generalization that most studies of plagiarism focus on violations of competitive etiquette and downplay misattributions in hierarchical organizational settings still applies.

"Patents don't really matter"

from Lara Youngs, Charlotte Observer:

While visiting Infinity's End one day, Gary McLemore came up with an unusual fashion statement.

Seeing many customers with piercings, he came up with the idea for sunglass lenses that attach to eyebrow rings and flip up for indoor wear.

Wondering if the plan was marketable, the 40-year-old sales trainee at Hughes Supply visited the studios of WTVI-TV (Channel 42) PBS 5 on Saturday for an audition that drew more than 100 would-be inventors. Eventually, the concept will become a fall television show that follows final contestants on their quest to have their dream become reality.

Produced by WTVI and Bouncing Brain Productions, Saturday's free audition melded the concepts of "American Idol" and "Antiques Roadshow." Those who made the initial cut pitched their ideas to a panel of judges to decide whether each concept should be developed, marketed and sold.

Unfortunately for McLemore, someone had already developed and patented an almost identical concept.

"It was sad, but I wasn't surprised," he said. Later, he added, "At least I didn't go to a patent lawyer and spend a lot of money."

The panel of four judges included Charlotte patent attorney Chad Tillman of Tillman Ivsan PLLC, as well as three members of area design firm Enventys, who included Louis Foreman, CEO; Managing Partner Matthew Wynn; and Ian Kovacevich, vice president of engineering and design.

Tillman said the auditions allowed people to learn more about complicated patent law and revealed how difficult it is to get something marketed.

"I can't tell you how many people get a patent and think they're going to get rich," he said.

While some turned up with just a sketch or concept, others had done research and test runs of their products.

Charlotte neighbors Deborah Mance -- who flew back from a business trip in Los Angeles to attend -- and Pam Hester brought a possible solution to a common scrapbooking problem. It cleared the judges' cut.

Both women said finishing scrapbook pages can be a long process and pieces can be scattered and lost.

Along with friend Mary LaValley, who could not attend, they created a binder called "Designs on Hold." Each scrapbook page can be designed on the binder and a magnetic sheet put down over it to keep everything in place.

Eleven pitches eventually got the green light from judges.

Michael Cable, executive producer for BBP, said the crew didn't know what to expect, but was impressed.

"Charlotte's a cool city, but I didn't know there were this many entrepreneurial minds," he said. He said the number of finalists was not predetermined because they weren't sure how many ideas would be successful.

Some at the audition were already successful inventors.

Chuck Foley, the 74-year-old inventor of the popular Milton Bradley game Twister, brought with him "The Shredder," which allows shredded pictures and letters to be put back together as a puzzle.

The Charlotte resident said patents don't really matter -- what matters is finding a manufacturer who can think out of the box.

"If you swat at it, it will never fly," he said. "If you show it to the people, they'll buy it."

Patent search strategies on USPTO database

from Craig Fieschko -- Design News, June 6, 2005

**Six steps**

[Steps 1-4 are citation centric and rely on the search/disclosure in the patent and willingness of later workers to cite relevant earlier work. Note how this broke down in Eolas case wherein earlier work of Wei was NOT cited in Eolas patent.]

1. IDENTIFY A FEW STARTING PATENTS
Use fielded searching in the USPTO Issued Patent search engine (not the Published Application search engine) to locate one or more "starting patents" that have strong relevance to your technology of interest. You only need one (or a handful) of starting patents. See figures above, showing an exemplary search for a handheld, ultrasonic surgical cutting tool.
2. FIND UPSTREAM PATENTS
"Upstream patents" are prior patents that the USPTO regarded to be technologically relevant to the starting patents. These are listed on the first pages of the starting patents under the heading "References Cited;" see the list in Figure 4 under "U.S. Patent Documents," or in Figure 3, where the patent numbers of the upstream patents are provided as links, which allow you to quickly access their texts. Review the upstream patents and add any that are relevant to your list of starting patents. Note that only a few upstream patents are usually relevant to what you're looking for; the remainder were cited by the USPTO because they're relevant to some subcomponent or small feature of the starting patents.
3. FIND DOWNSTREAM PATENTS
"Downstream patents" are later patents having USPTO citations to the starting patents because the USPTO regarded the starting patents to be technologically relevant. If you're viewing the text of a patent, you can access downstream patents by clicking the "Referenced By" link. Alternatively, you can access the search engine query box and search in the Cited References (REF) field by entering "REF/" followed by the patent number of a starting patent. Review the downstream patents, and if any are relevant, add them to your list of starting patents.
4. ITERATE
A search for further upstream and downstream patents—by returning to the second step above—can often prove fruitful. By following this process, you're effectively building the "family tree" for the starting patents by locating patents cited in, or citing to, the growing list of starting patents.
5. IDENTIFY COMMON CLASSES
Look at your collected starting patents and identify which classes are cited most frequently on the first page. You can then get a list of all patents in a particular class by accessing the search engine query box and searching in the U.S. Classification (CCL) field. Then review these patents and save those that are of interest (and add them to your starting patents and return to the second step above, if desired). It may also be helpful to now access the Manual of Classification and look at the descriptions of your classes of interest, as well as adjacent classes, to verify that the classes seem relevant to the technology you're seeking.
6. SEARCH ON CLASSES
Take your classes of interest (as well as any search strings you used for fielded searching, etc.) and search for relevant published patent applications in the USPTO Patent Application search engine. To reduce frustration, note that some fields in the USPTO Patent Search Engine are different from those in the USPTO Patent Application Search Engine, and some seemingly identical fields behave differently (with the USPTO's "Help" link providing tips for usage).



**other text**

While you can simply enter a string of terms into the search engine and obtain all the patents or published applications that contain these terms, the USPTO's search engines, like most patent search engines, helpfully allow "fielded" searching. Terms can be entered in certain fields, such as Title, Abstract, Assignee (Owner), etc., to locate patents or published patent applications having the entered terms in the specified fields (in the specified sections of the patents or applications).

The USPTO also allows strings of fielded search terms to be connected with Boolean terms such as AND, OR, and ANDNOT, and parentheses can be used to order the connected terms (see a sample search on page 80). Additionally, the ends of search terms can be truncated and the "wildcard" symbol $ can be substituted to search for variants of the term. For example, "circuit$" will search for the terms circuit, circuits, circuitry, etc. (Note that a term may not be truncated to less than four characters.) Search terms can also be combined in strings by using quotation marks. For example, entering the term "circuit board" (in quotes) will search for the adjacent words "circuit" and "board," in that order.

It might seem that a good way of locating relevant patents is to search in the Abstract (ABST) and/or Title (TTL) fields. Unfortunately, this is rarely the case. Titles are usually vaguely worded because patent attorneys fear the potential ramifications of a specifically worded title. The same is true of most Abstracts, which poorly represent the contents of their documents.

So it's no surprise, then, that an Abstract and/or Title search should never be regarded as complete and accurate. A Specification (SPEC) search, which extends to the detailed bodies of the patents or applications, is far more complete. Nevertheless, if a search strategy results in a very large number of hits, it may be preferable to begin a search by limiting it to the Title (TTL) or Abstract (ABST) fields.

Other useful search fields include the Assignee (AN) field, which may list the owner of the patent, and/or the Inventor (IN) field. You may be able to find relevant patents by searching for those that name a company and/or inventor who has expertise in your field of interest.

Nevertheless, while the use of fields, Boolean connectors, and wildcards can help you locate relevant patents and applications faster, many people still find it difficult to generate relevant search results.

All patents and patent applications are assigned "class numbers" by the USPTO codes that classify the patent or application into one or more very particular fields of technology, similar to the Dewey Decimal System. So if you can identify the classes of your problem or technology of interest, and then use the USPTO search engines to search documents in these classes, you'll often find relevant documents much faster.

To identify U.S. classes for particular fields of technology, you can access the Manual of U.S. Patent Classification at www.uspto.gov/web/classification/. Unfortunately, most users find the manual confusing and difficult to use, and it usually takes significant experience before one can quickly and accurately locate the appropriate class(es) relating to a technology in question.

By following the six easy steps I have outlined on page 80, you can bypass the manual almost entirely (or at least minimize its use) and get superior search results immediately.

Now What?
Once you're done, you can then use the search results in your research and design efforts. In some cases, you may even be able to adopt a patented invention as an "off-the-shelf" solution. You're usually free to use matter described in a patent so long as:

(1) The matter is not secured by this (or another) patent (i.e., the matter is not defined by the "claims" set forth at the end of a patent); or

(2) Even if the matter is covered by the claims, if the patent's expired. Usually, patents have terms lasting 20 years from their patent application filing date, or 20 years from the date of patent issuance, whichever date is later. Both of these dates are shown on the first page of a patent. However, patents can (and often do) expire earlier for failure to pay periodic maintenance fees to the USPTO. You can check this out at the USPTO website at https://ramps.uspto.gov/eram/.

Nevertheless, if you have questions about whether and how you can use certain matter, you really should get the assistance of a patent attorney. As the old saying goes, "anyone who serves as his own attorney has a fool for a client."

ALSO
The USPTO provides a database of issued patents, and a separate database of published patent applications. (Since it generally takes over 18 months for an application to reach issuance, published applications provide a preview of soon-to-come patents). The site allows users to search the full texts of patents from 1976 onward and patent applications from 2001 onward, and limited searching of earlier patents. Drawback: While the full texts of patents and applications are available, image copies are only printable/downloadable one page at a time unless you pay for e-mail or postal delivery of image copies.

Freepatentsonline
www.freepatentsonline.com

Pat2PDF

www.pat2pdf.org

These two websites compile full PDF image copies of U.S. patents for free, making them far easier to print and download (and Freepatentsonline allows searching as well). Or, access www.pat2pdf.com (not affiliated with the .org site) to pay for full PDF's of both U.S. and European patents.

Freshpatents
www.freshpatents.com

Enter a search query, and you'll be sent regular updates of corresponding newly published U.S. patent applications.

European Patent Office
http://ep.espacenet.com

The EPO's esp@cenet patent database allows free access to the patents of most major patenting countries, though searching is crude and image copies are printable/downloadable only one page at a time. However, by accessing "Online Public File Inspection" at http://my.epoline.org/portal/public under the Products and Services menu, you can download full PDF copies of European patents, provided you have the publication/application number.

Delphion
www.delphion.com

One of the oldest and most powerful patent search engines, Delphion allows multiple databases (basically, all those noted above, and more) to be searched simultaneously. Disadvantage: Formerly free, now it's pay to play.

News ranking: veracity of internet searches

Although Google, and its heavyweight competitors, may be spending billions of dollars and thousands of staff hours in trying to ensure that when you search on the internet, you receive not only exactly the information you want, but also information that is true, one gets different results searching the same topic at different times. If you get different results each time you search, how are going to know what's true?



from marketingvox:

Google Files News-Ranking and Other Patents Seeking Accuracy

18 Jun 2005

Google has filed several patents for technology that seeks to determine the veracity of the content offered up in search results, including news aggregated by Google News, The Guardian reports. Patent WO 2005/029368 is for technology that ranks news according to accuracy, reliability and topicality. Google wants to develop algorithms that account for the amount of important coverage produced by a source, the amount of traffic it attracts, circulation statistics, staff size, breadth of coverage and number of global operations.


A Google spokesperson said the company did not discuss individual patents but that Google News is "evolving all the time." Google News emerged directly from the company's policy of allowing its staff to spend a fifth of their time on their own projects. It now links to 4,500 sources worldwide and has become a valuable driver of traffic for traditional media sites and thousands of smaller, online publishers.

Competitors Microsoft, Yahoo and Ask Jeeves are also spending huge sums to develop new versions of the complex algorithms that power search engines. The search engine market is in a period of huge development and change, according to Forrester technology analyst Charlene Li: "As MSN launches its new search engine and players like Yahoo, Ask Jeeves, A9 and a slew of startups continue to innovate...the market remains open to big shifts."

Adverse patent re-exam result for NTP

Forbes reports an action unfavorable to NTP in a patent re-examination.

from Forbes:

The patent in question was the fifth in a row rejected by the patent office. Only three remain to be reexamined. The patent office had initiated the review of four of the disputed patents in January 2003 [ie, director-ordered re-exam], while Research In Motion [RIM] requested a review of others. The patents are owned by NTP, a holding company founded by Thomas Campagna, an inventor who died in June 2004.

The latest patent-office rejection appears to be setting the stage for a potential nullification of the entire set of patents at the heart of the dispute between NTP and RIM. It also opens up the possibility that their multiyear lawsuit--which the two parties agreed to settle last March--may turn out to be moot.

The rejection of the patents is not final. NTP will have the opportunity to appeal and convince the patent examiners that they have erred. The rejection essentially means that patent examiners believe the original patents never should have been awarded in the first place, and begins a process under which the patents may be overturned entirely. Such an action would only strengthen RIM's hand in court.

The decision is the latest turn in a three-year-old case that gets ever more confusing by the day. Last week the two companies announced they had reached an impasse in negotiating unspecified points of their settlement agreement, which would have had RIM paying NTP $450 million for unfettered use of the five patents that NTP claimed RIM had infringed.

RIM has since returned to court to enforce the terms of the agreement reached in March. Meanwhile, NTP said that if a settlement can't be reached, it intends to seek an injunction that would shut down RIM's BlackBerry wireless e-mail service in the United States.

RIM co-Chief Executive James L. Balsillie declined to comment on Friday's patent rejection, but said that he considered the settlement between RIM and NTP to still be in force.

"We are not trying to get out of the deal," Balsillie said. "We consider this thing behind us. That money to me is gone. It's very hard for me to figure this one out. It's not like we're saying we don't want to pay them."

A lawyer for NTP could not be reached for comment.

Balsillie also said that in the event that RIM does not ultimately prevail in its effort to enforce what it considers to be a binding settlement with NTP, it has developed a workaround that would allow a BlackBerry wireless device to function without infringing on any of the disputed patents.

"We're asking the court to enforce the agreement," Balsillie said. "And if that doesn't happen, there are other legal processes to follow. And if they don't come through for us, there is a workaround." He declined to describe the workaround in any detail.

RIM's apparent good news on the patent dispute front was tempered by a brief failure of its BlackBerry wireless-messaging network, which suffered an outage on Friday. Service to hundreds of thousands of BlackBerry users was interrupted. A RIM spokeswoman confirmed the outage, and said that it had been corrected for the majority of the customers affected within two hours. A reason for the outage was not given.

RIM says there are some 3 million BlackBerry users around the world.

Friday, June 17, 2005

RIM to design around NTP patents?

from Michael Singer of CNET:

Research In Motion has come up with a "workaround" to skirt patents at the center of its legal battle with NTP, and the technology could be used with all existing BlackBerry email devices, the firm's co-chief executive said on June 16.

"We've completed the workaround," RIM chairman and co-CEO Jim Balsillie told CNET's News.com. "We've tested it and we have a legal opinion on it. We have it as an option."

In a phone interview, Balsillie declined to give specifics on the technology, citing both companies' nondisclosure agreements and RIM's so-called quiet period prior to announcing its earnings.



Balsillie said he is prepared to win the long-running legal battle and was encouraged that the director of the U.S. Patent Trademark office asked that four of the five patents in dispute be reexamined--a process that could take years. [LBE note: the patents remain valid during re-exam.]


The Waterloo, Ontario-based RIM, which helped popularize mobile e-mailing with its thumb-operated BlackBerry, rattled investors earlier this month with news it failed to finalize a $450 million patent dispute settlement with closely held U.S.-based patent holding company NTP.

(...)
RIM has now asked a U.S. court to enforce the terms of the March deal. NTP opposes that and says the earlier deal did not constitute a meeting of minds.

In a court filing this week, RIM said the continued litigation "places a cloud of uncertainty" over its business and its ability to supply its technology.

"There's been an effort certainly by people to sort of cast uncertainty (on) our business and we don't want that. And that was part of the motivation for doing the original settlement," Balsillie said.

Merck v. Integra: win for big pharma

from BlackEnterprise:

In a potential blow to small biotechnology firms, the Supreme Court on Monday made it easier for other companies to use their research for drug development without running afoul of patent laws.

In a case that grew out of a dispute between two companies about research pioneered in San Diego, the court unanimously ruled that federal law provides a relatively broad exemption to patent protections for studies on potential new medications. That means that a compound patented by one company could be used by a competitor for its own drug development without paying a licensing fee.

"...The statutory text makes clear that it provides a wide berth for the use of patented drugs in activities related to the federal regulatory process," Justice Antonin Scalia wrote in the court's opinion.

However, the court did not apply the decision to "research tools" like equipment.

The ruling could be bad news for many of San Diego County's biotech companies. They rely on revenue from licensing their discoveries to other researchers, who now may be able to use them free of charge in many instances.

"It's a win for the (bigger) drug companies, for sure," said John Van Amsterdam, an attorney in Boston who specializes in biotechnology and pharmaceutical patents and was not involved in the case.


The high stakes were underlined by the large number of companies and interest groups that intervened, including the AARP. The nation's largest senior citizens advocacy group favored the sort of broad patent exemption granted by the court, arguing it could help drive down pharmaceutical costs by spurring further drug development.That position was echoed by the Justice Department.

***
from http://www.gazette.net/200524/business/news/280955-1.html

Big pharma officials say this week's Supreme Court ruling on drug patents will help their companies develop important drugs more quickly and cheaply.

But other bioscience leaders say the ruling just leads to more questions in a field in which legal issues are becoming as complex as the science.

The high court on Monday expanded the rights of drug companies to experiment with patented compounds and molecules patented by other companies.

The court ruled unanimously that pharmaceutical companies do not infringe on patents during pre-clinical research stages "reasonably" aimed toward eventual approval of a drug by the U.S. Food and Drug Administration.

In the ruling, the latest in a nine-year legal dispute, German drug firm Merck KGaA won its appeal that it has a right to proceed with pre-clinical studies with a certain peptide patented until 2006 by Integra LifeScience Corp. of New Jersey. A peptide is a biological molecule. Merck KGaA is not related to Merck & Co. of the United States.

The court reversed a lower court ruling that the safe harbor established by the Hatch-Waxman Act to exempt experiments from patent infringements applies only to later-stage clinical trials of humans.

Lila Feisee, director of intellectual property for the 1,000-member Biotechnology Industry Organization, said it may be too early to gauge the effect of Monday's ruling on both established companies and fledgling biotechs.

"No, there is no immediate impact. Everyone will continue to proceed [with drug development experiments] as usual -- that is, try it as they go," Feisee said.

The ruling "answers one question, that the exemption is not just limited to clinical studies," Feisee said. "But it opens many more, such as where do you draw the line?"

The Supreme Court sent the case back to the U.S. Circuit Court for further deliberations.

"This case now has to be thoroughly analyzed," Feisee said. "The lower court has to look at the data and determine what is considered reasonably related to a future FDA filing. All we know so far is that [use of a patented drug] doesn't have to be related to clinical trials. It is still not clear at this point if this new ruling benefits big pharma."

Lawyers at the Pharmaceutical Research and Manufacturers of America differ with Feisee.

"We think there is now more certainty about the parameters of the exemption. That helps companies proceed with confidence," said Jeff Trewitt, spokesman for PhRMA, which represents 90 drug companies and other members. "This is a victory for timely development of new medications for patients."

AARP, in a friend-of-the-court brief, agreed that, if the lower court restriction on the exemption stood, "the inevitable effect will be that the costs of drug development will be driven up even further and will serve to delay the development of new medicines."

The ruling will have no immediate impact on "big pharma or smaller biotechs," said Fred T. Hadeed, CFO of United Therapeutics of Silver Spring.

"I cannot predict what will happen," he said. "I think the whole situation was limited to what was going on between those two companies."

Hadeed said United Therapeutics does not experiment with "molecules from other people" and that he is not aware of it as a widespread practice in the biotech and drug industries. Trewitt said PhRMA's attorneys agree that it is not a common practice.

Officials of several other Maryland bioscience companies said they preferred to wait for the case to play itself out in the lower court before commenting.

James S. Burns, president and CEO of EntreMed Inc. in Rockville, said through a spokeswoman that he is quite interested in the case and that it needs "a lot more study." EntreMed focuses on drugs with antiangiogenic properties, which inhibit abnormal blood vessel growth associated with cancer, blindness, arthritis and atherosclerosis. At the center of the Supreme Court ruling was Integra's effort to stop Merck KGaA from conducting pre-clinical studies with certain peptides with antiangiogenic properties, to keep cancer tumors from forming abnormal blood vessels.

"The court has said if there is going to be an exemption in the later stages of clinical trials, there should be an exemption in the preclinical studies, too," PhRMA's Trewitt said. "Why have a half loaf of bread when you are entitled to the whole loaf?"

Scientists conducting basic research, however, say that the term "pre-clinical drug studies" is not always well defined. It can be part of the clinical trials, basic laboratory work or animal studies of a drug effect.

"This sets up a precedent -- there will be more cases," BIO's Feisee said. "For now it is up to the lower court to look at the data and determine if it this is reasonably related to an FDA filing. What's 'reasonably'?"

The Supreme Court has said that if a drug company thinks a drug it is testing in research might work for a particular therapy then it would "fall into the safe harbor of the law," Feisee said.

"Would you spend big money on developing a product using someone else's patented drug?" Hadeed asked. "Perhaps there is more to this story than is in the media so far."